Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Pancuronium bromide
Pfizer Healthcare Ireland
M03AC; M03AC01
Pancuronium bromide
2 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Other quaternary ammonium compounds; pancuronium
Not marketed
1991-03-07
Page 1 of 5 2019-0055386 PACKAGE LEAFLET: INFORMATION FOR THE USER PANCURONIUM BROMIDE 2 MG/ML SOLUTION FOR INJECTION PANCURONIUM BROMIDE 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. • If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Pancuronium Bromide Solution for Injection is and what it is used for 2. What you need to know before you use Pancuronium Bromide Solution for Injection 3. How to use Pancuronium Bromide Solution for Injection 4. Possible side effects 5. How to store Pancuronium Bromide Solution for Injection 6. Contents of the pack and other information 1. WHAT PANCURONIUM BROMIDE SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR Pancuronium bromide is one of a group of medicines called ‘non-depolarising’ muscle relaxants. Pancuronium Bromide Solution for Injection is used to relax muscles during surgery, including caesarean section and in intensive care. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PANCURONIUM BROMIDE SOLUTION FOR INJECTION DO NOT USE PANCURONIUM BROMIDE SOLUTION FOR INJECTION • if you are allergic to pancuronium bromide or any of the ingredients of this medicine (listed in section 6). • if you are using “depolarising” muscle relaxants, e.g. suxamethonium at the same time. WARNING AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST OR NURSE BEFORE USING PANCURONIUM BROMIDE SOLUTION FOR INJECTION if you have kidney, liver, lung or heart disease if you have high blood pressure if you have cancer, particularly lung cancer if you suffer from any of the following conditions: muscular dystrophy, myasthenia gravis, myasthenic syndrome (other neuromuscular Citiți documentul complet
Health Products Regulatory Authority 18 December 2020 CRN009ZDP Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pancuronium Bromide 2 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml contains 2 mg of pancuronium bromide. Each 2 ml ampoule contains 4 mg of pancuronium bromide. Excipients with known effect: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear, colourless solution with a pH of 3.8 – 4.2. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pancuronium bromide is a neuromuscular blocking agent with a long duration of action. It is used as an adjuvant in surgical anaesthesia to obtain relaxation of the skeletal muscles in a wide range of surgical procedures. It is also used as relaxant in orthopaedic manipulations. Used in intensive care therapy for a variety of pathologies e.g. intractable status asthmaticus and tetanus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY THE USE OF A PERIPHERAL NERVE STIMULATOR IS RECOMMENDED FOR MONITORING THE NEUROMUSCULAR BLOCK AND RECOVERY. The following may be used as a guideline: ADULT: Initial dose: 50-80 micrograms/kg (intubation within 150 to 120 seconds) Or 80-100 micrograms/kg (intubation accomplished within 120-90 seconds). Incremental doses: 10-20 micrograms/kg PAEDIATRIC: Initial dose: 60-100 micrograms/kg Incremental doses: 10-20 micrograms/kg NEONATES: Initial dose: 30-40 micrograms/kg Incremental doses: As neonates are sensitive this dose should be adjusted according to the initial response but generally incremental doses lie in the range 10 to 20 micrograms/kg. Ifsuxamethonium is used for intubation, the administration of pancuronium bromide should be delayed until the patient has clinically recovered from the neuromuscular block induced by suxamethonium. Health Products Regulatory Authority 18 December 2020 CRN009ZDP Page 2 of 7 Following the administration of suxamethonium, the dose of pancuronium bromide may be considerably reduced: Citiți documentul complet