Linezolid Polpharma 2mg/ml, oplossing voor infusie

Country: Netherlands

Language: Dutch

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Active ingredient:

LINEZOLID 2 mg/ml

Available from:

Pharmaceutical Works Polpharma S.A. 19, Pelplinska Street 83-200 STAROGARD GDANSKI (POLEN)

ATC code:

J01XX08

INN (International Name):

LINEZOLID 2 mg/ml

Pharmaceutical form:

Oplossing voor infusie

Composition:

CITROENZUUR 0-WATER (E 330) ; GLUCOSE 1-WATER ; NATRIUMHYDROXIDE (E 524) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),

Administration route:

Intraveneus gebruik

Therapeutic area:

Linezolid

Product summary:

Hulpstoffen: CITROENZUUR 0-WATER (E 330); GLUCOSE 1-WATER; NATRIUMHYDROXIDE (E 524); TRINATRIUMCITRAAT 2-WATER (E 331); WATER VOOR INJECTIE; ZOUTZUUR (E 507);

Authorization date:

2014-03-05

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID POLPHARMA 2 MG/ML OPLOSSING VOOR INFUSIE
Linezolid
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 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 or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Linezolid Polpharma is and what it is used for
2.
What you need to know before you are given Linezolid Polpharma
3.
How Linezolid Polpharma is given
4.
Possible side effects
5.
How to store Linezolid Polpharma
6.
Contents of the pack and other information
1.
WHAT LINEZOLID POLPHARMA IS AND WHAT IT IS USED FOR
Linezolid Polpharma 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 in adults. Your doctor will have decided if this
medicine is suitable to treat your infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LINEZOLID POLPHARMA
YOU MUST NOT BE GIVEN LINEZOLID POLPHARMA:

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 Parksinson’s disease

if you are breastfeeding. This is because linezolid passes into breast
milk and could affect the baby.
Linezolid Polpharma 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

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Linezolid Polpharma 2 mg/ml oplossing voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 2 mg of linezolid.
300 ml of solution for infusion contains 600 mg of linezolid.
Excipients with known effect: sodium, glucose.
This medicinal product contains 0.38 mg/ml (0.113 g/dose) of sodium.
This medicinal product contains 45.67 mg/ml (13.702 g/dose) of
glucose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
Isotonic, clear, colourless to yellow solution
pH: 4.3 – 5.3
osmolality: 280 – 340 mOsm/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
- Nosocomial pneumonia
- Community acquired pneumonia
Linezolid Polpharma 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 Polpharma 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 Polpharma 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
2
co-infection with Gram negative organisms if there are no alternative
treatmen