Linezolid 600mg/300ml infusion bags

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Linezolid

Tilgjengelig fra:

Panpharma UK Ltd

ATC-kode:

J01XX08

INN (International Name):

Linezolid

Dosering :

2mg/1ml

Legemiddelform:

Infusion

Administreringsrute:

Intravenous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 05010700; GTIN: 3391135490017

Informasjon til brukeren

LINEZOLID
LINEZOLID - SOLUTION FOR INFUSION
2 MG/ML
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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.
•
Linezolid 2 mg/ml Solution for Infusion is called ‘Linezolid
Infusion’ in this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Linezolid Infusion is and what it is used for
2. What you need to know before you are given Linezolid Infusion
3. How to use Linezolid Infusion
4. Possible side effects
5. How to store Linezolid Infusion
6. Contents of the pack and other information
1. WHAT LINEZOLID INFUSION IS AND WHAT IT IS USED FOR
Linezolid Infusion is an antibiotic of the oxazolidinones group. The
active substance is linezolid. Linezolid
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LINEZOLID INFUSION
YOU SHOULD NOT BE TREATED WITH LINEZOLID INFUSION:
•
If you are allergic (hypersensitive) 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 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 your baby.
•
If you are taking any of the following medications: serotonin
re-uptake inhibitors, tricyclic
antidepressants, serotonin 5-HT1 r

Preparatomtale

OBJECT 1
LINEZOLID 2MG/ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 18-Jul-2016 | Panpharma UK
Ltd
1. Name of the medicinal product
Linezolid 2 mg/ml Solution for Infusion
2. Qualitative and quantitative composition
Each ml contains 2 mg of linezolid. Each 300 ml infusion bag contains
600 mg of linezolid.
Excipients with known effect:
Each 300 ml bag contains approximately 13.7 g of glucose and 114 mg of
sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion.
Linezolid 2 mg/ml Solution for Infusion is an isotonic, clear,
colourless to yellowish solution, free from
visible particles.
The pH value of the solution for infusion ranges from 4.6 to 5.0 and
the solution has an osmolality
between 270 to 330 mOsm/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 2 mg/ml Solution for Infusion 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 sk