FrancophonIA/ELRC3.0 huggingface dataset:
Italian: FR - Francia ZYDUS France 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre France
Latvian: FR - Francija ZYDUS France 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre FRANCIJA
Italian: FR - Francia ZYDUS France 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre FRANCE
Latvian: FR - Francija ZYDUS France 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre Francija
Italian: LT - Lituania UAB Sanofi - Aventis Lietuva A. Juozapaviciaus 6/2
Latvian: LT - Lietuva UAB Sanofi - Aventis Lietuva A.
Italian: Repubblica Ceca sanofi-aventis s.r.o.
Latvian: CZ - Čehijas Republika sanofi-aventis s.r.o.
Italian: D-64295 Darmstadt Germany durafenat MF 200 mg compressa a rilascio modificato
Latvian: D-64295 Darmstadt Vācija durafenat MF 200 mg
Italian: S.C. SLAVIA PHARM S.R.L. B-dul Theodor Pallady nr. 44C Sector 3, Bucureşti Romania
Latvian: SLAVIA PHARM S.R.L. B-dul Theodor Pallady nr.
Italian: CY - Cipro Varnavas Hadjipanayis Ltd 7 Androcleous street
Latvian: CY - Kipra Varnavas Hadjipanayis Ltd 7 Androcleous street
Italian: 63804 Cournon d'Auvergne Cedex France
Latvian: 63804 Cournon d'Auvergne Cedex Francija
Italian: BEFIZAL L.P. 400 mg, comprimé enrobé à libération prolongée compressa a rilascio prolungato
Latvian: BEFIZAL L.P. 400 mg, comprimé enrobé à libération prolongée
Italian: Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal
Latvian: Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugāle
Italian: SE - Svezia Laboratoires Fournier SA 28 boulevard Clèmenceau BP 27912 21079 DIJON Cedex France
Latvian: Laboratoires Fournier SA 28 boulevard Clèmenceau BP 27912 21079 DIJON Cedex Francija
Italian: FR - Francia CRISTERS 22 quai Gallieni 92150 Suresnes France
Latvian: FR - Francija CRISTERS 22 quai Gallieni 92150 Suresnes Francija
Italian: FR - Francia CRISTERS 22 quai Gallieni 92150 Suresnes FRANCE
Latvian: FR - Francija CRISTERS 22 quai Gallieni 92150 Suresnes FRANCIJA
Italian: Hennig Arzneimittel GmbH & Co.KG
Latvian: DE - Vācija Hennig Arzneimittel GmbH & Co.KG
Italian: D-64295 Darmstadt Germany
Latvian: D-64295 Darmstadt Vācija
Italian: 7720 Pécsvárad Hungary
Latvian: Pannonpharma út 1. 7720 Pécsvárad Ungārija
Italian: BEZAFIBRATE ACTAVIS L.P. 400 mg, comprimé enrobé à libération prolongée compressa a rilascio prolungato
Latvian: BEZAFIBRATE ACTAVIS L.P. 400 mg, comprimé enrobé à libération prolongée
Italian: ES - Spagna KERN PHARMA S.L. Venus, 72.
Latvian: ES - Spānija KERN PHARMA S.L.
