FrancophonIA/ELRC3.0 huggingface dataset:
English: The following side effects have been reported in clinical trials with nivolumab:
Norwegian Bokmål: Følgende bivirkninger er rapportert i kliniske studier med nivolumab: Svært vanlige (kan påvirke flere enn 1 av 10 personer) Kvalme
English: No Grade 3-5 cases were reported in these studies.
Norwegian Bokmål: Ingen tilfeller av grad 3-5 ble rapportert i
English: Gently mix the infusion by manual
Norwegian Bokmål: Bland infusjonsvæsken ved forsiktig manuell rotasjon.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administra
Norwegian Bokmål: MT (EU)-nummer Legemidlets navn
English: Kruczkowskiego 8 00-380 Warzawa Poland
Norwegian Bokmål: Kruczkowskiego 8 00-380 Warszawa Poland
English: Beriplast and associated names Member State (in EEA)
Norwegian Bokmål: Beriplast og tilknyttede navn Medlemsland (i EØS)
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Norwegian Bokmål: VEDLEGG I LISTE OVER NAVN, LEGEMIDDELFORMER, STYRKER FOR LEGEMIDLENE, ADMINISTRASJONSMÅTER, INNEHAVERE AV MARKEDSFØRINGSTILLATELSEN I MEDLEMSLANDENE
English: Artiss and associated names; Tisseel and associated names; Tissucol and associated names Member State (in EEA)
Norwegian Bokmål: Artiss og tilknyttede navn, Tisseel og tilknyttede navn, Tissucol og tilknyttede navn Medlemsland (i EØS)
English: Czech Republic Baxter Czech spol.
Norwegian Bokmål: Baxter Czech spol.
English: United Kingdom Baxter Healthcare Limited, Caxton Way,
Norwegian Bokmål: Storbritannia Baxter Healthcare Limited, Caxton Way,
English: Baxter SA Boulevard René Branquart 80 7860 Lessines Belgium
Norwegian Bokmål: Boulevard René Branquart 80 7860 Lessines
English: Norfork IP24 3SE, United Kingdom
Norwegian Bokmål: Norfolk IP24 3SE, United Kingdom
English: Karla Engliše 3201/6
Norwegian Bokmål: Karla Engliše 3201/6 150 00 Praha 5
English: ARTISS soluciones para adhesivo tisular
Norwegian Bokmål: ARTISS soluciones para adhesivo tisular Ultracongeladas
English: BERIPLAST P 0.5 ml, 1 ml, 3 ml, powders and solvents for sealant Combi-Set
Norwegian Bokmål: BERIPLAST P 0.5 ml, 1 ml, 3 ml, powders and solvents for sealant
English: Norfork IP24 3SE,
Norwegian Bokmål: Norfolk IP24 3SE,
English: Beriplast P CombiSet 1 ml prašek in vehikel za lepilo za tkiva
Norwegian Bokmål: Combi-Set 1 ml prašek in vehikel za lepilo za tkiva
English: TISSEEL Lyo, TwoComponent Fibrin Sealant
Norwegian Bokmål: TISSEEL Lyo, Two-Component Fibrin Sealant
English: Baxter Medical AB, Isafjordstgatan 30B P.O.
