MINIMS PROXYMETACAINE Eye drops, solution (2015)
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Περιεχόμενα
Name of the medicinal product
Minims Proxymetacaine hydrochloride 0.5% w/v, Eye Drops, solution.
Qualitative and quantitative composition
Proxymetacaine hydrochloride 0.5% w/v. For excipients see section 6.1.
Pharmaceutical form
Eye drops, solution. Clear, colourless to pale yellow solution.
Therapeutic indications
To be used as a topical ocular anaesthetic.
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. ...
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 ...
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 intended ...
Interaction with other medicinal products and other forms of interaction
None stated.
Pregnancy and lactation
Safety for use in pregnancy and lactation has not been established, therefore, use only when considered essential by the physician.
Effects on ability to drive and use machines
May cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery unless vision is clear.
Undesirable effects
Pupillary dilatation or cycloplegic effects have rarely been observed with Proxymetacaine hydrochloride preparations. Irritation of the conjunctiva or other toxic reactions have occurred only rarely. A ...
Overdose
Not applicable.
Pharmacodynamic properties
Proxymetacaine hydrochloride, in common with other local anaesthetics, reversibly blocks the initiation and conduction of nerve impulses by decreasing the permeability of the neuronal membrane to sodium ...
Pharmacokinetic properties
Proxymetacaine hydrochloride is readily absorbed into the systemic circulation where, in common with other ester-type local anaesthetics, it is hydrolysed by plasma esterases. Proxymetacaine hydrochloride ...
Preclinical safety data
No adverse safety issues were identified during the development of this formulation. The ingredients are well established in clinical ophthalmology.
List of excipients
Purified water Hydrochloric acid Sodium hydroxide
Incompatibilities
None known.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Store at 2-8°C. Do not freeze. Keep container in the outer carton. If necessary, the product may be stored at temperatures not exceeding 25°C for up to 1 month only.
Nature and contents of container
A sealed conical shaped polypropylene container fitted with a twist and pull off cap. Each Minims unit contains approximately 0.5ml of solution. Each unit is overwrapped in a polyethylene sachet. 20 units ...
Special precautions for disposal and other handling
Each Minims unit should be discarded after a single use. If the product is to be stored unrefrigerated at temperatures not exceeding 25°C, prior to supply of the product by the pharmacy the adhesive label ...
Marketing authorization holder
Bausch & Lomb UK Limited, Bausch & Lomb House, 106 London Road, Kingston-Upon-Thames, Surrey, UK, KT2 6TN
Marketing authorization number(s)
PL 03468/0080
Date of first authorization / renewal of the authorization
13/11/2015
Date of revision of the text
27/11/2015
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