ECALTA 100 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

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

Do not use ECALTA

• if you are allergic to anidulafungin, to other echinocandins (e.g., caspofungin acetate), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to 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 given anesthetics during treatment with ECALTA.
• the appearance of signs of an allergic reaction such as itching, wheezing, skin rash.
• the appearance of signs of a reaction related to the infusion such as rash, hives, itching, or redness.
• the appearance of shortness of breath/breathing difficulties, dizziness, or fainting.

Children and adolescents

ECALTA should not be administered to patients less than 1 month old.

Using ECALTA with other medicines

Tell your doctor or pharmacist if you or your child are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

The effect of ECALTA on pregnant women is not known. Therefore, ECALTA is not recommended during pregnancy. Women of childbearing age should use effective contraception. Contact your doctor immediately if you become pregnant during treatment with ECALTA.

The effect of ECALTA on breastfeeding women is not known. Consult your doctor or pharmacist before taking ECALTA while breastfeeding.

Consult your doctor or pharmacist before taking any medicine.

ECALTA contains fructose

This medicine contains 119 mg of fructose (a type of sugar) in each vial. If your doctor has told you that you have an intolerance to some sugars, consult with them before using this medicine.

If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you should not receive this medicine. Patients with HFI cannot break down the fructose in this medicine, which can cause serious side effects.

Consult your doctor before receiving this medicine if you (or your child) have 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 medicine contains less than 1 mmol of sodium (23 mg) per vial; it is essentially "sodium-free".

3. How to use ECALTA

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

For use in adults, treatment starts 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 (aged 1 month to less than 18 years), treatment starts 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, by intravenous infusion (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 ECALTA to be administered each day, and will monitor both your response to treatment and your general condition.

In general, your treatment should continue for at least 14 days after the last day on which Candidawas detected in your blood.

If you receive more ECALTA than you should

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

If you miss a dose of ECALTA

Since this medicine will be administered under close medical supervision, it is unlikely that a dose will be missed. However, if you think a dose has been missed, talk to your doctor or other healthcare professional immediately.

Your doctor should not give you a double dose.

If you stop treatment with ECALTA

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

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

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

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

4. Possible side effects

Like all medicines, ECALTA can cause side effects, although not everybody gets 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 ECALTA, which may include difficulty breathing with wheezing or worsening of a pre-existing rash.

Serious side effects – tell your doctor or other healthcare professional immediately if you experience any of the following:

• Seizures (fits).
• Flushing.
• Rash, itching.
• Flushes.
• Hives.
• Sudden contraction of the muscles in the airways 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.
• Changes in blood test results indicating liver function.
• Rash, itching.
• Changes in blood test results indicating kidney function.
• Abnormal flow of bile from the gallbladder into the intestine (cholestasis).
• High blood sugar levels.
• High blood pressure.
• Low blood pressure.
• Sudden contraction of the muscles surrounding the airways resulting in wheezing or coughing.
• Difficulty breathing.

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

• Blood clotting disorders.
• Flushing.
• Flushes.
• Stomach pain.
• Hives.
• Pain at the injection site.

Frequency not known (cannot be estimated from the available data):

• Life-threatening allergic reactions.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of ECALTA

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

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month shown.

Store in a refrigerator (2°C - 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 should be administered at 25°C (room temperature) within the first 48 hours.

Medicines should not be disposed of via wastewater or household waste.

6. Contents of the pack and other information

Composition of ECALTA

• The active substance is anidulafungin. Each vial contains 100 mg of anidulafungin.
• The other ingredients are: fructose (see section 2 "ECALTA contains fructose"), mannitol, polysorbate 80, tartaric acid, sodium hydroxide (for pH adjustment) (see section 2 "ECALTA contains sodium"), hydrochloric acid (for pH adjustment).

Appearance and pack contents

ECALTA is presented in a carton containing 1 vial of 100 mg powder for concentrate for solution for infusion.

The powder is white or almost white.

Marketing Authorisation Holder

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

Manufacturer

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

You can request more information about this medicine from the local representative of the Marketing Authorisation Holder:

Spain

Pfizer, S.L.

Tel: +34 91 490 99 00

Date of last revision of this leaflet: 06/2023

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.

---------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals and applies only to the presentation of ECALTA 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 injections and then diluted ONLY with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion. The compatibility of the reconstituted ECALTA solution with intravenous substances, additives, or other medicines has not been established, except for sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.

Reconstitution

Each vial should be reconstituted under aseptic conditions with 30 ml of water for injections to achieve a concentration of 3.33 mg/ml. The reconstitution time can be up to 5 minutes. After dilution, the solution should be discarded if solid particles or a color change 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 further dilution.

Dilution and infusion

Parenteral medicines should be inspected visually for particulate matter and color change prior to administration, whenever the solution and container permit. If particulate matter or color change is identified, discard the solution.

Adult patients

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

Dilution requirements for the administration of ECALTA

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

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

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

Pediatric patients

For pediatric patients from 1 month to <18 years, the volume of infusion solution required to administer dose will vary depending on patient's weight. reconstituted should be further diluted a concentration 0.77 mg ml for final solution. programmable syringe pump or is recommended. The infusion rate should not exceed 1.1 mg/min (equivalent to 1.4 ml/min 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 anidulafungin 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%) solution for infusion or glucose 50 mg/ml (5%) solution 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%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion aseptically to an intravenous infusion bag or syringe necessary for administration.

For single use. The disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.