Linezolid Sandoz 600 mg/ 300 ml, oplossing voor infusie

国家: 荷兰

语言: 荷兰文

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

有效成分:

LINEZOLID

可用日期:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC代码:

J01XX08

INN（国际名称）:

LINEZOLID

药物剂型:

Oplossing voor infusie

组成:

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

给药途径:

Intraveneus gebruik

治疗领域:

Linezolid

產品總結:

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

授权日期:

2014-03-05

资料单张

Sandoz B.V.
Page 1/23
Linezolid Sandoz 600 mg/ 300 ml, oplossing voor
infusie
RVG 113204
1313-V7
1.3.1.3 Bijsluiter
April 2022
PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID SANDOZ 600 MG/ 300 ML, OPLOSSING VOOR INFUSIE
linezolid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 [nationally completed name] is and what it is used for
2.
What you need to know before you use [nationally completed name]
3.
How to use [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] 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 [nationally
completed name] is suitable to treat
your infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT USE [NATIONALLY COMPLETED NAME]
-
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 medicines may be used to treat depression or Parkinson’s
disease;
-
If you are breast-feeding. This is because [nationally completed name]
passes into breast milk
and could affect the baby.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking [nationally
completed name].
[Nation

产品特点

Sandoz B.V.
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Linezolid Sandoz 600 mg/ 300 ml, oplossing voor
infusie
RVG 113204
1311-V4
1.3.1.1 Samenvatting van de Productkenmerken
April 2022
1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Linezolid Sandoz 600 mg/ 300 ml, oplossing voor infusie
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 2 mg of linezolid.
Each 300 ml infusion bag contains 600 mg of linezolid.
Excipient(s) with known effect
Each ml of solution for infusion contains 0.38 mg of sodium.
Each 300 ml bag of solution for infusion contains 114 mg of sodium.
Each ml of solution for infusion contains 48 mg glucose monohydrate.
Each 300 ml bag of solution for infusion contains 14.4 g glucose
monohydrate.
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).
Sandoz B.V.
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Linezolid Sandoz 600 mg/ 300 ml, oplossing voor
infusie
RVG 113204
1311-V4
1.3.1.1 Samenvatting van de Productkenmerken
April 2022
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