Italian: ES - Spagna NOVARTIS FARMACEUTICA, S.A. Gran Via de les Corts Catalanes 764 Barcelona
Latvian: Gran Via de les Corts Catalanes 764 Barcelona
Italian: 92302 Levallois-Perret Cedex FRANCE
Latvian: 92302 Levallois-Perret Cedex FRANCIJA
Italian: 92302 Levallois-Perret Cedex France
Latvian: 92302 Levallois-Perret Cedex Francija
Italian: GERMANY
Latvian: Vācija
Italian: Germany
Latvian: VĀCIJA
Italian: 93330 Neuilly-sur-Marne France
Latvian: 93330 Neuilly-sur-Marne FRANCIJA
Italian: 93330 Neuilly-sur-Marne FRANCE
Latvian: 93330 Neuilly-sur-Marne Francija
Italian: TERAPIA S.A. Str. Fabricii Nr. 124 Cluj-Napoca Romania
Latvian: Str. Fabricii Nr. 124 Cluj-Napoca Rumānija
Italian: Floridsdorfer Hauptstraße 1 A-1210 Wien
Latvian: Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 A-1210 Wien
Italian: Fenofibrate - AS 267 mg 267 mg
Latvian: Fenofibrate - AS 267 mg
Italian: 2740-298 Porto Salvo Portugal
Latvian: 2740-298 Porto Salvo Portugāle
Italian: CHEPLAPHARM Arzneimittel GmbH
Latvian: DE - Vācija CHEPLAPHARM Arzneimittel GmbH
Italian: BE - Belgio LABORATOIRES S.M.B.
Latvian: BE - Beļģija LABORATOIRES S.M.B. S.A.
Italian: 26-28, rue de la Pastorale B- 1080 Bruxelles Belgium
Latvian: 26-28, rue de la Pastorale B- 1080 Bruxelles Beļģija
Italian: Wörwag Pharma GmbH & Co.
Latvian: DE - Vācija Wörwag Pharma GmbH & Co.
Italian: SISlovenia
Latvian: SISlovēnija
Italian: PannonPharma Kft. Pannonpharma út 1.
Latvian: PannonPharma Kft.
Italian: LACROMID 200 FC TABLETS 200mg compressa
Latvian: LACROMID 200 FC TABLETS 200mg tabletes
Italian: Empreendimento Lagoas Park Edifício 5C - 6º 2740-298 Porto Salvo Portugal
Latvian: Empreendimento Lagoas Park Edifício 5C - 6º 2740-298 Porto Salvo Portugāle
Italian: Bezabeta 400 retard compressa a rilascio prolungato
Latvian: Bezabeta 400 retard
Italian: PETERSFIELD, HANTSGU32 3QB United Kingdom
Latvian: PETERSFIELD, HANTSGU32
Italian: Bezafibrat 400 ret-1 A Pharma compressa a rilascio prolungato
Latvian: Bezafibrat 400 ret-1 A Pharma
Italian: 2740-299 Porto Salvo Portugal
Latvian: 2740-299 Porto Salvo Portugāle
Italian: FR - Francia SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret FRANCE
Latvian: FR - Francija SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret FRANCIJA
Italian: FR - Francia SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France
Latvian: FR - Francija SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret Francija
Italian: Heumann Pharma GmbH & Co.
Latvian: DE - Vācija Heumann Pharma GmbH & Co.
Italian: 6D 64295 Darmstadt Germany
Latvian: 64295 Darmstadt Vācija
Italian: UK ADDRESS: Pfizer Ltd., Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS UK
Latvian: UK ADDRESS: Pfizer Ltd., Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS Lielbritānija
Italian: FR - Francia Laboratoire RATIOPHARM 19, boulevard Paul Vaillant Couturier
Latvian: FR - Francija Laboratoire RATIOPHARM 19, boulevard Paul Vaillant Couturier
Italian: FR - Francia LABORATOIRE RATIOPHARM 19, boulevard Paul Vaillant Couturier
Latvian: FR - Francija LABORATOIRE RATIOPHARM 19, boulevard Paul Vaillant Couturier
Italian: UK ADDRESS: Pfizer Ltd., Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK
Latvian: UK ADDRESS: Pfizer Ltd., Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, Lielbritānija
Italian: PL - Polonia ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, D-89079
Latvian: PL - Polija ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, D-89079
Italian: Bahnhofstr.
Latvian: Greschbachstr.
