ROFERON-A PREFILLED SYRINGE FOR INJECTION 3 miu0.5 ml

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

INTERFERON ALFA-2A

Disponible des:

ROCHE SINGAPORE PTE. LTD.

Codi ATC:

L03AB04

Dosis:

3 MIU/0.5 ml

formulario farmacéutico:

INJECTION

Composición:

INTERFERON ALFA-2A 3 MIU/0.5 ml

Vía de administración:

SUBCUTANEOUS, INTRAMUSCULAR

tipo de receta:

Prescription Only

Fabricat per:

F HOFFMANN-LA ROCHE LTD

Estat d'Autorització:

ACTIVE

Data d'autorització:

1998-10-23

Informació per a l'usuari

ROFERON
®
 A

Interferon alfa 2a       

ANTIVIRAL AND ANTINEOPLASTIC AGENT 

1. 
P
HARMACEUTICAL 
F
ORM

Roferon-A is supplied as a ready-to-use solution
for injection.  

2. 
Q
UALITATIVE AND 
Q
UANTITATIVE 
C
OMPOSITION

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.  

3. 
C
LINICAL 
P
ARTICULARS

3.1 
THERAPEUTIC INDICATIONS 
Roferon-A is indicated for the treatment of: 
_Neoplasms of the lymphatic or hematopoietic system_: hairy cell leukemia, 
cutaneous T-cell lymphoma, chronic myelogenous leukemia. 
_ _
_Solid neoplasms_: AIDS-related Kaposi’s sarcoma in
patients without history of 
opportunistic infection, advanced renal cell carcinoma. 
_ _
_Viral diseases_: Adult patients with chronic active
hepatitis B who have markers for 
viral replication, i.e. those who
are positive for HBV-DNA, DNA polymerase or 
HBeAg; adult patients with chronic hepatitis C (hepatitis non-A, non-B) who are 
positive for HCV antibodies and have elevated serum alanine
aminotransferase 
(ALT) without liver decompensation (Child’s class A). 
The efficacy of interferon alfa-2a in
the treatment of hepatitis C is enhanced when 
combined  with ribavirin. Roferon-A should be gi

Fitxa tècnica

1
PFS-ROF-2017 02
ROFERON
® A
Interferon alfa 2a
ANTIVIRAL AND ANTINEOPLASTIC AGENT
1.
P
HARMACEUTICAL
F
ORM
Roferon-A is supplied as a ready-to-use solution for injection.
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
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.
3.
C
LINICAL
P
ARTICULARS
3.1
THERAPEUTIC INDICATIONS
Roferon-A is indicated for the treatment of:
_Neoplasms _
_of _
_the _
_lymphatic _
_or _
_hematopoietic _
_system_:
hairy
cell
leukemia,
cutaneous T-cell lymphoma, chronic myelogenous leukemia.
_ _
_Solid neoplasms_: AIDS-related Kaposi’s sarcoma in patients without
history of
opportunistic infection, advanced renal cell carcinoma.
_ _
_Viral diseases_: Adult patients with chronic active hepatitis B who
have markers for
viral replication, i.e. those who are positive for HBV-DNA, DNA
polymerase or
HBeAg; adult patients with chronic hepatitis C (hepatitis non-A,
non-B) who are
positive for HCV antibodies and have elevated serum alanine
aminotransferase
(ALT) without liver decompensation (Child’s class A).
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 contraindication to ribavirin.
3.2
DOSAGE AND METHOD OF ADMINISTRATION
3.2.1
STANDARD DOSAGE
Substitution
of
Roferon-A
by
any
other
biological
similar
medicinal
product
requires the consent of the prescribing physician.
Roferon-A
should
be
administered
by
s.c.
injection.
Refer
to
the
Copegus
prescribing information when Roferon-A is used in combination with
ribavirin.
3.2.2
SPECIAL DOSAGE INSTRUCTIONS
_Hairy cell leukemia _
_Initial dosage:_ 3 MIU daily for 16-24 weeks. If intolerance
develops, either the
daily dose should be lo