Levofloxacin Actavis 5 mg/ml Ögondroppar, lösning

Pays: Suède

Langue: suédois

Source: Läkemedelsverket (Medical Products Agency)

Ingrédients actifs:

levofloxacinhemihydrat

Disponible depuis:

Actavis Group PTC ehf.

Code ATC:

S01AE05

DCI (Dénomination commune internationale):

levofloxacin hemihydrate

Dosage:

5 mg/ml

forme pharmaceutique:

Ögondroppar, lösning

Composition:

bensalkoniumklorid Hjälpämne; levofloxacinhemihydrat 5,12 mg Aktiv substans

Type d'ordonnance:

Receptbelagt

Descriptif du produit:

Förpacknings: Droppflaska, 5 ml

Statut de autorisation:

Godkänd

Date de l'autorisation:

2016-03-17

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVOFLOXACIN ACTAVIS 5 MG/ML EYE DROPS, SOLUTION
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 or pharmacist.
-
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 pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What /…/ is and what it is used for
2.
What you need to know before you use /…/
3.
How to use /…/
4.
Possible side effects
5.
How to store /…/
6.
Contents of the pack and other information
1.
WHAT /…/ 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).
/.../ 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.
WHAT YOU NEED TO KNOW BEFORE YOU USE /…/
DO NOT USE /…/
-
if you are allergic to levofloxacin or other quinolones or any of the
other ingredients of this
medicine (listed in section 6).
If you are not sure, ask your doctor or pharmacist first.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using /…/
-
if an allergic reaction occurs even after a single dose, stop using
the medicine
-
if you observe worsening of your eye symptoms during treatment, please

Résumé des caractéristiques du produit

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levofloxacin Actavis 5 mg/ml eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of eye drops, solution, contains 5.12 mg of levofloxacin
hemihydrate equivalent to
5 mg of levofloxacin.
Excipient with known effect:
Each ml of eye drops, solution contains 0.05 mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, pale yellow to pale greenish-yellow solution, practically free
from visible particles.
The pH of the solution is 6.0-6.8 and the osmolality is 270-320
mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
/.../ 5 mg/ml eye drops 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).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
/.../ is indicated in adults, children aged ≥1 to 12 years and
adolescents aged 12 to 18 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.
To prevent contaminating the dropper tip and solution, the dropper tip
should not come into contact
with the eyelids or surrounding areas.
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.
2
/.../ is not recommended for use in children below age 1 year due to a
lack of data on safety and
efficacy.
_Use in the Elderly_
No adjustment of dosage is required.
_Pa