FrancophonIA/ELRC3.0 huggingface dataset:
Croatian: Francuska EFFIK 9-11 rue Jeanne Braconnier Bâtiment « Le Newton » 92366 Meudon la Foret cedex France
Maltese: 9-11 rue Jeanne Braconnier Bâtiment « Le Newton » 92366 Meudon la Foret cedex Franza
Croatian: Gynial GmbH Gablenzgasse 11/III 1150 Wien Austria
Maltese: L-Awstrija Gynial GmbH Gablenzgasse 11/III 1150 Wien
Croatian: Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Maltese: Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Croatian: Rua Consiglieri Pedroso, 123 2730-056 Barcarena Portugal
Maltese: Rua Consiglieri Pedroso, 123 2730-056 Barcarena Il-Portugall
Croatian: Luksemburg JANSSEN-CILAG N.V. Antwerpseweg 15-17
Maltese: Il-Belġju JANSSEN-CILAG N.V. Antwerpseweg 15-17
Croatian: JANSSEN-CILAG N.V. Antwerpseweg 15-17 2340 Beerse Belgium
Maltese: JANSSEN-CILAG N.V. Antwerpseweg 15-17 2340
Croatian: Temapharm Sp. z o.o. ul.
Maltese: SymPhar Sp. z o.o. ul.
Croatian: Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
Maltese: Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm
Croatian: Edward Thomsens Vej 14 DK-2300 København
Maltese: Edward Thomsens Vej 14 DK-2300 København S Id-Danimarka
Croatian: Psychiko, Greece
Maltese: Psychiko, Il-Greċja
Croatian: Kloosterstraat 6 5340 BH, Oss The Netherlands
Maltese: Kloosterstraat 6 5340 BH, Oss L-Olanda
Croatian: B 2340 Beerse Belgium
Maltese: B 2340 Beerse Il-Belġju
Croatian: Njemačka TEVA GmbH Graf-Arco-Str.
Maltese: Il-Ġermanja TEVA GmbH Graf-Arco-Str.
Croatian: Ladee Pharma Baltics UAB Žemaitijos g.13/Šiaulių g.10, LT-01134 Vilnius Lithuania
Maltese: Ladee Pharma Baltics UAB Žemaitijos g.13/Šiaulių g.10, LT-01134 Vilnius Il-Litwanja
Croatian: Španjolska MYLAN PHARMACEUTICALS S.L.
Maltese: MYLAN PHARMACEUTICALS S.L.
Croatian: Madaus GmbH Colonia Allee 15 51067 Köln Germany
Maltese: Madaus GmbH Colonia Allee 15 51067 Köln
Croatian: Budapest 1123 Hungary
Maltese: Budapest 1123
Croatian: Nizozemska Mylan B.V.
Maltese: Mylan B.V.
Croatian: Bayer, spol. s r.o. Digital Park II Einsteinova 25
Maltese: s r.o. Digital Park II
Croatian: Nordkanalstrasse 28 20097 Hamburg Germany
Maltese: Nordkanalstrasse 28 20097 Hamburg Il-Ġermanja
Croatian: 1800 Vilvoorde Belgium
Maltese: 1800 Vilvoorde Il-Belġju
Croatian: Nizozemska Apothecon B.V.
Maltese: Apothecon B.V.
Croatian: Francuska MSD France 34 avenue Léonard de Vinci 92418 Courbevoie Cedex France varnoline continu 0,15 mg 0,03 mg
Maltese: 34 avenue Léonard de Vinci 92418 Courbevoie Cedex Franza varnoline continu 0,15 mg 0,03 mg
Croatian: Ltd One Wood Street EC2V 7WS London United Kingdom
Maltese: One Wood Street EC2V 7WS
Croatian: Njemačka Aliud Pharma GmbH Gottlieb-Daimler-Str. 19
Maltese: Il-Ġermanja Aliud Pharma GmbH Gottlieb-Daimler-Str.
Croatian: Nizozemska Bayer B.V.
Maltese: Bayer B.V.
