Country: Միացյալ Թագավորություն
language: անգլերեն
source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium valproate
Wockhardt UK Ltd
Sodium valproate
100mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5012727907871
MPS READ DIRECTION WOCKHARDT TRAVEL DIRECTION Pharmacode: Process Black Keyline (non-printing) Text free area (non-printing) Wockhardt UK Limited SODIUM VALPROATE INJ 100MG/ML AMP COMMON LEAFLET 105857/6 See uploaded pdf 475 x 150mm MPI 3 04/08/2017 880758 446 6pt (Main Body) / 7.5pt (Variables) UK English 446 MEASURE BAR SHOULD BE 150MM AT 100% SCALE Customer Description Item Code Profile Size Min. Point Size Market Language Proof By Proof No. Date Artwork No. Pharma Code Colours Used WARNING! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our clientʼs brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT. artwork.leicester@CIRRUS-ARTWORK.com PACKAGE LEAFLET INFORMATION FOR THE PATIENT SODIUM VALPROATE 100MG/ML SOLUTION FOR INJECTION OR INFUSION THIS MEDICINE IS SUBJECT TO ADDITIONAL MONITORING. This will allow quick identifica tion of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. WARNING Valproate can cause birth defects and problems with early development of the child if it is given during pregnancy. If you are a female of childbearing age you should use an effective method of contraception throughout your treatment. Your doctor will discuss this with you but you should also follow the advice in section 2 of this leaflet. Tell your doctor at once if you become pregnant or think you might be pregnant. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get any side effects, talk to your doctor or p read_full_document
OBJECT 1 SODIUM VALPROATE 100MG/ML SOLUTION FOR INJECTION OR INFUSION Summary of Product Characteristics Updated 18-Oct-2017 | Wockhardt UK Ltd This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product Sodium Valproate 100mg/ml Solution for Injection or Infusion 2. Qualitative and quantitative composition Each ml of solution contains 100 mg sodium valproate. Each 4 ml ampoule contains 400 mg sodium valproate. Each 10 ml ampoule contains 1000 mg sodium valproate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for Injection or Infusion. A clear colourless solution. 4. Clinical particulars 4.1 Therapeutic indications The treatment of epileptic patients who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible. 4.2 Posology and method of administration Sodium valproate injection may be given by direct slow intravenous injection or by infusion using a separate intravenous line in normal saline, dextrose 5%, or dextrose saline. _DOSAGE_ Dosage requirements vary according to age and body weight. Each vial of sodium valproate injection is for single dose injection only. For instructions on preparation and dilution of sodium valproate injection before administration see section 6.6. Sodium valproate injection should not be administered via the same IV line as other IV additives. The intravenous solution is suitable for infusion by PVC, polyethylene or glass containers. Patients already satisfactorily treated with oral sodium valproate may be continued at their current dosage using continuous or repeated infusion. Other patients may be given a slow intravenous injection over 3-5 minutes, usually 400-800mg depending on body weight (up to 10mg/kg) followed by continuous or repeated infusion up to a maximum of 2 read_full_document