ECALTA 100 mg Powder And Solvent For Intravenous Infusion Solution

Зміст інструкції

1. ECALTA 100 mg powder for concentrate for solution for infusion
   1. WHAT ECALTA IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING OR GIVING ECALTA TO YOUR CHILD
   3. HOW TO USE ECALTA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ECALTA
   6. Contents of the pack and other information

ECALTA 100 mg powder for concentrate for solution for infusion

Anidulafungin

Read this leaflet carefully before you or your child use 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, ask 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 use or give ECALTA to your child
• 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 in paediatric patients
aged from 1 month to less than 18 years to treat a type of fungal infection of the blood or of
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 and this makes them fragile or unable to
grow.

2. WHAT YOU NEED TO 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 ingredients 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

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

Children and adolescents
ECALTA should not be given to patients 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 and breastfeeding
The effect of ECALTA on pregnant women is unknown. Therefore, the use of ECALTA is not
recommended during pregnancy. Women of childbearing potential should use adequate
contraception. Contact your doctor immediately if you become pregnant during
treatment with ECALTA.
The effect of ECALTA on breastfeeding women is unknown. Ask your doctor or
pharmacist for advice before using ECALTA during 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 some sugars, contact them before using this medicine.
If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic
disorder, you cannot take this medicine. Patients with HFI are unable to
metabolise the fructose contained in this medicine, which may therefore cause serious
side effects.
Tell your doctor before taking this medicine if you or your child have HFI or if
the child can no longer take 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 a healthcare professional (you will find further information on how this medicine is prepared in the section ‘How to prepare ECALTA’).
For use in adults, treatment starts with 200 mg on the first day (loading dose). This will be followed by a daily dose of 100 mg (maintenance dose).
For use in children and adolescents (aged 1 month and over and less than 18 years), treatment starts with 3.0 mg/kg (maximum dose 200 mg) on the first day (loading dose). This will be followed by a daily dose of 1.5 mg/kg (maximum dose 100 mg) (maintenance dose). The dose administered depends on the patient's weight.
ECALTA must be given to you once daily, via slow infusion (drip) into a vein.
For adults, this will take at least 1.5 hours for the maintenance dose and 3 hours for the loading dose. For children and adolescents, the infusion may take less time depending on the patient's weight.
The doctor will decide how long the treatment will last and the amount of ECALTA you will receive each day and will monitor your response to treatment and your condition.
In general, treatment should continue for at least 14 days from the last day that Candidawas found in the blood.

If you receive more ECALTA than you should
If you are worried that you may have been given a dose of ECALTA higher than you should have, inform your doctor or another healthcare professional immediately.

If you forget to use ECALTA
Because this medicine will be given to you under close medical supervision, it is unlikely that a dose will be forgotten. However, tell your doctor or pharmacist if you think a dose has been forgotten.
Your doctor should not give you a double dose.

If you stop using ECALTA
If your doctor stops treatment with ECALTA, no effects are expected.
Your doctor may prescribe another medicine following treatment with ECALTA to continue treatment of the fungal infection or to prevent it from coming back.
If the original symptoms of the infection return, inform your doctor or another healthcare professional immediately.
If you have any questions about using this medicine, 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 will be observed by the doctor while they check your response and your
condition.
During the administration of ECALTA, life-threatening allergic reactions have been rarely reported,
including difficulty breathing with wheezing or worsening of pre-existing rash.

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

• Convulsions (seizures)
• Flushing
• Skin rash, itching
• Hot flushes
• Hives
• Sudden contraction of the airway muscles which can cause wheezing or coughing
• Difficulty breathing

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

• Low levels of potassium in the blood (hypokalaemia)
• Diarrhoea
• Nausea

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

• Convulsions (seizures)
• 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 which can cause wheezing or coughing
• Difficulty breathing

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

• Blood clotting disorders
• Flushing
• Hot flushes
• Stomach pain
• Hives
• Pain at the injection site

Side effects of unknown frequency (frequency cannot be estimated based on available
data) are:

• Life-threatening allergic reactions

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or
nurse. You can also report side effects directly through the national reporting system listed in
Appendix 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 which is 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 may be stored at up to 25°C for a maximum of 24 hours. The solution
for infusion may 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 in wastewater or household waste.

