Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Glycopyrronium bromide
Accord-UK Ltd
A03AB02
Glycopyrronium bromide
200microgram/1ml
Solution for injection
Intravenous; Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 15010300; GTIN: 5055565712627
PACKAGE LEAFLET: INFORMATION FOR THE USER GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML INJECTION (GLYCOPYRRONIUM 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 further questions, please ask your doctor or 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 signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML INJECTION is and what it is used for 2. What you need to know before you use GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML INJECTION 3 . How to use GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML INJECTION 4. Possible side effects 5 . How to store GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML INJECTION 6. Contents of the pack and other information 1. WHAT GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML INJECTION IS AND WHAT IT IS USED FOR Glycopyrronium bromide belongs to a group of medicines called anti-muscarinic drugs. Glycopyrronium Bromide 200 micrograms/ml Injection may be given: • To protect against some of the unwanted effects of drugs such as neostigmine or pyridostigmine, which are given to reverse the effects of certain types of muscle-relaxing drugs (called non-depolarising muscle relaxants). • Before an operation to reduce saliva and other secretions and to reduce acidity in the stomach contents. • Before or during an operation, to reduce or prevent slowness of the heartbeat during surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML INJECTION Before you are given Glycopyrronium Bromide 200 micrograms/ml Injection, please read the following statements: DO NOT USE GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML INJECTION: • if you are allergic to glycopyrronium Lesen Sie das vollständige Dokument
OBJECT 1 GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML INJECTION ACCORD Summary of Product Characteristics Updated 07-Oct-2016 | Accord Healthcare Limited 1. Name of the medicinal product Glycopyrronium Bromide 200 micrograms/ml Injection 2. Qualitative and quantitative composition Each 1 ml of sterile solution for injection contains 200 micrograms of glycopyrronium bromide. Each 3 ml of sterile solution for injection contains 600 micrograms of glycopyrronium bromide. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection. Clear, colourless, sterile solution. 4. Clinical particulars 4.1 Therapeutic indications 1. To protect against the peripheral muscarinic actions of anticholinesterases such as neostigmine and pyridostigmine, used to reverse residual neuromuscular blockade produced by non- depolarising muscle relaxants. 2. As a pre-operative antimuscarinic agent to reduce salivary, tracheobronchial and pharyngeal sections and to reduce the acidity of the gastric contents. 3. As a pre-operative or intra-operative antimuscarinic to attenuate or prevent intra-operative bradycardia with the use of suxamethonium or due to cardiac vagal reflexes. 4.2 Posology and method of administration Route of Administration: Intravenous or intramuscular injection. Dosage: _Premedication_: Adults and elderly patients: 200 - 400 micrograms or 4 - 5 micrograms/kg to a maximum of 400 micrograms intravenously or intramuscularly. _Children: _ 4 - 8 micrograms/kg to a maximum of 200 micrograms intramuscularly or preferably by intravenous injection. Larger doses may result in a profound and prolonged antisialagogue effect which may be unpleasant for the patient. _Intra-operative use: _ Adults and elderly patients: By intravenous injection_:_ A single dose of 200 - 400 micrograms or 4 - 5 micrograms/kg to a maximum of 400 micrograms, repeated if necessary. Children: By intravenous injection: A single dose of 200 micrograms by intravenous injection should be used. Alternatively, a single dose of 4 - 8 mic Lesen Sie das vollständige Dokument