Ratiograstim

Ratiograstim may be available in the countries listed below.

Ingredient matches for Ratiograstim

Filgrastim

Filgrastim is reported as an ingredient of Ratiograstim in the following countries:

• Germany


• Ireland


• Sweden

International Drug Name Search

Ivermectina Genfar

Ivermectina Genfar may be available in the countries listed below.

Ingredient matches for Ivermectina Genfar

Ivermectin

Ivermectin is reported as an ingredient of Ivermectina Genfar in the following countries:

• Colombia

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Vacrax

Vacrax may be available in the countries listed below.

Ingredient matches for Vacrax

Acyclovir

Aciclovir is reported as an ingredient of Vacrax in the following countries:

• Singapore

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Clorazer

Clorazer may be available in the countries listed below.

Ingredient matches for Clorazer

Cefaclor

Cefaclor monohydrate (a derivative of Cefaclor) is reported as an ingredient of Clorazer in the following countries:

• Italy

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Dalacin

Dalacin may be available in the countries listed below.

UK matches:

• Dalacin C Capsules 75mg
• Dalacin C Capsules 75mg and 150mg (SPC)
• Dalacin C Phosphate (SPC)
• Dalacin Cream 2% (SPC)
• Dalacin T Topical Lotion or Clindamycin Phosphate Topical Lotion (SPC)
• Dalacin T Topical Solution (SPC)

Ingredient matches for Dalacin

Clindamycin

Clindamycin is reported as an ingredient of Dalacin in the following countries:

• Bulgaria


• Japan


• Malaysia


• Oman


• Slovenia

Clindamycin dihydrogen phosphate (a derivative of Clindamycin) is reported as an ingredient of Dalacin in the following countries:

• Argentina


• Austria


• Belgium


• Bulgaria


• Canada


• Croatia (Hrvatska)


• Denmark


• Estonia


• Finland


• Hungary


• Iceland


• India


• Ireland


• Latvia


• Lithuania


• Malaysia


• Malta


• Norway


• Oman


• Poland


• Slovakia


• South Africa


• Spain


• Sweden


• United Kingdom


• Venezuela

Clindamycin hydrochloride (a derivative of Clindamycin) is reported as an ingredient of Dalacin in the following countries:

• Argentina


• Belgium


• Denmark


• Estonia


• Finland


• Iceland


• Malta


• Norway


• Russian Federation


• Spain


• Sweden


• Venezuela

Clindamycin palmitate hydrochloride (a derivative of Clindamycin) is reported as an ingredient of Dalacin in the following countries:

• Norway


• Sweden

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

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Nopatic

Nopatic may be available in the countries listed below.

Ingredient matches for Nopatic

Gabapentin

Gabapentin is reported as an ingredient of Nopatic in the following countries:

• Mexico

International Drug Name Search

Ropin

Ropin may be available in the countries listed below.

Ingredient matches for Ropin

Ropinirole

Ropinirole hydrochloride (a derivative of Ropinirole) is reported as an ingredient of Ropin in the following countries:

• New Zealand

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Tolnaderm

Tolnaderm may be available in the countries listed below.

Ingredient matches for Tolnaderm

Tolnaftate

Tolnaftate is reported as an ingredient of Tolnaderm in the following countries:

• Ethiopia


• India


• Sri Lanka

International Drug Name Search

Thioproperazine

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

N05AB08

CAS registry number (Chemical Abstracts Service)

0000316-81-4

Chemical Formula

C22-H30-N4-O2-S2

Molecular Weight

446

Therapeutic Category

Neuroleptic

Chemical Name

10H-Phenothiazine-2-sulfonamide, N,N-dimethyl-10-[3-(4-methyl-1-piperazinyl)propyl]-

Foreign Names

• Thioproperazinum (Latin)
• Thioproperazin (German)
• Thiopropérazine (French)
• Tioproperazina (Spanish)

Generic Names

• Thioproperazine (OS: BAN)
• Thiopropérazine (OS: DCF)
• Thioperazin (IS)
• Thioproperazine Dimethanesulfonate (OS: JAN)
• Thioproperazine Mesilate (OS: BANM)
• Thioproperazine methanesulfonate (IS)
• Thiopropérazine (dimésilate de) (PH: Ph. Franç. Xe édit)

Brand Names

• Majeptil
  Sanofi-aventis, Greece; Sanofi-aventis, Russian Federation



• Tioridazina Lch
  Ivax, Peru

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
DCF	Dénomination Commune Française
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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Celibron

Celibron may be available in the countries listed below.

Ingredient matches for Celibron

Ambroxol

Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Celibron in the following countries:

• Greece

International Drug Name Search

Arlemide

Arlemide may be available in the countries listed below.

Ingredient matches for Arlemide

Aripiprazole

Aripiprazole is reported as an ingredient of Arlemide in the following countries:

• Argentina

International Drug Name Search

Tisacef

Tisacef may be available in the countries listed below.

Ingredient matches for Tisacef

Cefadroxil

Cefadroxil monohydrate (a derivative of Cefadroxil) is reported as an ingredient of Tisacef in the following countries:

• Indonesia

International Drug Name Search

Resporix

Resporix may be available in the countries listed below.

Ingredient matches for Resporix

Aluminium Hydroxide

Aluminium Hydroxide is reported as an ingredient of Resporix in the following countries:

• Japan

Dicycloverine

Dicycloverine hydrochloride (a derivative of Dicycloverine) is reported as an ingredient of Resporix in the following countries:

• Japan

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Hygromix

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Hygromix

Hygromycin B

Hygromycin B is reported as an ingredient of Hygromix in the following countries:

• United Kingdom


• United States

Tylosin

Tylosin phosphate (a derivative of Tylosin) is reported as an ingredient of Hygromix in the following countries:

• United States

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Sultamicilina MK

Sultamicilina MK may be available in the countries listed below.

Ingredient matches for Sultamicilina MK

Sultamicillin

Sultamicillin is reported as an ingredient of Sultamicilina MK in the following countries:

• Colombia


• Ecuador

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Metronidazol Genfar

Metronidazol Genfar may be available in the countries listed below.

