Mydrane

Patient Information Leaflet

Mydrane, (0.2 mg + 3.1 mg + 10 mg)/ml, solution for injection
Tropicamidum + Phenylephrini hydrochloridum + Lidocaini hydrochloridum monohydricum
Please read all of this leaflet carefully before this medicine is administered, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Mydrane is and what it is used for
2. Important information before administration of Mydrane
3. How to use Mydrane
4. Possible side effects
5. How to store Mydrane
6. Contents of the pack and other information

1. What Mydrane is and what it is used for

What Mydrane is
This medicine is a solution for injection into the eye.
It contains three active substances:

• Tropicamide, which belongs to a group of medicines that block nerve impulse transmission, known as anticholinergic agents,
• Phenylephrine (as phenylephrine hydrochloride), which belongs to a group of medicines that mimic the effect of nerve impulses, known as alpha-sympathomimetic agents,
• Lidocaine (as lidocaine hydrochloride monohydrate), which belongs to a class of medicines called amide-type local anaesthetics.

What this medicine is used for
This medicine is intended for use only in adults.
It is administered by an ophthalmic surgeon as an injection into the eye at the beginning of cataract surgery (clouding of the lens), in order to dilate the pupil (pupil dilation) and to achieve local anaesthesia of the eye during the surgical procedure.

2. Important information before using Mydrane

When not to use Mydrane:

• if the patient is allergic to tropicamide, hydrochloride phenylephrine and (or) lidocaine hydrochloride monohydrate or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to amide-type local anaesthetics,
• if the patient is allergic to atropine derivatives.

Warnings and precautions
Mydrane is not recommended:

• during cataract surgery combined with certain types of eye surgery (vitrectomy),
• if the anterior chamber of the eye is shallow,
• if the patient has a history of acute increase in intraocular pressure (acute angle-closure glaucoma).

Consult a doctor, especially if the patient has:

• high blood pressure (hypertension),
• thickening of the arterial walls (arteriosclerosis),
• any heart disease, particularly if it affects heart rate,
• contraindications to drugs that increase blood pressure (pressurizing amines) administered systemically,
• hyperthyroidism,
• prostatic gland disorders,
• epilepsy,
• any liver disease or kidney problems,
• any respiratory problems,
• muscle weakness and fatigue (myasthenia).

Mydrane and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use.

Pregnancy, breastfeeding and fertility
This medicine should not be used:

• during pregnancy,
• during breastfeeding.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Mydrane has a moderate effect on the ability to drive and operate machinery.
Therefore, driving vehicles and (or) operating machinery should be avoided until normal vision returns.

Mydrane contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered "sodium-free".

3. How to use Mydrane

The patient should receive this medicine only if sufficient pupil dilation has been achieved during the preoperative examination using standard pupil-dilating eye drops.
Dosage and method of administration

• The Mydrane injection will be administered by an ophthalmic surgeon, under local anaesthesia, at the beginning of cataract surgery.
• The recommended dose is 0.2 ml of solution as a single injection. An additional dose should not be injected, as no significant additional effect has been demonstrated and increased endothelial cell loss (cells of the posterior corneal layer) has been observed.
• The same dose is used for adults and elderly patients.

Use of a higher or lower than recommended dose of Mydrane
The medicine will be administered by an ophthalmic surgeon. Overdose is unlikely to occur.
Overdose may cause increased loss of corneal endothelial cells (cells of the layer covering the posterior surface of the cornea).
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The most serious well-known complications occurring during or after cataract surgery:
Not common: may affect up to 1 in 100 people

• lens damage (posterior capsule rupture),
• retinal swelling (cystoid macular edema). In such a case, urgent medical advice should be sought.

