Fydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection

Spain
Brand name Fydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection
Form solution for injection
Active substance / Dosage
LIDOCAINE HYDROCHLORIDE · 6,00 mg
PHENYLEPHRINE HYDROCHLORIDE · 1,86 mg
TROPICAMIDE · 0,12 mg
Prescription type Hospital Use Only
ATC code
S01F S01FA S01FA56
Registration number 80177
Manufacturer Laboratoires Thea

Table of Contents

Patient Information Leaflet

Introduction

Patient Information Leaflet

FYDRANE 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml, solution for injection

tropicamide / hydrochloride phenylephrine / hydrochloride lidocaine monohydrate

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

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

Leaflet Contents

  1. What FYDRANE is and what it is used for
  2. What you need to know before using FYDRANE
  3. How to use FYDRANE
  4. Possible adverse effects
  5. How to store FYDRANE
  6. Contents of the pack and other information

1. What FYDRANE is and what it is used for

What FYDRANE 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 the transmission of impulses through nerves (known as anticholinergics),
  • Phenylephrine (as phenylephrine hydrochloride), which belongs to a group of medicines that mimic the effects of impulses transmitted through certain nerves (known as alpha-sympathomimetics),
  • Lidocaine (as lidocaine hydrochloride monohydrate), which belongs to a group of medicines called amide-type local anesthetics.

What it is used for

This medicine is used only in adults.

It will be administered by your ophthalmic surgeon as an injection into the eye at the beginning of cataract surgery (clouding of the lens) to dilate the pupil of your eye (mydriasis) and to provide anesthesia in your eye during the surgical procedure.

2. What you need to know before using FYDRANE

FYDRANE must not be administered to you if:

  • you are allergic to tropicamide, phenylephrine hydrochloride and/or lidocaine hydrochloride monohydrate or to any of the other components of this medicine (listed in section 6),
  • you are allergic to amide-type local anesthetics (such as articaine, bupivacaine, mepivacaine, prilocaine, ropivacaine),
  • you are allergic to atropine derivatives.

Warnings and precautions

FYDRANE is not recommended:

  • in cataract surgery combined with certain types of eye surgery (vitrectomy),
  • if the front part (anterior chamber) of your eye is shallow,
  • if you have ever experienced an acute increase in intraocular pressure (acute angle-closure glaucoma).

Consult your doctor if you have:

  • high blood pressure (hypertension),
  • thickening of the arterial walls (atherosclerosis),
  • any heart disease, particularly if it affects your heart rate,
  • contraindications to medications that increase blood pressure (vasopressor amines: epinephrine, norepinephrine, dopamine, dobutamine) administered systemically,
  • overactive thyroid gland (hyperthyroidism),
  • prostate gland disorders,
  • seizures (epilepsy),
  • any liver or kidney problems,
  • any respiratory problems,
  • loss of muscle function and weakness (myasthenia gravis).

Use of FYDRANE with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy, breastfeeding and fertility

This medicine should not be used:

  • during pregnancy,
  • during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

FYDRANE has a moderate influence on the ability to drive and use machines. Therefore, you should not drive and/or operate machinery until your vision has returned to normal.

FYDRANE contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially "sodium-free".

3. How to use FYDRANE

This medicine should only be administered if satisfactory pupillary dilation with a topical mydriatic has previously been demonstrated during a preoperative assessment.

Dosage and method of administration

  • FYDRANE injection solution must be administered by an ophthalmic surgeon, under local anesthesia, at the beginning of cataract surgery.

  • The recommended dose is 0.2 ml of solution given as a single injection. Additional doses must not be injected, as cumulative effects have not been demonstrated and because an increased loss of endothelial cells (cells of the layer lining the posterior surface of the cornea) has been observed.

  • The same dose is used in adults and elderly patients.

If you are given too much or too little FYDRANE:

Your medication will be administered by an ophthalmic surgeon. It is unlikely that you will receive an overdose. An overdose may cause loss of corneal endothelial cells (cells of a layer covering the posterior surface of the cornea).

If you have any further questions about the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The most serious known complications occur during or after cataract surgery:

Uncommon: may affect up to 1 in 100 people

  • Lens injury (posterior capsule rupture),
  • Inflammation of the retina (cystoid macular edema).

Please seek urgent medical attention in these cases.

Other adverse effects:

Uncommon: may affect up to 1 in 100 people

  • Headache,
  • Corneal inflammation (keratitis), increased eye pressure, eye redness (ocular hyperemia),
  • High blood pressure (hypertension).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of FYDRANE

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, blister, and ampoule after "EXP.". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

For use in one eye only. This medicine should be used immediately after opening the ampoule.

