FrancophonIA/ELRC3.0 huggingface dataset:
English: EL - Greece NOVO NORDISK HELLAS Panagouli 80 & Agias Triadas 65, Agia Paraskevi
Finnish: EL - Kreikka NOVO NORDISK HELLAS Panagouli 80 & Agias Triadas 65, Agia
English: AT - Austria Merck Gesellschaft mbH Zimbagasse 5
Finnish: AT - Itävalta Merck Gesellschaft mbH Zimbagasse 5
English: FR - France FERRING SAS 7, rue Jean-Baptiste Clément
Finnish: FR - Ranska FERRING SAS 7, rue Jean-Baptiste Clément
English: Pfizer BV, Rivium Westlaan 142, 2909 LD CAPELLE A/D IJSSEL D - Nederland
Finnish: Pfizer BV, Rivium Westlaan 142, 2909 LD CAPELLE A/D IJSSEL DNederland
English: ES - Spain PFIZER, S.A.Avda.
Finnish: ES - Espanja PFIZER, S.A.Avda.
English: FR - France LILLY France 13, rue Pagès
Finnish: FR - Ranska LILLY France 13, rue Pagès
English: FR - France SANOFI AVENTIS France 1-13, boulevard Romain Rolland
Finnish: FR - Ranska SANOFI AVENTIS France 1-13, boulevard Romain Rolland
English: IT - Italy BAKER ITALIA SpA VIA DI PORTA PINCIANA, 6 00187 ROMA
Finnish: BAKER ITALIA SpA VIA DI PORTA PINCIANA, 6 00187 ROMA
English: FI - Finland Pfizer Oy, Tietokuja 4, 00330 Helsinki, Finland
Finnish: Pfizer Oy, Tietokuja 4, 00330 Helsinki, Finland
English: FI - Finland Eli Lilly Finland Oy Ab, Rajatorpantie 41 C, PL 16, 01641 Vantaa, Finland
Finnish: Eli Lilly Finland Oy Ab, Rajatorpantie 41 C, PL 16, 01641 Vantaa, Finland
English: Pfizer AS, Postboks 3, 1324 Lysaker, Norway
Finnish: NO - Norja Pfizer AS, Postboks 3, 1324 Lysaker, Norway
English: Ferring Lægemidler A/S, Kay Fiskers Plads 11, DK2300 Købenahvn S, Denmark
Finnish: DK - Tanska Ferring Lægemidler A/S, Kay Fiskers Plads 11, DK-2300 Købenahvn S, Denmark
English: 72UT
Finnish: 72 IU
English: IE - Ireland Ferring Ireland Ltd., United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
Finnish: Ferring Ireland Ltd., United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
English: Merck, S.A. Rua Alfredo da Silva, 3 C, 1300-040
Finnish: Merck, S.A. Rua Alfredo da Silva, 3 C, 1300-040 Lisboa, Portugal
English: Floridsdorfer Hauptstraße 1
Finnish: Hauptstraße 1
English: Lilly Deutschland GmbH Teichweg 3
Finnish: DE - Saksa Lilly Deutschland GmbH Teichweg 3
English: Merck Serono GmbH Alsfelder Str. 17
Finnish: DE - Saksa Merck Serono GmbH Alsfelder Str. 17
English: CZ - Czech Republic
Finnish: CZ - Tšekki
English: 2800 Lyngby
Finnish: 2800 Lyngby Denmark
English: Rua Alexandre HerculanoEdifício 1, Piso 6, 2795-240 Linda-a-Velha, Portugal
Finnish: Rua Alexandre Herculano - Edifício 1, Piso 6, 2795-240 Lindaa-Velha, Portugal
English: Elly Lilly Norge AS, Grensevien 99, 0663 Oslo, Norway
Finnish: NO - Norja Elly Lilly Norge AS, Grensevien 99, 0663
English: FI - Finland Merck Oy, Pihatörmä 1 C, 02240 Espoo, Finland
Finnish: Merck Oy, Pihatörmä 1 C, 02240 Espoo, Finland
English: Novo Nordisk - Comércio de Produtos Farmacêuticos, Lda.
Finnish: Novo NordiskComércio de Produtos Farmacêuticos, Lda.
English: LV - Latvia Pfizer Health AB, Vetenskapsvagen 10,SE191 90 Sollentuna, Sweden
Finnish: LV - Latvia Pfizer Health AB, Vetenskapsvagen 10,SE-191 90
English: Pharmacia GmbH Linkstr.
