Linezolid 600mg/300ml infusion bags

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Linezolid

متاح من:

Pfizer Ltd

ATC رمز:

J01XX08

INN (الاسم الدولي):

Linezolid

جرعة:

2mg/1ml

الشكل الصيدلاني:

Infusion

طريقة التعاطي:

Intravenous

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 05010700; GTIN: 5013457011081

نشرة المعلومات

Page 1 of 18
PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID 2 MG/ML SOLUTION FOR INFUSION
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.
-
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 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 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 ARE TREATED WITH LINEZOLID
DO NOT TAKE 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 taking 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 yo

خصائص المنتج

OBJECT 1
LINEZOLID 2MG/ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 26-Feb-2018 | Pfizer
Limited
1. Name of the medicinal product
Linezolid 2 mg/ml solution for infusion
2. Qualitative and quantitative composition
1 ml solution for infusion contains 2 mg linezolid. 300 ml infusion
bags contain 600 mg linezolid.
Excipients with known effect
Each 300 ml also contains 13.7 g glucose and 114 mg sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion.
Isotonic, clear, colourless to yellow solution with pH range of
4.4-5.2.
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 against Gram negative organisms must b