Ingredient matches for Metronidazol Genfar

Metronidazole

Metronidazole is reported as an ingredient of Metronidazol Genfar in the following countries:

• Colombia


• Ecuador


• Peru

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Febratic

Febratic may be available in the countries listed below.

Ingredient matches for Febratic

Ibuprofen

Ibuprofen is reported as an ingredient of Febratic in the following countries:

• Argentina


• Mexico

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Terazosin Hydrochloride

Ingredient matches for Terazosin Hydrochloride

Terazosin

Terazosin Hydrochloride (BANM, USAN) is known as Terazosin in the US.

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)
USAN	United States Adopted Name

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Clizine

Clizine may be available in the countries listed below.

Ingredient matches for Clizine

Meclozine

Meclozine dihydrochloride (a derivative of Meclozine) is reported as an ingredient of Clizine in the following countries:

• Taiwan

International Drug Name Search

Targus

Targus may be available in the countries listed below.

Ingredient matches for Targus

Flurbiprofen

Flurbiprofen is reported as an ingredient of Targus in the following countries:

• Brazil

International Drug Name Search

Licetol

Licetol may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Licetol

Dichlorvos

Dichlorvos is reported as an ingredient of Licetol in the following countries:

• Portugal

Propoxur

Propoxur is reported as an ingredient of Licetol in the following countries:

• Portugal

International Drug Name Search

Mizodin

Mizodin may be available in the countries listed below.

Ingredient matches for Mizodin

Primidone

Primidone is reported as an ingredient of Mizodin in the following countries:

• Poland

International Drug Name Search

Lamotrigine Biogaran

Lamotrigine Biogaran may be available in the countries listed below.

Ingredient matches for Lamotrigine Biogaran

Lamotrigine

Lamotrigine is reported as an ingredient of Lamotrigine Biogaran in the following countries:

• France

International Drug Name Search

Salapin

Salapin may be available in the countries listed below.

Ingredient matches for Salapin

Salbutamol

Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Salapin in the following countries:

• New Zealand

International Drug Name Search

Ranitidina Vannier

Ranitidina Vannier may be available in the countries listed below.

Ingredient matches for Ranitidina Vannier

Ranitidine

Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Ranitidina Vannier in the following countries:

• Argentina

International Drug Name Search

Artesunate

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

P01BE03

CAS registry number (Chemical Abstracts Service)

0182824-33-5

Chemical Formula

C19-H28-O8

Molecular Weight

384

Therapeutic Category

Antiprotozoal agent: Antimalarial

Chemical Names

(3R,5aS,6R,8aS,9R,10S,12R,12aR)-Decahydro-3,6,9-trimethyl-3,12-epoxy-12H-pyrano(4,3-j)-1,2-benzodioxepin-10-ol, hydrogen succinate (WHO)

4-Oxo-4-(((3R,5aS,6R,8aS,9R,10S,12R,12aR)-3,6,9-trimethyldecahydro-3,12-epoxypyrano(4,3-j)-1,2-benzodioxepin-10-yl hydrogen butanedioate

Butanedioic acid, mono((3R,5aS,6R,8aS,9R,10S,12R,12aR)-decahydro-3,6,9-trimethyl-3,12-epoxy-12H-pyrano(4,3-j)-1,2-benzodioxepin-10-yl) ester

Foreign Names

• Artesunatum (Latin)
• Artesunat (German)
• Artesunate (French)
• Artesunato (Spanish)

Generic Names

• Artesunate (OS: USAN, BAN)
• Artesunic Acid (IS)
• ARTS (IS)
• Artesunate (PH: Ph. Int. 4)
• Artesunatum (PH: Ph. Int. 4)

Brand Names

• Arsumax
  Sanofi-Synthelabo, Ghana; Sanofi-Synthelabo, Kenya; Sanofi-Synthelabo, Nigeria; Sanofi-Synthelabo, Tanzania; Sanofi-Synthelabo, Uganda



• Falcigo
  Cadila Gehört zu Zydus, India; Zydus Cadila, Myanmar



• Larimal (Artesunate and Amodiaquine)
  Ipca, Myanmar

International Drug Name Search

Glossary

BAN	British Approved Name
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name
WHO	World Health Organization

Click for further information on drug naming conventions and International Nonproprietary Names.

Lomustin (CCNU) Medac

Lomustin (CCNU) Medac may be available in the countries listed below.

Ingredient matches for Lomustin (CCNU) Medac

Lomustine

Lomustine is reported as an ingredient of Lomustin (CCNU) Medac in the following countries:

• Austria

International Drug Name Search

Triprolidine Hydrochloride

Triprolidine Hydrochloride may be available in the countries listed below.

Ingredient matches for Triprolidine Hydrochloride

Triprolidine

Triprolidine Hydrochloride (BANM, JAN) is known as Triprolidine in the US.

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)
JAN	Japanese Accepted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Rubex

Dosage Form: injection

FOR INTRAVENOUS USE ONLY

Warnings

1. Severe local tissue necrosis will occur if there is extravasation during administration (see DOSAGE AND ADMINISTRATION). Doxorubicin must not be given by the intramuscular or subcutaneous route.


2. Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The probability of developing impaired myocardial function based on a combined index of signs, symptoms and decline in left ventricular ejection fraction (LVEF) is estimated to be 1 to 2% at a total cumulative dose of 300 mg/m2 of doxorubicin, 3 to 5% at a dose of 400 mg/m2, 5 to 8% at 450 mg/m2 and 6 to 20% at 500 mg/m2*. The risk of developing CHF increases rapidly with increasing total cumulative doses of doxorubicin in excess of 450 mg/m2. This toxicity may occur at lower cumulative doses in patients with prior mediastinal irradiation or on concurrent cyclophosphamide therapy or with pre-existing heart disease. Pediatric patients are at increased risk for developing delayed cardiotoxicity.


3. Dosage should be reduced in patients with impaired hepatic function.


4. Severe myelosuppression may occur.


5. Doxorubicin should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.

* Data on file at Pharmacia & Upjohn.

