Brinzolamid/Timolol Mylan 10 mg/ml + 5 mg/ml Ögondroppar, suspension

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

brinzolamid; timololmaleat

Available from:

Mylan AB

ATC code:

S01ED51

INN (International Name):

brinzolamide; timololmaleat

Dosage:

10 mg/ml + 5 mg/ml

Pharmaceutical form:

Ögondroppar, suspension

Composition:

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

Prescription type:

Receptbelagt

Product summary:

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

Authorization status:

Avregistrerad

Authorization date:

2020-02-24

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Brinzolamide/Timolol Mylan 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 Brinzolamide/Timolol Mylan 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 Brinzolamide/Timolol
Mylan, the other medicinal product should be discontinued and
Brinzolamide/Timolol Mylan should
be started the following day.
Special populations
_Paediatric population _
The safety and efficacy of Brinzolamide/Timolol Mylan in children and
adolescents aged 0 to 18
years have not yet been established. No data are available.
_Hepatic and renal impairment _
3
No studies have been conducted with brinzolamide/timolol 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 imp