Roferon-A 6million units/0.5ml solution for injection pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Interferon alfa-2a

Available from:

Roche Products Ltd

ATC code:

L03AB04

INN (International Name):

Interferon alfa-2a

Dosage:

12mega unit/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08020400; GTIN: 5000471004472

Patient Information leaflet

1
uk-pl-roferon-clean-180420-3-4.5-6-9
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROFERON
®
-A
3 MILLION INTERNATIONAL UNITS (IU)
4.5 MILLION INTERNATIONAL UNITS (IU)
6 MILLION INTERNATIONAL UNITS (IU)
9 MILLION INTERNATIONAL UNITS (IU)
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Interferon alfa-2a
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Roferon-A is and what it is used for
2.
What you need to know before you use Roferon-A
3.
How to use Roferon-A
4.
Possible side effects
5.
How to store Roferon-A
6.
Contents of the pack and other information
7.
How to inject Roferon-A
1.
WHAT ROFERON-A IS AND WHAT IT IS USED FOR
Roferon-A contains an antiviral agent called interferon alfa-2a which
is similar to a natural substance
produced by the body to protect against viral infections, tumors and
foreign substances that may invade
the body. Once Roferon-A has detected and attacked a foreign
substance, it alters it by slowing, blocking,
or changing its growth or function.
Roferon-A is used to treat the following:
●
Viral infections, such as chronic hepatitis B and C.

Cancers of the blood (cutaneous T-cell lymphoma, hairy cell leukaemia
and chronic myelogenous
leukaemia).

Some other forms of cancer (renal cell carcinoma, follicular
non-Hodgkin’s lymphoma and
malignant melanoma).
If you are not sure why you have been prescribed Roferon-A, you should
discuss your illness and its
treatment with your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ROFERON-A
DO NOT USE ROFERON-A:

if

Summary of Product characteristics

OBJECT 1
ROFERON-A 6 MILLION INTERNATIONAL UNITS (IU)
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Summary of Product Characteristics Updated 04-Jun-2018 | Roche
Products Limited
1. Name of the medicinal product
Roferon-A 6 million international units (IU) solution for injection in
pre-filled syringe
2. Qualitative and quantitative composition
Each pre-filled syringe contains 6 million International Units
interferon alfa-2a* per 0.5 millilitres** (6
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.
- 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,
conventional therapy.
- Adult patients with histologically proven chronic hepatitis B who
have markers for viral replication, i.e.,
those who are positive for HBV DNA or HBeAg.
- Adult patients with histologically proven chronic hepatitis C who
are positive for HCV antibodies or
HCV RNA and have elevated serum alanine aminotransferase (ALT) without
liver decompensation.
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 riba