TRAVOPROST ratiopharm 40 microgram/ml, oogdruppels, benzalkoniumchloridevrije oplossing

Land: Holland

Sprog: hollandsk

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

Aktiv bestanddel:

TRAVOPROST

Tilgængelig fra:

Ratiopharm GmbH

ATC-kode:

S01EE04

INN (International Name):

TRAVOPROST

Lægemiddelform:

Oogdruppels, oplossing

Sammensætning:

BOORZUUR (E 284) ; MACROGOLGLYCEROLHYDROXYSTEARAAT ; MANNITOL (D-) (E 421) ; NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; POLYQUATERNIUM-1 ; PROPYLEENGLYCOL (E 1520) 7,5 mg/ml ; WATER, GEZUIVERD ; ZOUTZUUR (E 507),

Indgivelsesvej:

Oculair gebruik

Terapeutisk område:

Travoprost

Produkt oversigt:

Hulpstoffen: BOORZUUR (E 284); MACROGOLGLYCEROLHYDROXYSTEARAAT; MANNITOL (D-) (E 421); NATRIUMCHLORIDE; NATRIUMHYDROXIDE (E 524); POLYQUATERNIUM-1; PROPYLEENGLYCOL (E 1520) 7,5 mg/ml; WATER, GEZUIVERD; ZOUTZUUR (E 507);

Autorisation dato:

2015-02-21

Indlægsseddel

1
BIJSLUITER: INFORMATIE VOOR GEBRUIKER
TRAVOPROST ratiopharm 40 microgram/ml, oogdruppels,
benzalkoniumchloridevrije 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. 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
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.
ARE 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
DO NOT USE

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

TRAVOPROST 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.

TRAVOPROST 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 C

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
TRAVOPROST ratiopharm 40 microgram/ml, oogdruppels,
benzalkoniumchloridevrije 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 of polyquaternium-1, 7.5 mg
of propylene glycol, 2 mg of
macrogolglycerol hydroxystearate 40 (see section 4.4.)
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 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