Patient leaflet - Ecalta 100 mg powder for concentrate for solution for infusion
1. What ECALTA is and what it is used for
ECALTA contains the active substance anidulafungin and is prescribed in adults and in paediatric 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 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 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 need to know before you or your child use ECALTA
Do not use ECALTA
if you are allergic to anidulafungin, other echinocandins
(e.g. caspofungin acetate), or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist or nurse before using ECALTA.
Your doctor may decide to monitor you
for liver function more closely if you develop liver
problems during your treatment.
if you are given anaesthetics during your treatment with
ECALTA
for signs of an allergic reaction such as itching, wheezing,
blotchy skin
for signs of an infusion–related reaction which could
include a rash, hives, itching, redness,
for shortness of breath/breathing difficulties, dizziness or
lightheadedness
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 breast-feeding
The effect of ECALTA in pregnant women is not known. Therefore, ECALTA is not recommended during pregnancy. Effective contraception should be used in women of childbearing age. Contact your doctor immediately if you become pregnant while taking ECALTA.
The effect of ECALTA in breast-feeding women is not known. Ask your doctor or pharmacist for advice before taking ECALTA while breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicines.
ECALTA contains fructose
This medicine contains 119 mg fructose (a type of sugar) in each vial. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this medicine. Patients with HFI cannot break down fructose in this medicine, which may cause serious side effects.
You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.
ECALTA contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
3. How to use ECALTA
ECALTA will always be prepared and given to you or your child by a doctor or a healthcare professional (there is more information about the method of preparation at the end of the leaflet in the section for medical and healthcare professionals only).
For use in children and adolescents (age from 1 month to less than 18 years), the treatment starts with 3.0 mg/kg (not to exceed 200 mg) on the first day (loading dose). This will be followed by a daily dose of 1.5 mg/kg (not to exceed 100 mg) (maintenance dose). The dose that is given depends on the patient’s weight.
For use in adults, the treatment starts with 200 mg on the first day (loading dose). This will be followed by a daily dose of 100 mg (maintenance dose).
ECALTA should be given to you once a day, by slow infusion (a drip) into your 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.
Your doctor will determine the duration of your treatment and how much ECALTA you will receive each day and will monitor your response and condition.
In general, your treatment should continue for at least 14 days after the last day Candida was found in your blood.
If you receive more ECALTA than you should
If you are concerned that you may have been given too much ECALTA, tell your doctor or another healthcare professional immediately.
If you forgot to use ECALTA
As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. However tell your doctor or pharmacist if you think that a dose has been forgotten.
You should not be given a double dose by doctor.
If you stop using ECALTA
You should not experience any effects from ECALTA if your doctor stops ECALTA treatment.
Your doctor may prescribe another medicine following your treatment with ECALTA to continue treating your fungal infection or prevent it from returning.
If your original symptoms come back, tell your doctor or another healthcare professional immediately.
If you have any further questions on the use of this medicine, 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 will be noted by your doctor while monitoring your response and condition.
Life-threatening allergic reactions that might include difficulty breathing with wheezing or worsening of an existing rash have been rarely reported during administration of ECALTA.
Serious side effects – tell your doctor or another healthcare professional immediately should any of the following occur:
- Convulsion (seizure)
- Flushing
- Rash, pruritis (itching)
- Hot flush
- Hives
Sudden contraction of the muscles around the airways
resulting in wheezing or coughing
- Difficulty of breathing
Other side effects
Very common side effects (may affect more than 1 in 10 people) are:
- Low blood potassium (hypokalaemia)
- Diarrhoea
- Nausea
Common side effects (may affect up to 1 in 10 people) are:
- Convulsion (seizure)
- Headache
- Vomiting
- Changes in blood tests of liver function
- Rash, pruritis (itching)
- Changes in blood tests of kidney function
Abnormal flow of bile from the gallbladder into the
intestine (cholestasis)
- High blood sugar
- High blood pressure
- Low blood pressure
Sudden contraction of the muscles around the airways
resulting in wheezing or coughing
- Difficulty of breathing
Uncommon side effects (may affect up to 1 in 100 people) are:
- Disorder of blood clotting system
- Flushing
- Hot flush
- Stomach pain
- Hives
- Pain at injection site
Not known (frequency cannot be estimated from the available data) are:
- Life-threatening allergic reactions
Reporting of side effects
If you get any side effects, talk to your doctor or, pharmacist or nurse.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App
Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 (2oC – 8oC).
