FrancophonIA/ELRC3.0 huggingface dataset:
Italian: Limited, Wellcroft House, Wellcroft Road, Slough, Berkshire SL1
Latvian: Limited, Wellcroft House, Wellcroft Road, Slough,
Italian: 300 mg/10 mg capsula
Latvian: 300 mg/10 mg Kapsulas
Italian: Great West Road 980 Brentford TW8 9GS Regno Unito
Latvian: Great West Road 980 Brentford TW8 9GS Lielbritānija
Italian: Talvosilen forte 1000/60 1000mg/60 mg supposta uso rettale
Latvian: Talvosilen forte 1000/60 1000mg/60 mg Supozitoriji
Italian: 125/5 ml mg + 7,5/5 ml mg sciroppo
Latvian: 125/5 ml mg + 7,5/5 ml mg
Italian: S.C. Slavia Pharm S.R.L. Str. Ştirbei Vodă Nr. 53-55, Sector 1, Bucureşti,
Latvian: Ştirbei Vodă Nr. 53-55, Sector 1, Bucureşti,
Italian: Regno Unito ibuprofen + codeina Boots Ibuprofen and Codeina Tablets
Latvian: Ibuprofēns + kodeīns Boots Ibuprofen and Codeine Tablets
Italian: Alkaloid-Int. d.o.o.
Latvian: d.o.o.
Italian: S.C. MAGISTRA C & C S.R.L.Bd-ul Aurel Vlaicu nr. 82 A, Constanţa,
Latvian: MAGISTRA C & C S.R.L.Bd-ul Aurel Vlaicu nr.
Italian: Galen Limited, Seogoe Industiral Estate, Craigavon BT 63 5 UA Regno Unito
Latvian: Galen Limited, Seogoe Industiral Estate, Craigavon BT 63 5 UA Lielbritānija
Italian: Finlandiaia Oy Leiras Takeda Paciuksenkatu 21
Latvian: Oy Leiras Takeda Paciuksenkatu 21 PL 1406
Italian: Galen Limited, Seogoe Industiral Estate, Craigavon BT 63 5 UA, Regno Unito
Latvian: Galen Limited, Seogoe Industiral Estate, Craigavon BT 63 5 UA,
Italian: Craigavon BT 63 5 UA, Regno Unito
Latvian: Craigavon BT 63 5
Italian: Regno Unito Aventis Pharma Limited, One Onslow Street, Guilford, Surrey GU1 4SY Regno Unito
Latvian: Lielbritānija Aventis Pharma Limited, One Onslow Street, Guilford, Surrey GU1 4SY Lielbritānija
Italian: Via Lorenzini, 8 20139 Milano Italia paracetamolo + codeina fosfato
Latvian: Via Lorenzini, 8 20139 Milano Itālija
Italian: McNeil Products Ltd., Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG
Latvian: McNeil Products Ltd., Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG Lielbritānija
Italian: Ibuprofen and codeina tablets 200mg/12.8mg
Latvian: Ibuprofen and codeine tablets 200mg/12.8mg
Italian: Angenerico S.p.a. Via Nocera Umbra, 75 00181 Roma Italia paracetamolo + codeina
Latvian: Via Nocera Umbra, 75 00181 Roma Itālija
Italian: Regno Unito Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS Regno Unito
Latvian: Lielbritānija Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS Lielbritānija
Italian: Regno Unito McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG Regno Unito
Latvian: Lielbritānija McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG Lielbritānija
Italian: KG Benzstr.1 D-61352 Bad Homburg Germania
Latvian: Benzstr.1 D-61352
Italian: Germania OPTIMED Pharma GmbH
Latvian: OPTIMED Pharma GmbH
Italian: Paracetamolo 500mg Codeina fosfato 8mg Buclizine Hydrochloride 6.25mg
Latvian: Paracetamol 500mg Codeine Phosphate 8mg Buclizine Hydrochloride 6.25mg
Italian: Germania Berlin-Chemie AG Glienicker Weg 125
Latvian: Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Vācija
Italian: Germania bene - Arzneimittel GmbH
Latvian: Vācija bene - Arzneimittel GmbH
Italian: Slovacchia GlaxoSmithKline Consumer Healthcare, GlaxoSmithKline Export Ltd. 980 Great West Road,
Latvian: GlaxoSmithKline Consumer Healthcare, GlaxoSmithKline Export Ltd. 980 Great West Road,
Italian: Macarthy's Codeina fosfato Injection BP 60mg/ml
Latvian: Macarthy's Codeine Phosphate Injection BP 60mg/ml
Italian: Codeine fosfato emiidrato codi OPT
Latvian: Kodeīna fosfāta hemihidrāts codi OPT
Italian: Paracetamolo/Codeina DAFALGAN CODEINA, comprimé pelliculé
Latvian: Paracetamols/kodeīns DAFALGAN CODEINE, comprimé pelliculé
Italian: Contraneural Paracetamolo/Codein
Latvian: Contraneural Paracetamol/Codein
Italian: Clonmel Healthcare Ltd, Waterford Road, Conmel, Co. Tipperary Irlanda
Latvian: Clonmel Healthcare Ltd, Waterford Road, Conmel, Co.
