Aldurazyme 500units5ml solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Laronidase

Available from:

Genzyme Therapeutics Ltd

ATC code:

A16AB05

INN (International Name):

Laronidase

Dosage:

100unit/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09080100; GTIN: 5030045000203

Summary of Product characteristics

OBJECT 1
ALDURAZYME 100 U/ML CONCENTRATE FOR SOLUTION
FOR INFUSION
Summary of Product Characteristics Updated 23-Dec-2015 | Genzyme
Therapeutics
1. Name of the medicinal product
Aldurazyme 100 U/ml concentrate for solution for infusion
2. Qualitative and quantitative composition
1 ml contains 100 U (approximately 0.58 mg) of laronidase.
Each vial of 5 ml contains 500 U of laronidase.
The activity unit (U) is defined as the hydrolysis of one micromole of
substrate (4-MUI) per minute.
Laronidase is a recombinant form of human α-L-iduronidase and is
produced by recombinant DNA
technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Excipient(s) with known effect:
Each vial of 5 ml contains 1.29 mmol sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion.
A clear to slightly opalescent, and colourless to pale yellow
solution.
4. Clinical particulars
4.1 Therapeutic indications
Aldurazyme is indicated for long-term enzyme replacement therapy in
patients with a confirmed
diagnosis of Mucopolysaccharidosis I (MPS I; α-L-iduronidase
deficiency) to treat the non-neurological
manifestations of the disease (see section 5.1).
4.2 Posology and method of administration
Aldurazyme treatment should be supervised by a physician experienced
in the management of patients
with MPS I or other inherited metabolic diseases. Administration of
Aldurazyme should be carried out in
an appropriate clinical setting where resuscitation equipment to
manage medical emergencies would be
readily available.
Posology
The recommended dosage regimen of Aldurazyme is 100 U/kg body weight
administered once every
week.
_Paediatric population_
No dose adjustment is necessary for the paediatric population.
_Elderly_
The safety and efficacy of Aldurazyme in patients older than 65 years
have not been established and no
dosage regimen can be recommended in these patients.
_Renal and hepatic impairment_
The safety and efficacy of Aldurazyme in patients with renal or
hepatic insuffic