Land: Nya Zeeland
Språk: engelska
Källa: Medsafe (Medicines Safety Authority)
Oxcarbazepine 60 mg/mL; ;
Novartis New Zealand Ltd
Oxcarbazepine 60 mg/mL
60 mg/mL
Oral suspension
Active: Oxcarbazepine 60 mg/mL Excipient: Ascorbic acid Citrus limon Dispersible cellulose Macrogol stearate 400 Methyl hydroxybenzoate Propyl hydroxybenzoate Propylene glycol Purified water Saccharin sodium Sorbic acid Sorbitol
Bottle, glass, 100 mL
Prescription
Prescription
Novartis Grimsby Limited
Trileptal is indicated in adults and children aged 1 month and above for the treatment of · Partial seizures (which include the seizure subtypes of simple, complex and partial seizures evolving to secondarily generalised seizures) and · Generalised tonic-clonic seizures. Trileptal is indicated as a first-line antiepileptic drug for use as monotherapy or adjunctive therapy. Trileptal can replace other antiepileptic drugs when current therapy provides insufficient seizure control.
Package - Contents - Shelf Life: Bottle, glass, - 100 mL - 36 months from date of manufacture stored at or below 25°C 7 weeks opened stored at or below 25°C - Bottle, glass, - 250 mL - 36 months from date of manufacture stored at or below 25°C 7 weeks opened stored at or below 25°C
2000-08-21
TRILEPTAL ® 1 TRILEPTAL ® _oxcarbazepine _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Trileptal. 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 or your child taking this medicine against the benefits they expect it will have. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT TRILEPTAL IS USED FOR Trileptal belongs to a group of medicines called anticonvulsants or antiepileptics. Trileptal is used in adults and children to control some types of epilepsy. Epilepsy is a condition in which there are repeated convulsions or seizures (fits). Seizures happen because of a temporary fault in the brain's electrical system. Normally, brain cells coordinate body movements by sending out signals through the nerves to the muscles in an orderly way. In epilepsy, brain cells send out too many signals in a disorderly fashion. The result can be uncoordinated muscular activity that is called an epileptic seizure. Trileptal works by keeping the brain's overexcitable nerve cells under control, thereby, reducing the frequency of seizures. There are two main classes of seizures: generalised and partial. GENERALISED SEIZURES - involve a wide area of the brain, and can affect the whole body. • Tonic-clonic (or grand mal) seizures are a sub-type of generalised seizure in which th Läs hela dokumentet
NEW ZEALAND DATA SHEET 1. NAME OF THE MEDICINAL PRODUCT TRILEPTAL Film coated tablets and oral suspension Oxcarbazepine 150 mg, 300 mg*, and 600 mg, Film-Coated Tablets Oxcarbazepine 60 mg/mL Oral Suspension* 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg, 300 mg* or 600 mg oxcarbazepine. 1 mL of the oral suspension contains 60 mg oxcarbazepine*. For a full list of excipients, see Pharmaceutical Particulars, LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Film-coated tablets 150 mg: pale grey green, ovaloid slightly biconvex tablets, scored on both sides. Embossed with T/D on one side and C/G on the other side. 300 mg*: yellow, ovoid slightly biconvex tablets, scored on both sides. Embossed with TE/TE on one side and CG/CG on the other side. 600 mg: light pink, ovaloid slightly biconvex tablets scored on both sides. Embossed with TF/TF on one side and CG/CG on the other side. Oral suspension*. 600 mg/mL: off-white to slightly reddish brown oral suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Trileptal ® is indicated in adults and in children aged 1 month and above for the treatment of: • Partial seizures (which include the seizure subtypes of simple, complex and partial seizures evolving to secondarily generalised seizures) and • Generalised tonic-clonic seizures. Trileptal is indicated as a first-line antiepileptic drug for use as monotherapy or adjunctive therapy. Trileptal can replace other antiepileptic drugs when current therapy provides insufficient seizure control (see CLINICAL STUDIES). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Trileptal is suitable for use either as monotherapy or in combination with other antiepileptic drugs. In mono- and adjunctive therapy, treatment with Trileptal is initiated with a clinically effective dose given in two divided doses (see CLINICAL STUDIES). The dose may be increased depending on the clinical response of the patient. When other antiepileptic drugs are replaced by Trileptal, the dose of the concomitant Läs hela dokumentet