Bactroban 2% w/w Nasal Ointment

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Mupirocin

Доступно од:

PCO Manufacturing Ltd.

АТЦ код:

D06AX; D06AX09

INN (Међународно име):

Mupirocin

Дозирање:

2.0 percent weight/weight

Фармацеутски облик:

Nasal ointment

Тип рецептора:

Product subject to prescription which may not be renewed (A)

Терапеутска област:

Other antibiotics for topical use; mupirocin

Статус ауторизације:

Authorised

Датум одобрења:

2013-07-26

Информативни летак

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
BACTROBAN
®
2.0% W/W
NASAL OINTMENT
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 2.0% w/w Nasal
Ointment 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
1 s and what it is used for
1.
WHAT BACTROBAN IS AND WHAT IT IS USED
FOR
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
BACTROBAN
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

Карактеристике производа

Health Products Regulatory Authority
10 June 2022
CRN00CZ6V
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bactroban 2% w/w Nasal Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of nasal ointment contains 20 mg mupirocin (2.0% w/w) as
mupirocin calcium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal ointment.
_Product sourced from Spain and Greece:_
An off white smooth ointment.
4 CLINICAL PARTICULARS
As per PA1077/094/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/094/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
White soft paraffin
Mixed diglycerin ester of fatty acids (softisan 649)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
6.5 NATURE AND CONTENTS OF CONTAINER
Lacquered aluminium tube fitted with a nozzle and screw cap containing
3 g white ointment.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any product remaining at the end of treatment should be discarded.
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
Wash your hands after application.
Health Products Regulatory Authority
10 June 2022
CRN00CZ6V
Page 2 of 2
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/312/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 26
th
July 2013
Last updated: December 2016
10 DATE OF REVISION OF THE TEXT
June 2022