Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
ephedrine hydrochloride, Quantity: 30 mg
Juno Pharmaceuticals Pty Ltd
Injection, solution
Excipient Ingredients: citric acid monohydrate; dilute hydrochloric acid; water for injections; sodium hydroxide; sodium chloride; sodium citrate
Intravenous
10 pack
(S4) Prescription Only Medicine
Treatment of hypotension secondary to spinal anaesthesia
Visual Identification: A clear and colourless, isotonic, sterile and pyrogen free solution in packs of 10; Container Type: Syringe; Container Material: PP; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2018-03-23
Page 1 EPHEDRINE HYDROCHLORIDE AGUETTANT _Ephedrine Hydrochloride solution for injection, 30 mg/10 mL_ _ _ _ _ CONSUMER MEDICINE INFORMATION _Date of Dispensing _ _Consumer Name _ _Pharmacist Name_ _Consumer Address _ _Pharmacist Address_ _ _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ephedrine Hydrochloride Aguettant. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Ephedrine Hydrochloride Aguettant against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT EPHEDRINE HYDROCHLORIDE AGUETTANT INJECTION IS USED FOR Ephedrine Hydrochloride Aguettant is used to treat the low blood pressure which may occur during spinal anaesthesia. It works by contracting the blood vessels in your limbs, so that more blood is available for your heart. Your doctor may have prescribed this medicine for another reason. Ask your doctor if you have any questions about why it has been prescribed for you. Ephedrine Hydrochloride Aguettant is available only with a doctor’s prescription. Ephedrine Hydrochloride Aguettant is not approved for use in children. BEFORE YOU ARE GIVEN EPHEDRINE HYDROCHLORIDE AGUETTANT INJECTION _WHEN YOU MUST NOT BE _ _GIVEN IT_ _ _ YOU SHOULD NOT BE GIVEN EPHEDRINE HYDROCHLORIDE AGUETTANT IF: • YOU HAVE AN ALLERGY TO EPHEDRINE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET Symptoms of an allergic reaction to ephedrine may include: − shortness of breath, wheezing or difficulty in breathing − swelling of the face, lips, tongue or other parts of the body − rash, itching or hives on the skin. • YOU HAVE, OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: − heart problems − pheochromocytoma (a rare tumour of the adrenal gland near the kidney) − closed angle glaucoma (a conditio Прочитать полный документ
Australian Product Information Page | 1 EPHEDRINE HYDROCHLORIDE AGUETTANT SOLUTION FOR INJECTION _ _ _ (EPHEDRINE HYDROCHLORIDE) _ _ _ PRODUCT INFORMATION 1 NAME OF THE MEDICINE Ephedrine Hydrochloride Aguettant contains ephedrine hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ephedrine Hydrochloride Aguettant is a sterile solution of ephedrine hydrochloride in water for injections. Each 10 mL contains 30 mg of ephedrine hydrochloride (equivalent to 24.6 mg ephedrine), sodium chloride, citric acid monohydrate, and sodium citrate in Water for Injections. The pH is 4.0 – 5.5. Ephedrine Hydrochloride Aguettant contains no preservative and is for single use in one patient on one occasion only. Discard any remaining residue. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Ephedrine hydrochloride 30mg/10mL solution for injection polypropylene ampoule Ephedrine hydrochloride 30mg/10mL solution for injection polypropylene syringe 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ephedrine Hydrochloride Aguettant is indicated in the treatment of hypotension secondary to spinal anaesthesia 4.2 DOSE AND METHOD OF ADMINISTRATION Ephedrine Hydrochloride Aguettant is not approved for use in children (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). The injection should be given slowly. Care should be taken to avoid extravasation, since this may result in tissue necrosis and sloughing. Ephedrine hydrochloride should be administered in the lowest effective dose. The injection should be given as a slow intravenous injection of 3 to 7.5 mg (maximum 10 mg), repeated as needed every 3-4 min to a maximum of 30 mg. A lack of efficacy after 30 mg should lead to reconsideration of the choice of the therapeutic agent. During therapy with a pressor agent, blood pressure should be elevated to slightly less than the patient’s normal blood pressure. In previously normotensive patients, systolic blood pressure should be maintained at 80 to 100 mmHg. In previously hypertensiv Прочитать полный документ