100 mg powder for concentrate for infusion solution 
anidulafungin

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this leaflet, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist, or nurse.

– If you get any side effects, talk to your doctor or pharmacist, or nurse

-This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Anidulafungin Accord is and what it is used for 
2. What you need to know before you use Anidulafungin Accord 
3. How to take Anidulafungin Accord 
4. Possible side effects 
5. How to store Anidulafungin Accord 
6. Contents of the packaging and other information 

What Anidulafungin Accord is and what it is used for

Anidulafungin Accord contains the active substance anidulafungin and is prescribed to adults for the treatment of a type of fungal infection in the blood or other internal organs called invasive candidiasis. Infection is caused by fungal cells (yeasts) called Candida.

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

Anidulafungin Accord prevents normal development of the fungal cell wall. Fungal cells that have been exposed to the Anidulafungin Accord have incomplete or defective cell walls that make them fragile or unable to grow.

Anidulafungin contained in Anidulafungin Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Anidulafungin Accord

Do not use Anidulafungin Accord

  • if you are allergic to anidulafungin, other echinocandins (eg Cancidas), or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist or nurse before using Anidulafungin Accord.

Your doctor may decide to follow up

  • you more carefully regarding your liver function if you have problems with the liver during treatment
  • if you are anesthetized while being treated with Anidulafungin Accord.

Children

Anidulafungin Accord should not be given to children under 18 years of age.

Other medicines and Anidulafungin Accord

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

Do not start or stop taking any of your other medicines without first talking to your doctor or pharmacist.

Pregnancy and breastfeeding

The effect of the Anidulafungin Accord on pregnant women is unknown. Anidulafungin Accord is therefore not recommended during pregnancy. Women of childbearing potential should use effective contraception. Contact your doctor immediately if you become pregnant while being treated with Anidulafungin Accord.

The effect of Anidulafungin Accord during breastfeeding is unknown. If you are breast-feeding, ask your doctor or pharmacist for advice before taking Anidulafungin Accord.

Ask your doctor or pharmacist for advice before taking any medicine.

Anidulafungin Accord contains fructose

This medicine contains fructose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Anidulafungin Accord

Anidulafungin Accord will always be completed and given by a doctor or other healthcare professional (at the end of this leaflet in the section for healthcare professionals only you can read more about how the medicine is prepared).

Treatment starts with 200 mg on the first day (starting dose). It is followed by a daily dose of 100 mg (maintenance dose ).

You will receive the Anidulafungin Accord once a day, by slow infusion (drip) into a vein. This takes at least 1.5 hours for the maintenance dose and 3 hours for the starting dose.

Your doctor will decide how long you should be treated and how much Anidulafungin Accord you should receive each day and will check how you react to the treatment and how you feel.

In general, you will be treated for at least 14 days after the last day when Candida is found in your blood.

If you take more Anidulafungin Accord than you should

If you are concerned that you may have received too much Anidulafungin Accord, talk to your doctor or another healthcare professional immediately.

If you forget to use Anidulafungin Accord

As you will be closely monitored when you are treated with this medicine, it is unlikely that a dose can be missed. However, talk to your doctor or pharmacist if you think a dose may have been missed.

You should not be given a double dose by your doctor.

If you stop using Anidulafungin Accord

There should be no effects of Anidulafungin Accord after your doctor has stopped taking Anidulafungin Accord.

Your doctor may prescribe another medicine after treatment with Anidulafungin Accord to continue the treatment of your fungal infection or to prevent the recurrence of the fungal infection.

If your previous symptoms return, talk to your doctor or another healthcare professional immediately.

If you have any further questions on the use of this product, ask your doctor or 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 may be noticed by your doctor when checking your response to treatment and your medical condition.

Life-threatening allergic reactions that may include difficulty breathing with wheezing or worsening of an existing rash have been reported in rare cases during treatment with Anidulafungin Accord.

Serious side effects – Tell your doctor or other healthcare professionals immediately if any of the following occur:

  • Seizures
  • Pastures
  • Rash, itching
  • Hot flashes
  • Hives
  • Sudden contraction of the muscles around the airways that causes wheezing and coughing
  • Breathing difficulties

Other side effects are

Very common side effects (may affect more than 1 user in 10):

  • Low potassium levels in the blood ( hypokalaemia )
  • Diarrhea
  • Nausea

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

  • Seizures
  • Headache
  • Vomiting
  • Changed values ​​in liver function tests
  • Rash, itching
  • Changed values ​​in kidney function tests
  • Abnormal bile flow from the gallbladder to the intestine (bile stasis)
  • High blood sugar value
  • High blood pressure
  • Low blood pressure
  • Sudden contraction of the muscles around the airways that causes wheezing and coughing
  • Breathing difficulties

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

  • Disorders of the blood’s ability to coagulate
  • Hemorrhoids
  • Hot flashes
  • Magont
  • Hives
  • Injection site pain

Has been reported (occurs in an unknown number of users):

  • 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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Anidulafungin Accord

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 label and carton. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.

The reconstituted solution can be stored at up to 25 ° C for up to 24 hours. From a microbiological point of view, the medicine should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

The infusion solution can be stored at 25 ° C (room temperature) for 48 hours or stored frozen for 72 hours and should be given at 25 ° C (room temperature) within 48 hours.

From a microbiological point of view, the medicine should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ° C, unless reconstitution/dilution has taken place under controlled and validated aseptic conditions.

Medicines should not be disposed of via wastewater or household waste.

6. Contents of the packaging and other information

Content declaration

  • The active substance is anidulafungin. Each vial of powder contains 100 mg of anidulafungin. The reconstituted solution contains 3.33 mg/ml anidulafungin, and the diluted solution contains 0.77 mg/ml anidulafungin.
  • The other ingredients are fructose, mannitol, polysorbate 80, lactic acid, sodium hydroxide (for pH adjustment), and hydrochloric acid (for pH adjustment).

What the medicine looks like and the contents of the pack

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

The cake or powder is white to off-white.

Pack size: 1 vial

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 kV Utrecht

Netherlands

Manufacturer

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex, HA1 4HF,

UK

PharmIdea SIA

Rupnicu Str. 4

2114 Olaine

Latvia

Lyocontract GmbH,

Powder meadow 1,

Ilsenburg, Germany

Germany

Muhammad Nadeem

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