FrancophonIA/ELRC3.0 huggingface dataset:
English: Ferring Phamraceuticals Limited, The Courtyard, Waterside Drive, Langley, Berkshire SL3 6EZ, UK
Latvian: Phamraceuticals Limited, The Courtyard, Waterside Drive, Langley, Berkshire SL3 6EZ, UK
English: 1210 Wien
Latvian: 1210 Wien Austria
English: 2800 Lyngby
Latvian: 2800 Lyngby Denmark
English: Quinta da FonteEdifício D. José - Piso 1, 2780-730 Paço d' Arcos, Portugal
Latvian: Quinta da Fonte - Edifício D. José - Piso 1, 2780730 Paço d'
English: NOVO NORDISK PHARMA SA
Latvian: Novo Nordisk Pharma
English: Via Casilina, 125, Rome, 00176, Italy
Latvian: A Via Casilina, 125, Rome, 00176, Italy
English: 75014 Paris- France
Latvian: Lannelongue 75014 ParisFrance
English: LV - Latvia Merck Serono S.p.A., Via Casilina 125, I-00176
Latvian: Merck Serono S.p.A., Via Casilina 125, I-00176
English: CZ - Czech Republic
Latvian: SK - Slovākijas Republika
English: ET - Estonia Pfizer Enterprises SARL Round-Point du Kirchberg 51,Avenue J.F.Kennedy L-1855
Latvian: Pfizer Enterprises SARL Round-Point du Kirchberg 51,Avenue J.F.Kennedy L-1855
English: EL - Greece Pfizer Hellas S.A. Messoghion Ave., Neo Psychiko 15451, Athens, Greece
Latvian: 234, Messoghion Ave., Neo Psychiko 15451, Athens, Greece
English: 3991 RA Houten Netherlands
Latvian: Grootslag 1-5 3991 RA Houten Netherlands
English: Alkotás u. 53 1123 Budapest Hungary
Latvian: 53 1123 Budapest Hungary
English: FI - Finland Ferring Lääkkeet Oy, Piispansilta 11 A, PL 23, 02241 Espoo, Finland
Latvian: Ferring Lääkkeet Oy, Piispansilta 11 A, PL 23, 02241
English: Norditropin® SimpleXx®
Latvian: Norditropin NordiFlex®
English: Boulevard international 55 1070 Brussels Belgium
Latvian: NOVO NORDISK PHARMA SA Boulevard international 55 1070 Brussels Belgium
English: D-64289 Darmstadt
Latvian: Alsfelder Str. 17 D-64289 Darmstadt
English: 8mg (24 NE) /1,5ml parenteral use
Latvian: 8mg (24 NE) /1,5ml
English: LV - Latvia Pfizer Health AB, Vetenskapsvagen 10,SE191 90 Sollentuna, Sweden
Latvian: Pfizer Health AB, Vetenskapsvagen 10,SE-191 90
English: Eli Lilly Nederland BV Grootslag 1-5
Latvian: Eli Lilly Nederland BV
English: BGBulgaria
Latvian: BG - Bulgārija
English: ES - Spain MERCK S.L.Maria de Molina, 40 28006 Madrid
Latvian: MERCK S.L.Maria de Molina, 40
English: AT - Austria Eli Lilly GmbH Kölblgasse 8- 10
Latvian: Eli Lilly GmbH Kölblgasse 8- 10 1030 Wien Austria
English: 92158 Suresnes Cedex
Latvian: LILLY France 13, rue Pagès 92158 Suresnes Cedex
English: ELI LILLY BENELUX SA Rue de l'Etuve 52/1 1000 Brussels Belgium
Latvian: Rue de l'Etuve 52/1 1000 Brussels Belgium
English: Ferring Läkemedel AB Box 4041
Latvian: Ferring Läkemedel AB Box 4041 203 11 Malmö Sweden
English: Elly Lilly Norge AS, Grensevien 99, 0663 Oslo, Norway
Latvian: Elly Lilly Norge AS, Grensevien 99,
English: IT - Italy FERRING SpA VIA SENIGALLIA, 18/2
Latvian: FERRING SpA VIA SENIGALLIA,
English: Via Casilina 125 00176 Roma Italy
Latvian: Casilina 125 00176 Roma Italy
English: IS - Iceland Novo Nordisk AS Novo Allé
Latvian: Novo Nordisk AS Novo Allé
English: 1147 Wien
Latvian: Zimbagasse 5 1147 Wien Austria
English: Eli Lilly Danmark A/S, Nybrovej 110, DK-2800
Latvian: Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
English: FR - France FERRING SAS 7, rue Jean-Baptiste Clément
Latvian: FERRING SAS 7, rue JeanBaptiste Clément 94250 GentillyFrance
English: 00176 Roma Italy
Latvian: 00188 Rome Italy
English: ZOMACTON 10 mg/ml, poudre et solvant pour solution injectable en seringue préremplie subcutaneous
Latvian: ZOMACTON 10 mg/ml, poudre et solvant pour solution injectable en seringue préremplie
English: ES - Spain PFIZER, S.A.Avda.
