Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
cyclopentolate hydrochloride, Quantity: 10 mg/mL
Bausch & Lomb Australia Pty Ltd
Eye Drops, solution
Excipient Ingredients: purified water; hydrochloric acid
Ophthalmic
20 X 0.5mL
Medicine Registered
(S4) Prescription Only Medicine
To produce mydriasis and cycloplegia
Visual Identification: A clear, colourless solution, reasonably free from visible particulate matter; Container Type: Tube; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
1991-10-30
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 TAMPERING. If it has expired or is Прочетете целия документ
Minims Cyclopentolate PI-A20210428v6 Page 1 of 10_ _ AUSTRALIAN PRODUCT INFORMATION – MINIMS® CYCLOPENTOLATE HYDROCHLORIDE (CYCLOPENTOLATE HYDROCHLORIDE) EYE DROPS 1 NAME OF THE MEDICINE Cyclopentolate hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Minims Cyclopentolate Eye Drops are sterile preservative-free solutions containing cyclopentolate hydrochloride 0.5% (5 mg/mL) or 1% w/v (10 mg/mL) as the active ingredient. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Eye drops, solution. Minims Cyclopentolate Eye Drops are clear colourless solutions, reasonably free from visible particulate matter. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Minims Cyclopentolate Eye Drops are indicated to produce mydriasis and cycloplegia. 4.2 D OSE AND METHOD OF ADMINISTRATION Adults (including the elderly) Minims Cyclopentolate Eye Drops should be instilled drop wise into the eye according to the recommended dosage below. One drop as required. Maximum effect is induced 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 drop is 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, if the 0.5% solution does not induce cycloplegia, the dosage regimen (children) and/or the strength of cyclopentolate used should be increased accordingly. Minims Cyclopentolate PI-A20210428v6 Page 2 of 10_ _ Children <3 months: not recommended 3 months – 12 years: 1 drop of a 0.5% solution to each eye 12 years – adult: 1 drop of 0.5% or 1% solution to each eye repeated after 10 minutes if necessary Children should be observed for 45 minutes after installation. Parents are advised to avoid contact of the solution with the child’s Прочетете целия документ