VIVIDRIN

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

CROMOGLICATE SODIUM

Διαθέσιμο από:

Bausch & Lomb UK Limited

Φαρμακολογική κατηγορία (ATC):

S01GX01

INN (Διεθνής Όνομα):

CROMOGLICATE SODIUM

Δοσολογία:

20 Micromol

Φαρμακοτεχνική μορφή:

Eye Drops Solution

Τρόπος διάθεσης:

Product not subject to medical prescription

Θεραπευτική περιοχή:

cromoglicic acid

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

1991-03-26

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vividrin Antiallergic Eye Drops, Solution 2% w/v
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 20.0 mg of sodium cromoglicate.
Excipient: Contains benzalkonium chloride 100 micrograms per ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops solution
Colourless to slightly yellow, clear, aqueous eye drops solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acute or chronic allergic conjunctivitis e.g. hay-fever conjunctivitis
(vernal [kerato-] conjunctivitis).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Instill one drop into each eye four times a day or as directed by the
physician in the case of high pollen challenge. The
dose applies equally to children and adults.
Treatment with Vividrin Antiallergic Eye Drops should be continued
even after the complaints have disappeared as
long as the patient is exposed to the allergizing substances (pollen,
house dust, fungus spores, etc.).
4.3 CONTRAINDICATIONS
Vividrin Antiallergic Eye Drops are contra-indicated in persons who
have shown hypersensitivity to any component of
this product.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
May cause eye irritation. Avoid contact with soft contact lenses.
Remove contact lenses prior to application and wait at
least 15 minutes before re-insertion. Known to discolour soft contact
lenses.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known so far.
4.6 FERTILITY, PREGNANCY AND LACTATION
Although there has been no evidence of any embryotoxic effect,
Vividrin Antiallergic Eye Drops should, if possible,
not be used during the first three months of pregnancy.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
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