Ecalta

PACKAGE LEAFLET: INFORMATION FOR THE USER

ECALTA 100 mg powder for concentrate for solution for infusion

Anidulafungin
Please read this leaflet carefully before you or your child are given this medicine
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you or your child experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What ECALTA is and what it is used for
2. What you need to know before you or your child are given ECALTA
3. How to use ECALTA
4. Possible side effects
5. How to store ECALTA
6. Contents of the pack and other information

1. WHAT ECALTA IS AND WHAT IT IS USED FOR

ECALTA contains the active substance anidulafungin and is used in adults and pediatric patients aged 1 month to less than 18 years to treat a type of fungal infection of the blood or other internal organs called invasive candidiasis. The infection is caused by cells of a type of fungus (yeast) 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 fungal cell walls. In the presence of ECALTA, fungal cells have incomplete or defective cell walls, making them fragile or unable to grow.

2. WHAT YOU SHOULD KNOW BEFORE USING OR GIVING ECALTA TO YOUR CHILD

Do not use ECALTA

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using ECALTA.
Your doctor may decide to monitor you

• more closely for liver function if you develop liver problems during treatment
• if you are administered anaesthetics during treatment with ECALTA
• for signs of an allergic reaction such as itching, wheezing, skin patches
• for signs of an infusion-related reaction which may include rash, hives, itching, redness
• for shortness of breath/respiratory difficulty, dizziness or confusion

Children and adolescents
ECALTA must not be administered to patients under 1 month of age.
Other medicines and ECALTA
Inform your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.
Pregnancy and breastfeeding
It is unknown whether ECALTA affects pregnant women. Therefore, the use of ECALTA is not recommended during pregnancy. Women of childbearing age must use an adequate method of contraception. Contact your doctor immediately if you become pregnant during treatment with ECALTA.
It is unknown whether ECALTA passes into breast milk. Ask your doctor or pharmacist for advice before using ECALTA while breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
ECALTA contains fructose
This medicine contains 119 mg of fructose (a type of sugar) in each vial. If your doctor has told you that you have an intolerance to certain sugars, contact him before using this medicine.
If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not take this medicine. Patients with HFI are unable to metabolize the fructose contained in this medicine, which may therefore cause serious adverse effects.
Inform your doctor before taking this medicine if you or your child have HFI or if the child can no longer consume sweet foods or drinks because they cause discomfort, vomiting or unpleasant effects such as bloating, stomach cramps or diarrhoea.
ECALTA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially “sodium-free”.

3. HOW TO USE ECALTA

ECALTA will always be prepared and administered to you or your child by a doctor or healthcare professional (further information on the preparation method of this medicine can be found at the end of this leaflet, in the section dedicated to doctors and healthcare professionals).
For use in adults, treatment starts with 200 mg on the first day (loading dose), followed by a daily maintenance dose of 100 mg.
For use in children and adolescents (aged 1 month to less than 18 years), treatment starts with 3.0 mg/kg (maximum dose 200 mg) on the first day (loading dose), followed by a daily maintenance dose of 1.5 mg/kg (maximum dose 100 mg). The dose administered depends on the patient's body weight.
ECALTA must be administered once daily by slow intravenous infusion (drip).
In adults, the infusion will take at least 1.5 hours for the maintenance dose and 3 hours for the loading dose. In children and adolescents, the infusion time may be shorter depending on the patient's weight.
Your doctor will determine the duration of treatment, the daily amount of ECALTA you will receive, and will monitor your response to treatment and your clinical condition.
In general, treatment should continue for at least 14 days after the last day that Candida was detected in the blood.

If you receive more ECALTA than you should
If you are concerned that you may have received an excessive dose of ECALTA, inform your doctor or another healthcare professional immediately.

If you miss a dose of ECALTA
Since this medicine will be administered under close medical supervision, it is unlikely that a dose will be missed. However, inform your doctor or pharmacist if you think a dose has been missed.
You must not be given a double dose by your doctor.

