MYDRANE

Intracameral use. One ampoule for single eye use. Mydrane must be administered by an ophthalmic surgeon. Posology Mydrane should only be used in patients who have already demonstrated, at pre-operative assessment, a satisfactory pupil dilation with topical mydriatic therapy.

2 ml of Mydrane in one injection, at the start of the surgical procedure.

Special population Elderly:

No dose adjustment is necessary.

Paediatric population:

The safety and efficacy of Mydrane in children aged 0 to 18 years have not been established. 4). 2), no dose adjustment is necessary. Method of administration Intracameral use. The following procedure should be followed: 1. Five minutes before performing the preoperative antiseptic procedure and the first incision, one to two drops of anaesthetic eye drops should be instilled in the eye.

2. 2 ml of Mydrane is slowly injected in only one injection by an ophthalmic surgeon, via intracameral route, through the side port or principal port. 6.

1). Most were ocular and of mild to moderate intensity.

Summary of the safety profile:

Posterior capsule rupture and cystoid macular oedema are well known complications occurring during or after cataract surgery. They may occur uncommonly (less than 1 case per 100 patients).

Tabulated list of adverse reactions:

Adverse events are categorised by frequency 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 (frequency cannot be estimated from available data).

Adverse reactions, reported during clinical trials, are presented according to System Organ Class in the table below in order of decreased seriousness within each frequency grouping: System Organ class Frequency Adverse reaction Nervous system disorders uncommon Headache Eye disorders uncommon Keratitis, Cystoid macular oedema, Intraocular pressure increased, Posterior capsule rupture, Ocular hyperaemia Vascular disorders uncommon Hypertension Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

9). Corneal endothelial toxicity has not been reported at the recommended dose of Mydrane; nevertheless, due to limited data, this risk cannot be excluded. There is no clinical experience with Mydrane in: - insulin-dependent or uncontrolled diabetic patients, - patients with corneal disease, especially those with any coexisting endothelial cell impairment, - patients with history of uveitis, - patients with pupillary abnormalities or presenting an ocular traumatism, - patients with very dark irides, - cataract surgery when combined with corneal transplantation.

There is no experience in patients at risk of floppy iris syndrome with Mydrane. Such patients should benefit of a step-by-step pupil dilation strategy starting with the administration of mydriatic eye drops. There is no clinical experience during cataract surgery with Mydrane in patients treated with topical mydriatics and for whom pupil constriction (or even miosis) occurs during surgery.

Mydrane is not recommended to be used in cataract surgery when combined with vitrectomy, due to the vasoconstricting effects of phenylephrine. Mydrane is not recommended in subjects with a shallow anterior chamber or a history of acute narrow angle glaucoma.

Use of Mydrane in patients with shallow anterior chamber, a history of acute narrow angle glaucoma and/or insufficient pupil dilation can increase the risk of both iridocele and floppy iris syndrome. 2). Since systemic effects of phenylephrine and lidocaine are dose dependent, it is unlikely that these effects occur with Mydrane.

However, as the risk cannot be excluded, it is reminded that: - Phenylephrine has sympathomimetic activity that might affect patients in the event of hypertension, cardiac disorders, hyperthyroidism, atherosclerosis or prostate disorders and all subjects presenting with a contraindication to the systemic use of pressor amines; - Lidocaine should be used with caution in patients with epilepsy, myasthenia gravis, cardiac conduction disturbances, congestive heart failure, bradycardia, severe shock, impaired respiratory function or impaired renal function with a creatinine clearance of less than 10mL/minute.

1. - Known hypersensitivity to anaesthetics of the amide type. - Known hypersensitivity to atropine derivatives.