Travoprost/Timolol ratiopharm 40 microgram/ml + 5 mg/ml oogdruppels, oplossing

Ország: Hollandia

Nyelv: holland

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

Aktív összetevők:

TIMOLOLMALEAAT SAMENSTELLING overeenkomend met ; TIMOLOL 0-WATER ; TRAVOPROST

Beszerezhető a:

Ratiopharm GmbH

ATC-kód:

S01ED51

INN (nemzetközi neve):

TIMOLOLMALEAAT COMPOSITION corresponding to ; TIMOLOL 0-WATER ; TRAVOPROST

Gyógyszerészeti forma:

Oogdruppels, oplossing

Összetétel:

BENZALKONIUMCHLORIDE ; BOORZUUR (E 284) ; DINATRIUMEDETAAT 2-WATER ; MACROGOLGLYCEROLHYDROXYSTEARAAT ; MANNITOL (D-) (E 421) ; NATRIUMHYDROXIDE (E 524) ; TROMETAMOL ; WATER VOOR INJECTIE,

Az alkalmazás módja:

Oculair gebruik

Terápiás terület:

Timolol, Combinations

Termék összefoglaló:

Hulpstoffen: BENZALKONIUMCHLORIDE; BOORZUUR (E 284); DINATRIUMEDETAAT 2-WATER; MACROGOLGLYCEROLHYDROXYSTEARAAT; MANNITOL (D-) (E 421); NATRIUMHYDROXIDE (E 524); TROMETAMOL; WATER VOOR INJECTIE;

Engedély dátuma:

2017-07-20

Betegtájékoztató

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAVOPROST/TIMOLOL RATIOPHARM 40 MICROGRAM/ML + 5 MG/ML OOGDRUPPELS,
OPLOSSING
_ _
travoprost/timolol
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 Travoprost/Timolol is and what it is used for
2.
What you need to know before you use Travoprost/Timolol
3.
How to use Travoprost/Timolol
4.
Possible side effects
5.
How to store Travoprost/Timolol
6.
Contents of the pack and other information
1.
WHAT TRAVOPROST/TIMOLOL IS AND WHAT IT IS USED FOR
Travoprost/Timolol eye drops solution is a combination of two active
substances (travoprost and
timolol). Travoprost is a prostaglandin analogue which works by
increasing the outflow of liquid of
the eye, which lowers its pressure. Timolol is a beta blocker which
works by reducing the production
of fluid within the eye. The two substances work together to reduce
pressure within the eye.
Travoprost/Timolol eye drops are used to treat high pressure in the
eye in adults, including the
elderly. This pressure can lead to an illness called glaucoma.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TRAVOPROST/TIMOLOL
DO NOT USE TRAVOPROST/TIMOLOL EYE DROPS SOLUTION:
-
if you are allergic to travoprost, timolol, or any of the other
ingredients of this medicine (listed
in section 6).
-
if you are allergic to any prostaglandins or beta-blockers.
-
if you have now or have had in the past respiratory problems such as
asthma, severe chronic
obstructive bronchitis (severe lung disease which may cause
wheeziness, difficulty in breathing

Termékjellemzők

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Travoprost/Timolol ratiopharm 40 microgram/ml + 5 mg/ml oogdruppels,
oplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 40 micrograms of travoprost and 5 mg of
timolol (as timolol maleate).
Excipient with known effect:
Each ml of solution contains 0.15 mg of benzalkonium chloride and 5 mg
of macrogolglycerol
hydroxystearate (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: 5.5-7.0
Osmolality: 252-308 mOsmol/Kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Travoprost/Timolol is indicated in adults for the decrease of
intraocular pressure (IOP) in patients
with open-angle glaucoma or ocular hypertension who are insufficiently
responsive to topical beta-
blockers or prostaglandin analogues (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Use in adults, including the older population
The dose is one drop of Travoprost/Timolol in the conjunctival sac of
the affected eye(s) once daily,
in the morning or evening. It should be administered at the same time
each day.
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.
Special Populations
Hepatic and renal impairment
No studies have been conducted with Travoprost/Timolol or with timolol
5 mg/ml eye drops in
patients with hepatic or 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 low as 14
ml/min). No dose adjustment was
necessary in these patients.
Rvg 119284 EoP EU SPC met NL info
Patients with hepatic or renal impairment are unlikely to require dose
adjustment with
Travoprost/Timolol (see section 5.2).
Paediatric population
The safety and efficacy of Travoprost/Timolol in children and
adolescents below the age of 18 year