Norwegian Bokmål: Baxter Medical AB, Isafjordsgatan 30B P.O. Box 63
English: Beriplast P CombiSet 3 ml prašek in vehikel za lepilo za tkiva
Norwegian Bokmål: Combi-Set 3 ml prašek in vehikel za lepilo za tkiva
English: Combi-Set 2: thrombin: 500 IU/ml
Norwegian Bokmål: Combi-Set 2: Trombin : 500 IU/ml
English: Component Fibrin Sealant
Norwegian Bokmål: Two-component Fibrin Sealant
English: Tisseel - Lösungen für einen
Norwegian Bokmål: Tisseel - Lösungen für einen Gewebekleber
English: The Netherlands Baxter B.V. Kobaltweg 49, Utrecht 3542 CE
Norwegian Bokmål: Kobaltweg 49, 3542 CE Utrecht The Netherlands
English: Tisseel Lyo - Pulver und Lösungsmittel für einen
Norwegian Bokmål: Tisseel Lyo - Pulver und Lösungsmittel für einen Gewebekleber
English: Component 1
Norwegian Bokmål: Komponent 1
English: Component 2
Norwegian Bokmål: Komponent 2
English: ARTISS - Lösungen für einen
Norwegian Bokmål: ARTISS - Lösungen für einen Gewebekleber
English: Thrombin 1000 IU or Thrombin 8 UI; Calcium Chlorid Dihydrate 11.76 mg
Norwegian Bokmål: Trombin 1000 IE eller trombin 8 IE; kalsiumkloriddihydrat 11,76 mg
English: Calcium chloride: 40 µmol/ml
Norwegian Bokmål: Kalsiumklorid: 40 µmol/ml
English: Human fibrinogen (clottable protein): 72-110 mg/ml
Norwegian Bokmål: Humant fibrinogen (koagulerbart protein): 72110 mg/ml
English: Norfork
Norwegian Bokmål: Norfolk
English: Plasmafibrinonectinum 5,5mg/ml Factor XIII coagulationis humanus 30
Norwegian Bokmål: Plasmafibronektin 5,5 mg/ml Human koagulasjonsfaktor XIII 30 IE/ml
English: 2nd Component: Thrombin 500 UI/ml
Norwegian Bokmål: 2. komponent: Trombin 500 IE/ml
English: Thrombin 2500 IU or Thrombin 20 UI; Calcium Chlorid Dihydrate 29.4 mg
Norwegian Bokmål: Trombin 2500 IE eller trombin 20 IE; kalsiumkloriddihydrat 29,4 mg
English: Beriplast P CombiSet 0,5ml/1ml/3ml
Norwegian Bokmål: Combi-Set 0,5ml/1ml/3 ml
English: Thrombin: 500 IU/ml Calcium chloride: 5,9 mg/ml
Norwegian Bokmål: Trombin : 500 IU/ml Kalsiumklorid: 5,9 mg/ml
English: Calcium chloride: 40 µmol/ml Factor XIII: 30 IU/ml
Norwegian Bokmål: Kalsiumklorid: 40 µmol/ml Faktor XIII: ≤ 10 IE/ml
English: Component 1:
Norwegian Bokmål: Komponent 1:
English: Fibrinogen 72-110 mg/ml Factor XIII coagulationis humanus 10 IU/ml
Norwegian Bokmål: Fibrinogen 72-110 mg/ml Human koagulasjonsfaktor XIII 10 IE/ml
English: 1st Component:
Norwegian Bokmål: 1. komponent:
English: Thrombin 500 IU or Thrombin 4 UI; Calcium Chlorid Dihydrate 5.88 mg
Norwegian Bokmål: Trombin 500 IE eller trombin 4 IE; kalsiumkloriddihydrat 5,88 mg
English: Component 2:
Norwegian Bokmål: Komponent 2:
English: Thrombin (human) 500 I.E./ml Calcium chloride: 5,88 mg/ml
Norwegian Bokmål: Trombin (humant) 500 IE/ml Kalsiumklorid: 5,88 mg/ml
English: Beriplast P CombiSet 0,5 ml, Beriplast P CombiSet 1 ml,
Norwegian Bokmål: Beriplast P Combi-Set 0,5 ml, Beriplast P Combi-Set 1 ml, Beriplast P Combi-Set 3 ml
English: 150 00 Praha 5
Norwegian Bokmål: Tissucol Duo 500
