Diclofenac Devatis 1 mg/ml, oogdruppels, oplossing, verpakking voor éénmalig gebruik

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DICLOFENAC NATRIUM 1 mg/ml SAMENSTELLING overeenkomend met ; DICLOFENAC 0,93 mg/ml

Beschikbaar vanaf:

Devatis GmbH Spitalstrasse 22 795 39 LORRACH (DUITSLAND)

ATC-code:

S01BC03

INN (Algemene Internationale Benaming):

DICLOFENAC NATRIUM 1 mg/ml SAMENSTELLING overeenkomend met ; DICLOFENAC 0,93 mg/ml

farmaceutische vorm:

Oogdruppels, oplossing

Samenstelling:

BOORZUUR (E 284) ; MACROGOLGLYCEROLRICINOLEAAT ; TROMETAMOL ; WATER, GEZUIVERD,

Toedieningsweg:

Oculair gebruik

Therapeutisch gebied:

Diclofenac

Product samenvatting:

Hulpstoffen: BOORZUUR (E 284); MACROGOLGLYCEROLRICINOLEAAT; TROMETAMOL; WATER, GEZUIVERD;

Autorisatie datum:

2014-12-16

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
DICLOFENAC DEVATIS 1 MG/ML, OOGDRUPPELS, OPLOSSING, VERPAKKING VOOR
ÉÉNMALIG GEBRUIK
Diclofenac sodium
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 Diclofenac Devatis is and what it is used for
2.
What you need to know before you take Diclofenac Devatis
3.
How to take Diclofenac Devatis
4.
Possible side effects
5.
How to store Diclofenac Devatis
6.
Contents of the pack and other information
1. WHAT DICLOFENAC DEVATIS IS AND WHAT IT IS USED FOR
This medicine belongs to a group of medicines called non steroidal
anti-inflammatory drugs
(NSAIDs), with analgesic properties. The medicine reduces inflammation
and pain.
Diclofenac sodium is indicated for:
-
Prevention of postoperative inflammation in cataract surgery.
-
Maintenance of pupil dilation (mydriasis) during cataract surgery.
-
Treatment of ocular pain in photofractive surgery for up to the 24
first postoperative hours.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DICLOFENAC DEVATIS
DO NOT USE:
-
If you are allergic to diclofenac sodium or any of the other
ingredients of this medicine (listed in
section 6).
-
If you have experienced asthma, skin allergy, or intense inflammation
in your nose when using
other NSAIDs. Examples of NSAIDs are: acetylsalicylic acid, ibuprofen,
ketoprofen, piroxicam,
nepafenac.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Diclofenac Devatis.
If you use medicines that prolong the bleeding time or if you are
known to have a higher bleeding
tendency,

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAAM VAN HET GENEESMIDDEL
Diclofenac Devatis 1 mg/ml, oogdruppels, oplossing, verpakking voor
éénmalig gebruik
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 1 mg diclofenac sodium
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FROM
Eye drop, solution.
Clear and colourless solution. Free of particles.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-
Prevention of postoperative inflammation in cataract surgery.
-
Maintenance of mydriasis during cataract surgery.
-
Treatment of ocular pain in photorefractive surgery for up to the 24
first post-operative hours.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Ocular use
POSOLOGY
_ _
_Adults _
Inhibition of miosis during cataract surgery
-
Pre-operatively: one drop in the affected eye 3 to 5 times during the
1-2 hours before surgery.
Prevention of inflammation in cataract and anterior eye segment
surgeries:
-
Pre-operatively: one drop in the affected eye 3 to 5 times during the
1-2 hours before surgery;
-
Post-operatively: one drop in the affected eye three to five times
daily. A treatment duration
exceeding 4 weeks is not recommended.
Treatment of ocular pain in photorefractive surgery for up to the 24
first postoperative hours:
-
Pre-operatively: one drop two times in the affected eye within the
hour prior to surgery;
-
Post-operatively: one drop two times within the hour following surgery
and then one drop four
times within the 24 post-operative hours.
_ _
_Paediatric population _
Diclofenac Devatis is not indicated for the use in children. There is
only limited experience in children
aged 2 years and older from clinical studies on strabismus surgery.
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 Diclofenac
Devatis is to be used
immediately after opening since sterility cannot be maintained after
the individual single dose
cont