Brimonidine/Timolol Teva 2 mg/ml + 5 mg/ml, oogdruppels, oplossing

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

BRIMONIDINETARTRAAT SAMENSTELLING overeenkomend met ; BRIMONIDINE ; TIMOLOLMALEAAT SAMENSTELLING overeenkomend met ; TIMOLOL 0-WATER

Beschikbaar vanaf:

Teva Nederland B.V.

ATC-code:

S01ED51

INN (Algemene Internationale Benaming):

Brimonidine tartrate COMPOSITION corresponding to ; BRIMONIDINE ; TIMOLOLMALEAAT COMPOSITION corresponding to ; TIMOLOL 0-WATER

farmaceutische vorm:

Oogdruppels, oplossing

Samenstelling:

BENZALKONIUMCHLORIDE ; DINATRIUMWATERSTOFFOSFAAT 2-WATER (E 339) ; NATRIUMDIWATERSTOFFOSFAAT 2-WATER (E 339) ; NATRIUMHYDROXIDE (E 524) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),

Toedieningsweg:

Oculair gebruik

Therapeutisch gebied:

Timolol, Combinations

Product samenvatting:

Hulpstoffen: BENZALKONIUMCHLORIDE; DINATRIUMWATERSTOFFOSFAAT 2-WATER (E 339); NATRIUMDIWATERSTOFFOSFAAT 2-WATER (E 339); NATRIUMHYDROXIDE (E 524); WATER VOOR INJECTIE; ZOUTZUUR (E 507);

Autorisatie datum:

2016-11-15

Bijsluiter

BRIMONIDINE TARTRATE/TIMOLOL 2 MG/ML + 5 MG/ML EYE DROPS, SOLUTION
DK/H/2114-2129/001/DC
1
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
BRIMONIDINE/TIMOLOL TEVA 2 MG/ML + 5 MG/ML, OOGDRUPPELS, OPLOSSING
Brimonidine tartrate/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 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, pharmacist or nurse.
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
is an eye drop that is used to control
glaucoma. It contains two
different medicines (brimonidine and timolol) that both reduce high
pressure in the eye. Brimonidine
belongs to a group of medicines called alpha-2 adrenergic receptor
agonists. Timolol belongs to a
group of medicines called beta-blockers. is prescribed to reduce high
pressure in the eye when beta-blocker eye drops used alone are not
enough.
Your eye contains a clear, watery liquid that feeds the inside of the
eye. Liquid is constantly being
drained out of the eye and new liquid is made to replace this. If the
liquid cannot drain out quickly
enough, the pressure inside the eye builds up and could eventually
damage your sight. works by reducing the production of liquid and
increasing the amount of liquid that
is drai

Productkenmerken

BRIMONIDINE TARTRATE/TIMOLOL 2 MG/ML + 5 MG/ML EYE DROPS, SOLUTION
DK/H/2114-2129/001/DC
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Brimonidine/Timolol Teva 2 mg/ml + 5 mg/ml, oogdruppels, oplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains:
-
2.0 mg brimonidine tartrate, equivalent to 1.3 mg of brimonidine,
-
5.0 mg timolol as 6.8 mg timolol maleate.
_Excipient with known effect _
_ _
Contains benzalkonium chloride 0.05 mg/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, greenish-yellow solution.
Osmolality 260 – 320 mOsmol/kg
pH 6.6 – 7.2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of intraocular pressure (IOP) in patients with chronic
open-angle glaucoma or ocular
hypertension who are insufficiently responsive to topical
beta-blockers.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Paediatric population _
Brimonidine tartrate/timolol is contraindicated in neonates and
infants (less than 2 years of age) (see
sections 4.3, 4.4 , 4.8 and 4.9).
The safety and effectiveness of brimonidine tartrate/timolol in
children and adolescents (2 to 17 years
of age) have not been established and therefore, its use is not
recommended in children or adolescents
(see also sections 4.4 and 4.8).
_Posology in adults (including the elderly) _
The recommended dose is one drop of brimonidine tartrate/timolol in
the affected eye(s) twice daily,
approximately 12 hours apart. If more than one topical ophthalmic
product is to be used, the different
products should be instilled at least 5 minutes apart.
_Use in renal and hepatic impairment _
Brimonidine tartrate/timolol has not been studied in patients with
hepatic or renal impairment.
Therefore, caution should be used in treating such patients.
BRIMONIDINE TARTRATE/TIMOLOL 2 MG/ML + 5 MG/ML EYE DROPS, SOLUTION
DK/H/2114-2129/001/DC
2
METHOD OF ADMINISTRATION
_ _
As with any eye drops, to reduce possible systemic absorption, it is
recommended that the lachry