Latvian: PFIZER, S.A.Avda.
English: NLNetherlands
Latvian: NL - Nīderlande
English: Lilly Deutschland GmbH Teichweg 3
Latvian: Lilly Deutschland GmbH
English: Solution for injection, Cartridge s.c.
Latvian: Šķīdums injekcijai, kārtridžs
English: SAIZEN CLICKEASY 8 mg, poudre et solvant pour solution injectable subcutaneous
Latvian: SAIZEN CLICKEASY 8 mg, poudre et solvant pour solution injectable
English: Subcutanous use, intramuscular use
Latvian: Subkutānai lietošanai, intramuskulārai lietošanai
English: Saizen click easy 8 mg 8 mg s.c.
Latvian: Saizen click easy 8 mg 8 mg
English: SAIZEN 8 mg, poudre et solvant pour solution injectable subcutaneous
Latvian: SAIZEN 8 mg, poudre et solvant pour solution injectable
English: s r.o., Stroupežnického 17, 150 00 Praha 5, Czech Republic
Latvian: 17, 150 00 Praha
English: ZOMACTON 4 mg, poudre et solvant pour solution injectable en multidose subcutaneous
Latvian: ZOMACTON 4 mg, poudre et solvant pour solution injectable en multidose
English: IS - Iceland Merck AB SE-195 87 Stockholm Sweden
Latvian: Merck AB SE-195 87 Stockholm Sweden
English: EL - Greece Merck A.E. Hellas Kifisias Avenue 41-45 (Building B)
Latvian: Merck A.E. Hellas Kifisias Avenue 4145 (Building B) Marousi 15123 Athens
English: ZOMACTON 4 mg polvo y disolvente en jeringa precargada para solución inyectable powder for solution Subcutaneous use
Latvian: ZOMACTON 4 mg polvo y disolvente en jeringa precargada para solución inyectable
English: MAXOMAT 1,3 mg, poudre et solvant pour solution injectable subcutaneous
Latvian: MAXOMAT 1,3 mg, poudre et solvant pour solution injectable
English: powder for injection intramuscular and subcutaneous use
Latvian: Pulveris injekcijām Subkutānai lietošanai, intramuskulārai lietošanai
English: Lilly-Portugal, Produtos Farmacêuticos, Lda.
