Timolol drops eye

Land: Armenien

Sprog: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv bestanddel:

timolol (timolol maleate)

Tilgængelig fra:

S.C. Rompharm Company S.R.L.

ATC-kode:

S01ED01

INN (International Name):

timolol (timolol maleate)

Dosering:

5mg/ml

Lægemiddelform:

drops eye

Enheder i pakken:

5ml plastic vial-dropper

Recept type:

Prescription

Autorisation status:

Registered

Autorisation dato:

2021-12-20

Produktets egenskaber

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Timolol 5 mg/ml, eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains timolol 5.0 mg (as timolol maleate).
Excipients with known effect:
One ml of solution contains:
benzalkonium chloride 0.1 mg
disodium phosphate dodecahydrate 8.00 mg
sodium dihydrogen phosphate monohydrate 2.00 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution, practically free from visible particles.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Timolol is a beta-adrenoceptor blocking agent used topically in the
reduction of elevated
intra-ocular pressure in various conditions including following:
- Patients with ocular hypertension;
- Patients with chronic open-angle glaucoma including aphakic
patients;
- Some patient with secondary glaucoma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults:_
Posology:
Recommended therapy is one drop of Timolol 0.5% eye drops, solution in
the affected eye(s)
twice a day.
Timolol may be used with other agent(s) for lowering intra-ocular
pressure. The use of two
topical beta-adrenergic blocking agents is not recommended (see also
section 4.4).
Intraocular pressure should be reassessed approximately four weeks
after starting treatment
because response to Timolol 0.5% eye drops may take a few weeks to
stabilise.
Provided that the intraocular pressure is maintained at satisfactory
levels, many patients can
then be placed on once a day therapy.
2
Transfer from other agents
When another topical beta-blocking agent is being used, discontinue
its use after a full day of
therapy and start treatment with Timolol 0.5% eye drops the next day,
with one drop in each
affected eye twice a day.
When transferring a patient from a single anti-glaucoma agent other
than a topical beta-
blocking agent continue the agent and add one drop of Timolol 0.5% eye
drops in each
affected eye twice a day. On the following day, discontinue the
previous age