Italian: Edifício 5C - 6º 2740-298 Porto Salvo Portugal
Latvian: Edifício 5C - 6º 2740-298 Porto Salvo Portugāle
Italian: Reykjavíkurvegi, 76-78 IS-220 Hafnarfjörour Iceland
Latvian: Reykjavíkurvegi, 76-78 IS-220 Hafnarfjörour Islande
Italian: Empreendimento Lagoas Park, Edifício 7 - 2º/3º 2740-264 Porto Salvo Portugal
Latvian: Empreendimento Lagoas Park, Edifício 7 - 2º/3º 2740-264 Porto Salvo Portugāle
Italian: TERAPIA S.A. Str. Fabricii Nr. 124, Cluj-Napoca România
Latvian: Str. Fabricii Nr. 124, Cluj-Napoca Rumānija
Italian: SE - Svezia Pfizer AB 191 90 Sollentuna Sweden
Latvian: 191 90 Sollentuna Zviedrija
Italian: Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS
Latvian: PFIZER LIMITED. Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS
Italian: Netherlands
Latvian: NLNīderlande
Italian: Abbott Arzneimittel GmbH Hans-Boeckler-Allee 20 D-30173 Hannover Germany
Latvian: DE - Vācija Abbott Arzneimittel GmbH Hans-Boeckler-Allee 20
Italian: Laboratoires Fournier SA 8 Bd Clemenceau F-21000 Dijon France
Latvian: Laboratoires Fournier SA 8 Bd Clemenceau F-21000 Dijon Francija
Italian: D-64295 Darmstadt Germany durafenat retard capsula rigida a rilascio prolungato
Latvian: D-64295 Darmstadt Vācija durafenat retard
Italian: FR - Francia Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon
Latvian: FR - Francija Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon
Italian: Edifício 7 - 2º/3º 2740-299 Porto Salvo Portugal
Latvian: Edifício 7 - 2º/3º 2740-299 Porto Salvo Portugāle
Italian: Fenobrat capsula rigida a rilascio prolungato
Latvian: Fenobrat ilgstošās darbības kapsulas
Italian: 94200 Ivry sur Seine FRANCE
Latvian: 94200 Ivry sur Seine Francija
Italian: Edifício 7 - 2º/3º 2740-264 Porto Salvo Portugal
Latvian: Edifício 7 - 2º/3º 2740-264 Porto Salvo Portugāle
Italian: FENOFIBRATE EXPANPHARM 67 mg, comprimé compressa
Latvian: FENOFIBRATE EXPANPHARM 67 mg, comprimé tabletes
Italian: EL - Grecia PHARMACEUTICAL INDUSTRY E.G. KORONIS S.A.
Latvian: EL - Grieķija PHARMACEUTICAL INDUSTRY E.G.
Italian: 1 cours du Triangle 92936 Paris la Défense Cedex FRANCE
Latvian: 1 cours du Triangle 92936 Paris la Défense Cedex Francija
Italian: 1 cours du Triangle 92936 Paris la Défense Cedex France
Latvian: 1 cours du Triangle 92936 Paris la Défense Cedex FRANCIJA
Italian: FENOFIBRATE RATIOPHARM 145 mg, comprimé compressa
Latvian: FENOFIBRATE RATIOPHARM 145 mg, comprimé tabletes
Italian: IT - Italia Ratiopharm Gmbh Graf-Arco Strasse 3
Latvian: IT - Itālija Ratiopharm Gmbh Graf-Arco Strasse 3
Italian: PL - Polonia ratiopharm GmbH Graf-Arco-Strasse 3
Latvian: PL - Polija ratiopharm GmbH Graf-Arco-Strasse 3
Italian: ZAFIBRAL FC TABLETS 200mg compressa
Latvian: ZAFIBRAL FC TABLETS 200mg tabletes
Italian: FR - Francia Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Iceland
Latvian: FR - Francija Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Islande
Italian: Pfizer Pharma GmbH Linkstr.
