NANOGEN | Biosimilar STIMUS (Darbepoetin alfa)

STIMUS 10 mcg

Each pre-filled syringe (0.4 mL) contains:

Darbepoetin alfa 10mcg

Excipients: Monobasic sodium phosphate monohydrate, anhydrous dibasic sodium phosphate, sodium chloride, polysorbate 80, water for injection.

STIMUS 20 mcg

Each pre-filled syringe (0.5 mL) contains:

Darbepoetin alfa 20mcg

Excipients: Monobasic sodium phosphate monohydrate, anhydrous dibasic sodium phosphate, sodium chloride, polysorbate 80, water for injection.

STIMUS 40 mcg

Each pre-filled syringe (0.4 mL) contains:

Darbepoetin alfa 40mcg

Excipients: Monobasic sodium phosphate monohydrate, anhydrous dibasic sodium phosphate, sodium chloride, polysorbate 80, water for injection.

STIMUS 60 mcg

Each pre-filled syringe (0.3 mL) contains:

Darbepoetin alfa 60mcg

Excipients: Monobasic sodium phosphate monohydrate, anhydrous dibasic sodium phosphate, sodium chloride, polysorbate 80, water for injection.

STIMUS 100 mcg

Each pre-filled syringe (0.5 mL) contains:

Darbepoetin alfa 100mcg

Excipients: Monobasic sodium phosphate monohydrate, anhydrous dibasic sodium phosphate, sodium chloride, polysorbate 80, water for injection.

PHARMACEUTICAL FORM

Solution for infusion

Clear, colourless solution, packed in glass prefilled syringe, with needle avaiable, plastic plunger. No strange particles.

THERAPEUTIC INDICATIONS

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients.

Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients.

Poorly controlled hypertension.

STORAGE CONDITIONS, EXPIRATION DATE, PACKAGING SPECIDICATIONS

Storage conditions: Store in the refrigerator at 20C – 80C. Do not freeze. Protect from light.

Expiration date: 36 months from manufacturing date.

Packaging specifications: Box of 1 prefilled syringe of solution for injection.

NANOGEN | Biosimilar STIMUS (Darbepoetin alfa)