国: ニュージーランド
言語: 英語
ソース: Medsafe (Medicines Safety Authority)
Phenylephrine hydrochloride 2.5%{relative}; ;
Bausch & Lomb (NZ) Ltd
Phenylephrine hydrochloride 2.5% w/v
2.5 %
Eye drops, solution
Active: Phenylephrine hydrochloride 2.5%{relative} Excipient: Disodium edetate dihydrate Sodium metabisulfite Water for injection
Single use dropper, 0.5ml, 20 dose units
Pharmacy only
Pharmacy only
Siegfried PharmaChemikalien Minden GmbH
Phenylephrine is a directly acting sympathomimetic agent used topically in the eye as a mydriatic. It may be indicated to dilate the pupil in diagnostic or therapeutic procedures.
Package - Contents - Shelf Life: Single use dropper, 0.5ml - 20 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
1988-12-01
MINIMS ® PHENYLEPHRINE EYE DROPS 1 MINIMS ® PHENYLEPHRINE EYE DROPS _Phenylephrine Hydrochloride Eye Drops _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Minims Phenylephrine Eye Drops, including how to use the eye drops. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you using Minims Phenylephrine Eye Drops against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT MINIMS PHENYLEPHRINE EYE DROPS IS USED FOR Minims Phenylephrine Eye Drops belongs to a class of medicines called sympathomimetic agents. It is used to dilate (enlarge) the pupil of the eye so that your doctor can examine your eye(s). It is usually used at the beginning of an eye examination. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED TO YOU. Your doctor may have prescribed it for another reason. BEFORE YOU USE MINIMS PHENYLEPHRINE EYE DROPS _WHEN YOU MUST NOT USE IT _ DO NOT USE MINIMS PHENYLEPHRINE EYE DROPS IF YOU HAVE AN ALLERGY TO: * Any medicine containing Phenylephrine * Any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: * Shortness of breath * Wheezing or difficulty breathing * Swelling of the face, lips, tongue or other parts of the body * Rash, itching or hives on the skin DO NOT USE THE 10% STRENGTH OF MINIMS PHENYLEPHRINE EYE DROPS IN CHILDREN OR THE ELDERLY. Children and the elderly may be more susceptible to the effects of phenylephrine. DO NOT USE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or is damaged, return it to your pharmacist for disposal. IF YOU ARE NOT SURE WHETHER YOU SHOULD START US 完全なドキュメントを読む
NEW ZEALAND DATA SHEET 1 MINIMS Phenylephrine Hydrochloride, eye drops solution 2.5% MINIMS Phenylephrine Hydrochloride, eye drops solution 10% 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 mL unit contains 12.5 mg or 50 mg Phenylephrine hydrochloride. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Clear, colourless, single-use sterile eye drops. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Phenylephrine is a directly acting sympathomimetic agent used topically in the eye as a mydriatic. It may be indicated to dilate the pupil in diagnostic or therapeutic procedures. 4.2 Dose and method of administration Adults: Apply one drop to each eye. If necessary, this dose may be repeated once only, at least one hour after the first drop. N.B. The use of a drop of topical anaesthetic a few minutes before instillation of phenylephrine is recommended to prevent stinging. Children and the elderly: The use of phenylephrine 10% solution is contraindicated in these groups because of the increased risks of systemic toxicity (see Section 4.3 Contraindications). Phenylephrine 10% solution is contraindicated in children aged below 12 years. There are no data in children aged 12 to 18 years. Phenylephrine 10% solution is not recommended in these patients. Apply one drop of the 2.5% w/v solution topically to the eye. It is not usually necessary to exceed this dose. 4.3 Contraindications Patients with cardiac disease, hypertension, aneurysms, thyrotoxicosis, long- standing insulin dependent diabetes mellitus and tachycardia. Patients on monoamine oxidase inhibitors, tricyclic anti-depressants and anti- hypertensive agents (including beta-blockers). Patients with closed angle glaucoma (unless previously treated with iridectomy) and patients with a narrow angle prone to glaucoma precipitated by mydriatics. Phenylephrine 10% solution is contraindicated in children aged below 12 years and NEW ZEALAND DATA SHEET elderly. Hypersensitivity to phenylephrine or any component of the preparation. 4.4 Special warnin 完全なドキュメントを読む