Latvian: DE - Vācija Pfizer Pharma GmbH Linkstr. 10
Italian: MODALIM TABLETS 100mg 100mg compressa
Latvian: MODALIM TABLETS 100mg 100mg tabletes
Italian: PL - Polonia Sanofi-Aventis France boulevard Romain Rolland 1-13, F-75014 Paris,
Latvian: PL - Polija Sanofi-Aventis France boulevard Romain Rolland 1-13, F-75014 Paris,
Italian: AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
Latvian: DE - Vācija AbZ-Pharma GmbH Dr.Georg-Spohn-Str.
Italian: FENOFIBRATE EXPANPHARM 200 mg, comprimé compressa
Latvian: FENOFIBRATE EXPANPHARM 200 mg, comprimé tabletes
Italian: Cyprus
Latvian: Kipra
Italian: Ciprofibrato contenenti farmaci con autorizzazione all'immissione in commercio nell'Unione europea
Latvian: Ciprofibrātu saturošas zāles, kas reģistrētas Eiropas Savienībā
Italian: SE - Svezia Sandoz A/S C.F.Tietgens
Latvian: Sandoz A/S C.F.Tietgens Boulevard 40
Italian: Bezafibrat 400 retard Heumann compressa a rilascio prolungato
Latvian: Bezafibrat 400 retard Heumann
Italian: DEGermania
Latvian: DEVācija
Italian: Actavis Group PLC Reykjavikurvegur 76-78 IS- 220 Hafnarfjordur Iceland
Latvian: Actavis Group PLC Reykjavikurvegur 76-78 IS- 220 Hafnarfjordur Islande
Italian: BEZAFIBRAT ARENA 200 mg 200 mg compressa
Latvian: BEZAFIBRAT ARENA 200 mg 200 mg tabletes
Italian: S.A. 26-28 rue de la Pastorale B-1080 Bruxelles Belgium
Latvian: 26-28 rue de la Pastorale B-1080 Bruxelles Beļģija
Italian: Fenolip retard 250 mgKapseln capsula rigida a rilascio prolungato
Latvian: Fenolip retard 250 mgKapseln ilgstošās darbības cietās kapsulas
Italian: SKSlovacchia
Latvian: SEZviedrija
Italian: FI - Finlandia Actavis Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland
Latvian: FI - Somija Actavis Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Islande
Italian: Gemfibrozil contenenti farmaci con autorizzazione all'immissione in commercio nell'Unione europea
Latvian: Gemfibrozilu saturošas zāles, kas reģistrētas Eiropas Savienībā
Italian: HANTS GU32 3QB United Kingdom
Latvian: 3QB Lielbritānija
Italian: "Solo per uso sottocutaneo.
Latvian: "Tikai subkutānai lietošanai.
Italian: Questo testo:
Latvian: Šāds teksts:
Italian: Beriplast P (e denominazioni associate)
Latvian: Beriplast P (un sinonīmiskie nosaukumi)
Italian: Ferita aperta
Latvian: Atvērta brūce
Italian: Duplospra y MIS NIST B11
Latvian: Duplospray MIS regulators NIST B11
Italian: Un eccessivo spessore del coagulo potrebbe interferire negativamente con l'efficacia del prodotto e il processo di cicatrizzazione della ferita.
Latvian: Pārmērīgs recekļa biezums var negatīvi ietekmēt preparāta efektivitāti un brūces dzīšanas procesu.
Italian: Nota: le modifiche di questo riassunto delle caratteristiche del prodotto e del foglio illustrativo sono valide al momento della decisione da parte della Commissione.
Latvian: Piezīme: šie zāļu apraksta un lietošanas instrukcijas grozījumi ir spēkā Komisijas lēmuma pieņemšanas brīdī.
Italian: "ARTISS è inteso esclusivamente per l'uso ospedaliero da parte di medici o chirurghi esperti."
Latvian: "ARTISS ir paredzēts lietot tikai pieredzējušiem ārstiem vai ķirurgiem slimnīcas apstākļos."
