देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
levetiracetam, Quantity: 500 mg
Pfizer Australia Pty Ltd
Levetiracetam
Injection, concentrated
Excipient Ingredients: nitrogen; sodium acetate trihydrate; sodium chloride; glacial acetic acid; water for injections
Intravenous
10
(S4) Prescription Only Medicine
Hospira? Levetiracetam concentrate for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible. Levetiracetam 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 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.
Visual Identification: Clear, colourless solution presented in a clear glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2014-07-28
HOSPIRA™ LEVETIRACETAM CONCENTRATE FOR IV INFUSION H O S P I R A ™ L E V E T I R A C E T A M C O N C E N T R A T E F O R I V I N F U S I O N CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I BEING TREATED WITH HOSPIRA LEVETIRACETAM CONCENTRATE FOR IV INFUSION? Hospira Levetiracetam concentrate for IV infusion contains the active ingredient levetiracetam. Hospira Levetiracetam concentrate for IV infusion is used to control epilepsy. For more information, see Section 1. Why am I being treated with Hospira Levetiracetam concentrate for IV infusion? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE TREATMENT WITH HOSPIRA LEVETIRACETAM CONCENTRATE FOR IV INFUSION? Do not start treatment if you have ever had an allergic reaction to Hospira Levetiracetam concentrate for IV infusion or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before treatment with Hospira Levetiracetam concentrate for IV infusion? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Hospira Levetiracetam concentrate for IV infusion and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW IS HOSPIRA LEVETIRACETAM CONCENTRATE FOR IV INFUSION GIVEN? Your doctor will decide how much Hospira Levetiracetam concentrate for IV infusion you will receive. This depends on your age, your condition and whether or not you are taking any other medicines.More instructions can be found in Section 4. How is Hospira Levetiracetam concentrate for IV infusion given? in the full CMI. 5. WHAT SHOULD I KNOW DURING TREATMENT WITH HOSPIRA LEVETIRACETAM CONCENTRATE FOR IV INFUSION? THINGS YOU SHOULD DO • Call your doctor पूरा दस्तावेज़ पढ़ें
Version: pfplevti11021 Supersedes: pfplevti10221 Page 1 of 29 AUSTRALIAN PRODUCT INFORMATION – HOSPIRA ™ LEVETIRACETAM (LEVETIRACETAM) CONCENTRATE FOR IV INFUSION 1. NAME OF THE MEDICINE Levetiracetam 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Hospira Levetiracetam concentrate for IV infusion contains 500 mg of levetiracetam in 5 mL. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Concentrated injection for intravenous infusion. Hospira Levetiracetam concentrate for IV infusion is a clear, colourless and sterile aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hospira Levetiracetam concentrate for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible. Levetiracetam 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, 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. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE Levetiracetam therapy can be initiated with either intravenous or oral administration (oral dosage forms including tablets and oral solution are available as other registered products). Version: pfplevti11021 Supersedes: pfplevti10221 Page 2 of 29 Conversion to or from oral to intravenous can be done directly without titration. The total daily dose and frequency of administration should be maintained. Hospira Levetiracetam concentrate for IV infusion is for intravenous use only and must be diluted in at least 100 mL of a compatible diluent पूरा दस्तावेज़ पढ़ें