Bimato-Vision 0,1 mg/ml, oogdruppels, oplossing

Land: Holland

Sprog: hollandsk

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

Aktiv bestanddel:

BIMATOPROST 0,1 mg/ml

Tilgængelig fra:

OmniVision GmbH Lindberghstrasse 9 82178 PUCHHEIM (DUITSLAND)

ATC-kode:

S01EE03

INN (International Name):

BIMATOPROST 0,1 mg/ml

Lægemiddelform:

Oogdruppels, oplossing

Sammensætning:

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

Autorisation dato:

2015-04-21

Indlægsseddel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Bimato-Vision 0,1 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 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 Bimato-Vision 0,1 mg/ml is and what it is used for
2.
What you need to know before you use Bimato-Vision 0,1 mg/ml
3.
How to use Bimato-Vision 0,1 mg/ml
4.
Possible side effects
5.
How to store Bimato-Vision 0,1 mg/ml
6.
Contents of the pack and other information
1.
WHAT BIMATO-VISION 0,1 MG/ML IS AND WHAT IT IS USED FOR
Bimato-Vision 0,1 mg/ml is an antiglaucoma preparation. It belongs to
a group of medicines called
prostamides.
Bimato-Vision 0,1 mg/ml 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 BIMATO-VISION 0,1 MG/ML
DO NOT USE BIMATO-VISION 0,1 MG/ML:
-
if you are allergic to bimatoprost or any of the other ingredients of
this medicine (listed in section 6).
-
if you have had to stop using eye drops in the past because of a side
e

Produktets egenskaber

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bimato-Vision 0,1 mg/ml, oogdruppels, oplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 0.1 mg bimatoprost.
One drop contains approximately 2.5 micrograms bimatoprost.
Excipients with known effect:
This medicine contains 5 micrograms benzalkonium chloride in each drop
(= 1 dose)
which is equivalent to 0.20 mg/ml.
This medicine contains 23.7 micrograms phosphates in each drop (= 1
dose)
which is equivalent to 0.95 mg/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution.
pH 6.8 – 7.8; osmolality 260 – 330 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
Patients with 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
effect on liver function over
24 months.
Method of administration
Ocular use.
If more than one topical ophthalmic medicinal product is being used,
each one should be administered
at least 5 minutes apart.
2
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1