국가: 몰타
언어: 영어
출처: Medicines Authority
NEOSTIGMINE METILSULFATE
Mercury Pharmaceuticals (Ireland) Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland
N07AA01
NEOSTIGMINE METILSULFATE 2.5 mg/ml
SOLUTION FOR INJECTION
NEOSTIGMINE METILSULFATE 2.5 mg/ml
POM
OTHER NERVOUS SYSTEM DRUGS
Withdrawn
2006-11-28
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 nurse. If you get any of the side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. This product will be referred to as Neostigmine Injection from here on. WHAT IS IN THIS LEAFLET 1. What Neostigmine Injection is and what it is used for 2. What you need to know before you are given Neostigmine Injection 3. How Neostigmine Injection is given to you 4. Possible side effects 5. How to store Neostigmine Injection 6. Contents of the pack and other information 1. WHAT NEOSTIGMINE INJECTION IS AND WHAT IT IS USED FOR Neostigmine Injection belongs to a group of medicines called cholinesterase inhibitors. Neostigmine Injection is used: • to reverse the effects of some muscle relaxants • in a condition where muscles become abnormally tired and weak (myasthenia gravis) and it is not suitable to give the treatment by mouth • to improve the movement in the small intestine • to reduce the inability to pass water or to relieve the feeling of being bloated after an operation. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NEOSTIGMINE INJECTION YOU SHOULD NOT BE GIVEN NEOSTIGMINE INJECTION: • if you are allergic to neostigmine metilsulfate or any of the other ingredients of this medicine (listed in section 6) • if you have an obstruction in your stomach, intestine or cannot urinate • if you have stomach pain, inflammation or infection of the outer layer of your stomach or intestines (peritonitis) • if you are receiving suxamethonium, a muscle relaxant usually given during operations. Tell your doctor if any of these apply to you before you are given this medicine. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before Neostigmine Injection is given to you if • you suffer from asthma • you have a very slow heart be 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Neostigmine Metilsulfate 2.5mg/ml Solution for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml contains 2.5mg Neostigmine Metilsulfate. For a 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 The symptomatic treatment of myasthenia gravis where oral therapy is impractical. Reversal of the effects of non-depolarising neuromuscular blocking agents. The management of post-operative distension, paralytic ileus and urinary retention, where mechanical obstruction has been out-ruled. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Neostigmine Injection BP may be administered intramuscularly, subcutaneously or intravenously. Where the intravenous route is used, administration must be by very slow injection. TREATMENT OF MYASTHENIA GRAVIS Adults: Doses 1 to 2.5 mg may be given by I.M. or S.C. injection at intervals during the day when strength is most needed. The total daily dose is usually in the range of 5 to 20 mg but higher doses may be required by some patients. CHILDREN: Neonatal myasthenia can be treated with an initial dose of 0.1mg intramuscularly. Thereafter, the dosage should be titrated individually and is usually in the range of 0.05 to 0.25mg by injection. Treatment is rarely needed beyond eight weeks of age. Reversal of non-depolarising neuromuscular blocking agents. ADULTS AND CHILDREN: The usual dose is 0.05 to 0.07mg per kg body weight, given concomitantly with or after atropine sulphate, by slow intravenous injection over a period of 60 seconds. Additional neostigmine may be required to restore normal muscle power but a total of 5mg for adults and 2.5mg for children should not be exceeded. If preferred, the atropine sulph 전체 문서 읽기