Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
sodium valproate, Quantity: 400 mg
Wockhardt Bio Pty Ltd
Sodium valproate
Injection, solution
Excipient Ingredients: dibasic sodium phosphate dodecahydrate; monobasic sodium phosphate dihydrate; phosphoric acid; sodium hydroxide; water for injections
Intravenous, Intravenous Infusion
1, 10, 5
(S4) Prescription Only Medicine
Sodium Valproate Wockhardt is used for the treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.
Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-06-02
SODIUM VALPROATE WOCKHARDT CMI V 3.0 1 V3.0 SODIUM VALPROATE WOCKHARDT _Sodium Valproate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Sodium Valproate Wockhardt. It does not contain all of 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 using Sodium Valproate Wockhardt against the benefits it is expected to 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 SODIUM VALPROATE WOCKHARDT IS USED FOR Sodium Valproate Wockhardt is a medicine used to for the treatment of epilepsy in adults and children. Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe. Sodium Valproate Wockhardt belongs to a group of medicines called anticonvulsants. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. Sodium Valproate Wockhardt may also be used to control mania, a mental condition with episodes of overactivity, elation or irritability. Sodium Valproate Wockhardt may be used alone or in combination with other medicines to treat your condition. Sodium Valproate Wockhardt may be used short-term in place of oral sodium valproate tablets or liquid when the medicine cannot be given by mouth. Your doctor, however, may have prescribed Sodium Valproate Wockhardt for another reason. Ask your doctor if you have any questions about why it has been prescribed for you. There is no evidence that Sodium Valproate Wockhardt is addictive. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN IT _WHEN YOU MUST NOT RECEIVE _ _IT _ YOU SHOULD NOT RECEIVE SODIUM VALPROATE WOCKHARDT IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: • liver disease (hepatic Leggi il documento completo
SODIUM VALPROATE WOCKHARDT V4.1 Version 4.1 Page 1 of 29 Australian Product Information – SODIUM VALPROATE WOCKHARDT (SODIUM VALPROATE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Sodium Valproate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SODIUM VALPROATE WOCKHARDT solution for injection is available in ampoules containing the active ingredient sodium valproate 100 mg/mL. Each 4 mL ampoule contains 400 mg sodium valproate and each 10 mL ampoule contains 1000 mg sodium valproate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Is a clear and colourless solution for injection in a Type I glass ampoule. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS SODIUM VALPROATE WOCKHARDT is used for the treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible. 4.2 D OSE AND METHOD OF ADMINISTRATION SODIUM VALPROATE WOCKHARDT may be given by direct slow intravenous injection or by slow intravenous infusion in 0.9% NaCL (normal saline), 5% glucose solution or glucose saline, using a separate intravenous line. The recommended concentration of the intravenous infusion solution is 4 mg/mL, with 8 mg/mL being the maximum concentration. SODIUM VALPROATE WOCKHARDT should not be administered at the same time as other intravenous additives via the same IV line. The intravenous solution is suitable for infusion by PVC, polyethylene or glass containers. SODIUM VALPROATE WOCKHARDT should be replaced by oral sodium valproate therapy (available from other brands) as soon as practicable. Each ampoule of SODIUM VALPROATE WOCKHARDT is for single dose injection only. To reduce microbiological hazard, use as soon as practicable after dilution. If storage is necessary hold at 2 to 8ºC for not more than 24 hours. SODIUM VALPROATE WOCKHARDT is intended for use in one patient on one occasion only, any unused portion should be discarded. NEVER ADMINISTER SODIUM VALPROATE WOCKHARDT OTHER THAN BY THE Leggi il documento completo