Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
levetiracetam, Quantity: 250 mg
UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia
Levetiracetam
Tablet, film coated
Excipient Ingredients: magnesium stearate; croscarmellose sodium; macrogol 6000; colloidal anhydrous silica; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake
Oral
60 tablets
(S4) Prescription Only Medicine
Keppra (film coated tablets and oral solution) is indicated for - Use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation, - Monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. - Add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy (JME), and - Add on therapy in the treatment of primary generalised tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE). Keppra concentrate solution for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.
Visual Identification: Scored, blue, oblong, film-coated tablet debossed with the code 'ucb 250' on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2006-09-07
KEPPRA ® _ _tablets (pronounced “KEPP-ruh”) _Contains the active ingredient levetiracetam (pronounced "LEE ve tye RA se tam") _ _ _ CONSUMER MEDICINE INFORMATION _ _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Keppra. 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 Keppra 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 THE MEDICINE. You may need to read it again. WHAT KEPPRA IS USED FOR Keppra is used to control epilepsy. Epilepsy is a condition where you have repeated seizures. There are many different types of seizures, ranging from mild to severe. This medicine belongs to a group of medicines called antiepileptics. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. Keppra may be used alone, or in combination with other medicines, to treat your condition. Your doctor may have prescribed this medicine in addition to your current therapy. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. There is no evidence that this medicine is addictive. This medicine is available only with a doctor’s prescription. The safety and effectiveness of Keppra has not been established in patients less than 4 years of age. BEFORE YOU TAKE KEPPRA _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE KEPPRA IF YOU HAVE AN ALLERGY TO: • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE _(EXP)_ PRINTED ON THE PACK. DO NOT TAKE THIS MEDICINE IF THE Baca dokumen lengkapnya
KEPPRA Tablets and Oral Solution PI Page 1 of 27 AUSTRALIAN PRODUCT INFORMATION KEPPRA (LEVETIRACETAM) FILM-COATED TABLETS AND ORAL SOLUTION 1 NAME OF THE MEDICINE Levetiracetam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Keppra film-coated tablets are available in strengths of 250 mg, 500 mg, 750 mg and 1000 mg levetiracetam. Keppra oral solution is available as 100 mg/mL strength. Levetiracetam is a white to off white powder with a faint odour and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. Keppra oral solution contains the following excipients: Methylhydroxybenzoate, propylhydroxybenzoate, and maltitol solution. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Keppra film-coated tablets: _250 mg._ Blue, oblong, scored film-coated tablet debossed with the code ucb and 250 on one side. _500 mg._ Yellow, oblong, scored film-coated tablet debossed with the code ucb and 500 on one side. _750 mg*._ Orange, oblong, scored film-coated tablet debossed with the code ucb and 750 on one side. _1000 mg._ White, oblong, scored film-coated tablet debossed with the code ucb and 1000 on one side. _*not currently distributed in Australia._ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Keppra (film-coated tablets and oral solution) is indicated for: use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation; monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy; add-on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (JME); and KEPPRA Tablets and Oral Solution PI Page Baca dokumen lengkapnya