Zyvox 600mg/300ml infusion bags

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Linezolid

Fáanlegur frá:

Pfizer Ltd

ATC númer:

J01XX08

INN (Alþjóðlegt nafn):

Linezolid

Skammtar:

2mg/1ml

Lyfjaform:

Infusion

Stjórnsýsluleið:

Intravenous

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 05010700; GTIN: 5012882005498

Upplýsingar fylgiseðill

Page 1 of 17
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYVOX 2 MG/ML SOLUTION FOR INFUSION
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.
-
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 Zyvox is and what it is used for
2.
What you need to know before you take Zyvox
3.
How to take Zyvox
4.
Possible side effects
5.
How to store Zyvox
6.
Contents of the pack and other information
1.
WHAT ZYVOX IS AND WHAT IT IS USED FOR
Zyvox 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 Zyvox is suitable to treat your
infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE TREATED WITH ZYVOX
DO NOT TAKE ZYVOX:

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 Zyvox passes into breast
milk and could affect the baby.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Zyvox.
Zyvox 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 these categories a

Vara einkenni

OBJECT 1
ZYVOX 2 MG/ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 10-Jan-2017 | Pfizer
Limited
1. Name of the medicinal product
Zyvox 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
Zyvox 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 Zyvox 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)
Zyvox 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 concom