Finnish: DE - Saksa Pharmacia GmbH Linkstr.
English: FI - Finland Ferring Lääkkeet Oy, Piispansilta 11 A, PL 23, 02241 Espoo, Finland
Finnish: Ferring Lääkkeet Oy, Piispansilta 11 A, PL 23, 02241 Espoo, Finland
English: FR - France PFIZER HOLDING France 23-25, avenue du Docteur Lannelongue
Finnish: FR - Ranska PFIZER HOLDING France 23-25, avenue du
English: Kongens Lyngby, Denmark
Finnish: Kongens Lyngby,
English: IS - Iceland Eli Lilly Danmark Nybrovej 110
Finnish: Eli Lilly Danmark Nybrovej 110
English: Eli Lilly ČR, s.r.o.
Finnish: SK - Slovakia Eli Lilly ČR, s.r.o.
English: IT - Italy Pfizer Italia S.r.l.
Finnish: Pfizer Italia S.r.l.
English: Ferring Legemidler AS, Postboks 4445, 0403 Oslo, Norway
Finnish: NO - Norja Ferring Legemidler AS, Postboks 4445, 0403
English: Via Casilina 125 00176 Roma Italy
Finnish: Via Casilina 125 I-00176 Roma Italy
English: Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Finnish: DK - Tanska Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
English: 1,3 mg/ml or 3,3 mg/ml
Finnish: 1,3 mg/ml tai 3,3 mg/ml
English: EL - Greece FERRING HELLAS S.A. GKYZI 3, MAROUSI 15125
Finnish: EL - Kreikka FERRING HELLAS S.A. GKYZI 3, MAROUSI
English: 8NX, England
Finnish: 9NJ, UK
English: AT - Austria Novo Nordisk Pharma GmbH
Finnish: AT - Itävalta Novo Nordisk Pharma GmbH
English: 30 rue de Valmy 92800 Puteaux-France
Finnish: 92800 Puteaux-France
English: EL - Greece Pfizer Hellas S.A. Messoghion Ave., Neo Psychiko 15451, Athens, Greece
Finnish: EL - Kreikka Pfizer Hellas S.A. 234, Messoghion Ave., Neo Psychiko 15451, Athens, Greece
English: ELI LILLY ČR, s.r.o., Pobřežní 12, 180 00 Praha 8, Czech Republic
Finnish: ELI LILLY ČR, s.r.o., Pobřežní 12, 180 00
English: Ferring Magyarország Kft. Váci út 140.
Finnish: Ferring Magyarország Kft.
English: 1,3 mg/ml or 3,3mg/ml after diluting with water
Finnish: 1,3 mg/ml tai 3,3 mg/ml liuottamisen jälkeen
English: de la Industria, 30 Alcobendas 28108 MADRID
Finnish: Alcobendas 28108
English: Eli Lilly Danmark A/S, Nybrovej 110, DK-2800
Finnish: DK - Tanska Eli Lilly Danmark A/S, Nybrovej 110, DK-2800
English: SAIZEN (CLICK.EASY) 8 mg (5,83 mgml)
Finnish: SAIZEN (CLICK.EASY) 8 mg (5,83 mg/ml)
English: 16UT/ML
Finnish: 16 IU/ml
English: BEBelgium
Finnish: Belgium
English: I-00176 Roma
Finnish: 00176 Roma
English: Merck AB, 195 87 Stockholm, Sweden
Finnish: NO - Norja Merck AB, 195 87 Stockholm, Sweden
English: 36UT
Finnish: 36 IU
English: Saizen 8 mg/ml 8 mg/ml
Finnish: Saizen 8 mg/ml
English: 18UT
Finnish: 18 IU
English: FERRING NV Hopmarkt 9 b3 9300 Aalst Belgium
Finnish: BE - Belgia FERRING NV Hopmarkt 9 b3
English: 36UT/ML
Finnish: 36 IU/ml
English: Novo Nordisk Pharma GmbH
Finnish: DE - Saksa Novo Nordisk Pharma GmbH
English: NovoNordis A/S, Novo Alle, Basvaerd, DK
Finnish: SI - Slovenia NovoNordis A/S, Novo Alle, Basvaerd, DK
English: Merck Serono Europe Ltd 56 Marsh Wall London
Finnish: Merck Serono Europe Ltd
English: MT - Malta Pfizer Hellas S.A. Messoghion Ave., Neo Psychiko 15451, Athens, Greece
Finnish: 234, Messoghion Ave., Neo Psychiko 15451, Athens, Greece
English: NOVO NORDISK PHARMA SA
Finnish: BE - Belgia NOVO NORDISK PHARMA SA
English: EL - Greece FARMASERV LILLY AEBE 15TH Km NATIONAL HIGHWAY ATHENS-LAMIA KIFISSIA 14564, P.O.
