Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
levetiracetam, Quantity: 10 % w/v
AFT Pharmaceuticals Pty Ltd
Levetiracetam
Injection, concentrated
Excipient Ingredients: glacial acetic acid; sodium chloride; water for injections; sodium acetate trihydrate
Intravenous Infusion
500mg/5mL 10 vials
(S4) Prescription Only Medicine
LEVETIRACETAM-AFT 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 generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE).,LEVETIRACETAM-AFT concentrate solution for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.
Visual Identification: Clear, colourless, sterile solution (500mg/5ml), free from foreign particles, contained in transparent vial sealed with a rubber stopper and aluminium flip cap; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-11-07
Levetiracetam-AFT _LEVETIRACETAM CONCENTRATE SOLUTION FOR IV INFUSION _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Levetiracetam-AFT concentrate solution for IV infusion (Levetiracetam-AFT IV). 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 Levetiracetam- AFT 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 IN A SAFE PLACE. You may need to read it again. WHAT LEVETIRACETAM-AFT IV IS USED FOR Levetiracetam-AFT 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. Levetiracetam-AFT 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 Levetiracetam-AFT has not been established in patients less than 4 years of age. BEFORE YOU ARE GIVEN LEVETIRACETAM-AFT IV 1 | P a g e _WHEN YOU MUST NOT BE GIVEN IT _ YOU MUST NOT BE GIVEN LEVETIRACETAM-AFT IV 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 IF YOU ARE NOT SURE WH Soma hati kamili
1 AUSTRALIAN PRODUCT INFORMATION LEVETIRACETAM-AFT 500 MG/5 ML CONCENTRATE SOLUTION FOR INFUSION (LEVETIRACETAM) LEVETIRACETAM-AFT 100MG/ML ORAL SOLUTION (LEVETIRACETAM) 1 NAME OF THE MEDICINE Levetiracetam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Levetiracetam is a white to off-white powder with a faint odour and a bitter taste. It is very soluble in water (104 g/100mL). It is freely soluble in chloroform (65.3 g/100mL) and in methanol (53.6 g/100mL), soluble in ethanol (16.5 g/100mL), sparingly soluble in acetonitrile (5.7 g/100mL) and practically insoluble in n-hexane. Each mL of LEVETIRACETAM-AFT oral solution contains 100 mg of levetiracetam (100 mg/mL). Each 5 mL of LEVETIRACETAM-AFT concentrate solution for IV infusion contains 500 mg of levetiracetam (500 mg/ 5 mL). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM LEVETIRACETAM-AFT 100 mg/mL oral solution is a clear, colourless solution. LEVETIRACETAM-AFT 500 mg/ 5 ml concentrate solution for infusion is a clear, colourless, sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LEVETIRACETAM-AFT 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). Product information - clean 1.3.1.1 Pg. 1 2 • 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-AFT 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 _DOSAGE_ Conversion to Soma hati kamili