Italian: Non spruzzare più vicino della distanza raccomandata.
Latvian: Neizsmidziniet attālumā, kas ir mazāks par ieteikto.
Italian: ALLEGATO III EMENDAMENTI AI PARAGRAFI PERTINENTI DEL RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO E DEL FOGLIO ILLUSTRATIVO
Latvian: III PIELIKUMS GROZĪJUMI ATTIECĪGAJĀS ZĀĻU APRAKSTA UN LIETOŠANAS INSTRUKCIJAS SADAĻĀS
Italian: Duplospra y MIS Regolator e
Latvian: Duplospray MIS regulators
Italian: Pressione, distanza e dispositivi raccomandati per l'applicazione spray di [nome del prodotto]
Latvian: Ieteiktais spiediens, attālums un ierīces [izstrādājuma nosaukums] uzklāšanai izmidzinot
Italian: [NOME DEL PRODOTTO] non è raccomandato per la chirurgia laparoscopica.
Latvian: [PREPARĀTA NOSAUKUMS] nav ieteicams izmantot laparoskopiskās ķirurģijas procedūrās.
Italian: "Per garantire la sicurezza ottimale dell'uso di [NOME DEL PRODOTTO] mediante applicazione spray, devono essere seguite le seguenti raccomandazioni:
Latvian: Lai nodrošinātu optimāli drošu [PREPARĀTA NOSAUKUMS] lietošanu, uzklāšanai izsmidzinot, ir jāievēro tālāk minētie norādījumi:
Italian: 2-5 cm 1,2-1,5 bar (18-22 psi)
Latvian: 2-5 cm 1,2-1,5 bāri (18-22 psi)
Italian: Dopo tale decisione le informazioni sul prodotto verranno aggiornate dalle autorità nazionali competenti secondo le necessità.
Latvian: Pēc Komisijas lēmuma pieņemšanas dalībvalstu kompetentās iestādes atbilstoši atjauno attiecīgo zāļu aprakstu.
Italian: Nelle procedure minimamente invasive/laparoscopiche deve essere usato un dispositivo regolatore di pressione che eroghi una pressione massima non superiore a 1,5 bar (22 psi) e utilizzi esclusivamente biossido di carbonio.
Latvian: minimāli invazīvās/laparoskopijas procedūrās ir jāizmanto spiediena regulatora ierīce, kas nodrošina maksimālo spiedienu ne vairāk kā 1,5 bāri (22 psi) un kurā tiek izmantota tikai oglekļa dioksīda gāze;
Italian: Pressione dello spruzzo raccomandata
Latvian: Ieteicamais izsmidzināšanas spiediens
Italian: L'applicazione spray di [NOME DEL PRODOTTO] deve essere eseguita solo se è possibile rispettare accuratamente la distanza di nebulizzazione raccomandata dal produttore.
Latvian: [PREPARĀTA NOSAUKUMS] uzklāšanu izsmidzinot var izmantot tikai tādā gadījumā, ja ir iespējams precīzi noteikt ražotāja ieteikto izsmidzināšanas attālumu.
Italian: Per garantire la sicurezza ottimale dell'uso di [NOME DEL PRODOTTO], deve essere nebulizzato utilizzando un dispositivo regolatore di pressione che eroghi una pressione massima non superiore a 2,0 bar (28,5 psi).
Latvian: Lai nodrošinātu optimāli drošu [PREPARĀTA NOSAUKUMS] lietošanu, tas ir jāizsmidzina, izmantojot spiediena regulatora ierīci, kas nodrošina maksimālo spiedienu 2,0 bāri (28.5 psi).
Italian: Come usare [NOME DEL PRODOTTO]
Latvian: 3. Kā lietot [IZSTRĀDĀJUMA NOSAUKUMS]
Italian: • I dispositivi spray e le punte accessorie sono forniti con istruzioni per l'uso e raccomandazioni sui range di pressione e di distanza di nebulizzazione dalla superficie tissutale.
