FABRAZYME 35 MG

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

AGALSIDASE BETA

Dostopno od:

SANOFI ISRAEL LTD

Koda artikla:

A16AB04

Farmacevtska oblika:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Sestava:

AGALSIDASE BETA 35 MG/VIAL

Pot uporabe:

I.V

Tip zastaranja:

Required

Izdeluje:

GENZYME EUROPE B.V., THE NETHERLANDS

Terapevtska skupina:

AGALSIDASE BETA

Terapevtsko območje:

AGALSIDASE BETA

Terapevtske indikacije:

Fabrazyme is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease. (alfa - galactosidase A deficiency).

Datum dovoljenje:

2017-05-31

Navodilo za uporabo

876954
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
FABRAZYME 35 MG
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
ACTIVE INGREDIENT:
Each vial contains agalsidase beta 35 mg
After reconstitution each vial contains 5 mg of agalsidase beta per
ml.
Inactive ingredients and allergens: see section 2 ‘Important
information about some of this
medicine’s ingredients’ and section 6 ‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor
or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Fabrazyme is indicated for use as long‑term enzyme replacement
therapy in patients with a
confirmed diagnosis of Fabry disease.
THERAPEUTIC GROUP: other alimentary tract and metabolism products –
enzymes.
Fabrazyme contains the active substance agalsidase beta and is used as
enzyme replacement
therapy in Fabry disease, where the level of α‑galactosidase enzyme
activity is absent or lower
than normal. If you suffer from Fabry disease, a fat substance, called
globotriaosylceramide
)GL‑3(, is not removed from the cells of your body and starts to
accumulate in the walls of the
blood vessels in your organs.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
You are sensitive )allergic( to agalsidase beta or to any of the other
ingredients in this medicine
)see section 6(.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING FABRAZYME.
If you are treated with Fabrazyme, you may develop infusion related
reactions. An infusion
related reaction is any side effect occurring during the infusion or
until the end of the infusion day
)see section 4(. If you e

Lastnosti izdelka

1
1. NAME OF THE MEDICINAL PRODUCT
Fabrazyme 35 mg.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains a nominal value of 35 mg of agalsidase beta. After
reconstitution with 7.2 ml water for
injections, each vial of Fabrazyme contains 5 mg/ml (35 mg/7 ml) of
agalsidase beta. The reconstituted
solution must be diluted further (see section 6.6).
Agalsidase beta is a recombinant form of human α-galactosidase A and
is produced by recombinant DNA
technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
The amino acid sequence of
the recombinant form, as well as the nucleotide sequence which encoded
it, are identical to the natural
form of α-galactosidase.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white lyophilisate or powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fabrazyme is indicated for long-term enzyme replacement therapy in
patients with a confirmed diagnosis
of Fabry disease (α-galactosidase A deficiency).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Fabrazyme
treatment should be supervised by a physician experienced in the
management of patients
with Fabry Disease or other inherited metabolic diseases.
Posology
The recommended dose of Fabrazyme
is 1 mg/kg body weight administered once every 2 weeks as an
intravenous infusion.
Infusion of Fabrazyme at home may be considered for patients who are
tolerating their infusions well.
The decision to have a patient move to home infusion should be made
after evaluation and
recommendation by the treating physician. Patients experiencing
adverse events during the home
infusion need to immediately
STOP THE INFUSION PROCESS
and seek the attention of a healthcare
professional. Subsequent infusions may need to occur in a clinical
setting. Dose and infusion rate should
remain constant while at home, and not be changed without supervision
of a healthcare professional.
_ _
Special populations
_ _
_Renal impairment _
No dose adjustment is necessary fo