Tetracycline eye ointment 1% 10mg/g ointment eye

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ficha técnica Ficha técnica (SPC)
06-05-2016

Ingredientes activos:

tetracycline

Disponible desde:

Arpimed LLC

Código ATC:

S01AA09

Designación común internacional (DCI):

tetracycline

Dosis:

10mg/g

formulario farmacéutico:

ointment eye

Unidades en paquete:

3g aluminium tube

tipo de receta:

Prescription

Estado de Autorización:

Registered

Fecha de autorización:

2015-08-03

Ficha técnica

                                SUMMARY PRODUCT CHARACTERISTIC (SPC)
TETRACYCLINE EYE OINTMENT 1%
1.1 TRADE NAME
– Tetracycline eye ointment 1%
1.2 INTERNATIONAL NON-PROPERTY NAME – Tetracycline
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each of 100 gram of Tetracycline eye ointment 1% contains:
ACTIVE INGREDIENT:Tetracycline-1g
_INACTIVE INGREDIENTS_: see 6.1. List of excipients
3. PHARMACEUTICAL FORM
Eye ointment
Yellow or yellowish brown ointment.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment of bacterial (including chlamydial) eye infections,
caused by susceptible to
tetracycline
microorganisms:
blepharitis,
blepharoconjunctivitis,
keratitis,
keratoconjunctivitis, meybomit (sty) and trachoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical use.
Squeeze a thin strip (from 0.5 to 1 cm) of ointment for eyelid.
- at blepharitis, blepharoconjunctivitis: 3-4 times per day for 5–7
days;
- at
keratitis,
keratoconjunctivitis:
2-3
times
per
day
for
5–7
days.
If
there
is
no
improvement after 3-5 days, it is advisable to consult your doctor.
- at meybomit (sty): at night until signs of inflammation has
disappeared.
- at trachoma: every 2-4 hours or more frequently for 1to 2 weeks.
After subsidence of
inflamation the drug can be used 2-3 times per day. Duration of
therapy: 1-2 months.
4.3 CONTRAINDICATIONS
-
Hypersensitivity to any compounds of drug;
-
kidney and liver disorders;
-
pregnancy;
-
breastfeeding;
-
children under 8 years.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
After applying the ointment can be blurred vision, so it is not
recommended to drive
vehicles or engage in activities that require visual acuity prior to
its recovery.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Drug interactions are not described.
4.6. PREGNANCY AND LACTATION
Tetracycline eye ointment 1% is contraindicated during pregnancy and
lactation.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
After applying the ointment can be blurred vision, so it is not
recommended to drive
vehicles or engage in act
                                
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