Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diazepam
Wockhardt UK Ltd
N05BA01
Diazepam
2mg/1ml
Enema
Rectal
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010200; GTIN: 5012727902036
Process Black Text Free Area (non-printing) Keyline (non-printing) Wockhardt UK Limited Diazepam Rectube solution common leaflet 106002/3 See uploaded pdf 420mm x 160mm MPI 4 28/03/2017 835142 N/A 8pt (Main Body) / 8pt (Variables) UK English 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 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Diazepam RecTubes® are and what they are used for 2. What you need to know before you use Diazepam RecTubes® 3. How to use Diazepam RecTubes® 4. Possible side effects 5. How to store Diazepam RecTubes® 6. Contents of the pack and other information 1. WHAT DIAZEPAM RECTUBES® ARE AND WHAT THEY ARE USED FOR Diazepam RecTubes® contain diazepam which belongs to a group of medicines called benzodiazepines. Diazepam is used to treat: • severe anxiety and agitation • muscle spasms • epilepsy or febrile convulsions • symptoms of alcohol withdrawal Diazepam RecTubes® can also be used to provide sedation before operations (premedication). Your doctor may prescribe Diazepam RecTubes® for other uses. P Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diazepam RecTubes 2.5mg Rectal Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Diazepam 2.5mg in 1.25ml (2mg/ml) Excipients with known effect: Each 2.5mg tube contains: Benzoic acid (E210) –1.25mg Sodium benzoate (E211) – 61.25mg Propylene glycol –500mg. Benzyl alcohol – 18.75 mg For the_ _full list of excipients, see section_ _6.1 3 PHARMACEUTICAL FORM Rectal solution A clear, colourless or almost yellow solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diazepam has anticonvulsant, sedative, and muscle relaxant properties. It is used in the treatment of severe anxiety and tension states, as a sedative and premedication, in the control of muscle spasm, and in the management of alcohol withdrawal symptoms._ _ _ _ Diazepam rectal tubes may be used in acute severe anxiety and agitation, epileptic and febrile convulsions, tetanus, as a sedative in minor surgical and dental procedures, or in other circumstances in which a rapid effect is required but where intravenous injection is impracticable or undesirable. Diazepam rectal tubes may be of particular value for the immediate treatment of convulsions in infants and_ _children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Sensitivity to diazepam varies with age. _Adults: _ _Elderly patients: _ _0.5 mg/kg body weight _ _0.25 mg/kg body weight _ A maximum dose of 30 mg diazepam is recommended, unless adequate medical supervision and monitoring are available. Paediatric population: _ _ _Children above 1 year of age: _ _0.5 mg/kg body weight _ If convulsions are not controlled other anticonvulsive measures should be instituted. The dose can be repeated every 12 hours. Method of administration The solution is administered rectally. Adults should be in the lateral position; children should be in the prone or lateral position. a) Tear open the foil pack. Remove the cap. b) Insert the tube nozzle completely into the rectum. For children under 15kg, insert only half way. Hold the tube Perskaitykite visą dokumentą