Label: information for the user

ECALTA 100 mg powder for concentrate for solution for infusion

Anidulafungina

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

• Keep this label, 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1. What is ECALTA and for what it is used.

2. What you need to know before you or your child start using ECALTA.

3. How to use ECALTA.

4. Possible adverse effects.

5. Storage of ECALTA.

6. Contents of the package and additional information.

ECALTA contains the active ingredient anidulafungin and is prescribed for adultsand pediatric patients aged 1month to less than 18yearsto 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.

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

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

No use ECALTA

-if you are allergic to anidulafungin, 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 ECALTA. 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 ECALTA.
• 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 eruption, urticaria, itching, or redness.
• the appearance of shortness of breath/difficulty breathing, dizziness, or vertigo.

Children and adolescents

ECALTA should not be administered to patients under 1 month.

Use of ECALTA with other medications

Inform your doctor or pharmacist ifyou or your childare using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

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

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

Consult your doctor or pharmacist before taking any medication.

ECALTA contains fructose

This medication contains119mg of fructose (a type of sugar) in each vial.If your doctor has indicated that you have a fructose intolerance, consult with them before using this medication.

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 may 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.

ECALTA contains sodium

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

ECALTA 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).

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).

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.

ECALTA should be administered once a day, via intravenous infusion (in drip).For adults, themaintenance 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 ECALTA 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 ECALTA than you should

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

If you forget to use ECALTA

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 ECALTA

You should not notice any effects of ECALTA when your doctor suspends your treatment with ECALTA.

Your doctor may prescribe another medication after treatment with ECALTA 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, ECALTA can 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 ECALTA administration, which may include difficulty breathing with wheezing (a high-pitched sound when breathing) or worsening of an existing rash.

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

- Seizures (fits).

- Redness or flushing.

- Rash, pruritus (itching).

- Hives.

- Sudden muscle contraction 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 (fits).

- Headache.

- Vomiting.

- Alteration of blood test results indicating liver function.

- Rash, pruritus (itching).

- Alteration of blood test results indicating kidney function.

- Abnormal bile flow from the gallbladder into the intestine (cholestasis).

- Elevated blood sugar levels.

- Elevated blood pressure.

- Low blood pressure.

- Sudden muscle contraction resulting in wheezing and coughing.

- Difficulty breathing.

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

- Bleeding disorders related to blood coagulation.

- Redness or flushing.

- Hives.

- 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 national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about 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 (do not freeze) and must be administered at 25°C (room temperature) within the first 48 hours.

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

Composition of ECALTA

- The active ingredient is anidulafungin. Each vial of powder contains 100 mg of anidulafungin.

- The remaining ingredients are: fructose (see section 2 “ECALTA contains fructose”), mannitol, polisorbate 80, tartaric acid, sodium hydroxide (to adjust the pH) (see section 2 “ECALTA contains sodium”), hydrochloric acid (to adjust the pH).

Appearance of the product and contents of the package

ECALTA 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.

Marketing Authorization Holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium.

Responsible for manufacturing

Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs-Sint-Amands, Belgium.

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Spain

Pfizer, S.L.

Phone: +34 91 490 99 00

Last review date of this leaflet: 06/2023

For detailed information about this medicine, please visit the website of the European Medicines Agency:http://www.ema.europa.eu/.

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This information is intended for healthcare professionals only and is applicable to the ECALTA 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 ECALTA solution 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 may be stored at a temperature of up to 25°C for a period of up to 24 hours before subsequent dilution.

Dilution and infusion

Parenteral medicines must be visually inspected for solid particles and color changes before administration, whenever the solution and packaging permit. If solid particles or color changes 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.

Dilution requirements for ECALTA administration

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

BThe final infusion solution concentration 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, as described, are complete).

Pediatric patients

For pediatric patients from 1 month to <18 years, the volume of infusion solution required to administer the dose will vary depending on the patient's weight. The reconstituted solution must be diluted further to achieve a final infusion solution concentration of 0.77 mg/ml. A syringe pump or infusion pump is recommended.The infusion rate must not exceed 1.1 mg/minute (equivalent to 1.4 ml/minute or 84 ml/hour when reconstituted and diluted as described).

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 anidulafungin reconstituted required:

?Volume of anidulafungin (ml)=Dose of anidulafungin (mg)?3.33 mg/ml

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

?Total 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 to an infusion syringe or intravenous administration bag necessary for administration.

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