Package Insert: Information for the User
Anidulafungina Accord 100 mg Powder for Concentrate for Solution for Infusion EFG
Read this package insert carefully before you or your child start using this medicine, because it contains important information for you.
Contents of the package and additional information.
Anidulafungina Accord contains the active ingredient anidulafungina and is prescribed for adult and pediatric patients from 1 month to less than 18 years old to 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.
No use Anidulafungina Accord
Warnings and Precautions
Consult your doctor, pharmacist, or nurse before starting to use Anidulafungina Accord.
Your doctor may decide to monitor:
Children and Adolescents
Anidulafungina Accord should not be administered to patients under 1 month.
Other Medications and Anidulafungina Accord
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 Lactation
The effect of Anidulafungina Accord on pregnant women is unknown. Therefore, the use of Anidulafungina Accord 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 Anidulafungina Accord on women during lactation is unknown. Consult your doctor or pharmacist before taking Anidulafungina Accord while breastfeeding.
Consult your doctor or pharmacist before taking any medication.
Anidulafungina Accord contains fructose
This medication contains 102.5 mg of fructose (a type of sugar) in each vial. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before using this medication.
If you (or your child) suffer from hereditary fructose intolerance (IHF), a rare genetic disease,
you should not receive this medication. Patients with IHF cannot break down the fructose in this
medication, which can cause severe adverse effects.
Consult with your doctor before receiving this medication if you (or your child) suffer from IHF or cannot take sweet foods or drinks because they cause dizziness, vomiting, or unpleasant effects
such as bloating, stomach cramps, or diarrhea.
Anidulafungina Accord contains sodium
This medication contains less than 23 mg of sodium (1 mmol) per vial; that is, it is essentially “sodium-free”.
Anidulafungin Accord 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).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 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.
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).
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 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 Anidulafungin Accord than you shouldIf you think you have been given too much Anidulafungin Accord, consult your doctor or other healthcare professional immediately.
If you forgot to use Anidulafungin Accord
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 Anidulafungin Accord
You should not notice any effects from this medication when your doctor suspends your treatment with Anidulafungin Accord.
Your doctor may prescribe another medication after treatment with Anidulafungin Accord 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, Anidulafungina Accord 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 Anidulafungina Accord, 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:
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Unknown frequency (cannot be estimated from available data):
Reporting of 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 Medicines 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 after CAD. 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 25 °C for up to 24 hours. From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and usage conditions before use are the responsibility of the user.
The infusion solution can be stored at 25 °C (room temperature) for 48 hours (do not freeze) and should be administered at 25 °C (room temperature) within 48 hours.
From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and usage conditions before use are the responsibility of the user and usually will not last more than 24 hours between 2 and 8 °C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Medicines should not be disposed of through drains or trash.
Composition of Anidulafungin Accord
Appearance of the product and contents of the package
Anidulafungin Accord 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.
Package size: 1 vial
Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center
Moll de Barcelona, s/n.
Edifici Est 6th floor 08039 - Barcelona
Spain
Manufacturer
PharmIdea SIA
4 Rupnicu Str.
2114 Olaine
Latvia
O
Lyocontract GmbH
Pulverwiese 1
38871 Ilsenburg
Germany
O
LABORATORIOS ALCALÁ FARMA, S.L.
Address: Avenida de Madrid, 82,
Alcalá de Henares, 28802
Madrid, Spain
This medicine is authorized in the member states of the European Economic Area with the following names:
Member State | Medicine Name |
Austria | Anidulafungin Accord 100 mgPulver für ein Konzentrat zur Herstellung einer Infusionslösung |
Belgium | AnidulafungineAccord Healthcare 100 mg, poeder voor concentraat voor oplossing voor infusie |
Czech Republic | Anidulafungin Accord |
Croatia | Anidulafungin Accord 100 mg prašak za koncentrat za otopinu za infuziju |
Denmark | Anidulafungin Accord |
Germany | Anidulafungin Accord 100 mgPulver für ein Konzentrat zur Herstellung einer Infusionslösung |
Greece | Anidulafungin/Accord |
Finland | Anidulafungin Accord 100 mg aine konsentraattiliuosta varten infuusionesteen |
Ireland | Anidulafungin 100 mg powder for concentrate for solution for infusion |
Italy | Anidulafungina Accord |
Norway | Anidulafungin Accord |
Netherlands | Anidulafungine Accord 100 mg poeder voor concentraat voor oplossing voor infusie |
Portugal | Anidulafungina Accord |
Poland | Anidulafungina Accord |
Romania | Anidulafungina 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 |
Last review date of this leaflet:May 2022
The detailed and updated information on 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 presentation of Anidulafungin Accord 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 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 Accord with intravenous substances, additives, or other medicines, except for sodium chloride 9 mg/ml (0.9%) for infusion or glucose 50 mg/ml (5%) for infusion, has not been established.
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 reconstituted solution can be stored for up to 25°C for up to 24 hours before additional dilution. From a microbiological point of view, the product must be used immediately. If not used immediately, the times and conditions of storage in use before use are the responsibility of the user.
Dilution and infusion
Parenteral medicines must be visually inspected to detect 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 reconstituted vial(s) must be transferred aseptically to an intravenous administration bag (or bottle) containing sodium chloride 9 mg/ml (0.9%) for infusion or glucose 50 mg/ml (5%) for infusion to achieve the appropriate anidulafungin concentration. The following table provides the dilution requirements to achieve a final infusion solution concentration of 0.77 mg/ml and the infusion instructions for each dose.
Requirements for dilution for the administration of Anidulafungin Accord
Dose | Number of vials of powder Reconstituted volume | Infusion volume | Total infusion volume | Infusion rate | Minimum infusion duration | |
100 mg | 1 | 30 ml | 100 ml | 130 ml | 1.4 ml/min or 84 ml/hour | 90 min |
200 mg | 2 | 60 ml | 200 ml | 260 ml | 1.4 ml/min or 84 ml/hour | 180 min |
A9 mg/ml (0.9%) sodium chloride for infusion or 50 mg/ml (5%) glucose for infusion.
BThe concentration of the final 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 reconstituted and diluted according to the described instructions).
Pediatric patients
For pediatric patients from 1 month to <18> 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 the instructions).
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.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.