ROFERON A 18miu/0.6m %v/v Solution for Injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
09-06-2024
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Active ingredient:
INTERFERON ALFA-2A
Available from:
Roche Products Limited
INN (International Name):
INTERFERON ALFA-2A
Dosage:
18miu/0.6m %v/v
Pharmaceutical form:
Solution for Injection
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2013-09-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Roferon-A 18 million international units (MIU) solution for injection in cartridge.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each cartridge contains 18 Million International Units interferon alfa-2a* per 0.6 millilitres** (18MIU/0.6ml).
*produced in Escherichia coli by recombinant DNA technology.
**Contains volume overages
For a full list of excipients, see section 6.1.
Excipients recognized to have a known effect:
Benzyl alcohol (10mg/1ml)
3 PHARMACEUTICAL FORM
Solution for injection in cartridge.
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/mm
3
.
-
Chronic phase Philadelphia-chromosome positive chronic myelogenous leukaemia. Roferon-A
is not an alternative treatment for Chronic Myelogenous Leukaemia (CML) patients who have
a Human Leukocyte Antigen (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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/08/2013_
_CRN 2130242_
_page number: 1_
The efficacy of interferon alfa-2a in the treatment of hepatitis C is enhanced when combined with ribavirin. Roferon-A
should be given alone mainly in case of intolerance or
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