Finnish: EL - Kreikka FARMASERV LILLY AEBE 15TH Km NATIONAL
English: Via Casilina, 125, Rome, 00176, Italy
Finnish: Industria Farmaceutica Serono S.p. A Via Casilina, 125, Rome, 00176, Italy
English: ET - Estonia Merck Serono S.p.A.
Finnish: SK - Slovakia Merck Serono S.p.A.
English: Boulevard international 55 1070 Brussels Belgium
Finnish: 1050 Brussels Belgium
English: 8mg (24 NE) /1,5ml parenteral use
Finnish: 8 mg (24 IU) /1,5 ml
English: ELI LILLY BENELUX SA Rue de l'Etuve 52/1 1000 Brussels Belgium
Finnish: BE - Belgia ELI LILLY BENELUX SA Rue de l'Etuve 52/1
English: IT - Italy FERRING SpA VIA SENIGALLIA, 18/2
Finnish: FERRING SpA VIA SENIGALLIA, 18/2 20161 MILANO
English: IT - Italy ELI LILLY ITALIA SpA VIA GRAMSCI, 731/733
Finnish: ELI LILLY ITALIA SpA VIA GRAMSCI, 731/733 SESTO FIORENTINO 50019 FIRENZE
English: ZOMACTON 10 mg/ml, poudre et solvant pour solution injectable en seringue préremplie subcutaneous
Finnish: ZOMACTON 10 mg/ml, poudre et solvant pour solution injectable en seringue préremplie
English: AT - Austria Ferring Arzneimittel GmbH Wienerbergstr.
Finnish: AT - Itävalta Ferring Arzneimittel GmbH
English: 36 NE (12 mg/ml)
Finnish: 36 IU (12 mg)
English: PFIZER SA Bld de la Plaine,17 1050 Brussels Belgium
Finnish: BE - Belgia PFIZER SA Bld de la Plaine,17
English: 16 NE (5,3 mg/ml)
Finnish: 16 IU (5,3 mg)
English: Pobřežní 394/12 186 00 Praha Czech Republic
Finnish: Pobřežní 394/12
English: SAIZEN CLICKEASY 8 mg, poudre et solvant pour solution injectable subcutaneous
Finnish: SAIZEN CLICKEASY 8 mg, poudre et solvant pour solution injectable
English: Subcutanous injection
Finnish: Ihonalainen injektio
English: ET - Estonia Ferring GmbH Wittland 11
Finnish: DE - Saksa Ferring GmbH Wittland 11
English: mg/CARTRIDGE
Finnish: mg/injektiopullo
English: SAIZEN 8 mg, poudre et solvant pour solution injectable subcutaneous
Finnish: SAIZEN 8 mg, poudre et solvant pour solution injectable
English: 12UI
Finnish: 12 IU
English: IE - Ireland Merck Serono Limited, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, England
Finnish: Merck Serono Limited, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, England
English: IS - Iceland Novo Nordisk AS Novo Allé
Finnish: Novo Nordisk AS Novo Allé
English: ZOMACTON 4 mg, poudre et solvant pour solution injectable en multidose subcutaneous
Finnish: ZOMACTON 4 mg, poudre et solvant pour solution injectable en multidose
English: Zomacton 10 mg powder and solvent for solution for injection in pre-filled syringe powder and solvent for solution for injection in pre-filled syringe
Finnish: Zomacton 10 mg powder and solvent for solution for injection in pre-filled syringe
English: 2 mg (6IU) /CARTRIDGE
Finnish: 2 mg (6 IU)/sylinteriampulli
English: IE - Ireland Pharmacia Laboratories Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Finnish: Pharmacia Laboratories Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
English: MAXOMAT 1,3 mg, poudre et solvant pour solution injectable subcutaneous
Finnish: MAXOMAT 1,3 mg, poudre et solvant pour solution injectable
English: LV - Latvia Ferring GmbH, Wittland 11, 24109 Kiel, Germany
Finnish: LV - Latvia Ferring GmbH, Wittland 11, 24109 Kiel,
English: Pfizer Luxembourg SARL, 51 av. J.-F. Kennedy, 1855 Luxembourg
Finnish: SI - Slovenia Pfizer Luxembourg SARL, 51 av. J.-F.