Rubex Description

Doxorubicin is a cytotoxic anthracycline antibiotic isolated from cultures of Streptomyces peucetius var. caesius. Doxorubicin consists of a naphthacenequinone nucleus linked through a glycosidic bond at ring atom 7 to an amino sugar, daunosamine.

Chemically, doxorubicin hydrochloride is: (8S,10S) - 10 - [(3 - Amino - 2,3,6 - trideoxy - α - L - lyxo - hexopyranosyl) - oxy] - 8 - glycoloyl - 7,8,9,10 - tetrahydro - 6,8,11 - trihydroxy - 1 - methoxy - 5,12 - naphthacenedione hydrochloride [25316-40-9].

The structural formula is as follows:

Doxorubicin binds to nucleic acids, presumably by specific intercalation of the planar anthracycline nucleus with the DNA double helix. The anthracycline ring is lipophilic but the saturated end of the ring system contains abundant hydroxyl groups adjacent to the amino sugar, producing a hydrophilic center. The molecule is amphoteric, containing acidic functions in the ring phenolic groups and a basic function in the sugar amino group. It binds to cell membranes as well as plasma proteins. Rubex (doxorubicin hydrochloride for injection, USP) is for intravenous use only. It is available in 50 mg and 100 mg single dose vials as a red-orange lyophilized, sterile powder with added lactose (anhydrous), 250 mg and 500 mg, respectively.

Rubex - Clinical Pharmacology

The cytotoxic effect of doxorubicin on malignant cells and its toxic effects on various organs are thought to be related to nucleotide base intercalation and cell membrane lipid binding activities of doxorubicin. Intercalation inhibits nucleotide replication and action of DNA and RNA polymerases. The interaction of doxorubicin with topoisomerase II to form DNA-cleavable complexes appears to be an important mechanism of doxorubicin cytocidal activity. Doxorubicin cellular membrane binding may effect a variety of cellular functions. Enzymatic electron reduction of doxorubicin by a variety of oxidases, reductases and dehydrogenases generate highly reactive species including the hydroxyl free radical OH-. Free radical formation has been implicated in doxorubicin cardiotoxicity by means of Cu (II) and Fe (III) reduction at the cellular level. Cells treated with doxorubicin have been shown to manifest the characteristic morphologic changes associated with apoptosis or programmed cell death. Doxorubicin-induced apoptosis may be an integral component of the cellular mechanism of action relating to therapeutic effects, toxicities, or both.

Animal studies have shown activity in a spectrum of experimental tumors, immunosuppression, carcinogenic properties in rodents, induction of a variety of toxic effects, including delayed and progressive cardiac toxicity, myelosuppression in all species and atrophy to testes in rats and dogs.

Pharmacokinetic studies, determined in patients with various types of tumors undergoing either single or multi-agent therapy have shown that doxorubicin follows a multiphasic disposition after intravenous injection. The initial distributive half-life of approximately 5.0 minutes suggests rapid tissue uptake of doxorubicin, while its slow elimination from tissues is reflected by a terminal half-life of 20 to 48 hours. Steady-state distribution volumes exceed 20 to 30 L/kg and are indicative of extensive drug uptake into tissues. Plasma clearance is in the range of 8 to 20 mL/min/kg and is predominately by metabolism and biliary excretion. Approximately 40% of the dose appears in the bile in 5 days while only 5 to 12% of the drug and its metabolites appear in the urine during the same time period. Binding of doxorubicin and its major metabolite, doxorubicinol to plasma proteins is about 74 to 76% and is independent of plasma concentration of doxorubicin up to 2 µM. Enzymatic reduction at the 7 position and cleavage of the daunosamine sugar yields aglycones which are accompanied by free radical formation, the local production of which may contribute to the cardiotoxic activity of doxorubicin. Disposition of doxorubicinol (DOX-OL) in patients is formation rate limited. The terminal half-life of DOX-OL is similar to doxorubicin. The relative exposure of DOX-OL, compared to doxorubicin ranges between 0.4 to 0.6. In urine, <3% of the dose was recovered as DOX-OL over 7 days.

A published clinical study involving 6 men and 21 women with no prior anthracycline therapy reported a significantly higher median doxorubicin clearance in the men compared to the women (113 versus 44 L/hr). However, the terminal half-life of doxorubicin was longer in men compared to the women (54 versus 35 hrs).

In four patients dose-independent pharmacokinetics have been shown for doxorubicin in the dose range of 30 to 70 mg/m2. Systemic clearance of doxorubicin is significantly reduced in obese women with ideal body weight greater than 130%. There was a significant reduction in clearance without any change in volume of distribution in obese patients when compared with normal patients with less than 115% ideal body weight. The clearance of doxorubicin and doxorubicinol was also reduced in patients with impaired hepatic function. Doxorubicin was excreted in the milk of one lactating patient, with peak milk concentration at 24 hours after treatment being approximately 4.4-fold greater than the corresponding plasma concentration. Doxorubicin was detectable in the milk up to 72 hours after therapy with 70 mg/m2 of doxorubicin given as a 15 minute intravenous infusion and 100 mg/m2 of cisplatin as a 26 hour intravenous infusion. The peak concentration of doxorubicinol in milk at 24 hours was 0.2 µM and AUC up to 24 hours was 16.5 µM.hr while the AUC for doxorubicin was 9.9 µM.hr.

Following administration of 10 to 75-mg/m2 doses of doxorubicin to 60 children and adolescents ranging from 2 months to 20 years of age, doxorubicin clearance averaged 1443 +/- 114 mL/min/m2. Further analysis demonstrated that clearance in 52 children greater than 2 years of age (1540 mL/min/m2) was increased compared with adults. However, clearance in infants younger than 2 years of age (813 mL/min/m2) was decreased compared with older children and approached the range of clearance values determined in adults.

Doxorubicin does not cross the blood brain barrier.

Indications and Usage for Rubex

Rubex (doxorubicin hydrochloride for injection, USP) has been used successfully to produce regression in disseminated neoplastic conditions such as acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms’ tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin’s disease, malignant lymphoma and bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types.