Italian: Berkshire RG14 1JA, Regno Unito paracetamolo + codeina
Latvian: Berkshire RG14 1JA, Lielbritānija
Italian: DOLODENS GRAGEAS 10 mg, 15 mg and 100 mg compressa rivestita
Latvian: DOLODENS GRAGEAS 10 mg, 15 mg and 100 mg
Italian: 21,17 mg +325 mg compressa
Latvian: 21,17 mg +325 mg Tabletes
Italian: 170 09 Solna Svezia codeina idrocloride diidrato, papaverine idrocloride, morfine idrocloride, ioscine metonitrato, noscapine idrocloride
Latvian: Kodeīna hidrohlorīda dihidrāts, papaverīna hidrohlorīds, morfīna hidrohlorīds, hioscīna metonitrāts, noskapīna hidrohlorīds
Italian: Herterichstrasse 1 D-81479 Munchen Germania
Latvian: Herterichstrasse 1 D-81479 Munchen Vācija
Italian: FARMASIERRA LABORATORIOS, S.L. Ctra.
Latvian: FARMASIERRA LABORATORIOS, S.L.
Italian: Paracetamolo/Codeina ALGISEDAL, comprimé 400 mg/25 mg,
Latvian: Paracetamols/kodeīns ALGISEDAL, comprimé 400 mg/25 mg,
Italian: Regno Unito ibuprofen + codeina Nurofen Plus
Latvian: Ibuprofēns + kodeīns Nurofen Plus
Italian: 51063 Köln
Latvian: Neurather Ring 1 51063 Köln Vācija
Italian: Regno Unito Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Regno Unito codeina fosfato
Latvian: Lielbritānija Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Lielbritānija
Italian: Codeinafosfaat ratiopharm 20 mg, tabletten
Latvian: Codeinefosfaat ratiopharm 20 mg, tabletten
Italian: Nevrine codeina
Latvian: Nevrine codeine
Italian: Viale Amelia 70 00181 Roma Italia paracetamolo + codeina fosfato
Latvian: Viale Amelia 70 00181 Roma Itālija
Italian: 28,73 mg + 325 mg compressa
Latvian: 28,73 mg + 325 mg Tabletes
Italian: Uso Intramusculare
Latvian: Intramuskulārai lietošanai
Italian: Codeinafostaat 15 PCH, tabletten 15 mg
Latvian: Codeinefostaat 15 PCH, tabletten 15 mg
Italian: Migraleve Compresse rosas: Paracetamolo, codeina fosfato, buclizine hydrochloride
Latvian: Migraleve rozā tabletes: paracetamols, kodeīna fosfāts, buklizīna hidrohlorīds
Italian: Codeina fosfato+ paracetamolo custom Healthcare cocodamol 8/500mg capsules capsule
Latvian: Kodeīna fosfāts + paracetamols custom Healthcare cocodamol 8/500mg capsules
Italian: Codeinafosfaat ratiopharm 10 mg, tabletten
Latvian: Codeinefosfaat ratiopharm 10 mg, tabletten
Italian: 5 mg/5ml 200 mg/5ml sospensione
Latvian: 5 mg/5ml 200 mg/5ml
Italian: Vitabalans Oy Varastokatu 8, 13500 Hämeenlinna Finlandia
Latvian: Vitabalans Oy Varastokatu 8, 13500 Hämeenlinna Somija