English: Pfizer Enterprises SARL, Rond-point du Kirchberg, 51, Avenue J.F.Kennedy, L1855 Luxembourg, Luxembourg
Finnish: Kirchberg, 51, Avenue J.F.Kennedy, L-1855
English: MT - Malta Serono Ltd Bedfont Cross, Stanwell Road
Finnish: Bedfont Cross, Stanwell Road
English: ZOMACTON 4 mg polvo y disolvente en jeringa precargada para solución inyectable powder for solution Subcutaneous use
Finnish: ZOMACTON 4 mg polvo y disolvente en jeringa precargada para solución inyectable
English: HUMATROPE 72 NE (24 mg) injekció patronban powder and solvent for injection
Finnish: HUMATROPE 72 NE (24 mg) injekció patronban
English: Saizen 5, 83 mg/ml 5,83 mg/ml
Finnish: Saizen 5,83 mg/ml
English: Solution for injection s.c.
Finnish: Injektiokuiva-aine, liuosta varten s.c.
English: Roma, Italy
Finnish: IT - Italia
English: HUMATROPE 18 NE (6 mg) injekció patronban powder and solvent for injection
Finnish: HUMATROPE 18 NE (6 mg) injekció patronban
English: NORDITROPIN FLEX PRO 5mg/1,5ml PF PEN SOLUTION FOR INJECTION
Finnish: NORDITROPIN FLEXPRO 5mg/1,5ml PF PEN SOLUTION FOR INJECTION
English: Solution for injection, Cartridge s.c.
Finnish: Injektioneste, liuos s.c.
English: ZOMACTON 10 mg/ ml polvo y disolvente en jeringa precargada para solución inyectable powder for solution Subcutaneous use
Finnish: ZOMACTON 10 mg/ ml polvo y disolvente en jeringa precargada para solución inyectable
English: Pfizer Europe MA EEIG., Sandwich, Kent, CT13, 9NJ, United Kingdom
Finnish: LT - Liettua Pfizer Europe MA EEIG., Sandwich, Kent, CT13, 9NJ, United Kingdom
English: Solution for injection, pre-filled pen
Finnish: Injektioneste, liuos, esitäytetty kynä
English: SISlovenia
Finnish: LAMIA
English: NORDITROPIN FLEX PRO 15mg/1,5ml SOL FOR INJECTION PF PEN
Finnish: NORDITROPIN FLEXPRO 15mg/1,5ml SOL FOR INJECTION PF PEN
English: NORDITROPIN FLEX PRO 10mg/1,5ml SOL FOR INJECTION PF PEN
Finnish: NORDITROPIN FLEXPRO 10mg/1,5ml SOL FOR INJECTION PF PEN
English: SAIZEN 8 mg click.easy polvo y disolvente para solución inyectable powder for solution Subcutaneous use
Finnish: SAIZEN 8 mg click.easy polvo y disolvente para solución inyectable
English: IT - Italy NOVO NORDISK A/S Novo Allé DK-2880
Finnish: RO - Romania NOVO NORDISK A/S Novo Allé, DK-2880
English: UMATROPE 24 mg/3 ml, poudre et solvant pour solution injectable subcutaneous
Finnish: UMATROPE 24 mg/3 ml, poudre et solvant pour solution injectable
English: Humatrope 24mg For Injection powder for injection subcutaneous use
Finnish: Humatrope 24mg For Injection
English: SAIZEN 3,33 mg, poudre et solvant pour solution injectable subcutaneous
Finnish: SAIZEN 3,33 mg, poudre et solvant pour solution injectable
English: PL - Poland Pfizer Europe MA EEIG Ramsgate Road, CT13 9 NJ, Sandwich, Kent, United Kingdom
Finnish: Pfizer Europe MA EEIG Ramsgate Road, CT13 9 NJ, Sandwich, Kent, United Kingdom
English: Humatrope 12mg For Injection powder for injection subcutaneous use
Finnish: Humatrope 12mg For Injection
English: ET - Estonia Pfizer Enterprises SARL Round-Point du Kirchberg 51,Avenue J.F.Kennedy L-1855
Finnish: Pfizer Enterprises SARL Round-Point du Kirchberg
English: UMATROPE 6 mg/3 ml, poudre et solvant pour solution injectable subcutaneous
Finnish: UMATROPE 6 mg/3 ml, poudre et solvant pour solution injectable
English: HUMATROPE 36 NE (12 mg) injekció patronban powder and solvent for injection
Finnish: HUMATROPE 36 NE (12 mg) injekció patronban
English: ES - Spain NOVO NORDISK A/SNovo AlleBagsvaerdDK-2880
Finnish: ES - Espanja NOVO NORDISK A/SNovo
English: Solution for injection, prefilled pen s.c.