Croatian: Velvian Germany GmbH Carl-Zeiss-Ring 9
Maltese: Il-Ġermanja GmbH Carl-Zeiss-Ring 9
Croatian: Janssen - Cilag Pharma GmbH Vorgartenstraße 206b A-1020 Wien
Maltese: L-Awstrija Janssen - Cilag Pharma GmbH Vorgartenstraße 206b
Croatian: Rumunjska Gedeon Richter România S.A. Str. Cuza-Vodă, nr. 99-105
Maltese: Ir-Rumanija Gedeon Richter România S.A. Str. Cuza-Vodă, nr.
Croatian: DE-61118 Bad Vibel, Germany
Maltese: DE-61118 Bad Vibel, Il-Ġermanja
Croatian: Njemačka Aristo Pharma GmbH Wallenroder Straße 8-10
Maltese: Il-Ġermanja Aristo Pharma GmbH Wallenroder Straße 8-10
Croatian: Orivas UAB J.Jasinskio 16B LT-01112 Vilinius Lithuania
Maltese: Orivas UAB J.Jasinskio 16B LT-01112 Vilinius Il-Litwanja
Croatian: Island ratiopharm GmbH Graf-Arco Strasse 3 89079 ULM Germany
Maltese: L-Islanda ratiopharm GmbH Graf-Arco Strasse 3 89079 ULM
Croatian: Španjolska GEDEON RICHTER, PLC Gyömroi ut 19-21
Maltese: GEDEON RICHTER, PLC Gyömroi ut 19-21
Croatian: 20121 Milano
Maltese: 20121 Milano L-Italja
Croatian: Bayer Portugal, S.A. Rua Quinta do Pinheiro 5 2794-003 Carnaxide Portugal
Maltese: Bayer Il-Portugall, S.A. Rua Quinta do Pinheiro 5 2794-003 Carnaxide Il-Portugall
Croatian: LEON FARMA
Maltese: Sun-Farm
Croatian: BAYER OY Pansiontie 47 PL 415
Maltese: Il-Finlandja BAYER OY Pansiontie 47
Croatian: Teva Pharmaceuticals Slovakia s.r.o.
Maltese: Ls-Slovakkja Teva Pharmaceuticals Slovakia s.r.o.
Croatian: Nizozemska Sandoz B.V.
Maltese: Sandoz B.V.
Croatian: Španjolska Merck Sharp and Dohme de España, S.A c/ Josefa Valcárcel, 38
Maltese: Merck Sharp and Dohme de España, S.A c/ Josefa Valcárcel, 38 28027 Madrid España (Spanja)
Croatian: Njemačka Dr. Kade Pharmazeutische Fabrik GmbH
Maltese: Il-Ġermanja Dr. Kade Pharmazeutische Fabrik GmbH
Croatian: Rumunjska Bayer Pharma AG Muellerstrasse 170-178
Maltese: Ir-Rumanija Bayer Pharma AG Muellerstrasse 170-178
Croatian: Španjolska Famy Care Europe Ltd.
Maltese: Famy Care Europe Ltd.
Croatian: Gyömrői ut 19-21, H-1103 Budapest, Hungary
Maltese: Gyömröí út 19-21 HU-1103 Budapest L-Ungerija
Croatian: Njemačka Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11
Maltese: Il-Ġermanja Sandoz Pharmaceuticals GmbH Raiffeisenstr.
Croatian: H-1036 Budapest Hungary
Maltese: H-1036 Budapest L-Ungerija
Croatian: Nizozemska Janssen-Cilag B.V.
Maltese: Janssen-Cilag B.V.
Croatian: LadeePharma Kft Lajos utca 48-66 H-1036 Budapest Hungary
Maltese: LadeePharma Kft Lajos utca 48-66 H-1036 Budapest L-Ungerija
Croatian: Rumunjska Pfizer Europe MA EEIG Ramsgate Road
Maltese: Ir-Rumanija Pfizer Europe MA EEIG Ramsgate Road
Croatian: Wyeth LTD.
Maltese: L-Ungerija Wyeth LTD.
