BACTROBAN DERMAL

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

MUPIROCIN

متاح من:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC رمز:

D06AX09

الشكل الصيدلاني:

OINTMENT

تركيب:

MUPIROCIN 2 %W/W

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

GLAXO OPERATIONS (UK) LIMITED

المجموعة العلاجية:

MUPIROCIN

المجال العلاجي:

MUPIROCIN

الخصائص العلاجية:

Bactroban is a topical antibacterial agent, active against those organisms responsible for the majority of skin infections. Bactroban Dermal is used for skin infections, e.g. impetigo, folliculitis, furunculosis.

تاريخ الترخيص:

2023-05-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician’s prescription
only
Bactroban Dermal, ointment
Each 1 gram contains 20 mg mupirocin (2% w/w)
For the list of the inactive and allergenic ingredients in the
medicine, see section 2 –
“Important information about some of the ingredients in the
medicine” and section 6 –
“Additional information”.
Read this 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
physician 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?
Bactroban Dermal contains the active ingredient called mupirocin.
It is used to treat skin infections such as:
-
infected hair follicles which form pimples containing pus
(“folliculitis”)
-
an infectious skin infection with blistering and crusting known as
“impetigo”
-
recurring boils (“furunculosis”)
This ointment is for external use on your skin only.
Therapeutic group:
Antibiotic for topical use.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
• you are sensitive (allergic) to mupirocin or to any of the
additional ingredients
contained in this medicine (listed in section 6).
Do not use if the above applies to you. If you are not sure, do not
use this
medicine. Contact your physician or pharmacist before using Bactroban
Dermal.
• Do not use this medicine in your eyes, nose or around intravenous
cannula (‘drip’)
sites.
Special warnings regarding use of the medicine
• Bactroban Dermal may cause severe skin reactions or allergies. See
in section 4
‘Side Effects’.
• Do not use this medicine frequently, or for a prolonged period,
without consulting a
physician. Thrush (a yeast infection) may develop if Bactroban Dermal
is used for a
long time. If t

خصائص المنتج

Page 1 of 6
_ _
BACTROBAN DERMAL
1.
NAME OF THE MEDICINAL PRODUCT
Bactroban Dermal
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains 20 mg mupirocin (2% w/w mupirocin free
acid
) .
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ointment for topical administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bactroban is a topical antibacterial agent, active against those
organisms responsible
for the majority of skin infections. Bactroban Dermal is used for skin
infections, e.g.
impetigo, folliculitis, furunculosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including elderly/hepatically impaired) and children _
Two to three times a day for up to ten days, depending on the
response.
_Renally impaired _
See section 4.4
Method of administration
For topical administration.
A small quantity of Bactroban
Dermal
should be applied to cover the affected area.
The treated area may be covered by a dressing.
Any product remaining at the end of treatment should be discarded.
Do not mix with other preparations as there is a risk of dilution,
resulting in a
reduction of the antibacterial activity and potential loss of
stability of the mupirocin
in the ointment.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Page 2 of 6
This Bactroban
dermal
formulation is not suitable for ophthalmic or intranasal use.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Should a possible sensitisation reaction or severe local irritation
occur with the use of
Bactroban Dermal, treatment should be discontinued, the product should
be washed
off and appropriate therapy instituted.
As with other antibacterial products, prolonged use may result in
overgrowth of non-
susceptible organisms.
Pseudomembranous colitis has been reported with the use of antibiotics
and may
range in severity from mild to life-threatening. Therefore, it is
important to consider
its diagnosis in patients who develop diarrhoea during or after
a