Avonex 30micrograms0.5ml (6million units) solution for injection pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Interferon beta-1a

Available from:

6million units

ATC code:

L03AB07

INN (International Name):

Interferon beta-1a

Dosage:

12mega u/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

VMP not recommended to prescribe - patient training required

Product summary:

BNF: 08020400; GTIN: 0646520015096 0646520015324

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AVONEX 30 MICROGRAMS/0.5 ML SOLUTION FOR INJECTION
(Interferon beta-1a)
PRE-FILLED SYRINGE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Even if you have used Avonex before, some of the information may have
changed.
-
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.
(Notes information)
This leaflet is changed from time to time.
Please check every time you get your prescription refilled to see if
the leaflet has been updated.
WHAT IS IN THIS LEAFLET
1.
What AVONEX is and what it is used for
2.
What you need to know before you use AVONEX
3.
How to use AVONEX
4.
Possible side effects
5.
How to store AVONEX
6.
Contents of the pack and other information
7.
How to inject AVONEX
1
WHAT AVONEX IS AND WHAT IT IS USED FOR
WHAT AVONEX IS
The active substance in Avonex is a protein called
_interferon beta-1a._
Interferons are natural
substances made in your body to help protect you from infections and
diseases. The protein in Avonex
is made up of exactly the same ingredients as interferon beta that is
found in the human body.
WHAT AVONEX IS USED FOR
AVONEX IS USED TO TREAT MULTIPLE SCLEROSIS (MS)
. Treatment with Avonex can help to prevent you
from getting worse, although it will not cure MS.
EVERYONE HAS THEIR OWN SET OF MS SYMPTOMS.
These can include:
-
Feeling off-balance or light headed, walking problems, stiffness and
muscle spasms, tiredness,
numbness in the face, arms or legs
-
Acute or chronic pain, bladder and bowel problems, sexual problems and
problems seeing
things
-
Difficulty in thinking and concentrating, depression.
MS also tends

Summary of Product characteristics

OBJECT 1
AVONEX 30 MICROGRAMS/0.5 ML SOLUTION FOR
INJECTION.
Summary of Product Characteristics Updated 26-Jun-2017 | Biogen Idec
Ltd
1. Name of the medicinal product
AVONEX 30 micrograms/0.5 ml solution for injection.
2. Qualitative and quantitative composition
Each 0.5 ml pre-filled syringe contains 30 micrograms (6 million IU)
of interferon beta-1a.
The concentration is 30 micrograms per 0.5 ml.
Using the World Health Organisation (WHO) International Standard for
Interferon, 30 micrograms of
AVONEX contain 6 million IU of antiviral activity. The activity
against other standards is not known.
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear and colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
AVONEX is indicated for the treatment of
• Patients diagnosed with relapsing multiple sclerosis (MS). In
clinical trials, this was characterised by
two or more acute exacerbations (relapses) in the previous three-years
without evidence of continuous
progression between relapses; AVONEX slows the progression of
disability and decreases the frequency
of relapses.
• Patients with a single demyelinating event with an active
inflammatory process, if it is severe enough to
warrant treatment with intravenous corticosteroids, if alternative
diagnoses have been excluded, and if
they are determined to be at high risk of developing clinically
definite multiple sclerosis (see section 5.1).
AVONEX should be discontinued in patients who develop progressive MS.
4.2 Posology and method of administration
Treatment should be initiated under supervision of a physician
experienced in the treatment of the
disease.
Posology
_Adults: _The recommended dosage for the treatment of relapsing MS is
30 micrograms (0.5 ml solution),
administered by intramuscular (IM) injection once a week (see section
6.6). No additional benefit has
been shown by administering a higher dose (60 micrograms) once a week.
_Titration: _To help patients reduce th