Hydrocortisone eye ointment ointment eye

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

hydrocortisone (hydrocortisone acetate)

Dostępny od:

Arpimed LLC

Kod ATC:

S01BA02

INN (International Nazwa):

hydrocortisone (hydrocortisone acetate)

Dawkowanie:

5mg/g

Forma farmaceutyczna:

ointment eye

Sztuk w opakowaniu:

aluminium tube 3g

Typ recepty:

Prescription

Status autoryzacji:

Registered

Data autoryzacji:

2021-07-29

Charakterystyka produktu

SUMMARY PRODUCT CHARACTERISTIC (SPC)
1.1 NAME OF THE MEDICINAL PRODUCT
– Hydrocortisone eye ointment 5
mg/g
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains: ACTIVE INGREDIENT: Hydrocortisone acetate – 5 mg
Contains methylparaben.
_For a full list of excipients, see section 6.1. _
3. PHARMACEUTICAL FORM
Eye ointment.
White or almost white translucent unctuous mass with a slight smell of
ointment.
4
.CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Allergic
eye
diseases
(blepharitis,
eyelids
dermatitis,
conjunctivitis,
keratoconjunctivitis)

Inflammatory diseases of the eye anterior section in the absence of
violations
of the integrity of the corneal epithelium (conjunctivitis,
keratoconjunctivitis,
blepharitis)

Chemical and thermal eye burns (after corneal defects complete
healing).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical administration.
1-2 cm ribbon of ointment should be placed inside the lower
conjunctival sac 2-3
times daily for 1-2 weeks.
Do not use for more than 1-2 weeks without consulting a doctor.
4.3 CONTRAINDICATIONS
• Vaccinia, varicella, or other viral diseases of cornea and
conjunctiva
• Ocular herpes simplex
• Fungal diseases of ocular structures
• Mycobacterial ocular infections
• Acute, untreated purulent bacterial infections
• Hypersensitivity to hydrocortisone or to any of the excipients.
• Intraocular tuberculosis
• Glaucoma
• Trachoma
• Vaccination
• Eye injury
• Children under 18 years of age
_With caution _
Pregnancy and lactation_ _
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For ocular use only.
Contact lens wear is not recommended during treatment of an ocular
inflammation.
There is no evidence of safety in use in children under two years of
age.
The time interval between the topical instillation of eye drops and
ointment should
not be less than 15 minutes in simultaneous application.
In patients receiving prolonged ophthalmic corticosteroid therapy
(more than 10
days), intraocular pressure should be checked, particularl