Other adverse reactions:
Not common: may affect up to 1 in 100 people

• headache,
• corneal swelling (corneal edema), increased eye pressure, eye redness (ocular hyperemia),
• high blood pressure (hypertension).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Mydrane medicine
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or ampoule.
The expiry date refers to the last day of the stated month.
No special storage conditions are required.
For single use only. The medicine should be used immediately after first opening the ampoule.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Mydrane contains

• In each 0.2 ml dose, the active substances are: tropicamide 0.04 mg, phenylephrine hydrochloride 0.62 mg and lidocaine hydrochloride monohydrate 2 mg, corresponding to 0.2 mg tropicamide, 3.1 mg phenylephrine hydrochloride and 10 mg lidocaine hydrochloride monohydrate per 1 ml.
• Other components: sodium chloride, disodium phosphate dodecahydrate, disodium phosphate dihydrate, disodium edetate and water for injections.

What Mydrane looks like and contents of the pack
Mydrane is a clear, slightly brownish-yellow solution for injection, practically free from visible particles, supplied in a 1 ml brown glass ampoule. Each sterile ampoule contains 0.6 ml of solution for injection and is packed individually or together with one sterile 5-micron filter needle into a sealed Paper/PVC blister.
Each carton contains 20 or 100 sterile ampoules with sterile 5-micron filter needles, either separately or in the same blister. The 5-micron filter needles are to be used exclusively for withdrawing the solution from the ampoule. All components are intended for single use only.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
FRANCE
This medicinal product is authorised for marketing in the European Economic Area member states under the following names:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Germany, Denmark, Greece, Finland, France, Croatia,
Iceland, Italy, Luxembourg, Netherlands, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia,
United Kingdom ........................................................................................................................... Mydrane
Ireland, Spain.........................................................................................................................Fydrane
Norway .......................................................................................................................................Mydane
Detailed information about this medicinal product is available on the website of the Office for Registration:
www.urpl.gov.pl

Information intended exclusively for medical professionals:

Pharmaceutical incompatibilities
No incompatibilities have been described in the literature or during clinical studies with products most commonly used during cataract surgery. This has also been confirmed for commonly used viscoelastic materials through pharmaceutical interaction studies.
Warning
Do not use if the blister is damaged or broken. Open only under sterile conditions.
The contents of an unopened blister are guaranteed to be sterile.
How to prepare and administer Mydrane
Solution for single use in one eye only, intended solely for administration into the anterior chamber of the eye.
The Mydrane medicinal product must be administered by injection into the anterior chamber of the eye (intracameral injection) by an ophthalmic surgeon under recommended aseptic catarqact surgery conditions.
Prior to intracameral injection, the solution should be inspected visually and should only be used if it is a clear, slightly brownish-yellow solution, practically free from visible particles.
The recommended dose is 0.2 ml of Mydrane; an additional dose should not be injected, as no significant additional effect has been demonstrated and increased endothelial cell loss has been observed.
This product should be used immediately after opening the vial and should not be reused for the second eye or for another patient.
Only for the kit (i.e. blister containing vial and needle): attach the label
(blister label) to the patient's medical record.

To prepare Mydrane for administration into the anterior chamber of the eye, follow the instructions below:
	1. Check the unopened blister to ensure it is intact. Open the blister by peeling the foil under aseptic conditions to maintain sterility of the contents. 2. Open the sterile ampoule containing the medicinal product by breaking it. The ampoule with a single-point score must be opened as follows: hold the lower part of the ampoule with your thumb facing the coloured dot. Hold the top of the ampoule with the other hand, placing your thumb on the coloured dot, and snap backward to break along the scored line beneath this dot. 3. Attach the sterile 5-micron filter needle (provided in the pack) to a sterile syringe. Remove the protective cap from the sterile 5-micron filter needle and draw at least 0.2 ml of the injection solution from the ampoule into the syringe. 4. Detach the needle from the syringe and attach an appropriate sterile cannula suitable for administration into the anterior chamber of the eye to the syringe. 5. Carefully remove air from the syringe. Adjust the volume to 0.2 ml. The syringe is now ready for injection. 6. Slowly inject the 0.2 ml volume from the syringe into the anterior chamber of the eye, administering a single injection through a side port or main incision.
After use, any remaining prepared solution must be discarded. Do not store any unused portion for later use.

Any unused residues of the medicinal product or its waste should be disposed of in accordance with local regulations. Used needles should be discarded into a sharps medical waste container.