What ECALTA contains
- The active substance is anidulafungin. Each vial of powder contains 100 mg anidulafungin.
- The other ingredients are: fructose, mannitol, polysorbate 80, tartaric acid, sodium hydroxide (for pH-adjustment), 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 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 0152 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 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.
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. 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.
If not further diluted immediately, the reconstituted solution should be stored at 2°C ? 8°C and diluted within an hour of reconstitution.
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 0.77 mg/ml. The table below provides the volumes required for each dose.
Dilution requirements for ECALTA administration
Dose Infusion volume ARate of infusion Number of vials of powder Total reconstituted volume Total infusion volume BMinimum duration of infusion 100 mg 1 30 ml 100 ml 130 ml 90 min 1.4 ml min 200 mg 2 60 ml 200 ml 260 ml 180 min 1.4 ml min Either 9 mgml 0.9 sodium chloride for infusion or 50 mgml 5 glucose for infusion. A B Infusion solution concentration is 0.77 mgml
The rate of infusion should not exceed 1.1 mg/minute (equivalent to 1.4 ml/minute when reconstituted and diluted per instructions).
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.