OMIDRIA Concentrate for solution for intraocular irrigation Ref.[51721] Active ingredients: Ketorolac Phenylephrine

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).

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 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. For dilution instructions, see section 6.6.

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.

In case of accidental intracameral injection of the concentrated solution, the anterior chamber should be evacuated immediately and irrigated with standard ophthalmological irrigation solution.

Systemic overdose of phenylephrine may cause a rapid rise in blood pressure. It may also cause headache, anxiety, nausea, and vomiting, and ventricular arrhythmias. In the event of phenylephrine overdose, prompt injection of a rapidly acting alpha-adrenergic blocking agent, such as phentolamine, has been recommended.

Unopened: 5 years.

Once opened the medicinal product should be diluted immediately.

After dilution, chemical and physical in-use stability has been demonstrated for 6 hours at 25˚C. Use within 6 hours of dilution. From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Do not store above 25˚C.

Keep the vial in the outer carton in order to protect from light.

Following dilution do not store above 25˚C.

Colourless 5 mL type I glass vial closed with a butyl rubber stopper and a polypropylene flip-off cap. Each single-use vial is packaged in a cardboard carton.

Pack size: multipack containing 10 (1 pack of 10) single-use vials.

To prepare Omidria for intraocular irrigation, dilute 4.0 mL (the content of 1 vial) of concentrate for solution in 500 mL of standard ophthalmological irrigation solution.

The following instructions must be adhered to:

• The vial should be visually inspected for particulate matter. Only a clear, colourless to slightly yellow concentrate for solution without visible particles should be used.
• Using aseptic technique, withdraw 4.0 mL of concentrate for solution using an appropriate sterile needle.
• 4.0 mL of concentrate for solution should be injected into a 500 mL bag/bottle of irrigation solution.
• The bag/bottle should be gently inverted in order to mix the solution. The solution should be used within 6 hours of preparation.
• The bag/bottle must be visually inspected for particulate matter. Only a clear, colourless solution without visible particles should be used.
• No other medicinal products should be added to the prepared irrigation solution.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.