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

merck sharp & dohme corp. - peginterferon alfa-2b (unii: g8rgg88b68) (peginterferon alfa-2b - unii:g8rgg88b68) - peginterferon alfa-2b 40 ug in 0.1 ml - sylatron™ is an alpha interferon indicated for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. sylatron is contraindicated in patients with: - a history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b - autoimmune hepatitis - hepatic decompensation (child-pugh score >6 [class b and c]) risk summary based on findings from animal studies, sylatron can cause embryo-fetal harm when administered to a pregnant woman. available human data with sylatron use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. administration of nonpegylated interferon alfa-2b was abortifacient in rhesus monkeys at doses approximately 13 times higher than the recommended dose of 6 mcg/kg/week (see data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage is 2-4% and

Israel - English - Ministry of Health

aop orphan pharmaceuticals israel ltd, israel - ropeginterferon alfa-2b - solution for injection - ropeginterferon alfa-2b 500 mcg/ml - ropeginterferon alfa-2b - besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.

Israel - English - Ministry of Health

aop orphan pharmaceuticals israel ltd, israel - ropeginterferon alfa-2b - solution for injection - ropeginterferon alfa-2b 1000 mcg/ml - ropeginterferon alfa-2b - besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.

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

merck sharp & dohme corp. - peginterferon alfa-2b (unii: g8rgg88b68) (interferon alfa-2b - unii:43k1w2t1m6) - peginterferon alfa-2b 50 ug in 0.5 ml - pegintron® , as part of a combination regimen, is indicated for the treatment of chronic hepatitis c (chc) in patients with compensated liver disease. - pegintron in combination with ribavirin and an approved hepatitis c virus (hcv) ns3/4a protease inhibitor is indicated in adult patients with hcv genotype 1 infection (see labeling of the specific hcv ns3/4a protease inhibitor for further information). - pegintron in combination with ribavirin is indicated in patients with genotypes other than 1, pediatric patients (3-17 years of age), or in patients with genotype 1 infection where use of an hcv ns3/4a protease inhibitor is not warranted based on tolerability, contraindications or other clinical factors. pegintron monotherapy should only be used in the treatment of chc in patients with compensated liver disease if there are contraindications to or significant intolerance of ribavirin and is indicated for use only in previously untreated adult patients. combination therapy provides substantially better respons

European Union - English - EMA (European Medicines Agency)

aop orphan pharmaceuticals gmbh - ropeginterferon alfa-2b - polycythemia vera - immunostimulants, - besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - peginterferon alfa-2b - hepatitis c, chronic - immunostimulants, - adults (tritherapy)pegintron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy.please refer to the ribavirin and boceprevir summaries of product characteristics (smpcs) when pegintron is to be used in combination with these medicines.adults (bitherapy and monotherapy)pegintron is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv.pegintron in combination with ribavirin (bitherapy) is indicated for the treatment of chc infection in adult patients who are previously untreated including patients with clinically stable hiv co-infection and in adult patients who have failed previous treatment with interferon-alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon-alpha monotherapy.interferon monotherapy, including pegintron, is indicated mainly in case of intolerance or contraindication to ribavirin.please refer to the ribavirin smpc when pegintron is to be used in combination with ribavirin.paediatric population (bitherapy)pegintron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have chc, previously untreated, without liver decompensation, and who are positive for hcv-rna.when deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. the decision to treat should be made on a case-by-case basis.please refer to the ribavirin smpc for capsules or oral solution when pegintron is to be used in combination with ribavirin.

European Union - English - EMA (European Medicines Agency)

merck sharp dohme ltd  - peginterferon alfa-2b - hepatitis c, chronic - immunostimulants, - adults (tritherapy)viraferonpeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy.please refer to the ribavirin and boceprevir summaries of product characteristics (smpcs) when viraferonpeg is to be used in combination with these medicines.adults (bitherapy and monotherapy)viraferonpeg is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv.viraferonpeg in combination with ribavirin (bitherapy) is indicated for the treatment of chc infection in adult patients who are previously untreated including patients with clinically stable hiv co-infection and in adult patients who have failed previous treatment with interferon alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon alpha monotherapy.interferon monotherapy, including viraferonpeg, is indicated mainly in case of intolerance or contraindication to ribavirin.please refer to the ribavirin smpc when viraferonpeg is to be used in combination with ribavirin.paediatric population (bitherapy)viraferonpeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis c, previously untreated, without liver decompensation, and who are positive for hcv-rna.when deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. the decision to treat should be made on a case-by-case basis.please refer to the ribavirin smpc for capsules or oral solution when viraferonpeg is to be used in combination with ribavirin.

