Roferon-A solution for s/c injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

interferon alfa-2a

Available from:

F. Hoffmann-La Roche Ltd.

ATC code:

L03AB04

INN (International Name):

interferon alfa-2a

Dosage:

3000000IU/0,5ml

Pharmaceutical form:

solution for s/c injection

Units in package:

(1) pre-filled syringe 0,5ml and needle

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-11-07

Patient Information leaflet

ROFERON
®
-A
Interferon alfa-2a
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Antiviral and antineoplastic agent
1.2
TYPE OF DOSAGE FORM
Roferon-A is supplied as a ready-to-use solution for injection.
1.3
ROUTE OF ADMINISTRATION
Subcutaneous injection
1.4
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _
interferon alfa-2a.
Interferon alfa-2a is produced biosynthetically using
recombinant DNA technology, and is the product of a cloned
human leukocyte interferon gene inserted into and expressed
in
_E.coli_
.
Each prefilled syringe (for single-dose, s.c. injection) contains
3, 4.5, 6 or 9 MIU interferon alfa-2a in 0.5 ml.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
Roferon-A is indicated for the treatment of:
_Neoplasms of the lymphatic or hematopoietic system:_
Hairy
cell leukemia, multiple myeloma, cutaneous T-cell lymphoma,
Philadelphia chromosome-positive chronic myelogenous
leukemia, thrombocytosis associated with myeloproliferative
diseases.
Roferon-A is indicated as adjunctive treatment to
chemotherapy (with or without radiotherapy) in patients with
low-grade non-Hodgkin’s lymphoma.
_Solid neoplasms:_
AIDS-related Kaposi’s sarcoma in patients
without history of opportunistic infection, advanced renal cell
carcinoma, metastatic malignant melanoma, surgically resected
malignant melanoma without nodal or distant metastases.
_Viral diseases:_
Patients with proven chronic hepatitis B
(e.g. by liver biopsy) who have elevated serum ALT and
markers for viral replication, i.e. those who are positive for
HBV-DNA, DNA polymerase or HBeAg without liver
decompensation (Child’s class A); patients with proven
chronic hepatitis C (e.g. by liver biopsy) who are positive for
HCV antibodies and have elevated serum ALT without liver
decompensation (Child’s class A); condylomata acuminata.
The optimal way to use Roferon-A in patients with chronic
hepatitis C is in combination with ribavirin. This combination is
indicated in previously untreated patients as well as in patients
who ha

Summary of Product characteristics

1
Roferon-ie-spc-clean-1405-3-4.5-6-9-pfs
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Roferon-A 3 million international units (IU) solution for injection in
pre-filled syringe
Roferon-A 4.5 million international units (IU) solution for injection
in pre-filled syringe
Roferon-A 6 million international units (IU) solution for injection in
pre-filled syringe
Roferon-A 9 million international units (IU) 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
**
(3 million IU/0.5 ml).
4.5 million International Units interferon alfa-2a* per 0.5
millilitres
**
(4.5 million IU/0.5 ml).
6 million International Units interferon alfa-2a* per 0.5 millilitres
**
(6 million IU/0.5 ml).
9 million International Units interferon alfa-2a* per 0.5 millilitres
**
(9 million IU/0.5 ml).
* produced in Escherichia coli by recombinant DNA technology
**
Contains volume overages
For the full list of excipients, see section 6.1.
Excipients recognized to have a known effect:
Benzyl alcohol (10 mg/1 ml)
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 leukemia.
-
AIDS patients with progressive, asymptomatic Kaposi's sarcoma who have
a CD4 count
> 250/mm
3
.
-
Chronic phase Philadelphia-chromosome positive chronic myelogenous
leukemia. 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,
conventio