Myozyme 50mg powder for concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alglucosidase alfa

Available from:

Genzyme Therapeutics Ltd

ATC code:

A16AB07

INN (International Name):

Alglucosidase alfa

Dosage:

50mg

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: 5030045000159

Patient Information leaflet

OTHER MEDICINES AND MYOZYME
Tell your doctor or pharmacist if you are using, have
recently used or might use any other medicines.
PREGNANCY AND BREAST-FEEDING AND FERTILITY
There is no experience of the use of Myozyme in pregnant
women. You should not be given Myozyme during
pregnancy unless clearly necessary. You are recommended
to stop breast-feeding when you are given Myozyme.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
DRIVING AND USING MACHINES
Take care when driving or using any tools or machines
shortly after infusion of Myozyme, since you may
experience dizziness.
MYOZYME CONTAINS SODIUM
This medicine contains less than 1 mmol sodium (23 mg)
per vial, i.e. essentially ‘sodium free’.
3. HOW MYOZYME IS GIVEN
Myozyme will be given to you under the supervision of
a doctor who is experienced in the treatment of Pompe
disease.
The dose you receive is based on your body weight.
The recommended dosage of Myozyme is 20 mg per kg of
body weight. It will be given to you once every 2 weeks.
USE IN CHILDREN AND ADOLESCENTS
The recommended dosage of Myozyme in children and
adolescents is the same as in adults.
INSTRUCTIONS FOR PROPER USE
Myozyme is given through a drip into a vein (by
intravenous infusion). It is supplied as a powder which will
be mixed with sterile water before it is given.
IF YOU ARE GIVEN MORE MYOZYME THAN YOU SHOULD
There is no experience with overdose of Myozyme.
IF YOU FORGET TO USE MYOZYME
If you have missed an infusion, please contact your doctor.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Side effects were mainly seen while patients were being
given the medicine or shortly after (“infusion related
effects”). Some of these infusion related side effects were
serious or life-threatening. Life thr

Summary of Product characteristics

OBJECT 1
MYOZYME 50 MG, POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 23-Aug-2017 | Genzyme
Therapeutics
1. Name of the medicinal product
Myozyme 50 mg powder for concentrate for solution for infusion
2. Qualitative and quantitative composition
One vial contains 50 mg of alglucosidase alfa.
After reconstitution, the solution contains 5 mg of alglucosidase
alfa* per ml and after dilution, the
concentration varies from 0.5 mg to 4 mg/ml.
*Human acid α-glucosidase is produced in Chinese hamster ovary cells
(CHO) by recombinant DNA
technology.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion.
White to off-white powder.
4. Clinical particulars
4.1 Therapeutic indications
Myozyme is indicated for long-term enzyme replacement therapy (ERT) in
patients with a confirmed
diagnosis of Pompe disease (acid α-glucosidase deficiency).
Myozyme is indicated in adults and paediatric patients of all ages.
4.2 Posology and method of administration
Myozyme treatment should be supervised by a physician experienced in
the management of patients with
Pompe disease or other inherited metabolic or neuromuscular diseases.
Posology
The recommended dose regimen of alglucosidase alfa is 20 mg/kg of body
weight administered once
every 2 weeks.
Patient response to treatment should be routinely evaluated based on a
comprehensive evaluation of all
clinical manifestations of the disease.
_Paediatric and older people _
There is no evidence for special considerations when Myozyme is
administered to paediatric patients of
all ages or older people.
_Patients with renal and hepatic impairment_
The safety and efficacy of Myozyme in patients with renal or hepatic
impairment have not been evaluated
and no specific dose regimen can be recommended for these patients.
Method of administration
Myozyme should be administered as an intravenous infusion.
Infusions should be administered incrementally. It is recommended that
the infusion begin