Italian: Hampshire, RG25 3ED, Regno Unito
Latvian: Overton, Hampshire, RG25 3ED,
Italian: Paracetamolo/Codeina GAOSEDAL CODEINA, comprimé
Latvian: Paracetamols/kodeīns GAOSEDAL CODEINE, comprimé
Italian: 3 Rue Joseph Monier 92500 Rueil Malmaison Francia paracetamolo + codeina fosfato
Latvian: 3 Rue Joseph Monier 92500 Rueil Malmaison Francija
Italian: Salicilamide+ Codeina + Caffeina + Propifenazone
Latvian: Salicilamīds + kodeīns + kofeīns + propifenazons
Italian: 170 09 Solna Svezia codeina fosfato emiidrata
Latvian: 170 09 Solna Zviedrija
Italian: Contraneural Paracetamolo/Codein 500 mg/30 mg
Latvian: Contraneural Paracetamol/Codein 500 mg/30 mg
Italian: Finlandiaia Vitabalans Oy Varastokatu 8
Latvian: Vitabalans Oy Varastokatu 8
Italian: Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET
Latvian: Road, Eaton Socon, St Neots,
Italian: Repubblica Ceca bene-Arzneimittel GmbH
Latvian: Čehijas Republika bene-Arzneimittel GmbH
Italian: Codeinafostaat 20 PCH, tabletten 20 mg
Latvian: Codeinefostaat 20 PCH, tabletten 20 mg
Italian: Efferalgan Codeina
Latvian: Efferalgan Codeine
Italian: Ibuprofen and Codeina 200 mg/ 12.8 mg compressa rivestita con films
Latvian: Ibuprofen and Codeine 200 mg/ 12.8 mg filmcoated Tablets
Italian: Codeina/Paracetamolo ALGOCALM
Latvian: Kodeīns/paracetamols ALGOCALM
Italian: Codeina HCl 20 PCH, tabletten 20 mg
Latvian: Codeine HCl 20 PCH, tabletten 20 mg
Italian: Codeina HCl 10 PCH, tabletten 10 mg
Latvian: Codeine HCl 10 PCH, tabletten 10 mg
Italian: 0,8mg, 40 mg, 13 mg, 0,5 mg, 6 mg supposta uso rettale
Latvian: 0,8mg, 40 mg, 13 mg, 0,5 mg, 6 mg
Italian: Solpadeine Migraine Ibuprofen & Codeina Tablets compressa rivestita con film
Latvian: Solpadeine Migraine Ibuprofen & Codeine Tablets
Italian: Codeina/Paracetamolo Citodon forte
Latvian: Kodeīns/paracetamols Citodon forte
Italian: Manx Pharma Cocodamol 30 mg/500 mg compressa effervescentes
Latvian: Manx Pharma Cocodamol 30 mg/500 mg effervescent tablets
Italian: Actavis UK Limited Whiddon Valley, Barnstaple, Devon, EX32 8NS Regno Unito
Latvian: Actavis UK Limited Whiddon Valley, Barnstaple, Devon, EX32
Italian: U kabelovny 130 102 37 Praha 10Dolní Měcholupy Repubblica Ceca
Latvian: U kabelovny 130 102 37 Praha 10Dolní Měcholupy Čehijas Republika
Italian: Bristol Labs Codeina fosfato Tablets 15mg
Latvian: Bristol Labs Codeine Phosphate Tablets 15mg
