국가: 싱가포르
언어: 영어
출처: HSA (Health Sciences Authority)
Ketorolac tromethamine
ALLERGAN SINGAPORE PTE. LTD.
S01BC05
0.45% W/V
SOLUTION, STERILE
Ketorolac tromethamine 0.45% W/V
OPHTHALMIC
Prescription Only
Allergan Sales, LLC
ACTIVE
2012-10-29
Page 1 of 2 Part #: 72220AS10DRAFT Drawing #: 0274401 Artwork is actual size Drop template and notes before processing XXXX ACUV AIL™ (KE TOR OLA C T ROM ETH AM INE OP HTH ALM IC SO LUT ION ) 0 .45 % 72220AS10DrAFT 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 beginning 1 day prior to cataract surgery, and continued through the first 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) WARNINGS AND PRECAUTIONS • Delayed healing (5.1) • Potential for cross-sensitivity (5.2) • Increased bleeding time due to interference with thrombocyte aggregation (5.3) • Corneal effects including keratitis (5.4) ADVERSE REACTIONS Most common adverse reactions occurring in 1-6% of patients were increased intraocular pressure, conjunctival hemorrhage, and vision blurred. (6.1) SEE 15 FOR PATIENT COUNSELING INFORMATION. REVISED: MAY-2010 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATION S AND USAGE 2 DOSAGE AN D ADMINISTRATION 2.1 Recommended Dosing 2.2 Use with Other Topical Ophthalmic Medications 3 DOSAGE FOR MS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Delayed Healing 5.2 Potential for Cross-Sensitivity 5.3 Increased Bleeding Time 5.4 Corneal Effects 5.5 Contact Lens Wear 6 ADVERSE REACTIONS 6.1 Clinical Studies 7 USE IN SPECIFIC POPULATIONS 7.1 Pregnancy 7.2 Nursing Mothers 7.3 Pediatric Use 전체 문서 읽기
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 beginning 1 day prior to cataract surgery, and continued through the first 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) • Cross-sensitivity (5.1) WARNINGS AND PRECAUTIONS • Increased bleeding time due to interference with thrombocyte aggregation (5.2) • Delayed healing (5.3) • Corneal effects including keratitis (5.4) • Contact lens wear (5.5) • Eye injury and contamination (5.6) ADVERSE REACTIONS Most common adverse reactions occurring in 1-6% of patients were increased intraocular pressure, conjunctival hemorrhage, and vision blurred. (7.1) SEE 16 FOR PATIENT COUNSELING INFORMATION. REVISED: APR-2018 FULL PRESCRIBING INFORMATION: CONTENTS* 1. INDICATIONS AND USAGE 2. DOSAGE AND ADMINISTRATION 2.1 Recommended Dosing 3. DOSAGE FORMS AND STRENGTHS 4. CONTRAINDICATIONS 5. WARNINGS AND PRECAUTIONS 5.1 Cross-Sensitivity 5.2 Bleeding 5.3 Delayed Healing 5.4 Corneal Effects 5.5 Contact Lens Wear 5.6 Eye Injury and Contamination 6. DRUG INTERACTIONS 7. ADVERSE REACTIONS 7.1 Clinical Studies Experience 7.2 Post-marketing Experience 8. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Nursing Mothers 8.3 Pediatric Use 8.4 Geriatric Use 9. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES 10. OVERDOSE 11. DESCRIPTION 12. CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacokinetics 13. NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14. CLINICAL STUDIES 15 전체 문서 읽기