Amgevita

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Adalimumab 50 mg/mL;  
Available from:
Amgen New Zealand Limited
Dosage:
40 mg/0.8mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Adalimumab 50 mg/mL   Excipient: Glacial acetic acid Polysorbate 80 Sodium hydroxide Sucrose Water for injection
Prescription type:
Prescription
Therapeutic indications:
Rheumatoid Arthritis AMGEVITA is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. This includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. AMGEVITA can be used alone or in combination with methotrexate.
Product summary:
Package - Contents - Shelf Life: Syringe, glass, (Type I), pre-filled (0.8 mL deliverable volume), with stainless steel needle & bromobutyl plunger - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 25°C protect from light - Syringe, glass, (Type I), pre-filled (0.8 mL deliverable volume), with stainless steel needle & bromobutyl plunger - 2 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 25°C protect from light - Syringe, glass, (Type I), pre-filled (0.8 mL deliverable volume), with stainless steel needle & bromobutyl plunger - 4 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 25°C protect from light - Syringe, glass, (Type I), pre-filled (0.8 mL deliverable volume), with stainless steel needle & bromobutyl plunger - 6 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 25°C protect from light
Authorization number:
TT50-10415a
Authorization date:
2018-05-17

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