REBIF 22 interferon beta-1a (rch) 22 microgram/0.5mL injection pre-filled syringe autoinjector
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
29-11-2017
Send request.
Active ingredient:
Interferon beta-1a, Quantity: 44 microgram/mL
Available from:
Merck Healthcare Pty Ltd
INN (International Name):
Interferon beta-1a
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: sodium hydroxide; poloxamer; benzyl alcohol; methionine; acetic acid; water for injections; mannitol
Administration route:
Subcutaneous
Units in package:
12 pre-filled syringes in single-use autoinjectors, 1 pre-filled syringe in single-use autoinjector, 3 pre-filled syringes in single-use autoinjectors
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
REBIF is indicated for the treatment of: ? Patients with a single demyelinating event in the central nervous system with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis. High risk can be inferred from cerebral MRI with 2 or more lesions suggestive of demyelination.,? Ambulatory patients with multiple sclerosis who have experienced two or more relapses within the last 2 years. REBIF therapy should not be initiated in secondary progressive MS patients who no longer experience relapses.?
Product summary:
Visual Identification: Clear, colourless solution.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2010-10-21
Summary of Product characteristics
Version: A019-0820
Page 1 of 26
Supersedes: A018-0220
AUSTRALIAN PRODUCT INFORMATION
REBIF
(INTERFERON BETA-1A)
1.
NAME OF THE MEDICINE
Interferon beta-1a
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
REBIF is registered in two strengths of 22 microgram/0.5 mL (6 MIU)
and 44 microgram/0.5
mL (12 MIU) of interferon beta-1a (rch) in pre-filled syringes for
single dose use (0.5 mL) and
in cartridges for multidose use (1.5 mL). There is also a pre-filled
syringe presentation which
includes a RebiDose® single use autoinjector (0.5 mL).
REBIF also contains mannitol, poloxamer, methionine, water for
injections and benzyl alcohol.
Sodium hydroxide and acetic acid are used for pH adjustment.
For the full list of excipients, see Section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
Solution for injection
Clear to opalescent solution, with pH 3.5 to 4.5 and osmolarity 250 to
450 mOsm/L.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
REBIF is indicated for the treatment of:
•
Patients with a single demyelinating event in the central nervous
system with an
active inflammatory process, if alternative diagnoses have been
excluded, and if
they are determined to be at high risk of developing clinically
definite multiple
sclerosis. High risk can be inferred from cerebral MRI with 2 or more
lesions
suggestive of demyelination.
•
Ambulatory patients with multiple sclerosis who have experienced two
or more
relapses within the last 2 years.
REBIF therapy should not be initiated in secondary progressive MS
patients who no longer
experience relapses.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Treatment should be initiated under supervision of a physician
experienced in the treatment of
multiple sclerosis.
When first starting treatment with REBIF, it is recommended that the
dose be gradually
increased in order to allow tachyphylaxis to develop thus reducing the
risk of adverse reactions.
It is recommended that 20% of the total dose be administered during
the first two weeks of
therapy, 50% of the total dose be administered in we
Read the complete document
