Bimatoprost Sandoz 0,3 mg/ml, oogdruppels, oplossing

Land: Niederlande

Sprache: Niederländisch

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

Wirkstoff:

BIMATOPROST 0,3 mg/ml

Verfügbar ab:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-Code:

S01EE03

INN (Internationale Bezeichnung):

BIMATOPROST 0,3 mg/ml

Darreichungsform:

Oogdruppels, oplossing

Zusammensetzung:

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

Verabreichungsweg:

Oculair gebruik

Therapiebereich:

Bimatoprost

Produktbesonderheiten:

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

Berechtigungsdatum:

1900-01-01

Gebrauchsinformation

Sandoz B.V.
Page 1/6
Bimatoprost Sandoz 0,3 mg/ml, oogdruppels,
oplossing, RVG 113250
V11
1.3.1.3 Bijsluiter
December 2021
PACKAGE LEAFLET: INFORMATION FOR THE USER
BIMATOPROST SANDOZ
® 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 {[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] 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

Fachinformation

Sandoz B.V.
Page 1/8
Bimatoprost Sandoz 0,3 mg/ml, oogdruppels,
oplossing, RVG 113250
V6
1.3.1.1 Samenvatting van de Productkenmerken
December 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bimatoprost Sandoz 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
Bimatoprost is indicated in 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 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
reaction on liver function over 24
months.
Method of administration
If more than one topical ophthalmic medicinal product is being used,
each one should be administered
at least 5 minutes apart.
4.3
CONTRAINDICATIONS
Sandoz B.V.
Page 2