Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
ATROPINE SULFATE
Bausch & Lomb UK Limited
S01FA01
ATROPINE SULFATE
EYE DROPS, SOLUTION
ATROPINE SULFATE 1 % (W/V)
POM
OPHTHALMOLOGICALS
Authorised
2005-10-04
minims atropine sulphate #1% w/v Eye drops, solution minims atropine sulphate #1% w/v Eye drops, solution 85881 C1UKIE01 Active ingredient: Each unit (0.5ml) contains atropine sulphate 5mg. Excipients: Purified water and hydrochloric acid (for pH-adjustment). British Pharmacopoeia Evocative Code: ATR 1.0 DOSAGE Use as directed by medical practitioner. DIRECTIONS FOR USE 1 Peel the overwrap apart and withdraw the Minims ® unit. 2 Twist cap and pull off. 3 Squeeze the unit to obtain the number of drops required. 4 FOR SINGLE USE ONLY. DISCARD ANY UNUSED SOLUTION. For ocular use. 20 sterile single-dose containers of 0.5 ml. Manufacturer: Laboratoire Chauvin Z.I. Ripotier Haut 07200 Aubenas - France PL 03468/0068 PA 555/17/1 MAL19861687A HK-08619 SIN4317P MA 147/00101 10668GB Bausch & Lomb UK Ltd, 106 London Road, Kingston-Upon-Thames, Surrey, KT2 6TN, United Kingdom Minims is a registered trademark of Bausch & Lomb Incorporated or its affiliates. 5 027519 000302 ATROPINE SULPHATE 1% w/v Eye Drops, Solution ® 20 Single-dose containers Preservative-free ATROPINE SULPHATE 1% w/v Eye Drops, Solution ® ATROPINE SULPHATE 1% w/v Eye Drops, Solution ® ATROPINE SULPHATE 1% w/v Eye Drops, Solution ® One MINIMS UNIT One patient Do not store above 25°C. Do not freeze. STORE IN ORIGINAL CONTAINER TO PROTECT FROM LIGHT. Keep out of the reach and sight of children. KARTONIK CARTON Nazwa produktu Product name Kraj Country (ISO) Wymiar komponentu Component size Kolory nadruku Colours Dane techniczne Technical data Krój czcionki Fonts Used Kod kreskowy Barcode _(EAN, PZN etc.)_ Wielkość opakowania Pack size Kod farmaceutyczny Pharmacode Kod wersji Valeant code version Nr Wykrojnika Spec. No. Kod Wytwórcy Manufacturer code Data Date Nr korekty Proof Nr Komentarze Comments _(Reason for the change)_ Rozmiar czcionki Font size MINIMUM 5,84 PT Graphics&Packing Technology Section ICN Polfa Rzeszów S.A. _MAH transfer from Chauvin Pharmaceuticals Ltd UK to B+L UK Ltd_ _PMR_ICN-14-0723-A_ _Packing Site: Aubenas Plant_ Opracowane pr Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Minims Atropine Sulphate 1%. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Clear, colourless, sterile eye drops containing Atropine Sulphate Ph Eur 1% w/v. 3. PHARMACEUTICAL FORM Sterile, single-use eye drops. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a topical mydriatic and cycloplegic. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults (including the elderly)_: One drop to be instilled into the eye, or as required. 4.3 CONTRA-INDICATIONS Hypersensitivity to any component of the preparation. Due to the risk of precipitating an acute attack, do not use 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 is used. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The protracted mydriasis which is difficult to reverse, may be a disadvantage. Systemic absorption 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.) 4.5 INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION None known. 4.6 PREGNANCY AND LACTATION The safety for use in pregnancy a Citiți documentul complet