国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Atropine sulfate
Martindale Pharmaceuticals Ltd
A03BA01
Atropine sulfate
200microgram/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 15010300; GTIN: 5026468000340
3. HOW ATROPINE SOLUTION FOR INJECTION IS GIVEN THIS MEDICINE IS AN INJECTION WHICH WILL BE GIVEN TO YOU BY A DOCTOR OR NURSE. Your doctor will decide the correct dose you require. ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS OF AGE: • 0.5mg into a vein, followed by further doses of 0.5mg if necessary, up to a maximum of 3mg. CHILDREN UNDER 12 YEARS OF AGE: This medicine is not recommended for children under 12. IF YOU THINK YOU HAVE BEEN GIVEN TOO MUCH ATROPINE SOLUTION FOR INJECTION THAN YOU SHOULD BE GIVEN: This medicine is given to you by your doctor so it is unlikely you will receive too much. Your doctor has information on how to recognise and treat an overdose. If you are concerned about your treatment, please talk to your doctor. 4. POSSIBLE SIDE EFFECTS Like all medicines Atropine Solution for injection can cause side effects, although not everybody gets them. The following side effects have been reported. CONTACT YOUR DOCTOR OR NURSE IMMEDIATELY IF YOU GET ANY OF THE FOLLOWING: • Sudden life – threatening allergic reaction such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing. OTHER SIDE EFFECTS INCLUDE: • blurred vision • increase in pressure in the eye • dry mouth • nausea • thirst • dilation of the pupils • uncomfortable sensitivity to light (photophobia) • decrease in tears production in the eyes • flushing • dryness of the skin • fast heart beat ( tachycardia) • palpitations (you are aware of your heart beating) • difficulty in passing urine • constipation • vomiting • nervousness • confusion especially in the elderly • thickening of the phlegm produced while coughing • restlessness • hallucinations • changes in the way the heart beats (arrhythmias) • severe confusion ( delirium) REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor, pharmacist or nurse: This includes any possible side effects not listed in this leaflet. You 阅读完整的文件
OBJECT 1 ATROPINE SULFATE 1MG IN 5ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Summary of Product Characteristics Updated 18-Jan-2017 | Martindale Pharma 1. Name of the medicinal product Atropine Sulfate 1mg in 5ml Solution for injection in pre-filled syringe. 2. Qualitative and quantitative composition Each 5 ml syringe contains 1 mg Atropine sulfate Each 1ml of solution for injection contains 0.2 mg Atropine sulphate For the full list of excipients, see section 6.1. . 3. Pharmaceutical form Solution for injection in pre-filled syringe. Clear and practically particulate free solution pH 3 - 4.5. 4. Clinical particulars 4.1 Therapeutic indications Reversal of excessive of bradycardia. The administration is given in the algorithm for the emergency treatment of Peri - arrest arrhythmias produced by European Resuscitation Council's and Resuscitation Council (UK). 4.2 Posology and method of administration _Adults and children over 12 years _ Initially 0.5mg by intravenous injection and then increments of 0.5mg to a maximum of 3mg. Paediatric population Not recommended. _Elderly _ As for Adults. Method of administration: Atropine 1mg in 5ml is administered by intravenous injection. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in 6.1 o Closed-angle glaucoma o Risk of urinary retention because of prostatic or urethral disease o Myasthenia gravis unless given in conjunction with anticholinesterase o Breast-feeding (see section 4.6). o Achalasia of the oesophagus 4.4 Special warnings and precautions for use Use with caution in case of: Prostatic enlargement Renal or hepatic insufficiency Cardiac insufficiency, arrhythmias, hyperthyroidism Chronic obstructive pulrnonary disease, as a reduction in bronchial secretions may lead to the formation of bronchial plugs Paralytic ileus, intestinal atonia in elderly, toxic megacolon Pyloric stenosis Fever, or when ambient temperature is high In the elderly, who are more susceptible to adverse effects. . 4.5 Interaction with oth 阅读完整的文件