Anidulafungin accord

Anidulafungin Accord, 100 mg, powder for solution for infusion concentrate
Anidulafunginum
Please read the entire leaflet before administering the medicine to an adult patient or child,
as it contains important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any further questions.
• If any of the side effects worsen in an adult patient or child, or if any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Anidulafungin Accord is and what it is used for.
2. Important information before using Anidulafungin Accord in adult patients or children.
3. How to use Anidulafungin Accord.
4. Possible side effects.
5. How to store Anidulafungin Accord.
6. Contents of the package and other information.

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

Anidulafungin Accord contains the active substance anidulafungin and is prescribed for adults and children and adolescents aged 1 month to 18 years for the treatment of fungal infection of the blood or internal organs, known as invasive candidiasis. This infection is caused by fungal (yeast) cells called Candida.
Anidulafungin Accord belongs to a group of medicines called echinocandins. Medicines in this group are used to treat serious fungal infections.
Anidulafungin Accord inhibits the synthesis of a component of the fungal cell wall. Fungal cells exposed to Anidulafungin Accord have incomplete or damaged cell walls, making them susceptible to damage or unable to grow.

2. Information before using Anidulafungina Accord in adults

or child

When not to use Anidulafungina Accord

• If the patient is allergic to anidulafungin, other echinocandin drugs (e.g. acetylglucosamine caspofungin), or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Anidulafungina Accord, discuss this with your doctor,
pharmacist, or nurse.
Your doctor may decide to monitor:

• liver function more closely if the patient develops liver function abnormalities during treatment,
• whether the patient is receiving anaesthetic drugs during treatment with Anidulafungina Accord,
• whether the patient is experiencing symptoms of an allergic reaction, such as itching, wheezing, skin rash,
• whether the patient is experiencing infusion-related symptoms, which may include rash, urticaria, itching, redness,
• whether the patient is experiencing shortness of breath/difficulty breathing, dizziness, or feeling faint.

Children and adolescents

Anidulafungina Accord must not be used in patients under 1 month of age.

Anidulafungina Accord and other medicines

Tell your doctor or pharmacist about all medicines currently used or recently used
by the adult patient or child.

Pregnancy and breastfeeding

The effect of Anidulafungina Accord in pregnant women is unknown. Therefore, Anidulafungina
Accord must not be used during pregnancy. Women of childbearing age should use effective
contraceptive methods. If pregnancy occurs while taking Anidulafungina
Accord, inform your doctor immediately.
The effect of Anidulafungina Accord in breastfeeding women is unknown. Before starting
treatment with Anidulafungina Accord during breastfeeding, consult your
doctor or pharmacist.
Always consult your doctor or pharmacist before taking any medicine.

Anidulafungina Accord contains fructose

The medicine contains 102.5 mg of fructose (a type of sugar) per vial. If the patient has previously been diagnosed with intolerance to certain sugars, consult your doctor before using this medicine.
If the adult patient (or child) has a rare inherited genetic disorder called hereditary fructose intolerance (HFI), this medicine must not be taken. Patients with HFI are unable to metabolize the fructose contained in this medicine, which may lead to severe adverse effects.
Before taking this medicine, tell your doctor if the adult patient (or child) has HFI or cannot consume sweet foods or drinks due to experiencing nausea, vomiting, or symptoms such as bloating, stomach cramps, or diarrhea.

Anidulafungina Accord contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning the medicine is considered "sodium-free".

3. How to use Anidulafungina Accord

Anidulafungina Accord will always be prepared and administered by a doctor or other medical personnel
(for more information on how to prepare the medicine, see the end of this leaflet, in the section intended exclusively for medical staff).
In children and adolescents (aged 1 month to 18 years), treatment starts with a loading dose of
3.0 mg/kg body weight on the first day (dose not exceeding 200 mg). This is followed by a maintenance dose of
1.5 mg/kg body weight/day (dose not exceeding 100 mg).
The dose administered depends on the patient's body weight.
In adults, treatment starts with a loading dose of 200 mg given on the first day.
This is followed by a daily maintenance dose of 100 mg.
Anidulafungina Accord should be administered once daily by slow intravenous infusion (drip infusion).
In adults, the infusion should last at least 1.5 hours for the maintenance dose and 3 hours for the loading dose.
In children and adolescents, the infusion may be shorter, depending on the patient's body weight.
The doctor will determine the duration of treatment and the daily dose of Anidulafungina Accord, and will monitor the patient's response to treatment and clinical condition.
Generally, treatment should continue for at least 14 days after the last day on which Candida fungi were detected in the patient's blood.

