Package Insert: Information for the User

Anidulafungina Accord 100 mg Powder for Concentrate for Solution for Infusion EFG

Read this package insert carefully before you or your child start using this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you or your child experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information.

Anidulafungina Accord contains the active ingredient anidulafungina and is prescribed for adult and pediatric patients from 1 month to less than 18 years old to treat a type of fungal infection of the blood or other internal organs called invasive candidiasis. The infection is caused by fungal cells (yeast) known asCandida.

This medication belongs to a group of medications called echinocandins. These medications are used for the treatment of severe fungal infections.

Anidulafungina prevents the normal development of the cell wall of fungal cells. In the presence of Anidulafungina, the cell wall of fungal cells is incomplete or defective, making them fragile or unable to grow.

No use Anidulafungina Accord

• If you are allergic to anidulafungina, other echinocandins (such as caspofungin acetate), or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Anidulafungina Accord.

Your doctor may decide to monitor:

• Your liver function closely if you develop any liver problems during treatment.
• If you are administered anesthetics during treatment with Anidulafungina Accord.
• The appearance of signs of an allergic reaction such as itching, wheezing (sibilant sounds), skin rashes.
• The appearance of signs of a perfusion-related reaction such as rash, urticaria, itching, or redness.
• The appearance of shortness of breath/difficulty breathing, dizziness, or vertigo.

Children and Adolescents

Anidulafungina Accord should not be administered to patients under 1 month.

Other Medications and Anidulafungina Accord

Inform your doctor or pharmacist if you or your child are using, have used recently, or may need to use any other medication.

Pregnancy and Lactation

The effect of Anidulafungina Accord on pregnant women is unknown. Therefore, the use of Anidulafungina Accord during pregnancy is not recommended. Women of childbearing age should use an effective contraceptive method. Contact your doctor immediately if you become pregnant during treatment with this medication.

The effect of Anidulafungina Accord on women during lactation is unknown. Consult your doctor or pharmacist before taking Anidulafungina Accord while breastfeeding.

Consult your doctor or pharmacist before taking any medication.

Anidulafungina Accord contains fructose

This medication contains 102.5 mg of fructose (a type of sugar) in each vial. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before using this medication.

If you (or your child) suffer from hereditary fructose intolerance (IHF), a rare genetic disease,

you should not receive this medication. Patients with IHF cannot break down the fructose in this

medication, which can cause severe adverse effects.

Consult with your doctor before receiving this medication if you (or your child) suffer from IHF or cannot take sweet foods or drinks because they cause dizziness, vomiting, or unpleasant effects

such as bloating, stomach cramps, or diarrhea.

Anidulafungina Accord contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per vial; that is, it is essentially “sodium-free”.

Anidulafungin Accord will always be prepared and administered to you or your child by a doctor or other healthcare professional (for more information on the preparation method, see the section intended only for doctors or healthcare professionals, at the end of the prospectus).by a doctor or other healthcare professional (for more information on the preparation method, see the section intended only for doctors or healthcare professionals, at the end of the prospectus).

For use in children and adolescents (1 month to less than 18 years old), treatment begins with 3.0 mg/kg (not exceeding 200 mg) on the first day (loading dose), followed by a daily dose of 1.5 mg/kg (not exceeding 100 mg) (maintenance dose). The dose administered depends on the patient's weight.

For use in adults, treatment begins with 200 mg on the first day (loading dose), followed by a daily dose of 100 mg (maintenance dose).

This medication should be administered once a day, via intravenous infusion (in drip). For adults, the maintenance dose takes 1.5 hours to administer and the loading dose 3 hours.. For children and adolescents, the infusion may take less time depending on the patient's weight.

Your doctor will determine the duration of treatment and the amount of medication to be administered each day, and will monitor both your response to treatment and your overall condition.

Generally, your treatment should continue for at least 14 days after the last day on which Candida was detected in your blood.

If you receive more Anidulafungin Accord than you shouldIf you think you have been given too much Anidulafungin Accord, consult your doctor or other healthcare professional immediately.

If you forgot to use Anidulafungin Accord

Since this medication will be administered under strict medical supervision, it is unlikely that you will forget a dose. However, if you think you may have forgotten to administer a dose, consult your doctor or other healthcare professional immediately.

Your doctor should not administer a double dose.

If you interrupt treatment with Anidulafungin Accord

You should not notice any effects from this medication when your doctor suspends your treatment with Anidulafungin Accord.

Your doctor may prescribe another medication after treatment with Anidulafungin Accord to continue treating your fungal infection or prevent a relapse.

If your initial symptoms of the infection return, consult your doctor or other healthcare professional immediately.

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

Like all medicines, Anidulafungina Accord may cause side effects, although not everyone will experience them. Some of these side effects will be taken into account by your doctor when monitoring your response and condition.

Rarely, life-threatening allergic reactions have been reported during the administration of Anidulafungina Accord, which may include difficulty breathing with wheezing (a high-pitched sound when breathing) or worsening of an existing rash.

Severe side effects – inform your doctor or any other healthcare professional immediately if any of the following side effects occur:

• Seizures (convulsions).
• Redness or flushing.
• Rash, pruritus (itching).
• Angioedema.
• Urticaria.
• Sudden contraction of the respiratory muscles resulting in wheezing or coughing.
• Difficulty breathing.

Very common side effects (may affect more than 1 in 10 people):

• Low levels of potassium in the blood (hypokalemia).
• Diarrhea.
• Nausea.

