País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Laronidase 0.58 mg/mL (rch)
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Laronidase 0.58 mg/mL (rch)
500 U/5mL
Concentrate for infusion
Active: Laronidase 0.58 mg/mL (rch) Excipient: Dibasic sodium phosphate monohydrate Monobasic sodium phosphate monohydrate Polysorbate 80 Sodium chloride Water for injection
Vial, glass, 5 mL
Prescription
Prescription
BioMarin Pharmaceutical Inc
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
2003-04-15
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 Leia o documento completo