Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Hyoscine hydrobromide
Martindale Pharmaceuticals Ltd
A04AD
Hyoscine hydrobromide
600 microgram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Other antiemetics
Marketed
2005-08-26
WHAT IS IN THIS LEAFLET 1. What Hyoscine Injection is and what it is used for 2. What you need to know before Hyoscine Injection is given 3. How Hyoscine Injection is given 4. Possible side effects 5. How to store Hyoscine Injection 6. Contents of the pack and other information 1. WHAT HYOSCINE INJECTION IS AND WHAT IT IS USED FOR Hyoscine Injection is used to treat nausea (feeling sick), vomiting (being sick), vertigo, loss of balance and motion sickness. Hyoscine Injection is also used to prevent you from producing too much saliva if you have been given a general anaesthetic. 2. WHAT YOU NEED TO KNOW BEFORE HYOSCINE INJECTION IS GIVEN YOU SHOULD NOT BE GIVEN HYOSCINE INJECTION IF YOU: • are allergic to hyoscine hydrobromide or any of the other ingredients of this medicine listed in section 6. • suffer from myasthenia gravis ( extreme muscle weakness) • suffer from megacolon ( dilated large bowel) • suffer from blockage of stomach (pyloric stenosis) or bowel • suffer from an inactive or paralysed bowel (paralytic ileus) • suffer from a racing heart • are a man who has an enlarged prostrate with urinary retention. • suffer from an eye problem called angle-closure glaucoma • are an elderly patient. WARNINGS AND PRECAUTIONS TELL YOUR DOCTOR OR NURSE BEFORE BEING GIVEN HYOSCINE INJECTION IF YOU: • suffer from epilepsy, as there is an increased seizure frequency in epileptic patients • have Down’s Syndrome • suffer from liver or kidney problems • suffer from diarrhoea • suffer from heart burn • have a fever • suffer from heart problems(i.e heart attack, high blood pressure, heart failure or are undergoing cardiac surgery) • suffer from overactive thyroid • suffer from inflammation of the bowel (colitis). CHILDREN: Use with caution. Children are more susceptible to side effects. PLEASE CONTACT YOUR DOCTOR OR NURSE IMMEDIATELY if you experience severe persistent or worsening stomach pain; together with, nausea, vomiting, changes in bowel movements, stomach tenderness, fainting or b Przeczytaj cały dokument
Health Products Regulatory Authority 12 April 2019 CRN008R64 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hyoscine Hydrobromide Martindale Pharma 600 micrograms/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml contains 600 micrograms of Hyoscine Hydrobromide. Excipient with known effect Contains 3.54 mg/ml of sodium For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection A clear colourless solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Nausea, vomiting, vertigo, labyrinthine disorders, motion sickness. 2. To prevent excessive bronchial salivary secretions during the use of general anaesthesia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults 1. 200 micrograms as a single dose. 2. 200 – 600 micrograms, 30 – 60 minutes before induction of anaesthesia. Paediatric population 1. 6 micrograms/ kg as a single dose. 2. 15 micrograms/ kg, 30 – 60 minutes before induction of anaesthesia. Children (under 4 months) Not recommended. Elderly Hyoscine is not recommended for use in the elderly. Method of administration By subcutaneous or intramuscular injection. In adults, the injection may if required also be given by the intravenous route for acute use. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hyoscine should not be administered to patients with myasthenia gravis, megacolon, angle-closure glaucoma, tachycardia, prostatic enlargement with urinary retention, gastrointestinal obstruction, mechanical stenosis in the region of the gastrointestinal tract or paralytic ileus. Health Products Regulatory Authority 12 April 2019 CRN008R64 Page 2 of 5 Hyoscine should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Caution is necessary in treating patients with cardiovascular disease (e.g. acute myocardial infarction, h Przeczytaj cały dokument