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

Negara: Belanda

Bahasa: Belanda

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

Bahan aktif:

TIMOLOLMALEAAT SAMENSTELLING overeenkomend met ; TIMOLOL 0-WATER ; TRAVOPROST

Tersedia dari:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Kode ATC:

S01ED51

INN (Nama Internasional):

TIMOLOLMALEAAT COMPOSITION corresponding to ; TIMOLOL 0-WATER ; TRAVOPROST

Bentuk farmasi:

Oogdruppels, oplossing

Komposisi:

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

Rute administrasi :

Oculair gebruik

Area terapi:

Timolol, Combinations

Tanggal Otorisasi:

2019-02-18

Selebaran informasi

Sandoz B.V.
Page 1/8
Travoprost/Timolol Sandoz 40 microgram/ml + 5 mg/ml, oogdruppels,
oplossing
RVG 121982
20191206
1.3.1.3. Bijsluiter
December
2019
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAVOPROST/TIMOLOL SANDOZ 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 {[Nationally completed name]} is and what it is used for
2.
What you need to know before you use {[Nationally completed name]}
3.
How to use {[Nationally completed name]}
4.
Possible side effects
5.
How to store {[Nationally completed name]}
6.
Contents of the pack and other information
1.
WHAT {[NATIONALLY COMPLETED NAME]} IS AND WHAT IT IS USED FOR
{[Nationally completed name]} 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.
{[Nationally completed name]} 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 {[NATIONALLY COMPLETED NAME]}
DO NOT USE {[NATIONALLY COMPLETED NAME]}:

if you are allergic to travoprost, timolol, or any of the other
ingredients of this medicine
(listed in section 6)

if you are allerg

Karakteristik produk

Sandoz B.V.
Page 1/13
Travoprost/Timolol Sandoz 40 microgram/ml + 5 mg/ml, oogdruppels,
oplossing
RVG 121982
20191206
1.3.1.1 Samenvatting van de Productkenmerken
December 2019
1.
NAME OF THE MEDICINAL PRODUCT
Travoprost/Timolol Sandoz 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).
Excipients with known effect
Each mL of solution contains 150 micrograms of benzalkonium chloride
and 5 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, aqueous solution, practically free from particles.
Product has osmolality 280 mOsm/Kg ± 10% and pH: 5.5-7.0
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] 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 [Nationally completed name] 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 40
micrograms/mL + 5 mg/mL eye
drops or with timolol 5 mg/ml eye drops in patients with hepatic or
renal impairment.
Sandoz B.V.
Page 2/13
Travoprost/Timolol Sandoz 40 microgram/ml + 5 mg/ml, oogdruppels,
oplossing
RVG 121982
20191206
1.3.1.1 Samenvatting van de Productkenmerken
December 2019
Travoprost has been studied in patients with mild to severe hepatic
impai