Levofloxacine Sandoz infuus 5 mg/ml, oplossing voor infusie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LEVOFLOXACINE 0,5-WATER SAMENSTELLING overeenkomend met ; LEVOFLOXACINE

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

J01MA12

INN (Algemene Internationale Benaming):

LEVOFLOXACIN 0,5-WATER COMPOSITION corresponding to ; LEVOFLOXACIN

farmaceutische vorm:

Oplossing voor infusie

Samenstelling:

NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),

Toedieningsweg:

Intraveneus gebruik

Therapeutisch gebied:

Levofloxacin

Product samenvatting:

Hulpstoffen: NATRIUMCHLORIDE; NATRIUMHYDROXIDE (E 524); WATER VOOR INJECTIE; ZOUTZUUR (E 507);

Autorisatie datum:

2015-11-17

Bijsluiter

Sandoz B.V.
Page 1/12
Levofloxacine
®
Sandoz infuus 5 mg/ml, oplossing voor
infusie
RVG 115544
1313-V8
1.3.1.3 Bijsluiter
November 2020
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOFLOXACINE SANDOZ
® INFUUS 5 MG/ML, OPLOSSING VOOR INFUSIE
levofloxacin
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
The name of your medicine is {nationally completed name}. It contains
a medicine called
levofloxacin. This belongs to a group of medicines called antibiotics.
Levofloxacin is a ‘quinolone’
antibiotic. It works by killing the bacteria that cause infections in
your body.
Levofloxacin solution for infusion can be used to treat infections of
the:
• Lungs, in people with pneumonia
• Urinary tract, including your kidneys or bladder
•
Prostate gland, where you have a long lasting infection
• Skin and underneath the skin, including muscles. This is sometimes
called ‘soft tissue’
In some special situations, Levofloxacin solution for infusion may be
used to lessen the chances of
getting a pulmonary disease named anthrax or worsening of the disease
after you are exposed to the
bacteria causing anthrax.
_ _
2. WHAT YOU NEED TO KNOW BEFORE YOU USE {NATIONALLY COMPLETED NAME}
DO NOT USE {NATIONALLY COMPLETED NAME}IF:
Sandoz B.V.
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Levofloxacine
®
Sandoz infuus 5 mg/ml, oplossing voor
in

Productkenmerken

Sandoz B.V.
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Levofloxacine Sandoz infuus 5 mg/ml, oplossing voor infusie
RVG 115544
1311-V8
1.3.1.1. Samenvatting van de productkenmerken
November 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levofloxacine Sandoz infuus 5 mg/ml, oplossing voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 5 mg of levofloxacin (as
hemihydrate).
Each bag of 50 ml contains 250 mg of levofloxacin (as hemihydrate).
Each bag of 100 ml contains 500 mg of levofloxacin (as hemihydrate).
Excipient(s) with known effect
Each ml of solution for infusion contains 0.15 mmol (3.5 mg) sodium.
Each bag of 50 ml contains 7.76 mmol (178.4 mg) sodium.
Each bag of 100 ml contains 15.53 mmol (357.0 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear greenish-yellow solution free from particles.
pH 4.3 – 5.3
Osmolality 280 – 340 mosml/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levofloxacin 5mg/mL Solution for infusion is indicated in adults for
the treatment of the following
infections (see sections 4.4 and 5.1):
•
Acute pyelonephritis and complicated urinary tract infections (see
section 4.4)
•
Chronic bacterial prostatitis
•
Inhalation Anthrax (postexposure prophylaxis and curative treatment)
(see section 4.4).
In
the
below-mentioned
infections
Levofloxacin
should
be
used
only
when
it
is
considered
inappropriate to use antibacterial agents that are commonly
recommended for the initial treatment of
these infections.
_ _
•
Community-acquired pneumonia
Sandoz B.V.
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Levofloxacine Sandoz infuus 5 mg/ml, oplossing voor infusie
RVG 115544
1311-V8
1.3.1.1. Samenvatting van de productkenmerken
November 2020
•
Complicated skin and soft tissue infections
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Levofloxacin solution for infusion is administered by
SLOW
intravenous infusion once or twic