Treprovist 0.3 mg/ml, oogdruppels, oplossing

Land: Holland

Sprog: hollandsk

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

Aktiv bestanddel:

BIMATOPROST

Tilgængelig fra:

Sandoz B.V.

ATC-kode:

S01EE03

INN (International Name):

BIMATOPROST

Lægemiddelform:

Oogdruppels, oplossing

Sammensætning:

BENZALKONIUMCHLORIDE ; CITROENZUUR 1-WATER (E 330) ; DINATRIUMWATERSTOFFOSFAAT 7-WATER (E 339) ; NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; WATER, GEZUIVERD ; ZOUTZUUR (E 507),

Indgivelsesvej:

Oculair gebruik

Terapeutisk område:

Bimatoprost

Produkt oversigt:

Hulpstoffen: BENZALKONIUMCHLORIDE; CITROENZUUR 1-WATER (E 330); DINATRIUMWATERSTOFFOSFAAT 7-WATER (E 339); NATRIUMCHLORIDE; NATRIUMHYDROXIDE (E 524); WATER, GEZUIVERD; ZOUTZUUR (E 507);

Autorisation dato:

2013-10-21

Indlægsseddel

Sandoz B.V.
Treprovist 0,3 mg/ml, oogdruppels, oplossing
Page 1/6
RVG 112545
1311-v6
1.3.1.3 Bijsluiter
Januari 2019
PACKAGE LEAFLET: INFORMATION FOR THE USER
TREPROVIST 0,3 MG/ML, OOGDRUPPELS, OPLOSSING
bimatoprost
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What BIMATOPROST 0.3 mg/ml is and what it is used for
2.
What you need to know before you use BIMATOPROST 0.3 mg/ml
3.
How to use BIMATOPROST 0.3 mg/ml
4.
Possible side effects
5.
How to store BIMATOPROST 0.3 mg/ml
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] is an antiglaucoma preparation. It belongs
to a group of medicines called
prostamides.
[Nationally completed name] is used to reduce high pressure in the
eye. This medicine may be used on its
own or with other drops called beta-blockers which also reduce
pressure.
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. This medicine works by increasing
the amount of liquid that is drained.
This reduces the pressure inside the eye. If the high pressure is not
reduced, it could lead to a disease called
glaucoma and eventually damage your sight.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE [NATIONALLY COMPLETED NAME]
DO NOT USE [NATIONALLY COMPLETED NAME]:
-
if you are allergic (hypersensitive) to bimatoprost or any o

Produktets egenskaber

Sandoz B.V.
Treprovist 0,3 mg/ml, oogdruppels, oplossing
Page 1/9
RVG 112545
1311-v5
1.3.1.1 Samenvatting van de Productkenmerken
Januari 2019
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Treprovist 0,3 mg/ml, oogdruppels, oplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 0.3 mg bimatoprost.
One drop contains approximately 7.5 micrograms bimatoprost.
Excipient(s) with known effect
One ml of solution contains 0.05 mg benzalkonium chloride.
One ml of solution contains 0.95 mg of phosphates.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution, practically free from particles.
pH 6.8 – 7.8; osmolality 260 – 330 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated for the reduction of elevated
intraocular pressure in
chronic open-angle glaucoma and ocular hypertension in adults (as
monotherapy or as
adjunctive therapy to beta-blockers).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one drop in the affected eye(s) once daily,
administered in the
evening. The dose should not exceed once daily as more frequent
administration may lessen
the intraocular pressure lowering effect.
_Paediatric population _
The safety and efficacy of bimatoprost in children aged 0 to 18 years
has not yet been
established.
_Hepatic and renal impairment _
Bimatoprost has not been studied in patients with renal or moderate to
severe hepatic
impairment and should therefore be used with caution in such patients.
In patients with a
Sandoz B.V.
Treprovist 0,3 mg/ml, oogdruppels, oplossing
Page 2/9
RVG 112545
1311-v5
1.3.1.1 Samenvatting van de Productkenmerken
Januari 2019
history of mild liver disease or abnormal alanine aminotransferase
(ALT), aspartate
aminotransferase (AST) and/or bilirubin at baseline, bimatoprost 0.3
mg/ml eye drops,
solution had no adverse effect on liver function over 24 months.
Method of Administration
If more than one to