Linezolid Rowex 2 mg/ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Linezolid

Available from:

Rowex Ltd

ATC code:

J01XX; J01XX08

INN (International Name):

Linezolid

Dosage:

2 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

Administration route:

intravenous or oral use

Units in package:

1, 2, 5, 10, 20 or 25 infusion bag

Prescription type:

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

Manufactured by:

Synthon BV, Synthon Hispania SL, Sant Boi de Llobregat, Sandoz GmbH, Salutas Pharma GmbH, Lek Pharmaceuticals d.d.

Therapeutic group:

Other antibacterials

Therapeutic area:

Other antibacterials; linezolid

Therapeutic indications:

It is indicated for the treatment of community acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by susceptible Gram positive bacteria and for the treatment of complicated skin and soft tissue infections

Authorization status:

Not marketed

Authorization date:

2015-07-31

Patient Information leaflet

WHAT IS IN THIS LEAFLET:
1. What Linezolid Rowex is and what it is used for
2.
What you need to know before you use Linezolid
Rowex
3. How to use Linezolid Rowex
4. Possible side effects
5. How to store Linezolid Rowex
6. Contents of the pack and other information
1 WHAT LINEZOLID ROWEX IS AND
WHAT IT IS USED FOR
Linezolid Rowex contains the active substance
linezolid. 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 Rowex is suitable to treat
your infection.
2 WHAT YOU NEED TO KNOW BEFORE
YOU USE LINEZOLID ROWEX
DO NOT USE LINEZOLID ROWEX
– 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
medicinal products may be used to treat depression
or Parkinson’s disease;
– If you are breast-feeding. This is because Linezolid
Rowex passes into breast milk and could affect the
baby.
WARNINGS AND PRECAUTIONS
Linezolid Rowex 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 apply to you.
– Do you have high blood pressure, whether or not
you are taking medicines for this?
– Have you been diagnosed with an overactive
thyroid?
– Do you have a tumour of the adrenal glands
(phaeochromocytoma) or carcinoid syndrome
(caused by tumours of the hormone system with
symptoms of diarrhoea, flushing of the skin,
wheezing)?
– Do you suffer from manic depression,
schizoaffective

Summary of Product characteristics

Health Products Regulatory Authority
18 January 2019
CRN008HHY
Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linezolid Rowex 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)
Health Products Regulatory Authority
18 January 2019
CRN008HHY
Page 2 of 23
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