Oftan Dexamethason drops eye

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

dexamethasone (dexamethasone sodium phosphate)

Available from:

Santen Oy

ATC code:

S01BA01

INN (International Name):

dexamethasone (dexamethasone sodium phosphate)

Dosage:

1mg/ml

Pharmaceutical form:

drops eye

Units in package:

5ml plastic bottle-dropper

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-04-16

Summary of Product characteristics

_SMPC/ OFTAN DEXAMETHASON EYE DROPS, SOLUTION _
_PAGE 1 (4)_
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
OFTAN
® DEXAMETHASON 1 MG/ML EYE DROPS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexamethasone 1 mg/ml (dexamethasone sodium phosphate 1.32 mg/ml).
Preservative: benzalkonium chloride 40 microg/ml
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nonpurulent inflammatory and allergic eye diseases, such as
conjunctivitis, keratitis, iritis,
iridocyclitis, corneal traumas and marginal ulcers as well as
postoperative conditions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Instil 1–2 drops in the eye(s), initially once an hour, then 3–5
times a day. The duration of treatment
is a few days to a few weeks.
4.3
CONTRAINDICATIONS
- Ocular tuberculosis
- Herpes simplex
- Varicella
- Vaccinia and several other viral and fungal eye infections.
- Purulent eye infections without concomitant antimicrobial therapy.
- Perforation of the cornea.
- Children and adolescents below age 18 (because effectiveness and
safety have not been
established in children or adolescents below age 18)
- Hypersensitivity to the active substance or to any of the
excipients.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Using a cortisone product for more than 2 weeks may increase
intraocular pressure. Topical use of
glucocorticoids may delay healing of corneal traumas. Corticosteroid
treatment may mask bacterial
or fungal infection, the progression of which may cause permanent
damage in the eye. Oftan
Dexamethason eye drops can be used in the treatment of an infected eye
only with a specific
antibiotic therapy.
Oftan Dexamethason eye drops contain benzalkonium chloride as a
preservative, which may cause
eye irritation. Benzalkonium chloride may precipitate in soft contact
lenses and discolour the
lenses. If it is necessary to wear contact lenses during Oftan
Dexamethason treatment, remove the