Страна: Сингапур
Език: английски
Източник: HSA (Health Sciences Authority)
PEGINTERFERON ALFA-2A
DKSH SINGAPORE PTE. LTD.
L03AB11
135 mcg/0.5 ml
INJECTION
PEGINTERFERON ALFA-2A 135 mcg/0.5 ml
SUBCUTANEOUS
Prescription Only
F HOFFMANN-LA ROCHE LTD
ACTIVE
2003-06-05
1 PEGASYS ® Peginterferon alfa-2a ___________________________________________________________________________________________ 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Immunostimulants/ Interferons ATC code: L03A B11 1.2 TYPE OF DOSAGE FORM Pegasys is supplied as a sterile, ready-to-use liquid for subcutaneous injection as prefilled syringes and vials: • 180 mcg Pegasys prefilled syringe: each single use syringe contains 0.5 mL with 180 mcg peginterferon alfa-2a. • 135 mcg Pegasys prefilled syringe: each single use syringe contains 0.5 mL with 135 mcg peginterferon alfa-2a. • single dose vials: each vial contains 1.0 mL with 180 mcg of peginterferon alfa-2a. . • single dose vials: each vial contains 1.0 mL with 135 mcg of peginterferon alfa-2a. . 1.3 ROUTE OF ADMINISTRATION Subcutaneous injection 1.4 STERILE / RADIOACTIVE STATEMENT Not applicable 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient_: peginterferon alfa-2a. 2 C LINICAL P ARTICULARS 2.1 THERAPEUTIC INDICATIONS Pegasys is indicated for the treatment of chronic hepatitis C in adult patients who are positive for serum HCV-RNA, including patients with compensated cirrhosis and patients with HIV disease that is clinically stable (e.g. antiretroviral therapy not required or receiving stable antiretroviral therapy). The optimal way to use Pegasys in patients with chronic hepatitis C is in combination with ribavirin. The combination of Pegasys and ribavirin is indicated in naive patients and patients_ _who have failed previous treatment with interferon alpha (pegylated or non-pegylated) alone or in combination therapy with ribavirin. Monotherapy is indicated mainly in case of intolerance or contraindication to ribavirin. Chronic Hepatitis B: Pegasys is indicated for the treatment o Прочетете целия документ
PFS-PEG-2021 12-0 PEGASYS® Peginterferon alfa-2a 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Immunostimulants/ Interferons ATC code: L03A B11 1.2 TYPE OF DOSAGE FORM Pegasys is supplied as a sterile, ready-to-use liquid for subcutaneous (SC) injection as prefilled syringes and vials: • 180 mcg Pegasys prefilled syringe: each single use syringe contains 0.5 mL with 180 mcg peginterferon alfa-2a. • 135 mcg Pegasys prefilled syringe: each single use syringe contains 0.5 mL with 135 mcg peginterferon alfa-2a. • single dose vials: each vial contains 1.0 mL with 180 mcg of peginterferon alfa-2a. . • single dose vials: each vial contains 1.0 mL with 135 mcg of peginterferon alfa-2a. . 1.3 ROUTE OF ADMINISTRATION Subcutaneous injection 1.4 STERILE / RADIOACTIVE STATEMENT Not applicable 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient_ : peginterferon alfa-2a. Excipients: As registered locally. 2 CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATIONS Pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis C (CHC) in patients with compensated liver disease. This includes patients with compensated cirrhosis and patients with HIV disease that is clinically stable (e.g. antiretroviral therapy not required or receiving stable antiretroviral therapy). The optimal way to use Pegasys in patients with chronic hepatitis C is in combination with ribavirin. The combination of Pegasys and ribavirin is indicated in naive patients and patients _ _ who have failed previous treatment with interferon alpha (pegylated or non-pegylated) alone or in combination therapy with ribavirin. Monotherapy is indicated mainly in case of intolerance or contraindication to ribavirin. Chronic Hepatitis B (CHB): Pegasys is indicated for the treatment of both HBeAg-positive and HBeAg-negative chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication and liver inflammation. 2.2 DOSAGE AND METHOD OF ADMINISTRATION GENERAL The safet Прочетете целия документ