Latvian: Lilly-Portugal, Produtos
English: IE - Ireland Pharmacia Laboratories Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Latvian: Pharmacia Laboratories Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
English: Pfizer Enterprises SARL, Rond-point du Kirchberg, 51, Avenue J.F.Kennedy, L1855 Luxembourg, Luxembourg
Latvian: Pfizer Enterprises SARL, Rond-point du Kirchberg, 51, Avenue
English: AT - Austria Merck Gesellschaft mbH Zimbagasse 5
Latvian: Merck Gesellschaft mbH
English: ELI LILLY ČR, s.r.o., Pobřežní 12, 180 00 Praha 8, Czech Republic
Latvian: CZ - Čehijas Republika ELI LILLY ČR, s.r.o., Pobřežní 12,
English: SAIZEN 8 mg click.easy polvo y disolvente para solución inyectable powder for solution Subcutaneous use
Latvian: SAIZEN 8 mg click.easy polvo y disolvente para solución inyectable
English: Merck Serono GmbH Alsfelder Str. 17
Latvian: Merck Serono GmbH
English: ZOMACTON 10 mg/ ml polvo y disolvente en jeringa precargada para solución inyectable powder for solution Subcutaneous use
Latvian: ZOMACTON 10 mg/ ml polvo y disolvente en jeringa precargada para solución inyectable
English: BEBelgium
Latvian: BE - Beļģija
English: HUMATROPE 72 NE (24 mg) injekció patronban powder and solvent for injection
Latvian: HUMATROPE 72 NE (24 mg) injekció patronban
English: Merck Serono Europe Ltd 56 Marsh Wall London
Latvian: CZ - Čehijas Republika Merck Serono Europe Ltd
English: Novo Nordisk Pharma GmbH
Latvian: Novo Nordisk Pharma GmbH Brucknerstr. 1
English: IE - Ireland Merck Serono Limited, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, England
Latvian: Merck Serono Limited, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, England
English: HUMATROPE 18 NE (6 mg) injekció patronban powder and solvent for injection
Latvian: HUMATROPE 18 NE (6 mg) injekció patronban
English: 10MG/1.5ML Solution for injection subcutaneous use
Latvian: 10MG/1.5ML ŠĶĪDUMS INJEKCIJAI Subkutānai lietošanai
English: Novo Nordisk A/S Novo Allé
Latvian: NOVO NORDISK A/SNovo
English: Pfizer Luxembourg SARL, 51 av. J.-F. Kennedy, 1855 Luxembourg
Latvian: J.F.Kennedy, L1855 Luxembourg, Luxembourg
English: PL - Poland Industria Farmaceutica Serono S.p. A
Latvian: Farmaceutica Serono S.p.
English: UMATROPE 24 mg/3 ml, poudre et solvant pour solution injectable subcutaneous
Latvian: UMATROPE 24 mg/3 ml, poudre et solvant pour solution injectable
English: Ferring Magyarország Kft. Váci út 140.
Latvian: Váci út 140.
English: Humatrope 24mg For Injection powder for injection subcutaneous use
Latvian: Humatrope 24mg For Injection
English: SAIZEN 3,33 mg, poudre et solvant pour solution injectable subcutaneous
Latvian: SAIZEN 3,33 mg, poudre et solvant pour solution injectable
English: HUMATROPE 36 NE (12 mg) injekció patronban powder and solvent for injection
Latvian: HUMATROPE 36 NE (12 mg) injekció patronban
English: Humatrope 12mg For Injection powder for injection subcutaneous use
Latvian: Humatrope 12mg For Injection
English: LTLithuania
Latvian: LT - Lietuva
English: UMATROPE 6 mg/3 ml, poudre et solvant pour solution injectable subcutaneous
Latvian: UMATROPE 6 mg/3 ml, poudre et solvant pour solution injectable
English: SAIZEN 1,33 mg, poudre et solvant pour solution injectable subcutaneous
Latvian: SAIZEN 1,33 mg, poudre et solvant pour solution injectable
English: 15MG/1.5ML Solution for injection subcutaneous use
Latvian: 15MG/1.5ML ŠĶĪDUMS INJEKCIJAI Subkutānai lietošanai
English: Novo Nordisk Pharma Riverside Business Park B-1070 Bruxelles
Latvian: Riverside Business Park
English: UMATROPE 12 mg/3 ml, poudre et solvant pour solution injectable subcutaneous
Latvian: UMATROPE 12 mg/3 ml, poudre et solvant pour solution injectable
English: DK 2750 Ballerup Denmark
Latvian: Pfizer APS Lautrupvang 8 DK 2750 Ballerup Denmark
English: HUMATROPE 24 mg polvo y disolvente para solución inyectable powder for solution Subcutaneous use
Latvian: HUMATROPE 24 mg polvo y disolvente para solución inyectable
English: 10MG/1.5ML SOLUTION FOR INJECTION
Latvian: 10MG/1.5ML Šķīdums injekcijai
English: Solution for injection Subcutanous use
Latvian: ŠĶĪDUMS INJEKCIJAI Subkutānai lietošanai
English: ES - Spain LILLY, S.A. Avda.
