Dorzolamide/Timolol Apotex 20mg/ml + 5mg/ml, oogdruppels, oplossing

国: オランダ

言語: オランダ語

ソース: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

有効成分:

DORZOLAMIDEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; DORZOLAMIDE ; TIMOLOLMALEAAT SAMENSTELLING overeenkomend met ; TIMOLOL 0-WATER

から入手可能:

Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN

ATCコード:

S01ED51

INN（国際名）:

DORZOLAMIDEHYDROCHLORIDE COMPOSITION corresponding to ; DORZOLAMIDE ; TIMOLOLMALEAAT COMPOSITION corresponding to ; TIMOLOL 0-WATER

医薬品形態:

Oogdruppels, oplossing

構図:

BENZALKONIUMCHLORIDE ; HYDROXYETHYLCELLULOSE ; MANNITOL (D-) (E 421) ; NATRIUMHYDROXIDE (E 524) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER VOOR INJECTIE,

投与経路:

Oculair gebruik

治療領域:

Timolol, Combinations

製品概要:

Hulpstoffen: BENZALKONIUMCHLORIDE; HYDROXYETHYLCELLULOSE; MANNITOL (D-) (E 421); NATRIUMHYDROXIDE (E 524); TRINATRIUMCITRAAT 2-WATER (E 331); WATER VOOR INJECTIE;

承認日:

2013-10-17

情報リーフレット

Dorzolamide/Timolol 20 mg/ml + 5 mg/ml Eye Drops, Solution –
RVG 112496
MODULE 1.3
Product Information
Version: 2020-01
MODULE 1.3.1
Package Leaflet
Replaces : 2019-08
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DORZOLAMIDE/TIMOLOL APOTEX 20 MG/ML + 5 MG/ML, OOGDRUPPELS, OPLOSSING
(dorzolamide / 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, 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 Dorzolamide/Timolol Apotex is and what it is used for
2.
What you need to know before you use Dorzolamide/Timolol Apotex
3.
How to use Dorzolamide/Timolol Apotex
4.
Possible side effects
5.
How to store Dorzolamide/Timolol Apotex
6.
Contents of the pack and other information
1.
WHAT DORZOLAMIDE/TIMOLOL APOTEX IS AND WHAT IT IS USED FOR
Dorzolamide/Timolol Apotex contains two medicines: dorzolamide and
timolol.
-
Dorzolamide belongs to a group of medicines called “carbonic
anhydrase inhibitors”.
-
Timolol belongs to a group of medicines called “beta blockers”.
These medicines lower the pressure in the eye in different ways.
Dorzolamide/Timolol Apotex is prescribed to lower raised pressure in
the eye in the treatment of
glaucoma when beta-blocker eye-drop medicine used alone is not
adequate.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DORZOLAMIDE/TIMOLOL APOTEX
DO NOT USE DORZOLAMIDE/TIMOLOL APOTEX:
-
if you are allergic to dorzolamide hydrochloride, timolol maleate,
beta-blockers or any of the other
ingredients of this medicine (listed in section 6).
-
if you have now or have had in past respiratory problems such as
asthma, severe chronic

製品の特徴

Dorzolamide/Timolol 20 mg/ml + 5 mg/ml Eye Drops, Solution –
RVG 112496
MODULE 1.3
Product Information
Version: 2019-08
MODULE 1.3.1
Summary of Product Characteristics
Replaces : 2018-06-
20b
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dorzolamide/Timolol Apotex 20 mg/ml + 5 mg/ml, oogdruppels, oplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 20 mg dorzolamide (as dorzolamide hydrochloride) and
5 mg timolol (as
timolol maleate). Each drop contains 0.6 mg dorzolamide and 0.15 mg
timolol.
Excipient with known effect: Benzalkonium chloride 0.075 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
A clear to slightly opalescent, nearly colorless slightly viscous
solution of approximately
pH 5.6 and 280 mOsmols/L.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indicated in the treatment of elevated intraocular pressure (IOP) in
patients with open-angle
glaucoma or pseudoexfoliative glaucoma when topical beta-blocker
monotherapy is not
sufficient.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dose is one drop in the (conjunctival sac of the) affected eye(s)
two times daily.
If another topical ophthalmic agent is being used, Dorzolamide/Timolol
Apotex and the
other agent should be administered at least ten minutes apart.
Patients should be instructed to wash their hands before use and avoid
allowing the tip of
the container to come into contact with the eye or surrounding
structures.
Dorzolamide/Timolol 20 mg/ml + 5 mg/ml Eye Drops, Solution –
RVG 112496
MODULE 1.3
Product Information
Version: 2018-06-20
MODULE 1.3.1
Summary of Product Characteristics
Replaces : 2013-07-17
2
Patients should also be instructed that ocular solutions, if handled
improperly, can become
contaminated by common bacteria known to cause ocular infections.
Serious damage to the
eye and subsequent loss of vision may result from using contaminated
solutions.
When using nasolacrimal occlusion or closing the eyelids for 2
minutes, the systemic
absor