Linezolid Krka 600 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Linezolid

Available from:

KRKA, d.d., Novo mesto

ATC code:

J01XX; J01XX08

INN (International Name):

Linezolid

Dosage:

600 milligram(s)

Pharmaceutical form:

Film-coated tablet

Administration route:

oral use

Units in package:

10, 20, 30 film-coated tablets, in a box

Prescription type:

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

Manufactured by:

KRKA, d.d

Therapeutic group:

Antibacterials for systemic use, other antibacterials

Therapeutic area:

Other antibacterials; linezolid

Therapeutic indications:

Linezolid Krka 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 Krka 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

Authorization status:

Marketed

Authorization date:

2015-09-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LINEZOLID KRKA 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Linezolid Krka is and what it is used for
2.
What you need to know before you take Linezolid Krka
3.
How to take Linezolid Krka
4.
Possible side effects
5.
How to store Linezolid Krka
6.
Contents of the pack and other information
1.
WHAT LINEZOLID KRKA IS AND WHAT IT IS USED FOR
Linezolid Krka is an antibiotic of the oxazolidinones group that works
by stopping the growth of
certain bacteria (germs) that cause infections. It is used to treat
pneumonia and some infections in the
skin or under the skin. Your doctor will have decided if Linezolid
Krka is suitable to treat your
infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LINEZOLID KRKA
DO NOT TAKE LINEZOLID KRKA:
-
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: for example 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 Krka passes into
breast milk and could
affect the baby.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Linezolid Krka.
Linezolid Krka may not be suitable for you if you answer yes to any of
the following questions. In this
case tel

Summary of Product characteristics

Health Products Regulatory Authority
10 July 2023
CRN00DFRZ
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linezolid Krka 600 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg linezolid.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to almost white, oval, slightly biconvex film-coated tablet.
Tablet dimension: 18 x 9 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nosocomial pneumonia
Community acquired pneumonia
Linezolid Krka 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 Krka 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 Krka 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 (see section 4.4). In these
circumstances treatment against Gram negative organisms
must be initiated concomitantly.
Linezolid should only be initiated in a hospital environment and after
consultation wit