SYLATRON- peginterferon alfa-2b kit Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

sylatron- peginterferon alfa-2b kit

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

Pegasys Liên Minh Châu Âu - Tiếng Đan Mạch - EMA (European Medicines Agency)

pegasys

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 og 5. 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. med hensyn til beslutningen om at indlede behandling hos pædiatriske patienter, se afsnit 4. 2, 4. 4 og 5. 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 og 5. for at hepatitis c virus (hcv) genotype specifik aktivitet, se afsnit 4. 2 og 5. 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. når det besluttes at indlede behandling i barndommen, er det vigtigt at overveje, væksthæmning, der er fremkaldt af en kombination terapi. reversibilitet af væksthæmning er usikker. beslutningen om at behandling skal ske på grundlag af en individuel vurdering (se afsnit 4.

Pegasys Liên Minh Châu Âu - Tiếng Malt - EMA (European Medicines Agency)

pegasys

pharmaand gmbh - peginterferon alfa-2a - hepatitis c, chronic; hepatitis b, chronic - immunostimulanti, - 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 u 5. 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. fir-rigward tal-deċiżjoni li tinbeda l-kura f'pazjenti pedjatriċi ara sezzjonijiet 4. 2, 4. 4 u 5. 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 u 5. għall-vajrus tal-epatite Ċ (hcv) ġenotip attività speċifika, ara sezzjonijiet 4. 2 u 5. 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. meta jiddeċiedu li tibda l-kura fit-tfulija, huwa importanti li tikkunsidra l-inibizzjoni tat-tkabbir indotta mill-terapija kombinata. l-riversibbiltà ta ' inibizzjoni tat-tkabbir huwa inċert. id-deċiżjoni li l-kura għandha tittieħed fuq bażi ta'każ b'każ (ara sezzjoni 4.