6. Contents of the pack and other information

What ECALTA contains

• 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 pH adjustment) (see section 2 “ECALTA contains sodium”), hydrochloric acid (for pH adjustment).

Description of the appearance of ECALTA and contents of the pack
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 on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL
filialas Lietuvoje
Tel. +3705 2514000

България
Пфайзер Люксембург САРЛ, Клон България
Тел.: +359 2 970 4333

Magyarország
Pfizer Kft.
Tel. + 36 1 488 37 00

Česká republika
Pfizer, spol. s r.o.
Tel: +420-283-004-111

Malta
Vivian Corporation Ltd.
Tel : +356 21344610

Danmark
Pfizer ApS
Tlf: +45 44 20 11 00

Nederland
Pfizer bv
Tel: +31 (0)10 406 43 01

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
Pfizer ΕΛΛΑΣ A.E.
Τηλ.: +30 210 6785 800

Polska
Pfizer Polska Sp. z o.o.,
Tel.: +48 22 335 61 00

España
Pfizer, S.L.
Tel: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: + 351 214 235 500

France
Pfizer
Tél: +33 (0)1 58 07 34 40

România
Pfizer România S.R.L
Tel: +40 (0)21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: + 385 1 3908 777

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: + 386 (0)152 11 400

Ireland
Pfizer Healthcare Ireland
Tel: 1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421-2-3355 5500

Ísland
Icepharma hf.,
Sími: + 354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358(0)9 43 00 40

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 5505 2000

Kύπρος
Pfizer ΕΛΛΑΣ A.E. (Cyprus Branch)
Τηλ: +357 22 817690

United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0)1304 616161

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/
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The following information is intended exclusively for physicians or healthcare professionals and relates
only to the pack of ECALTA 100 mg powder for concentrate for solution for infusion 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 %) or glucose 50 mg/ml (5 %) solution for
infusion. Compatibility of reconstituted ECALTA with substances
for intravenous use, additives or medicines other than sodium chloride 9 mg/ml (0.9 %) or
glucose 50 mg/ml (5 %) solution for infusion has not been established. The infusion solution must not be frozen.

Reconstitution
Each vial must be reconstituted in aseptic conditions with 30 ml of water for injections to obtain a
concentration of 3.33 mg/ml. The reconstitution time may take up to 5 minutes. After subsequent
dilution, the solution must be discarded if the presence of particles or colour change is identified.
The reconstituted solution may be stored at up to 25°C for a maximum of 24 hours before
subsequent dilution.

Dilution and infusion

Whenever the solution and container permit, parenteral medicines
must be visually inspected before administration to detect the presence
of particles and colour changes. If the presence of particles or
a colour change is identified, the solution must be discarded.
Adult patients
The contents of the reconstituted vial must be transferred in aseptic conditions into a bag (or
bottle) for intravenous use containing sodium chloride 9 mg/ml (0.9 %) or glucose 50 mg/ml (5 %) to
obtain the appropriate anidulafungin concentration. The table
below provides the dilution to obtain a concentration of 0.77 mg/ml for the final infusion solution and the
infusion instructions for each dose.
Dilution requirements for the 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 from 1 month to < 18 years, the volume of infusion solution
required to deliver the dose varies depending on the patient's weight. The reconstituted solution must be
further diluted to obtain a concentration of 0.77 mg/ml for the final infusion solution.
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 necessary 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) = Anidulafungin dose (mg) - 3.33 mg/ml
• 3. Calculate the total volume of dosing solution (ml) required to obtain a final concentration of 0.77 mg/ml:
• Total volume of dosing solution (ml) = Anidulafungin dose (mg) - 0.77 mg/ml
• 4. Calculate the volume of diluent [5% dextrose injection, USP or 0.9% sodium chloride injection, USP (normal saline)] required to prepare the dosing solution:
• Diluent volume (ml) = Total volume of dosing solution (ml) - Volume of anidulafungin (ml)
• 5. Aseptically transfer the required volumes (ml) of anidulafungin and 5% dextrose injection, USP or 0.9% sodium chloride injection, USP (normal saline) into an infusion syringe or intravenous infusion bag for administration.

For single use only. Unused medicine and waste materials derived from such medicine must be
disposed of in accordance with local regulations.