LINEZOLID 600 Milligram Film Coated Tablet

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

LINEZOLID

Disponibil de la:

Actavis Group PTC ehf

Codul ATC:

J01XX08

INN (nume internaţional):

LINEZOLID

Dozare:

600 Milligram

Forma farmaceutică:

Film Coated Tablet

Calea de administrare:

oral use

Unități în pachet:

Packs of 1, 10, 20, 30, 50 or 60 tablets

Tip de prescriptie medicala:

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

Produs de:

Actavis ehf

Grupul Terapeutică:

Other antibacterials

Zonă Terapeutică:

Other antibacterials

Indicații terapeutice:

Nosocomial pneumonia Community acquired pneumonia 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.

Statutul autorizaţiei:

Authorised

Data de autorizare:

2015-03-13

Prospect

Linezolid 600mg Tablets PIL - UK/Eire
item no: AAAJ1269
print proof no: 2
origination date: 24.06.16
originated by: S.Anson
revision date: 28.06.16
revised by: S.Anson
dimensions: 190 x 380  
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
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date sent:  N/A
supplier: Malta Zejtun
technically app. date: N/A
min pt size: 9
TECHNICAL APPROVAL
Black
T00075-01 Malta Zejtun 190x380 PIL
LINEZOLID 600MG FILM-COATED TABLETS
Linezolid
_Continued over page_
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.
•  
The full name of this medicine is Linezolid 600mg Film-
coated Tablets but within the leaflet it will be referred to as 
Linezolid Tablets.
WHAT IS IN THIS LEAFLET
1

WHAT LINEZOLID TABLETS ARE AND WHAT THEY ARE 
USED FOR
2

WHAT YOU NEED TO KNOW BEFORE YOU TAKE LINEZOLID 
TABLETS
3

HOW TO TAKE LINEZOLID TABLETS
4

POSSIBLE SIDE EFFECTS
5

HOW TO STORE LINEZOLID TABLETS
6

CONTENTS OF THE PACK AND OTHER INFORMATION
1

WHAT LINEZOLID TABLETS ARE AND WHAT THEY ARE 
USED FOR
Linezolid Tablets are an antibiotic of the oxazolidinones group 
that work 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 Tablets are suitable to treat your infection.
2

WHAT YOU NEED TO KNOW BEFORE YOU TAKE LINEZOLID 
TABLETS

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linezolid 600 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg linezolid.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, biconvex oval tablet, 9.3 mm x 19 mm. The tablet has “L” on one side and “600” on the opposite side.
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 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 (see section 4.4). In these circumstances treatment ag