Bimatoprost AET 0,1 mg/ml, oogdruppels, oplossing

País: Holanda

Língua: holandês

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

Ingredientes ativos:

BIMATOPROST 0,1 mg/ml

Disponível em:

Alfred Tiefenbacher (GmbH & Co. KG) Van-der-Smissen- Strasse 1 22767 HAMBURG (DUITSLAND)

Código ATC:

S01EE03

DCI (Denominação Comum Internacional):

BIMATOPROST 0,1 mg/ml

Forma farmacêutica:

Oogdruppels, oplossing

Composição:

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

Via de administração:

Oculair gebruik

Área terapêutica:

Bimatoprost

Resumo do produto:

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

Data de autorização:

2015-04-21

Folheto informativo - Bula

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BIMATOPROST AET 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 BIMATOPROST 0.1 mg/ml is and what it is used for
2.
What you need to know before you use BIMATOPROST 0.1 mg/ml
3.
How to use BIMATOPROST 0.1 mg/ml
4.
Possible side effects
5.
How to store BIMATOPROST 0.1 mg/ml
6.
Contents of the pack and other information
1.
WHAT BIMATOPROST 0.1 MG/ML IS AND WHAT IT IS USED FOR
BIMATOPROST is an antiglaucoma preparation. It belongs to a group of
medicines called prostamides.
BIMATOPROST 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 BIMATOPROST 0.1 MG/ML
DO NOT USE BIMATOPROST 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
effect of the preservative
benzalkoni

Características técnicas

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bimatoprost AET 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.
Excipient with known effect:
One ml of solution contains 0.20 mg benzalkonium
chloride.
One ml of solution contains 0.95 mg phosphates.
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
If more than one topical ophthalmic medicinal product is being used,
each one should be administered
at least 5 minutes apart.
4.3
CONTRAINDICATIONS
2
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
BIMATOPROST 0.1 mg/ml is contraindicated in patients who have had a
suspected previous adverse
reaction to benzalkonium chloride