ECALTA 100 mg powder and solvent for concentrate for solutionfor infusion

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 ECALTA, fungal cells have incomplete or defective cell walls, making them fragile or unable to grow.

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

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 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.

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.

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 1.5 hours 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.

Like all medicines, ECALTA can cause side effects, although not everybody gets them.

The frequency of possible side effects is listed below is defined using the following convention: very common (affects more than 1 user in 10), common (affects 1 to 10 users in 100), uncommon (affects 1 to 10 users in 1,000), rare (affects 1 to 10 users in 10,000), not known (frequency cannot be estimated from the available data).

Common side effects

• 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

• 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.

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 25ºC.
The reconstituted solution should not be stored above 25ºC. Do not freeze.
The infusion solution should not be stored above 25ºC. Do not refrigerate or freeze. Medicines should not be disposed of via wastewater or household waste.

What ECALTA contains

• The active substance is anidulafungin. Each vial of 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.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation for ECALTA is held by:
Pfizer Limited, Ramsgate Rd, Sandwich, Kent, CT13 9NJ, United Kingdom

Manufacturer

Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België BelgiqueBelgien Pfizer S.A.N.V. TélTel 32 02 554 62 11 LuxembourgLuxemburg Pfizer S.A. Tél 32 02 554 62 11

, . 359 2 970 4333 Magyarország Pfizer Kft. Tel. 36 1 488 37 00

eská republika Pfizer s.r.o. Tel 420-283-004-111 Malta V.J. Salomone Pharma Ltd. Tel 356 21 22 01 74

Danmark Pfizer ApS Tlf 45 44 20 11 00 Nederland Pfizer bv Tel 31 010 406 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 6 405 328 Österreich Pfizer Corporation Austria Ges.m.b.H. Tel 43 01 521 15-0

Pfizer Hellas A.E. 30 210 6785 800 Polska Pfizer Polska Sp. z o.o., Tel. 48 22 335 61 00

España Pfizer S.A. Tel 34 91 490 99 00 Portugal Laboratórios Pfizer, Lda. Tel 351 214 235 500

France Pfizer Tél 33 01 58 07 34 40 România Pfizer România S.R.L Tel 40 021 207 28 00

Ireland Pfizer Healthcare Ireland Tel 1800 633 363 toll free Tel 44 01304 616161 Slovenija Pfizer Luxembourg SARL Pfizer, podrunica za svetovanje s podroja farmacevtske dejavnosti, Ljubljana Tel 386 01 52 11 400

Ísland Vistor hf., Sími 354 535 7000 Slovenská republika Pfizer Luxembourg SARL, organizaná zloka Tel 421-2-3355 5500

Italia Pfizer Italia S.r.l. Tel 39 06 33 18 21 SuomiFinland Pfizer Oy PuhTel 35809 43 00 40

GEO. PAVLIDES ARAOUZOS LTD, 35722818087 Sverige Pfizer AB Tel 46 08 5505 2000

United Kingdom Pfizer Limited Latvija Pfizer Luxembourg SARL Filile Latvij Tel 371 670 35 775 Tel 44 01304 616161

Lietuva

Pfizer Luxembourg SARL
filialas Lietuvoje
Tel. +3705 2514000

This leaflet was last approved in {MM/YYYY}.

<--------------------------------------------------------------------------------------------------------------- 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.

Dilutionand 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 Infusion volume ATotal infusion volume Infusion solution concentration Rate of infusion Total reconstituted volume 100 mg 1 30 ml 1 box 250 ml 280 ml 0.36 mgml 3.0 mlmin 200 mg 2 60 ml 2 boxes 500 ml 560 ml 0.36 mgml 3.0 mlmin A Either 9 mgml 0.9 sodium chloride for infusion or 50 mgml 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.