Finnish: Injektioneste, liuos, esitäytetty kynä s.c.
English: SAIZEN 1,33 mg, poudre et solvant pour solution injectable subcutaneous
Finnish: SAIZEN 1,33 mg, poudre et solvant pour solution injectable
English: Lisboa, Portugal
Finnish: PT - Portugali
English: UMATROPE 12 mg/3 ml, poudre et solvant pour solution injectable subcutaneous
Finnish: UMATROPE 12 mg/3 ml, poudre et solvant pour solution injectable
English: 24mg /Cartridge s.c.
Finnish: Humatrop 24 mg mg/sylinteriampulli s.c.
English: HUMATROPE 24 mg polvo y disolvente para solución inyectable powder for solution Subcutaneous use
Finnish: HUMATROPE 24 mg polvo y disolvente para solución inyectable
English: DK 2750 Ballerup Denmark
Finnish: Pfizer APS Lautrupvang 8 DK 2750 Ballerup Denmark
English: 10MG/VIAL + 1ML SOLV
Finnish: mg/injektiopullo + 1 ml liuotin
English: HUMATROPE 6 mg polvo y disolvente para solución inyectable powder for solution Subcutaneous use
Finnish: HUMATROPE 6 mg polvo y disolvente para solución inyectable
English: DKDenmark
Finnish: Floridsdorfer
English: IE - Ireland Serono Limited, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14
Finnish: Serono Limited, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, England
English: Humatrop 6 mg
Finnish: Humatrope 6mg For Injection
English: Subcutanous use, intramuscular use
Finnish: Injektioneste, liuos, esitäytetty ruisku
English: HUMATROPE 12 mg polvo y disolvente para solución inyectable powder for solution Subcutaneous use
Finnish: HUMATROPE 12 mg polvo y disolvente para solución inyectable
English: Eli Lilly farmacevtska družba, d.o.o., Brnčičeva 41g, 1231 LjubljanaČrnuče, Slovenia
Finnish: SI - Slovenia Eli Lilly farmacevtska družba, d.o.o.,
English: 5MG/1,5ML CARTRIDGE
Finnish: 5 mg/1,5 mg
English: powder for injection intramuscular and subcutaneous use
Finnish: Injektiokuiva-aine Lihakseen ja ihon alle
English: PL - Poland Novo Nordisk A/S Novo Alle, Bagsvaerd, DK2880, Denmark
Finnish: Novo Nordisk A/S Novo Alle, Bagsvaerd, DK-2880, Denmark
English: 20161 MILANO
Finnish: 186 00 Praha
English: Novo Nordisk A/S, Novo Allé DK-2880 Bagsværd, Denmark
Finnish: NOVO NORDISK A/S Novo Allé DK-2880 Bagsvaerd Denmark
English: NovoNordisk A/S, Novo Allé, 2880 Bagsværd, Danmark
Finnish: NO - Norja NovoNordisk A/S, Novo Allé, 2880 Bagsværd, Danmark
English: Norditropin NordiFlex 10 mg/1.5 mL Solution for injection, prefilled syringe
Finnish: Norditropin NordiFlex 10 mg/1.5 ml, solution for injection, in pre-filled pen
English: CY - Cyprus NOVO NORDISK A/S, Novo Allé, DK-2880 BAGSVAERD, DENMARK
Finnish: LT - Liettua Novo Nordisk A/S, Novo Allé DK-2880 Bagsværd, Denmark
English: Norditropin NordiFlex 5 mg/1,5 mlInjektionslösung in einem Fertigpen solution for injection, in pre-filled pen
Finnish: Norditropin NordiFlex 5 mg/1.5 ml, solution for injection, in pre-filled pen
English: SC
Finnish: Kiel
English: Norditropin SimpleXx 10 mg / 1,5 mL solution for injection injection
Finnish: Norditropin SimpleXx 10 mg / 1.5 ml, solution for injection
English: Norditropin Nordiflex 5mg/1,5ml solution for injection subcutaneous
Finnish: NORDITROPIN NORDIFLEX 5 mg / 1.5 ml solución inyectable
English: Saizen 5.83 mg/ml Solution for Injection solution for injection Subcutanous injection
Finnish: Saizen 5.83 mg/ml Solution for Injection
English: Norditropin NordiFlex 15 mg/1.5 mL Solution for injection, prefilled syringe
Finnish: Norditropin NordiFlex 15 mg/1.5 ml, solution for injection, in pre-filled pen
English: Solution for injection Single dose container s.c.
