Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
KETOROLAC TROMETAMOL
MENARINI INDRIA LABORATORIES - Indonesia
KETOROLAC TROMETAMOL
0.45 W/V %
TETES MATA
DUS, 1 VIAL PLASTIK @ 0.4 ML
ALLERGAN SALES LLC - United States of America
2020-03-26
ACUVAIL™ (KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION) 0.45% HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ACUVAIL™ SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ACUVAIL™. ACUVAIL™ (KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION) 0.45% --------------------------------------------------------- INDICATIONS AND USAGE ---------------------------------------------- ACUVAIL™ ophthalmic solution is a nonsteroidal, anti-inflammatory indicated for the treatment of pain and inflammation following cataract surgery. (1) ----------------------------------------------------- DOSAGE AND ADMINISTRATION ------------------------------------------ One drop of ACUVAIL™ should be applied by the patient to the affected eye twice daily after cataract surgery until the pain disappears or maximum 2 weeks of the postoperative period. (2.1) --------------------------------------------------- DOSAGE FORMS AND STRENGTHS 4.5 mg/mL ketorolac tromethamine solution in a single-use vial. (3) Excipient List: Carboxymethylcellulose Sodium, 7M8SFPH (Medium Viscosity) Carboxymethylcellulose Sodium, 7H3SXF (High Viscosity) Sodium Chloride Sodium Citrate Dihydrate Sodium Hydroxide (1N) Hydrochloric Acid (1N) Purified Water ----------------------------------------------------- WARNINGS AND PRECAUTIONS ------------------------------------------ Delayed healing (5.1) Cross-sensitivity or Hypersensitivity (5.2) Increased bleeding time due to interference with thrombocyte aggregation (5.3) Corneal effects including keratitis (5.4) Contact lens wear (5.5) Eye injury and contamination (5.6) DISETUJUI OLEH BPOM: 05/03/2020 EREG10043711800009 ------------------------------------------------------------ ADVERSE REACTIONS ------------------------------------------------- Most common adverse reactions occurring in 1-6% of patients were increased intraocular pressure, conjunctival hemorrhage, and vision blurred. (6.1) SEE 16 FOR PA Baca dokumen lengkapnya