Label: information for the user

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

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 you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you or your child experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this label. See section 4.

1. What isAnidulafungina Tevaand what it is used for

2. What you or your child need to know before starting to useAnidulafungina Teva

3. How to useAnidulafungina Teva

4. Possible side effects

5. Storage ofAnidulafungina Teva

6. Contents of the pack and additional information

Anidulafungina Teva contains the active ingredient anidulafungina and is prescribed for adultsand pediatric patients from 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.

This medication 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.

Do not use Anidulafungina Teva:

• if you are allergic to anidulafungina, to other echinocandins (for example, caspofungin, micafungin), or to 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 Teva.

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 this medication.
• any sign of an allergic reaction, such as itching, wheezing, skin rash
• any sign of a reaction related to infusion that could include skin rash, urticaria, itching, redness,
• shortness of breath/difficulty breathing, dizziness, or disorientation

Children and adolescents

Anidulafungina Teva should not be administered to patients under 1 month.

Use of Anidulafungina Teva with other medications

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

Pregnancy and breastfeeding

The effect of this medication on pregnant women is unknown. Therefore, the use of Anidulafungina Teva 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 this medication.

The effect of this medication on women during breastfeeding is unknown. Consult your doctor or pharmacist before taking Anidulafungina Teva while breastfeeding.

Consult your doctor or pharmacist before taking any medication.

Anidulafungina Teva contains sodium

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

Anidulafungina Teva 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.

This medication 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 medication 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 Anidulafungina Teva than you should

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

If you forget to use Anidulafungina Teva

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

Your doctor should not administer a double dose.

If you interrupt treatment with Anidulafungina Teva

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

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

If your 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, Anidulafungin Teva 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 the administration of Anidulafungin Teva, which may include difficulty breathing with wheezing (a high-pitched sound when breathing) or worsening of an existing rash.

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

- Seizures (convulsions).

- Redness or flushing.

- Rash, pruritus (itching).

- Hives.

- Sudden contraction of the respiratory muscles resulting in gasping 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 (convulsions).

- 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 contraction of the muscles covering the airways producing wheezing and coughing.

- Difficulty breathing.

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

- Blood clotting disorders.

- 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 that does not appear 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 (do not freeze) and must be administered at 25 °C (room temperature) within the first 48 hours.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medications that you no longer need. In this way, you will help protect the environment.

Anidulafungin Teva Composition

• The active ingredient is anidulafungin. Each vial of powder contains 100 mg of anidulafungin.
• The rest of the ingredients are: sucrose, polisorbate 80 (E 433), tartaric acid, sodium hydroxide (E 524) (to adjust the pH), hydrochloric acid (E 507) (to adjust the pH).

Appearance of the product and contents of the package

Anidulafungin Teva is available as a powder for concentrate for solution for infusion in a box containing 1 vial.

The powder is white to off-white in color,without visible evidence of contamination.

Marketing Authorization Holder and Responsible Manufacturer

Teva B.V.

Swensweg, 5

2031GA Haarlem, Netherlands

Local Representative:

Teva Pharma S.L.U.

C/Anabel Segura 11,

Edificio Albatros B 1ªplanta

28108 Alcobendas

Spain

Responsible Manufacturer

Teva Operations Poland Sp. z.o.o

Ul. Mogilska 80

Krakow 31-546 Poland

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruma Filipovica 25

Zagreb

10000 Croatia

or

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

11th Ion Mihalache Boulevard

Bucharest 011171 Romania

or

Merckle GmbH

Graf-Arco-Str.3

89079 Ulm

Germany

Last review date of this leaflet:November 2021

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

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This information is intended solely for doctors or healthcare professionals and is applicable only to the Anidulafungin Teva 100 mg powder for concentrate for solution for infusion presentation that contains 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 Teva 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. The infusion solution should not be frozen.

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 appearance after reconstitution is a transparent, 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 subsequent dilution.

Dilution and Infusion

Intravenous medications must be visually inspected for the presence of solid particles and changes in coloration before 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 by adding the solution slowly to a bag (or vial) for intravenous administration containing sodium chloride 9 mg/ml (0.9%) for infusion or glucose 50 mg/ml (5%) for infusion, with gentle, constant agitation, to achieve the appropriate concentration of anidulafungin.

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 Anidulafungin Teva

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

Pediatric Patients

For pediatric patients from 1 month to <18>The infusion rate should not exceed 1.1 mg/minute (equivalent to 1.4 ml/minute or 84 ml/hour when reconstituted and diluted according to instructions). (see sections 4.2 and 4.4)

1. Calculate the dose for the patient and reconstitute the (the) vial(s) as required according to the reconstitution instructions to achieve a concentration of 3.33 mg/ml.
2. Calculate the volume (ml) of anidulafungin reconstituted 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 aseptically 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.