Fabrazyme 35mg powder for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Agalsidase beta

Available from:

Genzyme Therapeutics Ltd

ATC code:

A16AB04

INN (International Name):

Agalsidase beta

Dosage:

35mg

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09080100; GTIN: 5030045000173

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FABRAZYME 35 MG
powder for concentrate for solution for infusion
AGALSIDASE BETA
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 Fabrazyme is and what it is used for
2.
What you need to know before you use Fabrazyme
3.
How to use Fabrazyme
4.
Possible side effects
5.
How to store Fabrazyme
6.
Contents of the pack and other information
1. WHAT FABRAZYME IS AND WHAT IT IS USED FOR
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 of your organs.
Fabrazyme is indicated for use as long-term enzyme
replacement therapy in patients with a confirmed diagnosis
of Fabry disease.
Fabrazyme is indicated in adults, children and adolescents
aged 8 years and older.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FABRAZYME
DO NOT USE FABRAZYME
-
if you are allergic to agalsidase beta or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Fabrazyme.
If you are treated with Fabrazyme, you may develop
infusion associated reactions. An infusion-associated
reaction is any side effect occurring during the infusion
or until the end of the infusion day (see section 4)

Summary of Product characteristics

OBJECT 1
FABRAZYME 5 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 19-May-2017 | Genzyme
Therapeutics
1. Name of the medicinal product
Fabrazyme 35 mg powder for concentrate for solution for infusion
Fabrazyme 5 mg powder for concentrate for solution for infusion
2. Qualitative and quantitative composition
Fabrazyme 35 mg powder for concentrate for solution for infusion
Each vial of Fabrazyme 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).
Fabrazyme 5 mg powder for concentrate for solution for infusion
Each vial of Fabrazyme contains a nominal value of 5 mg of agalsidase
beta. After reconstitution with 1.1
ml water for injections, each vial of Fabrazyme contains 5 mg/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 a 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 A.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion.
White to off-white lyophilised cake 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).
Fabrazyme is indicated in adults, children and adolescents aged 8
years and older.
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 Fabraz