Croatian: 5340 BH, Oss The Netherlands
Maltese: 5340 BH, Oss L-Olanda
Croatian: Germany previva sanol 20 Tabletten
Maltese: Il-Ġermanja previva sanol 20 Tabletten
Croatian: UAB Orivas J.Jasinskio 16B, LT-01112 Vilnius Lithuania
Maltese: Orivas J.Jasinskio 16B, LT-01112 Vilnius Il-Litwanja
Croatian: Germany previva sanol 30 Tabletten
Maltese: Il-Ġermanja previva sanol 30 Tabletten
Croatian: Nizozemska betapharm Arzneimittel GmbH Kobelweg 95
Maltese: L-Olanda betapharm Arzneimittel GmbH Kobelweg 95
Croatian: Bayer Pharma AG Müllerstrasse 178 D-13342 Berlin Germany
Maltese: Bayer Pharma AG Müllerstrasse 178 D-13342 Berlin Il-Ġermanja
Croatian: Medico Uno Pharma Kft.
Maltese: Medico Uno Pharma
Croatian: WH-Pharma s.r.o. Talafusova 970
Maltese: Talafusova 970
Croatian: Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Denmark
Maltese: Stragen Nordic A/S, Helsingørgade 8C, DK-3400
Croatian: Dezogestrel/ Etinylestradiol
Maltese: Desogestrel/ Etinylestradiol
Croatian: 5 Ks. J. Poniatowskiego Street 05-825 Grodzisk Mazowiecki Poland
Maltese: Poniatowskiego Street 05-825
Croatian: Njemačka Janssen-Cilag GmbH Johnson & Johnson Platz 1 41470 Neuss
Maltese: Il-Ġermanja Janssen-Cilag GmbH Johnson & Johnson Platz 1
Croatian: HU-1103 Budapest Hungary
Maltese: HU-1103 Budapest L-Ungerija
Croatian: Alkotás street 53 Budapest 1123
Maltese: Alkotás street 53
Croatian: 851 01 Bratislava Slovak republic
Maltese: 851 01 Bratislava Ls-Slovakkja
Croatian: Mikrogramm/150 Mikrogramm 21+7 Filmtabletten
Maltese: Mikrogramm 21+7 Filmtabletten
Croatian: Francuska SANDOZ 49 avenue Georges Pompidou 92593 Levellois-Perret Cedex France
Maltese: 49 avenue Georges Pompidou 92593 Levellois-Perret Cedex Franza
Croatian: Francuska SANDOZ 49 avenue Georges Pompidou 92593 Levallois-Perret Cedex France
Maltese: 49 avenue Georges Pompidou 92593 Levallois-Perret Cedex Franza
Croatian: Rumunjska Teva Pharmaceuticals S.R.L.
Maltese: Ir-Rumanija Teva Pharmaceuticals S.R.L.
Croatian: Nizozemska Pfizer B.V.
Maltese: Pfizer B.V.
Croatian: Zakłady Farmaceutyczne POLPHARMA S.A. ul. Pelplińska 19
Maltese: Zakłady Farmaceutyczne POLPHARMA S.A. ul.
Croatian: Dienogest Etinilestradiol ladonna sanol 2 mg /0,03 mg
Maltese: Dienogest Ethinylestradiol ladonna sanol 2 mg /0,03 mg
Croatian: Gedeon Richter France, 1-3 Ruse Caumartin, Paris 75009, France
Maltese: Ir-Renju Unit Gedeon Richter Franza, 1-3 Ruse Caumartin, Paris 75009,
Croatian: Parque Empresarial la Moraleja 28108 Alcobendas (Madrid) Spain
Maltese: Pharmacia Grupo Pfizer S.L. Avda. de Europa 20 B Parque Empresarial la Moraleja 28108 Alcobendas (Madrid) Spanja
Croatian: C/ Anabel Segura, 11
Maltese: TEVA PHARMA S.L.U. C/ Anabel Segura, 11 Edificio Albatros B 1ª planta
Croatian: Janssen-Cilag AS Drammensveien 288 0283 Oslo
Maltese: In-Norveġja Janssen-Cilag AS Drammensveien 288
Croatian: Španjolska SANDOZ FARMACÉUTICA, S.A. Avda.
Maltese: SANDOZ FARMACÉUTICA, S.A. Avda.
