Levofloxacine Rafarm zonder conserveermiddel 5 mg/ml oogdruppels, oplossing

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LEVOFLOXACINE 0,5-WATER 5,1 mg/ml SAMENSTELLING overeenkomend met ; LEVOFLOXACINE 5 mg/ml

Beschikbaar vanaf:

Rafarm SA 12 Kapodistriou str. Korinthou str. 15451 N. PSYCHIKO - ATHENS (GRIEKENLAND)

INN (Algemene Internationale Benaming):

LEVOFLOXACINE 0,5-WATER 5,1 mg/ml SAMENSTELLING overeenkomend met ; LEVOFLOXACINE 5 mg/ml

farmaceutische vorm:

Oogdruppels, oplossing

Samenstelling:

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

Toedieningsweg:

Oculair gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

Version 1.0, October 2019
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOFLOXACINE RAFARM ZONDER CONSERVEERMIDDEL 5 MG/ML OOGDRUPPELS,
OPLOSSING
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.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Levofloxacine Rafarm zonder conserveermiddel 5 mg/ml oogdruppels,
oplossing is and what it
is used for
2.
What you need to know before you use Levofloxacine Rafarm zonder
conserveermiddel 5 mg/ml
oogdruppels, oplossing
3.
How to use Levofloxacine Rafarm zonder conserveermiddel 5 mg/ml
oogdruppels, oplossing
4.
Possible side effects
5.
How to store Levofloxacine Rafarm zonder conserveermiddel 5 mg/ml
oogdruppels, oplossing
6.
Contents of the pack and other information
1.
WHAT LEVOFLOXACINE RAFARM ZONDER CONSERVEERMIDDEL 5 MG/ML OOGDRUPPELS,
OPLOSSING IS AND
WHAT IT IS USED FOR
Levofloxacin is an antibiotic of the type called fluoroquinolones
(sometimes shortened to quinolones). It
works by killing some types of bacteria that can cause infections.
When levofloxacin is given in eye drops, it is used in children aged 1
year or over and in adults to treat
bacterial infections that affect the front surfaces of the eye.
One type of infection in this area is called bacterial conjunctivitis,
which is an infection of the covering of
the front of the eye (conjunctiva).
Levofloxacine Rafarm zonder conserveermiddel 5 mg/ml oogdruppels,
oplossing is not recommended to be
used in children aged below 1 year.
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days.
2.

Productkenmerken

Version 1.1, November 2019
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Levofloxacine Rafarm zonder conserveermiddel 5 mg/ml oogdruppels,
oplossing
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of eye drops, solution, contains 5.12 mg of levofloxacin
hemihydrate,
equivalent to 5 mg of levofloxacin.
Each drop contains approximately 0.2 mg of levofloxacin hemihydrate,
equivalent to
0.195 mg of levofloxacin.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Eye drops, solution.
Clear with a light yellow colour solution, with no visible particles.
Isotonic solution adjusted to physiological pH-value range.
pH: 6.0-7.0
Osmolality: 260 to 340 mOsmol/kg
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levofloxacine Rafarm zonder conserveermiddel 5 mg/ml oogdruppels,
oplossing are
indicated for the topical treatment of bacterial external ocular
infections in patients ≥1
year of age caused by levofloxacin susceptible microorganisms (see
also sections 4.4
and 5.1).
Considerations should be given to official guidance on the appropriate
use of
antibacterial agents.
Levofloxacine Rafarm zonder conserveermiddel 5 mg/ml oogdruppels,
oplossing is
indicated in adults, children aged ≥1 year to 12 years and
adolescents aged 12 to 18
years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Version 1.1, November 2019
For all patients instil one to two drops in the affected eye(s) every
two hours up to 8
times per day while awake for the first two days and then four times
daily on days 3
through 5.
_ _
If different topical ocular medications are used concomitantly, at
least a 15-minute
interval is required between instillations.
The duration of treatment depends on the severity of the disorder and
on the clinical
and bacteriological course of infection. The usual treatment duration
is 5 days.
Safety and efficacy in the treatment of corneal ulcer and ophthalmia
neonatorum has
not been established.
Levofloxacine Rafarm zonder conserveermiddel 5 mg/ml oogdruppels,
oplossing is
not re