ANIDULAFUNGINA SWANPOND INVESTMENTS 100 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION EFG

2. What you need to know before you or your child start using Anidulafungin Swanpond Investments

Do not use Anidulafungin Swanpond Investments:

• 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 anidulafungin. 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 anidulafungin.
• the appearance of signs of an allergic reaction such as itching, wheezing (whistling sound when breathing), skin rash.
• the appearance of signs of an infusion-related reaction such as rash, hives, itching, or redness.
• the appearance of shortness of breath/difficulty breathing, dizziness, or fainting.

Children and adolescents

Anidulafungin should not be given to patients less than 1 month old.

Other medicines and Anidulafungin Swanpond Investments

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 anidulafungin on pregnant women is not known. Therefore, anidulafungin is not recommended during pregnancy. Women of childbearing potential should use effective contraception. Contact your doctor immediately if you become pregnant during treatment with this medicine.

The effect of anidulafungin on breastfeeding women is not known. Talk to your doctor or pharmacist before taking this medicine while 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.

Talk to your doctor or pharmacist before taking any medicine.

Anidulafungin Swanpond Investments contains sodium

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

3. How to use Anidulafungin Swanpond Investments

Anidulafungin 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 package 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.

Anidulafungin 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 this medicine 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 that Candida was detected in your blood.

If you receive more Anidulafungin Swanpond Investments than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you miss a dose of Anidulafungin Swanpond Investments

Since this medicine is administered under strict 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 administer a double dose.

If you stop treatment with Anidulafungin Swanpond Investments

You should not notice any of the effects of this medicine when your doctor stops your treatment with this medicine.

Your doctor may prescribe another medicine after treatment with this medicine 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 product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, anidulafungin 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 anidulafungin, which may include difficulty breathing with wheezing (whistling sound when breathing) 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).
• Redness or flushing
• Rash, itching (pruritus).
• Hot flushes.
• Hives.
• Sudden contraction of the muscles that line 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
• Alteration of blood test values indicating liver function.
• Rash, itching (pruritus).
• Alteration of blood test values 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 that line the airways resulting in wheezing or coughing.
• Difficulty breathing.

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

• Blood clotting disorders.
• Redness or flushing
• Hot 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 through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anidulafungin Swanpond Investments

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 after EXP. The expiry date refers to the last day of the month shown.

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

Reconstituted solution: The reconstituted solution can be stored at a temperature of up to 25°C for 24 hours.

Infusion solution: The infusion solution can be stored at 25°C for 48 hours. Do not freeze. Do not refrigerate.

Medicines should not be disposed of via wastewater or household waste. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anidulafungin Swanpond Investments

• The active substance is anidulafungin. Each vial contains 100 mg of anidulafungin.

• The other ingredients are: sucrose, polysorbate 80, tartaric acid, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment).

Appearance and pack size

Anidulafungin is presented in Type I glass vials of 30 ml with a elastomeric stopper (butyl rubber) and an aluminum cap with a polypropylene disc.

Pack size: 1 vial.

The powder is white to off-white, with no visible evidence of contamination.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Swan Pond Investments Ltd

Inniscarra

Main Street,

Rathcoole,

Co. Dublin D24 E029

Ireland

Manufacturer:

Actavis Italy S.p.A,

Nerviano Plant,

Italy

Or

Balkanpharma Dupnitsa AD.

3 Samokovsko Shosse Street

Dupnitsa, 2600

Bulgaria

Date of last revision of this leaflet: April 2023

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

<--------------------------------------------------------------------------------------------------->

This information is intended only for healthcare professionals and is applicable only to the presentation of Anidulafungin Swanpond Investments 100 mg powder for concentrate for solution for infusion EFG that contains a single vial:

The contents of the vial must be reconstituted with water for injections and subsequently 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 Anidulafungin Swanpond Investments 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. The infusion solution should not be frozen.

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 is clear and colorless or slightly yellowish.

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

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

Adult patients

The contents of the reconstituted vial(s) should be transferred aseptically to an intravenous administration 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. Requirements for dilution for the administration of Anidulafungin Swanpond Investments.

Requirements for dilution for the administration of Anidulafungin Swanpond Investments

A Or 9 mg/ml (0.9%) sodium chloride for infusion, or 50 mg/ml (5%) glucose 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 subsequently diluted, according to the instructions described).

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 or pump 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.

Calculate the volume (ml) of anidulafungin required:

1. 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:
1. 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:
1. 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. Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.