País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
sodium valproate, Quantity: 400 mg
Juno Pharmaceuticals Pty Ltd
Injection, solution
Excipient Ingredients: water for injections
Intravenous, Intravenous Infusion
10 ampoules
(S4) Prescription Only Medicine
Sodium valproate Juno 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: Sodium valproate Juno 400 mg/4 mL is a clear colourless sterile solution presented in transparent colorless type 1 glass ampoules of 5 ml in 10 pack; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2017-12-13
Sodium Valproate Juno 1 SODIUM VALPROATE JUNO 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 USING SODIUM VALPROATE JUNO? Sodium Valproate Juno contains the active ingredient sodium valproate. Sodium Valproate Juno is used for the treatment of epilepsy in adults and children For more information, see Section 1. Why am I using Sodium Valproate Juno? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE SODIUM VALPROATE JUNO? Do not use if you have ever had an allergic reaction to Sodium Valproate Juno 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 I use Sodium Valproate Juno? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Sodium Valproate Juno 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 DO I USE SODIUM VALPROATE JUNO? • If you are not currently taking Sodium Valproate Juno or any other form of sodium valproate by mouth, your doctor will decide what dose you will receive, depending on your condition and other factors such as your weight. Sodium Valproate Juno will be given to you as an infusion or injection into the veins. More instructions can be found in Section 4. How do I use Sodium Valproate Juno? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING SODIUM VALPROATE JUNO? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Sodium Valproate Juno. • If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine. • If you become pregnant while you are taking this medicine, tell your doctor immediately. THINGS YOU SHOULD NOT D Leia o documento completo
Australian Product Information Page | 1 AUSTRALIAN PRODUCT INFORMATION SODIUM VALPROATE JUNO_ (SODIUM VALPROATE) _ _ _ 1 NAME OF THE MEDICINE Sodium valproate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium valproate Juno is a clear colourless sterile solution containing sodium valproate 400 mg in 4 mL water for injections. The pH of the solution ranges from 7.0 to 9.0. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Sodium valproate, 400 mg / 4 mL, solution for injection ampoule 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sodium valproate Juno 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 DOSE AND METHOD OF ADMINISTRATION Sodium valproate Juno 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 Juno 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 Juno should be replaced by oral sodium valproate therapy as soon as practicable. Each ampoule of Sodium valproate Juno is for single dose injection only. Sodium valproate Juno is intended for use in one patient on one occasion only, any unused portion should be discarded. NEVER ADMINISTER SODIUM VALPROATE JUNO OTHER THAN BY THE INTRAVENOUS ROUTE (see SECTIONS 4.3 CONTRAINDICATIONS). MONOTHERAPY Daily dosage requirements vary according to age and body weight. ADULTS Patients already satisfactorily treated with sodium valproate may be continued at their current dosage using continuous infusion. For example, a patient stabilised on 25 mg/kg administered daily shou Leia o documento completo