MINIMS PREDNISOLONE Single-use eye drops (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Minims Prednisolone Sodium Phosphate.
Qualitative and quantitative composition
Clear, colourless, sterile eye drops containing Prednisolone Sodium Phosphate Ph. Eur. 0.5% w/v. For the full list of excipients, see section 6.1.
Pharmaceutical form
Sterile single-use eye drop.
Therapeutic indications
Non-infected inflammatory conditions of the eye.
Posology and method of administration
Posology Adults and the elderly One or two drops applied topically to the eye as required. Paediatric population At the discretion of the physician.
Contraindications
Use is contraindicated in viral, fungal, tuberculous and other bacterial infections. Prolonged application to the eye of preparations containing corticosteroids has caused increased intraocular pressure ...
Special warnings and precautions for use
Care should be taken to ensure that the eye is not infected before Minims Prednisolone is used. Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during ...
Interaction with other medicinal products and other forms of interaction
Corticosteroids are known to increase the effects of barbiturates, sedative hypnotics and tricyclic antidepressants. They will, however, decrease the effects of anticholinesterases, antiviral eye preparations ...
Pregnancy and lactation
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development and although the relevance of this finding to human beings has not been established, the use ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Eye disorders Not known: vision, blurred (see also section 4.4) Prolonged treatment with corticosteroids in high dosage is occasionally associated with cataract. The systemic effects of steroids are possible ...
Overdose
As Minims are single dose units, overdose is unlikely to occur.
Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, plain ATC code: S01BA04 Mechanism of action The actions of corticosteroids are mediated by the binding of the corticosteroid molecules to receptor molecules ...
Pharmacokinetic properties
The oral availability, distribution and excretion of prednisolone is well documented. A figure of 82 ± 13% has been quoted as the oral availability and 1.4 ± 0.3ml/min/kg as the clearance rate. A half ...
Preclinical safety data
The use of prednisolone in ophthalmology is well-established. Little specific toxicology work has been reported, however, the breadth of clinical experience confirms its suitability as a topical ophthalmic ...
List of excipients
Disodium edetate Sodium dihydrogen phosphate Sodium chloride Sodium hydroxide for pH adjustment Purified water
Incompatibilities
Not applicable.
Shelf life
15 months.
Special precautions for storage
Store below 25°C. Do not freeze. Protect from light.
Nature and contents of container
A sealed conical shaped polypropylene container fitted with a twist and pull off cap. Each Minims unit is overwrapped in an individual polypropylene/paper pouch. Each container holds approximately 0.5ml ...
Special precautions for disposal and other handling
Each Minims unit should be discarded after a single use. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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 03468/0079
Date of first authorization / renewal of the authorization
Date of first authorisation: 11<sup>th</sup> March 1981
Date of revision of the text
08 May 2017
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