Azarga 10mgmL + 5mgmL eye drops suspension

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Brinzolamide; Timolol Maleate 6.8mg/mL eqv Timolol (as free base)

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

S01ED51

Dosage:

10mg/mL

Pharmaceutical form:

SUSPENSION, STERILE

Composition:

Brinzolamide 10mg/mL; Timolol Maleate 6.8mg/mL eqv Timolol (as free base) 5mg/mL

Administration route:

OPHTHALMIC

Prescription type:

Prescription Only

Manufactured by:

S.A. Alcon Couvreur N.V

Authorization status:

ACTIVE

Authorization date:

2010-05-19

Patient Information leaflet

KAPVORM
140 x 504 / 140 x 22 mm
AANTAL KLEUREN :  1
VC   13-11-2008
EET
RECTO-verso
Azarga  5 ml - 24m
code 45834-0
BELGIUM
V3
Quark 6
PMS ZWART
À 100 %
1. NAME OF THE MEDICINAL PRODUCT
AZARGA
®
10 mg/ml + 5 mg/ml eye drops, suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of suspension contains 10 mg brinzolamide and 5 mg
timolol (as timolol maleate).
For excipients : see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops, suspension.
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
Use in adults, including the elderly
The dose is one drop of AZARGA
®
eye drops, suspension in the
conjunctival sac of the affected eye(s) twice daily.
Nasolacrimal occlusion or gently closing the eyelid after instilla-
tion is recommended. This may reduce the systemic absorption
of medicinal products administered via the ocular route and
result in a decrease in systemic adverse reactions.
If more than one topical ophthalmic medicinal product is being
used, the medicines must be administered at least 5 minutes
apart.
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 agent with
AZARGA
®
eye drops, suspension, the other agent should be dis-
continued and AZARGA
®
eye drops, suspension should be start-
ed the following day.
Paediatric patients
AZARGA
®
eye drops, suspension is not recommended for use in
children below 18 years due to a lack of data on safety and effi-
cacy.
Use in hepatic and renal impairment
No studies have been conducted with AZARGA
®
eye drops, sus-
pension or with timolol 5 mg/ml eye drops in patients with
hepatic or renal impairment. No dosage adjustment is neces-
sary in patients with hepatic imp

Summary of Product characteristics

Azarga May 2022.SIN
Page 1 of 14
1.
NAME OF THE MEDICINAL PRODUCT
AZARGA
® (10 mg/mL brinzolamide + 5 mg/mL timolol) eye drops, suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of suspension contains 10 mg brinzolamide and 5 mg timolol (as
timolol maleate).
Preservative: 1 mL of suspension contains 0.1 mg benzalkonium
chloride.
For the full list of excipients: see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, suspension.
White to off-white uniform suspension.
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 AZARGA
®
eye drops in the conjunctival sac of the affected eye(s) twice
daily.
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.
If more than 1 topical ophthalmic medicinal product is used, the
medicines must be administered at
least 5 minutes apart.
When substituting another ophthalmic antiglaucoma agent with AZARGA
®
eye drops, the other
agent should be discontinued and AZARGA eye drops should be started
the following day.
Use in paediatric patients
AZARGA
®
eye drops is not recommended for use in children below 18 years due to
a lack of data
on safety and efficacy.
Use in geriatric patients
No overall differences in safety and effectiveness have been observed
between elderly and other
adult populations.
Use in patients with hepatic or renal impairment
No studies have been conducted with AZARGA
®
eye drops 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.
Azarga May 2022.SIN
Page 2 of 14
AZARGA
®
eye drops has not been studied in patients with s