100 mg powder for concentrate for infusion solution
anidulafungin
1. What Anidulafungin Teva is and what it is used for
Anidulafungin Teva 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 Teva belongs to a group of medicines called echinocandins. These medicines are used to treat serious fungal infections
Anidulafungin Teva prevents the normal development of the fungal cell wall. Fungal cells that have been exposed to Anidulafungin Teva have incomplete or defective cell walls that make them fragile or unable to grow.
Anidulafungin contained in Anidulafungin Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Anidulafungin Teva
Do not use Anidulafungin Teva
- if you are allergic to anidulafungin, other echinocandins (eg caspofungin acetate), 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 taking Anidulafungin Teva.
Your doctor may decide to follow you
- more carefully regarding your liver function if you have liver problems during treatment.
- if you get anesthesia while you are being treated with Anidulafungin Teva for signs of an allergic reaction, such as itching, wheezing, flammable skin
- for signs of an infusion-related reaction, which may include rash, hives, itching, redness
- regarding shortness of breath/difficulty breathing, dizziness or feeling unsteady.
Children and young people
The anidulafungin Teva should not be given to children under 18 years of age.
Other medicines and Anidulafungin Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
The effect of Anidulafungin Teva on pregnant women is unknown. Anidulafungin Teva 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 Teva.
The effect of Anidulafungin Teva during breastfeeding is unknown. If you are breast-feeding, ask your doctor or pharmacist for advice before taking Anidulafungin Teva.
Ask your doctor or pharmacist for advice before taking any medicine.
Anidulafungin Teva contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free’.
3. How to use Anidulafungin Teva
Anidulafungin Teva 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 Anidulafungin Teva 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 Teva 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 use more Anidulafungin Teva than you should
If you are concerned that you may have received too much Anidulafungin Teva, talk to your doctor or another healthcare professional immediately.
If you forget to use Anidulafungin Teva
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 Teva
There should be no effects of Anidulafungin Teva after your doctor has stopped taking Anidulafungin Teva.
Your doctor may prescribe another medicine after treatment with Anidulafungin Teva 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 Teva.
Serious side effects – Tell your doctor or another healthcare professional 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):
- low potassium levels in the blood ( hypokalaemia )
- diarrhea
- nausea.
Common (may affect up to 1 in 10 people):
- 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 or coughing
- breathing difficulties
Uncommon (may affect up to 1 in 100 people):
- disorders of the blood’s ability to coagulate
- hot flashes
- hot flashes
- magnet
- 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 Teva
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 ºC for up to 24 hours.
The infusion solution can be stored at 25 ºC (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 of powder contains 100 mg of anidulafungin.
- The other ingredients are sucrose, polysorbate 80 (E 433), tartaric acid, sodium hydroxide (E524) (for adjusting the pH value), hydrochloric acid (E 507) (for adjusting the pH value)
What the medicine looks like and the contents of the pack
Anidulafungin Teva is supplied as a powder for concentrate for solution for infusions a carton of 1 vial.
The powder is white to off-white, free from visible signs of contamination.
Marketing Authorization Holder and Manufacturer
Manufacturer
Actavis Italy SpA
Viale Pasteur 10, Nerviano
Milan 20014, Italy
SC SINDEN-PHARMA SRL
11th Ion Mihalache Boulevard
Bucharest 011171, Romania
Teva Operations Poland Sp. zoo
ul. Mogilska 80,
Kraków 31-546, Poland
Teva Pharma BV
Swensweg 5
2031 GA Haarlem, The Netherlands
PLIVA Hrvatska doo (PLIVA Croatia Ltd.)
Prilaz baruna Filipovića 25
Zagreb, 10000, Croatia