COMPOSITION

Each vial of lyophilized powder contains: Peginterferon alfa-2a 180 mcg and 1 vial solvent (1 mL)
Each glass vial of 1 mL contains : Peginterferon alfa-2a 180 mcg
Each prefilled syringe of 0.5 mL contains: Peginterferon alfa-2a 180 mcg

THERAPEUTIC INDICATIONS

- Chronic hepatitis B
Pegnano is indicated for the treatment of HBeAg-positive or HBeAg-negative-chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, increased ALT and histologically verified liver inflammation and/or fibrosis.
- Chronic hepatitis C
Pegnano is indicated for the treatment of chronic hepatitis C in adult patients who are positive for serum HCV-RNA, including patients with compensated cirrhosis and/or co-infected with clinically stable HIV.
The optimal way to use Pegnano in patients with chronic hepatitis C is in combination with ribavirin. The combination of Pegnano and ribavirin is indicated in naive patients and patients who have failed previous treatments with interferon alpha (PEGylated or non-PEGylated) alone or in combination with ribavirin.
Monotherapy is indicated mainly in case of intolerance or contradication to ribavirin.
Administration route: SC injection

CONTRAINDICATIONS

Hypersensitivity to the active substance, to interferon alfa, or to any of the excipients
- Autoimmune hepatitis
- Severe hepatic dysfunction or decompensated cirrhosis of the liver
- Neonates and young children up to 3 years old, because of the excipient benzyl alcohol
- A history of severe pre-existing cardiac diseases, including unstable or uncontrolled cardiac diseases in the previous six months
- Initiation of Pegnano is contraindicated in HIV-HCV patients with cirrhosis and a Child-Pugh

STORAGE, SHELF-LIFE AND PACKING UNITS

Storage: Store at 2°C - 8°C. Do not freeze. Protect from light. The solution for injection should be inspected visually for particulates and discoloration before administration.
Shelf Life: 24 months from manufacturing date. Reconstituted solution is stable for 30 days at 2°C - 8°C.
Packing units:
Box of 01 vial of lyophilized powder and 1 vial solvent (1 mL)
Box of 01 or 06 prefilled syringe(s) (0,5 mL)
Box of 01 or 05 vial(s) of solution for injection (1 mL)

COMPOSITION

Each lyophilized powder vial contains: rHu EPO 2000 IU, 4000 IU, 10000IU
Each glass vial of 1 mL contains : rHu EPO 2000 IU, 4000 IU, 10000 IU
Each prefilled syringe of 0.5 mL contains :rHu EPO 2000 IU, 4000 IU, 10000 IU
THERAPEUTIC INDICATIONS

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:
• Treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis
• Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis.
-Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).

Administration route: SC or IV injection.

CONTRAINDICATIONS

NANOKINE should NOT be used for patients:

· Have uncontrolled hypertension.
· Develop pure red cell aplasia (PRCA) following treatment with erythropoietin
· Hypersensitivity to the active substance or to any of the excipients.
· Have surgery and cannot receive adequate antithrombotic prophylaxis for any reason.
· Have autologous blood predonation programmes
· Are scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation
· Suffer severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.

STORAGE, SHELF-LIFE AND PACKING UNITS

Storage: at 2°C - 8°C. Do not freeze. Protect from light.
Shelf life: 24 months from manufacturing date. Reconstituted solution is stable for 7 days at temperatures of 2°C - 8°C.
Packing units:
Box of 1 vial of lyophilized powder NANOKINE 2000 IU, 4000 IU, 10000 IU and 1 vial solvent (1 mL)
Box of 1,10 vial(s) of solution for injection NANOKINE 2000 IU, 4000 IU, 10000 IU (1 mL)
Box of 01, 06, 12 prefilled syringe(s) of solution for injection NANOKINE 2000 IU, 4000 IU, 10000 IU