Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
riluzole, Quantity: 50 mg
Pharmacor Pty Ltd
Riluzole
Tablet, film coated
Excipient Ingredients: magnesium stearate; hypromellose; microcrystalline cellulose; calcium phosphate; croscarmellose sodium; colloidal anhydrous silica; purified water; titanium dioxide; macrogol 400
Oral
56's blister pack (4 x 14's blister), 14's blister pack (1 x 14's blister)
(S4) Prescription Only Medicine
Riluzole is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS)
Visual Identification: White to off-white coloured, capsule shaped film coated tablet, debossed with 'RIL' on one side and '50' on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2014-06-04
1 PHARMACOR RILUZOLE VER-02 MARCH 2018 PHARMACOR RILUZOLE _riluzole_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Pharmacor Riluzole. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THIS MEDICINE. You may need to read it again. WHAT PHARMACOR RILUZOLE IS USED FOR The brand name of your medicine is Pharmacor Riluzole. The active ingredient in the medicine is called riluzole. Pharmacor Riluzole is used to treat people with amyotrophic lateral sclerosis, which can cause muscle degeneration leading to muscle weakness. It is a form of Motor Neurone Disease. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. It is important to remember that you may not feel any different when you take Pharmacor Riluzole. The benefits of using Pharmacor Riluzole may not be noticeable to you. You should not stop taking Pharmacor Riluzole without speaking to your doctor first. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE PHARMACOR RILUZOLE IF YOU: * HAVE LIVER DISEASE * ARE PREGNANT OR INTEND TO BECOME PREGNANT * ARE BREASTFEEDING OR INTEND TO BREASTFEED DO NOT TAKE THIS MEDICINE IF YOU ARE ALLERGIC TO RILUZOLE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. DO NOT GIVE THIS MEDICINE TO A CHILD. There is no experience with the use of this medicine in children. DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE (EXP) PRINTED ON THE PACK. If you take it after the expiry date has passed, it may not work as well. DO NOT USE IT IF THE PACKAGING IS DAMAG Lees het volledige document
PHARMACOR RILUZOLE VER-02 MARCH 2018 1 PRODUCT INFORMATION PHARMACOR RILUZOLE (RILUZOLE) T ABLETS NAME OF THE MEDICINE NON-PROPRIETARY NAME Riluzole CHEMICAL STRUCTURE CAS 1744-22-5 DESCRIPTION Pharmacor Riluzole is a tablet containing riluzole, a benzothiazole. Chemical name: 2-amino-6- trifluoromethoxybenzothiazole. The tablet also contains dibasic calcium phosphate dihydrate; croscarmellose sodium, hypromellose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, as excipients. The tablet coating contains opadry white Y-1-7000H and purified water. Riluzole is a white to slightly yellow, fine crystalline, non-hygroscopic powder. I t i s freely soluble in acetonitrile, in alcohol and in methylene chloride; very slightly soluble in hexane and water. PHARMACOLOGY PHARMACODYNAMICS The aetiology and pathogenesis of amyotrophic lateral sclerosis (ALS) are not known, although a number of hypotheses have been advanced. One hypothesis is that motor neurones made vulnerable through either genetic predisposition or environmental factors, are injured by glutamate. In some cases of familial ALS, enzyme superoxide dismutase has been found to be defective. The mechanism of action of riluzole has not been completely elucidated but evidence to date suggests that it may involve inactivation of voltage dependent sodium channels and impairment of glutamatergic neurotransmission. There are no validated animal models of ALS in which to test riluzole. Riluzole has been shown to cross the blood brain barrier and to possess neuroprotective properties in various _in _ _vivo _ experimental models of neuronal injury known to involve excitotoxic mechanisms, such as cerebral ischemia. _In vitro_, riluzole protects cultured rat motorneurones from the excitotoxic effects of glutamic acid and prevents the death of cortical neurones induced by anoxia. In healthy volunteers at therapeutic doses, r iluzole has been shown to protect to some extent against the hypobaric hypoxia induced at an equivalent altitude of 5000 m. Als Lees het volledige document