Finnish: Injektioneste, liuos, säiliö s.c.
English: MT - Malta NovoNordisk A/S Novo Alle, DK - 2880
Finnish: BG - Bulgaria Novo Nordisk A/S, Novo Alle, DK-2880
English: SKSlovakia
Finnish: Slovenia
English: Saizen 8 mg/ml Solution for Injection solution for injection Subcutanous injection
Finnish: Saizen 8 mg/ml Solution for Injection
English: Subcutanous use
Finnish: Parenteraalinen käyttö
English: GENOTROPIN 36 m.j. (12 mg)
Finnish: GENOTROPIN 36 m.j.
English: Zomacton 4mg injection 4mg powder for solution for injection
Finnish: Zomacton 4mg injection 4 mg
English: Norditropin SimpleXx 5 mg / 1,5 mL solution for injection injection
Finnish: NORDITROPIN SIMPLEXx 5 mg/1.5 ml solución inyectable
English: SUBCUTANEOUS INJECTION
Finnish: Injektiokuiva-aine Ihon alle
English: Norditropin Nordiflex 15mg/1,5ml solution for injection subcutaneous
Finnish: NORDITROPIN NORDIFLEX 15 mg/1,5 ml solución inyectable
English: Pfizer Europe MA EEIG Ramsgate Road, Sandwich CT13 9NJ Kent United Kingdom
Finnish: RO - Romania PFIZER EUROPE MA EEIG Ramsgate Road, Sandwich, Kent CT13
English: Norditropin Nordiflex 10mg/1,5ml solution for injection subcutaneous
Finnish: NORDITROPIN NORDIFLEX 10 mg/1,5 ml solución inyectable
English: It is given by infusion lasting 2 hours every day for five days.
Finnish: Se annetaan kaksi tuntia kestävänä infuusiona päivittäin viiden vuorokauden ajan.
English: This cycle of treatment should be repeated every 2 to 6 weeks.
Finnish: Hoitojakso tulee toistaa 2-6 viikon välein.
English: Further information on Ivozall can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ivozall.
Finnish: Lisää tietoa Ivozall-valmisteesta on saatavissa viraston verkkosivustolla osoitteessa ema.europa.eu/medicines/human/EPAR/ivozall.
English: Ivozall (clofarabine)
Finnish: Ivozall (klofarabiini)
English: What are the benefits and risks of Ivozall?
Finnish: Mitkä ovat Ivozallin hyödyt ja riskit?
English: The recommended dose of Ivozall is based on the patient's height and weight.
Finnish: Ivozallin suositeltu annos perustuu potilaan pituuteen ja painoon.
English: What is Ivozall and what is it used for?
Finnish: Mitä Ivozall on ja mihin sitä käytetään?
English: Side effects reported with Ivozall are carefully evaluated and any necessary action taken to protect patients.
Finnish: Ivozallin ilmoitetut haittavaikutukset arvioidaan huolellisesti ja suoritetaan kaikki tarvittavat toimet potilaiden suojelemiseksi.
English: Other information about Ivozall
Finnish: Muita tietoja Ivozall-valmisteesta
English: What measures are being taken to ensure the safe and effective use of Ivozall?
Finnish: Miten voidaan varmistaa Ivozallin turvallinen ja tehokas käyttö?
English: Ivozall (clofarabine) EMA/519636/2019
Finnish: Ivozall (klofarabiini) EMA/519636/2019
English: Doctors should review treatment in patients whose condition does not improve after one or two treatment cycles.