Italian: Paracetamolo/Codeina DAFALGAN CODEINA, comprimé effervescent sécable
Latvian: Paracetamols/kodeīns DAFALGAN CODEINE, comprimé effervescent sécable
Italian: HIPOCRATE 2000 S.R.L. Str. Prahova, Nr. 6A, Sector 1, Bucureşti 012423, România paracetamolo , codeina fosfato emiidrato ,caffeina anidra
Latvian: Prahova, Nr. 6A, Sector 1, Bucureşti 012423, Rumānija
Italian: Herterichstrasse 1 814 79 München Germania
Latvian: Herterichstrasse 1 814 79 München Vācija
Italian: Brentford TW8 9GS Regno Unito
Latvian: Brentford TW8 9GS Lielbritānija
Italian: Codeina/Paracetamolo PARACETAMOLO/CODEI NA VITABALANS
Latvian: Kodeīns/paracetamols PARACETAMOL/CODEINE VITABALANS
Italian: Germania Aristo Pharma GmbH Wallenroder Str. 8-10
Latvian: Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Vācija
Italian: 25 mg/ml + 1,5 mg/ml sciroppo
Latvian: 25 mg/ml + 1,5 mg/ml
Italian: Paracetamolo/Codeina CO-CODAMOL
Latvian: Paracetamols/kodeīns CO-CODAMOL
Italian: U Kabelovny 130 Dolni Mecholupy 102 37 Prague 10 Repubblica Ceca
Latvian: U Kabelovny 130 Dolni Mecholupy 102 37 Prague 10 Čehijas Republika
Italian: Migraleve Compressa rivestita con films
Latvian: Migraleve Film-coated Tablets
Italian: Medocodene 30/500 Capsules
Latvian: Paracetamols + kodeīns Medocodene 30/500 Capsules
Italian: Syndol Compressa rivestita con films Paracetamolo 450 mg Codeina fosfato Emiidrata 10 mg Doxylamine succinate 5 mg
Latvian: Paracetamol 450 mg Codeine Phosphate Hemihydrate 10 mg Doxylamine succinate 5 mg
Italian: ALKALOID - INT d.o.o Šlandrova ulica 4, 1231 LjubljanaČrnuče, Slovenia paracetamolo, propifenazono , cafeina , codeina fosfato sesquihidrat
Latvian: ALKALOID - INT d.o.o Šlandrova ulica 4, 1231 LjubljanaČrnuče, Slovēnija
Italian: Germania Merck Serono GmbH Alsfelder Str. 17
Latvian: Merck Serono GmbH Alsfelder Str. 17 64289 Darmstadt Vācija
Italian: Apfen Plus 200mg / 12.8mg Compressa rivestita con films compressa rivestita con film
Latvian: Apfen Plus 200mg / 12.8mg Film-Coated Tablets
Italian: 500 mg + 9,6 mg compressa
Latvian: 500 mg + 9,6 mg Tabletes
Italian: Kapake 15mg/500mg 15mg + 500mg compressa
Latvian: Kapake 15mg/500mg 15mg + 500mg Tabletes
Italian: Codeina fosfato, idrossicina dicloridrato ,propifenazone
Latvian: Kodeīna fosfāts, hidroksicīna dihlorhidrāts un propifenazons
Italian: KERN PHARMA, S.L. Venus, 72
Latvian: KERN PHARMA, S.L.
