Linezolid 2 mg/ml solution for infusion

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Linezolid

متاح من:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC رمز:

J01XX; J01XX08

INN (الاسم الدولي):

Linezolid

جرعة:

2 milligram(s)/millilitre

الشكل الصيدلاني:

Solution for infusion

نوع الوصفة الطبية :

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

المجال العلاجي:

Other antibacterials; linezolid

الوضع إذن:

Not marketed

تاريخ الترخيص:

2015-11-06

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID 2 MG/ML SOLUTION FOR INFUSION
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, pharmacist or
nurse.
-
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 is and what it is used for
2.
What you need to know before you use Linezolid
3.
How to use 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 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 USE LINEZOLID
DO NOT USE LINEZOLID:
-
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 passes into
breast milk and could affect the baby.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Linezolid.
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 treatment is better for you.
Ask your doctor if you are not sure whether thes

خصائص المنتج

Health Products Regulatory Authority
12 August 2021
CRN009WWW
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linezolid 2 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 2 mg linezolid. Each 300 ml infusion bag contains 600 mg
linezolid.
Excipient(s) with known effect
Each 1 ml of solution for infusion contains 0.38 mg sodium.
Each 300 ml bag solution for infusion contains 114 mg sodium.
Each 1 ml of solution for infusion contains 48 mg glucose.
Each 300 ml bag solution for infusion contains 14.4 g glucose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Isotonic, clear, colourless to yellow solution.
The pH of the solution is 4.5 - 5.0.
Osmolality is 270 – 330 mosmol/kg
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 kn