Țară: Australia
Limbă: engleză
Sursă: 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
10, 1, 5
(S4) Prescription Only Medicine
VALWOK 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
VALWOK CMI V 3.0 1 V3.0 VALWOK _Sodium Valproate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Valwok. 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 Valwok 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 VALWOK IS USED FOR Valwok 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. Valwok 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. Valwok may also be used to control mania, a mental condition with episodes of overactivity, elation or irritability. Valwok may be used alone or in combination with other medicines to treat your condition. Valwok 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 Valwok for another reason. Ask your doctor if you have any questions about why it has been prescribed for you. There is no evidence that Valwok 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 VALWOK IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: • liver disease (hepatic dysfunction) or severe hepatitis. • a family history of hepatitis, especially when caused by medicines. Medicines used in the treatment of epilepsy, including Valwok may have adverse effects on the liver and the kidneys. • a urea cycle disorder or a famil Citiți documentul complet
VALWOK V4.1 Version 4.1 Page 1 of 29 Australian Product Information –VALWOK (SODIUM VALPROATE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Sodium Valproate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION VALWOK 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 VALWOK 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 VALWOK 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. VALWOK 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. VALWOK should be replaced by oral sodium valproate therapy (available from other brands) as soon as practicable. Each ampoule of VALWOK 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. VALWOK is intended for use in one patient on one occasion only, any unused portion should be discarded. NEVER ADMINISTER VALWOK OTHER THAN BY THE INTRAVENOUS ROUTE (see Section 4.3 CONTRAINDICATIONS). Monotherapy Daily dosage requirements vary according to age and body weight. VALWOK V4.1 Version 4.1 Page 2 of 29 Adults Patients already satisfac Citiți documentul complet