Italian: Codeina/Paracetamolo Citodon
Latvian: Kodeīns/paracetamols Citodon
Italian: ITALFARMACO, S.A. San Rafael, 3
Latvian: San Rafael, 3
Italian: International, Brentford, TW8 9GS Regno Unito
Latvian: International, Brentford, TW8 9GS Lielbritānija
Italian: FARMALIDER, S.A. Aragoneses, 15 28108 Madrid Spagna
Latvian: Aragoneses, 15 28108 Madrid Spānija
Italian: 'PARACETAMOLOO + CODEINA ANGENERICO
Latvian: Paracetamols + kodeīns 'PARACETAMOLO + CODEINA ANGENERICO
Italian: Codeinafostaat 10 PCH, tabletten 10 mg
Latvian: Codeinefostaat 10 PCH, tabletten 10 mg
Italian: GlaxoSmithKline Consumer Healthcare S.A. Site Apollo avenue Pascal 2-6 B1300 Wavre Belgio
Latvian: Site Apollo avenue Pascal 2-6 B1300 Wavre
Italian: Nurofen Plus Tablets Ibuprofen 200mg Codeina fosfato Emiidrata 12.8mg compressa rivestita con film
Latvian: Nurofen Plus Tablets Ibuprofen 200mg Codeine Phosphate Hemihydrate 12.8mg
Italian: Sterop Laboratoires nv Avenue de Scheut 46
Latvian: Sterop Laboratoires nv
Italian: 032266 Bucureşti, Romania codeina
Latvian: 44 B,sector 3, 032266 Bucureşti, Rumānija
Italian: Tylex 30 mg / 500 mg Compressa effervescentes.
Latvian: Tylex 30 mg / 500 mg Effervescent Tablets.
Italian: Ennogen Pharma Cocodamol compressa effervescente
Latvian: Ennogen Pharma Cocodamol
Italian: Codeina fosfato
Latvian: Kodeīna fosfāts
Italian: Codeina fosfato + aspirina
Latvian: Kodeīna fosfāts + aspirīns
Italian: Paracetamolo/Codeina CLARADOL CODEINA 500 mg/20 mg, comprimé
Latvian: Paracetamols/kodeīns CLARADOL CODEINE 500 mg/20 mg, comprimé
Italian: Slovenia codeina, paracetamolo, propifenazone, caffeina
Latvian: Kodeīns + paracetamols, propifenazons, kofeīns
Italian: Sterwin Meds Cocodamol 30/500 compressa effervescentes 30mg/500mg
Latvian: Sterwin Meds Cocodamol 30/500 effervescent tablets 30mg/500mg
Italian: 500 mg/30 mg, comprimé effervescent sécable
Latvian: FRANCIJA 500 mg/30 mg, comprimé effervescent sécable
Italian: U kabelovny 130 102 37 Praha 10 Repubblica Ceca
Latvian: U kabelovny 130 102 37 Praha 10 Čehijas Republika
Italian: 325 mg and 15 mg compressa
Latvian: 325 mg and 15 mg Tabletes
Italian: Codeine fosfato emiidrato paracetamolo talvosilen 1000 mg/20 mg Zäpfchen supposta uso rettale
Latvian: Kodeīna fosfāta hemihidrāts Paracetamols talvosilen 1000 mg/20 mg Zäpfchen
Italian: Waymade codeina fosfato tablets 15mg
Latvian: Waymade codeine phosphate tablets 15mg
Italian: PARACETAMOLO/CODEÍ NA KERN PHARMA 500 mg/ 30 mg comprimidos EFG
Latvian: PARACETAMOL/CODEÍN A KERN PHARMA 500 mg/ 30 mg comprimidos EFG
Italian: 400 mg and 30 mg Granuli per sospensione orale
Latvian: 400 mg and 30 mg Granulas iekšķīgi lietojamas suspensijas pagatavošanai
Italian: 56014 Loc.
Latvian: Via Meucci, 36 56014 Loc.
