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HSA Approval

CRAVIT OPHTHALMIC SOLUTION 1.5% w/v

SIN15047P

CRAVIT OPHTHALMIC SOLUTION 1.5% w/v

CRAVIT OPHTHALMIC SOLUTION 1.5% w/v

July 18, 2016

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Regulatory Information

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Therapeutic

Prescription Only

Formulation Information

SOLUTION, STERILE

**DOSAGE AND ADMINISTRATION** Usually, instill 1 drop a time to the eye 3 times daily. The dosage may be adjusted according to the patient’s symptoms.

OPHTHALMIC

Medical Information

**INDICATIONS** <Indicated bacteria> Susceptible strains of _Staphylococcus_ sp., _Streptococcus_ sp., _Streptococcus pneumoniae_, _Enterococcus_ sp., _Micrococcus_ sp., _Moraxella_ sp., _Corynebacterium_ sp., _Klebsiella_ sp., _Enterobacter_ sp., _Serratia_ sp., _Proteus_ sp., _Haemophilus influenzae_, _Haemophilus aegyptius_ \[Koch-Weeks bacillus\], _Pseudomonas_ sp., _Pseudomonas aeruginosa_, _Acinetobacter_ sp., and _Propionibacterium acnes_. <Indications> Blepharitis, dacryocystitis, hordeolum, conjunctivitis, tarsadenitis, keratitis (including corneal ulcer), and postoperative infections. **<Precautions related to Indications>** 1. In order to avoid the emergence of resistant bacteria, bacterial susceptibility should be confirmed and treatment with this drug should be limited to the minimum period required for the eradication of the infection. 2. The efficacy of this product to methicillin-resistant _Staphylococcus aureus_ (MRSA) has not been proven. Therefore, other drug having a potent anti-MRSA activity should be administered immediately to patients positively infected with MRSA and not showing any improvement of symptoms with this product.

**CONTRAINDICATIONS (This product is contraindicated in the following patients.)** Patients with a history of hypersensitivity to the ingredient of this product, ofloxacin or any quinolone antibiotics.

S01AE05

levofloxacin

Manufacturer Information

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Santen Pharmaceutical Co., Ltd. Noto Plant

Active Ingredients

Levofloxacin hydrate

15mg/ml

Levofloxacin

Documents

Package Inserts

Cravit 1.5 SG PI.pdf

Approved: January 13, 2021

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