REBIF 44 MCG

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

INTERFERON BETA 1A

Dostopno od:

MERCK SERONO LTD

Koda artikla:

L03AB07

Farmacevtska oblika:

SOLUTION FOR INJECTION

Sestava:

INTERFERON BETA 1A 88 MCG/ML

Pot uporabe:

S.C

Tip zastaranja:

Required

Izdeluje:

MERCK EUROPE B.V., THE NETHERLANDS

Terapevtsko območje:

INTERFERON BETA-1A

Terapevtske indikacije:

Rebif (interferone beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability. Efficacy of Rebif in chronic progressive multiplbe sclerosis has not been established.Rebif is indicated for the treatment of patients with a single demyelinating event 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.These patients should have MRI findings which are compatible with the diagnosis of multiple sclerosis.

Datum dovoljenje:

2023-01-31

Navodilo za uporabo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
PRE-FILLED SYRINGE
CARTRIDGE FOR INSERTION INTO AN ELECTRONIC SYRINGE
THE ACTIVE INGREDIENT:
Interferon beta-1a
Each pre-filled syringe of REBIF® 22 MCG including a needle,
contains:
22 micrograms (6 million International Units [IU]) interferon
beta-1a in 0.5 mL.
The preparation contains 2.5 mg benzyl alcohol.
Each pre-filled syringe of REBIF® 44 MCG including a needle,
contains:
44 micrograms (12 million International Units [IU]) interferon
beta-1a in 0.5 mL.
The preparation contains 2.5 mg benzyl alcohol.
Each cartridge of REBIF® 22 MCG inserted into an appropriate
syringe, contains:
66 micrograms (18 million International Units [IU]) interferon
beta-1a in 1.5 mL.
The preparation contains 7.5 mg benzyl alcohol.
Each cartridge of REBIF® 44 MCG inserted into an appropriate
syringe, contains:
132 micrograms (36 million International Units [IU]) interferon
beta-1a in 1.5 mL.
The preparation contains 7.5 mg benzyl alcohol.
Inactive ingredients: see section 6 and section 2 under “Important
information about some of the ingredients of the medicine”.
•
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains concise information about the
medicine.
•
Keep this leaflet at hand; you may need to read it again.
•
If you have further questions, refer to the doctor or pharmacist.
•
This medicine has been prescribed for the treatment of your
ailment. Do not pass it on to others. It may harm them even
if it seems to you that their medical condition is similar.
•
Use the medicine properly.
•
Consult the pharmacist if you need further information. Refer
to the doctor if the signs of the disease (symptoms) worsen or
are not improving.
•
If you experience any side effects, refer to your doctor. This
includes any possible side effect not included in this leaflet.
See section 4.
1. WHAT IS THE MEDICINE INTENDED FOR
Rebif (

Lastnosti izdelka

PRESCRIBING INFORMATION
REBIF
® 22MCG
REBIF
® 44MCG
1.
NAME OF THE MEDICINAL PRODUCT
Rebif 22 micrograms/0.5 mL solution for injection in pre-filled
syringe
Rebif
44
micrograms/0.5 mL solution for injection in pre-filled syringe
Rebif 22 micrograms/0.5 mL solution for injection in cartridge
Rebif
44
micrograms/0.5 mL solution for injection in cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
REBIF 22 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Each pre-filled syringe (0.5 mL) contains 22 micrograms (6 MIU*) of
interferon beta-1a**.
Excipient with known effect: Contains 2.5 mg benzyl alcohol per dose
of 0.5 mL.
For the full list of excipients, see section 6.1.
REBIF 44 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Each pre-filled syringe (0.5 mL) contains 44 micrograms (12 MIU*) of
interferon beta-1a**.
Excipient with known effect: Contains 2.5 mg benzyl alcohol per dose
of 0.5 mL.
For the full list of excipients, see section 6.1.
REBIF 22 MICROGRAMS SOLUTION FOR INJECTION IN CARTRIDGE
Each pre-filled cartridge contains 66 micrograms (18 MIU*) of
interferon beta-1a** in
1.5 mL
solution, corresponding to 44 micrograms/mL.
Excipient with known effect: Contains 2.5 mg benzyl alcohol per dose
of 0.5 mL.
For the full list of excipients, see section 6.1.
REBIF 44 MICROGRAMS SOLUTION FOR INJECTION IN CARTRIDGE
Each pre-filled cartridge contains 132 micrograms (36 MIU*) of
interferon beta-1a** in
1.5 mL
solution, corresponding to 88 micrograms/mL.
2
Excipient with known effect: Contains 2.5 mg benzyl alcohol per dose
of 0.5 mL.
For the full list of excipients, see section 6.1.
* Million International Units, measured by cytopathic effect (CPE)
bioassay against the
in-house
interferon beta-1a standard which is calibrated against the current
international NIH standard (GB-23-902-531).
** produced in Chinese hamster ovary Cells (CHO-K1) by recombinant DNA
technology.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe
Clear to opalescent solution, with pH 3.5 to 4.5 and osmolarity 2