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

pharmaessentia usa - ropeginterferon alfa-2b (unii: 981tme683s) (ropeginterferon alfa-2b - unii:981tme683s) - besremi is indicated for the treatment of adults with polycythemia vera. besremi is contraindicated in patients with: - existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt - hypersensitivity to interferons including interferon alfa-2b or any of the inactive ingredients of besremi - moderate (child-pugh b) or severe (child-pugh c) hepatic impairment - history or presence of active serious or untreated autoimmune disease - immunosuppressed transplant recipients risk summary available human data with besremi use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal studies assessing reproductive toxicity of besremi have not been conducted. based on mechanism of action and the role of interferon alfa in pregnancy and fetal development, besremi may cause fetal harm and should be assumed to have abortifacient potential when administered to a pregnant woman. there are adverse effects on maternal and fetal outcomes associated with polycythemia vera in pregnancy (see clinical considerations) . advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo-fetal risk untreated polycythemia vera during pregnancy is associated with adverse maternal outcomes such as thrombosis and hemorrhage. adverse pregnancy outcomes associated with polycythemia vera include increased risk for miscarriage. there are no data on the presence of besremi in human or animal milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in breastfed children from besremi, advise women not to breastfeed during treatment and for 8 weeks after the final dose. besremi may cause embryo-fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing pregnancy testing prior to besremi treatment is recommended for females of reproductive potential. contraception females advise female patients of reproductive potential to use effective contraception during treatment with besremi and for at least 8 weeks after the final dose. infertility females based on its mechanism of action, besremi can cause disruption of the menstrual cycle [see clinical pharmacology (12.1)] . no animal fertility studies have been conducted with besremi. safety and effectiveness in pediatric patients have not been established. clinical studies of besremi did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other therapy. no dose adjustment is necessary in patients with estimated glomerular filtration rate (egfr) ≥30 ml/min [see clinical pharmacology (12.3)]. avoid use of besremi in patients with egfr <30 ml/min [see warnings and precautions (5.12)]. besremi is contraindicated in patients with hepatic impairment (child-pugh b or c) [see contraindications (4)] . increased liver enzyme levels have been observed in patients treated with besremi. when the increase in liver enzyme levels is progressive and persistent, reduce the dose of besremi. if the increase in liver enzymes is progressive and clinically significant despite dose-reduction, or if there is evidence of hepatic impairment (child-pugh b or c), discontinue besremi [see dosage and administration (2.2) and warnings and precautions (5.11)] . - keep your besremi prefilled syringes in their original carton (figure b) while stored. - do not freeze the prefilled syringes. - do not use a prefilled syringe that has been frozen or left in direct sunlight. - keep besremi prefilled syringes, needles, and all medicines out of the reach of children. - your healthcare provider will tell you the prescribed dose that you should take and the right amount of besremi to measure in the prefilled syringe for your dose. each time you inject, be sure that you know the prescribed dose of besremi to inject. your dose may change over time. - besremi is for subcutaneous (under the skin) injection only. - besremi is for one-time use only. do not reuse your prefilled syringe or needle. - do not use a prefilled syringe or needle that is damaged or broken. contact your healthcare provider for a replacement prefilled syringe or additional needles. - inject besremi into the top of the thighs or lower stomach-area just under the skin. do not inject besremi into any other area of the body. - throw away (dispose of) the besremi prefilled syringe with needle attached right away after use, even if there is medicine left in the prefilled syringe. see step 10 in the section " dispose of used prefilled syringes and needles." - lower stomach (abdomen) area, at least 2 inches away from the belly button, - top of thighs. do not inject into skin that is irritated, red, bruised, infected, or scarred. besremi is for subcutaneous (under the skin) injection only. rotate (change) the injection site for each injection. - hold the prefilled syringe at eye level with the needle pointing straight up over a paper towel, sink, or trash can. - check that you can see the dose lines and number markings on the prefilled syringe. - pinch the end of the plunger as shown (figure z). - slowly push up on the plunger to remove liquid medicine until the top edge of the gray stopper lines up with the marking for your prescribed dose (figure z). keep holding straight up as you set the dose. important: if you accidentally remove too much liquid medicine, do not inject. contact your healthcare provider or pharmacist. - put your used prefilled syringes and needles in a fda-cleared sharps disposal container right away after use (figure af). do not throw away (dispose of) loose prefilled syringes and needles in the household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - always keep the sharps disposal container out of the reach of children.

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.