Ganfort
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
21-10-2019
Karatteristiċi tal-prodott
(SPC)
21-10-2019
Rapport ta 'Valutazzjoni Pubblika
(PAR)
29-09-2016
Ingredjent attiv:
bimatoprost, timolol
Disponibbli minn:
Allergan Pharmaceuticals Ireland
Kodiċi ATC:
S01ED51
INN (Isem Internazzjonali):
bimatoprost / timolol
Grupp terapewtiku:
Ophthalmologicals,
Żona terapewtika:
Glaucoma, Open-Angle, Ocular Hypertension
Indikazzjonijiet terapewtiċi:
Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
Sommarju tal-prodott:
Revision: 18
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2006-05-18
Fuljett ta 'informazzjoni
42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE USER
GANFORT 0.3 MG/ML + 5 MG/ML
EYE DROPS, SOLUTION
Bimatoprost/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 any further questions, please ask your doctor, pharmacist,
or nurse.
-
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 GANFORT is and what it is used for
2.
What you need to know before you use GANFORT
3.
How to use GANFORT
4.
Possible side effects
5
How to store GANFORT
6.
Contents of the pack and other information
1. WHAT GANFORT IS AND WHAT IT IS USED FOR
GANFORT contains two different active substances (bimatoprost and
timolol) that both reduce
pressure in the eye. Bimatoprost belongs to a group of medicines
called prostamides, a prostaglandin
analogue. Timolol belongs to a group of medicines called
beta-blockers.
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 (an illness called
glaucoma). GANFORT works by reducing the production of liquid and also
increasing the amount of
liquid that is drained. This reduces the pressure inside the eye.
GANFORT eye drops are used to treat high pressure in the eye in
adults, including the elderly
.
This
high pressure can lead to glaucoma. Your doctor will prescribe you
GANFORT when other eye drops
containing beta-blockers or prostaglandin analogues have not worked
sufficiently on their own.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE GANFO
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
One ml of solution contains 0.3 mg of bimatoprost and 5 mg of timolol
(as 6.8 mg of timolol maleate).
Excipient with known effect
Each ml of solution contains 0.05 mg of benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of intraocular pressure (IOP) in adult patients with
open-angle glaucoma or ocular
hypertension who are insufficiently responsive to topical
beta-blockers or prostaglandin analogues.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Recommended dosage in adults (including older people) _
The recommended dose is one drop of GANFORT in the affected eye(s)
once daily, administered
either in the morning or in the evening. It should be administered at
the same time each day.
Existing literature data for GANFORT suggest that evening dosing may
be more effective in IOP
lowering than morning dosing. However, consideration should be given
to the likelihood of
compliance when considering either morning or evening dosing (see
section 5.1).
If one dose is missed, treatment should continue with the next dose as
planned. The dose should not
exceed one drop in the affected eye(s) daily.
_Renal and hepatic impairment _
GANFORT has not been studied in patients with hepatic or renal
impairment. Therefore caution
should be used in treating such patients.
_Paediatric population_
The safety and efficacy of GANFORT in children aged 0 to 18 years has
not been established. No data
are available.
_ _
Method of administration
If more than one topical ophthalmic medicinal product is to be used,
each one should be instilled at
least 5 minutes apart.
When using nasolacrimal occlusion or closing the eyelids for 2
minutes, the systemic absorption is
reduced. This may result in a decrease
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