ANIDULAFUNGINA TEVA 100 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you use Anidulafungina Teva

Do not use Anidulafungina Teva:

• if you are allergic to anidulafungina, to other echinocandins (e.g., caspofungina, micafungina), 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 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 medicine.
• any sign of an allergic reaction, such as itching, wheezing, rash
• any sign of a reaction related to the infusion that could include skin rash, hives, itching, redness
• shortness of breath/difficulty breathing, dizziness or fainting

Children and adolescents

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

Using Anidulafungina Teva 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 this medicine on pregnant women is not known. Therefore, Anidulafungina Teva 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 this medicine on breastfeeding women is not known. Talk to your doctor or pharmacist before taking Anidulafungina Teva while breastfeeding.

Talk to your doctor or pharmacist before taking any medicine.

Anidulafungina Teva contains sodium

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

Anidulafungina Teva contains polysorbate

This medicine contains 250 mg of polysorbate 80 in each vial, which is equivalent to 3.6 mg/kg in adults (e.g., 70 kg body weight). Polysorbates can cause allergic reactions. Tell your doctor if you or your child have any known allergies.

Polysorbates may have an effect on your heart and blood circulation (abnormal or irregular heartbeat or decreased blood pressure).

3. How to use Anidulafungina Teva

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 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.

This medicine 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 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 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 Candidawas detected in your blood.

If you receive more Anidulafungina Teva than you should

If you think you have been given too much Anidulafungina Teva, talk to your doctor or another healthcare professional immediately.

If you miss a dose of Anidulafungina Teva

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 another healthcare professional immediately.

Your doctor should not give you a double dose.

If you stop using Anidulafungina Teva

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

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

If the initial symptoms of the infection return, talk to your doctor or another 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, Anidulafungina Teva 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 Anidulafungina Teva, which may include difficulty breathing with wheezing (a whistling sound when breathing) or worsening of a pre-existing rash.

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

• Seizures (fits).
• Redness or flushing
• Rash, itching.
• Flushing.
• Hives.
• Sudden contraction of the muscles in 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 potassium levels 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 producing wheezing and coughing.
• Difficulty breathing.

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

• Blood clotting disorders.
• Redness or flushing.
• Flushing.
• 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 get 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 Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anidulafungina Teva

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 must be administered at 25°C (room temperature) within the first 48 hours.

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 Teva

• The active substance is anidulafungina. Each vial of powder contains 100 mg of anidulafungina.
• 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 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, with no visible signs of contamination.

Marketing authorisation holder and 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

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

Date of last revision of this leaflet:November 2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (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 Teva 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 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 Anidulafungina Teva 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 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 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 subsequent dilution.

Dilution and infusion

Parenteral medicines should be inspected visually for particulate matter and color change before 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, adding the solution 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, with gentle constant agitation, to achieve the appropriate anidulafungina 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 Teva

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 reconstitution and subsequent dilution are completed, 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/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 necessary vial(s) according to the reconstitution instructions to achieve a concentration of 3.33 mg/ml.
2. Calculate the volume (ml) of reconstituted anidulafungina required:

• Volume of anidulafungina (ml) = Dose of anidulafungina (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 anidulafungina (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 anidulafungina (ml)

1. Transfer the required volumes (ml) of anidulafungina and sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion aseptically to an infusion syringe or intravenous infusion bag 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.