Use of a higher than recommended dose of Anidulafungina Accord
If there is suspicion that the dose of Anidulafungina Accord was too high, inform the doctor or other medical personnel immediately.

Missed dose of Anidulafungina Accord
Since the medicine will be administered under strict medical supervision, it is unlikely that a dose will be missed. However, if there is suspicion that a dose has been missed, inform the doctor or pharmacist.
The doctor should not administer a double dose of the medicine.

Stopping Anidulafungina Accord
If treatment with Anidulafungina Accord is discontinued by the doctor, no symptoms are expected to occur.
After treatment with Anidulafungina Accord, the doctor may prescribe another medicine to continue treatment of the fungal infection or to prevent recurrence of fungal infections.
If the original symptoms return, inform the doctor or medical personnel immediately.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them. Some of these adverse reactions will be monitored by the doctor during assessment of the patient's response to treatment and overall condition.

Life-threatening allergic reactions have been rarely reported during administration of Anidulafungina Accord, such as difficulty breathing with wheezing or worsening of existing rash.

Serious adverse reactions – if any of the following adverse reactions occur, inform your doctor or healthcare professional immediately:

• Seizures (epileptic fits);
• Sudden redness of the skin, especially of the face;
• Rash, itching;
• Hot flushes;
• Urticaria;
• Sudden bronchospasm causing wheezing and cough;
• Difficulty breathing.

Other adverse reactions
Very common adverse reactions (may occur in more than 1 in 10 people):

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

Common adverse reactions (may occur in up to 1 in 10 people):

• Seizures (epileptic fits);
• Headache;
• Vomiting;
• Abnormal liver function test results in blood tests;
• Rash, itching;
• Abnormal kidney function test results in blood tests;
• Impaired bile flow from the gallbladder to the intestines (cholestasis);
• High blood sugar levels;
• High blood pressure;
• Low blood pressure;
• Sudden bronchospasm causing wheezing and cough;
• Difficulty breathing.

Uncommon adverse reactions (may occur in up to 1 in 100 people):

• Blood clotting disorders;
• Sudden redness of the skin, especially of the face;
• Hot flushes;
• Abdominal pain;
• Urticaria;
• Pain at injection site.

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

• Life-threatening allergic reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Anidulafungina Accord

Keep out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the specified month.
Store in a refrigerator (2–8°C).
The reconstituted solution may be stored at a temperature up to 25°C for 24 hours.
From a microbiological standpoint, the solution should be used immediately. If the product is not used immediately, the user is responsible for the storage conditions and duration, which must not exceed 24 hours at 2°C–8°C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.
The diluted infusion solution may be stored at a temperature up to 25°C (room temperature) for 48 hours (do not freeze); the solution should be administered at room temperature (25°C) within 48 hours.
From a microbiological standpoint, the solution should be used immediately. If the product is not used immediately, the user is responsible for the storage conditions and duration, which must not exceed 24 hours at 2°C–8°C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.
Medicines should not be disposed of via wastewater or household waste.

6. Contents of the pack and other information

What Anidulafungina Accord contains

• The active substance is anidulafungin. Each vial contains 100 mg of anidulafungin. The reconstituted solution contains 3.33 mg/ml of anidulafungin, and the diluted solution contains 0.77 mg/ml of anidulafungin.
• The other ingredients are: fructose (see section 2 “Anidulafungina Accord contains fructose”), mannitol, polysorbate 80, (S)-lactic acid, hydrochloric acid concentrated (to adjust pH), sodium hydroxide (to adjust pH) (see section 2 “Anidulafungina Accord contains sodium”).

