Leaflet: information for the user

Anidulafungina Normon 100 mg powder for concentrate for solution for infusion EFG

Anidulafungina

Read this leaflet carefully before you start using this medicine, because 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.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What Anidulafungina Normon is and what it is used for

2. What you need to know before you start using Anidulafungina Normon

3. How to use Anidulafungina Normon

4. Possible side effects

5. Storage of Anidulafungina Normon

6. Contents of the pack and additional information

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

Anidulafungina 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 Normon

• if you are allergic to anidulafungina, other echinocandins (for example, 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.

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.
• the appearance of signs of an allergic reaction such as itching, breathing sounds (sibilance), 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 should not be administered to patients under 1 month.

Use of Anidulafungina Normon with other medications

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

Pregnancy and lactation

The effect of anidulafungina on pregnant women is unknown. Therefore, the use of Anidulafungina 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 Anidulafungina.

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

Consult your doctor or pharmacist before taking any medication.

Anidulafungina Normon contains fructose

This medication contains 102.5 mg of fructose in each vial. The additive effect of medications containing fructose (or sorbitol) administered concomitantly and the ingestion of fructose (or sorbitol) in the diet should be taken into account.

If you (or your child) suffer from hereditary fructose intolerance (HFI), a rare genetic disease, you should not receive this medication.

Patients with HFI cannot break down the fructose in this medication, which can cause severe adverse effects.

Consult your doctor before receiving this medication if you (or your child) suffer from HFI or cannot take sweet foods or drinks because they cause dizziness, vomiting, or unpleasant effects such as bloating, stomach cramps, or diarrhea.

Anidulafungina Normon contains sodium

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

Anidulafungina will always be prepared and administered 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).

Anidulafungina 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 takes 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 Anidulafungina 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 use more Anidulafungina Normon than you should

If you think you have been given too much Anidulafungina, consult your doctor or other healthcare professional immediately.

If you forget to use Anidulafungina Normon

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

Your doctor should not administer a double dose.

If you interrupt treatment with Anidulafungina Normon

You should not notice any effects from Anidulafungina when your doctor suspends your treatment with Anidulafungina.

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

If the 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, this medicine 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 anidulafungin administration, which may include difficulty breathing with wheezing (a high-pitched sound when breathing) or worsening of a pre-existing rash.

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

• Seizures.
• Redness or flushing.
• Rash, pruritus.
• 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.
• Headache.
• Vomiting.
• Abnormal values in blood tests indicating liver function.
• Rash, pruritus.
• Abnormal values 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 or clotting 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 side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products 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. 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 a temperature of up to 25°C for a period of up to 24 hours. The infusion solution can be stored at 25°C (room temperature) for 48 hours, and must be administered at 25°C (room temperature) within the first 48 hours.

Medicines should not be disposed of through drains or in the trash.

Composition of Anidulafungin Normon

• The active ingredient is anidulafungin. Each vial of powder contains 100 mg of anidulafungin.
• The remaining ingredients are: fructosa (see section “Anidulafungin Normon contains fructosa”), manitol (E 421), polisorbato 80 (E 433), tartaric acid (E 334), sodium hydroxide (E 524) and/or hydrochloric acid (E 507) as pH adjusters.

Appearance of Anidulafungin Normon and contents of the package

Anidulafungin 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 in color.

Glass vial type I, 32 ml with chlorobutyl stopper and aluminum flip-off cap.

Holder of the Marketing Authorization and Responsible for Manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the last review of this leaflet:October 2022

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

This information is intended solely for doctors or healthcare professionals and is applicable only to the Anidulafungin Normon 100 mg powder for concentrate for solution for infusion presentation containing 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 with intravenous substances, additives, or other medications, 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 at a temperature of up to 25°C for a period of up to 24 hours before subsequent dilution.

Dilution and infusion

Intravenous medications must be visually inspected for the presence of solid particles and changes in coloration prior to 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 vial(s) must be transferred aseptically to a bag (or bottle) for intravenous administration containing sodium chloride 9 mg/ml (0.9%) for infusion or glucose 50 mg/ml (5%) for infusion to achieve the required concentration. The following table provides the dilution to a concentration of 0.77 mg/ml for the final infusion solution and infusion instructions for each dose.

Dilution requirements for the administration of Anidulafungin Normon

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

BThe concentration of the 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 reconstitution and subsequent dilution have been completed, according to the instructions described).

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:

• Volume of anidulafungin (ml) = Anidulafungin dose (mg) ÷ 3.33 mg/ml

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

• Total volume of dosing solution (ml) = Anidulafungin dose (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 to a syringe for infusion or an intravenous infusion bag as 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.