Regulatory Information
DKSH SINGAPORE PTE. LTD.
DKSH SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
SOLUTION, STERILE
**4.2 Posology and method of administration** **Posology** Use in adults, including the elderly Instill one drop into the affected eye(s) twice daily. Use in paediatric population Safety in low birth weight infants, newborns, infants, and children has not been established. **Method of Administration** 1. Route of administration: Instillation only. 2. When dispensing the drug: Instruct patients on the following: 1. In the instillation, the patient should tilt the head backwards, open the affected eye, instill the drug into the conjunctival sac, close the eyelid for 1 to 5 minutes while compressing the lacrimal part, and open the eye. 2. Be careful during the instillation to avoid direct contact of the tip of the container with the eye in order to prevent contamination of the drug. 3. Instill with an interval of at least 5 minutes when using the drug in combination with other ophthalmic solutions.
OPHTHALMIC
Medical Information
**4.1 Therapeutic indications** GLANATEC is indicated to decrease elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma as adjunctive therapy in patients who are insufficiently responsive to topical beta-blockers or prostaglandin analogues, or as monotherapy in patients who are intolerant or contraindicated to other intraocular pressure lowering medications.
**4.3 Contraindications** GLANATEC is contraindicated in patients with history of hypersensitivity to any of the components of GLANATEC (see Section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
pending
xpending
Manufacturer Information
DKSH SINGAPORE PTE. LTD.
Teika Pharmaceutical Co., Ltd. Shinjo Factory
Active Ingredients
Documents
Package Inserts
Glanatec ophthalmic solution Package Insert.pdf
Approved: February 18, 2020