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HSA Approval

ZYMAR OPHTHALMIC SOLUTION 0.3%

SIN12612P

ZYMAR OPHTHALMIC SOLUTION 0.3%

ZYMAR OPHTHALMIC SOLUTION 0.3%

November 5, 2004

ABBVIE PTE. LTD.

ABBVIE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantABBVIE PTE. LTD.
Licence HolderABBVIE PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

SOLUTION

**DOSAGE AND ADMINISTRATION** The recommended dosage regimen for the treatment of bacterial conjunctivitis is: Days 1 and 2: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times daily. Days 3 through 7: Instill one drop up to four times daily while awake.

OPHTHALMIC

Medical Information

**INDICATIONS AND USAGE** ZYMAR® solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: **Aerobic Gram-Positive Bacteria:**_Cornyebacterium propinquum\*__Streptococcus mitis\*__Staphylococcus aureus__Streptococcus pneumoniae__Staphylococcus epidermidis_ **Aerobic Gram-Negative Bacteria:**_Haemophilus influenzae_ \\* Efficacy for this organism was studied in fewer than 10 infections.

**CONTRAINDICATIONS** ZYMAR® solution is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication.

S01AX21

xs 01 ax 21

Manufacturer Information

ABBVIE PTE. LTD.

ALLERGAN SALES LLC

Active Ingredients

GATIFLOXACIN

3 mg/ml

Gatifloxacin

Documents

Package Inserts

Zymar Ophthalmic Solution PI.pdf

Approved: September 8, 2017

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