United States - English - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg - ribavirin capsules in combination with interferon alfa-2b (pegylated and nonpegylated) is indicated for the treatment of chronic hepatitis c (chc) in patients 3 years of age and older with compensated liver disease [see warnings and precautions (5.9, 5.10), and use in specific populations (8.4)]. the following points should be considered when initiating ribavirin capsules combination therapy with pegintron® or intron a® : - combination therapy with ribavirin /pegintron is preferred over ribavirin /intron a as this combination provides substantially better response rates [see clinical studies (14) ]. - patients with the following characteristics are less likely to benefit from retreatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection [see clinical studies (14) ]. - no safety and efficacy data are available for treatment duration lasting longer than

India - English - Central Drugs Standard Control Organization

ranbaxy - interferon - 3miu(r-human interferon alpha 2b) - vial

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

virbac (australia) pty ltd - recombinant omega interferon of feline origin - parenteral liquid/solution/suspension - recombinant omega interferon of feline origin vaccine active 10.0 mu/ml - immunotherapy - cat | dog - adult | cat - queen | cat - tom | kitten - canine parvovirus | feline calicivirus | calicivirus (feline) | fcv | parvovirus

European Union - English - EMA (European Medicines Agency)

pharmaand gmbh - peginterferon alfa-2a - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - chronic hepatitis b adult patients pegasys is indicated for the treatment of hepatitis b envelope antigen (hbeag)-positive or hbeag-negative chronic hepatitis b (chb) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (alt) and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1). paediatric patients 3 years of age and older pegasys is indicated for the treatment of hbeag-positive chb in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum alt levels. with respect to the decision to initiate treatment in paediatric patients see sections 4.2, 4.4 and 5.1. chronic hepatitis c adult patients pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis c (chc) in patients with compensated liver disease (see sections 4.2, 4.4 and 5.1). for hepatitis c virus (hcv) genotype specific activity, see sections 4.2 and 5.1. paediatric patients 5 years of age and older pegasys in combination with ribavirin is indicated for the treatment of chc in treatment-naïve children and adolescents 5 years of age and older who are positive for serum hcv-rna. when deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. the reversibility of growth inhibition is uncertain. the decision to treat should be made on a case by case basis (see section 4.4).,

