ToboDexin ointment eye

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

tobramycin, dexamethasone

Dostępny od:

Balkanpharma-Razgrad AD

Kod ATC:

S01CA01

INN (International Nazwa):

tobramycin, dexamethasone

Dawkowanie:

3mg/g+ 1mg/g

Forma farmaceutyczna:

ointment eye

Sztuk w opakowaniu:

aluminium tube 5g

Typ recepty:

Prescription

Status autoryzacji:

Registered

Data autoryzacji:

2021-04-23

Ulotka dla pacjenta

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TOBODEXIN 3 MG/G + 1 MG/G EYE OINTMENT
Tobramycin + Dexamethasone
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 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 ToboDexin eye ointment is and what it is used for
2.
What you need to know before you use ToboDexin eye ointment
3.
How to use ToboDexin eye ointment
4.
Possible side effects
5.
How to store ToboDexin eye ointment
6.
Contents of the pack and other information
1.
WHAT TOBODEXIN EYE OINTMENT IS AND WHAT IT IS USED FOR
ToboDexin is a combined medicinal product, containing dexamethasone
and tobramycin, and is
intended for use in the eye.
Dexamethasone is a corticosteroid with pronounced anti-inflammatory
action. Tobramycin is an
antibiotic of the group of the so-called aminoglycosides, which is
active against a large number of
microorganisms that cause infections of the eye.
It is used to prevent and treat inflammation of the eye, as well as to
prevent possible infection of the
eye after cataract surgery in adults and children over 2 years of age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TOBODEXIN EYE OINTMENT
DO NOT USE TOBODEXIN EYE OINTMENT

if you are allergic (hypersensitive) to tobramycin and/or
dexamethasone or any of the other
ingredients of this medicine (listed in section 6).

if you have herpes simplex keratitis, varicella or other viral
diseases of the cornea or
conjunctiva;

in the presence of eye infections caused by mycobacteria (ocular
tuberculosis);

in the presence of fungal diseases of the eye or untreated parasi

Charakterystyka produktu

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ToboDexin 3 mg/g + 1 mg/g eye ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances per 1 g ointment: 3.0 mg tobramycin (as sulfate) and
1.0 mg dexamethasone.
Excipients: for the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye ointment with white to pale yellow color with uniform consistency
without agglomerates and air
bubbles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention and treatment of inflammation and prevention of infection
associated with cataract surgery
in adults and children aged 2 years and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Dosage _
The dosage and duration of treatment are decided by the attending
physician.
_Adults: _
A small amount of the medicine (a strip with length of about 1.5 cm)
is inserted in the conjunctival sac
of the affected eye/eyes, three to four times daily. The frequency of
administration should be gradually
reduced on the basis of improvement in clinical performance. The
treatment should not be interrupted
prematurely.
ToboDexin eye ointment can be used together with ToboDexin eye drops,
suspension as it is placed
after the drops, at night before bedtime. The ointment should be last.
Regular monitoring of the intraocular pressure is recommended.
Use in the Elderly:
Clinical studies have indicated dosage modifications are not required
for use in the elderly.
Paediatric population:
ToboDexin eye ointment may be used in children 2 years of age and
older at the same dose as in
adults. Currently available data is described in section 5.1.
The safety and efficacy in children younger than 2 years of age have
not been established, and no data
is available.
Use in hepatic and renal impairment:
There are no data on the use of tobramycin/dexamethasone-containing
ophthalmic products in these
patient groups. Due to the low systemic absorption of tobramycin and
dexamethasone after topical
ocular administration of the medicinal product, no specific dosage is