The reconstituted solution may be stored up to 25oC for up to 24 hours. The infusion solution may be stored at 25oC (room temperature) for 48 hours, (do not freeze) and should be administered at 25oC (room temperature) within 48 hours.
Do not throw away any medicines via 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 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).
What ECALTA looks like and contents of the pack
ECALTA is supplied as 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 Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Manufacturer
Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium
For any information about this medicine, please contact: Medical Information, Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS.
Telephone 01304 616161.
This leaflet was last revised in 03/2021
-----------------------------------------------------------------------The following information is intended for medical or healthcare professionals only and applies only to the single vial ECALTA 100 mg powder for concentrate for solution for infusion presentation:
The contents of the vial must be reconstituted with water for injections and subsequently diluted with ONLY 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion. The compatibility of reconstituted ECALTA with intravenous substances, additives, or medicines other than 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion has not been established. The infusion solution must not be frozen.
Reconstitution
Aseptically reconstitute each vial with 30 mL water for injections to provide a concentration of 3.33 mg/mL. The reconstitution time can be up to 5 minutes. After subsequent dilution, the solution is to be discarded if particulate matter or discolouration is identified.
The reconstituted solution may be stored up to 25oC for up to 24 hours prior to further dilution.
Dilution and infusion
Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. If either particulate matter or discolouration is identified, discard the solution.
Adult Patients
Aseptically transfer the contents of the reconstituted vial(s) into an intravenous bag (or bottle) containing either 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion to obtain the appropriate anidulafungin concentration. The table below provides the dilution to a concentration of 0.77 mg/mL for the final infusion solution and infusion instructions for each dose.
Package leaflet: Information for the user
ECALTA®
100 mg powder for concentrate for solution for infusion
Anidulafungin
| Dilution requirements for ECALTA administration | |||||||
| Dose | Number of vials of powder | Total reconstituted volume | Infu volu | sion me A | Total infusion volumeB | Rate of infusion | Minimum duration of infusion |
| 100 mg | 1 | 30 mL | 10 | 0 mL | 130 mL | 1.4 mL/min or 84 mL/ hour | 90 min |
| 200 mg | 2 | 60 mL | 20 | 0 mL | 260 mL | 1.4 mL/min or 84 mL/ hour | 180 min |
| A Either 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg | |||||||
/mL (5%)
B Infusion solution concentration is 0.77 mg/mL The rate of infusion should not exceed 1.1 mg/min (equivalent | glucose for infusion. | |||||
to 1.4 ml
84 mL/ hour when reconstituted and diluted per instructions). Paediatric Patients For paediatric patients aged 1 month to < 18 years, the volum | /min or | |||||
e of infus
| on the weight of the patient. The reconstituted solution must | ion solution required to deliver the dose will vary depending | |||||
be further
| infusion solution. A programmable syringe or infusion pump i | diluted to a concentration of 0.77 mg/mL for the final | |||||
s recomm
| 1.1 mg/minute (equivalent to 1.4 mL/minute or 84 m | ended. The rate of infusion should not exceed | |||||
L/hour w
| hen reconstituted and diluted per instructions). | |||||
accordin
3.33 mg/mL
| g to reconstitution instructions to provide a concentration of | |||||
in require
| d: | |||||
ngin (mg)
| ÷ 3.33 mg/mL | |||||
red to pro
| vide a final concentration of 0.77 mg/mL: | |||||
idulafungi
| n (mg) ÷ 0.77 mg/mL | |||||
USP or 0
to prepare the dosing solution:
| .9% Sodium Chloride Injection, USP (normal saline)] required | |||||
olution (m
| L) – Volume of anidulafungin (mL) | |||||
afungin a
| Injection, USP (normal saline) into an infusion syringe o | nd 5% Dextrose Injection, USP or 0.9% Sodium Chloride | |||||
r IV infusi
| For single use only. Waste materials should be disposed of in | on bag needed for administration. | |||||
accordan
| Ref: ECW 20_0 | ce with local requirements. | |||||
PAA135150
342