Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Cyclopentolate hydrochloride 0.5% (+ 5% overage);
Bausch & Lomb (NZ) Ltd
Cyclopentolate hydrochloride 0.5% (+ 5% overage)
0.5 %
Eye drops, solution
Active: Cyclopentolate hydrochloride 0.5% (+ 5% overage) Excipient: Hydrochloric acid Purified water
Single use dropper, 20 x 0.5ml, 20 dose units
Prescription
Prescription
Union Quimico Farmaceutica SA (Uquifa SA)
As a topical mydriatic and cycloplegic.
Package - Contents - Shelf Life: Single use dropper, 0.5ml - 20 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
1988-12-01
MINIMS ® CYCLOPENTOLATE EYE DROPS 1 MINIMS ® CYCLOPENTOLATE EYE DROPS _Cyclopentolate Hydrochloride Eye Drops _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Minims Cyclopentolate 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 Cyclopentolate 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 CYCLOPENTOLATE EYE DROPS IS USED FOR Minims Cyclopentolate Eye Drops belongs to a class of medicines called antimuscarinic agents. It is used to dilate (enlarge) the pupil of the eye and to temporarily paralyse the lens 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 CYCLOPENTOLATE EYE DROPS _WHEN YOU MUST NOT USE IT _ DO NOT USE MINIMS CYCLOPENTOLATE EYE DROPS IF YOU HAVE AN ALLERGY TO: * Any medicine containing cyclopentolate * 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 MINIMS CYCLOPENTOLATE EYE DROPS IF YOU HAVE OR SUSPECT YOU HAVE ANGLE CLOSURE GLAUCOMA (HIGH PRESSURE IN THE EYE). Cyclopentolate can increase the pressure in the eye. DO NOT USE THIS MEDICINE IN NEONATES OR INFANTS LESS THAN 3 MONTHS OLD. DO NOT USE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERIN Perskaitykite visą dokumentą
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME MINIMS CYCLOPENTOLATE HYDROCHLORIDE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Clear, colourless, sterile eye drops containing cyclopentolate hydrochloride BP 0.5% w/v or 1.0% w/v. 3. PHARMACEUTICAL FORM Single-use, sterile eye drops. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a topical mydriatic and cycloplegic. 4.2 DOSE AND METHOD OF ADMINISTRATION Adults (including the elderly): Instil dropwise into eye according to the recommended dosage. One or two drops as required. Maximum effect is induced in 30 - 60 minutes after instillation. For refraction and examination of the back of the eye: 1 drop of solution, which may be repeated after five minutes, is usually sufficient. For anterior and posterior uveitis (if associated with signs of anterior uveitis) and for the breakdown of posterior synechiae: 1 - 2 drops are instilled every 6 - 8 hours. Resistance to cycloplegia can occur in young children, in patients with dark skin and/or patients with dark irides, therefore, the strength of cyclopentolate used should be adjusted accordingly. Children: < 3 months: Not recommended 3 months - 12 years: 1 drop of a 1% solution to each eye. 12 years - adult: 1 drop of 0.5% solution to each eye repeated after 10 minutes if necessary. Children should be observed for 45 minutes after instillation. 2 4.3 CONTRAINDICATIONS Do not use in patients with a known hypersensitivity to any component of the preparation. Do not use in patients with narrow-angle glaucoma or in those with a shallow anterior chamber (see section 4.4 Special warnings and precautions for use). Do not use in geriatric patients and other patients who may be predisposed to an increased intraocular pressure. Do not use in sensitive patients, especially infants, premature births, small children, adults over 65 years old and patients with Down’s syndrome, as well as in children with brain damage (see section 4.4 Special warnings and precautions for use). Do not use in children with organic brain syndromes, includ Perskaitykite visą dokumentą