Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
hydrocortisone (hydrocortisone acetate)
Arpimed LLC
S01BA02
hydrocortisone (hydrocortisone acetate)
5mg/g
ointment eye
aluminium tube 3g
Prescription
Registered
2016-07-28
SUMMARY PRODUCT CHARACTERISTIC (SPC) HYDROCORTISONE EYE OINTMENT 1.1 TRADE NAME – Hydrocortisone eye ointment 2. COMPOSITION Each gram contains: ACTIVE INGREDIENT: Hydrocortisone acetate – 5 mg _For a full list of excipients, see section 6.1. _ 3. PHARMACEUTICAL FORM 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, particularly in patients with a history or presence of open-angle Прочитать полный документ