Bactroban Nasal Ointment 2% w/w

Страна: Мальта

мова: англійська

Джерело: Malta Medicines Authority

Активний інгредієнт:

MUPIROCIN

Доступна з:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Код атс:

D06AX09

ІПН (Міжнародна Ім'я):

MUPIROCIN 20 mg/g

Фармацевтична форма:

NASAL OINTMENT

Склад:

MUPIROCIN 20 mg/g

Тип рецепту:

POM

Терапевтична области:

ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE

Статус Авторизація:

Authorised

Дата Авторизація:

2005-11-24

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
BACTROBAN NASAL OINTMENT 2.0% W/W
MUPIROCIN
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, nurse 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, nurse or pharmacist.
This includes any possible side-effects
not listed in this leaflet. See section 4.
•
In this leaflet, Bactroban Nasal Ointment 2.0% w/w will be called
Bactroban.
WHAT IS IN THIS LEAFLET
1.
What Bactroban is and what it is used for
2.
What you need to know before you use Bactroban
3.
How to use Bactroban
4.
Possible side effects
5.
How to store Bactroban
6.
Contents of the pack and other information
Bactroban contains the active substance mupirocin as mupirocin
calcium. Bactroban is an antibiotic
ointment.
It is used:
•
to kill a group of bacteria in the nose called ‘Staphylococci’
•
this group includes MRSA (Methicillin Resistant
_Staphylococcus aureus_
)
•
this ointment is for use in your nose only.
DO NOT USE BACTROBAN IF:
•
you are allergic to mupirocin or any of the other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Bactroban
•
Do not put Bactroban into your mouth or swallow it.
•
Do not put Bactroban in your eyes. If you get it in your eyes, wash it
out immediately.
•
If you develop a severe skin reaction or allergy wipe off the
ointment, stop using it and tell your doctor as
soon as possible.
•
Prolonged use of Bactroban may result in overgrowth of non-susceptible
organisms.
OTHER MEDICINES AND BACTROBAN
Tell your doctor, nurse or pharmacist if you are using, have recently
used or might use any other medicines.
PREGNANCY AND BREAST-FEEDING
If you are p

Характеристики продукта

_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bactroban
®
Nasal Ointment 2% w/w
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of nasal ointment contains 20 mg mupirocin (2.0% w/w) as
mupirocin
calcium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal ointment.
An off white smooth ointment.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bactroban
Nasal
Ointment
is
indicated
for
the
treatment
of
nasal
carriage
of
staphylococci, including methycillin resistant
_staphylococcus aureus_
(MRSA).
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _
Bactroban Nasal Ointment should be applied to the anterior nares two
to three times a day,
as follows:
A small amount of the ointment about the size of a match head is
placed on the little finger
and applied to the inside of each nostril. The nostrils are closed by
pressing the sides of
the nose together; this will spread the ointment throughout the nares.
A cotton bud may be
used instead of the little finger for the application in particular to
infants or patients who
are very ill.
Nasal carriage should normally clear within 5-7 days of commencing
treatment.
Method of administration
Topical
_ _
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In the rare event of a possible sensitisation reaction or severe local
irritation
occurring with the use of the product, treatment should be
discontinued, the
product should be wiped off and appropriate alternative therapy for
the infection
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 deve