Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

1. NAME OF THE MEDICINAL PRODUCT

 Roferon-A 3 million international units (MIU) solution for injection in pre-filled syringe

Roferon-A 4.5 million international units (MIU) solution for injection in pre-filled syringe

Roferon-A 6 million international units (MIU) solution for injection in pre-filled syringe

Roferon-A 9 million international units (MIU) solution for injection in pre-filled syringe

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each pre-filled syringe contains:

3 Million International Units interferon alfa-2a* per 0.5 millilitres**(3MIU/0.5ml).

4.5 Million International Units interferon alfa-2a* per 0.5 millilitres**(4.5MIU/0.5ml).

6 Million International Units interferon alfa-2a* per 0.5 millilitres**(6MIU/0.5ml).

9 Million International Units interferon alfa-2a* per 0.5 millilitres**(9MIU/0.5ml).

* produced in Escherichia coli by recombinant DNA technology

**Contains volume overages

For a full list of excipients, see section 6.1.

Excipients recognised to have a known effect:

Benzyl alcohol (10mg/1ml)

3. PHARMACEUTICAL FORM

 Solution for injection in pre-filled syringe.

Solution is clear and colourless to light yellow.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

 Roferon-A is indicated for the treatment of:

- Hairy cell leukaemia.

- AIDS patients with progressive, asymptomatic Kaposi's sarcoma who have a CD4 count > 250/mm3.

- Chronic phase Philadelphia-chromosome positive chronic myelogenous leukaemia. Roferon-A is not an alternative treatment for CML patients who have an HLA-identical relative and for whom allogeneic bone marrow transplantation is planned or possible in the immediate future. It is still unknown whether Roferon-A can be considered as a treatment with a curative potential in this indication.

- Cutaneous T-cell lymphoma. Interferon alfa-2a (Roferon-A) may be active in patients who have progressive disease and who are refractory to, or unsuitable for, conventional therapy.

- Adult patients with histologically proven chronic hepatitis B who have markers for viral replication, i.e., those who are positive for HBV DNA or HBeAg.

- Adult patients with histologically pr