Latvian: LILLY, S.A.
English: FR - France NOVO NORDISK PHARMACEUTIQUE SAS Le Palatin
Latvian: NOVO NORDISK PHARMACEUTIQUE SAS
English: HUMATROPE 6 mg polvo y disolvente para solución inyectable powder for solution Subcutaneous use
Latvian: HUMATROPE 6 mg polvo y disolvente para solución inyectable
English: 16 UI (5,3 mg) powder and solvent for solution for injection
Latvian: 16 UI (5,3 mg) Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
English: FR - France PFIZER HOLDING France 23-25, avenue du Docteur Lannelongue
Latvian: 23-25, avenue du Docteur
English: Italy
Latvian: London
English: Marousi 15123
Latvian: BOX 51288
English: FR - France SANOFI AVENTIS France 1-13, boulevard Romain Rolland
Latvian: 1-13, boulevard Romain Rolland 75014 ParisFrance
English: sc
Latvian: Ltd.
English: HUMATROPE 12 mg polvo y disolvente para solución inyectable powder for solution Subcutaneous use
Latvian: HUMATROPE 12 mg polvo y disolvente para solución inyectable
English: Injektionslösung in einem Fertigpen solution for injection, in pre-filled pen
Latvian: Injektionslösung in einem Fertigpen šķīdums injekcijai, pildspalvveida pilnšļirce
English: DKDenmark
Latvian: Ferring
English: 6, 12, 24 mg Powder and solvent for solution for injection (poeder en oplosmiddel voor oplossing voor injectie
Latvian: 6, 12, 24 mg Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
English: PL - Poland Novo Nordisk A/S Novo Alle, Bagsvaerd, DK2880, Denmark
Latvian: Novo Nordisk A/S Novo Alle, Bagsvaerd, DK2880, Denmark
English: 15MG/1.5ML SOLUTION FOR INJECTION
Latvian: 15MG/1.5ML Šķīdums injekcijai
English: IT - Italy NOVO NORDISK A/S Novo Allé DK-2880
Latvian: NOVO NORDISK A/S Novo Allé DK-2880
English: ET - Estonia Ferring GmbH Wittland 11
Latvian: CZ - Čehijas Republika Ferring GmbH, Wittland 11, D
English: FR - France MERCK SANTE 37, rue Saint-Romain 69008 Lyon France
Latvian: MERCK SANTE 37, rue SaintRomain
English: Zomacton 4mg injection 4mg powder for solution for injection
Latvian: Zomacton 4mg injection 4mg
English: Feltham, Middlesex TW14 8NX0
Latvian: Serono Ltd Bedfont Cross, Stanwell Road Feltham, Middlesex TW14 8NX0
English: AT - Austria Ferring Arzneimittel GmbH Wienerbergstr.
