ANIDULAFUNGINA STADA 100 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

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

Do not use Anidulafungina Stada

• if you are allergic to anidulafungin, to other echinocandins (e.g., caspofungin), 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 Anidulafungina Stada.

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.
• for signs of an allergic reaction, such as itching, wheezing, reddened skin.
• for signs of an infusion-related reaction that could include rash, hives, itching, flushing.
• difficulty breathing/shortness of breath, dizziness or fainting.

Children and adolescents

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

Other medicines and Anidulafungina Stada

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 age should use effective contraception. Contact your doctor immediately if you become pregnant during treatment with anidulafungin.

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

Talk to your doctor or pharmacist before taking any medicine.

Anidulafungina Stada contains sodium

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

3. How to use Anidulafungina Stada

Anidulafungina 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 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.

Anidulafungina must 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 anidulafungina 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 Anidulafungina Stada than you should

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

If you miss a dose of Anidulafungina Stada

Since this medicine will be administered under close medical supervision, it is unlikely that you will miss a dose. 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 Anidulafungina Stada

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

Your doctor may prescribe another medicine after treatment with anidulafungin 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 other questions about the use of this medicine, 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 can include difficulty breathing with wheezing (a 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 side effects:

• Seizures (fits).
• Redness or flushing.
• Rash, itching.
• Hot flushes.
• Hives.
• Sudden contraction of the muscles that line the airways, resulting in wheezing or coughing.
• Difficulty breathing.

Other side effects

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 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, even if you think they are not serious. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anidulafungina Stada

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 stated.

Store in a 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anidulafungina

• The active substance is anidulafungin. Each vial contains 100 mg of anidulafungin.
• The other ingredients are: sucrose, polysorbate 80 (E 433), tartaric acid, sodium hydroxide (E 524) (for pH adjustment), hydrochloric acid (E 507) (for pH adjustment).

Appearance of the product and pack contents

Anidulafungina Stada 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, with no visible signs of contamination.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Actavis Italy S.p.A

Viale Pasteur 10, Nerviano

Milan 20014

Italy

or

S.C. SINDAN-PHARMA S.R.L.

11th Ion Mihalache Boulevard

Bucharest 011171

Romania

or

STADA Arzneimittel AG

Stadastr. 2-18

61118 Bad Vilbel

Germany

or

Stada Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

This medicine is authorised in the Member States of the European Economic Area under the following names:

Netherlands: Anidulafungine CF 100 mg powder for concentrate for solution for infusion

Austria: Anidualfungin STADA 100 mg powder for concentrate for solution for infusion

Belgium: Anidulafungine EG 100 mg powder for concentrate for solution for infusion

Germany: Anidulafungin STADA 100 mg powder for concentrate for solution for infusion

Denmark: Anidulafungin STADA

Finland: Anidulafungin STADA 100 mg powder for concentrate for solution for infusion

Spain: Anidulafungina STADA 100 mg powder for concentrate for solution for infusion EFG

Italy: Anidulafungin EG

Luxembourg: Anidulafungine EG 100 mg powder for solution for infusion

Sweden: Anidulafungin STADA 100 mg powder for concentrate for solution for infusion

Slovenia: Anidulafungin STADA 100 mg powder for concentrate for solution for infusion

United Kingdom: Anidulafungin 100 mg powder for concentrate for solution for infusion

Date of last revision of this leaflet:June 2022

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

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This information is intended only for healthcare professionals and is applicable only to the presentation of Anidulafungina Stada 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 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 anidulafungin 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 must not be frozen.

Reconstitution

Each vial should be reconstituted under aseptic conditions with 30 ml of water for injection 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 change in coloration are identified. The appearance after reconstitution is a clear, colorless to yellow solution.

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 coloration before administration, whenever the solution and container permit. If particulate matter or coloration is identified, discard the solution.

Adult patients

The contents of the reconstituted vial(s) should be transferred aseptically, adding slowly 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 anidulafungina

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 described).

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 should be further diluted to a concentration of 0.77 mg/ml for the final infusion solution. A programmable syringe pump or infusion 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.

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
2. 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 will be carried out in accordance with local regulations.