What Ecalta is and what it is used for
Ecalta is prescribed to treat a type of fungal infection of the blood called candidaemia. 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 anidulafungin, fungal cells have incomplete or defective cell walls, making them fragile or unable to grow.
What you should know before you are treated with Ecalta
You should not be treated with Ecalta
- if you are allergic (hypersensitive) to anidulafungin, other echinocandins (e.g. CANCIDAS), or any of the other ingredients of Ecalta
Take special care with Ecalta
- if you develop liver problems during your treatment. If this happens, your doctor may decide to monitor your liver function more closely.
- if you are given anaesthetics during your treatment with Ecalta.
Children
Ecalta should not be given to patients under 18 years of age.
Taking other medicines
There are no known interactions with other medicines likely to be given at the same time as Ecalta (i.e., rifampicin, ciclosporin, tacrolimus, voriconazole and amphotericin B). Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Do not start or stop any other medicines without your doctor’s or pharmacist’s approval.
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 chilbearing 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.
Driving and using machines
No studies on the effect on the ability to drive and use machines have been performed.
Important information about some of the ingredients of Ecalta
This medicinal product contains fructose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicinal product contains 24 vol% ethanol (alcohol), i.e. up to 6 g per dose consumed over a 1.5-hour period (12 g loading dose consumed over a 3-hour period); this is equivalent to 144 ml beer (288 ml beer for the loading dose) or 60 ml wine (120 ml wine for the loading dose). Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children, and in high-risk groups such as those with liver disease or epilepsy.
The amount of alcohol in this medicinal product may alter the effects of other medicines.
The amount of alcohol in this medicinal product may impair your ability to drive or use machines.
How to use Ecalta
Ecalta will always be prepared and given to you 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).
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. This will take at least 1.5hours for the maintenance dose and 3 hours for the loading dose.
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 a dose of Ecalta has been forgotten
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. Do not take a double dose to make up for a forgotten dose.
Effects when treatment with Ecalta is stopped
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 product, ask your doctor or pharmacist.
Possible side effects
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Like all medicines, Ecalta can cause side effects, although not everybody gets them.
Common side effects (likely to occur in fewer than 1 in 10 patients):
- Disorder of blood clotting system
- Low blood potassium (hypokalaemia)
- Convulsion (seizure)
- Headache
- Flushing
- Diarrhoea, vomiting, nausea
- Changes in blood tests of liver function
- Rash, pruritis (itching)
- Changes in blood tests of kidney function
Uncommon side effects (likely to occur in fewer than 1 in 100 patients):
- High blood sugar High blood pressure
- Hot flush Stomach pain
- Abnormal flow of bile from the gallbladder into the intestine (cholestasis) Hives Pain at injection site
Not known
- Low blood pressure
- Sudden contraction of the muscles around the airways resulting in wheezing or coughing
- Difficulty of breathing
If any of the side effects you experience are severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Ecalta
Keep out of the reach and sight of children.
Do not use Ecalta after the expiry date which is stated on the label. The expiry data refers to the last day of that month.
Do not store Ecalta above 25°C.
The reconstituted solution should not be stored above 25°C. Do not freeze.
The infusion solution should not be stored above 25°C. Do not refrigerate or freeze.
Medicines should not be disposed of via wastewater or household waste.
Further information
What Ecalta contains
The active substance is anidulafungin. Each vial with powder contains 100 mg anidulafungin.
The other ingredients are Powder: fructose, mannitol, polysorbate 80, tartaric acid, sodium hydroxide (for pH-adjustment), hydrochloric acid (for pH-adjustment)
Solvent: ethanol anhydrous, water for injections
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 and 1 vial of 30 ml solvent.
The powder for concentrate for solution for infusion is white to off-white. The solvent is a clear colourless solution.
The following information is intended for medical or healthcare professionals only: Ecalta must be reconstituted with the solvent (20% (w/w) ethanol anhydrous in 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.
Reconstitution
Aseptically reconstitute each vial with the solvent (20% (w/w) ethanol anhydrous in water for injections) to provide a concentration of 3.33 mg/ml. The reconstitution time can be up to 5 minutes. The reconstituted solution should be clear and free from visible particulates. After subsequent dilution, the solution is to be discarded if particulate matter or discoloration is identified.
The reconstituted solution must be further diluted within an hour and administered within 24 hours.
Dilution and infusion
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 obtaining an anidulafungin concentration of 0.36 mg/ml. The table below provides the volumes required for each dose.
Dilution requirements for Ecalta administration
| Dose | Number of boxes | Totalreconstituted
volume |
Infusion volume A | Total infusion volume | Infusion solution concentration | Rate of infusion |
| 100 mg | 1 | 30 ml (1 box) | 250 ml | 280 ml | 0.36 mg/ml | 3.0 ml/min |
| 200 mg | 2 | 60 ml (2 boxes) | 500 ml | 560 ml | 0.36 mg/ml | 3.0 ml/min |
Either 9 mg/ml (0.9%) sodium chloride for infusion or 50 mg/ml (5%) glucose for infusion.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either particulate matter or discolouration are identified, discard the solution.
For single use only. Waste materials should be disposed of in accordance with local requirements.