Linezolid 600mg tablets

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Linezolid

Dostupno od:

Sandoz Ltd

ATC koda:

J01XX08

INN (International ime):

Linezolid

Doziranje:

600mg

Farmaceutski oblik:

Oral tablet

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 05010700; GTIN: 5050650131024

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID 600 MG
FILM-COATED TABLETS
For adults
Linezolid
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 or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Linezolid is and what it is used for
2. What you need to know before you take Linezolid
3. How to take Linezolid
4. Possible side effects
5. How to store Linezolid
6. Contents of the pack and other information
1. WHAT LINEZOLID 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. It is used in adults
to treat pneumonia and
some infections in the skin or under the skin. Your doctor will have
decided if Linezolid is
suitable to treat your infection.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LINEZOLID
DO NOT TAKE LINEZOLID:
•
if you are allergic (hypersensitive) to linezolid or any of the other
ingredients of this
medicine
•
if you are taking or have taken within the last 2 weeks any medicines
known as
monoamine oxidase inhibitors (MAOIs: for example phenelzine,
isocarboxazid, selegiline,
moclobemide). These medications may be used to treat depression or
Parkinson’s disease;
•
if you are breastfeeding. This is because Linezolid passes into breast
milk and could affect
the baby.
WARNINGS AND PRECAUTIONS
Linezolid 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 treatment or may decide that another
t

Svojstava lijeka

OBJECT 1
LINEZOLID 600 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 30-Sep-2016 | Sandoz
Limited
1. Name of the medicinal product
Linezolid 600 mg Film-coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 600 mg of linezolid.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
White to off white colored biconvex oval shaped film-coated tablet,
18.8mm long, 9.9mm wide and
6.4mm thick with “LZ600” debossed on one side and plain on the
other side.
4. Clinical particulars
4.1 Therapeutic indications
- Nosocomial pneumonia
- Community acquired pneumonia
Linezolid is indicated 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
Gram-negative pathogen is documented or
suspected.
- Complicated skin and soft tissue infections (see section 4.4)
Linezolid is indicated 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 (see section 4.4). In these
circumstances treatment against Gram-negative organisms must be
initiated concomitantly.
Linezolid should only be in