ALDURAZYME INJECTION

Country: Јужноафричка Република

Језик: Енглески

Извор: South African Health Products Regulatory Authority (SAHPRA)

Доступно од:

Sanofi-Aventis South Africa (Pty) Ltd

Дозирање:

See ingredients

Фармацеутски облик:

INJECTION

Састав:

EACH 5,0 ml SOLUTION CONTAINS LARONIDASE 500,0 IU

Статус ауторизације:

Registered

Датум одобрења:

2015-06-08

Информативни летак

sanofi-aventis south africa (pty) ltd
ALDURAZYME
Revision date: 20 March 2023
Page 1 of 8
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
ALDURAZYME
®
, 500 U/5 ML
CONCENTRATE FOR SOLUTION FOR INFUSION
LARONIDASE
Sugar free.
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE USING ALDURAZYME.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor or your
pharmacist.
•
ALDURAZYME has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as yours.
WHAT IS IN THIS LEAFLET
1.
What ALDURAZYME is and what it is used for
2.
What you need to know before you are given ALDURAZYME
3.
How ALDURAZYME is given
4.
Possible side effects
5.
How to store ALDURAZYME
6.
Contents of the pack and other information.
1.
WHAT ALDURAZYME IS AND WHAT IT IS USED FOR
_Active ingredient:_ Each vial of 5 mL contains 500 U (2,9 mg) of
laronidase.
1 mL contains 100 U (0,58 mg) of laronidase.
ALDURAZYME is used to treat some of the symptoms of a genetic
condition called
mucopolysaccharidosis I (MPS I).
sanofi-aventis south africa (pty) ltd
ALDURAZYME
Revision date: 20 March 2023
Page 2 of 8
It is given to treat the non-neurological manifestations of the
disease.
People with MPS I disease have either a low level or none of an enzyme
called α-L-iduronidase,
which breaks down specific substances (glycosaminoglycans) in the
body. As a result, these
substances do not get broken down and processed by the body as they
should. They accumulate
in many tissues in the body, which causes the symptoms of MPS I.
ALDURAZYME is an artificial enzyme called laronidase. This can replace
the natural enzyme
which is lacking in MPS I disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ALDURAZYME
ALDURAZYME SHOULD NOT BE ADMINISTERED TO YOU:
If you have a severe allergic (hypersensitive) reaction to laronidase
or any of the other ingredients
of ALDURAZYME
(listed in section 6) and these reactions occurred again

Карактеристике производа

sanofi-aventis south africa (pty) ltd
ALDURAZYME
Revision date: 20 March 2023
Page 1 of 15
PROFESSIONAL INFORMATION
SCHEDULING STATUS: S4
1.
NAME OF THE MEDICINE
ALDURAZYME
®
, 500 U/5 mL concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is laronidase. Each vial of 5 mL contains 500 U
(2,9 mg) of laronidase.
1 mL contains 100 U (0,58 mg) 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 WITH KNOWN EFFECT:
Each vial of 5 mL contains 1,29 mmol sodium.
Sugar free.
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 liquid.
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).
sanofi-aventis south africa (pty) ltd
ALDURAZYME
Revision date: 20 March 2023
Page 2 of 15
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ALDURAZYME treatment should be supervised by a medical practitioner
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 as an intravenous infusion.
_SPECIAL POPULATIONS _
_Paediatric patients: _
The safety and effectiveness of ALDURAZYME have been established in
patients 5 years of age
and younger.
No dose adjustment is necessary for the paediatri