Contraindications

Doxorubicin therapy should not be started in patients who have marked myelosuppression induced by previous treatment with other antitumor agents or by radiotherapy. Doxorubicin treatment is contraindicated in patients who received previous treatment with complete cumulative doses of doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenes.

Warnings

Special attention must be given to the cardiotoxicity induced by doxorubicin. Irreversible myocardial toxicity, manifested in its most severe form by life-threatening or fatal congestive heart failure, may occur either during therapy or months to years after termination of therapy. The probability of developing impaired myocardial function, based on a combined index of signs, symptoms and decline in left ventricular ejection fraction (LVEF) is estimated to be 1 to 2% at a total cumulative dose of 300 mg/m2 of doxorubicin, 3 to 5% at a dose of 400 mg/m2, 5 to 8% at a dose of 450 mg/m2 and 6 to 20% at a dose of 500 mg/m2 given in a schedule of a bolus injection once every 3 weeks (data on file at Pharmacia & Upjohn). In a retrospective review by Von Hoff et al, the probability of developing congestive heart failure was reported to be 5/168 (3%) at a cumulative dose of 430 mg/m2 of doxorubicin, 8/110 (7%) at 575 mg/m2 and 3/14 (21%) at 728 mg/m2. The cumulative incidence of CHF was 2.2%. In a prospective study of doxorubicin in combination with cyclophosphamide, fluorouracil and/or vincristine in patients with breast cancer or small cell lung cancer, the cumulative incidence of congestive heart failure was 5 to 6%. The probability of CHF at various cumulative doses of doxorubicin was 1.5% at 300 mg/m2, 4.9% at 400 mg/m2, 7.7% at 450 mg/m2 and 20.5% at 500 mg/m2.

Cardiotoxicity may occur at lower doses in patients with prior mediastinal irradiation, concurrent cyclophosphamide therapy exposure at an early age and advanced age. Data also suggest that pre-existing heart disease is a co-factor for increased risk of doxorubicin cardiotoxicity. In such cases, cardiac toxicity may occur at doses lower than the respective recommended cumulative dose of doxorubicin. Studies have suggested that concomitant administration of doxorubicin and calcium channel entry blockers may increase the risk of doxorubicin cardiotoxicity. The total dose of doxorubicin administered to the individual patient should also take into account previous or concomitant therapy with related compounds such as daunorubicin, idarubicin and mitoxantrone. Cardiomyopathy and/or congestive heart failure may be encountered several months or years after discontinuation of doxorubicin therapy.

The risk of congestive heart failure and other acute manifestations of doxorubicin cardiotoxicity in pediatric patients may be as much or lower than in adults. Pediatric patients appear to be at particular risk for developing delayed cardiac toxicity in that doxorubicin induced cardiomyopathy impairs myocardial growth as pediatric patients mature, subsequently leading to possible development of congestive heart failure during early adulthood. As many as 40% of pediatric patients may have subclinical cardiac dysfunction and 5 to 10% of pediatric patients may develop congestive heart failure on long term follow-up. This late cardiac toxicity may be related to the dose of doxorubicin. The longer the length of follow-up the greater the increase in the detection rate.

Treatment of doxorubicin induced congestive heart failure includes the use of digitalis, diuretics, after load reducers such as angiotensin I converting enzyme (ACE) inhibitors, low salt diet, and bed rest. Such intervention may relieve symptoms and improve the functional status of the patient.

Monitoring Cardiac Function

In adult patients severe cardiac toxicity may occur precipitously without antecedent ECG changes. Cardiomyopathy induced by anthracyclines is usually associated with very characteristic histopathologic changes on an endomyocardial biopsy (EM biopsy), and a decrease of left ventricular ejection fraction (LVEF), as measured by multi-gated radionuclide angiography (MUGA scans) and/or echocardiogram (ECHO), from pretreatment baseline values. However, it has not been demonstrated that monitoring of the ejection fraction will predict when individual patients are approaching their maximally tolerated cumulative dose of doxorubicin. Cardiac function should be carefully monitored during treatment to minimize the risk of cardiac toxicity. A baseline cardiac evaluation with an ECG, LVEF, and/or an echocardiogram (ECHO) is recommended especially in patients with risk factors for increased cardiac toxicity (pre-existing heart disease, mediastinal irradiation, or concurrent cyclophosphamide therapy). Subsequent evaluations should be obtained at a cumulative dose of doxorubicin of at least 400 mg/m2 and periodically thereafter during the course of therapy. Pediatric patients are at increased risk for developing delayed cardiotoxicity following doxorubicin administration and therefore a follow-up cardiac evaluation is recommended periodically to monitor for this delayed cardiotoxicity.

In adults, a 10% decline in LVEF to below the lower limit of normal or an absolute LVEF of 45%, or a 20% decline in LVEF at any level is indicative of deterioration in cardiac function. In pediatric patients, deterioration in cardiac function during or after the completion of therapy with doxorubicin is indicated by a drop in fractional shortening (FS) by an absolute value of ≥10 percentile units or below 29%, and a decline in LVEF of 10 percentile units or an LVEF below 55%. In general, if test results indicate deterioration in cardiac function associated with doxorubicin, the benefit of continued therapy should be carefully evaluated against the risk of producing irreversible cardiac damage.

Acute life-threatening arrhythmias have been reported to occur during or within a few hours after doxorubicin administration.

There is a high incidence of bone marrow depression, primarily of leukocytes, requiring careful hematologic monitoring. With the recommended dose schedule, leukopenia is usually transient, reaching its nadir 10 to 14 days after treatment with recovery usually occurring by the 21st day. White blood counts as low as 1000/mm3 are to be expected during treatment with appropriate doses of doxorubicin. Red blood cell and platelet levels should also be monitored since they may also be depressed. Hematologic toxicity may require dose reduction or suspension or delay of doxorubicin therapy. Persistent severe myelosuppression may result in superinfection or hemorrhage.

