Victrelis® Pegatron® Combination Therapy

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Boceprevir 200mg; Peginterferon alfa-2b 100ug; Ribavirin 200mg;  

Beschikbaar vanaf:

Merck Sharp & Dohme (New Zealand) Limited

INN (Algemene Internationale Benaming):

Boceprevir 200 mg

Dosering:

200mg/100mcg/200mg

farmaceutische vorm:

Combination

Samenstelling:

Active: Boceprevir 200mg Excipient: Capsugel yellow 2276 Capsugel yellow 4077 Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Pregelatinised maize starch Sodium laurilsulfate Tekprint red SB-1100 Active: Peginterferon alfa-2b 100ug Excipient: Dibasic sodium phosphate Dibasic sodium phosphate monohydrate Polysorbate 80 Sucrose Active: Ribavirin 200mg   Excipient: Croscarmellose sodium Gelatin Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sodium laurilsulfate TekPrint blue SB-6018 Titanium dioxide Water for injection

Eenheden in pakket:

Blister pack, Rebetol, 112 capsules

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

MSD International GmbH (Singapore Branch)

therapeutische indicaties:

Victrelis Pegatron Combination Therapy is indicated for the treatment of Chronic Hepatitis C (CHC) genotype 1 infection, in adult patients (18 years and older) with compensated liver disease who are previously untreated or who have failed previous therapy.

Product samenvatting:

Package - Contents - Shelf Life: Blister pack, Rebetol - 112 capsules - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Victrelis PVC/PCTFE/Al blisters - 336 capsules - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light and moisture 3 months opened stored at or below 30°C protect from light and moisture - Cartridge, glass, PEG-Intron redipen 4x 100?g - 400 ?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, 112x Rebetol blisters + 336x Victrelis + 4 x 100?g Peg-Intron Redipen -   - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light and moisture

Autorisatie datum:

2012-01-31