Brinzolamide/Timolol STADA 10 mg/ml + 5 mg/ml Ögondroppar, suspension

Land: Zweden

Taal: Zweeds

Bron: Läkemedelsverket (Medical Products Agency)

Werkstoffen:

brinzolamid; timololmaleat

Beschikbaar vanaf:

STADA Arzneimittel AG

ATC-code:

S01ED51

INN (Algemene Internationale Benaming):

brinzolamide; timololmaleat

Dosering:

10 mg/ml + 5 mg/ml

farmaceutische vorm:

Ögondroppar, suspension

Samenstelling:

timololmaleat 6,83 mg Aktiv substans; bensalkoniumklorid Hjälpämne; brinzolamid 10 mg Aktiv substans; mannitol Hjälpämne

Prescription-type:

Receptbelagt

Product samenvatting:

Förpacknings: Droppbehållare, 5 ml; Droppbehållare, 3 x 5 ml; Droppbehållare, 6 x 5 ml

Autorisatie-status:

Godkänd

Autorisatie datum:

2020-02-05

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
10 mg/ml + 5 mg/ml eye drops, suspension
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of suspension contains 10 mg brinzolamide and timolol maleate
corresponding to 5 mg
timolol.
Excipient with known effect:
One ml of suspension contains 0.10 mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, suspension (eye drops)
White to off-white uniform suspension, pH 7.2 (approximately).
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Decrease of intraocular pressure (IOP) in adult patients with
open-angle glaucoma or ocular
hypertension for whom monotherapy provides insufficient IOP reduction
(see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Use in adults, including the elderly
The dose is one drop of /.../ in the conjunctival sac of the affected
eye(s) twice daily.
When using nasolacrimal occlusion or closing the eyelids, the systemic
absorption is reduced. This
may result in a decrease in systemic side effects and an increase in
local activity (see section 4.4).
If a dose is missed, treatment should be continued with the next dose
as planned. The dose should not
exceed one drop in the affected eye (s) twice daily.
When substituting another ophthalmic antiglaucoma medicinal product
with /.../, the other medicinal
product should be discontinued and /.../ should be started the
following day.
Special populations
_Paediatric population _
The safety and efficacy of /.../ in children and adolescents aged 0 to
18 years have not yet been
established. No data are available.
_Hepatic and renal impairment _
No studies have been conducted with /.../ or with timolol 5 mg/ml eye
drops in patients with hepatic or
renal impairment. No dosage adjustment is necessary in patients with
hepatic impairment or in patients
with mild to moderate renal impairment.
3
/.../ has not been studied in patients with severe renal impairment
(creatinine clearanc