Država: Nova Zelandija
Jezik: angleščina
Source: Medsafe (Medicines Safety Authority)
Sodium valproate 100 mg/mL
AFT Pharmaceuticals Ltd
100 mg/mL
Solution for injection
Active: Sodium valproate 100 mg/mL Excipient: Dibasic sodium phosphate dodecahydrate Monobasic potassium phosphate Water for injection
Prescription
The treatment of patients with epilepsy or bipolar disorder, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.
Package - Contents - Shelf Life: Ampoule, glass, (Type 1), 4 mL fill - 1 dose units - 48 months from date of manufacture stored at or below 30°C - Ampoule, glass, (Type 1), 10 mL fill - 1 dose units - 48 months from date of manufacture stored at or below 30°C - Ampoule, glass, (Type 1), 3 mL fill - 1 dose units - 48 months from date of manufacture stored at or below 30°C - Ampoule, glass, (Type 1), 4 mL fill - 4 dose units - 48 months from date of manufacture stored at or below 30°C - Ampoule, glass, (Type 1), 3 mL fill - 4 dose units - 48 months from date of manufacture stored at or below 30°C - Ampoule, glass, (Type 1), 10 mL fill - 4 dose units - 48 months from date of manufacture stored at or below 30°C - Ampoule, glass, (Type 1), 3 mL fill - 5 dose units - 48 months from date of manufacture stored at or below 30°C - Ampoule, glass, (Type 1), 4 mL fill - 5 dose units - 48 months from date of manufacture stored at or below 30°C - Ampoule, glass, (Type 1), 10 mL fill - 5 dose units - 48 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 3 mL fill - 1 dose units - 6 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 10 mL fill - 1 dose units - 48 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 4 mL fill - 1 dose units - 6 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 4 mL fill - 4 dose units - 6 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 3 mL fill - 4 dose units - 6 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 10 mL fill - 4 dose units - 48 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 10 mL fill - 5 dose units - 48 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 4 mL fill - 5 dose units - 6 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 3 mL fill - 5 dose units - 6 months from date of manufacture stored at or below 30°C
2019-03-04
Valproate-AFT Page 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 or to control bipolar mood disorder where periods of mania alternate with periods of depression. 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 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 Preberite celoten dokument
New Zealand Data Sheet Valproate-AFT - sodium valproate 1 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Valproate-AFT Intravenous solution for infusion or injection, 300 mg/3 ml, vials Valproate-AFT Intravenous solution for infusion or injection, 400 mg/4 ml, vials Valproate-AFT Intravenous solution for infusion or injection, 1000 mg/10 ml vials Valproate-AFT Intravenous solution for infusion or injection 300 mg/3 ml, ampoules Valproate-AFT Intravenous solution for infusion or injection, 400 mg/4 ml, ampoules Valproate-AFT Intravenous solution for infusion or injection, 1000 mg/10 ml ampoules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Valproate-AFT Solution for Infusion or Injection is a sterile, non-pyrogenic solution containing 100 mg/mL of sodium valproate For the full list of excipients, see Section 6.1, List of Excipients. 3 PHARMACEUTICAL FORM Solution for injection or infusion, 100 mg/mL 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ The treatment of patients with epilepsy or bipolar disorder, who would normally be maintained on oral sodium valproate/valproic acid, and for whom oral therapy is temporarily not possible. 4.2 DOSE AND METHOD OF ADMINISTRATION _ _ Valproate-AFT IV 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 IV 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. New Zealand Data Sheet Valproate-AFT - sodium valproate 2 Each vial or ampoule of Valproate-AFT IV is for single dose injection only. To reduce microbiological hazard, use as soon as practicable after reconstitution. If storage is necessary hold at 2 to 8ºC for not more than 24 hours. Valproate-AFT IV is intended for use in o Preberite celoten dokument