DuoTrav
Ülke: Avrupa Birliği
Dil: İngilizce
Kaynak: EMA (European Medicines Agency)
Bilgilendirme broşürü
(PIL)
08-10-2021
Ürün özellikleri
(SPC)
08-10-2021
Kamu Değerlendirme Raporu
(PAR)
20-10-2010
Aktif bileşen:
travoprost, timolol
Mevcut itibaren:
Novartis Europharm Limited
ATC kodu:
S01ED51
INN (International Adı):
travoprost, timolol
Terapötik grubu:
Ophthalmologicals
Terapötik alanı:
Glaucoma, Open-Angle; Ocular Hypertension
Terapötik endikasyonlar:
Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
Ürün özeti:
Revision: 18
Yetkilendirme durumu:
Authorised
Yetkilendirme tarihi:
2006-04-23
Bilgilendirme broşürü
25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUOTRAV 40 MICROGRAMS/ML + 5 MG/ML EYE DROPS, SOLUTION
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 DuoTrav is and what it is used for
2.
What you need to know before you use DuoTrav
3.
How to use DuoTrav
4.
Possible side effects
5.
How to store DuoTrav
6.
Contents of the pack and other information
1.
WHAT DUOTRAV IS AND WHAT IT IS USED FOR
DuoTrav eye drop solution is a combination of two active substances
(travoprost and timolol).
Travoprost is a prostaglandin analogue which works by increasing the
outflow of aqueous fluid from
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.
DuoTrav 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 DUOTRAV
DO NOT USE DUOTRAV
if you are allergic to travoprost, prostaglandins, timolol, beta
blockers or any of the other
ingredients of this medicine (listed in section 6).
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
and/or long-standing cough), or other types of breathing problems.
if you have severe hay fever.
if you have a slow heartbeat, heart f
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Ürün özellikleri
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
DuoTrav 40 micrograms/mL + 5 mg/mL eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains 40 micrograms of travoprost and 5 mg of
timolol (as timolol maleate).
Excipient(s) with known effect
Each mL of solution contains polyquaternium-1 (POLYQUAD) 10 microgram,
propylene glycol
7.5 mg and polyoxyethylene hydrogenated castor oil 40 1 mg (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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DuoTrav 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 elderly _
The dose is one drop of DuoTrav 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 DuoTrav 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.
Patients with hepatic or renal impairment are unlikely to require dose
adjustment with DuoTrav (see
section 5.2).
3
_Paediatric population _
The safety and efficacy of DuoTrav in children and adolescents below
the age of 18 years have not
been established. No data are available.
Method of administration
For ocular use.
The pa
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