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HSA Approval

BRIMOCHEK -T EYE DROPS SOLUTION

SIN15191P

BRIMOCHEK -T EYE DROPS SOLUTION

BRIMOCHEK -T EYE DROPS SOLUTION

March 9, 2017

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Regulatory Information

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Therapeutic

Prescription Only

Formulation Information

SOLUTION, STERILE

**DOSAGE AND ADMINISTRATION** _Recommended dosage in adults (including the elderly)_ The recommended dose is one drop of Brimocheck T in the affected eye(s) twice daily, approximately 12 hours apart. If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart. As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctual occlusion) for one minute. This should be performed immediately following the instillation of each drop. To avoid contamination of the eye or drops do not allow the dropper tip to come into contact with any surface.

OPHTHALMIC

Medical Information

**INDICATIONS AND USAGE** Reduction of intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers.

**CONTRAINDICATIONS** - Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease - Sinus bradycardia, sick sinus syndrome, sino-atrial nodal block, second or third degree atrioventricular block, not controlled with a pace-maker, overt cardiac failure, cardiogenic shock - Use in neonates and infants (children under the age of 2 years; see PAEDIATRIC USE section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - Patients receiving monoamine oxidase (MAO) inhibitor therapy - Patients on antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin) - Hypersensitivity to the active substances or any of the excipients

S01ED51

timolol, combinations

Manufacturer Information

GOLDPLUS UNIVERSAL PTE LTD

Indoco Remedies Limited (Plant II)

Active Ingredients

Brimonidine 1.3mg/ ml eqv brimonidine tartrate

2.0mg/ml

Brimonidine

Timolol Maleate 6.8mg/ml equivalent to Timolol

5mg/ ml

Timolol

Documents

Package Inserts

Package Insert v2.pdf

Approved: February 22, 2023

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