Anidulafungin Normon 100 mg powder for concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

anidulafungin

Read the entire leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Anidulafungina Normon is and what it is used for
2. What you need to know before using Anidulafungina Normon
3. How to use Anidulafungina Normon
4. Possible side effects
5. How to store Anidulafungina Normon
6. Contents of the pack and other information

1. What Anidulafungin Normon is and what it is used for

Anidulafungin Normon contains the active substance anidulafungin and is prescribed in adults and pediatric patients from 1 month to less than 18 years of age for the treatment of a type of fungal infection in the blood or other internal organs called invasive candidiasis. The infection is caused by fungal (yeast) cells known as Candida.

Anidulafungin belongs to a group of medicines called echinocandins. These medicines are used to treat serious fungal infections.

Anidulafungin prevents the normal development of the fungal cell wall. In the presence of anidulafungin, the fungal cell wall is incomplete or defective, making the cells fragile or unable to grow.

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

Do not use Anidulafungin Normon

• if you are allergic to anidulafungin, other echinocandins (for example, caspofungin acetate), or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Anidulafungin Normon.

Your doctor may decide to monitor:

• your liver function carefully if you develop any liver problems during treatment.
• if you are administered anesthetics during treatment with Anidulafungin Normon.
• for signs of an allergic reaction such as itching, breathing noises (wheezing), or skin rashes.
• for signs of an infusion-related reaction such as rash, hives, itching, or redness.
• for signs of shortness of breath/difficulty breathing, dizziness, or fainting.

Children and adolescents

Anidulafungin Normon must not be given to patients under 1 month of age.

Use of Anidulafungin Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

It is not known whether anidulafungin affects pregnant women. Therefore, the use of Anidulafungin Normon during pregnancy is not recommended. Women of childbearing age should use an effective method of contraception. Contact your doctor immediately if you become pregnant during treatment with Anidulafungin Normon.

It is not known whether anidulafungin affects breastfeeding women. Consult your doctor or pharmacist before taking Anidulafungin Normon if you are breastfeeding.

Consult your doctor or pharmacist before taking any medicine.

Anidulafungin Normon contains fructose

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

If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, this medicine must not be given.

Patients with HFI cannot metabolize the fructose in this medicine, which may lead to serious adverse effects.

Consult your doctor before receiving this medicine if you (or your child) have HFI or cannot consume 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; hence, it is essentially “sodium-free”.

3. How to use Anidulafungin Normon

Anidulafungin will always be prepared and administered to you by a doctor or other healthcare professional (for further information on the preparation method, see the section intended exclusively for doctors or healthcare professionals at the end of the 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 maintenance dose of 1.5 mg/kg (not exceeding 100 mg). The dose administered depends on the patient's body weight.

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

Anidulafungin must be administered once daily by intravenous infusion (drip). In adults, the maintenance dose takes 1.5 hours to administer and the loading dose takes 3 hours. In children and adolescents, the infusion may take less time depending on the patient's body 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 overall 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 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 forget to use 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 must not administer a double dose.

If you stop treatment with Anidulafungin Normon

You should not experience any effects from anidulafungin once your doctor stops your treatment.

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

If the initial symptoms of the infection return, consult your doctor or other healthcare professional immediately.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Some of these adverse effects will be taken into account by your doctor when monitoring your response and condition.

Rarely, life-threatening allergic reactions have been reported during administration of anidulafungin, which may include difficulty breathing with wheezing (a whistling sound when breathing) or worsening of a pre-existing rash.

Serious adverse effects – contact your doctor or another healthcare professional immediately if any of the following adverse effects occur:

• Seizures (fits).
• Redness or flushing.
• Rash, pruritus (itching).
• Hot flushes.
• Urticaria.
• Sudden contraction of the respiratory muscles resulting in gasping or coughing.
• Difficulty breathing.

Very common adverse effects (may affect more than 1 in 10 people):

• Low blood potassium levels (hypokalaemia).
• Diarrhoea.
• Nausea.

Common adverse effects (may affect up to 1 in 10 people):

• Seizures (fits).
• Headache.
• Vomiting.
• Changes in blood test results indicating liver function.
• Rash, pruritus (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 lining the airways causing whistling sounds and coughing.
• Difficulty breathing.

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

• Disorders related to blood coagulation.
• Redness or flushing.
• Hot flushes.
• Stomach pain.
• Urticaria.
• Pain at the injection site.

Frequency not known (cannot be estimated from available data):

• Life-threatening allergic reactions.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Anidulafungin Normon

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.

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

The reconstituted solution may be stored at a temperature of up to 25°C for a period of up to 24 hours. The infusion solution may be stored at 25°C (room temperature) for 48 hours 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.

6. Contents of the container and other information

Composition of Anidulafungin Normon

• The active substance is anidulafungin. Each powder vial 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 container

Anidulafungin 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.

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

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the most recent revision of this leaflet: October 2022

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

You can access detailed information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83990/P_83990.html

This information is intended solely for physicians or healthcare professionals and applies only to the presentation of Anidulafungin Normon 100 mg powder for concentrate for solution for infusion containing a single vial:

The contents of the vial must be reconstituted with water for injections and subsequently diluted ONLY with 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion. Compatibility of the reconstituted anidulafungin solution with other intravenous substances, additives, or medicinal products has not been established, except with 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion.

Reconstitution

Each vial must be reconstituted aseptically with 30 ml of water for injections to achieve a concentration of 3.33 mg/ml. Reconstitution may take up to 5 minutes. After reconstitution, discard the solution if solid particles or discoloration are observed.

The reconstituted solution may be stored at temperatures up to 25°C for up to 24 hours prior to subsequent dilution.

Dilution and infusion

Parenteral medicinal products should be inspected visually for solid particles and discoloration prior to administration, whenever the solution and container permit. If solid particles or discoloration are observed, discard the solution.

Adult patients

The contents of the reconstituted vial(s) should be aseptically transferred into an intravenous infusion bag (or bottle) containing either 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion, to obtain the appropriate concentration. The following table provides dilution instructions to achieve a final infusion solution concentration of 0.77 mg/ml and infusion instructions for each dose.

Dilution requirements for administration of Anidulafungin Normon

A 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 must not exceed 1.1 mg/min (equivalent to 1.4 ml/min or 84 ml/hour once reconstitution and subsequent dilution have been completed according to the instructions described).

Pediatric patients

For pediatric patients aged 1 month to <18 years, the volume of infusion solution required to administer the dose will vary depending on the patient's body weight. The reconstituted solution must be further diluted to a final concentration of 0.77 mg/ml for the infusion solution. A programmable syringe or infusion pump is recommended. The infusion rate must not exceed 1.1 mg/minute (equivalent to 1.4 ml/minute or 84 ml/hour when reconstituted and diluted according to instructions).

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

2. Calculate the volume (ml) of reconstituted anidulafungin required:

• Volume of anidulafungin (ml) = Anidulafungin dose (mg) ÷ 3.33 mg/ml

3. 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

4. Calculate the volume of diluent [9 mg/ml (0.9%) sodium chloride for infusion or 50 mg/ml (5%) glucose for infusion] required to prepare the dosing solution:

• Volume of diluent (ml) = Total volume of dosing solution (ml) – Volume of anidulafungin (ml)

5. Aseptically transfer the required volumes (ml) of reconstituted anidulafungin and 9 mg/ml (0.9%) sodium chloride for infusion or 50 mg/ml (5%) glucose for infusion into an intravenous infusion syringe or infusion bag as required for administration.

For single use only. Any unused medicinal product and materials that have come into contact with it must be disposed of in accordance with local regulations.