Pegatron Combination Therapy

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Peginterferon alfa-2b 50ug; Ribavirin 200mg;  

Disponibil de la:

Merck Sharp & Dohme (New Zealand) Limited

INN (nume internaţional):

Peginterferon alfa-2b 50 µg

Dozare:

200mg+50µg (CLEARCLICK)

Forma farmaceutică:

Combination

Compoziție:

Active: Peginterferon alfa-2b 50ug Excipient: Dibasic sodium phosphate Monobasic sodium phosphate dihydrate Polysorbate 80 Sucrose Water for injection Active: Ribavirin 200mg   Excipient: Croscarmellose sodium Gelatin Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sodium laurilsulfate TekPrint blue SB-6018 Titanium dioxide

Unități în pachet:

Blister pack, 14 capsules

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

Schering-Plough Company

Indicații terapeutice:

PEGATRON Combination Therapy is indicated for the treatment of na?ve, relapse and non-responder patients with chronic hepatitis C (see Clinical Trials). Patients must be 18 years of age or older and have compensated liver disease. PEGATRON Combination Therapy is also indicated for the treatment of patients with chronic hepatitis C who are co-infected with clinically stable HIV. Interferon alfa monotherapy (including PEG-INTRON) is indicated mainly in case of intolerance or contraindication to ribavirin. Rebetol capsules must not be used alone because ribavirin is not effective as monotherapy in the treatment of hepatitis C. PEGATRON Combination Therapy is indicated for the treatment of chronic hepatitis C in children and adolescents with a bodyweight of NLT 27 kg with compensated liver disease and who have not received previous interferon treatment.

Rezumat produs:

Package - Contents - Shelf Life: Blister pack, - 14 capsules - 36 months from date of manufacture stored at or below 25°C - Cartridge, - 50 ?g - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, 112 capsules+ 4 PEG- Intron CLEARCLICK - 4 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, 84 capsules+4 PEG- Intron CLEARCLICK - 4 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, 112 capsules+4 redipens - 4 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, 84 capsules+4 redipens - 4 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Data de autorizare:

2002-08-23