Dorzostill 20 mg/ml, oogdruppels, oplossing

Land: Holland

Sprog: hollandsk

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

Aktiv bestanddel:

DORZOLAMIDEHYDROCHLORIDE 22,3 mg/ml SAMENSTELLING overeenkomend met ; DORZOLAMIDE 20 mg/ml

Tilgængelig fra:

Bruschettini s.r.l. Via Isonzo, 6 16 147 GENOVA (ITALIË)

ATC-kode:

S01EC03

INN (International Name):

DORZOLAMIDEHYDROCHLORIDE 22,3 mg/ml SAMENSTELLING overeenkomend met ; DORZOLAMIDE 20 mg/ml

Lægemiddelform:

Oogdruppels, oplossing

Sammensætning:

BENZALKONIUMCHLORIDE ; HYDROXYETHYLCELLULOSE ; MANNITOL (D-) (E 421) ; NATRIUMHYDROXIDE (E 524) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER, GEZUIVERD ; ZOUTZUUR (E 507),

Indgivelsesvej:

Oculair gebruik

Terapeutisk område:

Dorzolamide

Produkt oversigt:

Hulpstoffen: BENZALKONIUMCHLORIDE; HYDROXYETHYLCELLULOSE; MANNITOL (D-) (E 421); NATRIUMHYDROXIDE (E 524); TRINATRIUMCITRAAT 2-WATER (E 331); WATER, GEZUIVERD; ZOUTZUUR (E 507);

Autorisation dato:

1900-01-01

Indlægsseddel

BRUSCHETTINI S.R.L.
DORZOSTILL 20 mg/ml eye drops, solution
MODULE 1
1
Deficiency to DK/H/1534/001/IB/023 – NOV2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
DORZOSTILL 20 MG/ML, OOGDRUPPELS, OPLOSSING
DORZOLAMIDE
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 is and what it is used for
2.
What you need to know before you use
3.
How to use
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
is an ophthalmic product (eye drops)
containing dorzolamide, which belongs to
the group of medicinal products called carbonic anhydrase inhibitors.
The eye drops are used for the reduction of increased pressure in the
eye and to treat glaucoma. The drops can
be used either alone or with other eye drops which lower pressure in
the eye (so-called beta-blockers).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
DO NOT USE
-
if you are allergic to dorzolamide or any of the other ingredients of
this medicine (listed in section 6).
-
if you have severe kidney problems
-
if you have a disturbance in the pH (acid/alkali balance) of your
blood
WARNINGS AND PRECAUTIONS

Talk to your doctor or pharmacist before taking if:
-
you have or have had liver problems in the past
-
if you h

Produktets egenskaber

BRUSCHETTINI S.R.L.
DORZOSTILL 20 mg/ml eye drops, solution
MODULE 1
1
Deficiency to DK/H/1534/001/IB/023 -NOV2023
1.
NAME OF THE MEDICINAL PRODUCT
Dorzostill 20 mg/ml, oogdruppels, oplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 20.0 mg dorzolamide (as 22.3 mg dorzolamide
hydrochloride).
Excipient(s) with known effect:
contains benzalkonium chloride 0.075 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Clear or slightly opalescent, colourless, particle free, isotonic,
buffered slightly viscous aqueous solution with
pH approx. 5.65.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ is indicated: _
•
as adjunctive therapy to beta-blockers,
•
as monotherapy in patients unresponsive to beta-blockers or in whom
beta-blockers are contraindicated,
_in the treatment of elevated intra-ocular pressure in: _
•
ocular hypertension,
•
open-angle glaucoma,
•
pseudo-exfoliative glaucoma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: for ocular use.
When used as monotherapy, the dose is one drop of dorzolamide in the
conjunctival sac of the affected eye(s),
three times daily.
When used as adjunctive therapy with an ophthalmic beta-blocker, the
dose is one drop of dorzolamide in the
conjunctival sac of the affected eye(s), two times daily.
When substituting dorzolamide for another ophthalmic anti-glaucoma
agent, discontinue the other agent after
proper dosing on one day, and start dorzolamide on the next day.
If more than one topical ophthalmic medicinal product is being used,
the products should be administered at
least ten minutes apart.
See section 4.4 concerning the use of contact lenses.
Patients should be instructed to avoid allowing the tip of the
dispensing container to contact the eye or
surrounding structures.
BRUSCHETTINI S.R.L.
DORZOSTILL 20 mg/ml eye drops, solution
MODULE 1
2
Deficiency to DK/H/1534/001/IB/023 -NOV2023
Patients should also be instructed that ocular solutions, if h