|
NAME
OF THE MEDICAL PRODUCT
Dexamytrex
Ophtiole
QUALITATIVE
AND QUANTITATIVE COMPOSITION
Active substance (1 ml collyrium contains:)
Gentamicine Sulphate
............................................... 5.0 mg
Dexamethasone
Dihydrogenophosphate, disodium salt ............................1.0 mg
Cetrimide................................................................
0.05 mg
PHARMACEUTICAL FORM
Collyrium.
PHARMACOTHERAPEUTIC
CLASS
XVI -1 –Drugs of topical application in Ophthalmology.
MARKETING
AUTHORIZATION HOLDER
L.Lepori, Lda
Rua da Imprensa Nacional, 86-88
1250-127 LISBOA
THERAPEUTIC
INDICATIONS
Infections of the anterior segment of the eye caused by pathogenic germs
sensible to gentamicine, i.e., bacterial inflammations of the conjunctiva,
cornea – without epithelial lesion – and eyelids that show
severe inflammatory reactions.
Highly infected allergic inflamations of the conjunctiva and eyelid.
CONTRAINDICATIONS
AND SIDE EFFECTS
Acute purulent diseases of the anterior segment of the eye; herpes “corneae
superficialis” lesions and ulcerous processes of the cornea; ocular
tuberculosis; fungic infections in the eyes; open or closed angle glaucoma;
hypersensitivity to dexamethasone and/or gentamicine. Glaucoma and cataracts
during prolonged use. In rare cases it may occur a pricking sensation
of short duration.
DRUG
INTERACTIONS AND OTHER FORMS OF INTERACTION
Unknown.
SPECIAL
PRECAUTIONS FOR USE
Nothing to refer.
EFFECTS
ON PREGNANT WOMEN, BREAST-FEEDING WOMEN, CHILDREN, ELDERLY PATIENTS AND
PATIENTS WITH SPECIAL PATHOLOGIES
Because
there are no studies in pregnant women this product should not be used
in this situation.
EFFECTS
ON THE ABILITY TO DRIVE AND USE MACHINES
Even
when it is correctly used, this medicine influences the visual capacity;
drivers should exercise care when using the product.
LIST
OF EXCIPIENTS
Sodium monohydrogenophosphate, potassium dihydrogenophosphate,
Glycerol, sodium disulfide, Polyvinylpirrolidone, Hydroxypropylmethylcellulose,
Sodium edetate (Titriplex III), sodium hydroxide solution1N for pH adjustment,
Chloridric acid 1N for pH adjustment, distilled water.
POSOLOGY
AND ADMINISTRATION MODE
In
general, instil in the affected eye, 1 drop of collyrium in the conjunctival
sac, 4 to 6 times a day.
INDICATION
OF THE MOST FAVOURABLE MOMENT FOR THE ADMINISTRATION OF THE MEDICINE
Consult
your doctor.
DURATION
OF THE AVERAGE TREATMENT
The
duration of the treatment should not exceed 2 weeks; during treatment
results should be checked; it is recommended the surveillance of the intraocular
pressure.
WARNINGS
If you forget to administer one or more doses, treatment must be continued.
No
special precaution is necessary to suspend the treatment, and no overdosage
cases are to be considered.
If
you notice any side effect not mentioned in this leaflet, please inform
your doctor or pharmacist.
Check
if the product is within the expiry date mentioned in the package.
Store
at a temperature below 25ºC. Protect the vial containing the collyrium
from the light, placing it inside the cardboard package after each application.
Always
keep medicines out of reach and sight of children.
DATE
OF THE LAST REVISION OF THE LEAFLET:
January 2000.
top
|
