País: Nueva Zelanda
Idioma: inglés
Fuente: Medsafe (Medicines Safety Authority)
Fingolimod hydrochloride 0.56mg; ; ;
Novartis New Zealand Ltd
Fingolimod hydrochloride 0.56 mg
0.5 mg
Capsule
Active: Fingolimod hydrochloride 0.56mg Excipient: Capsugel white 4998 Gelatin Ink Iron oxide yellow Magnesium stearate Mannitol Titanium dioxide
Blister pack, PVC/PVDC/Al, 7 capsules
Prescription
Prescription
Novartis International Pharmaceutical Ltd Ireland
GILENYA is indicated as a disease modifying therapy for the treatment of patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 7 capsules - 18 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, PVC/PVDC/Al - 28 capsules - 18 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, PVC/PVDC/Al - 84 capsules - 18 months from date of manufacture stored at or below 30°C protect from moisture
2010-09-09
GILENYA ® Page 1 of 7 GILENYA _Fingolimod hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about GILENYA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.MEDSAFE.GOVT.NZ . Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will provide. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT GILENYA IS USED FOR GILENYA is a medicine used to treat relapsing multiple sclerosis (MS). GILENYA does not cure MS, but it helps to reduce the number of relapses that occur and to slow the build-up of physical problems due to MS (disability progression). GILENYA 0.5 mg hard capsules contain the active substance fingolimod, which belongs to a group of medicine known as sphingosine-1-phosphate (S1-P) receptor modulators. MULTIPLE SCLEROSIS (MS) is a long- term condition that affects the central nervous system (CNS), particularly how the brain and spinal cord work. In MS inflammation destroys the protective sheath (called myelin) around the nerves in the CNS and stops the nerves from working properly. This process is called demyelination. The exact cause of MS is unknown. An abnormal response by the body’s immune system is thought to play an important part in the process which damages the CNS. People with MS experience repeated bouts of nervous system symptoms that reflect inflammation Leer el documento completo
New Zealand Data sheet Page 1 of 31 1 PRODUCT NAME GILENYA® 0.5 mg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 0.5 mg fingolimod (as hydrochloride). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM GILENYA 0.5 mg : white to almost white powder in white opaque body and bright yellow opaque cap gelatin capsules, size 3, radial imprint with black ink “FTY 0.5 mg” on cap and two radial bands imprinted on body with yellow ink. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications GILENYA is indicated as a disease modifying therapy for the treatment of patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability. 4.2 Dose and method of administration Posology The recommended dose of GILENYA is one 0.5 mg capsule taken orally once daily, which can be taken with or without food. If a dose is missed treatment should be continued with the next dose as planned. On initiation of GILENYA treatment, after the first dose, it is recommended that all patients be observed, with hourly pulse and blood pressure measurement, for a period of 6 hours for signs and symptoms of bradycardia. All patients should have an electrocardiogram performed prior to dosing and at the end of the 6-hour monitoring period (see section 4.4 special warnings and precautions, Bradyarrhythmia). For recommendations related to switching patients from other disease modifying therapies to GILENYA (see section 4.4 special warnings and precautions: Prior treatment with immunosuppressants). Special populations _Children _ GILENYA is not indicated for use in paediatric patients. (See section 5 PHARMACOLOGICAL PROPERTIES). _The Elderly (≥ 65 years) _ GILENYA should be used with caution in patients aged 65 years and over (see section 5 PHARMACOLOGICAL PROPERTIES). _Patients with Renal Impairment _ No GILENYA dose adjustments are needed in patients with renal impairment (see section 5 PHARMACOLOGICAL PROPERTIES). New Zealand Data sheet Page 2 of 31 _Pa Leer el documento completo