국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
levetiracetam, Quantity: 500 mg
Sandoz Pty Ltd
Levetiracetam
Injection, concentrated
Excipient Ingredients: sodium chloride; water for injections; sodium acetate trihydrate; glacial acetic acid
Intravenous Infusion
10 vials, 1 vial
(S4) Prescription Only Medicine
Levetiracetam Sandoz concentrate solution for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.,Levetiracetam Sandoz 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 JME. ? Add on therapy in the treatment of PGTC seizures in adults and children from 4 years of age with IGE.
Visual Identification: Clear, colourless solution.; 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
Registered
2013-02-05
LEVETIRACETAM SANDOZ ® _Levetiracetam concentrate solution for IV infusion_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Levetiracetam Sandoz Concentrate for IV Infusion (Levetiracetam Sandoz 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 this medicine 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. You may need to read it again. WHAT LEVETIRACETAM SANDOZ IV IS USED FOR Levetiracetam Sandoz IV 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. It contains the active ingredient, levetiracetam which 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 Sandoz IV 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. Your doctor may have prescribed it for another reason. 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 Sandoz IV has not been established in patients less than 4 years of age. BEFORE YOU ARE GIVEN LEVETIRACETAM SANDOZ IV _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • levetiracetam, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description • any other similar medicines. Some of the symptoms of an aller 전체 문서 읽기
210809-Levetiracetam Sandoz-pi Page 1 of 26 AUSTRALIAN PRODUCT INFORMATION LEVETIRACETAM SANDOZ ® (LEVETIRACETAM) CONCENTRATE SOLUTION FOR IV INFUSION 1 NAME OF THE MEDICINE Levetiracetam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL of Levetiracetam Sandoz Concentrate solution for IV infusion contains 500 mg levetiracetam. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Levetiracetam Sandoz concentrate solution for IV infusion is a clear colourless solution. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Levetiracetam Sandoz concentrate solution for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible. Levetiracetam Sandoz 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). • Add on therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE). 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE Conversion to or from oral to intravenous can be done directly without titration. The total daily dose and frequency of administration should be maintained. _MONOTHERAPY _ The recommended starting dose is 250 mg twice daily, which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. The maximum dose is 1,500 mg twice daily. _ADD-ON THERAPY _ _Adults (> 18 years of age) and adolescents (aged 12 to 전체 문서 읽기