Croatian: N.V. Organon P.O.Box 20
Maltese: Organon P.O.Box 20
Croatian: Rua Quinta Pinheiro, 5 2794-003 Carnaxide Portugal
Maltese: Rua Quinta Pinheiro, 5 2794-003 Carnaxide Il-Portugall
Croatian: Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal
Maltese: Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Il-Portugall
Croatian: The Netherlands
Maltese: L-Olanda
Croatian: Rumunjska LadeePharma Kft Lajos utca 48-66
Maltese: Ir-Rumanija LadeePharma Kft Lajos utca 48-66
Croatian: Španjolska SANDOZ FARMACEUTICA, S.A. Avda.
Maltese: SANDOZ FARMACEUTICA, S.A. Avda.
Croatian: Scarlatti, 31 20124 Milano Italy
Maltese: Via D. Scarlatti, 31 20124
Croatian: Njemačka Mithra Pharmaceuticals S.A. Rue Saint Georges 5
Maltese: Il-Ġermanja Mithra Pharmaceuticals S.A. Rue Saint Georges 5
Croatian: Kent CT13 9NJ United Kingdom
Maltese: Kent CT13 9NJ Ir-Renju Unit
Croatian: Rowex Ltd Bantry Co.
Maltese: Rowex Ltd Bantry Co. Cork L-Irlanda
Croatian: Njemačka Helm AG Nordkanalstrasse 28 20097 Hamburg Germany
Maltese: Il-Ġermanja Helm AG Nordkanalstrasse 28 20097 Hamburg Il-Ġermanja
Croatian: Njemačka betapharm Arzneimittel GmbH Kobelweg 95
Maltese: Il-Ġermanja betapharm Arzneimittel GmbH Kobelweg 95
Croatian: Španjolska QUALITEC EUROPA, S.L Paseo Pintor Rosales, 42
Maltese: EUROPA, S.L Paseo Pintor Rosales, 42 28008 Madrid Spanja
Croatian: Boccioni, 1 21040 Origgio (VA) Italy
Maltese: Boccioni, 1 21040
Croatian: Pfizer Hungary LTD.
Maltese: L-Ungerija Pfizer L-Ungerija LTD.
Croatian: 1327 AH Almere The Netherlands
Maltese: Veluwezoom 22 1327 AH Almere L-Olanda
Croatian: 82109 Bratislava Slovak Republic
Maltese: 82109 Bratislava
Croatian: Swensweg 5
Maltese: Šmartinska cesta 53
Croatian: Rumunjska Ivowen Limited 3 Anglesa St
Maltese: Ir-Rumanija Ivowen Limited 3 Anglesa St
Croatian: Nieuwe Donk 3
Maltese: Centrafarm B.V. Nieuwe Donk 3
Croatian: 0,15 mg/0,02 mg Tableta
Maltese: 0,15 mg/0,02 mg Pillola
Croatian: Island
Maltese: L-Islanda
Croatian: NELYA 0,015 MG/0,06 MG
Maltese: NELYA 0,015 MG/0,06
Croatian: N.V. Organon Kloosterstraat 6 P.O.
Maltese: N.V. Organon Kloosterstraat 6 P.O. Box 20
Croatian: Francuska ZYDUS FRANCE ZAC Les Hautes Patures 25 Rue des peuliers 92752 Nanterre Cedex France
Maltese: Rue des peuliers 92752 Nanterre Cedex Franza
Croatian: Telecom Gardens Medialaan 40
Maltese: Il-Belġju SANDOZ N.V. Telecom Gardens Medialaan 40
Croatian: 85737 Ismaning Germany
Maltese: 85737 Ismaning Il-Ġermanja
Croatian: VONILLE 0,060 MG/0,015 MG
Maltese: VONILLE 0,060 MG/0,015
Croatian: Rumunjska Johnson & Johnson d.o.o. Šmartinska cesta 53
Maltese: Ir-Rumanija Johnson & Johnson d.o.o.
Croatian: Španjolska Schering - Plough S.A. c/ Josefa Valcárcel, 38
Maltese: Schering - Plough S.A. c/ Josefa Valcárcel, 38 28027 Madrid España (Spanja)
Croatian: Nizozemska LadeePharma Kft Lajos u 48-66 1036
Maltese: LadeePharma Kft Lajos u 48-66 1036 Budapest
Croatian: Germany aida
Maltese: Il-Ġermanja aida
Croatian: Plom, 2-4, 5ª planta
Maltese: Plom, 2-4, 5ª planta 08038 Barcelona Spanja
Croatian: Nizozemska Teva Nederland B.V.