Latvian: Ferring Arzneimittel GmbH
English: Norditropin NordiFlex 10 mg/1.5 mL Solution for injection, prefilled syringe
Latvian: Norditropin NordiFlex 10 mg/1.5 ml, solution for injection, in pre-filled pen
English: powder for solution for injection subcutaneous
Latvian: Pulveris injekcijām Subkutānai lietošanai
English: 10 mg/1.5 mL Solution for injection, prefilled syringe
Latvian: 10 mg/1.5 mL Šķīdums injekcijai, pildspalvveida pilnšļirce
English: 16 IU (5.3 mg) powder and solvent for solution for injection
Latvian: 16 IU (5.3 mg) Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
English: IE - Ireland Serono Limited, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14
Latvian: Serono Limited, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, England
English: Norditropin SimpleXx 10 mg / 1,5 mL solution for injection injection
Latvian: Norditropin SimpleXx 10 mg / 1.5 ml, solution for injection
English: Ferring GmbH,Wittland 11, D-24109 Kiel, Germany
Latvian: Ferring GmbH, Wittland 11, 24109 Kiel, Germany
English: 15 mg/1.5 mL Solution for injection, prefilled syringe
Latvian: 15 mg/1.5 mL Šķīdums injekcijai, pildspalvveida pilnšļirce
English: Norditropin Nordiflex 5mg/1,5ml solution for injection subcutaneous
Latvian: NORDITROPIN NORDIFLEX 5 mg / 1.5 ml solución inyectable
English: Saizen 5.83 mg/ml Solution for Injection solution for injection Subcutanous injection
Latvian: Saizen 5.83 mg/ml Solution for Injection
English: Subcutanous injection
Latvian: Injekcijām
English: Norditropin NordiFlex 15 mg/1.5 mL Solution for injection, prefilled syringe
Latvian: Norditropin NordiFlex 15 mg/1.5 ml, solution for injection, in pre-filled pen
English: Norditropin NordiFlex 5 mg/1,5 mlInjektionslösung in einem Fertigpen solution for injection, in pre-filled pen
Latvian: Norditropin NordiFlex 5 mg/1.5 ml, solution for injection, in pre-filled pen
English: Genotropin Miniquick 1.8 mg/0.25 ml Powder and solvent for solution for injection
Latvian: Genotropin Miniquick 1.8 mg/0.25 ml Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
English: Genotropin Miniquick 1.6 mg/0.25 ml Powder and solvent for solution for injection
Latvian: Genotropin Miniquick 1.6 mg/0.25 ml Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
English: Annex I
Latvian: Teichweg 3
English: 6mg /Cartridge Powder and solvent for solution for injection s.c.
Latvian: 6mg /Cartridge Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
English: Genotropin Miniquick 1.4 mg/0.25 ml Powder and solvent for solution for injection
Latvian: Genotropin Miniquick 1.4 mg/0.25 ml Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
English: EL - Greece FERRING HELLAS S.A. GKYZI 3, MAROUSI 15125
Latvian: GKYZI 3, MAROUSI
English: Genotropin Miniquick 1.2 mg/0.25 ml Powder and solvent for solution for injection
Latvian: Genotropin Miniquick 1.2 mg/0.25 ml Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
English: 5 mg/1.5 mL Solution for injection, prefilled syringe
Latvian: 5 mg/1.5 mL Šķīdums injekcijai, pildspalvveida pilnšļirce
English: AT - Austria Novo Nordisk Pharma GmbH
Latvian: Novo Nordisk Pharma GmbH Opernring 3-5 1010 Wien Austria
English: Genotropin Miniquick 0.2 mg/0.25 ml Powder and solvent for solution for injection
Latvian: Genotropin Miniquick 0.2 mg/0.25 ml Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
English: Saizen 8 mg/ml Solution for Injection solution for injection Subcutanous injection
Latvian: Saizen 8 mg/ml Solution for Injection
English: Norditropin FlexPro 5 mg/1,5 ml Injektionslösung in einem Fertigpen solution for injection, in pre-filled pen
Latvian: Norditropin FlexPro 5 mg/1,5 ml Injektionslösung in einem Fertigpen šķīdums injekcijai, pildspalvveida pilnšļirce
English: Powder and Solvent for Solution for Injection in cartridge
Latvian: Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai, kārtridžs
English: GENOTROPIN 36 m.j. (12 mg)
Latvian: GENOTROPIN 36 m.j.
