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HSA Approval

GANFORT PF EYE DROPS (Bimatoprost 0.3mg/ml, Timolol 5.0mg/ml)

SIN14966P

GANFORT PF EYE DROPS (Bimatoprost 0.3mg/ml, Timolol 5.0mg/ml)

GANFORT PF EYE DROPS (Bimatoprost 0.3mg/ml, Timolol 5.0mg/ml)

March 11, 2016

ABBVIE PTE. LTD.

ABBVIE PTE. LTD.

Regulatory Information

ABBVIE PTE. LTD.

ABBVIE PTE. LTD.

Therapeutic

Prescription Only

Formulation Information

SOLUTION, STERILE

**DOSAGE AND ADMINISTRATION** The recommended dose is one drop of GANFORT® PF in the affected eye(s) once daily, administered either in the morning or in the evening. It should be administered at the same time each day. Existing literature data for GANFORT® suggest that evening dosing may be more effective in IOP lowering than morning dosing. However, consideration should be given to the likelihood of compliance when considering either morning or evening dosing. In order to minimise systemic absorption of GANFORT® PF eye drops, apply pressure to the tear duct for at least 2 minutes immediately following administration of the drug **(See Precautions** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ **)**. If more than one topical ophthalmic medicinal product is to be used, each one should be instilled at least 5 minutes apart. The unit dose container is for single use only; one container is sufficient to treat both eyes. Any unused solution should be discarded immediately after use. If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily.

OPHTHALMIC

Medical Information

**INDICATIONS** GANFORT® PF eye drops are indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.

**CONTRAINDICATIONS** - Hypersensitivity to the active substances or to any of the excipients. - 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 pacemaker; overt cardiac failure, cardiogenic shock.

S01ED51

timolol, combinations

Manufacturer Information

ABBVIE PTE. LTD.

Allergan Pharmaceuticals Ireland

Active Ingredients

Timolol Maleate 6.8 mg/ml eqv Timolol

5 mg/ml

Timolol

Bimatoprost

0.3 mg/ml

Bimatoprost

Documents

Package Inserts

Ganfort PF Eye Drops PI.pdf

Approved: December 1, 2021

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