Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Atropine sulfate monohydrate 1%{relative};
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Atropine sulfate monohydrate 1% w/v
1 %
Eye drops, solution
Active: Atropine sulfate monohydrate 1%{relative} Excipient: Benzalkonium chloride Boric acid Disodium edetate dihydrate Hypromellose Water
Bottle, dropper, 15 mL
Prescription
Prescription
Boehringer Ingelheim Pharma GmbH & Co KG
Package - Contents - Shelf Life: Bottle, dropper, - 15 mL - 24 months from date of manufacture stored at or below 25°C
1969-12-31
1 NEW ZEALAND CONSUMER MEDICINE INFORMATION ATROPT _(At-rop-t)_ _Atropine sulphate (at-rop-een sul-fay-t) 0.5%, 1% _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ATROPT EYE DROPS. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using ATROPT against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS ATROPT The name of your medicine is ATROPT EYE DROPS. The active ingredient is called atropine sulphate. ATROPT widens the pupil of the eye and blocks the ability to change the focus of the eye. ATROPT EYE DROPS are for use in the eyes only. They should not be taken by mouth. WHAT IS ATROPT EYE DROPS USED FOR ATROPT EYE DROPS are used in eye examinations as well as other circumstances when the pupil is to be widened and/or the accommodation frozen. Your doctor, however, may have prescribed ATROPT EYE DROPS for another purpose. Ask your doctor if you have any questions about why ATROPT EYE DROPS have been prescribed for you. If you have any concerns, you should discuss this with your doctor or in his/her absence with your pharmacist. ATROPT EYE DROPS are available only on a doctor’s prescription. BEFORE YOU USE ATROPT EYE DROPS _ _ _When you must not use it _ Do not use ATROPT EYE DROPS if you are allergic to: • Atropine or any of the ingredients listed at the end of this leaflet. Do not use ATROPT EYE DROPS if you have angle closure glaucoma or a family history of glaucoma. ATROPT like all medicines, should not be used during pregnancy unless your doctor specifically tells you to (CATEGORY A). DO NOT USE ATROPT EYE DROPS AFTER THE EXPIRY DATE PRINTED ON THE PACK. If you use it after the expiry date has passed, it may have no effect at all, or worse, there may be an entirely unexpecte Leggi il documento completo
NEW ZEALAND DATA SHEET 1. ATROPT EYE DROPS (ATROPINE SULFATE 1%) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL contains 10 mg atropine Sulfate (1 %). Atropine Sulfate exists as odourless, colourless crystals or white crystalline powder. It effloresces in dry air. Atropine Sulfate is soluble in water (1 in 0.5), in boiling water (1 in 2.5), in alcohol (1 in 5), in glycerol (1 in 2.5), practically insoluble in chloroform and ether. A 2% solution in water has a pH of 4.5 to 6.2. Solutions may be sterilised by autoclave. Atropine Sulfate is both a mydriatic and cycloplegic and has the following molecular formula: (C 17 H 23 NO 3 ) 2 , H 2 SO 4 ,H 2 O. Relative molecular mass is 694.8. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM ATROPT EYE DROPS contains atropine Sulfate (1%) in a sterile aqueous base. A clear, or almost clear, slightly viscous, colourless liquid which foams on shaking. Odourless. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ATROPT EYE DROPS are indicated where it is necessary to dilate the pupil and paralyse accommodation. 4.2 DOSE AND METHOD OF ADMINISTRATION Instil one drop into the eye as required for treatment. To minimise the risk of systemic absorption, gentle pressure should be applied to the tear duct for one minute after application. 4.3 CONTRAINDICATIONS ATROPT EYE DROPS are contraindicated in the presence of angle closure glaucoma or where angle closure glaucoma is suspected. If used in glaucoma susceptible patients, an estimation of the depth of the angle of the anterior chamber should be performed prior to the initiation of therapy. Hypersensitivity to any ingredient in ATROPT EYE DROPS. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients treated prior to ophthalmic examination should be escorted to and from the surgery. _ _ _USE IN CHILDREN _ ATROPT EYE DROPS should be used with extreme caution, if at all, in infants and small children and in children with spastic paralysis or brain damage, due to their increased susceptibility to the systemic e Leggi il documento completo