Valsts: Jaunzēlande
Valoda: angļu
Klimata pārmaiņas: Medsafe (Medicines Safety Authority)
Idursulfase 2 mg/mL;
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Idursulfase 2 mg/mL
2 mg/mL
Concentrate for infusion
Active: Idursulfase 2 mg/mL Excipient: Dibasic sodium phosphate heptahydrate Monobasic sodium phosphate monohydrate Polysorbate 20 Sodium chloride Water for injection
Vial, glass, 5mL Type 1, B2-coated butyl stopper, aluminium seal, plastic flip off cap, 1 dose unit
Prescription
Prescription
Shire Human Genetic Therapies Inc
ELAPRASE is indicated for the long term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).
Package - Contents - Shelf Life: Vial, glass, 5mL Type 1, B2-coated butyl stopper, aluminium seal, plastic flip off cap - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. do not shake 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
2008-01-18
ELAPRASE ® 1 ELAPRASE ® _Idursulfase 6 mg/3 mL, Concentrate for Solution for Infusion _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Elaprase. It does not contain all the available information about Elaprase. It does not take the place of talking to your doctor or a trained health care professional. All medicines have risks and benefits. Your doctor has weighed the risks of you or your child having Elaprase against the benefits they expect it will have. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR NURSE. KEEP THIS LEAFLET. You may need to read it again. WHAT ELAPRASE IS USED FOR Elaprase is used as enzyme replacement therapy to treat Hunter syndrome (Mucopolysaccharidosis II), a rare genetic disease in which an enzyme called iduronate-2-sulfatase is missing or the level of the enzyme is lower than normal. Hunter syndrome generally occurs in males and rarely in females. Elaprase is available only with a doctor's prescription. Only your or your child’s treating doctor can start the treatment and supervise the ongoing treatment. Elaprase is to be given only to the person for whom it has been prescribed. _HOW IT WORKS _ Patients with Hunter syndrome do not produce enough of their own enzyme, iduronate-2-sulfatase. The reduced iduronate-2-sulfatase levels in patients result in the accumulation of substances called glycosaminoglycans (GAG) in a number of cells and tissues. This causes the affected cells and tissues to function abnormally, thereby causing problems for various organs in the body. Elaprase is an enzyme replacement therapy that is intended to restore sufficient levels of enzyme to assist in the removal of the accumulated substances and to reduce further accumulation. ASK YOUR TREATING DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU OR YOUR CHILD. BEFORE YOU ARE GIVEN ELAPRASE _WHEN YOU OR YOUR CHILD _ _MUST NOT BE GIVEN IT _ DO NOT TAKE ELAPRASE IF YOU OR YOUR CHILD HAVE A KNOWN, SEVERE, LIFE- THREAT Izlasiet visu dokumentu
elaprase-ccdsv14-dsv4-20jun22 Page 1 of 18 NEW ZEALAND DATA SHEET 1 PRODUCT NAME ELAPRASE (idursulfase) 6 mg/3 mL concentrate for intravenous solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The solution in each vial contains an idursulfase concentration of 2 mg/mL at a pH of approximately 6. The extractable volume of 3 mL from each vial provides 6 mg idursulfase. ELAPRASE does not contain preservatives; vials are for single use only. For full list of excipients, see Section 6.1 List of excipients 3 PHARMACEUTICAL FORM ELAPRASE, for intravenous infusion, is supplied as a sterile, aqueous, clear to slightly opalescent colourless solution that must be diluted prior to administration in 0.9% Sodium Chloride for Injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ELAPRASE is indicated for the long term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment should be supervised by a physician or healthcare professional experienced in the management of patients with MPS II or other inherited metabolic disorders. The recommended dosage regimen of ELAPRASE is 0.5 mg/kg of body weight administered every week as an intravenous infusion. Infusion of ELAPRASE at home may be considered after the most careful consideration of the risks and benefits in patients who: a) are tolerating their infusions well b) have received a minimum of 6 months of treatment in the clinic c) have been free of infusion related reactions for a period of 6 months d) have stable airway disease elaprase-ccdsv14-dsv4-20jun22 Page 2 of 18 Home infusions must be administered by a healthcare professional. Health professionals administering the product must be: a) adequately trained in cardiopulmonary resuscitative measures b) have ready access to emergency medical services c) trained in recognising and managing serious infusion related reactions, hypersensitivity reactions and medical emergencies, including measures appropriate for the age of the patient, und Izlasiet visu dokumentu