국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
ephedrine hydrochloride
Mayne Pharma International Pty Ltd
Ephedrine hydrochloride
Registered
v 1.0 1 EPHEDRINE HYDROCHLORIDE MYX™ INJECTION _Ephedrine Hydrochloride MYX, solution for injection, 25 mg/1 mL _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ephedrine Hydrochloride MYX. 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 MYX 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 MYX INJECTION IS USED FOR Ephedrine Hydrochloride MYX 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 MYX is available only with a doctor’s prescription. Ephedrine Hydrochloride MYX is not approved for use in children. BEFORE YOU ARE GIVEN EPHEDRINE HYDROCHLORIDE MYX INJECTION _WHEN YOU MUST NOT GIVEN _ _IT _ YOU SHOULD NOT BE GIVEN EPHEDRINE HYDROCHLORIDE MYX 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 condition in which there is a build up of pressure in the eye) - mood/thought disorders and were given monoamine oxidase (MAO) inhibitors in last two weeks or about to commenc 전체 문서 읽기
v 2.0 1 AUSTRALIAN PRODUCT INFORMATION EPHEDRINE HYDROCHLORIDE MYX ® (EPHEDRINE HYDROCHLORIDE) INJECTION 1. NAME OF THE MEDICINE Ephedrine hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ephedrine Hydrochloride MYX Injection is a sterile solution of ephedrine hydrochloride in water for injections. Each mL contains 25 mg of ephedrine hydrochloride (equivalent to 20.5 mg ephedrine) in water for injections. For the full list of excipients, see _section 6.1 List of Excipients_ . 3. PHARMACEUTICAL FORM Ephedrine Hydrochloride MYX is a clear and colourless solution for injection. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Ephedrine Hydrochloride MYX Injection is indicated in the treatment of hypotension secondary to spinal anaesthesia. 4.2. DOSE AND METHOD OF ADMINISTRATION Ephedrine Hydrochloride MYX Injection is not approved for use in children (see _section_ _4.4 Special Warnings and Precautions for Use – Paediatric Use_ ). Ephedrine Hydrochloride MYX Injection must be diluted prior to administration. Ephedrine Hydrochloride MYX Injection contains no preservative and is for single use in one patient on one occasion only. Discard any remaining residue. 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. Dilute 1 mL of Ephedrine Hydrochloride MYX Injection to 10 mL with saline 0.9% to produce a 2.5 mg/mL solution. This solution should be given as a slow intravenous v 2.0 2 injection of 2.5 to 5 mg (maximum 10 mg), repeated as needed every 3-4 minutes 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 hypertensive patien 전체 문서 읽기