Dexa-Gentamicin Eye Drops

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GENTAMICIN, DEXAMETHASONE SODIUM, PHOSPHATE

Available from:

Ursapharm Arzeneitmittel GmbH Industriestrasse, 66129 Saarbrucken, Germany

ATC code:

S01CA01

INN (International Name):

DEXAMETHASONE SODIUM PHOSPHATE 1 mg/ml GENTAMICIN 5 mg/ml

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

DEXAMETHASONE SODIUM PHOSPHATE 1 mg/ml GENTAMICIN 5 mg/ml

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Authorised

Authorization date:

2005-06-30

Patient Information leaflet

1.3.1 SPC, labelling and package leaflet
Edition 01/2020
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXA-GENTAMICIN EYE DROPS
Active substances: Dexamethasone sodium phosphate 1.0 mg/ml and
gentamicin sulfate 5.0 mg/ml
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 further questions, ask your doctor or 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 of the 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 drops is and what it is used for
2.
What you need to know before you use Dexa-Gentamicin eye drops
3.
How to use Dexa-Gentamicin eye drops
4.
Possible side effects
5.
How to store Dexa-Gentamicin eye drops
6.
Contents of the pack and other information
1.
WHAT DEXA-GENTAMICIN EYE DROPS IS AND WHAT IT IS USED FOR
Antiallergic, antiinflammatory and anti-infective eye drops
Dexa-Gentamicin eye drops are indicated in infections of the anterior
eye including conjunctivitis,
keratitis,
blepharitis,
and
hordeolum,
caused
by
gentamicin-sensitive
pathogens;
allergic
inflammation of the anterior eye with bacterial superinfection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DEXA-GENTAMICIN EYE DROPS
DO NOT USE DEXA-GENTAMICIN EYE DROPS
-
If you are allergic to dexamethasone sodium phosphate or gentamicin
sulfate or to one of the
other ingredients (listed in section 6).
-
If you suffer from a herpes-simplex-infection of the cornea (herpes
corneae superficialis)
-
In case of injuries and ulcerations of the cornea
-
In case of an increased intraocular pressure (closed- and open-angle
glaucoma)
-
In case of tuberculous infections of the eye
-
In case of fungal infections as well as solely bacterial infections of
the eye
1.3.1 S

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 drops
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1 ml of solution contains:
Dexamethasone sodium phosphate 1.0 mg
Gentamicin sulfate 5.0 mg
(equivalent to 3 mg gentamicin)
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Eye drops, solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Infections of the anterior eye including conjunctivitis, keratitis,
blepharitis, and hordeolum, caused
by
gentamicin-sensitive
pathogens;
allergic
inflammation
of
the
anterior
eye
with
bacterial
superinfection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Instill 1 drop 4-6 times daily into the conjunctival sac.
Method of administration
For ocular use.
Treatment with Dexa-Gentamicin eye drops should normally not extent a
period of 2 weeks. The
exact duration of Dexa-Gentamicin eye drops therapy should be based on
the physician´s judgement
when all factors including efficacy, severity of the symptoms, and
potential side effects are
considered.
Generally eye drops should be applied in such a way that any contact
of the bottle tip with eye or
skin is avoided.
_Paediatric population _
No data available.
1.3.1 SPC, labelling and package leaflet
Edition 07/2017
4.3
CONTRAINDICATIONS
Hypersensitivity to one of the active substances or to any of the
excipients listed in section 6.1,
herpes
corneae
superficialis,
injuries
and
ulcerations
of
the
cornea,
closed
and
open-angle
glaucoma, tuberculous or fungal infections of the eye, solely
bacterial infections.
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 predisposed patients,
including children and patients treated with CYP3A4 inhibitors
(including ritonavir and cobicistat).
In these cases, treatment should be progressively discontinued.
Visual distur