If you stop treatment with ECALTA
If your doctor stops treatment with ECALTA, no adverse effects are expected.
Your doctor may prescribe another medicine after ECALTA treatment to continue treating the fungal infection or to prevent its recurrence.
If the original symptoms of infection reappear, inform your doctor or another healthcare professional immediately.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone experiences them. Some of these side effects will be monitored by your doctor while assessing your response and overall condition.
Life-threatening allergic reactions have been reported rarely during administration of ECALTA, including breathing difficulties with wheezing or worsening of pre-existing rashes.

Serious side effects – inform your doctor or another healthcare professional immediately if you experience any of the following:

• Seizures (convulsive attacks)
• Flushing
• Skin rash, itching
• Hot flushes
• Hives (urticaria)
• Sudden contraction of the airway muscles that may cause wheezing or coughing
• Difficulty breathing

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

• Low blood potassium levels (hypokalaemia)
• Diarrhoea
• Nausea

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

• Seizures (convulsive attacks)
• Headache
• Vomiting
• Changes in liver function tests
• Skin rash, itching
• Changes in kidney function tests
• Impairment of bile flow from the gallbladder to the intestine (cholestasis)
• High blood sugar levels
• High blood pressure
• Low blood pressure
• Sudden contraction of the airway muscles that may cause wheezing or coughing
• Difficulty breathing

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

• Bleeding disorders
• Flushing
• Hot flushes
• Stomach discomfort
• Hives (urticaria)
• Pain at the injection site

Side effects of unknown frequency (frequency cannot be estimated from the available data):

• Life-threatening allergic reactions

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system detailed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

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 stated on the label. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C-8 °C).
The reconstituted solution can be stored up to 25°C for a maximum of 24 hours. The infusion solution can be stored at 25°C (room temperature) for up to 48 hours (do not freeze) and must be administered at 25°C (room temperature) within 48 hours.
Do not dispose of any medicine via wastewater or household waste.

6. Package contents and other information

What ECALTA contains

• The active substance is anidulafungin. Each vial of powder contains 100 mg of anidulafungin.
• The other components are: fructose (see section 2 “ECALTA contains fructose”), mannitol, polysorbate 80, tartaric acid, sodium hydroxide (for pH adjustment) (see section 2 “ECALTA contains sodium”), hydrochloric acid (for pH adjustment).

Description of the appearance of ECALTA and pack contents
ECALTA is available in a pack containing 1 vial of 100 mg powder for concentrate for solution for infusion.
The powder is white to off-white in colour.
Marketing Authorisation Holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium
Manufacturer
Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium
For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg Pfizer Luxembourg SARL
Pfizer NV/SA filialas Lietuvoje
Tél/Tel: +32 (0)2 554 62 11 Tel. +3705 2514000
България Magyarország
Пфайзер Люксембург САРЛ, Клон България Pfizer Kft.
Тел.: +359 2 970 4333 Tel. + 36 1 488 37 00
Česká republika Malta
Pfizer, spol. s r.o. Vivian Corporation Ltd.
Tel: +420-283-004-111 Tel : +356 21344610
Danmark Nederland
Pfizer ApS Pfizer bv
Tlf: +45 44 20 11 00 Tel: +31 (0)10 406 43 01
Deutschland Norge
PFIZER PHARMA GmbH Pfizer AS
Tel: +49 (0)30 550055-51000 Tlf: +47 67 52 61 00
Eesti Österreich
Pfizer Luxembourg SARL Eesti filiaal Pfizer Corporation Austria Ges.m.b.H.
Tel: +372 666 7500 Tel: +43 (0)1 521 15-0
Ελλάδα Polska
Pfizer ΕΛΛΑΣ A.E. Pfizer Polska Sp. z o.o.,
Tel.: +48 22 335 61 00
Τηλ.: +30 210 6785 800
España Portugal
Pfizer, S.L. Laboratórios Pfizer, Lda.
Tel: +34 91 490 99 00 Tel: + 351 214 235 500
France România
Pfizer Pfizer România S.R.L
Tél: +33 (0)1 58 07 34 40 Tel: +40 (0)21 207 28 00
Hrvatska Slovenija
Pfizer Croatia d.o.o. Pfizer Luxembourg SARL
Tel: + 385 1 3908 777 Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: + 386 (0)152 11 400
Ireland Slovenská republika
Pfizer Healthcare Ireland Pfizer Luxembourg SARL, organizačná zložka
Tel: 1800 633 363 (toll free) Tel: +421-2-3355 5500
Tel: +44 (0)1304 616161
Ísland Suomi/Finland
Icepharma hf., Pfizer Oy
Sími: + 354 540 8000 Puh/Tel: +358(0)9 43 00 40
Italia Sverige
Pfizer S.r.l. Pfizer AB
Tel: +39 06 33 18 21 Tel: +46 (0)8 5505 2000
Kύπρος United Kingdom (Northern Ireland)
Pfizer ΕΛΛΑΣ Α.Ε. (Cyprus Branch) Pfizer Limited
Tel: +44 (0)1304 616161
Τηλ: +357 22 817690
Latvija
Pfizer Luxembourg SARL
Filiāle Latvijā
Tel: +371 670 35 775
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