English: Clottable protein: 375-575 mg, thereof Fibrinogen 350-550 mg; Plasma Fibronectin 10-45 mg; Factor XIII 50-250 UI;
Norwegian Bokmål: Proteiner totalt 500-650 mg; koagulerbart protein: 375575 mg, derav fibrinogen 350550 mg; plasmafibronektin 10-45 mg; faktor XIII 50-250 IE; plasminogen 0,2-0,6 mg; aprotinin 15000 KIE;
English: TISSUCOL Kit 1,0 kétkomponensű fibrinragasztó
Norwegian Bokmål: Kit 1,0 kétkomponensű fibrinragasztó
English: Tisseel duo quick Plasmaproteinum humanum 100-130 mg/ml: Fibrinogen 90mg/ml
Norwegian Bokmål: Humant plasmaprotein 100130 mg/ml: Fibrinogen 90 mg/ml
English: 2nd Component:
Norwegian Bokmål: 2. komponent:
English: Fibrinogen human 90,00 mg /ml Factor XIII : 10,00 UI/ml Fibronectin : 5,50 mg/ml Plasminogen : 0,08 mg/ml Aprotinin 3000,0 UIK*** /ml
Norwegian Bokmål: Faktor XIII: 10,00 IE/ml Fibronektin: 5,50 mg/ml Plasminogen: 0,08 mg/ml Aprotinin 3000,0 KIE***/ml
English: TISSUCOL Kit 2,0 kétkomponensű fibrinragasztó
Norwegian Bokmål: Kit 2,0 kétkomponensű fibrinragasztó
English: TISSUCOL Kit 5,0 kétkomponensű fibrinragasztó
Norwegian Bokmål: Kit 5,0 kétkomponensű fibrinragasztó
English: Syringe TISSUCOL-APROTININ: Total Proteins 100-130 mg/ml; clottable protein 75-115 mg/ml, of which fibrinogen 70-110 mg/ml and plasmatic fibronectin 2-9 mg/ml: Factor XIII 10-50 UI/ml; Plasminogen 0.04-0.12 mg/ml; Aprotinin 3000 UIK/ml (1.67 UPE/ml); Syringe THROMBIN-CALCIUM CHLORIDE: Proteins 50mg/ml; Thrombin 500 UI/ml; calcium chloride 40 µmol/ml
Norwegian Bokmål: Sprøyte TISSUCOLAPROTININ: Proteiner totalt 100-130 mg/ml; koagulerbart protein 75-115 mg/ml, derav fibrinogen 70110 mg/ml og plasmafibronektin 2-9 mg/ml; faktor XIII 10-50 IE/ml; plasminogen 0,040,12 mg/ml; aprotinin 3000 KIE/ml (1,67 EPU/ml); sprøyte TROMBINKALSIUMKLORID: Proteiner 50 mg/ml; trombin 500 IE/ml; kalsiumklorid 40 µmol/ml
English: Human fibrinogen: 90 mg Coagulation factor XIII: 60 UI Aprotinin: 1000 KUI Trombin: 7,6 mg Calcium chloride: 5,9 mg
Norwegian Bokmål: Humant fibrinogen: 90 mg Koagulasjonsfaktor XIII: 60 UI Aprotinin: 1000 KUI Trombin: 7,6 mg Kalsiumklorid: 5,9 mg
English: UI/ml; Plasminogen 0.04-0.12 mg/ml;
Norwegian Bokmål: Faktor XIII: 10-50 IE/ml Plasminogen: 0,040,12 mg/ml
English: Intralesional use
Norwegian Bokmål: Bruk inni skadet område
English: Clottable protein: 150-230 mg, thereof Fibrinogen 140-220 mg; Plasma Fibronectin 4-18 mg; Factor XIII 20-100 UI;
Norwegian Bokmål: Proteiner totalt 200-260 mg; koagulerbart protein: 150230 mg, derav fibrinogen 140220 mg; plasmafibronektin 4-18 mg; faktor XIII 20-100 IE; plasminogen 0,08-0,24 mg; aprotinin 6000 KIE;
English: ARTISS LYOPulver und Lösungsmittel für einen
Norwegian Bokmål: ARTISS LYO - Pulver und Lösungsmittel für einen Gewebekleber
English: Total Protein 100-130 mg; Clottable protein: 75-115 mg, thereof Fibrinogen 70-110 mg; Plasma Fibronectin 2-9 mg; Factor XIII 10-50 UI;