Italian: Repubblica Ceca codeina + paracetamolo + fenpiverine + pitofenone
Latvian: Kodeīns + paracetamols + fenpiverīns + pitofenons
Italian: Voltaren Plus 50 mg/50 mg Filmtabletten compressa rivestita con film
Latvian: Voltaren Plus 50 mg/50 mg Filmtabletten
Italian: 30mg + 500 mg capsula
Latvian: 30mg + 500 mg Kapsulas
Italian: Combaren 50 mg/50 mg Filmtabletten compressa rivestita con film
Latvian: Combaren 50 mg/50 mg Filmtabletten
Italian: Paracetamolo/Codeina KLIPAL CODEINA 600 mg/50 mg, comprimé
Latvian: Paracetamols/kodeīns KLIPAL CODEINE 600 mg/50 mg, comprimé
Italian: 500mg + 30mg capsula
Latvian: 500mg + 30mg Kapsulas
Italian: Paracetamolo/Codeina KLIPAL CODEINA 300 mg/25 mg, comprimé
Latvian: Paracetamols/kodeīns KLIPAL CODEINE 300 mg/25 mg, comprimé
Italian: 1000mg/60 mg supposta uso rettale
Latvian: 1000mg/60 mg Supozitoriji
Italian: Mylan bvba/sprl Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgio
Latvian: Terhulpsesteenweg 6A B-1560 Hoeilaart Beļģija
Italian: Paracetamolo/Codeina/ Caffeina
Latvian: Paracetamols/kodeīns /kofeīns
Italian: Repubblica Ceca paracetamolo+ codeina ULTRACOD 500 mg/30 mg
Latvian: Paracetamols + kodeīns ULTRACOD 500 mg/30 mg
Italian: Codeine fosfato emiidrato paracetamolo talvosilen 250 mg/5 mg Zäpfchen supposta uso rettale
Latvian: Kodeīna fosfāta hemihidrāts Paracetamols talvosilen 250 mg/5 mg Zäpfchen
Italian: Capsula rigida Uso orale
Latvian: Cietās kapsulas Iekšķīgai lietošanai
Italian: 125 mg + 7,5 mg Granulato effervescente
Latvian: 125 mg + 7,5 mg Putojošās granulas
Italian: Polonia bene Arzneimittel GmbH
Latvian: Polija bene Arzneimittel GmbH
Italian: Germania Pfizer Pharma GmbH Linkstr.
Latvian: Pfizer Pharma GmbH Linkstr. 10
Italian: PARACETAMOLO/CODEÍ NA PHARMAKERN 500 mg/ 30 mg comprimidos EFG
Latvian: PARACETAMOL/CODEÍN A PHARMAKERN 500 mg/ 30 mg comprimidos EFG
Italian: Dafalgan codeina
Latvian: Dafalgan codeine
Italian: In seguito a tali nuove misure:
Latvian: Šo jauno pasākumu rezultātā:
Italian: 24 aprile 2015 EMA/249413/2015
Latvian: 2015. gada 24. aprīlis EMA/249413/2015
Italian: 1 Il CMDh è un organismo di regolamentazione dei medicinali che rappresenta gli Stati membri dell'Unione europea (UE), Islanda, Liechtenstein e Norvegia.
Latvian: 1 CMDh ir zāļu regulējošā iestāde, kas pārstāv Eiropas Savienības (ES) dalībvalstis, Islandi, Lihtenšteinu un Norvēģiju.
Italian: Ciò significa che codeina non deve essere utilizzata in questo gruppo di pazienti.
Latvian: Tas nozīmē, ka šai pacientu grupai šīs zāles lietot nedrīkst.
Italian: • Se voi o vostro figlio siete in trattamento con codeina e avete domande o dubbi riguardo alla terapia, rivolgetevi a un medico o a un farmacista.
Latvian: • Ja Jūsu bērnu ārstē ar kodeīnu un Jums ir kādi jautājumi vai bažas par ārstēšanu, konsultējieties ar ārstu vai farmaceitu.
Italian: Il CMDh è un organismo che rappresenta gli Stati membri dell'UE, oltre a Islanda, Liechtenstein e Norvegia, e che ha la responsabilità di garantire norme di sicurezza armonizzate per i medicinali autorizzati mediante procedure nazionali nell'UE.
Latvian: CMDh, iestāde, kas pārstāv ES dalībvalstis, kā arī Islandi, Lihtenšteinu un Norvēģiju, ir atbildīga par drošuma standartu saskaņošanu zālēm, kuras apstiprinātas ar nacionālajām procedūrām visā ES.
Italian: Il riesame è stato condotto dal comitato per la valutazione dei rischi nell'ambito della farmacovigilanza (PRAC), il comitato dell'EMA responsabile della valutazione degli aspetti concernenti la sicurezza dei medicinali per uso umano, che ha formulato una serie di raccomandazioni.
