País: África do Sul
Língua: inglês
Origem: South African Health Products Regulatory Authority (SAHPRA)
Sanofi-Aventis South Africa (Pty) Ltd
See ingredients
INJECTION
EACH 5,0 ml SOLUTION CONTAINS LARONIDASE 500,0 IU
Registered
2015-06-08
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 Leia o documento completo
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 Leia o documento completo