Linezolid Teva 600mg Film-coated Tablets

Држава: Малта

Језик: Енглески

Извор: Malta Medicines Authority

Активни састојак:

LINEZOLID

Доступно од:

Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

АТЦ код:

J01XX08

INN (Међународно име):

LINEZOLID 600 mg

Фармацеутски облик:

FILM-COATED TABLET

Састав:

LINEZOLID 600 mg

Тип рецептора:

POM

Терапеутска област:

ANTIBACTERIALS FOR SYSTEMIC USE

Статус ауторизације:

Withdrawn

Датум одобрења:

2015-05-14

Информативни летак

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID TEVA 600 MG FILM-COATED TABLETS
linezolid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 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 or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Linezolid Teva is and what it is used for
2.
What you need to know before you take Linezolid Teva
3.
How to take Linezolid Teva
4.
Possible side effects
5.
How to store Linezolid Teva
6.
Contents of the pack and other information
1.
WHAT LINEZOLID TEVA IS AND WHAT IT IS USED FOR
Linezolid is an antibiotic of the oxazolidinones group that works by
stopping the growth of certain bacteria
(germs) that cause infections.
Linezolid is used to treat pneumonia and some infections in the skin
or under the skin. Your doctor will have
decided if Linezolid Teva is suitable to treat your infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LINEZOLID TEVA
DO NOT TAKE LINEZOLID TEVA:

If you are allergic to linezolid or any of the other ingredients of
this medicine (listed in section 6).

If you are taking or have taken within the last 2 weeks any medicines
known as monoamine oxidase
inhibitors (MAOIs, e.g. phenelzine, isocarboxazid, selegiline,
moclobemide). These medications may be
used to treat depression or Parkinson's disease.

If you are breast-feeding. This is because linezolid passes into
breast milk and could affect the baby.
Linezolid Teva may not be suitable for you if you answer YES to any of
the following questions. In this case
tell your doctor as he/she will need to check your general health and
your blood pressure before and during
your treatmen

Карактеристике производа

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Linezolid Teva 600 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg linezolid.
Excipient with known effect:
Each film-coated tablet contains 195.50 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White, film coated modified capsule shaped tablet, debossed with "600"
on one side. The other side is
scored. Dimensions: approx. 20 x 9 mm.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nosocomial pneumonia
Community acquired pneumonia

Linezolid is indicated in adults for the treatment of community
acquired pneumonia and nosocomial
pneumonia when known or suspected to be caused by susceptible Gram
positive bacteria. In
determining whether linezolid is an appropriate treatment, the results
of microbiological tests or
information on the prevalence of resistance to antibacterial agents
among Gram positive bacteria
should be taken into consideration. (See section 5.1 for the
appropriate organisms).

Linezolid is not active against infections caused by Gram negative
pathogens. Specific therapy
against Gram negative organisms must be initiated concomitantly if a
mixed infection with a Gram
negative pathogen is documented or suspected.
Complicated skin and soft tissue infections (see section 4.4)

Linezolid is indicated in adults for the treatment of complicated skin
and soft tissue infections ONLY
when microbiological testing has established that the infection is
known to be caused by susceptible
Gram positive bacteria.

Linezolid is not active against infections caused by Gram negative
pathogens. Linezolid should only
be used in patients with complicated skin and soft tissue infections
with known or possible co-
infection with Gram negative organisms if there are no alternative
treatment options available