Medicines should not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of FYDRANE

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

Appearance of the product and pack size

FYDRANE is a transparent, yellow to slightly brownish injection solution, practically free from visible particles, packed in a 1 ml amber glass ampoule. Each sterile ampoule contains 0.6 ml of injection solution and is supplied either alone or together with a sterile 5-micron filter needle in a sealed paper/PVC blister.

Each pack contains 1, 20 or 100 sterile ampoules (with a sterile 5-micron filter needle). The 5-micron filter needle is intended solely for withdrawing the contents from the vial.

All components are for single use only.

Not all pack sizes may be marketed.

Marketing Authorization Holder

LABORATOIRES THEA

RUE LOUIS BLÉRIOT, 12

F-63017 CLERMONT-FERRAND CEDEX 2

FRANCE

Manufacturer

DELPHARM TOURS

RUE PAUL LANGEVIN

37170 CHAMBRAY LES TOURS

FRANCE

OR

LABORATOIRES THEA

RUE LOUIS BLÉRIOT, 12

F-63017 CLERMONT-FERRAND CEDEX 2

FRANCE

Local representative:

LABORATORIOS THEA, S.A.

C/ Enric Granados, nº 86-88, 2nd floor

08008 Barcelona

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria, Belgium, Bulgaria, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Italy, Luxembourg, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, Sweden, United Kingdom……………………………………………………………Mydrane

Ireland, Spain…………………………………………………………………………………Fydrane

Norway…………………………………………………………………………………………Mydane

Date of the most recent review of this leaflet: September 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.es/

This information is intended for healthcare professionals only:

Incompatibilities

Incompatibilities of the active substances with most products used in cataract surgery have not been reported in the literature, nor during clinical trials. For commonly used viscoelastic agents, this has also been confirmed by pharmacological interaction testing.

Warnings

Do not use if the blister is damaged or broken. Open only under aseptic conditions. The sterility of the blister contents is guaranteed.

How to prepare and administer FYDRANE

Single-use solution for one eye only, administered by intracameral route.

FYDRANE must be administered by intravitreal injection into the anterior chamber of the eye (intracameral injection) by an ophthalmic surgeon under the aseptic conditions recommended for cataract surgery.

Prior to intracameral injection, the solution should be visually inspected and used only if it is a clear, yellow to slightly brownish solution, practically free from visible particles.

The recommended dose is 0.2 ml of FYDRANE; an additional dose should not be injected, as significant cumulative effects have not been demonstrated and increased endothelial cell loss has been observed.

The product must be used immediately after opening the ampoule and must not be reused for the other eye or for any other patient.

For the kit presentation only (i.e., blister containing one ampoule and one needle): attach the detachable label from the blister to the patient's medical record.

To prepare FYDRANE for intracameral administration, please follow these instructions:

Black and white technical drawing of a medicinal vial with text label inserted in a rectangular blister pack with central opening

Black and white schematic drawing showing two hands holding and manipulating a small central container or medical device

Technical diagram of a 5-micron filter needle connected to a cylindrical container with horizontal grooves

Diagram showing various mounting options of needles with different lengths and angles onto a central syringe body

Technical drawing of a syringe with needle and indication of 0.2 ml dose marked by a black reference line

  1. Inspect the unopened blister to ensure it is intact. Open the blister by peeling off the foil under aseptic conditions to maintain sterility of the contents.
  1. Open the sterile vial containing the medicinal product. To open the OPC vial (One Point Cut, single opening point), proceed as follows: hold the bottom of the vial with the thumb pointing toward the colored dot. Hold the top of the vial with the other hand and, placing the thumb on the colored dot, apply backward pressure to break the glass at the pre-scored line beneath the dot.
  1. Attach the sterile 5 µm filter needle (supplied) to a sterile syringe. Remove the protective cap from the sterile 5 µm filter needle and withdraw at least 0.2 mL of injectable solution from the vial into the syringe.
  1. Detach the needle from the syringe and connect the syringe to a suitable cannula for the anterior chamber.
  1. Slowly expel air from the syringe. Adjust the volume to 0.2 mL. The syringe is now ready for injection.
  1. Slowly inject the 0.2 mL volume from the syringe into the anterior chamber of the eye via a single injection through either the side port or main port.

After use, properly dispose of any remaining solution. Do not retain for future use.

Disposal of unused medication and all materials that have come into contact with it must be carried out in accordance with local regulations. Dispose of used needles in a sharps container.