TOBREX OPHTHALMIC OINTMENT

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

TOBRAMYCIN

متاح من:

NOVARTIS ISRAEL LTD

ATC رمز:

S01AA12

الشكل الصيدلاني:

OPHTALMIC OINTMENT

تركيب:

TOBRAMYCIN 0.3 %

طريقة التعاطي:

OCULAR

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ALCON COUVREUR, BELGIUM

المجموعة العلاجية:

TOBRAMYCIN

المجال العلاجي:

TOBRAMYCIN

الخصائص العلاجية:

Antibiotic for the treatment of eye infections caused by bacteria sensitive to Tobramycin.

تاريخ الترخيص:

2015-03-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986
The medicine is dispensed with a doctor’s prescription only.
TOBREX
® OPHTHALMIC OINTMENT
COMPOSITION:
Each 1 gram contains:
Tobramycin 3 mg
For inactive and allergenic ingredients, see section 6 -
Further information.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE. This leaflet contains concise information
about the medicine. If you have further questions, refer to
the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it
on to others. It may harm them even if it seems to you that
their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
THERAPEUTIC ACTION: An antibiotic preparation for the
treatment of eye inflammations caused by bacteria sensitive
to tobramycin.
THERAPEUTIC GROUP: Aminoglycoside antibiotics.
2. BEFORE USING THE MEDICINE:
X DO NOT USE THE MEDICINE IF:
• You are sensitive )allergic( to tobramycin or to any of the
additional ingredients contained in the medicine )see
section 6(.
Symptoms of allergy generally include: shortness of
breath, wheezing or breathing difficulties, swelling of
the face, lips, tongue or other parts of the body, rash,
itching, hives.
• You have a known sensitivity to aminoglycoside
antibiotics.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE:
! BEFORE BEGINNING TREATMENT WITH TOBREX OPHTHALMIC
OINTMENT, TELL THE DOCTOR IF:
- You have had an allergy to other medicines, food,
preservatives or dyes.
- You have or have ever had a neuromuscular disorder,
such as myasthenia gravis, Parkinson’s disease. Consult
your doctor. Antibiotics of this kind may worsen muscle
weakness.
- You are pregnant or are planning a pregnancy. The doctor
will discuss with you the risks and benefits of using Tobrex
Ophthalmic Ointment during pregnancy.
- You are breastfeeding or plan to breastfeed. The doctor
will discuss with you the risks and benefits of using Tobrex
Ophthalmic Ointment when breastfeeding.
- Prolonged use of antibiotics

خصائص المنتج

NEW ZEALAND SPC MAY 2019
TOB OIN API APR20 V1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TOBREX OPHTHALMIC OINTMENT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g of Tobrex Eye Ointment contains the active ingredient
tobramycin 3 mg in 1 g.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye ointment.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Antibiotic for the treatment of eye infections caused by bacteria
sensitive to Tobramycin.
4.2.
POSOLOGY
AND METHOD OF ADMINISTRATION
Posology
-
In mild disease: a small amount of ointment 2 to 3 times per day,
-
In more severe infections: a small amount of ointment every 3 to 4
hours until
improvement, following which treatment should be reduced prior to
discontinuation.
The length of the treatment is dependent on the origin of the
infection and may vary
from a couple of days up to some weeks.
Method of administration
For ocular use.
To prevent contamination of the tube tip and ointment, care must be
taken not to
touch the eyelids, surrounding areas, or other surfaces with the tube
tip.
Keep the tube tightly closed when not in use.
In case of concomitant therapy with other topical ocular medicines, an
interval of 5 –
10 minutes should be allowed between successive applications.
4.3.
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
•
Hypersensitivity to aminoglycosides.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE
EYE.
NEW ZEALAND SPC MAY 2019
TOB OIN API APR20 V1
HYPERSENSITIVITY
Sensitivity to topically administered aminoglycosides may occur in
some patients.
Severity of
hypersensitivity reactions may vary from local effects to generalized
reactions such as
erythema, itching, urticarial, skin rash, anaphylaxis, anaphylactoid
reactions, or bullous
reactions. If hypersensitivity develops with this product,
discontinue use and institute
appropriate therapy.
If Tobrex Eye Ointment is a