Roferon-A

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Interferon alfa-2a 3 MIU/mL

Available from:

Roche Products (NZ) Ltd

INN (International Name):

Interferon alfa-2a 3 MIU/mL

Dosage:

3 MIU/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Interferon alfa-2a 3 MIU/mL Excipient: Albumin Ammonium acetate Benzyl alcohol Glacial acetic acid Polysorbate 80 Sodium chloride Sodium hydroxide Water for injection

Units in package:

Vial, 1 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

F Hoffmann-La Roche Ltd

Product summary:

Package - Contents - Shelf Life: Vial, - 1 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1995-03-06

Summary of Product characteristics

Roferon A 190307
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Roferon A (interferon alfa-2a) 3 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 of
interferon alfa-2a per 0.5mL.
There are volume overages of approximately 20% to compensate for the
volume which
remains after administration.
Excipients with known effect
Benzyl alcohol (10mg/1mL)
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
Clear, colourless to slightly yellowish aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Roferon-A is indicated for the treatment of basal cell carcinoma,
carcinoid syndrome, chronic
active hepatitis B, chronic lymphocytic leukaemia (early stage),
chronic myelogenous
leukaemia, chronic non-A, non-B hepatitis (hepatitis C), condylomata
acuminata, cutaneous
T cell lymphoma (mycosis fungoides and Sezary syndrome), essential
thrombocythaemia,
hairy cell leukaemia, Kaposi's sarcoma associated with AIDS, malignant
melanoma, multiple
myeloma, non-Hodgkin's lymphoma (low and intermediate grade), renal
cell carcinoma
(recurrent, advanced and/or metastatic).
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Roferon-A is usually administered as a subcutaneous (sc) injection.
Each pre-filled syringe
pack includes a 12 mm needle for sc injection.
Roferon-A may be administered by intramuscular (im) injection into
either the deltoid or
gluteus muscle. The appropriate needle will need to be used.
Basal Cell Carcinoma
The recommended dosage, depending on the size of the lesion, is 1.5
– 6 MIU of Roferon-A
three times a week, administered intralesionally or sc for 3 weeks.
It may take up to 8 weeks for the treatment effect to become apparent.
Carcinoid Syndrome
The recommended dosage is 3 – 6 MIU three times a week by injection.
Chronic Active Hepatitis B
Therapeutic trials in patients with chronic active h