Latvian: • Izsmidzināšanas ierīcei un piederuma uzgalam ir pievienotas lietošanas instrukcijas ar norādēm par ieteiktajiem spiediena diapazoniem un izsmidzināšanas attālumu no audu virsmas.
Italian: [NOME DEL PRODOTTO] deve essere ricostituito e somministrato seguendo le istruzioni indicate e solo con i dispositivi raccomandati per il presente prodotto (vedere paragrafo 6.6).
Latvian: sagatavojiet [PREPARĀTA NOSAUKUMS] un lietojiet to atbilstoši norādījumiem un izmantojot ierīces, ko ieteicams lietot ar šo izstrādājumu (skatīt 6.6 apakšpunktu).
Italian: Prima di usare [NOME DEL PRODOTTO]
Latvian: 2. Pirms [PREPARĀTA NOSAUKUMS] lietošanas
Italian: Procedure laparoscopiche/minimame nte invasive
Latvian: Laparoskopijas/ minimāli invazīvās procedūras nav piemērojams
Italian: 10-15 cm 1,5-2,0 bar (21,5-28,5 psi)
Latvian: 10-15 cm 1,5-2,0 bāri (21.5-28.5 psi)
Italian: Questo paragrafo del foglio illustrativo deve includere il seguente testo, in grassetto e sottolineato, dove indicato:
Latvian: Šajā lietošanas instrukcijas sadaļā ir jāiekļauj tālāk minētais teksts treknrakstā un ar pasvītrojumu atbilstoši norādījumiem.
Italian: Regolatore di pressione da utilizzare
Latvian: Izmantojamai s spiediena regulators
Italian: Punta sostituibile
Latvian: Aizvietojams uzgalis
Italian: Tissucol e denominazioni associate
Latvian: Tissucol un sinonīmiskie nosaukumi
Italian: • "[NOME DEL PRODOTTO] non deve essere utilizzato nella chirurgia laparoscopica.
Latvian: • "[PREPARĀTA NOSAUKUMS] nedrīkst izmantot laparoskopiskās ķirurģijas procedūrās (minimāli invazīvā ķirurģija).
Italian: In questo paragrafo deve essere inserito il seguente testo:
Latvian: Jāizvieto ar šādu tekstu:
Italian: Nelle ferite chirurgiche aperte deve essere usato un dispositivo regolatore di pressione che eroghi una pressione massima non superiore a 2,0 bar (28,5 psi).
Latvian: atvērtas operācijas gadījumā ir jāizmanto spiediena regulatora ierīce, kas nodrošina maksimālo spiedienu ne vairāk kā 2,0 bāri (28,5 psi);
Italian: Distanza dal tessuto raccomandata
Latvian: Ieteicamais attālums no mērķa audiem
Italian: 1,5-2,0 bar (21,5-28,5 psi
Latvian: 1,5-2,0 bāri 28.5 psi).
Italian: Per l'applicazione spray, vedere i paragrafi 4.4 e 6.6 per raccomandazioni specifiche sulla lunghezza delle punte applicatrici e su pressione e distanza dal tessuto necessarie per ciascuna procedura chirurgica."
Latvian: Specifiskus norādījumus par izsmidzināšanā nepieciešamo spiedienu, ķirurģiskajā procedūrā izmantojamo attālumu no audiem un aplikatora uzgaļa garumu skatiet 4.4 un 6.6 apakšpunktā."
Italian: Tisseel e denominazioni associate
Latvian: Tisseel un sinonīmiskie nosaukumi
Italian: Il rischio sembra essere maggiore quando le colle di fibrina vengono nebulizzate con aria invece che con CO2, pertanto non può essere escluso con [Nome del prodotto] quando viene nebulizzato su ferite chirurgiche aperte.
