Traelb 40 microgram/ml oogdruppels, oplossing

Ország: Hollandia

Nyelv: holland

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

Aktív összetevők:

TRAVOPROST

Beszerezhető a:

Alfred Tiefenbacher (GmbH & Co. KG) Van-der-Smissen- Strasse 1 22767 HAMBURG (DUITSLAND)

ATC-kód:

S01EE04

INN (nemzetközi neve):

TRAVOPROST

Gyógyszerészeti forma:

Oogdruppels, oplossing

Összetétel:

BOORZUUR (E 284) ; MACROGOLGLYCEROLHYDROXYSTEARAAT ; MANNITOL (D-) (E 421) ; NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; POLIDRONIUM CHLORIDE ; PROPYLEENGLYCOL (E 1520) ; WATER, GEZUIVERD ; ZOUTZUUR (E 507), BOORZUUR (E 284) ; MACROGOLGLYCEROLHYDROXYSTEARAAT ; MANNITOL (D-) (E 421) ; NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; POLYQUATERNIUM-1 ; PROPYLEENGLYCOL (E 1520) ; WATER, GEZUIVERD ; ZOUTZUUR (E 507),

Az alkalmazás módja:

Oculair gebruik

Terápiás terület:

Travoprost

Termék összefoglaló:

Hulpstoffen: BOORZUUR (E 284); MACROGOLGLYCEROLHYDROXYSTEARAAT; MANNITOL (D-) (E 421); NATRIUMCHLORIDE; NATRIUMHYDROXIDE (E 524); POLYQUATERNIUM-1; PROPYLEENGLYCOL (E 1520); WATER, GEZUIVERD; ZOUTZUUR (E 507);

Engedély dátuma:

2015-11-18

Betegtájékoztató

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAELB 40 MICROGRAM/ML OOGDRUPPELS, OPLOSSING
Travoprost
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 Traelb is and what it is used for
2.
What you need to know before you use Traelb
3.
How to use Traelb
4.
Possible side effects
5.
How to store Traelb
6.
Contents of the pack and other information
1.
WHAT TRAELB IS AND WHAT IT IS USED FOR
Traelb
CONTAINS TRAVOPROST,
one of a group of medicines called
PROSTAGLANDIN ANALOGUES
. It works
by reducing the pressure in the eye. It may be used on its own or with
other drops e.g. beta-blockers,
which also reduce pressure.
Traelb
IS USED TO REDUCE HIGH PRESSURE IN THE EYE IN ADULTS, ADOLESCENTS AND
CHILDREN FROM 2
MONTHS OLD ONWARD.
This pressure can lead to an illness called
GLAUCOMA.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TRAELB
DO NOT USE TRAELB

IF YOU ARE ALLERGIC
to travoprost or any of the other ingredients of this medicine (listed
in
section 6).
Ask your doctor for advice if this applies to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Traelb

Traelb
MAY INCREASE
the length, thickness, colour and/or number of your
EYELASHES
. Changes
in the eyelids including unusual hair growth or in the tissues around
the eye have also been
observed.

Traelb may
CHANGE THE COLOUR OF YOUR IRIS
(the coloured part of your eye). This change may
be permanent. A change in the colour of the skin around the eye may
also occur.

If you have had
CATARACT SURGERY
, talk to your doctor be

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Traelb 40 microgram/ml oogdruppels, oplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains 40 micrograms of travoprost.
Excipient(s) with known effect:
Each mL of solution contains 10 microgram ofpolidronum chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution. (Eye drops)
Clear, colourless solution.
pH 6.3 to 7.3;
osmolality 265 - 320 mOsmol/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Decrease of elevated intraocular pressure in adult patients with
ocular hypertension or open-angle
glaucoma (see section 5.1).
Decrease of elevated intraocular pressure in paediatric patients aged
2 months to < 18 years with
ocular hypertension or paediatric glaucoma (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Use in adults, including elderly population _
The dose is one drop of Traelb in the conjunctival sac of the affected
eye(s) once daily. Optimal effect
is obtained if the dose is administered in the evening.
Nasolacrimal occlusion or gently closing the eyelid after
administration is recommended. This may
reduce the systemic absorption of medicinal products administered via
the ocular route and result in a
decrease in systemic adverse reactions.
If more than one topical ophthalmic medicinal product is being used,
the medicinal products must be
administered at least 5 minutes apart (see section 4.5).
If a dose is missed, treatment should be continued with the next dose
as planned. The dose should not
exceed one drop in the affected eye(s) daily.
When substituting another ophthalmic antiglaucoma medicinal product
with travoprost eye drops, the
other medicinal product should be discontinued and travoprost eye
drops should be started the
following day.
_Patients with hepatic and renal impairment _
Travoprost has been studied in patients with mild to severe hepatic
impairment and in patients with
mild to severe renal impairment (creatinine clearance as