DEX-OTIC TEVA

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

متاح من:

VITAMED PHARMACEUTICAL INDUSTRIES LTD

ATC رمز:

S02CA06

الشكل الصيدلاني:

DROPS

تركيب:

POLYMYXIN B SULFATE 10000 IU/ML; DEXAMETHASONE SODIUM PHOSPHATE 1 MG/ML; NEOMYCIN SULFATE 5 MG/ML

طريقة التعاطي:

OTIC

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

VITAMED LTD, ISRAEL

المجال العلاجي:

DEXAMETHASONE AND ANTIINFECTIVES

الخصائص العلاجية:

For the treatment of superficial bacterial infections of the external auditory canal, caused by organisms susceptible to the action of the antibiotics

تاريخ الترخيص:

2023-08-31

نشرة المعلومات

Patient package insert in accordance with
the Pharmacist’s Regulations (Preparations) – 1986
This medicine is dispensed with a doctor’s prescription only.
*ALTERNATE FORMULA
DEX-OTIC
®
TEVA* EAR DROPS
COMPOSITION: Each 1 ml contains:
Dexamethasone Sodium Phosphate 1 mg
Neomycin Sulfate 5 mg
Polymyxin B Sulfate 10,000 I.U.
Inactive ingredients: See Section 6 – Additional Information.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS
MEDICINE. This leaflet contains concise information about the
medicine. If you have
further questions, refer to a doctor or pharmacist.
THIS MEDICINE WAS PRESCRIBED TO TREAT YOUR ILLNESS. DO NOT PASS IT ON
TO OTHERS. IT MAY HARM THEM, EVEN IF IT SEEMS TO YOU THAT THEIR
ILLNESS IS SIMILAR.
1. WHAT IS THE MEDICINE INTENDED FOR?
TREATMENT OF SUPERFICIAL INFECTIONS OF THE OUTER EAR CAUSED BY
BACTERIA SUSCEPTIBLE TO THE MEDICINE.
THERAPEUTIC GROUP:
Dexamethasone Sodium Phosphate has anti-inflammatory activity.
Neomycin Sulfate and Polymyxin B Sulfate have anti-bacterial activity.
2. BEFORE USING THIS MEDICINE
! DO NOT USE THIS PREPARATION IF:
! BEFORE USING DEX-OTIC TEVA TELL YOUR DOCTOR IF:
• You are pregnant or breastfeeding.
• You are suffering, or have suffered in the past, from impaired
hearing, herpes simplex (HSV), chicken pox, chronic herpes of the ear
or
tuberculosis of the ear, viral or fungal infections of the skin or the
ear; if you are suspected or known to be suffering from a perforated
eardrum; or
in cases of chronic ear infections.
! SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
• If you are sensitive to any type of food or medicine, such as
aminoglycosides, polymyxin or sulfites, you must inform your doctor
before taking
this medicine.
• Prolonged use or the use of a high dose of this medicine on open
wounds or injured skin may cause deafness. This is especially
important in the
case of children.
• Do not swallow. If the medicine has been swallowed, especially by
a child, refer immediately to a doctor or to a hospital emergency
room.
!