ANIDULAFUNGINA NORMON 100 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you use Anidulafungin Normon

Do not use Anidulafungin Normon

• 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

Consult your doctor, pharmacist or nurse before starting treatment with 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, 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

Anidulafungin should not be administered to patients under 1 month.

Using Anidulafungin Normon with other medicines

Tell your doctor or pharmacist if you 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, the use of Anidulafungin is not recommended during pregnancy. Women of childbearing age should use an effective contraceptive method. Contact your doctor immediately if you become pregnant during treatment with Anidulafungin.

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

Consult your doctor or pharmacist before taking any medicine.

Anidulafungin Normon contains fructose

This medicine contains 102.5 mg of fructose in each vial. The additive effect of medicines containing fructose (or sorbitol) administered concomitantly and the intake of fructose (or sorbitol) in the diet should be taken into account

If you (or your child) suffer from hereditary fructose intolerance (HFI), a rare genetic disease, you should not receive this medicine.

Patients with HFI cannot break down the fructose in this medicine, which may cause serious side effects.

Consult your doctor before receiving this medicine if you (or your child) suffer from HFI or cannot take sweet foods or drinks because they cause dizziness, vomiting or unpleasant effects such as bloating, stomach cramps or diarrhea.

Anidulafungin Normon contains sodium

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

3. How to use Anidulafungin Normon

Anidulafungin will always be prepared and administered 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 children and adolescents (aged 1 month to less than 18 years), treatment is initiated 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.

For use in adults, treatment is initiated with 200 mg on the first day (loading dose), followed by a daily dose of 100 mg (maintenance dose).

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 Anidulafungin 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 use more Anidulafungin Normon than you should

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

If you miss a dose of Anidulafungin Normon

Since this medicine will be administered under strict medical supervision, it is unlikely that a dose will be missed. However, if you think a dose may have been missed, consult your doctor or other healthcare professional immediately.

Your doctor should not administer a double dose.

If you stop treatment with Anidulafungin Normon

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 recur, consult 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, this medicine 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 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.
• Flushing.
• Hives.
• Sudden contraction of the muscles that line the airways resulting in wheezing or coughing.
• Breathing difficulties.

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.
• 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.
• Breathing difficulties.

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 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 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 Anidulafungin Normon

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 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 Anidulafungin Normon

• The active substance is anidulafungin. Each vial of powder contains 100 mg of anidulafungin.
• The other ingredients are: fructose (see section "Anidulafungin Normon contains fructose"), mannitol (E 421), polysorbate 80 (E 433), tartaric acid (E 334), sodium hydroxide (E 524) and/or hydrochloric acid (E 507) as pH adjusters.

Appearance of Anidulafungin Normon and contents of the pack

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

The powder is white or off-white.

Type I glass vial, 32 ml with a chlorobutyl stopper and an aluminum flip-off cap.

Marketing Authorisation Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of last revision of this leaflet:October 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products: http://www.aemps.

This information is intended only for healthcare professionals and is applicable only to the presentation of Anidulafungin Normon 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 Anidulafungin solution with intravenous substances, additives or other medicines has not been established, except with 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 subsequent 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 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 Anidulafungin Normon

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 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 diluted further 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 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 reconstituted anidulafungin required:

• Volume of anidulafungin (ml) = Anidulafungin dose (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) = Anidulafungin dose (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 will be carried out in accordance with local regulations.