Doxorubicin may potentiate the toxicity of other anticancer therapies. Exacerbation of cyclophosphamide induced hemorrhagic cystitis and enhancement of the hepatotoxicity of 6-mercaptopurine have been reported. Radiation induced toxicity to the myocardium, mucosae, skin and liver have been reported to be increased by the administration of doxorubicin. Pediatric patients receiving concomitant doxorubicin and actinomycin-D have manifested acute “recall” pneumonitis at variable times after local radiation therapy.

Since metabolism and excretion of doxorubicin occurs predominantly by the hepatobiliary route, toxicity to recommended doses of doxorubicin can be enhanced by hepatic impairment; therefore, prior to the individual dosing, evaluation of hepatic function is recommended using conventional laboratory tests such as SGOT, SGPT, alkaline phosphatase and bilirubin. (See DOSAGE AND ADMINISTRATION.)

Necrotizing colitis manifested by typhlitis (cecal inflammation), bloody stools and severe and sometimes fatal infections have been associated with a combination of doxorubicin given by I.V. push daily for 3 days and cytarabine given by continuous infusion daily for 7 or more days.

On intravenous administration of doxorubicin, extravasation may occur with or without an accompanying stinging or burning sensation, even if blood returns well on aspiration of the infusion needle (see DOSAGE AND ADMINISTRATION). If any signs or symptoms of extravasation have occurred, the injection or infusion should be immediately terminated and restarted in another vein.

Pregnancy Category D

Safe use of doxorubicin in pregnancy has not been established. Doxorubicin is embryotoxic and teratogenic in rats and embryotoxic and abortifacient in rabbits. There are no adequate and well-controlled studies in pregnant women. If doxorubicin is to be used during pregnancy, or if the patient becomes pregnant during therapy, the patient should be apprised of the potential hazard to the fetus. Women of childbearing age should be advised to avoid becoming pregnant.

Precautions

General

Doxorubicin is not an anti-microbial agent.

Information for Patients

Rubex (doxorubicin hydrochloride for injection, USP) imparts a red coloration to the urine for 1 to 2 days after administration, and patients should be advised to expect this during active therapy.

Drug Interactions

Paclitaxel: Two published studies report that initial administration of paclitaxel infused over 24 hours followed by doxorubicin administered over 48 hours resulted in a significant decrease in doxorubicin clearance with more profound neutropenic and stomatitis episodes than the reverse sequence of administration.

Progesterone: In a published study, progesterone was given intravenously to patients with advanced malignancies (ECOG PS <2) at high doses (up to 10 g over 24 hours) concomitantly with a fixed doxorubicin dose (60 mg/m2) via bolus. Enhanced doxorubicin-induced neutropenia and thrombocytopenia were observed.

Verapamil: A study of the effects of verapamil on the acute toxicity of doxorubicin in mice revealed higher initial peak concentrations of doxorubicin in the heart with a higher incidence and severity of degenerative changes in cardiac tissue resulting in a shorter survival.

Cyclosporine: The addition of cyclosporine to doxorubicin may result in increases in AUC for both doxorubicin and doxorubicinol possibly due to a decrease in clearance of parent drug and a decrease in metabolism of doxorubicinol. Literature reports suggest that adding cyclosporine to doxorubicin results in more profound and prolonged hematologic toxicity than doxorubicin alone. Coma and/or seizures have also been described.

Literature reports have also described the following drug interactions: phenobarbital increases the elimination of doxorubicin, phenytoin levels may be decreased by doxorubicin, streptozocin (Zanosar®) may inhibit hepatic metabolism of doxorubicin, and administration of live vaccines to immunosuppressed patients including those undergoing cytotoxic chemotherapy may be hazardous.

Laboratory Tests

Initial treatment with doxorubicin requires observation of the patient and periodic monitoring of complete blood counts, hepatic function tests, and radionuclide left ventricular ejection fraction (see WARNINGS).

Like other cytotoxic drugs, doxorubicin may induce “tumor lysis syndrome” and hyperuricemia in patients with rapidly growing tumors. Appropriate supportive and pharmacologic measures may prevent or alleviate this complication.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Formal long-term carcinogenicity studies have not been conducted with doxorubicin. Doxorubicin and related compounds have been shown to have mutagenic and carcinogenic properties when tested in experimental models (including bacterial systems, mammalian cells in culture, and female Sprague-Dawley rats).

The possible adverse effect on fertility in males and females in humans or experimental animals have not been adequately evaluated. Testicular atrophy was observed in rats and dogs.

A variant of chemotherapy-related acute non-lymphocytic leukemia has been reported to occur infrequently a few years after multiple drug treatment of some neoplasms, which sometimes included doxorubicin. The exact role of doxorubicin has not been elucidated.

Pediatric patients treated with doxorubicin or other topoisomerase II inhibitors are at a risk for developing acute myelogenous leukemia and other neoplasms. The extent of increased risk associated with doxorubicin has not been precisely quantified.

Pregnancy Category D

(See WARNINGS.)

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from doxorubicin, mothers should be advised to discontinue nursing during doxorubicin therapy.

Pediatric Use

Pediatric patients are at increased risk for developing delayed cardiotoxicity. Follow-up cardiac evaluations are recommended periodically to monitor for the delayed cardiotoxicity (see WARNINGS).

Doxorubicin, as a component of intensive chemotherapy regimens administered to pediatric patients, may contribute to prepubertal growth failure. It may also contribute to gonadal impairment, which is usually temporary.

Adverse Reactions

Dose limiting toxicities of therapy are myelosuppression and cardiotoxicity. Other reactions reported are:

Cardiotoxicity – (See WARNINGS.)

Cutaneous– Reversible complete alopecia occurs in most cases. Hyperpigmentation of nailbeds and dermal creases, primarily in pediatric patients, and onycholysis have been reported in a few cases. Recall of skin reaction due to prior radiotherapy has occurred with doxorubicin administration.

