Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
sodium valproate, Quantity: 100 mg/mL
AFT Pharmaceuticals Pty Ltd
Injection, intravenous infusion
Excipient Ingredients: water for injections; nitrogen; monobasic potassium phosphate; dibasic sodium phosphate dodecahydrate
Intravenous
5 vials box, 4 vials box, 1 vial box
(S4) Prescription Only Medicine
Valproate-AFT 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: Valproate-AFT comes as a clear colourless solution in glass vials; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2019-02-14
_Valproate-AFT_ 1 VALPROATE-AFT _Sodium Valproate_ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Valproate-AFT. 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 Valproate-AFT 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 VALPROATE-AFT IS USED FOR Valproate-AFT 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. Valproate-AFT 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. Valproate-AFT may also be used to control mania, a mental condition with episodes of overactivity, elation or irritability. Valproate-AFT may be used alone or in combination with other medicines to treat your condition. Valproate-AFT 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 Valproate-AFT for another reason. Ask your doctor if you have any questions about why it has been prescribed for you. There is no evidence that Valproate- AFT 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 VALPROATE- AFT 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 Valproate-AFT m Lees het volledige document
Page 1 of 30 AUSTRALIAN PRODUCT INFORMATION – VALPROATE-AFT (SODIUM VALPROATE) 1 NAME OF THE MEDICINE Sodium valproate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Valproate-AFT Solution for Infusion or Injection is a sterile, non-pyrogenic solution: - 300 mg/3 ml of solution packed in 5 ml capacity glass ampoule. - 400 mg/4 ml of solution packed in 5 ml capacity glass ampoule. - 1000 mg/10 ml of solution packed in 10 ml capacity glass ampoule. - 300 mg/3 ml of solution packed in 5 ml capacity glass vial. - 400 mg/4 ml of solution packed in 5 ml capacity glass vial. - 1000 mg/10 ml of solution packed in 10 ml capacity glass vial. For the full list of excipients, see Section 6.1, List of Excipients. Sodium valproate is a white, odourless, crystalline powder with a saline taste. It is highly soluble in water and alcohol. Its molecular weight is 166 . 2 . It is quite dissimilar to other established anticonvulsants such as barbiturates, hydantoins, succinamides, oxazolidinediones and acetylureas in that it has no nitrogen or aromatic moiety. 3 PHARMACEUTICAL FORM Solution for injection or infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _EPILEPSY_ _ _ Valproate-AFT 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. Page 2 of 30 4.2 DOSE AND METHOD OF ADMINISTRATION Sodium valproate tablets, liquid and syrup are unavailable in the Valproate-AFT brand. Information obtained using sodium valproate tablet, liquid and syrup formulations have been retained throughout the PI, where appropriate, for continuity and prescriber information. Valproate-AFT 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. Valproate-AFT should not be adminis Lees het volledige document