البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
oxcarbazepine, Quantity: 60 mg/mL
Novartis Pharmaceuticals Australia Pty Ltd
Oral Liquid, suspension
Excipient Ingredients: saccharin sodium; propylene glycol; purified water; methyl hydroxybenzoate; sorbitol solution (70 per cent) (non-crystallising); PEG-8 stearate; sorbic acid; propyl hydroxybenzoate; ascorbic acid; dispersible cellulose; Fragrance (perfume)
Oral
1 x 250 mL bottle, 1 x 100 mL bottle, 1 x oral dosing syringe
(S4) Prescription Only Medicine, Not scheduled. Not considered by committee
For use as monotherapy or adjunctive therapy for the treatment of partial seizures and generalised tonic-clonic seizures, in adults and children.
Visual Identification: Off-white to slightly reddish-brown suspension; Container Type: Bottle; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2001-12-17
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.NOVARTIS.COM.AU. 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 the sufferer may l اقرأ الوثيقة كاملة
1 AUSTRALIAN PRODUCT INFORMATION – TRILEPTAL (OXCARBAZEPINE) FILM-COATED TABLET AND ORAL SUSPENSION 1 NAME OF THE MEDICINE oxcarbazepine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet of Trileptal contains 150 mg, 300 mg or 600 mg oxcarbazepine. Each mL of oral suspension contains 60 mg oxcarbazepine. Excipients with known effect (oral suspension only): hydroxybenzoates, saccharin, sorbates, sugar alcohols. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM _Tablets _ Trileptal 150 mg: oval, scored, pale grey green tablets coded TD on one side and CG on the other. Trileptal 300 mg: oval, scored, yellow tablets coded TE/TE on one side and CG/CG on the other. Trileptal 600 mg: oval, scored, light pink tablets coded TF/TF on one side and CG/CG on the other. _Oral suspension _ Trileptal 60 mg/mL: off-white to slightly reddish brown oral suspension supplied with an oral dosing syringe and a press-in bottle adaptor. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Trileptal is indicated for use as monotherapy or adjunctive therapy for the treatment of partial seizures and generalised tonic-clonic seizures, in adults and children. 4.2 D OSE AND METHOD OF ADMINISTRATION 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 section 5.1 Pharmacodynamic properties, subsection Clinical trials). The dose may be increased depending on the clinical response of the patient. When other antiepileptic drugs (AEDs) are replaced by Trileptal, the dose of the concomitant AED(s) should be reduced gradually on initiation of Trileptal therapy. In adjunctive therapy, as the total antiepileptic drug load of the patient is increased, the dose of concomitant AED(s) may need to be reduced and/or the Trileptal dose increased more slowly. Trileptal oral suspension and Trileptal film-coated tablet اقرأ الوثيقة كاملة