Gastrointestinal– Acute nausea and vomiting occurs frequently and may be severe. This may be alleviated by antiemetic therapy. Mucositis (stomatitis and esophagitis) may occur 5 to 10 days after administration. The effect may be severe leading to ulceration and represents a site of origin for severe infections. The dosage regimen consisting of administration of doxorubicin on three successive days results in greater incidence and severity of mucositis. Ulceration and necrosis of the colon, especially the cecum, may occur leading to bleeding or severe infections which can be fatal. This reaction has been reported in patients with acute non-lymphocytic leukemia treated with a 3-day course of doxorubicin combined with cytarabine. Anorexia and diarrhea have been occasionally reported.

Vascular– Phlebosclerosis has been reported especially when small veins are used or a single vein is used for repeated administration. Facial flushing may occur if the injection is given too rapidly.

Local – Severe cellulitis, vesication and tissue necrosis will occur if extravasation of doxorubicin occurs during administration. Erythematous streaking along the vein proximal to the site of the injection has been reported (see DOSAGE AND ADMINISTRATION).

Hematologic– The occurrence of secondary acute myeloid leukemia with or without a preleukemic phase has been reported rarely in patients concurrently treated with doxorubicin in association with DNA-damaging antineoplastic agents. Such cases could have a short (1-3 years) latency period. Pediatric patients are also at risk of developing secondary acute myeloid leukemia.

Hypersensitivity– Fever, chills and urticaria have been reported occasionally. Anaphylaxis may occur. A case of apparent cross sensitivity to lincomycin has been reported.

Neurological – Peripheral neurotoxicity in the form of local-regional sensory and/or motor disturbances have been reported in patients treated intra-arterially with doxorubicin, mostly in combination with cisplatin. Seizures were reported in one patient receiving a very high dose of doxorubicin (2 to 3 times the approved dosage) in combination with high-dose cyclophosphamide.

Other– Conjunctivitis and lacrimation occur rarely.

Overdosage

Acute overdosage with doxorubicin enhances the toxic effects of mucositis, leukopenia and thrombocytopenia. Treatment of acute overdosage consists of treatment of the severely myelosuppressed patient with hospitalization, antimicrobials, platelet transfusions and symptomatic treatment of mucositis. Use of hemopoietic growth factor (G-CSF, GM-CSF) may be considered.

Cumulative dosage with doxorubicin increases the risk of cardiomyopathy and resultant congestive heart failure (see WARNINGS). Treatment consists of vigorous management of congestive heart failure with digitalis preparations, diuretics, and after load reducers such as ACE inhibitors.

Rubex Dosage and Administration

Care in the administration of Rubex will reduce the chance of perivenous infiltration (see WARNINGS). It may also decrease the chance of local reactions such as urticaria and erythematous streaking. On intravenous administration of doxorubicin, extravasation may occur with or without an accompanying burning or stinging sensation, even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation have occurred, the injection or infusion should be immediately terminated and restarted in another vein. If extravasation is suspected, intermittent application of ice to the site for 15 min, q.i.d. x 3 days may be useful. The benefit of local administration of drugs has not been clearly established. Because of the progressive nature of extravasation reactions, close observation and plastic surgery consultation is recommended. Blistering, ulceration and/or persistent pain are indications for wide excision surgery, followed by split-thickness skin grafting.

The most commonly used dose schedule when used as a single agent is 60 to 75 mg/m2 as a single intravenous injection administered at 21-day intervals. The lower dosage should be given to patients with inadequate marrow reserves due to old age, or prior therapy, or neoplastic marrow infiltration. Rubex has been used concurrently with other approved chemotherapeutic agents. Evidence is available that in some types of neoplastic disease combination chemotherapy is superior to single agents. The benefits and risks of such therapy continue to be elucidated. When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 given as a single intravenous injection every 21 to 28 days. Doxorubicin dosage must be reduced in case of hyperbilirubinemia as follows:

Plasma bilirubin concentration (mg/dL)	Dosage reduction (%)
1.2 - 3	50
3.1 - 5	75

Reconstitution Directions: Rubex 50 mg and 100 mg vials should be reconstituted with 25 mL and 50 mL, respectively, of Sodium Chloride Injection, USP (0.9%) to give a final concentration of 2 mg/mL of doxorubicin hydrochloride. An appropriate volume of air should be withdrawn from the vial during reconstitution to avoid excessive pressure buildup. Bacteriostatic diluents are not recommended.

After adding the diluent, the vial should be shaken and the contents allowed to dissolve. The reconstituted solution is stable for 7 days at room temperature and under normal room light (100 foot-candles) and 15 days under refrigeration 2°-8° C (36°-46° F). It should be protected from exposure to sunlight and any unused solution should be discarded.

It is recommended that Rubex be slowly administered into the tubing of a freely running intravenous infusion of Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP. The tubing should be attached to a Butterfly® needle inserted preferably into a large vein. If possible, avoid veins over joints or in extremities with compromised venous or lymphatic drainage. The rate of administration is dependent on the size of the vein, and the dosage. However, the dose should be administered in not less than 3 to 5 minutes. Local erythematous streaking along the vein as well as facial flushing may be indicative of too rapid an administration. A burning or stinging sensation may be indicative of perivenous infiltration and the infusion should be immediately terminated and restarted in another vein. Perivenous infiltration may occur painlessly.

Doxorubicin should not be mixed with heparin or fluorouracil since it has been reported that these drugs are incompatible to the extent that a precipitate may form. Until specific compatibility data are available, it is not recommended that doxorubicin be mixed with other drugs.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Handling and Disposal — Skin reactions associated with doxorubicin have been reported. Skin accidently exposed to doxorubicin should be rinsed copiously with soap and warm water, and if the eyes are involved, standard irrigation techniques should be used immediately. The use of goggles, gloves, and protective gowns is recommended during preparation and administration of the drug.

Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published1-7. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

Caregivers of pediatric patients receiving doxorubicin should be counseled to take precautions (such as wearing latex gloves) to prevent contact with the patient’s urine and other body fluids for at least 5 days after each treatment.

