Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
atropine sulfate monohydrate, Quantity: 10 mg/mL
Bausch & Lomb Australia Pty Ltd
Eye Drops, solution
Excipient Ingredients: hydrochloric acid; purified water
Ophthalmic
20 X 0.5mL single dose units
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 Material: PP; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1991-10-30
MINIMS ATROPINE SULPHATE EYE DROPS _Atropine sulfate monohydrate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Minims Atropine Sulphate 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 your using Minims Atropine Sulphate 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 ATROPINE SULPHATE EYE DROPS IS USED FOR Minims Atropine Sulphate 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 ATROPINE SULPHATE EYE DROPS _WHEN YOU MUST NOT USE IT_ DO NOT USE MINIMS ATROPINE SULPHATE EYE DROPS IF YOU HAVE AN ALLERGY TO: • Any medicine containing atropine • 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 ATROPINE SULPHATE EYE DROPS IF YOU HAVE OR SUSPECT YOU HAVE ANGLE CLOSURE GLAUCOMA (HIGH PRESSURE IN THE EYE). Atropine can increase the pressure in the eye. 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 Leggi il documento completo
Minims Atropine PI-A20200429 v4 Page 1 of 7 AUSTRALIAN PRODUCT INFORMATION – MINIMS ATROPINE SULPHATE (ATROPINE SULFATE MONOHYDRATE) EYE DROPS 1 NAME OF THE MEDICINE Atropine sulfate monohydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Minims Atropine Eye Drops contain atropine sulfate monohydrate 1% w/v. No preservatives are contained in the formulation. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM A single-use eye drops, solution. Minims Atropine Eye Drops are clear, colourless sterile eye drops. No preservatives are contained in the formulation. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Minims Atropine Eye Drops are indicated to produce mydriasis and cycloplegia. 4.2 D OSE AND METHOD OF ADMINISTRATION Adults (including the elderly): One drop to be instilled into the eye, or as required. Systemic absorption of atropine may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.). Each Minims Atropine Eye Drops unit should be discarded after a single use. 4.3 C ONTRAINDICATIONS Minims Atropine Eye Drops are contraindicated in patients with hypersensitivity to any of the components of the preparation. Minims Atropine Eye Drops are contraindicated in the presence of angle closure glaucoma or where angle closure glaucoma is suspected. Minims Atropine PI-A20200429 v4 Page 2 of 7 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE IDENTIFIED PRECAUTIONS Minims Atropine Eye Drops are for topical ophthalmic use only. The solution should not be injected. Due to the risk of precipitating an acute attack, atropine eye drops should not be used in cases of confirmed narrow-angle glaucoma or where latent narrow angle glaucoma is suspected. If in doubt, it is recommended that an alternative preparation be used. Atropine eye drops shou Leggi il documento completo