Țară: Irlanda
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Sursă: HPRA (Health Products Regulatory Authority)
PROXYMETACAINE HYDROCHLORIDE
Chauvin Pharmaceuticals Limited
PROXYMETACAINE HYDROCHLORIDE
0.5 %w/v
Eye Drops Solution
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
Minims P ro xymet acaine Hy dr ochlor ide Inser t - UK & Ir eland (A ubenas) R enee C ondon - e: r enee .condon@bausch.com - t: 585.338.8252 - f: 585.338.8959 9335200 5336 BLACK CY AN MAGENT A YELLOW PMS 320 PMS 2985 PMS 346 BLACK 1 2 3 4 5 6 7 8 SPECIAL INSTRUCTIONS / PLACED IMAGES: N/A TYPE SIZE: 16pt/6.5pt (MAX/MIN) MINIMS ® PROXYMETACAINE HYDROCHLORIDE 0.5% EYE DROPS 0.5% W/V PROXYMETACAINE HYDROCHLORIDE BP ABOUT MINIMS PROXYMETACAINE HYDROCHLORIDE 0.5% The name of this medicine is Minims Proxymetacaine hydrochloride 0.5%. Each Minims unit is a sterile, single-use eye drops container which contains 0.5% w/v proxymetacaine hydrochloride solution. The solution also contains purified water and small amounts of hydrochloric acid and sodium hydroxide. Each Minims unit contains approximately 0.5ml of solution. Each carton contains 20 Minims units. Proxymetacaine hydrochloride is used as a local anaesthetic. WHO MAKES MINIMS PROXYMETACAINE HYDROCHLORIDE 0.5%? Minims Proxymetacaine hydrochloride 0.5% is manufactured by Laboratoire Chauvin S.A. Z.I. Ripotier, 07200/Aubenas, France. The Marketing Authorisations for Minims Proxymetacaine hydrochloride 0.5% (PL 0033/0151 & PA 118/46/1) are held by Chauvin Pharmaceuticals Ltd, 106 London Road, Kingston-Upon- Thames KT2 6TN, England. WHAT IS IT FOR ? Minims Proxymetacaine hydrochloride 0.5% is used to numb the eye temporarily. This could be necssary for a number of reasons. Most often, Minims Proxymetacaine hydrochloride 0.5% is used to allow your doctor or eye specialist to measure the pressure inside your eye or perform minor operations such as the removal of stitches and foreign bodies. This product is not intended to be used as a long term treatment for painful eye conditions. BEFORE USING MINIMS PROXYMETACAINE HYDROCHLORIDE 0.5% • Are you allergic to Proxymetacaine hydrochloride? • Do you suffer from heart disease? • Do you have an over Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minims Proxymetacaine hydrochloride 0.5% w/v, Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Proxymetacaine hydrochloride 0.5 % w/v. _For excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Eye drops, solution. Clear, colourless to pale yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS To be used as a topical ocular anaesthetic. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults (including the elderly) and children:_ Deep anaesthesia: Instil 1 drop every 5 - 10 minutes for 5 - 7 applications. Removal of sutures: Instil 1 or 2 drops 2 to 3 minutes before removal of stitches. Removal of foreign bodies: Instil 1 or 2 drops prior to operating. Tonometry: Instil 1 or 2 drops immediately before measurement. Do not use if the solution is more than pale yellow in colour. Each Minims unit should be discarded after a single use A period of at least one minute should be allowed after administration of Minims Proxymetacaine hydrochloride 0.5%, before subsequent administration of other topical agents. 4.3 CONTRAINDICATIONS Do not use in patients with a known hypersensitivity to any component of the preparation. In view of the immaturity of the enzyme system which metabolises the ester type local anaesthetics in premature babies, this product should be avoided in these patients. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/01/2014_ _CRN 2042320_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product should be used cautiously and sparingly in patients with known allergies, cardiac disease or hyperthyroidism because of the increased risk of sensitivity reactions. This product is not Citiți documentul complet