Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Atracurium besilate
Actavis UK Ltd
M03AC04
Atracurium besilate
10mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 15010500; GTIN: 5012617020086
Atracurium 10 mg/ml Sol. for injection/infusion PIL - UK item no: AAAF6972 print proof no: 5 origination date: 22.07.13 originated by: DR revision date: 04.11.13 revised by: DR dimensions: 148 x 520 pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. 2. 3. date sent: 22.07.13 supplier: Rotexmedica technically app. date: 24.07.13 min pt size: 8.5pt TECHNICAL APPROVAL _Continued top of next column_ AAAF6972 _Continued over page_ _Continued over page_ ATRACURIUM 10MG/ML SOLUTION FOR INJECTION/INFUSION _Continued top of next column_ AAAF6972 Atracurium besilate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. • This medicine has been prescribed for you only. Do 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. • The full name of this medicine is Atracurium 10mg/ml Solution for Injection/Infusion but within the leaflet it will be referred to as Atracurium. W HAT IS IN THIS LEAFLET 1 WHAT ATRACURIUM IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU USE ATRACURIUM 3 HOW TO USE ATRACURIUM 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE ATRACURIUM 6 CONTENTS OF THE PACK AND OTHER IN FOR MATION 1 WHAT ATRACURIUM IS AND WHAT IT IS USED FOR Atracurium belongs to a group of medicines called muscle relaxants. It is used to relax muscles during surgery. ATRACURIUM IS USED: • during surgery, other procedures and in intensive care • during general anaesthesia to ease tracheal intubation (a tube into the windpipe) and controlled ventilation. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE ATRACURIUM DO NOT USE ATRACURIUM • if you allergic (hypersensitive) to atracurium, cisatracurium Lugege kogu dokumenti
OBJECT 1 ATRACURIUM 10MG/ML SOLUTION FOR INJECTION/INFUSION Summary of Product Characteristics Updated 21-Jan-2014 | Accord-UK Ltd 1. Name of the medicinal product Atracurium 10mg/ml Solution for Injection/Infusion 2. Qualitative and quantitative composition 1 ml solution contains 10 mg of atracurium besilate. One ampoule with 2.5 ml solution contains 25 mg atracurium besilate. One ampoule with 5.0 ml solution contains 50 mg atracurium besilate. One ampoule with 25.0 ml solution contains 250 mg atracurium besilate For a full list of excipients, see section 6.1 3. Pharmaceutical form Solution for injection and Concentrate for solution for infusion Clear and colourless solution 4. Clinical particulars 4.1 Therapeutic indications Atracurium besilate is used intravenously as an adjunct to general anaesthesia, during surgical and other procedures and in intensive care to facilitate tracheal intubation and controlled ventilation. 4.2 Posology and method of administration In common with all neuromuscular blocking agents, monitoring of neuromuscular function is recommended during the use of atracurium besilate injection, in order to individualise dosage requirements. USE IN ANAESTHESIA ● _In adults: Use as an injection_ Atracurium besilate is administered by intravenous injection and must not be applied intramuscularly. _Relaxation_ The dosage range recommended for adults is 0.3 to 0.6 mg atracurium/kg (depending on the duration of full block required). This dose will provide adequate relaxation for about 15 to 35 minutes. _Intubation_ Endotracheal intubation can usually be accomplished within 90 seconds from the intravenous injection of 0.5 to 0.6 mg atracurium/kg. _Repeated dose_ Full block can be prolonged with supplementary doses of 0.1 to 0.2 mg atracurium/kg. Generally, the first maintenance dose is required 20 to 45 minutes after the initial bolus dose, then typically at 15 to 25 minutes intervals, however, the need for maintenance doses should be determined by the individual patient's requirements and responses Lugege kogu dokumenti