Maltese: Teva Nederland B.V. Swensweg 5
Croatian: Rumunjska Medico Uno Pharma Kft.
Maltese: Ir-Rumanija Medico Uno Pharma
Croatian: Pfizer, spol. s r.o.
Maltese: Pfizer, spol.
Croatian: MPCA BVBA Vrijestraat 28 9960 Assenede Belgium
Maltese: 9960 Assenede Il-Belġju
Croatian: Luksemburg Mithra Pharmaceuticals S.A. Rue Saint Georges 5
Maltese: Il-Belġju Mithra Pharmaceuticals S.A. Rue Saint Georges 5
Croatian: Gestoden/ethinylestra diol 75/20 Mylan
Maltese: Gestoden/ethinylestra diol 75/20
Croatian: Etinilestradiol Gestoden
Maltese: Ethinylestradiol Gestodene
Croatian: Etonogestrel Etinilestradiol
Maltese: Etonogestrel Ethinylestradiol
Croatian: Francuska Laboratoires Majorelle 12 Rue de Berri
Maltese: Laboratoires Majorelle 12 Rue de Berri F-75008 Paris Franza
Croatian: Francuska MSD France 34 avenue Léonard de Vinci 92418 Courbevoie Cedex France
Maltese: 34 avenue Léonard de Vinci 92418 Courbevoie Cedex Franza
Croatian: Barcelona
Maltese: Berlin
Croatian: Sandoz Pharmaceuticals d.d. Verovškova 57
Maltese: Ls-Slovakkja Sandoz Pharmaceuticals d.d.
Croatian: Francuska MSD France 34 avenue Léonard de Vinci 92418 Courbevoie Cedex France varnoline
Maltese: 34 avenue Léonard de Vinci 92418 Courbevoie Cedex Franza varnoline
Croatian: 821 02 Bratislava Slovak republic
Maltese: 821 02 Bratislava
Croatian: HARMONET OBALENÉ TABLETY
Maltese: HARMONET OBALENÉ
Croatian: 5026 RH Tilburg
Maltese: Dr. Paul Janssenweg 150 5026 RH Tilburg L-Olanda
Croatian: Luksemburg Gedeon Richter France SARL 1-3 rue Caumartin
Maltese: Gedeon Richter Franza SARL 1-3 rue Caumartin 75009 Paris
Croatian: Švedska
Maltese: Stockholm Sweden
Croatian: 67, 70, 210, 215 i 219.
Maltese: fil-codons 41, 67, 70, 210, 215 u 219.
Croatian: ViiV Healthcare BV Huis ter Heideweg 62 3705 LZ Zeist Nizozemska
Maltese: ViiV Healthcare BV Huis ter Heideweg 62 3705 LZ Zeist L-Olanda
Croatian: OSTALO otopina sorbitola (3.2 g, 10.2 g, 13.4 g)/lamivudin
Maltese: Soluzzjoni ta' sorbitol (3.2g , 10.2 g, 13.4 g)/ Lamivudine
Croatian: Lamivudin:
Maltese: Lamivudine:
Croatian: zidovudin AUC ↓12%
Maltese: L-AUC ta' Zidovudine ↓12%
Croatian: 17. JEDNISTVENI IDENTIFIKATOR - 2D BARKOD
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
Croatian: Priory Street
Maltese: Priory Street, Ware,
Croatian: zidovudin AUC ↑33% atovakvon AUC ↔
Maltese: L-AUC ta' Zidovudine ↑33% L-AUC ta' Atovaquone ↔
Croatian: • vrućica (visoka temperatura)
Maltese: • deni (temperatura għolja)
Croatian: Drugi lijekovi i Combivir
Maltese: Mediċini oħra u Combivir
Croatian: (pancitopenija).
Maltese: (epatite).
Croatian: PROIZVOĐAČ(I) ODGOVORAN (NI) ZA PUŠTANJE
Maltese: MANIFATTUR(I) RESPONSABBLI
Croatian: Djeca s tjelesnom težinom između 21 kg i 30 kg
Maltese: Tfal li jiżnu bejn 21 u 30 kg
Croatian: Hertfordshire, SG12 0DJ, Ujedinjeno Kraljevstvo ili
Maltese: Hertfordshire, SG12 0DJ, Ir-Renju Unit jew
Croatian: Pogledajte dio 4 za više informacija.