Finnish: Lääkärin on arvioitava hoitoa potilailla, joiden sairaudessa ei ole parannusta yhden tai kahden hoitojakson jälkeen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivozall have been included in the summary of product characteristics and the package leaflet.
Finnish: Suositukset ja varotoimet, joita terveydenhuollon ammattilaisten ja potilaiden on syytä noudattaa, jotta Ivozallin käyttö olisi turvallista ja tehokasta, sisältyvät valmisteyhteenvetoon ja pakkausselosteeseen.
English: Why is Ivozall authorised in the EU?
Finnish: Miksi Ivozall on hyväksytty EU:ssa?
English: Because Ivozall is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Finnish: Koska Ivozall on geneerinen lääkevalmiste, sen hyödyn ja riskien katsotaan olevan samat kuin viitevalmisteen.
English: This stops the cells making new DNA and RNA and from dividing, thereby slowing down the growth of cancer cells.
Finnish: Tämä estää soluja muodostamasta uutta DNA:ta ja RNA:ta sekä estää solujen jakautumisen, jolloin syöpäsolujen kasvu hidastuu.
English: An overview of Ivozall and why it is authorised in the EU
Finnish: Yleistietoa Ivozall-valmisteesta ja siitä, miksi se on hyväksytty EU:ssa
English: Treatment should be started and supervised by a doctor who has experience in the management of patients with acute leukaemias.
Finnish: Hoidon aloittavan ja sitä valvovan lääkärin tulee olla perehtynyt akuutteja leukemioita sairastavien potilaiden hoitoon.
English: This is because Ivozall is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Finnish: Tämä johtuu siitä, että Ivozall annetaan infuusiona laskimoon, joten vaikuttava aine kulkee suoraan verenkiertoon.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Evoltra, and do not need to be repeated for Ivozall.
Finnish: Vaikuttavan aineen hyötyä ja riskejä koskevat tutkimukset hyväksytyissä käyttöaiheissa on jo suoritettu viitevalmiste Evoltralla, joten niitä ei ole tarpeen toistaa Ivozallin osalta.
English: It is used when the disease has not responded to, or has come back (relapsed) after at least two other treatments and when no other treatment is expected to work.
Finnish: Sitä annetaan, kun vähintään kaksi muuta hoitoa eivät ole aikaansaaneet hoitovastetta tai kun sairaus on uusiutunut niiden jälkeen ja muiden hoitojen ei odoteta tehoavan siihen.
English: It belongs to the group of cancer medicines called ‘antimetabolites'.
Finnish: Se kuuluu syöpälääkkeissä antimetaboliittien ryhmään.
English: As for all medicines, data on the use of Ivozall are continuously monitored.
Finnish: Kuten kaikkien lääkkeiden, myös Ivozallin käyttöä koskevia tietoja seurataan jatkuvasti.
English: There was no need for ‘bioequivalence' studies to investigate whether Ivozall is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Finnish: Biologista samanarvoisuutta koskevia tutkimuksia ei ollut tarpeen suorittaa sen selvittämiseksi, imeytyvätkö Ivozall ja viitevalmiste samalla tavalla ja saavat aikaan veressä saman pitoisuuden vaikuttavaa ainetta.
English: Ivozall is a cancer medicine that is used to treat children and adults up to 21 years of age who have acute lymphoblastic leukaemia (ALL), a cancer of the lymphocytes (a type of white blood cell).
Finnish: Sitä käytetään hoidettaessa lasten ja enintään 21-vuotiaiden aikuisten akuuttia lymfoblastileukemiaa (ALL), joka on imusolujen (valkoisten verisolujen tyyppi) syöpä.
English: This means that clofarabine resembles adenine and by taking adenine's place in the body, it interferes with the action of enzymes involved in making genetic material, called ‘DNA polymerase' and ‘RNA reductase'.
Finnish: Tämä tarkoittaa sitä, että klofarabiini muistuttaa adeniinia, jonka paikan ottamalla se estää geneettisen materiaalin syntyyn osallistuvien entsyymien, DNA-polymeraasin ja RNA-reduktaasin, toiminnan.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Ivozall has been shown to be comparable to Evoltra.
Finnish: Euroopan lääkevirasto katsoi, että Ivozallin on osoitettu olevan verrattavissa Evoltraan EU:n vaatimusten mukaisesti.