United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - imatinib mesylate (unii: 8a1o1m485b) (imatinib - unii:bkj8m8g5hi) - imatinib 100 mg - newly diagnosed adult and pediatric patients with philadelphia chromosome positive chronic myeloid leukemia (ph+ cml) in chronic phase. patients with philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. adult patients with relapsed or refractory philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all). pediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) in combination with chemotherapy. adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with aggressive systemic mastocytosis without the d816v c-kit mutation or with c-kit mutational status unknown. adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the fip1l1-pdgfrα fusion kinase (mutational analysis or fluorescence in situ hybridization [fish] demonstration of chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-pdgfrα fusion kinase negative or unknown. adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans. patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors. adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist. none.  risk summary gleevec can cause fetal harm when administered to a pregnant woman based on human and animal data. there are no clinical studies regarding use of gleevec in pregnant women. there have been postmarket reports of spontaneous abortions and congenital anomalies from women who have been exposed to gleevec during pregnancy. reproductive studies in rats have demonstrated that imatinib mesylate induced teratogenicity and increased incidence of congenital abnormalities following prenatal exposure to imatinib mesylate at doses equal to the highest recommended human dose of 800 mg/day based on bsa. advise women to avoid pregnancy when taking gleevec. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus. the background risk of major birth defects and miscarriage for the indicated population is not known; however, in the u.s. general population, the estimated background risk of major birth defects of clinically recognized pregnancies is 2% to 4% and of miscarriage is 15% to 20%. data animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of imatinib mesylate up to 100 mg/kg/day and 60 mg/kg/day, respectively, during the period of organogenesis. in rats, imatinib mesylate was teratogenic at 100 mg/kg/day (approximately equal to the maximum human dose of 800 mg/day based on bsa), the number of fetuses with encephalocoele and exencephaly was higher than historical control values and these findings were associated with missing or underdeveloped cranial bones. lower mean fetal body weights were associated with retarded skeletal ossifications. in rabbits, at doses 1.5 times higher than the maximum human dose of 800 mg/day based on bsa, no effects on the reproductive parameters with respect to implantation sites, number of live fetuses, sex ratio or fetal weight were observed. the examinations of the fetuses did not reveal any drug related morphological changes. in a pre- and postnatal development study in rats, pregnant rats received oral doses of imatinib mesylate during gestation (organogenesis) and lactation up to 45 mg/kg/day. five animals developed a red vaginal discharge in the 45 mg/kg/day group on days 14 or 15 of gestation, the significance of which is unknown since all females produced viable litters and none had increased post-implantation loss. other maternal effects noted only at the dose of 45 mg/kg/day (approximately one-half the maximum human dose of 800 mg/day based on bsa) included an increased number of stillborn pups and pups dying between postpartum days 0 and 4. in the f1 offspring at this same dose level, mean body weights were reduced from birth until terminal sacrifice and the number of litters achieving criterion for preputial separation was slightly decreased. there were no other significant effects in developmental parameters or behavioral testing. f1 fertility was not affected but reproductive effects were noted at 45 mg/kg/day, including an increased number of resorptions and a decreased number of viable fetuses. the no-observed-effect level (noel) for both maternal animals and the f1 generation was 15 mg/kg/day. risk summary imatinib and its active metabolite are excreted into human milk. because of the potential for serious adverse reactions in breastfed infants from gleevec, advise a lactating woman not to breastfeed during treatment and for 1 month after the last dose. human data based on data from 3 breastfeeding women taking gleevec, the milk:plasma ratio is about 0.5 for imatinib and about 0.9 for the active metabolite. considering the combined concentration of imatinib and active metabolite, a breastfed infant could receive up to 10% of the maternal therapeutic dose based on body weight. human postmarketing reports and animal studies have shown gleevec to be harmful to the developing fetus [see use in specific populations (8.1)] . pregnancy testing test pregnancy status in females with reproductive potential prior to the initiation of treatment with gleevec. contraception females advise female patients of reproductive potential to use effective contraception (methods that result in less than 1% pregnancy rates) when using gleevec during treatment and for fourteen days after stopping treatment with gleevec [see use in specific populations (8.1)] . infertility the risk of infertility in females or males of reproductive potential has not been studied in humans. in a rat study, the fertility in males and females was not affected [see nonclinical toxicology (13)] . the safety and effectiveness of gleevec have been demonstrated in pediatric patients with newly diagnosed ph+ chronic phase cml and ph+ all [see clinical studies (14.2, 14.4)].  there are no data in children under 1 year of age. in the cml clinical studies, approximately 20% of patients were older than 65 years. in the study of patients with newly diagnosed cml, 6% of patients were older than 65 years. the frequency of edema was higher in patients older than 65 years as compared to younger patients; no other difference in the safety profile was observed [see warnings and precautions (5.1)] . the efficacy of gleevec was similar in older and younger patients. in the unresectable or metastatic gist study, 16% of patients were older than 65 years. no obvious differences in the safety or efficacy profile were noted in patients older than 65 years as compared to younger patients, but the small number of patients does not allow a formal analysis. in the adjuvant gist study, 221 patients (31%) were older than 65 years. no difference was observed in the safety profile in patients older than 65 years as compared to younger patients, with the exception of a higher frequency of edema.  the efficacy of gleevec was similar in patients older than 65 years and younger patients. the effect of hepatic impairment on the pharmacokinetics of both imatinib and its major metabolite, cgp74588, was assessed in 84 patients with cancer with varying degrees of hepatic impairment at imatinib doses ranging from 100 mg to 800 mg. mild and moderate hepatic impairment do not influence exposure to imatinib and cgp74588. in patients with severe hepatic impairment, the imatinib cmax and area under curve (auc) increased by 63% and 45% and the cgp74588 cmax and auc increased by 56% and 55%, relative to patients with normal hepatic function [see clinical pharmacology (12.3)] . reduce the dose by 25% for patients with severe hepatic impairment [see dosage and administration (2.12)] . the effect of renal impairment on the pharmacokinetics of imatinib was assessed in 59 patients with cancer and varying degrees of renal impairment at single and steady state imatinib doses ranging from 100 to 800 mg/day. the mean exposure to imatinib (dose normalized auc) in patients with mild and moderate renal impairment increased 1.5- to 2-fold compared to patients with normal renal function. there are not sufficient data in patients with severe renal impairment [see clinical pharmacology (12.3)] . dose reductions are necessary for patients with moderate and severe renal impairment [see dosage and administration (2.12)] .