Maltese: Ara Sezzjoni 4 għal aktar informazzjoni.
Croatian: Fenitoin AUC ↑↓
Maltese: L-AUC ta' Phenytoin ↑↓
Croatian: Ta će doza postići prosječni AUC0-12 u rasponu 3800-5300 ng h/ml.
Maltese: Din id-doża twassal għal AUC0-12 bejn wieħed u ieħor minn 3,800 sa 5,300ng.h/ml.
Croatian: Obratite pozornost na važne simptome
Maltese: Oqogħod attent għal sintomi importanti
Croatian: Bioraspoloživost oralnog lamivudina u odraslih normalno iznosi između 80-85%, a bioraspoloživost zidovudina 60-70%.
Maltese: lamivudine li jittieħed mill-ħalq fl-adulti hi normalment bejn it-80-85% u għal zidovudine 60-70%.
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET ViiV Healthcare BV
Maltese: FIS-SUQ ViiV Healthcare BV
Croatian: Istodobna terapija, osobito akutna terapija s potencijalno nefrotoksičnim ili mijelosupresivnim lijekovima (npr. sistemski pentamidin, dapson, pirimetamin, kotrimoksazol, amfotericin, flucitozin, ganciklovir, interferon, vinkristin, vinblastin i doksorubicin) mogu također povisiti rizik za razvoj nuspojava na zidovudin.
Maltese: Kura, speċjalment terapija akuta, flimkien ma' prodotti mediċinali li jistgħu jkunu nefrotossiċi jew mijelosoppressivi (eż. pentamidine sistemiku, dapsone, pyrimethamine, co-trimoxazole, amphotericin, flucytosine, ganciclovir, interferon, vincristine, vinblastine u doxorubicin) tista' wkoll iżżid ir-riskju ta' reazzjonijiet avversi għal zidovudine.
Croatian: Datum prvog odobrenja: 18. ožujka 1998.
Maltese: Data tal-ewwel awtorizzazzjoni: 18 ta' Marzu 1998 Data tal-aħħar tiġdid: 13 ta' Frar 2008
Croatian: Nadzor nad koncentracijama fenitoina.
Maltese: Immonitorja l konċentrazzjonijiet ta' phenytoin.
Croatian: • jezgra tablete; mikrokristalična celuloza, natrijev škroboglikolat (bez glutena), magnezijev stearat, koloidni silicijev dioksid
Maltese: • Il-qalba tal-pillola; microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate, colloidal silicon dioxide
Croatian: • Periodička izvješća o neškodljivosti Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenom člankom 107.cstavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
Croatian: Prema učestalosti nuspojave su definirane kao vrlo česte (≥1/10), česte (≥1/100 do <1/10), manje česte (≥1/1000 do <1/100), rijetke (≥1/10 000 do <1/1000) i vrlo rijetke (<1/10 000).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (>1/10), komuni (>1/100 sa <1/10), mhux komuni (>1/1,000 sa 1/100), rari (>1/10,000 sa <1/1,000), rari ħafna (<1/10,000).
Croatian: Jednokratna doza oralne otopine lamivudina od 300 mg lamivudin:
Maltese: Doża waħda lamivudine soluzzjoni orali 300 mg Lamivudine:
Croatian: • metadon, koji se primjenjuje kao nadomjesna terapija za heroin
Maltese: • methadone, jintuża bħala sostitut tal-eroina
Croatian: Medijan (raspon) tmax za lamivudin iznosio je 0,75 sata (0,50-2,00), a za zidovudin 0,50 sata (0,25-2,00).
Maltese: Il-valuri Tmax medjani (firxa) ta' lamivudine u ta' zidovudine kienu 0.75 (0.50 - 2.00) sigħat u 0.50 (0.25-2.00) sigħat rispettivament.
Croatian: Bolesnike s povećanim rizikom treba pažljivo pratiti.
Maltese: Pazjenti f'riskju qawwi għandhom ikunu taħt osservazzjoni stretta.
