Roferon-A

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Interferon alfa-2a 6 MIU/mL;  

Available from:

Roche Products (NZ) Ltd

INN (International Name):

Interferon alfa-2a 6 MIU/mL

Dosage:

3MIU/0.5mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Interferon alfa-2a 6 MIU/mL   Excipient: Ammonium acetate Benzyl alcohol Glacial acetic acid Polysorbate 80 Sodium chloride Sodium hydroxide Water for injection

Units in package:

Syringe, glass, 0.5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Roche Diagnostics GmbH

Therapeutic indications:

Roferon-A is indicated for the treatment of basal cell carcinoma, carcinoid syndrome, chronic lymphocytic leukaemia (early stage), chronic myelogenous leukaemia, , 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 or metastatic).

Product summary:

Package - Contents - Shelf Life: Syringe, glass, - 0.5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1996-05-01

Patient Information leaflet

Roferon-A

190314
1
_ _
CONSUMER MEDICINE INFORMATION
ROFERON
®
-A
INTERFERON ALFA-2A
3 MILLION IU (MIU) IN 0.5 ML PREFILLED SYRINGES FOR INJECTION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Roferon-A.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
Roferon-A against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ROFERON-A IS USED FOR
Roferon-A contains an active ingredient called interferon alfa-2a.
Roferon-A belongs to a group of medicines called interferons. It is a
similar form of
interferon to one of the interferons made naturally by your own immune
system as a defence
against viruses and tumours. Roferon-A works by slowing the growth of
certain tumour cells
and viruses, and by boosting the effects of your own immune system to
fight them.
Roferon-A is used in the treatment of viral infections of the liver
(chronic active hepatitis B
and chronic hepatitis C).
Roferon-A treatment will not prevent a hepatitis B or C infected
person from giving another
person hepatitis B or C.
When used for treating hepatitis C, Roferon-A is sometimes used in
combination with a
medicine called COPEGUS
®
(ribavirin). If you are also taking COPEGUS, please read the
Consumer Medicine Information for COPEGUS – it contains important
information on how
to use COPEGUS safely.
Roferon-A is also used in the treatment of various types of cancer
such as kidney cancer
(renal cell carcinoma), cancer of the lymph glands (cutaneous T-cell
lymphoma), blood
cancer (hairy cell leukaemia, chronic lymphocytic leukaemia (CLL),
chronic myelogenous
leukaemia (CML), multiple myeloma and other bone marrow conditions
causing platelet
disorders), skin cancer (malignant melanoma, basal cell carcinoma),
non-Hodgkin’s
lymphoma a

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