How is Rubex Supplied

Rubex® (doxorubicin hydrochloride for injection, USP) is available as follows:

50 mg —	Each single-dose vial contains 50 mg of doxorubicin HCl, USP as a sterile red-orange lyophilized powder, NDC 0015-3352-22. Available as one individually cartoned vial.
100 mg —	Each single-dose vial contains 100 mg of doxorubicin HCl, USP as a sterile red-orange lyophilized powder, NDC 0015-3353-22. Available as one individually cartoned vial.

Storage

Store dry powder at controlled room temperature 15°-30° C (59°-86° F) (see USP). Protect from light.

The reconstituted solution is stable for 7 days at room temperature or 15 days under refrigeration 2°-8° C (36°-46° F).

Protect from exposure to sunlight. Retain in carton until time of use.

Contains no preservative. Discard unused portion.

REFERENCES

1. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, US Government Printing Office, Washington, DC 20402.


2. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA, 1985;253 (11):1590-1592.


3. National Study Commission on Cytotoxic Exposure — Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD, Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.


4. Clinical Oncological Society of Australia. Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia 1983;1:426-428.


5. Jones RB, et al: Safe Handling of Chemotherapeutic Agents:A Report from the Mount Sinai Medical Center. CA —A Cancer Journal for Clinicians 1983; (Sept/Oct) 258-263.


6. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm 1990;47:1033-1049.


7. Controlling occupational exposure to hazardous drugs. (OSHA WORK PRACTICE GUIDELINES). Am J Health-Syst Pharm 1996;53:1669-1685.

3351DIM-08

51-004726-04

1085217A2

Revised: May 2001

Rubex  doxorubicin hydrochloride  injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0015-3352 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength doxorubicin hydrochloride (doxorubicin) Active 50 MILLIGRAM  In 25 MILLILITER lactose Inactive 250 MILLIGRAM  In 25 MILLILITER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0015-3352-22 1 VIAL In 1 CARTON contains a VIAL, SINGLE-DOSE 1 25 mL (MILLILITER) In 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0015-3352-22)

Rubex  doxorubicin hydrochloride  injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0015-3353 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength doxorubicin hydrochloride (doxorubicin) Active 100 MILLIGRAM  In 50 MILLILITER lactose Inactive 500 MILLIGRAM  In 50 MILLILITER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0015-3353-22 1 VIAL In 1 CARTON contains a VIAL, SINGLE-DOSE 1 50 mL (MILLILITER) In 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0015-3353-22)

Revised: 06/2007Bristol-Myers Squibb Company

More Rubex resources

• Rubex Use in Pregnancy & Breastfeeding
• Rubex Drug Interactions
• Rubex Support Group
• 2 Reviews for Rubex - Add your own review/rating

• Adriamycin Concise Consumer Information (Cerner Multum)


• Adriamycin Advanced Consumer (Micromedex) - Includes Dosage Information


• Adriamycin MedFacts Consumer Leaflet (Wolters Kluwer)


• Doxorubicin Hydrochloride Monograph (AHFS DI)

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Refacto

Generic Name: antihemophilic factor (Intravenous route)

an-tee-hee-moe-FIL-ik FAK-tor

Commonly used brand name(s)

In the U.S.

• Advate


• Helixate FS


• Hemofil-M


• Hyate:C


• Koate DVI


• Kogenate FS


• Kogenate FS w/BIO-SET


• Monarc-M


• Monoclate-P


• Recombinate


• Refacto


• Xyntha

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antihemophilic Agent

Uses For Refacto

Antihemophilic factor (AHF) injection is used to treat serious bleeding episodes in patients with a bleeding problem called hemophilia A. The bleeding episode may be related to an injury (trauma) or a surgical procedure. AHF is a protein that is produced naturally in the body. It helps the blood form clots to stop bleeding and prevents bleeding problems from happening as often.

Hemophilia A, also called classical hemophilia, is a condition where the body does not make enough AHF. If you do not have enough AHF and you become injured, your blood will not form clots properly. You might bleed into and damage your muscles and joints. AHF injection is given to increase the levels of AHF in the blood.

There are several different types of AHF. They are made from human blood or artificially by a man-made process (recombinant). AHF made from human blood has been treated and is not likely to contain harmful viruses, such as hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS). The man-made AHF products do not contain these viruses.

This medicine is available only with your doctor's prescription.

Before Using Refacto

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of antihemophilic factor injection in children.

No information is available on the relationship of age to the effects of Hemofil® M in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of Advate® have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related medical problems, which may require caution and an adjustment in the dose for patients receiving Advate®.

No information is available on the relationship of age to the effects of antihemophilic factor injection in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to hamster or mouse proteins, history of or


• von Willebrand disease—Should not be used in patients with these conditions.

Proper Use of antihemophilic factor

This section provides information on the proper use of a number of products that contain antihemophilic factor. It may not be specific to Refacto. Please read with care.

A doctor or other trained health professional will give you or your child this medicine in a hospital or clinic setting. This medicine is given through a needle placed in one of your veins.

This medicine may also be given at home to patients who do not need to be in a hospital or clinic. If you or your child are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Make sure you understand all of the instructions before giving yourself an injection. Your dose may change based on where you are bleeding. Do not use more medicine or use it more often than your doctor tells you to.

Use only the brand of this medicine that your doctor prescribed. Not all brands are prepared in the same way and the dose may be different.

Every package of medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

To prepare the medicine using 2 bottles (vials) or containers:

• Take the bottles of powder medicine and liquid (diluent) out of the refrigerator and warm them to room temperature.


• Wipe the rubber surface of the bottles with an alcohol swab and allow them to dry.


• Follow the specific directions for your brand of medicine when you prepare the injection.


• Add the liquid to the powder using the special transfer needle or transfer device that comes with the package.


• When injecting the liquid into the dry medicine, aim the stream of liquid against the wall of the container of dry medicine to prevent foaming.


• Swirl the bottle gently to dissolve the medicine. Do not shake the bottle. Shaking will create foam in the mixture.


• Check the mixture to make sure it is clear. Do not use the medicine if you can see anything solid in the mixture or if the mixture is cloudy.


