Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Atracurium besilate
Pfizer Ltd
M03AC04
Atracurium besilate
10mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 15010500; GTIN: 5015997144519
PACKAGE LEAFLET: INFORMATION FOR THE USER ATRACURIUM BESILATE 10 MG/ML SOLUTION FOR INJECTION The active substance is atracurium besilate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What Atracurium Besilate Solution for Injection is and what it is used for 2. What you need to know before you use Atracurium Besilate Solution for Injection 3. How to use Atracurium Besilate Solution for Injection 4. Possible side effects 5. How to store Atracurium Besilate Solution for Injection 6. Contents of the pack and other information 1. WHAT ATRACURIUM BESILATE SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR Atracurium Besilate Solution for Injection is a medicine which acts as a muscle relaxant. Atracurium Besilate Solution for Injection is used during surgery to relax muscles and to assist with inserting a breathing tube and with artificial breathing. It is also used to help with artificial breathing in patients in intensive care. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ATRACURIUM BESILATE SOLUTION FOR INJECTION DO NOT USE ATRACURIUM BESILATE SOLUTION FOR INJECTION - IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO ATRACURIUM BESILATE or any of the other ingredients of this drug (see section 6) WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR, PHARMACIST OR NURSE BEFORE USING ATRACURIUM BESILATE SOLUTION FOR INJECTION IF YOU - are pregnant or breast-feeding (see Pregnancy and breast-feeding) - have HEART OR CIRCULATION PROBLEMS - have PROBLEMS WITH YOUR LUNGS - have a HISTORY OF ALLERGY OR ASTHMA - suffer from MYASTHENIA GRAVIS, EATON-LAMBERT SYNDROME OR OTHER NEUROMUSCULAR DISEASES (these may result in muscle weakness) - have SEVERE ELECTROLYTE DISORDERS (unusual levels of ions such as sodium, potassium or chloride in your blood) - are SUF Прочитать полный документ
OBJECT 1 ATRACURIUM BESILATE 10 MG/ML SOLUTION FOR INJECTION - VIAL Summary of Product Characteristics Updated 31-Jan-2017 | Hospira UK Ltd 1. Name of the medicinal product Atracurium Besilate 10 mg/ml Solution for Injection 2. Qualitative and quantitative composition Atracurium besilate 10 mg/ml (equivalent to atracurium 7.5 mg/ml) 2.5 ml of solution contains 25 mg atracurium besilate 5 ml of solution contains 50 mg atracurium besilate 25 ml of solution contains 250 mg atracurium besilate For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection A clear colourless or faint yellow solution 4. Clinical particulars 4.1 Therapeutic indications Atracurium Besilate Injection is indicated as an adjunct to general anaesthesia during surgery to relax skeletal muscles, and to facilitate endotracheal intubation and mechanical ventilation. It is also indicated to facilitate mechanical ventilation in intensive care unit (ICU) patients. 4.2 Posology and method of administration USE AS AN ADJUNCT TO GENERAL ANAESTHESIA Atracurium Besilate Injection should only be administered by intravenous injection. DO NOT GIVE ATRACURIUM BESILATE INJECTION INTRAMUSCULARLY since this may result in tissue irritation and there are no clinical data to support this route of administration. To avoid distress to the patient, Atracurium Besilate Injection should not be administered before unconsciousness has been induced. Atracurium Besilate Injection should not be mixed in the same syringe, or administered simultaneously through the same needle, with alkaline solutions (e.g. barbiturate solutions). See section 6.6 for a list of compatible infusion solutions. 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. Initial bolus doses for intubation An initial atracurium besilate dose of 0.3 to 0.6 mg/kg (depending on the duration of full block required), given as an intrav Прочитать полный документ