Common side effects (may affect up to 1 in 10 people):

• Seizures (convulsions).
• Headache.
• Vomiting.
• Abnormal results in blood tests indicating liver function.
• Rash, pruritus (itching).
• Abnormal results in blood tests indicating kidney function.
• Abnormal bile flow from the gallbladder into the intestine (cholestasis).
• High levels of sugar in the blood.
• High blood pressure.
• Low blood pressure.
• Sudden contraction of the muscles covering the airways producing stridor and coughing.
• Difficulty breathing.

Uncommon side effects (may affect up to 1 in 100 people):

• Bleeding disorders.
• Redness or flushing.
• Angioedema.
• Abdominal pain.
• Urticaria.
• Pain at the injection site.

Unknown frequency (cannot be estimated from available data):

• Life-threatening allergic reactions.

Reporting of side effects

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

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C).

The reconstituted solution can be stored at 25 °C for up to 24 hours. From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and usage conditions before use are the responsibility of the user.

The infusion solution can be stored at 25 °C (room temperature) for 48 hours (do not freeze) and should be administered at 25 °C (room temperature) within 48 hours.

From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and usage conditions before use are the responsibility of the user and usually will not last more than 24 hours between 2 and 8 °C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

Medicines should not be disposed of through drains or trash.

Composition of Anidulafungin Accord

• The active ingredient is anidulafungin. Each vial of powder contains 100 mg of anidulafungin. The reconstituted solution contains 3.33 mg/ml of anidulafungin and the diluted solution contains 0.77 mg/ml of anidulafungin.
• The remaining ingredients are: fructose (see section 2 "Anidulafungin Accord contains fructose"), mannitol, polisorbate 80, lactic acid, sodium hydroxide (to adjust the pH) (see section 2 "Anidulafungin Accord contains sodium"), hydrochloric acid (to adjust the pH).

Appearance of the product and contents of the package

Anidulafungin Accord is presented in a box containing 1 vial of 100 mg powder for concentrate for solution for infusion.

The powder is white or off-white.

Package size: 1 vial

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n.

Edifici Est 6th floor 08039 - Barcelona

Spain

Manufacturer

PharmIdea SIA

4 Rupnicu Str.

2114 Olaine

Latvia

O

Lyocontract GmbH

Pulverwiese 1

38871 Ilsenburg

Germany

O

LABORATORIOS ALCALÁ FARMA, S.L.

Address: Avenida de Madrid, 82,

Alcalá de Henares, 28802

Madrid, Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: May 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended solely for doctors or healthcare professionals and is applicable only to the presentation of Anidulafungin Accord 100 mg powder for concentrate for solution for infusion that contains a single vial:

The contents of the vial must be reconstituted with water for injection and, subsequently, diluted ONLY with sodium chloride 9 mg/ml (0.9%) for infusion or with glucose 50 mg/ml (5%) for infusion. The compatibility of the reconstituted solution of Anidulafungin Accord with intravenous substances, additives, or other medicines, except for sodium chloride 9 mg/ml (0.9%) for infusion or glucose 50 mg/ml (5%) for infusion, has not been established.

Reconstitution

Each vial must be reconstituted in aseptic conditions with 30 ml of water for injection to achieve a concentration of 3.33 mg/ml. The reconstitution time may be up to 5 minutes. After dilution, the solution must be discarded if solid particles or a change in coloration are identified.

The reconstituted solution can be stored for up to 25°C for up to 24 hours before additional dilution. From a microbiological point of view, the product must be used immediately. If not used immediately, the times and conditions of storage in use before use are the responsibility of the user.

Dilution and infusion

Parenteral medicines must be visually inspected to detect solid particles and changes in coloration before administration, whenever the solution and packaging permit. If solid particles or changes in coloration are identified, discard the solution.

Adult patients

The contents of the reconstituted vial(s) must be transferred aseptically to an intravenous administration bag (or bottle) containing sodium chloride 9 mg/ml (0.9%) for infusion or glucose 50 mg/ml (5%) for infusion to achieve the appropriate anidulafungin concentration. The following table provides the dilution requirements to achieve a final infusion solution concentration of 0.77 mg/ml and the infusion instructions for each dose.

Requirements for dilution for the administration of Anidulafungin Accord

A 9 mg/ml (0.9%) sodium chloride for infusion or 50 mg/ml (5%) glucose for infusion.

B The concentration of the final infusion solution is 0.77 mg/ml.

The infusion rate must not exceed 1.1 mg/min (equivalent to 1.4 ml/min or 84 ml/hour once reconstituted and diluted according to the described instructions).

Pediatric patients

For pediatric patients from 1 month to <18> The infusion rate must not exceed 1.1 mg/minute (equivalent to 1.4 ml/minute or 84 ml/hour when reconstituted and diluted according to the instructions).

1. Calculate the dose for the patient and reconstitute the necessary vial(s) according to the reconstitution instructions to achieve a concentration of 3.33 mg/ml.

1. Calculate the volume (ml) of reconstituted anidulafungin required:

1. Calculate the total volume of the dosing solution (ml) required to achieve a final concentration of 0.77 mg/ml:

• Volume of dosing solution (ml) = Dose of anidulafungin (mg) ÷ 0.77 mg/ml

1. Calculate the volume of diluent (sodium chloride 9 mg/ml (0.9%) for infusion or glucose 50 mg/ml (5%) for infusion) required to prepare the dosing solution:

• Volume of diluent (ml) = Total volume of dosing solution (ml) – Volume of anidulafungin (ml)

1. Transfer the required volumes (ml) of anidulafungin and sodium chloride 9 mg/ml (0.9%) for infusion or glucose 50 mg/ml (5%) for infusion aseptically to an infusion syringe or an intravenous infusion bag necessary for administration.

For single use. The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.