Bimatoprost/Timolol ratiopharm 0,3 mg/ml + 5 mg/ml oogdruppels, oplossing

国家: 荷兰

语言: 荷兰文

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

有效成分:

BIMATOPROST ; TIMOLOLMALEAAT SAMENSTELLING overeenkomend met ; TIMOLOL 0-WATER

可用日期:

Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)

ATC代码:

S01ED51

INN（国际名称）:

BIMATOPROST ; TIMOLOLMALEAAT COMPOSITION corresponding to ; TIMOLOL 0-WATER

药物剂型:

Oogdruppels, oplossing

组成:

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

给药途径:

Oculair gebruik

治疗领域:

Timolol, Combinations

產品總結:

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

授权日期:

2017-11-02

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
BIMATOPROST/TIMOLOL RATIOPHARM 0,3 MG/ML + 5 MG/ML OOGDRUPPELS,
OPLOSSING
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 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/TIMOLOL is and what it is used for
2.
What you need to know before you use BIMATOPROST/TIMOLOL
3.
How to use BIMATOPROST/TIMOLOL
4.
Possible side effects
5.
How to store BIMATOPROST/TIMOLOL
6.
Contents of the pack and other information
1.
WHAT BIMATOPROST/TIMOLOL IS AND WHAT IT IS USED FOR
BIMATOPROST/TIMOLOL 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).
BIMATOPROST/TIMOLOL works by reducing the production of liquid and
also increasing the amount of
liquid that is drained. This reduces the pressure inside the eye.
BIMATOPROST/TIMOLOL 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
BIMATOPROST/TIMOLOL when other eye drops containing beta-blockers or
prostaglandin analog

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bimatoprost/Timolol ratiopharm 0,3 mg/ml + 5 mg/ml oogdruppels,
oplossing
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.
The pH of solution is 6.5 to 7.8, the osmolality is 260 to 320
mOsmol/kg.
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 BIMATOPROST/TIMOLOL 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 bimatoprost/timolol 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 _
Bimatoprost/timolol 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 bimatoprost/timolol 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 usi