What Anidulafungina Accord looks like and contents of the pack
Anidulafungina Accord is available in a pack containing 1 vial with 100 mg of powder for preparation of concentrate for infusion solution.
The powder or cake is white or almost white.
The pack contains 1 vial.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw, Poland

Manufacturers
PHARMIDEA SIA
Rūpnīcu iela 4, Olaine, Olaine novads
LV-2114
Latvia
LYOCONTRACT GmbH
Pulverwiese 1
38871 Ilsenburg
Germany
LABORATORIOS ALCALÁ FARMA, S.L.
Avenida de Madrid, 82
Alcalá de Henares, 28802
Madrid, Spain

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

| Country | Product Name | |--------|--------------| | Austria | Anidulafungin Accord 100 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung | | Belgium | Anidulafungine Accord Healthcare 100 mg, poeder voor concentraat voor oplossing voor infusie | | Croatia | Anidulafungin Accord 100 mg prašak za koncentrat za otopinu za infuziju | | Czech Republic | Anidulafungin Accord | | Denmark | Anidulafungin Accord | | Finland | Anidulafungin Accord 100 mg aine konsentraattiliuosta varten infuusionesteeseen | | Greece | Anidulafungin Accord | | Spain | Anidulafungina accord 100 mg polvo para concentrado para solución para perfusión EFG | | Netherlands | Anidulafungine Accord 100 mg poeder voor concentraat voor oplossing voor infusie | | Ireland | Anidulafungin 100 mg powder for concentrate for solution for infusion | | Germany | Anidulafungin Accord 100 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung | | Norway | Anidulafungin Accord | | Poland | Anidulafungina Accord | | Portugal | Anidulafungina Accord | | Romania | Anidulafungină Accord 100 mg pulbere pentru concentrat pentru solutie perfuzabila | | Slovenia | Anidulafungin Accord 100 mg prašek za koncentrat za raztopino za infundiranje | | Sweden | Anidulafungin Accord 100 mg pulver till koncentrat till infusionsvätska, lösning | | United Kingdom | Anidulafungin 100 mg powder for concentrate for solution for infusion | | Italy | Anidulafungina Accord |

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The following information is intended exclusively for medical personnel and applies only to a single vial of the product Anidulafungina Accord, 100 mg, powder for preparation of concentrate for infusion solution:
The content of the vial should be dissolved in water for injections and then diluted EXCLUSIVELY with either 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion. Compatibility of the dissolved Anidulafungina Accord with intravenous medicinal products, excipients or other drugs 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. The infusion solution must not be frozen.

Reconstitution
Under aseptic conditions, dissolve the contents of each vial by adding 30 ml of water for injections to obtain a concentrate with a concentration of 3.33 mg/ml. Dissolution may take up to 5 minutes. The reconstituted solution should be clear and free from visible solid particles. If solid particles or discoloration are observed after dilution, the solution must be discarded.
After reconstitution, the solution may be stored at a temperature not exceeding 25°C for up to 24 hours prior to dilution. From a microbiological standpoint, the solution should be used immediately. If not used immediately, the responsibility for storage conditions and duration lies with the user.

Dilution and infusion
Parenteral medicinal products should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter or discoloration is observed, the solution must be discarded.

Adults
The dissolved solution from the vial should be transferred, under aseptic conditions, 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 achieve the appropriate concentration.

The table below provides the required volumes of diluent for each dose.

Dilution requirements for Anidulafungina Accord prior to administration

The infusion rate should not exceed 1.1 mg/min (corresponding to 1.4 ml/min or 84 ml/hour,
if the product has been reconstituted and diluted according to the instructions).
Children and adolescents
For children and adolescents aged 1 month to <18 years, the volume of infusion solution required to administer the correct dose will vary depending on the patient's body weight. After reconstitution, the solution should be further diluted to a concentration of 0.77 mg/ml to obtain the final infusion solution. A programmable syringe or infusion pump is recommended. The infusion rate should not exceed 1.1 mg/min (corresponding to 1.4 ml/min or 84 ml/hour, if the product has been reconstituted and diluted according to the instructions) (see sections 4.2 and 4.4).

1. Calculate the patient's dose and reconstitute the contents of the vial(s) according to the reconstitution instructions to obtain a concentration of 3.33 mg/ml (see sections 2 and 4.2).
2. Calculate the required volume (ml) of reconstituted anidulafungin:

• Volume of anidulafungin (ml) = anidulafungin dose (mg)/3.33 mg/ml 3. Calculate the total volume of the dosing solution (ml) required to achieve the 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 [5% dextrose injection, USP or 0.9% sodium chloride injection, USP (normal saline)] 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 anidulafungin and 5% dextrose injection, USP or 0.9% sodium chloride injection, USP (normal saline) into a syringe or infusion bag.

For single use only. Waste must be disposed of in accordance with local
requirements.