VOLTAROL OPTHA MULTIDOSE Eye drops solution (2014)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Voltarol Ophtha Multidose 0.1% Eye Drops.
Qualitative and quantitative composition
Contains diclofenac sodium 1mg/ml.
Pharmaceutical form
Eye drops solution.
Therapeutic indications
Inhibition of peroperative miosis during cataract surgery (Voltarol Ophtha Multidose has no intrinsic mydriatic properties and does not replace standard mydriatic agents). Treatment of post-operative inflammation ...
Posology and method of administration
Voltarol Ophtha eye drop solution is for instillation into the conjunctival sac only. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the ...
Contraindications
Patients with known hypersensitivity to any of the ingredients. Like other non-steroidal anti-inflammatory agents, Voltarol is also contraindicated in patients in whom attacks of asthma, urticaria or acute ...
Special warnings and precautions for use
This product contains benzalkonium chloride as a preservative, which may be deposited in soft contact lenses. Therefore this product should not be used while wearing soft contact lenses. The lenses must ...
Interaction with other medicinal products and other forms of interaction
Concomitant use of topical NSAIDs such as diclofenac and topical steroids in patients with significant pre-existing corneal inflammation may increase the risk of developing corneal complications, therefore ...
Pregnancy and lactation
Pregnancy There are no data on the use of Voltarol Ophtha or Voltarol Ophtha Multidose 0.1% in pregnancy. Studies in animals with diclofenac have shown reproductive toxicity (see Section 5.3). 1<sup>st ...
Effects on ability to drive and use machines
Patients with blurred vision should refrain from driving a vehicle or operating machines.
Undesirable effects
Very frequent: Eye pain. The other frequently observed adverse reaction is a transient, mild to moderate eye irritation. Other less frequently observed reactions are eye pruritus, ocular hyperaemia and ...
Overdose
There is practically no risk of adverse effects due to accidental oral ingestion, since a 5ml bottle of the eye drops contains only 5mg of diclofenac sodium, corresponding to about 3% of the recommended ...
Pharmacodynamic properties
Voltarol Ophtha Multidose contains diclofenac sodium, a non-steroidal compound with pronounced anti-inflammatory and analgesic properties. Inhibition of prostaglandin biosynthesis, which has been demonstrated ...
Pharmacokinetic properties
In rabbits, peak concentrations of <sup>14</sup>C-labelled diclofenac could be demonstrated in the cornea and conjunctiva 30 minutes after application. The highest amounts are found in these two tissues ...
Preclinical safety data
Preclinical data of systemically applied diclofenac from acute and repeated dose toxicity studies, as well as from genotoxicity and carcinogenicity studies revealed no specific hazard for humans at the ...
List of excipients
Benzalkonium chloride Disodium edetate Hydroxypropyl γ-cyclodextrin Hydrochloric acid Propylene glycol Trometamol Tyloxapol Water for injections
Incompatibilities
None known.
Shelf life
Shelf life Unopened: 24 months. Opened: 4 weeks.
Special precautions for storage
No special precautions for storage.
Nature and contents of container
5ml white LDPE bottle with LDPE dropper and HDPE closure.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Laboratoires Thea, 12, rue Louis-Blériot, 63017 Clermont-Ferrand Cedex 2, France
Marketing authorization number(s)
PL 20162/0017
Date of first authorization / renewal of the authorization
22/08/2002 / 26/02/2009
Date of revision of the text
15/12/2014
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