Latvian: Pārskatīšanu veica Farmakovigilances riska novērtēšanas komiteja (PRAC), kas ir EMA komiteja, par cilvēkiem paredzēto zāļu drošuma jautājumu izvērtēšanu atbildīgā komiteja, kas sagatavoja ieteikumu kopu.
Italian: Questo riesame è stato condotto in seguito a un precedente riesame di codeina usata nei bambini per alleviare il dolore, che si è risolto con l'introduzione di varie limitazioni per garantire che il medicinale fosse usato in maniera il più possibile sicura.
Latvian: Šis pārskats seko iepriekšējam pārskatam par kodeīna lietošanu sāpju mazināšanā bērniem, kā rezultātā ieviesa vairākus ierobežojumus, lai nodrošinātu, ka zāles lieto pēc iespējas drošāk.
Italian: Poiché i medicinali contenenti codeina sono tutti autorizzati a livello nazionale, le raccomandazioni del PRAC sono state trasmesse al CMDh, per l'adozione di una posizione definitiva.
Latvian: Tā kā visas kodeīnu saturošas zāles ir reģistrētas attiecīgās valsts līmenī, PRAC ieteikumus pārsūtīja uz CMDh, lai saņemtu tās atzinumu.
Italian: Le nuove misure sono state introdotte dopo un riesame del comitato per la valutazione dei rischi nell'ambito della farmacovigilanza (PRAC) dell'EMA.
Latvian: Jaunie pasākumi atbilst EMA Farmakovigilances riska vērtēšanas komitejas (PRAC) pārskatam.
Italian: Inoltre, i bambini già affetti da problemi respiratori potrebbero essere maggiormente vulnerabili ai problemi respiratori causati da codeina.
Latvian: Turklāt bērni, kuriem jau ir elpošanas traucējumi, var būt jutīgāki pret kodeīna izraisītiem elpošanas traucējumiem.
Italian: Tali nuove misure fanno seguito a un riesame dei dati disponibili sulla sicurezza e l'efficacia di codeina usata per il trattamento di tosse e raffreddore, compresi i dati provenienti da studi clinici, studi osservazionali e meta-analisi, dati post-immissione in commercio in Europa e altra letteratura pubblicata sull'uso di codeina nei bambini.
Latvian: Šie jaunie pasākumi tiek ieviesti pēc kodeīna pieejamo drošuma un efektivitātes datu, tostarp klīnisko pētījumu, novērojuma pētījumu un metaanalīžu datu, kā arī pēcreģistrācijas datu Eiropā un citas publicētas zinātniskās literatūras par kodeīna lietošanu bērniem, pārskatīšanas.
Italian: • Dopo un riesame a livello dell'UE di codeina usata per il trattamento di tosse e raffreddore, sono state apportate modifiche alle modalità di impiego del medicinale, per garantire che i benefici continuino a essere superiori ai rischi nei bambini e negli adolescenti.
Latvian: • Pēc ES mēroga pārskatīšanas par kodeīna lietošanu klepus un saaukstēšanās ārstēšanai zāļu lietošanā ieviestas izmaiņas, lai nodrošinātu, ka bērniem un pusaudžiem ieguvumi turpina pārsniegt riskus.
Italian: Livelli elevati di morfina possono avere effetti, tra cui difficoltà respiratorie.
Latvian: Augsts morfīna līmenis var izraisīt smagas blakusparādības, piemēram, apgrūtinātu elpošanu.
Italian: Codeina è commercializzata come medicinale a ingrediente unico o in associazione ad altri principi attivi.
Latvian: Kodeīns ir pieejams kā zāles ar vienu sastāvdaļu vai kombinācijā ar citām aktīvajām vielām.
Italian: • I genitori di un paziente o le persone che hanno in affidamento un soggetto trattato con codeina e che notano uno qualsiasi dei seguenti sintomi devono interrompere la somministrazione del medicinale e rivolgersi immediatamente a un medico: respirazione rallentata o superficiale, confusione, sonnolenza, pupille contratte, sensazione di malessere o malessere vero e proprio, costipazione e perdita di appetito.