English: NOVO NORDISK A/S Novo Allé, DK-2880 Bagsværd, Denmark
Latvian: Novo Nordisk, A/S Novo Allé, DK-2880 Bagsvaerd, Denmark
English: I-00176 Roma
Latvian: Casilina 125 I-00176 Roma Italy
English: 36 IU (12 mg) powder and solvent for solution for injection
Latvian: 36 IU (12 mg) Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
English: Norditropin SimpleXx 5 mg / 1,5 mL solution for injection injection
Latvian: NORDITROPIN SIMPLEXx 5 mg/1.5 ml solución inyectable
English: Norditropin Nordiflex 15mg/1,5ml solution for injection subcutaneous
Latvian: NORDITROPIN NORDIFLEX 15 mg/1,5 ml solución inyectable
English: HUHungary
Latvian: AlleBagsvaerdDK
English: Genotropin Miniquick 0.8 mg/0.25 ml Powder and solvent for solution for injection
Latvian: Genotropin Miniquick 0.8 mg/0.25 ml Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
English: Genotropin Miniquick 0.6 mg/0.25 ml Powder and solvent for solution for injection
Latvian: Genotropin Miniquick 0.6 mg/0.25 ml Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
English: Norditropin Nordiflex 10mg/1,5ml solution for injection subcutaneous
Latvian: NORDITROPIN NORDIFLEX 10 mg/1,5 ml solución inyectable
English: 5 mg/ 1,5 mg Solution for injection in pre-filled pen
Latvian: 5 mg/ 1,5 mg Šķīdums injekcijai, pildspalvveida pilnšļirce
English: This cycle of treatment should be repeated every 2 to 6 weeks.
Latvian: Terapijas cikls ir jāatkārto ik pēc 2 līdz 6 nedēļām.
English: Other information about Ivozall
Latvian: Cita informācija par Ivozall
English: Further information on Ivozall can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ivozall.
Latvian: Sīkāka informācija par Ivozall ir atrodama aģentūras tīmekļa vietnē: ema.europa.eu/medicines/human/EPAR/ivozall.
English: What measures are being taken to ensure the safe and effective use of Ivozall?
Latvian: Kas tiek darīts, lai garantētu drošu un efektīvu Ivozall lietošanu?
English: Doctors should review treatment in patients whose condition does not improve after one or two treatment cycles.
Latvian: Ārstiem jāpārskata to pacientu ārstēšana, kuru stāvoklis pēc viena vai diviem ārstēšanas cikliem nav uzlabojies.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Ivozall has been shown to be comparable to Evoltra.
Latvian: Eiropas Zāļu aģentūra secināja, ka saskaņā ar ES prasībām ir pierādīts, ka Ivozall ir salīdzināmas ar Evoltra.
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.
Latvian: Tās tiek lietotas, ja slimība nav reaģējusi uz citu ārstēšanu vai ir recidivējusi pēc vismaz divām citām terapijām un nav sagaidāms, ka cita terapija varētu iedarboties.
English: It is given by infusion lasting 2 hours every day for five days.
Latvian: Zāles tiek ievadītas piecas dienas katru dienu divu stundu ilgas infūzijas veidā.
English: As for all medicines, data on the use of Ivozall are continuously monitored.
Latvian: Tāpat kā par visām zālēm dati par Ivozall lietošanu tiek pastāvīgi uzraudzīti.
English: Ivozall can only be obtained with a prescription.
Latvian: Ivozall var iegādāties tikai pret recepti.
English: Side effects reported with Ivozall are carefully evaluated and any necessary action taken to protect patients.
Latvian: Ziņotās ar Ivozall lietošanu saistītās blakusparādības tiek rūpīgi izvērtētas, un tiek veikti visi pacientu aizsardzībai nepieciešamie pasākumi.
English: As for every medicine, the company provided studies on the quality of Ivozall.
Latvian: Tāpat kā visām zālēm, uzņēmums iesniedza pētījumus par Ivozall kvalitāti.
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.
Latvian: Pētījumi par aktīvās vielas ieguvumu un risku apstiprinātajā lietošanā jau ir veikti ar atsauces zālēm Evoltra, un ar Ivozall tie nav jāatkārto.
English: Therefore, the Agency's view was that, as for Evoltra, the benefits of Ivozall outweigh the identified risks and it can be authorised for use in the EU.
Latvian: Tāpēc aģentūra uzskatīja, ka, tāpat kā Evoltra gadījumā, Ivozall ieguvums pārsniedz identificēto risku un tās var reģistrēt lietošanai ES.
