Pegatron Combination Therapy

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Peginterferon alfa-2b 120ug; Ribavirin 200mg;  

Beschikbaar vanaf:

Merck Sharp & Dohme (New Zealand) Limited

INN (Algemene Internationale Benaming):

Peginterferon alfa-2b 120 µg

Dosering:

200mg+120µg(CLEARCLICK)

farmaceutische vorm:

Combination

Samenstelling:

Active: Peginterferon alfa-2b 120ug 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

Eenheden in pakket:

Blister pack, 14 capsules

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

Schering-Plough Company

therapeutische indicaties:

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.

Product samenvatting:

Package - Contents - Shelf Life: Blister pack, - 14 capsules - 36 months from date of manufacture stored at or below 25°C - Cartridge, - 120 ?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, 140 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, 140 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)

Autorisatie datum:

2002-08-23