Croatian: Lamivudin pokazuje linearnu farmakokinetiku u rasponu terapijskih doza i ograničeno se veže za glavni protein u plazmi-albumin (<36% serumskog albumina in vitro).
Maltese: Lamivudine juri farmakokinetika lineari fuq il-firxa ta' dożi terapewtiċi u juri irbit limitat mal-albumin, il-proteina l-aktar komuni tal-plażma (<36% albumin fis serum in vitro). lL-għaqda ta' zidovudine mal-proteini tal-plażma hi bejn 34% u 38%.
Croatian: Oba se lijeka u stanicama metaboliziraju u svoje aktivne oblike, lamivudin 5'-trifosfat (TP) i zidovudin 5'-TP.
Maltese: Iż-żewġ prodotti mediċinali jiġu metabolizzati fiċ-ċelluli, għas-sustanza attiva, lamivudine 5'- trifosfat (TP) u zidovudine 5'-TP rispettivament.
Croatian: Glaxo Operations UK Limited (posluje kao Glaxo Wellcome Operations)
Maltese: (jinnegozja bħala Glaxo Wellcome Operations),
Croatian: Vrijednosti CSSmax su bile 4,45 μM (1,19 μg/ml) nakon primjene 120 mg zidovudina (u otopini)/m2 površine tijela, te 7,7 μM (2,06 μg/ml) nakon doze od 180 mg/m2 površine tijela.
Maltese: 4.45μM (1.19μg/ml) wara doża ta' 120mg ta' zidovudine (f'soluzzjoni)/m2 ta' surface area tal-ġisem u 7.7μM (2.06μg/ml) f'surface area tal-ġisem ta' 180mg/m².
Croatian: Vrlo rijetke nuspojave
Maltese: Effetti sekondarji rari
Croatian: zidovudin AUC ↓48% (UGT indukcija)
Maltese: L-AUC ta' Zidovudine ↓48% (induzzjoni ta' UGT)
Croatian: 16. PODACI NA BRAILLEOVOM PISMU combivir
Maltese: INFORMAZZJONI BIL-BRAILLE combivir
Croatian: Nadzor zbog znakova toksičnosti zidovudina (vidjeti dio 4.8).
Maltese: Immonitorja għal sinjali ta' tossiċità ta' zidovudine (ara sezzjoni 4.8).
Croatian: 17. JEDNISTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
Maltese: Barcode 2D li għandha l-identifikatur uniku inkluż.
Croatian: trimetoprim/sulfametoksazol (kotrimoksazol)/zidovudin
Maltese: Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Zidovudine
Croatian: Ograničeni podaci iz kliničkih ispitivanja ne ukazuju na značajno povišen rizik za razvoj nuspojava na zidovudin sa kotrimoksazolom (vidjeti informacije vezane za interakcije u tablici iznad koje se odnose lamivudin i kotrimoksazol), aerosolni pentamidin, pirimetamin i aciklovir u dozama primijenjenim kao profilaksa.
Maltese: Dejta limitata minn provi kliniċi ma turix riskju ogħla b'mod sinifikanti ta' reazzjonijiet avversi meta zidovudine jingħata ma' cotrimoxazole (ara l-informazzjoni dwar interazzjoni hawn fuq marbuta ma' lamivudine u co-trimoxazole), pentamidine aerosolizzat, pyrimethamine u acyclovir fid-dożi użati għall-profilassi.
Croatian: • povišena razina enzima koji se zovu amilaze
Maltese: • żieda f'enzima msejħa amylase.
Croatian: Pneumocystis jirovecii pneumonije (PCP) i toksoplazmoze nisu proučavane, te bi ih trebalo izbjegavati
Maltese: Pneumocystis jirovecii (PCP) u toxoplasmosis għadhom ma ġewx studjati u għandhom jiġu evitati.
Croatian: Farmakokinetika u djece: Farmakokinetički profil zidovudina u djece starije od 5-6 mjeseci života je sličan onome u odraslih.
Maltese: Farmakokinetika fit-tfal: Fi tfal ta' aktar minn 5-6 xhur, il-profil farmakokinetiku ta' zidovudine huwa bħal dak fl-adulti.
Croatian: • vinkristin, vinblastin ili doksorubicin, za liječenje karcinoma.
