BACTROBAN NASAL

Страна: Израел

Език: английски

Източник: Ministry of Health

Активна съставка:

MUPIROCIN AS CALCIUM

Предлага се от:

GLAXO SMITH KLINE (ISRAEL) LTD

АТС код:

R01AX06

Лекарствена форма:

OINTMENT

Композиция:

MUPIROCIN AS CALCIUM 2 %W/W

Начин на приложение:

NASAL

Вид предписание :

Required

Произведено от:

GLAXO OPERATIONS (UK) LIMITED

Терапевтична група:

MUPIROCIN

Терапевтична област:

MUPIROCIN

Терапевтични показания:

The elimination of nasal carriage of staphylococci, including methycillin-resistant staphylococus aureus (MRSA).

Дата Оторизация:

2020-09-30

Листовка

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a physician's prescription only
BACTROBAN NASAL
OINTMENT
EACH GRAM CONTAINS 20 MG MUPIROCIN (AS CALCIUM) (2% W/W)
For a list of the inactive and allergenic ingredients in the
preparation, see
section 6 – "Additional 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 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 Nasal contains an active ingredient called mupirocin
calcium.
It is used:
•
To kill a group of bacteria in the nose called ׳
Staphylococci'
•
This group includes methicillin-resistant
Staphylococcus aureus
(MRSA)
•
This ointment is intended for use in your nose only.
THERAPEUTIC GROUP:
Antibiotic for topical use.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to mupirocin calcium, mupirocin or any of
the
additional ingredients contained in the medicine (as detailed in
section 6
"Additional information").
If you are not sure if this applies to you, do not use this medicine.
Refer to
your physician or pharmacist before using Bactroban Nasal.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
Bactroban Nasal can cause allergies or severe skin reactions. See
'Conditions
to look out for' in Section 4.
Do not use this medicine frequently, or for a prolonged period,
without
consulting a physician.
Thrush (a yeast infection) may develop if Bactroban Nasal is used for
a long
time. If this occurs, tell your physician or pharmacist.
Keep the ointment away from the eyes.
-
If the ointment gets into your eyes accidentally, wash them thoroughly
with
water.
DRUG INTERACTIONS
IF YOU ARE TAKING OR HAVE RECENTLY TAKEN OTHER MEDICINES, INC

Данни за продукта

_ _
Page 1 of 6
BACTROBAN NASAL
1.
NAME OF THE MEDICINAL PRODUCT
Bactroban Nasal
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of nasal ointment contains mupirocin calcium equivalent to
20
mg
mupirocin (2% w/w
mupirocin free acid).
3.
PHARMACEUTICAL FORM
White soft paraffin based nasal ointment containing a glycerin ester.
Off-white smooth ointment.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The elimination of nasal carriage of staphylococci, including
methicillin resistant
S
_taphylococcus aureus_
(MRSA).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Dosage: _
_Adults (including the elderly_
_/renally impaired/hepatically impaired_
_) and _
_children: _
_ _
_ _
Apply a
small
quantity
of
Mupirocin nasal
ointment
,
about the size of a match head
(approximately 30 mg
of
ointment) to
each nostril
twice a day for at least 5 days.
_Method of Administration: _
Use a cotton tipped applicator. After application, the
nostrils
should be
closed by
pressing the sides of the nose together
several times.
Nasal carriage should normally
be
clear within
three to five
days of treatment.
Dosage should not exceed ten days.
Do not mix with other preparations as there is a risk of dilution,
resulting in a
reduction in the antibacterial activity and potential loss of
stability of the
mupirocin in the ointment.
4.3
CONTRAINDICATIONS
_ _
Page 2 of 6
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Should a possible sensitisation reaction or severe local irritation
occur with the use of
Bactroban Nasal Ointment, treatment should be discontinued, the
product should be
wiped away 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 o