Negara: Selandia Baru
Bahasa: Inggris
Sumber: Medsafe (Medicines Safety Authority)
Riluzole 50mg
Apotex NZ Ltd
Riluzole 50 mg
50 mg
Film coated tablet
Active: Riluzole 50mg Excipient: Calcium hydrogen phosphate dihydrate Croscarmellose sodium Hypromellose Macrogol 8000 Magnesium stearate Microcrystalline cellulose Purified talc Purified water Titanium dioxide
Prescription
Apotex Pharmachem India Pvt. Ltd.
Riluzole is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).
Package - Contents - Shelf Life: Blister pack, white opaque PVC film with aluminium foil - 56 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, 75cc round, white, opaque HDPE, blue PP child-resistant caps - 56 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, 75cc round, white, opaque HDPE, blue or white PP caps - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, 200cc round, white, opaque HDPE, blue or white PP caps - 500 tablets - 24 months from date of manufacture stored at or below 25°C
2014-01-24
APO-RILUZOLE TABLETS 1 APO-RILUZOLE TABLETS _Contains the active ingredient riluzole_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 (AUSTRALIA ONLY)_ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about riluzole. 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 last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Riluzole. It contains the active ingredient Riluzole. It 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. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. It is important to remember that you may not feel any different when you take riluzole. The benefits of using riluzole may not be noticeable to you. You should not stop taking riluzole without speaking to your doctor first There is no evidence that this medicine is addictive. _USE IN CHILDREN_ This medicine should not be used in children. BEFORE YOU TAKE THIS MEDICIN Baca dokumen lengkapnya
NEW ZEALAND DATA SHEET APO-RILUZOLE RILUZOLE USP 50MG FILM-COATED TABLETS Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 of 13 PRESENTATION APO-RILUZOLE 50mg are white to off white coloured, film coated, capsule shaped, biconvex tablets engraved "APO" on one side and "RI-50" on the other side. Each tablet typically weighs 190mg. INDICATIONS Riluzole is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). DOSAGE AND ADMINISTRATION The recommended daily dose in adults or elderly is 100mg (50mg every 12 hours). No significant increase in benefit can be expected from higher daily doses. Due to the reduction in absorption observed when administered with high fat meals, APO- RILUZOLE should not be taken with a fat containing meal. CHILDREN: the safety and effectiveness of riluzole in any neurodegenerative process occurring in children or adolescents have not been established. PATIENTS WITH IMPAIRED RENAL FUNCTION: see Warnings section. PATIENTS WITH IMPAIRED HEPATIC FUNCTION: see Contraindications and Warnings sections. MAXIMUM TOLERATED DAILY DOSE Recommended daily dose in adults or elderly is 100mg (50mg every 12 hours). CONTRAINDICATIONS Patients who have a history of severe hypersensitivity reactions to riluzole or any of the tablet components. Patients who have a hepatic disease or hepatic impairment (baseline transaminases greater than 3 times the upper limit of normal). Patients who are pregnant or lactating. WARNINGS AND PRECAUTIONS Liver impairment: Riluzole is contraindicated in patients with hepatic disease or hepatic impairment (baseline transaminases greater than 3 times the upper limit of normal). Riluzole should be prescribed with care in patients with a history of abnormal liver function, or in patients with slightly elevated serum transaminase (ALT/SGPT; AST/SGOT up to 3 times the ULN), bilirubin and/or gamma-glutamyl transferase (GGT) levels. Baseline APO-RILUZOLE RILUZOLE USP 50MG FILM-COATED TABLETS Please refer to Medsafe webs Baca dokumen lengkapnya