Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
KETOROLAC TROMETHAMINE; KETOROLAC TROMETHAMINE
Allergan Malaysia Sdn Bhd
KETOROLAC TROMETHAMINE; KETOROLAC TROMETHAMINE
30 single-use vials x 0.4mL ml
Allergan Sales, LLC
ACUVAIL™ OPHTHALMIC SOLUTION Ketorolac tromethamine (0.45%) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What ACUVAIL™ is used for 2. How ACUVAIL™ works 3. Before you use ACUVAIL™ 4. How to use ACUVAIL™ 5. While you are using it 6. Side effects 7. Storage and Disposal of ACUVAIL™ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ACUVAIL™ IS USED FOR ACUVAIL™ is used for the treatment of pain and inflammation following cataract surgery. ACUVAIL™ belongs to a group of medicines known as non-steroidal anti- inflammatory drugs (NSAIDs). HOW ACUVAIL™ WORKS It works by reducing the production of certain substances (such as prostaglandins) that cause inflammation, and pain. BEFORE YOU USE ACUVAIL™_ _ - _When you must not use it _ _ _ Do not use ACUVAIL™ if you are allergic (hypersensitive) to ketorolac, or any of the other ingredients of ACUVAIL™ (for a full list of ingredients, see section 8 “PRODUCT DESCRIPTION”). If you are hypersensitive to, or have had an allergic reaction to aspirin or other NSAIDs. Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms. _ _ - _Pregnancy and lactation _ _ _ Ask your doctor or pharmacist for advice before using any medicine. ACUVAIL™ should not be used if you are pregnant or might become pregnant or are breast feeding, unless your doctor recommends it. - _Children: _ _ _ Safety and effectiveness of ACUVAIL™ in children have not been established. ACUVAIL™ should not be administered while wearing contact lenses. _ _ - _Before you start use it _ Talk to your doctor if: - You are currently using any other topical NSAIDs. - You have bleeding tendencies. - You have complicated ocular surgeries, diabetes, dry eye syndrome, rheumatoid arthritis (systemic inflammatory disorder that Soma hati kamili
* ARTWORK IS ACTUAL SIZE * DROP NOTES AND TEMPLATE BEFORE PROCESSING * IF REQUIRED, BARCODE AND CONTROL BAR(S) WILL BE ADDED BY SUPPLIER * PERFORATION REQUIRED: NO Part Number: 96557MY_INT_01 Drawing Number: 0120001 V-Code 128C: FPO Page: 1 of 2 ™ 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 ————————————— • Cross-sensitivity (5.1)• 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 increas\�ed 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 USAGE2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosing3 DOSAGE FORMS AND STRENG Soma hati kamili