Levofloxacine Sandoz 5 mg/ml, oplossing voor infusie

País: Països Baixos

Idioma: neerlandès

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

ingredients actius:

LEVOFLOXACINE 0,5-WATER SAMENSTELLING overeenkomend met ; LEVOFLOXACINE

Disponible des:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Codi ATC:

J01MA12

Designació comuna internacional (DCI):

LEVOFLOXACIN 0,5-WATER COMPOSITION corresponding to ; LEVOFLOXACIN

formulario farmacéutico:

Oplossing voor infusie

Composición:

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

Vía de administración:

Intraveneus gebruik

Área terapéutica:

Levofloxacin

Resumen del producto:

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

Data d'autorització:

2009-06-19

Informació per a l'usuari

Sandoz B.V.
Page 1
Levofloxacine Sandoz 5 mg/ml, oplossing voor infusie
RVG 101408
V11
1.3.1.3 Bijsluiter
December 2019
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOFLOXACINE SANDOZ
® 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.
[Nationally completed name] 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, [Nationally completed name] 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 ARE GIVEN [NATIONALLY COMPLETED NAME]
DO NOT HAVE THIS MEDICINE AND TELL YOUR DOCTOR IF:
Sandoz B.V.
Page 2
Levofloxacine Sandoz 5 mg/ml, oplossing voor infusie
RVG 101408
V11
1.3.1.3 Bijsl

Fitxa tècnica

Sandoz B.V.
Pagina 1
Levofloxacine Sandoz 5 mg/ml, oplossing voor infusie
RVG 101408
1311-v11
1.3.1.1. Samenvatting van de Productkenmerken
December 2019
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levofloxacine Sandoz 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 vial of 50 ml contains 250 mg of levofloxacin (as hemihydrate).
Each vial of 100 ml contains 500 mg of levofloxacine (as hemihydrate).
Excipients with known effect:
Each vial of 50 ml contains 7.7 mmol (177 mg) sodium.
Each vial of 100 ml contains 15.4 mmol (354 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Yellow to greenish yellow clear solution, practically free from
particles.
pH 4.1-5.1
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] 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 treatment of these
infections.

Community-acquired pneumonia

Complicated skin and soft tissue infections
Sandoz B.V.
Pagina 2
Levofloxacine Sandoz 5 mg/ml, oplossing voor infusie
RVG 101408
1311-v11
1.3.1.1. Samenvatting van de Productkenmerken
December 2019
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
[Nationally completed name] is administered by SLOW intravenous
infusion once or twice daily. The
dosage depends on the type and severity of the infection and the
susceptibility of the presumed
causative pathogen. Treat