100 mg powder for concentrate for infusion solution 
anidulafungin

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

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

What Anidulafungin STADA is and what it is used for

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

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

Anidulafungin contained in Anidulafungin Stada 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 you use Anidulafungin STADA

Do not use Anidulafungin STADA

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

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Anidulafungin Stada.

Your doctor may decide to monitor you

  • more carefully regarding your liver function if you have liver problems during treatment
  • if you are given anesthesia while being treated with Anidulafungin Stada
  • for signs of an allergic reaction, such as itching, wheezing, spotty skin
  • for signs of an infusion-related reaction that may include rash, hives, itching, redness
  • regarding shortness of breath/difficulty breathing, dizziness, or feeling unsteady.

Children and young people

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

Other medicines and Anidulafungin STADA

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

Pregnancy, breastfeeding, and fertility

The effect of Anidulafungin Stada on pregnant women is unknown. Anidulafungin Stada 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 Stada.

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

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

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Anidulafungin STADA

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

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 Anidulafungin Stada 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 Stada 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 forget to use Anidulafungin STADA

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 STADA

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

Your doctor may prescribe another medicine after treatment with Anidulafungin Stada 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, 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 Stada.

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

  • seizures
  • herds
  • rash, itching
  • hot flashes
  • hives
  • sudden contraction of the muscles around the airways that causes wheezing or coughing
  • breathing difficulties.

Additional side effects are

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

  • low potassium levels in the blood ( hypokalaemia )
  • diarrhea
  • nausea.

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

  • seizures
  • headache
  • vomiting
  • altered values ​​in liver function tests
  • rash, itching
  • altered values ​​in renal function tests
  • abnormal bile flow from the gallbladder to the intestine (bile stasis)
  • high blood sugar level
  • high blood pressure
  • low blood pressure
  • sudden contraction of the muscles around the airways that causes wheezing and coughing
  • breathing difficulties.

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

  • disorders of the blood’s ability to coagulate
  • hot flashes
  • hot flashes
  • magont
  • hives
  • injection site pain.

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

  • 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 STADA

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. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C – 8 ° C).

The reconstituted solution can be stored at up to 25 o C for up to 24 hours. The infusion solution can be stored at 25 o C (room temperature) for 48 hours. Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is anidulafungin. Each vial contains 100 mg of anidulafungin.

The other ingredients are sucrose, polysorbate 80 (E433), tartaric acid, sodium hydroxide (E524) (for adjusting the pH value), hydrochloric acid (E507) (for adjusting the pH value).

What the medicine looks like and the contents of the pack

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

White to off-white powder, free from visible signs of contamination.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

Actavis Italy SpA

Viale Pasteur 10, Nerviano

Milano 20014

Italy

SC SINDEN-PHARMA SRL

11th Ion Mihalache Boulevard

Bucharest 011171, Romania

Stada Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

Centrafarm Services BV

New Donk 9

4870 AC Etten-Leur

Netherlands

Local representative

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Muhammad Nadeem

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