Land: Malta
Språk: engelsk
Kilde: Medicines Authority
CYCLOPENTOLATE HYDROCHLORIDE
Bausch & Lomb UK Limited
S01FA04
CYCLOPENTOLATE HYDROCHLORIDE
EYE DROPS, SOLUTION
CYCLOPENTOLATE HYDROCHLORIDE 1 % (W/V)
POM
OPHTHALMOLOGICALS
Authorised
2005-10-04
MINIMS® CYCLOPENTOLATE HYDROCHLORIDE 1% W/V Eye drops, solution For ocular use 1 sterile single-dose container of 0.5ml Preservative-free CYC 1.0 FOR SINGLE USE ONLY, DISCARD ANY UNUSED SOLUTION GB241C02-02.15 02/02/15 14:43 1 BN. EXP. X00000 00 0000 BAUSCH&LOMB PL03468/0071 PA555/18/1 POM CYCLOPENTOLATE HYDROCHLORIDE 1% w/v Eye Drops, Solution ® CYCLOPENTOLATE HYDROCHLORIDE 1% w/v Eye Drops, Solution ® 85888 C1UKIE01 CYCLOPENTOLATE HYDROCHLORIDE 1% w/v Eye Drops, Solution ® 20 Single-dose containers Preservative-free Manufacturer: Laboratoire Chauvin Z.I. Ripotier Haut 07200 Aubenas - France 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. PL 03468/0071 PA 555/18/1 MAL19870979A HK-08203 SIN4201P MA147/00103 10671GB Active ingredient: Each unit (0.5ml) contains cyclopentolate hydrochloride 5mg. Excipients: Purified water and hydrochloric acid (for pH-adjustment). British Pharmacopoeia Evocative Code: CYC 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. CYCLOPENTOLATE HYDROCHLORIDE 1% w/v Eye Drops, Solution ® 5 027519 000708 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. minims cyclopento- late hydro- chloride #1% w/v- Eye drops, solution minims cyclopento- late hydro- chloride #1% w/v- Eye drops, solution DO NOT DISPENSE IF SEAL IS BROKEN BN: A99999 DOM: 99-9999 EXP: 99-9999 DO NOT DISPENSE IF SEAL IS BROKEN BN: A99999 DOM: 99-9999 EXP: 99-9999 KARTONIK CARTON Nazwa produktu Product name Kraj Country (ISO) Wymiar komponentu Component size Kolory nadruku Colours Dane techniczne Technical data Kr Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Minims Cyclopentolate Hydrochloride 1%. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Clear, colourless, sterile eye drops containing cyclopentolate hydrochloride BP 1% 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 POSOLOGY 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. 4.3 CONTRAINDICATIONS Do not use i Les hele dokumentet