Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Ketorolac trometamol 5 mg/mL; ;
AbbVie Limited
Ketorolac trometamol 5 mg/mL
0.5% w/v
Eye drops, solution
Active: Ketorolac trometamol 5 mg/mL Excipient: Benzalkonium chloride Disodium edetate dihydrate Hydrochloric acid Macrogols Purified water Sodium chloride Sodium hydroxide
Bottle, dropper, 3mL, 3 mL
Prescription
Prescription
Recordati SpA
Package - Contents - Shelf Life: Bottle, dropper, - 3 mL - 24 months from date of manufacture stored at or below 25°C - Bottle, dropper, - 5 mL - 24 months from date of manufacture stored at or below 25°C - Bottle, dropper, - 10 mL - 24 months from date of manufacture stored at or below 25°C
1996-06-20
ACULAR ® CMI v6-PI-v5 Page 1 of 3 ACULAR ® EYE DROPS (KETOROLAC TROMETAMOL) 5 MG/ML EYE DROPS CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ACULAR ® eye drops, including how to use the eye drops. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using ACULAR ® eye drops against the benefits they expect it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. KEEP THIS LEAFLET WITH THE MEDICINE . YOU MAY NEED TO READ IT AGAIN. WHAT ACULAR ® EYE DROPS ARE USED FOR These eyedrops contain the drug ketorolac trometamol and are used to treat itchy eyes occurring in the condition called seasonal allergic conjunctivitis. They are also used for the relief of swelling and redness after cataract surgery. Ketorolac trometamol works by decreasing prostaglandin E 2 levels in the eye. Prostaglandins are normally produced by the body and are thought to be associated with pain, itching and inflammation. ACULAR ® eye drops are only available with a doctor’s prescription from pharmacies. Ask your doctor if you have any questions about why ACULAR ® eye drops have been prescribed for you. BEFORE YOU USE ACULAR ® EYE DROPS _WHEN YOU MUST NOT USE IT _ Do not use ACULAR ® eye drops if: • You have an allergy to ketorolac trometamol or to any of the ingredients listed at the end of this leaflet • You have ever had an allergic reaction to aspirin or certain types of medicines used for arthritis or pain relief (non steroidal anti- inflammatory drugs) • The seal around the cap is broken • The bottle/packaging shows signs of tampering • The product does not look quite right • The expiry date on the bottle has passed. If you use this medicine after the expiry date has passed, it may not work effectively. Do not put the eye drops into your eye(s) while you are wearing soft Lire le document complet
NEW ZEALAND DATA SHEET ACULAR ® (ketorolac trometamol 5 mg/mL) Data Sheet V5.0 CCDS 4 25 April 2023 Page 1 of 7 1 PRODUCT NAME ACULAR ® (Ketorolac trometamol) 5 mg/mL Eye Drops 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACULAR contains ketorolac trometamol (5 mg/mL) as the active ingredient. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Ketorolac trometamol is a white to off-white crystalline substance, which is a racemic mixture. It may exist in three crystalline forms, all of which are equally soluble in water. Ketorolac trometamol 5mg/mL ophthalmic solution is a clear, colourless to pale yellow, sterile, isotonic aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ACULAR ® eye drops are indicated for the short term (2 - 4 weeks) prophylaxis and reduction in inflammation in patients undergoing cataract extraction. ACULAR ® eye drops are also indicated for the short term (2 - 4 weeks) relief of symptoms of seasonal allergic conjunctivitis. 4.2 DOSE AND METHOD OF ADMINISTRATION SEASONAL ALLERGIC CONJUNCTIVITIS The recommended dose of ACULAR ® eye drops for allergic conjunctivitis is one drop (0.25 mg) instilled in the eye four times daily. Treatment may be continued for up to four weeks. POST-OPERATIVE INFLAMMATION The recommended dose of ACULAR ® eye drops for the prophylaxis and treatment of post operative inflammation in patients who have undergone cataract extraction is 1 - 2 drops (0.25 to 0.5 mg) four times daily, starting 24 hours before surgery and continuing for 2 - 4 weeks. 4.3 CONTRAINDICATIONS ACULAR ® eye drops are contraindicated in patients hypersensitive to any of the components of the medication. The potential exists for cross sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory medicines. ACULAR ® is contraindicated in patients who have previously exhibited sensitivities to these drugs. ACULAR ® eye drops are contraindicated in children. NEW ZEALAND DATA SHEET ACULAR Lire le document complet