English: This stops the cells making new DNA and RNA and from dividing, thereby slowing down the growth of cancer cells.
Latvian: Rezultātā šūnas vairs neproducē jaunas DNS un RNS, kā arī nenotiek šūnu dalīšanās, tādējādi palēninot vēža šūnu augšanu.
English: What is Ivozall and what is it used for?
Latvian: Kas ir Ivozall un kāpēc tās lieto?
English: Treatment should be started and supervised by a doctor who has experience in the management of patients with acute leukaemias.
Latvian: Ārstēšana ir jāsāk un jāuzrauga ārstam ar pieredzi akūtas leikēmijas pacientu ārstēšanā.
English: What are the benefits and risks of Ivozall?
Latvian: Kāda ir Ivozall ieguvuma un riska attiecība?
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).
Latvian: Ivozall ir pretvēža zāles, ko lieto, lai ārstētu bērnus un pieaugušos līdz 21 gada vecumam, kuriem ir akūta limfoblastiskā leikēmija (ALL), kas ir limfocītu (balto asins šūnu veida) vēzis.
English: An overview of Ivozall and why it is authorised in the EU
Latvian: Ivozall pārskats un kāpēc tās ir reģistrētas ES
English: It belongs to the group of cancer medicines called ‘antimetabolites'.
Latvian: Šīs zāles pieder pretvēža zāļu grupai, ko sauc par antimetabolītiem.
English: This is because Ivozall is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Latvian: Tas ir tādēļ, ka Ivozall tiek ievadītas infūzijas veidā vēnā, lai aktīvā viela tieši nonāktu asinsritē.
English: This means that Ivozall contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Evoltra.
Latvian: Tas nozīmē, ka Ivozall satur tādu pašu aktīvo vielu un darbojas tāpat kā “atsauces zāles”, kas jau ir reģistrētas Eiropas Savienībā (ES) ar nosaukumu Evoltra.
English: Because Ivozall is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Latvian: Tā kā Ivozall ir ģenēriskas zāles, to ieguvumu un riska attiecību uzskata par līdzvērtīgu atsauces zāļu ieguvuma un riska attiecībai.
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.
Latvian: “Bioekvivalences” pētījumi, lai noskaidrotu, vai Ivozall uzsūcas līdzīgi atsauces zālēm, lai panāktu tādu pašu aktīvās vielas līmeni asinīs, nebija nepieciešami.
English: Why is Ivozall authorised in the EU?
Latvian: Kāpēc Ivozall ir reģistrētas ES?
English: For more information about using Ivozall, see the package leaflet or contact your doctor or pharmacist.
Latvian: Papildu informāciju par Ivozall lietošanu skatīt zāļu lietošanas instrukcijā vai jautāt ārstam vai farmaceitam.
English: Ivozall contains the active substance clofarabine and is a ‘generic medicine'.
Latvian: Ivozall satur aktīvo vielu klofarabīnu un ir “ģenēriskas zāles”.
English: Ivozall (clofarabine) EMA/519636/2019
Latvian: EMA/519636/2019
English: Clofarabine is an ‘analogue' of adenine, one of the building blocks of the genetic material of cells (DNA and RNA).
Latvian: Klofarabīns ir “analogs” adenīnam, kas ir viens no šūnu ģenētiskā materiāla (DNS un RNS) uzbūves elementiem.
English: The recommended dose of Ivozall is based on the patient's height and weight.
Latvian: Ieteicamo Ivozall devu aprēķina, pamatojoties uz pacienta augumu un masu.
English: The active substance in Ivozall, clofarabine, is a cytotoxic agent (a medicine that kills cells that are dividing, such as cancer cells).
Latvian: Ivozall aktīvā viela klofarabīns ir citotoksisks aģents (zāles, kas iznīcina šūnas, kuras dalās, piemēram, vēža šūnas).
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'.
Latvian: Tas nozīmē, ka organismā klofarabīns līdzinās adenīnam un to aizstāj, traucējot ģenētiskā materiāla veidošanā iesaistīto fermentu - DNS polimerāzes un RNS reduktāzes - darbību.