Aldurazyme
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
23-02-2023
Send request.
Active ingredient:
Laronidase 0.58 mg/mL (rch)
Available from:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
INN (International Name):
Laronidase 0.58 mg/mL (rch)
Dosage:
500 U/5mL
Pharmaceutical form:
Concentrate for infusion
Composition:
Active: Laronidase 0.58 mg/mL (rch) Excipient: Dibasic sodium phosphate monohydrate Monobasic sodium phosphate monohydrate Polysorbate 80 Sodium chloride Water for injection
Units in package:
Vial, glass, 5 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
BioMarin Pharmaceutical Inc
Product summary:
Package - Contents - Shelf Life: Vial, glass, - 5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 12 hours reconstituted (not refrigerated) stored at or below 25°C
Authorization date:
2003-04-15
Patient Information leaflet
ALDURAZYME®
1
ALDURAZYME®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ALDURAZYME?
ALDURAZYME contains the active ingredient laronidase. ALDURAZYME is
used as enzyme replacement therapy in
Mucopolysaccharidosis I (MPS I) storage disorder, a disease in which
the level of α-L-iduronidase is absent or lower than normal.
For more information, see Section 1. Why am I using ALDURAZYME?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ALDURAZYME?
Do not use if you have ever had an allergic reaction to laronidase or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS
(PARTICULARLY BREATHING PROBLEMS), TAKE ANY OTHER MEDICINES, OR
ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
ALDURAZYME?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ALDURAZYME and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE ALDURAZYME?
•
ALDURAZYME will be given to you directly into the vein (intravenously)
by a trained health care professional in a hospital or a
clinic
•
The recommended dosage for ALDURAZYME is 100 U/kg (0.58 mg/kg) of body
weight once every week
More instructions can be found in Section 4. How do I use ALDURAZYME?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ALDURAZYME?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, or pharmacist you visit that you are using
ALDURAZYME
•
Have any tests when your treating physician says to
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how ALDURAZYME affects
you
DRINKING ALCOHOL
•
Tell your doctor if you drink alcohol
LOOKING AFTER
YOUR MEDICINE
•
ALDURAZYME will be stored in the hospital or clinic pha
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