The following information is intended exclusively for physicians or healthcare professionals and applies only to the ECALTA 100 mg powder for concentrate for solution for infusion pack containing a single vial.
The contents of the vial must be reconstituted with water for injections and subsequently diluted ONLY with sodium chloride 9 mg/ml (0.9%) for infusion or glucose 50 mg/ml (5%) for infusion. Compatibility of reconstituted ECALTA with other intravenous substances, additives or medicinal products other than sodium chloride 9 mg/ml (0.9%) for infusion or glucose 50 mg/ml (5%) for infusion has not been established. The infusion solution must not be frozen.
Reconstitution
Each vial must be reconstituted under aseptic conditions with 30 ml of water for injections to obtain a concentration of 3.33 mg/ml. The reconstitution process may take up to 5 minutes. After subsequent dilution, the solution must be discarded if particulate matter or discoloration is observed.
The reconstituted solution may be stored at up to 25°C for a maximum of 24 hours prior to subsequent dilution.
Dilution and infusion
Whenever the solution and container permit, parenteral medicinal products should be visually inspected prior to administration for the presence of particulate matter and discoloration. If particulate matter or discoloration is observed, the solution must be discarded.
Adult patients
The contents of the reconstituted vial must be transferred under aseptic conditions into an intravenous 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 table below provides the dilution required to obtain a final infusion solution concentration of 0.77 mg/ml and the infusion instructions for each dose.
Dilution requirements for administration of ECALTA

The infusion rate must not exceed 1.1 mg/min (equivalent to 1.4 ml/min or 84 ml/hour when
reconstituted and diluted as instructed).
Paediatric patients
For paediatric patients aged 1 month to < 18 years, the volume of infusion solution required to deliver the dose varies according to the patient's weight. The reconstituted solution must be further diluted to obtain a final infusion solution concentration of 0.77 mg/ml. The use of a programmable syringe or an infusion pump is recommended. The infusion rate must not exceed 1.1 mg/min (equivalent to 1.4 ml/min or 84 ml/hour when reconstituted and diluted as instructed).

1. Calculate the patient's dose and reconstitute the required vial(s) according to the reconstitution instructions to obtain a concentration of 3.33 mg/ml.
2. Calculate the volume (ml) of reconstituted anidulafungin required:
   • Volume of anidulafungin (ml) = Dose of anidulafungin (mg) ÷ 3.33 mg/ml
3. Calculate the total volume of dosing solution (ml) required to achieve a final concentration of 0.77 mg/ml:
   • Total volume of dosing solution (ml) = Dose of anidulafungin (mg) ÷ 0.77 mg/ml
4. Calculate the volume of diluent [5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline)] needed to prepare the dosing solution:
   • Volume of diluent (ml) = Total volume of dosing solution (ml) – Volume of anidulafungin (ml)
5. Aseptically transfer the required volumes (ml) of reconstituted anidulafungin and 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline) into an infusion syringe or intravenous infusion bag as required for administration.

For single use only. Unused medicine and waste material arising from this medicine must be
disposed of in accordance with local regulations.