Latvian: • Ja kodeīnu lietojušam pacientam vecāki vai aprūpētāji novēro kādu no turpmāk minētajiem simptomiem, pārtrauciet zāļu lietošanu un nekavējoties vērsieties pēc medicīniskas palīdzības: lēna vai sekla elpošana, apjukums, miegainība, šauras zīlītes, slikta dūša vai vemšana, aizcietējumi vai apetītes zudums.
Italian: In totale, nella letteratura pubblicata sono stati individuati 14 casi di intossicazione da codeina in pazienti pediatrici (di età compresa tra 17 giorni e 6 anni), correlati al trattamento di tosse e infezione respiratoria; quattro di questi casi si sono risolti con il decesso del paziente.
Latvian: Kopumā publicētajā zinātniskajā literatūrā noteica 14 kodeīna intoksikācijas gadījumus bērniem (vecumā no 17 dienām līdz 6 gadiem), kas saistīti ar klepus un elpceļu infekcijas ārstēšanu, četriem no tiem bija letāls galarezultāts.
Italian: Il riesame di codeina utilizzata per il trattamento di tosse e raffreddore nei bambini è iniziato nell'aprile 2014 su richiesta dell'agenzia tedesca dei medicinali (BfArM), ai sensi dell'articolo 31 della direttiva 2001/83/CE.
Latvian: Pēc Vācijas Zāļu aģentūras (BfArM) pieprasījuma, atbilstoši Direktīvas 2001/83/EK 31. pantam, 2014. gada aprīlī uzsāka kodeīna pārskatīšanu klepus un saaukstēšanās gadījumā bērniem.
Italian: Il PRAC ha altresì osservato che tosse e raffreddore sono generalmente condizioni autolimitanti e che le prove dell'efficacia di codeina nel trattamento della tosse nei bambini sono limitate.
Latvian: PRAC vēl secināja, ka saaukstēšanās un klepus parasti ir pašlimitējošas saslimšanas un pierādījumi par kodeīna efektivitāti klepus ārstēšanā bērniem ir ierobežoti.
Italian: Poiché si è appurato che considerazioni analoghe potevano applicarsi all'uso di codeina per il trattamento di tosse e raffreddore nei bambini, è stato avviato un secondo riesame a livello dell'UE riguardante questo impiego.
Latvian: Kad secināja, ka līdzīgi ierobežojumi varētu būt piemērojami kodeīna lietošanai klepus un saaukstēšanās gadījumā bērniem, uzsāka otru ES mēroga pārskatu.
Italian: Nell'UE i medicinali contenenti codeina sono stati autorizzati mediante procedure nazionali e sono disponibili su prescrizione medica o come farmaci da banco nei diversi Stati membri.
Latvian: ES kodeīnu saturošas zāles ir apstiprinātas nacionālo procedūru veidā un ir pieejamas vai nu ar recepti, vai dažās dalībvalstīs tās ir bezrecepšu zāles.
Italian: • L'uso di codeina è inoltre controindicato nelle donne in allattamento e nei pazienti di tutte le età di cui è nota l'appartenenza alla categoria dei metabolizzatori ultrarapidi di CYP2D6.
Latvian: • Kodeīns vēl ir kontrindicēts sievietēm zīdīšanas periodā un pacientiem, kuri ir strauji CYP2D6
Italian: In alcuni individui codeina è convertita in morfina a una velocità superiore al normale, il che determina la presenza di elevati livelli di morfina nel sangue.
Latvian: Dažu cilvēku organisms kodeīnu pārvērš morfīnā ātrāk nekā parasti, tādēļ viņiem asinīs ir augsts morfīna līmenis.
Italian: Le limitazioni all'uso di codeina per il trattamento di tosse e raffreddore sono ampiamente in linea con le precedenti raccomandazioni per codeina utilizzata come antidolorifico.
Latvian: Kodeīna ierobežojumi klepus un saaukstēšanās gadījumā galvenokārt saskan ar iepriekšējām rekomendācijām kodeīna lietošanā sāpju mazināšanai.