Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
levetiracetam, Quantity: 100 mg/mL
Arrotex Pharmaceuticals Pty Ltd
Levetiracetam
Injection, intravenous infusion
Excipient Ingredients: sodium acetate trihydrate; sodium chloride; water for injections; glacial acetic acid
Intravenous Infusion
10 x 5mL vials
(S4) Prescription Only Medicine
Levetiracetam concentrate solution for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible. 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 generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE).
Visual Identification: A clear, colourless, sterile solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-03-12
LEVETIRACETAM APOTEX SOLUTION FOR INFUSION _Contains the active ingredient levetiracetam_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 being given this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Levetiracetam APOTEX Solution for Infusion. It contains the active ingredient levetiracetam. It 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. Levetiracetam belongs to a group of medicines called anti-epileptics. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. Levetiracetam solution for infusion may be used alone, or in combination with other medicines, to treat your condition. 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. There is no evidence that this medicine is addictive. This medicine should not be used in children. The safety and effectiveness of this medicine has not been established in patients less than 4 years of age. BEFORE YOU ARE GIVEN THIS MEDICINE _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU SHOULD NOT BE GIVEN THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • any medicine containing levetiracetam • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reactio Læs hele dokumentet
1 AUSTRALIAN PRODUCT INFORMATION LEVETIRACETAM IV APOTEX (LEVETIRACETAM) CONCENTRATE SOLUTION FOR IV INFUSION 1 NAME OF THE MEDICINE Levetiracetam. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Levetiracetam concentrate solution for IV infusion contains 500 mg of levetiracetam (500 mg/5 mL) as the active ingredient. One vial of levetiracetam concentrate solution for IV infusion contains 500 mg of levetiracetam (500 mg/5 mL). For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM The concentrated solution for IV infusion is a clear, colourless, sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levetiracetam concentrate solution for IV infusion 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 generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE). Levetiracetam concentrate solution for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible. 4.2 DOSE AND METHOD OF ADMINISTRATION Levetiracetam IV APOTEX concentrate solution is intended for IV infusion. DOSAGE Levetiracetam therapy can be initiated with either intravenous or oral administration. Conversion to or from oral to intravenous can be done directly without titration. The total daily dose and frequency of administration should be maintained. Levetiracetam concentrate solution for IV infusion is for intravenous use only and must be diluted in at least 100 mL of a compatible diluent and administered as a Læs hele dokumentet