• Use a plastic disposable syringe to remove the mixture from the bottle. Use a special filter needle if your brand of medicine provides one.


• Give the injection as directed by your doctor.


• If you are using more than one bottle of medicine for your dose, prepare the second bottle the same way. Add the mixture from the second bottle to the same syringe.

To prepare the medicine using a prefilled dual-chamber syringe (Xyntha®):

• Take the prefilled dual-chamber syringe out of the refrigerator and warm it to room temperature.


• The dual-chamber syringe has the powder medicine in one part and the liquid (diluent) in the second part of the syringe.


• Attach the plunger rod to the syringe according to the directions. Keep the syringe pointed up to prevent leaking of the liquid.


• Remove the white seal and the grey rubber tip cap. Put the blue vented cap on the syringe. Do not touch the open ends of the syringe and the blue cap.


• Slowly push the plunger until the 2 stoppers inside the syringe are together. This will push all of the liquid into the chamber with the powder medicine.


• Keep the syringe pointed up and gently swirl the syringe to mix the liquid and powder.


• Check the mixture to make sure it is clear. Do not use the medicine if you can see anything solid in the mixture or if the mixture is cloudy.


• Keep the syringe pointed up and push the plunger until most of the air is removed.


• A special infusion set comes with the package. Remove the blue cap and attach the infusion set to the syringe.


• Give the injection as directed by your doctor.


• If you are using more than one syringe of medicine for your dose, prepare the second dual-chamber syringe the same way. The mixture from each syringe will be combined together in a separate syringe before your injection. Your doctor will show you how to do this.

Use the mixture within 3 hours after it is prepared. It must not be stored and used later. Do not put the mixture in the refrigerator.

Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your doctor.

Talk to your doctor before traveling. You should plan to bring enough medicine for your treatment when traveling.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (injection):
  
  • For bleeding episodes in patients with hemophilia A:
    
    • Adults and teenagers—Dose is based on body weight and the type of bleeding episode. The dose must be determined by your doctor.
    
    
    • Children—Dose is based on body weight and the type of bleeding episode. The dose must be determined by your child's doctor.
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

The AHF products should be stored in the original container in the refrigerator. Do not let the packages freeze. They can also be kept at room temperature for short periods of time, such as 3 to 6 months. Store the medicine as directed by your doctor or by the manufacturer of the brand you are using. Protect the container from heat and direct light.

If you move the medicine from the refrigerator to room temperature, write the date you take it from the refrigerator on the container. The length of time the medicine can remain at room temperature will depend on the brand you use. If you have already stored the medicine at room temperature, do not return it to the refrigerator. If you do not use the medicine within the time recommended by the manufacturer, you must destroy the medicine.

Precautions While Using Refacto

It is very important that your doctor check you or your child closely while you are receiving this medicine to make sure it is working properly. Blood tests may be needed.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and check with your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; lightheadedness or dizziness; or any swelling of your hands, face, or mouth after you receive this medicine.

It is recommended that you carry an identification (ID) card or letter stating that you have hemophilia A and the type of medicine you are using. If you have any questions about what kind of identification to carry, check with your doctor.

Check with your doctor right away if you have any symptoms of parvovirus infection: fever, chills, drowsiness, runny nose, and followed by a rash or joint pain.

Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during manufacture of these medicines. Although the risk is low, talk with your doctor if you have any concerns.

The stopper of the bottle (vial) contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.

Refacto Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Fever

Less common or rare

• Changes in facial skin color


• chills


• fast or irregular breathing


• nausea


• puffiness or swelling of the eyelids or around the eyes


• sensation of burning, warmth, heat, numbness, tightness, or tingling


• shortness of breath


• skin rash, hives, or itching


• tightness in the chest


• troubled breathing


• unusual tiredness or weakness


• wheezing

Incidence not known

• Bluish color of the fingernails, lips, skin, palms, or nail beds


• blurred vision


• chest pain or discomfort


• confusion


• cough


• deep or fast breathing with dizziness


• difficult or labored breathing


• difficulty with swallowing


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fast, pounding, or irregular heartbeat or pulse


• noisy breathing


• numbness of the feet, hands, and around the mouth


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• slow or irregular heartbeat


• sweating


• swelling of the face, throat, or tongue


• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Headache

Less common

• Burning, stinging, or swelling at the place of injection


• diarrhea


• dizziness or lightheadedness


• dry mouth or bad taste in the mouth


• lack or loss of strength


• nosebleed


• redness of the face


• vomiting

Rare

• Change in taste


• loss of taste

Incidence not known

• Abdominal or stomach pain


• feeling of warmth


• increased sweating


• irritability


• muscle or bone pain


• redness of the eye


• redness of the face, neck, arms, and occasionally, upper chest


• redness of the skin


• trouble seeing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Refacto side effects (in more detail)

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More Refacto resources

• Refacto Side Effects (in more detail)
• Refacto Use in Pregnancy & Breastfeeding
• Refacto Support Group
• 0 Reviews for Refacto - Add your own review/rating

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• Advate MedFacts Consumer Leaflet (Wolters Kluwer)


• Advate Prescribing Information (FDA)


• Advate Consumer Overview


• Antihemophilic Factor (Human) Monograph (AHFS DI)


• Antihemophilic Factor (Recombinant) Monograph (AHFS DI)


• Helixate FS Prescribing Information (FDA)


• Kogenate Consumer Overview


• Kogenate FS Prescribing Information (FDA)


• Kogenate FS MedFacts Consumer Leaflet (Wolters Kluwer)


• Monoclate-P Prescribing Information (FDA)


• Recombinate Prescribing Information (FDA)


• Xyntha Prescribing Information (FDA)


• Xyntha MedFacts Consumer Leaflet (Wolters Kluwer)


• Xyntha Consumer Overview

Compare Refacto with other medications

• Hemophilia A

Ezol

In the US, Ezol is a member of the drug class analgesic combinations and is used to treat Headache.

Ingredient matches for Ezol

Omeprazole

Omeprazole is reported as an ingredient of Ezol in the following countries:

• India

International Drug Name Search