OMIDRIA

Omidria must be administered in a controlled surgical setting by a qualified ophthalmological surgeon experienced in intraocular lens replacement surgery. 0 mL of Omidria concentrate for solution diluted in 500 mL of irrigation solution administered by intraocular irrigation to the affected eye during surgery.

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.

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 dilution). Single use only. Omidria has not been evaluated in the absence of standard preoperative mydriatic and anesthetic agents.

Preoperative antibiotic, anaesthetics, corticosteroid, mydriatic, and non-steroidal anti-inflammatory drugs (NSAID) eye drops may be administered at the discretion of the treating ophthalmologist. Before administering the medicinal product Omidria must be diluted into 500 mL of irrigation solution before use.

6. The Omidria-containing irrigation solution is intended to be used during the surgical procedure in the same manner that the standard irrigation solution would be used.

− Summary of the safety profile The safety profile of Omidria is based on data from 459 adult patients collected during clinical development obtained in randomised controlled studies. Adverse reactions reported in patients receiving Omidria were typical postoperative findings and most were mild to moderate in intensity and resolved without intervention or any residual effects.

3%). Each of these same findings was reported at a similar frequency in patients receiving placebo. Following post-marketing exposure to Omidria, primarily in the Unites States of America (USA), there have been very few suspected adverse reactions.

The most common adverse reactions are a small number of cases with corneal oedema which were mostly non-serious and self-limiting. The overall safety profile of Omidria on the market is similar to the clinical study experience with this medicinal product.

Tabulated list of adverse reactions The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).

System organ class Common Uncommon Nervous system disorders Headache. Eye disorders Eye pain; Anterior chamber inflammation; Conjunctival hyperaemia; Corneal oedema; Photophobia. Ocular discomfort; Eye inflammation; Eye irritation; Conjunctival oedema; Corneal disorder; Mydriasis; Vision blurred; Visual acuity reduced; Vitreous floaters; Eye pruritus; Eyelid pain; Foreign body sensation in eyes; Glare; Intraocular pressure increased.

Gastrointestinal disorders Nausea. General disorders and administration site conditions Inflammation. Pain. Description of specific adverse reactions Cardiovascular reactions and cross-sensitivity reactions are known adverse reactions associated with topical ophthalmic use of phenylephrine and ketorolac when used as monotherapy at higher concentraton levels than present in Omidria.

This medicinal product must be diluted before intraocular use. Omidria is indicated for addition to irrigation solution used during intraocular lens replacement procedures only. Omidria is not indicated for undiluted use, intravitreal injection, general topical ophthalmic use, or non-ocular systemic use.

The safety and efficacy of Omidria have not been evaluated in patients with a history of uveitis, iris trauma, or alpha-adrenergic antagonist use. The following warnings and precautions related to topical ophthalmic use of phenylephrine and ketorolac should be considered with the use of Omidria: Cardiovascular reactions There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using ophthalmic phenylephrine.

These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. Significant elevations in blood pressure have been reported following instillation of topical ocular phenylephrine. Anticipated systemic exposure is minimal and transient, however, caution should be used in treating patients with poorly controlled hypertension.

The risk of blood pressure elevations may be increased in patients requiring prolonged surgery. Hyperthyroidism and unstable cardiovascular disease should be addressed prior to surgery. Cross-sensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs.

There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac ophthalmic solution in patients who either have a known hypersensitivity to acetylsalicylic acid/NSAIDs, or a past medical history of asthma.

Therefore, use Omidria with caution in individuals who have previously exhibited sensitivities to these active substances. Cardiovascular reactions and cross-sensitivity reactions are known to occur with topical ophthalmic use of phenylephrine and ketorolac when used as monotherapy at higher concentration levels than present in Omidria.

1. Patients with narrow-angle glaucoma.