Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
ketorolac, phenylephrine
Rayner Surgical (Ireland) Limited
S01
phenylephrine, ketorolac
Ophthalmologicals
Lens Implantation, Intraocular; Pain, Postoperative
Omidria is indicated in adults for maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery.
Revision: 7
Authorised
2015-07-28
B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: INFORMATION FOR THE USER OMIDRIA 10 MG/ML + 3 MG/ML CONCENTRATE FOR SOLUTION FOR INTRAOCULAR IRRIGATION phenylephrine/ketorolac READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Omidria is and what it is used for 2. What you need to know before you use Omidria 3. How Omidria is used 4. Possible side effects 5. How Omidria is stored 6. Contents of the pack and other information 1. WHAT OMIDRIA IS AND WHAT IT IS USED FOR Omidria is a medicine used during surgery on the eye. It contains the active substances phenylephrine and ketorolac. Phenylephrine acts to keep the pupil dilated (widened). Ketorolac is a painkiller that belongs to the group called non-steroidal anti-inflammatory drugs (NSAIDS); it also helps stop the pupil from contracting (getting smaller). Omidria is used in adults to rinse the eye during surgery to implant a new lens (part of the eye that focuses light passing through the pupil to allow you to see clearly). This is known as intraocular lens replacement. The medicine is used to keep the pupil dilated (widened) during surgery and to reduce eye pain after the procedure. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OMIDRIA DO NOT USE OMIDRIA: - if you are allergic to phenylephrine or ketorolac or any of the other ingredients of this medicine (listed in section 6); - if you have an eye condition called narrow-angle glaucoma. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Omidria if you: - have heart disease; - have raised blood pressure; - have overactive thyroid gland (hyperthyroidism); - are allergic to acetylsalicylic acid or other painkillers called Lire le document complet
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 4 mL of concentrate for solution in the vial contains phenylephrine hydrochloride equivalent to 40.6 mg (10.2 mg/mL) of phenylephrine and ketorolac trometamol equivalent to 11.5 mg (2.88 mg/mL) of ketorolac. After dilution in 500 mL of irrigation solution, the solution contains 0.081 mg/mL of phenylephrine and of 0.023 mg/mL ketorolac. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for intraocular irrigation. Clear, colourless to slightly yellow, solution with a pH: 6.3 ±0.3. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Omidria is indicated in adults for maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Omidria must be administered in a controlled surgical setting by a qualified ophthalmological surgeon experienced in intraocular lens replacement surgery. Posology The recommended dose is 4.0 mL of Omidria concentrate for solution diluted in 500 mL of irrigation solution administered by intraocular irrigation to the affected eye during surgery. For instructions on dilution of the medicinal product before administration, see section 6.6. _Special populations _ _Elderly _ The elderly population has been studied in clinical studies. No dose adjustment is required. _Renal or hepatic impairment _ No formal studies have been conducted with Omidria in patients with renal or hepatic impairment. No dose adjustment or special considerations are anticipated for patients with renal or hepatic impairment (see section 5.2). 2 _Paediatric population _ The safety and efficacy of Omidria in children aged below 18 years have not been established. No data are available. Method of administration Intraocular use (after Lire le document complet