MedPath
HSA Approval

PAZEO OPHTHALMIC SOLUTION 0.7%

SIN15242P

PAZEO OPHTHALMIC SOLUTION 0.7%

PAZEO OPHTHALMIC SOLUTION 0.7%

May 22, 2017

NOVARTIS (SINGAPORE) PTE LTD

NOVARTIS (SINGAPORE) PTE LTD

Regulatory Information

NOVARTIS (SINGAPORE) PTE LTD

NOVARTIS (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

Formulation Information

SOLUTION, STERILE

**4.2 Posology and method of administration** One drop in each affected eye once daily. _Pediatric Use_ The safety and effectiveness has been established in pediatric patients 2 years of age and above. _Geriatric Use_ No dosage regimen adjustment is required in patients 65 years of age or above. _Special populations_ Olopatadine Eye Drops, Solution has not been studied in patients with renal or hepatic disease. However, no dosage adjustment is expected to be necessary in hepatic or renal impairment. Method of administration - For topical ocular use only. Not for injection or oral use. - After the bottle cap is removed, if the tamper evident snap collar is loose, snap collar should be removed before using the product. - To avoid contamination, the dropper tip should not touch any surface. The dropper tip should also not come into contact with the eye as this may cause injury to the eye. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity. - The bottle should be kept tightly closed when not in use. - If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart. Eye ointments should be administered last. - Patients should be advised not to wear a contact lens if their eye is red. - Pazeo should not be used to treat contact lens related irritation.

OPHTHALMIC

Medical Information

**4.1 Therapeutic Indications** PAZEO is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

**4.3. Contraindications** Hypersensitivity to the active substance or to any of the excipients.

S01GX09

olopatadine

Manufacturer Information

NOVARTIS (SINGAPORE) PTE LTD

Alcon Laboratories, Inc. (ASPEX) / (Fort Worth North)

S.A. Alcon-Couvreur N.V.

Active Ingredients

Olopatadine Hydrochloride 0.776% eqv Olopatadine

0.7%

Olopatadine

Documents

Package Inserts

PAZEO ophthalmic solution 0.7% PI.pdf

Approved: April 25, 2019

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