Latvian: Risks ir lielāks, ja fibrīna sīlanti tiek izsmidzināti, izmantojot gaisu, nevis CO2, un tāpēc to nevar izslēgt, ja [PREPARĀTA NOSAUKUMS] tiek izsmidzināts atvērtas operācijas gadījumā.
Italian: Punte applicatrici da utilizzare
Latvian: Izmantojamie aplikatora uzgaļi
Italian: Il rischio sembra essere maggiore quando le colle di fibrina vengono nebulizzate con aria invece che con CO2, pertanto non può essere escluso con [Nome del prodotto].
Latvian: Risks ir lielāks, ja fibrīna sīlanti tiek izsmidzināti, izmantojot gaisu, nevis CO2, un tāpēc [PREPARĀTA NOSAUKUMS] lietošanas gadījumā to nevar izslēgt.
Italian: Questo paragrafo del RCP deve includere il seguente testo, in grassetto e sottolineato, dove indicato:
Latvian: Šajā zāļu apraksta sadaļā ir jāiekļauj tālāk minētais teksts treknrakstā un ar pasvītrojumu atbilstoši norādījumiem.
Italian: Artiss e denominazioni associate
Latvian: Artiss un sinonīmiskie nosaukumi
Italian: Questo evento sembra essere correlato all'uso del dispositivo spray a pressioni più elevate rispetto a quelle raccomandate e/o troppo vicino alla superficie tissutale.
Latvian: Šie gadījumi ir saistīti ar to, ka izsmidzināšanas ierīce tiek lietota ar spiedienu, kas ir lielāks par ieteicamo, un/vai tuvu audu virsmai.
Italian: Quando si applica [NOME DEL PRODOTTO] utilizzando un dispositivo spray, assicurarsi di usare una pressione all'interno del range di pressione raccomandato dal produttore del dispositivo (vedere la tabella riportata nel paragrafo 6.6 per pressione e distanza).
Latvian: Pirms [PREPARĀTA NOSAUKUMS] izsmidzināšanas, izmantojot izsmidzināšanas ierīci, pārliecinieties, ka izsmidzināšanas ierīcē tiek izmantots spiediens ražotāja ieteicamajā spiediena diapazonā (lai iegūtu informāciju par spiedienu un attālumu, skatiet 6.6 apakšpunktu).
Italian: "L'uso di [NOME DEL PRODOTTO] è limitato a chirurghi esperti, specializzati nell'uso di [NOME DEL PRODOTTO]."
Latvian: "[PREPARĀTA NOSAUKUMS] lietot ir atļauts pieredzējušiem ķirurgiem, kas ir apguvuši [PREPARĀTA NOSAUKUMS] lietošanas metodes.
Italian: Al foglio illustrativo di Beriplast P e denominazioni associate devono essere apportate le seguenti variazioni:
Latvian: Beriplast P un sinonīmisko nosaukumu lietošanas instrukcijā ir jāveic tālāk minētie grozījumi.
Italian: A questo paragrafo deve essere aggiunto il seguente testo:
Latvian: Šajā sadaļā jāpievieno tālāk minētais teksts.
Italian: • "Molto raramente si sono verificati casi di embolia gassosa potenzialmente letale/letale (ingresso di aria nella circolazione del sangue, che può essere grave o mettere in pericolo di vita) con l'uso di dispositivi spray che utilizzano regolatori di pressione per la somministrazione delle colle di fibrina.
Latvian: • "Fibrīna sīlanta uzklāšanā, lietojot izsmidzināšanas ierīci, kurā ir izmantots spiediena regulators, ļoti reti ir novēroti dzīvībai bīstami/letāli gaisa vai gāzes embolijas (gaisa iekļūšana asinsritē, kas var radīt ļoti smagas vai dzīvībai bīstamas sekas) gadījumi.
Italian: • [NOME DEL PRODOTTO] deve essere somministrato seguendo strettamente le istruzioni indicate e solo con i dispositivi raccomandati per il presente prodotto.
