100 mg powder for concentrate for solution for infusion 
Anidulafungin

Read all of this leaflet carefully before you or your child 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 or your child experiences side effects, talk to a doctor or 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 ECALTA is and what it is used for 
2. What you need to know before you or your child use ECALTA 
3. How to use ECALTA 
4. Possible side effects 
5. How to store ECALTA 
6. Contents of the packaging and other information 

1. What ECALTA is and what it is used for

ECALTA contains the active substance anidulafungin and is prescribed to adult and pediatric patients aged 1 month to under 18 years 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.

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

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

2. What you need to know before you or your child use ECALTA

Do not use ECALTA

  • 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 a doctor or pharmacist or nurse before using ECALTA.

Your doctor may decide to follow you

  • more carefully regarding your liver function if you have liver problems during treatment
  • if you are given anesthesia while you are being treated with ECALTA
  • 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

ECALTA should not be given to children under 1 month of age.

Other medicines and ECALTA

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

Pregnancy, breastfeeding, and fertility

The effect of ECALTA on pregnant women is unknown. ECALTA 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 ECALTA.

The effect of ECALTA on breast-feeding is unknown. If you are breast-feeding, ask your doctor or pharmacist for advice before taking ECALTA.

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

ECALTA contains fructose

This medicine contains 119 mg fructose (a type of sugar) per vial. If you have been told by your doctor that you have an allergy to certain sugars, contact your doctor before taking this medicine.

If you (or your child) have hereditary fructose intolerance, a rare, inherited disease, you (or your child) should not use this medicine. Patients with hereditary fructose intolerance can not break down the fructose found in the medicine, which can cause serious side effects.

Talk to your doctor before using this medicine if you (or your child) have hereditary fructose intolerance or if your child can no longer eat sweet food or drink without feeling sick, vomiting, or feeling uncomfortable such as bloating stomach cramps, or diarrhea.

ECALTA contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free’.

3. How to use ECALTA

ECALTA will always be completed and given to you or your child 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 drug is completed).

When used in adults, treatment starts with 200 mg on the first day (starting dose). It is followed by a daily dose of 100 mg (maintenance dose ).

When used in children and adolescents (aged 1 month to under 18 years), treatment starts with 3.0 mg/kg (must not exceed 200 mg) on ​​the first day (starting dose). It is followed by a daily dose of 1.5 mg/kg (must not exceed 100 mg) (maintenance dose). The dose given is dependent on the weight of the patient.

You will receive ECALTA once a day, by slow infusion (drip) into a vein. For adults, this takes at least 1.5 hours for the maintenance dose and 3 hours for the starting dose. For children and adolescents, the infusion may be faster depending on the patient’s weight.

Your doctor will decide how long you should be treated and how much ECALTA 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 ECALTA than you should

If you are concerned that you may have received too much ECALTA, talk to your doctor or another healthcare professional right away.

If you forget to use ECALTA

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 ECALTA

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

Your doctor may prescribe another medicine after treatment with ECALTA 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 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 ECALTA.

Serious side effects – Tell your doctor or another healthcare professional 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

Additional side effects are

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

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

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

  • 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) are:

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

No known frequency (frequency can not be calculated from available data) is:

  • Life-threatening allergic reactions

5. How to store ECALTA

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 last day of the specified month is the expiration date.

Store in a refrigerator (2 ºC-8 ºC).

The reconstituted solution can be stored at up to 25 ° C for up to 24 hours. The infusion solution can be stored at 25 ° C (room temperature) for 48 hours (do not freeze) and should be given at 25 ° C (room temperature) within 48 hours.

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 other ingredients are fructose (see section 2 “ECALTA contains fructose”), mannitol, polysorbate 80, tartaric acid, sodium hydroxide (for adjusting the pH value) (see section 2 “ECALTA contains sodium”) and hydrochloric acid (for adjusting the pH value) ).

What the medicine looks like and the contents of the pack

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

The powder is white to off-white.

Marketing Authorisation Holder

Pfizer Limited, Ramsgate Rd, Sandwich, Kent, CT13 9NJ, UK

Manufacturer:

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / Belgien Lithuania
Pfizer SA / NV Tel: +32 (0) 2 554 62 11 Pfizer Luxembourg SARL branches in LithuaniaTel. +3705 2514000
Bulgaria  Luxembourg / Luxemburg
Pfizer Luxembourg SAARЛ, Clone of BulgariaTel: +359 2 970 4333 Pfizer SATel: +32 (0) 2 554 62 11
Czech Republic Hungary
Pfizer sroTel: + 420-283-004-111 Pfizer Kft.Tel. + 36 1 488 37 00
Denmark Malta
Pfizer ApSTel: +45 44 20 11 00 Vivian Corporation Ltd.Tel: +356 21344610
Germany The Netherlands
Pfizer Pharma PFE GmbHTel: +49 (0) 800 8535555 Pfizer bvTel: +31 (0) 10 406 43 01
Eesti Norway
Pfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500 Pfizer ASTel: +47 67 52 61 00
Greece  Austria
Pfizer ΕΛΛΑΣ AE.:Ηλ .: +30 210 6785 800 Pfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0
Spain Poland
Pfizer, SLTel: +34 91 490 99 00 Pfizer Polska Sp. z oo,Tel .: +48 22 335 61 00
France Portugal
Pfizer Tel: +33 (0) 1 58 07 34 40 Pfizer Laboratories, Lda.Tel: + 351 214 235 500
Croatia Romania
Pfizer Croatia dooTel: +385 1 3908 777 Pfizer România SRLTel: +40 (0) 21 207 28 00
Ireland Slovenia
Pfizer Healthcare IrelandTel: 1800 633 363 (toll free)Tel: +44 (0) 1304 616161 Pfizer Luxembourg SARLPfizer, a company in the field of pharmaceuticals, LjubljanaTel: + 386 (0) 1 52 11 400
Iceland Slovak Republic
Icepharma hf., Phone: + 354 540 8000 Pfizer Luxembourg SARL, organizer el: + 421–2–3355 5500
Italy Finland / Finland
Pfizer ΕΛΛΑΣ Α.Ε. (Cyprus Branch):Ηλ: +357 22 817690 Pfizer ABTel: +46 (0) 8 550 52 000
Latvia United Kingdom
Pfizer Luxembourg SARLFiliāle LatvijāTel: +371 670 35 775 Pfizer LimitedTel: +44 (0) 1304 616161

Muhammad Nadeem

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