Maltese: • vincristine, vinblastine jew doxorubicin, biex jikkuraw il-kanċer.
Croatian: Lamivudin-TP i zidovudinTP pokazuju selektivnu inhibicijsku aktivnost prema HIV-1 i HIV-2 replikaciji in vitro, a lamivudin djeluje i protiv kliničkog izolata HIV-a rezistentnog na zidovudin.
Maltese: Lamivudine - TP u Zidovudine - TP għandhom attivita' inibitorja selettiva kontra r-replikazzjoni in vitro ta' l-HIV-1 u l-HIV-2 ;lamivudine hu wkoll attiv kontra iżolati kliniċi ta' l-HIV li huma reżistenti għal zidovudine.
Croatian: zidovudin AUC ↑106% (UGT inhibicija)
Maltese: L-AUC ta' Zidovudine ↑106% (impediment ta' UGT)
Croatian: trimetoprim/sulfametoksazol (kotrimoksazol)/lamivudin (160 mg/800 mg jedanput dnevno tijekom 5 dana /300 mg jednokratna doza)
Maltese: Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Lamivudine (160 mg/800 mg darba kuljum għal 5t ijiem/doża waħda ta' 300
Croatian: FARMACEUTSKI PODACI
Maltese: PRODOTTI MEDIĊINALI
Croatian: zidovudin AUC ↑43% metadon AUC ↔
Maltese: L-AUC ta' Zidovudine ↑43% L-AUC ta' Methadone ↔
Croatian: Stoga postoji nizak potencijal za interakcije s antiretrovirusnim inhibitorima protease, nenukleozidima i ostalim lijekovima koji se metaboliziraju putem glavnih P450 enzima.
Maltese: Għalhekk, ftit li xejn hemm possibbiltà għal interazzjonijiet ma' mediċini antiretrovirali impedituri ta' protease, mhux nuklejosidi u prodotti mediċinali oħra mmetabolizzati mill-enzimi P450 prinċipali.
Croatian: natrijev škroboglikolat silicijev dioksid, koloidni magnezijev stearat Film ovojnica tablete: hipromeloza (E464) titanijev dioksid (E171) makrogol 400 polisorbat 80
Maltese: Hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80
Croatian: U intravenskim studijama izmjerene su srednje vrijednosti prividnog volumena raspodjele od 1,3 l/kg za lamivudin i 1,6 l/kg za zidovudin.
Maltese: Studji dwar lamivudine u zidovudine injettati ġol-vini urew li l-volum medju evidenti ta' distribuzzjoni hu 1.3 u 1.6 l/kg rispettivament.
Croatian: Znakovi osteonekroze uključuju:
Maltese: Sinjali ta' ostejonekrożi jinkludu:
Croatian: • upala gušterače (pankreatitis)
Maltese: • infjammazzjoni tal-frixa (pankrejatite)
Croatian: GlaxoSmithKline Pharmaceuticals S.A. ul. Grunwaldzka 189 60-322 Poznan Poljska
Maltese: Grunwaldzka 189 60-322 Poznan Il-Polonja
Croatian: Nadzor nad znakovima toksičnosti zidovudina (vidjeti dio 4.8).
Maltese: tossiċità ta' zidovudine (ara sezzjoni 4.8).
Croatian: Zidovudin se dobro apsorbira iz crijeva i u svim ispitivanim dozama, u djece i odraslih, bioraspoloživost se kretala između 60 i 74%, sa srednjom vrijednosti od 65%.
Maltese: Zidovudine jiġi assorbit tajjeb mill-musrana u fil-livelli kollha ta' dożi studjati fit tfal u fl-adulti, il-biodisponibilità kienet ta' bejn 60-74% b'medja ta' 65%. Livelli ta' Cssmax kienu ta'
Croatian: • lijekove (obično u tekućem obliku) koji sadrže sorbitol i druge šećerne alkohole (poput ksilitola, manitola, laktitola ili maltitola), ako se uzimaju redovito.
Maltese: • mediċini (normalment likwidi) li fihom sorbitol u alkoħol ieħor taz-zokkor (bħal xylitol, mannitol, lactitol jew maltitol), jekk jittieħdu regolament.
Croatian: Manje često: miopatija
Maltese: Mhux komuni: Mijopatija