Dexa-Gentamicin Eye Ointment

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GENTAMICIN, DEXAMETHASONE

Available from:

Ursapharm Arzeneitmittel GmbH Industriestrasse, 66129 Saarbrucken, Germany

ATC code:

S01CA01

INN (International Name):

DEXAMETHASONE 0.3 mg/g GENTAMICIN 5 mg/g

Pharmaceutical form:

EYE OINTMENT

Composition:

DEXAMETHASONE 0.3 mg/g GENTAMICIN 5 mg/g

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Authorised

Authorization date:

2006-10-10

Patient Information leaflet

1.3.1 SPC, labelling and package leaflet
Edition 07/2017
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEXA-GENTAMICIN, EYE OINTMENT
Active substances: Dexamethasone 0.3 mg/g and Gentamicin sulfate 5.0
mg/g
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any questions please ask your doctor or your pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dexa-Gentamicin, eye ointment is and what it is used for
2.
What you need to know before you use Dexa-Gentamicin, eye ointment
3.
How to use Dexa-Gentamicin, eye ointment
4.
Possible side effects
5.
How to store Dexa-Gentamicin, eye ointment
6.
Contents of the pack and other information
1.
WHAT DEXA-GENTAMICIN, EYE OINTMENT IS AND WHAT IT IS USED FOR
Dexa-Gentamicin eye ointment is active against inflammations or
hypersensitivities against certain
substances (allergies) of the eye.
Dexa-Gentamicin eye ointment is indicated for the local treatment of
inflammations of the anterior
eye together with an infection with gentamicin-sensitive germs or in
case of a risk of bacterial
infection, allergic inflammations of the conjunctiva and the eye lid
with bacterial superinfection.
2.
WHAT DO YOU NEED TO KNOW BEFORE USING DEXA-GENTAMICIN, EYE OINTMENT
Do not use Dexa-Gentamicin, eye ointment
-
If you are allergic (hypersensitive) to the active substances or one
of the other ingredients of
this medicine listed in section 6.1
-
If
you
suffer
from
superficial
herpes
simplex
infection
of
the
cornea
(herpes
corneae
superficialis)
-
In case of injuries and ulcerations of the cornea
-
In case of closed and open-angle glaucoma
-
In case of tuberculosis of the ey

Summary of Product characteristics

1.3.1 SPC, labelling and package leaflet
Edition 07/2017
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dexa-Gentamicin, eye ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of eye ointment contains:
Dexamethasone
0.3 mg
Gentamicin sulfate
5.0 mg
(equivalent to 3 mg Gentamicin)
Contains wool fat.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye ointment
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Inflammations of the anterior eye together with an infection with
gentamicin-sensitive germs or in case
of a risk of a bacterial infection. Allergic inflammation of the
conjunctiva and the eye lid with bacterial
superinfection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
If not otherwise prescribed a 1 cm strip of eye-ointment is applied
2-3 times daily into the conjunctival
sac
(1
cm
strip
of
eye-ointment
corresponds
to
0.1
mg
gentamicin
sulfate
and
0.006
mg
dexamethasone).
Method of administration
For ocular use
The treatment with Dexa-Gentamicin, eye ointment should normally not
extend beyond a period of two
weeks. Periodically, depending on the clinical picture, efficacy
should be controlled and decided if the
therapy should be continued or changed.
Generally, eye ointments should be used avoiding contact of the
tube-tip with the eye or the skin of the
face.
1.3.1 SPC, labelling and package leaflet
Edition 07/2017
_Paediatric population _
No data available.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1, herpes
corneae
superficialis,
injuries
and
ulcerations
of
the
cornea,
narrow-
and
open-angle-glaucoma,
tuberculosis of the eye, solely bacterial or fungal infections of the
eye.
Contact lenses should not be worn during the treatment with
Dexa-Gentamicin eye ointment.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Cushing's
syndrome
and/or
adrenal
suppression
associated
with
systemic
absorption
of
ocular
dexamethasone may occur after intensive or long-term continuous
therapy in pre