United States - English - NLM (National Library of Medicine)

golden state medical supply, inc. - imatinib mesylate (unii: 8a1o1m485b) (imatinib - unii:bkj8m8g5hi) - imatinib 100 mg - newly diagnosed adult and pediatric patients with philadelphia chromosome positive chronic myeloid leukemia (ph+ cml) in chronic phase. patients with philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. adult patients with relapsed or refractory philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all). adult patients with myelodysplastic/myeloproliferative diseases associated with pdgfr (platelet-derived growth factor receptor) gene re-arrangements as determined with an fda-approved test [ see dosage and administration ( 2.6) ]. adult patients with aggressive systemic mastocytosis without the d816v c-kit mutation as determined with an fda-approved test [ see dosage and administration ( 2.7) ] or with c-kit mutational status unknown. adult patients with hypereosinophilic syndrome and/or chronic eosinoph

Australia - English - Department of Health (Therapeutic Goods Administration)

biogen australia pty ltd - interferon beta-1a, quantity: 60 microgram/ml - injection, solution - excipient ingredients: arginine hydrochloride; polysorbate 20; sodium acetate; water for injections; glacial acetic acid - avonex is indicated for the treatment of patients with relapsing forms of multiple sclerosis (ms). avonex is indicated in patients who have experienced a single demyelinating event and are at risk of developing clinically definite ms based on the presence of brain mri abnormalities characteristic of ms. avonex 60 mcg is indicated for the treatment of secondary progressive ms in patients in whom relapse is still a feature of disease. avonex 60 mcg should not be initiated in patients with secondary progressive ms who have not experienced relapse in the previous 12 months.

Australia - English - Department of Health (Therapeutic Goods Administration)

echo therapeutics pty ltd - peginterferon alfa-2a, quantity: 180 microgram - injection, solution - excipient ingredients: acetic acid; water for injections; sodium acetate; sodium chloride; polysorbate 80; benzyl alcohol - chronic hepatitis c (chc): the combination of pegasys and copegus is indicated for the treatment of chronic heptitis c in patients who have received no prior interferon therapy (treatment naive patients) and patients who have failed previous treatment with interferon alfa (pegylated or non-pegylated) alone or in combination therapy with ribavirin. the combination of pegasys and copegus is also indicated for the treatment of chronic hepatitis c in patients with clinically stable human immunodeficiency virus (hiv) co-infection who have previously not received interferon therapy. pegasys monotherapy is indicated for the for the treatment of chronic heptitis c in treatment naive patients (see dosage and administration; chronic hepatitis c: treatment naive patients). patients must be 18 years of age or older and have compensated liver disease. chronic hepatitis b (chb): pegasys is indicated for the treatment of chronic heptitis b in adult patients with evidence of viral replication and liver inflammation and compensated liver disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

echo therapeutics pty ltd - peginterferon alfa-2a, quantity: 135 microgram - injection, solution - excipient ingredients: water for injections; sodium acetate; acetic acid; polysorbate 80; sodium chloride; benzyl alcohol - chronic hepatitis c (chc): the combination of pegasys and copegus is indicated for the treatment of chronic heptitis c in patients who have received no prior interferon therapy (treatment naive patients) and patients who have failed previous treatment with interferon alfa (pegylated or non-pegylated) alone or in combination therapy with ribavirin. the combination of pegasys and copegus is also indicated for the treatment of chronic hepatitis c in patients with clinically stable human immunodeficiency virus (hiv) co-infection who have previously not received interferon therapy. pegasys monotherapy is indicated for the for the treatment of chronic heptitis c in treatment naive patients (see dosage and administration; chronic hepatitis c: treatment naive patients). patients must be 18 years of age or older and have compensated liver disease. chronic hepatitis b (chb): pegasys is indicated for the treatment of chronic heptitis b in adult patients with evidence of viral replication and liver inflammation and compensated liver disease.

United States - English - NLM (National Library of Medicine)

dr.reddy's laboratories inc - imatinib mesylate (unii: 8a1o1m485b) (imatinib - unii:bkj8m8g5hi) - newly diagnosed adult and pediatric patients with philadelphia chromosome positive chronic myeloid leukemia (ph+cml) in chronic phase. patients with philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. adult patients with relapsed or refractory philadelphia chromosome positive acute lymphoblastic leukemia (ph+all). pediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) in combination with chemotherapy. adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with aggressive systemic mastocytosis without the d816v c-kit mutation or with c-kit mutational status unknown. adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the fip1l1-pdgfrα fusion kinase (mutational analysis or fluorescence in situ hybridizat