Ofloxacine Devatis 3 mg/ml, oogdruppels, oplossing, Verpakking voor éénmalig gebruik

국가: 네덜란드

언어: 네덜란드어

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

유효 성분:

OFLOXACINE 3 mg/ml

제공처:

Devatis GmbH Spitalstrasse 22 795 39 LORRACH (DUITSLAND)

ATC 코드:

S01AE01

INN (국제 이름):

OFLOXACINE 3 mg/ml

약제 형태:

Oogdruppels, oplossing

구성:

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

관리 경로:

Oculair gebruik

치료 영역:

Ofloxacin

제품 요약:

Hulpstoffen: NATRIUMCHLORIDE; NATRIUMHYDROXIDE (E 524); WATER, GEZUIVERD; ZOUTZUUR (E 507);

승인 날짜:

1900-01-01

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
OFLOXACINE DEVATIS 3 MG/ML, OOGDRUPPELS, OPLOSSING, VERPAKKING VOOR
ÉÉNMALIG GEBRUIK
Ofloxacin
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 Ofloxacine Devatis is and what it is used for
2.
What you need to know before you use Ofloxacine Devatis
3.
How to use Ofloxacine Devatis
4.
Possible side effects
5.
How to store Ofloxacine Devatis
6.
Contents of the pack and other information
1. WHAT OFLOXACINE DEVATIS IS AND WHAT IT IS USED FOR
Ofloxacine Devatis is an eye drop to treat external eye infections
such as bacterial conjunctivitis
(inflammation of the conjunctiva) and keratitis (inflammation of the
cornea) in adults and children
caused by ofloxacin-sensitive organisms.
Ofloxacin is an antibacterial agent and belongs to a group of
medicines called fluoroquinolones
(sometimes shortened to quinolones).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OFLOXACINE DEVATIS
DO NOT TAKE:
-
If you are allergic (hypersensitive) to ofloxacin, to any other
quinolones (the group of this
medicine) or any of the other ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Ofloxacine Devatis.
-
if you are sensitive to other quinolone antibacterial agents
-
if you suffer from defects or ulcers of the ocular surface.
Long term use may result in a new bacterial infection which does not
respond to Ofloxacine Devatis.
Tendon swelling and rupture have happened in people taking oral or
intravenous fluoroquinolones

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAAM VAN HET GENEESMIDDEL
Ofloxacine Devatis 3 mg/ml, oogdruppels, oplossing, Verpakking voor
éénmalig gebruik
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 3 mg ofloxacin in a preservative free formulation.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FROM
Eye drop solution in single-dose container for administration by
instillation in the conjunctival sac.
Clear, pale light yellow solution, free from visible particles.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ofloxacine Devatis is indicated for the topical treatment of external
ocular infections (such as
conjunctivitis and keratitis) in adults and children caused by
ofloxacin - sensitive organisms.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Ocular use
POSOLOGY
Instillation of one drop of Ofloxacine Devatis in the conjunctival sac
of the affected eye(s) every two
to four hours for the first two days, followed by four times daily.
The length of treatment should not exceed 14 days.
_Paediatric population _
No dose adjustment is necessary.
_ _
_Elderly population _
No dose adjustment is necessary (see section 4.4).
METHOD OF ADMINISTRATION
Patients should be instructed to avoid contact between the tip of the
SINGLE-DOSE
container and the
eyes or areas around the eyes.
The solution from one individual single-dose container of Ofloxacine
Devatis is to be used
immediately after opening since sterility cannot be maintained after
the individual single-dose
container is opened.
If another topical agent is being used, Ofloxacine Devatis and the
other agent should be administered
at least 15 minutes apart. Eye ointments should always be applied at
last.
4.3 CONTRAINDICATIONS
-
Hypersensitivity to the active substance, any other quinolones or to
any of the excipients listed in
section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Safety and effectiveness in infants below the age of one