INDOCOLLYRE Eye Drops Pdr & Solv for Soln 0.1 %w/v

Данни за продукта

                                PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Indocollyre 0.1%, eye drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted each 5ml contains 5mg of Indometacin,
as a 0.1% w/v solution.
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Eye drops, powder and
solvent for solution. The appearance of the powder in
the vial is white to cream-coloured. The 
solvent solution appears as a clear, colourless and
viscous solution.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Prevention of per-operative miosis during cataract surgery.
Prevention of inflammatory manifestations related to
surgical operations for cataract and to anterior segment
  of the eye.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
ADULTS
-
Prevention of per-operative miosis during cataract surgery, 1 drop
every 30 minutes within 2 hours preceding
 the operation.
-
Prevention of inflammatory manifestations related to cataract and
to anterior segment of the eye surgery.
-
1 drop 4 to 6 times a day before operation, 1 drop every 30
minutes within 2 hours preceding the operation,
 and 1 drop 4 times per day for one month.
-
To administer treatment, gently pull down the lower lid
of the eye and apply one drop of solution while
 looking upwards.
CHILDREN
Safety and efficacy of use in children has not been established.
4.3 CONTRAINDICATIONS
This product is contra-indicated in the following situations:
from the 6
th
 month of pregnancy onwards (see: Pregnancy and Breast-feeding),
allergy to indomethacin or to drugs with similar activity e.g.
other non-steroidal anti-inflammatory drugs
  or aspirin, allergy to the preservative (thiomersal),
previous asthma attacks caused by aspirin
or other non-steroidal anti-inflammatory drugs.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 09/11
                                
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