GELTEARS Eye gel (2017)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
GelTears.
Qualitative and quantitative composition
Clear, colourless gel containing 0.2% w/w carbomer 980 Ph.Eur. For the full list of excipients, see section 6.1.
Pharmaceutical form
Eye gel.
Therapeutic indications
Substitution of tear fluid in the management of dry eye conditions, including keratoconjunctivitis sicca and unstable tear film.
Posology and method of administration
Adults (including the elderly) and children One drop to be instilled into the conjunctival fold of each affected eye 3-4 times daily or as required, depending on the degree of discomfort.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Blurred vision can occur if too much gel is instilled at one time, or if the gel is used too frequently. This effect can last for up to an hour. Recovery can be aided by blinking vigorously for a few seconds. ...
Interaction with other medicinal products and other forms of interaction
No significant interactions have been reported.
Pregnancy and lactation
Safety for use in pregnancy and lactation has not been established, therefore, Geltears should not be used in these circumstances.
Effects on ability to drive and use machines
As with other ophthalmic preparations, transient blurring of vision may occur on instillation. If affected, the patient should be advised not to drive or operate hazardous machinery until normal vision ...
Undesirable effects
Corneal irritation due to benzalkonium chloride could possibly occur with prolonged use. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal ...
Overdose
Not applicable.
Pharmacodynamic properties
Pharmacotherapeutic group: Artificial tears and other indifferent preparations ATC code: S01XA20 GelTears contains Carbomer 980, a hydrophilic, high molecular weight polymer of carboxyvinylic acid. The ...
Pharmacokinetic properties
No human pharmacokinetic studies are available, however, absorption or accumulation in ocular tissues is likely to be negligible due to the high molecular weight of the active ingredient.
Preclinical safety data
No adverse safety issues were detected during the development of this formulation. The ingredients are well established in clinical ophthalmology.
List of excipients
Benzalkonium chloride 0.01% w/w (as a preservative) Water for ιnjection Sorbitol Sodium hydroxide for pH adjustment
Incompatibilities
Not applicable.
Shelf life
The shelf life expiry date shall not exceed 3 years from the date of its manufacture when stored below 25°C. Any remaining gel should be discarded 28 days after first opening the tube.
Special precautions for storage
The product should be transported in the original packaging. It should be stored below 25°C.
Nature and contents of container
Sterile ophthalmic gel presented in 5g and 10g plasticised, lacquered aluminium tubes, closed with a tamper evident polyethylene cap. Each tube is individually cartonned with a patient information leaflet. ...
Special precautions for disposal and other handling
Not applicable.
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 03468/0043
Date of first authorization / renewal of the authorization
25/05/2008
Date of revision of the text
05/10/2017
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