Latvian: • Lietojiet [PREPARĀTA NOSAUKUMS] tikai atbilstoši norādījumiem un tikai izmantojot ierīces, kuras ieteicams lietot ar šo preparātu.
Italian: Il prodotto deve essere ricostituito e somministrato seguendo le istruzioni indicate e solo con i dispositivi forniti con il presente prodotto."
Latvian: Sagatavojiet preparātu un lietojiet to atbilstoši norādījumiem un izmantojot ierīces, kuras paredzētas lietošanai ar šo preparātu."
Italian: Applicatore Duplospray MIS da 30 cm
Latvian: EasySpray 10-15 cm
Italian: • Molto raramente si sono verificati casi di embolia gassosa potenzialmente letale/letale (ingresso di aria nella circolazione del sangue, che può essere grave o mettere in pericolo di vita) con l'uso di dispositivi spray che utilizzano regolatori di pressione per la somministrazione delle colle di fibrina.
Latvian: • Fibrīna sīlanta uzklāšanā, lietojot izsmidzināšanas ierīci, kurā ir izmantots spiediena regulators, ļoti reti ir novēroti dzīvībai bīstami/letāli gaisa vai gāzes embolijas (gaisa iekļūšana asinsritē, kas var radīt ļoti smagas vai dzīvībai bīstamas sekas) gadījumi.
Italian: Ferita aperta dovuta ad intervento su tessuto sottocutaneo
Latvian: Zemādas audu atvērtas brūces operācija
Italian: B. Foglio illustrativo
Latvian: A. Zāļu apraksts
Italian: Non sono stati forniti altri dettagli.
Latvian: Sīkāka informācija nav pieejama.
Italian: Il CHMP ha concordato che la DHPC debba essere fornita a tutti gli utilizzatori di questi prodotti in Europa, non oltre il 15 gennaio 2013.
Latvian: CHMP noteica, ka DHPC jānosūta visiem šo zāļu lietotājiem Eiropā ne vēlāk kā līdz 2013. gada 15. janvārim.
Italian: Pressione eccessiva
Latvian: 2. pārmērīgs spiediens;
Italian: I principi attivi di questi prodotti sono diversi e la differenza principale risiede nel componente antifibrinolitico.
Latvian: Šo zāļu aktīvās sastāvdaļas ir dažādas, galvenās atšķirības ir saistītas ar antifibrinolītisko komponentu.
Italian: Tisseel/Tissucol e Artiss
Latvian: Tisseel/Tissucol un Artiss
Italian: Tisseel e Tissucol differiscono per il contenuto in fattore XIII.
Latvian: Tisseel un Tissucol atšķiras pēc XIII faktora satura.
Italian: Il CHMP ha anche concluso il riesame di Evicel in base all'articolo 20.
Latvian: CHMP noslēdza arī Evicel pārskatīšanu saskaņā ar 20. pantu.
Italian: Beriplast P non viene nebulizzato con un regolatore di pressione automatizzato.
Latvian: Beriplast P neizsmidzina, izmantojot automātisko spiediena regulatoru.
Italian: Artiss è indicato solo per uso sottocutaneo.
Latvian: Artiss ir indicētas vienīgi subkutānai lietošanai.
Italian: Beriplast P, Tisseel, Tissucol e Artiss contengono aprotinina, mentre Quixil contiene acido tranexamico.
Latvian: Beriplast P, Tisseel, Tissucol un Artiss satur aprotinīnu, bet Quixil - traneksāmskābi.
Italian: Il CHMP ha concordato con una comunicazione diretta agli operatori sanitari (DHPC) per comunicare l'esito della presente revisione.
Latvian: CHMP apstiprināja Tiešo paziņojumu veselības aprūpes speciālistiem [Direct Healthcare Professional Communication (DHPC), lai paziņotu par šīs pārskatīšanas procedūras iznākumu.