Norwegian Bokmål: Proteiner totalt 100-130 mg; koagulerbart protein: 75-115 mg, derav fibrinogen 70-110 mg; plasmafibronektin 2-9 mg; faktor XIII 10-50 IE; plasminogen 0,04-0,12 mg; aprotinin 3000 KIE;
English: Factor XIII ≤ 10 UI/ml Aprotinin: 3000 UIK/ml Human Thrombin: 500 UI/ml Calcium chloride: 40 μmol/ml
Norwegian Bokmål: Faktor XIII ≤ 10 IE/ml Aprotinin: 3000 KIE/ml Humant trombin: 500 IE/ml Kalsiumklorid: 40 μmol/ml
English: Fibrinogen: 72-110mg/ml Aprotinin: 3000KIU/ml Thrombin: 500 IU/ml in 45-55mg total protein
Norwegian Bokmål: Fibrinogen: 72-110 mg/ml Aprotinin: 3000 KIE/ml Trombin: 500 IE/ml i 45-55 mg protein totalt Kalsiumklorid: 40 µmol/ml
English: Thrombin human 500 IE/ml plasmaproteinum humanum 50mg/ml Calcium Chloride Dihydrate 40 μg/ml
Norwegian Bokmål: Plasminogen 80 μg/ml Humant trombin 500 IE/ml Kalsiumkloriddihydrat 40 μg/ml
English: Human Fibrinogen 91 gm/ml Human Factor XIII 10 IU/ml Bovine Aprotinin 3000 IU/ml Human Thrombin 500 IU/ml Calcium Chloride 40 micromol/ml
Norwegian Bokmål: Humant fibrinogen 91 mg/ml Human faktor XIII 10 IE/ml Bovint aprotinin 3000 KIE/ml Humant trombin 500 IE/ml Kalsiumklorid 40 μmol/ml
English: Human fibrinogen 91 mg/ml Aprotinin 3000 KIU/ml Human Thrombin 4 IU/ml Calcium Chloride 40 µmol/ml
Norwegian Bokmål: Humant fibrinogen 91 mg/ml Aprotinin 3000 KIE/ml Humant trombin 4 IE/ml Kalsiumklorid 40 µmol/ml
English: Aprotinin: 3000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 40 μmol/ml
Norwegian Bokmål: Aprotinin: 3000 KIE/ml Trombin: 500 IE/ml Kalsiumklorid: 40 μmol/ml
English: Human fibrinogen: 90 mg/ml Coagulation factor XIII: 60 e/ml Aprotinin: 1000 EIK/ml Thrombin: 7,6 mg/ml Calcium chloride: 5,9 mg/ml
Norwegian Bokmål: Humant fibrinogen: 90 mg/ml Koagulasjonsfaktor XIII: 60 e/ml Aprotinin: 1000 EIK/ml Trombin : 7,6 mg/ml Kalsiumklorid: 5,9 mg/ml
English: Fibrinogen: 90 mg/ml Aprotinin (bovine): 1000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 5,9 mg/ml Factor XIII: 60 U/ml
Norwegian Bokmål: Fibrinogen: 90 mg/ml Aprotinin (bovint): 1000 KIU/ml Trombin : 500 IU/ml Kalsiumklorid: 5,9 mg/ml Koagulasjonsfaktor XIII: 60 U/ml
English: Sealant
Norwegian Bokmål: Topisk
English: Human fibrinogen: 72-110 mg/ml Factor xiii: ≤10 UI Aprotinin: 3000 KU12/ml Human thrombin: 500 UI3/ml Calcium chloride: 40 micromol/ml
Norwegian Bokmål: Humant fibrinogen: 72110 mg/ml faktor XIII: ≤10 IE Aprotinin: 3000 KIE2/ml Humant trombin: 500 IE3/ml Kalsiumklorid: 40 µmol/ml
English: Combi-Set 1: fibrinogen: 90 mg/ml coagulation factor XIII: 60 U/ml aprotinin: 1000 KIU/ml=0.56 PEU/ml
Norwegian Bokmål: Combi-Set 1: fibrinogen: 90 mg/ml Koagulasjonsfaktor XIII: 60 U/ml aprotinin:
English: Thrombin S lyophilized: 500 I.E/ml Thrombin L lyophilized: 4 I.E/ml Calcium chloride: 5,88 mg/ml
Norwegian Bokmål: Lyofilisert trombin L: 4 IE/ml Kalsiumklorid: 5,88 mg/ml
English: Fibrinogen: 70 - 110 mg/ml Fibronectine 2 - 9 mg/ml Thrombin: 500 IU/ml Calcium chloride: 40 µmol/ml Factor XIII: 10-50 IU/ml Aprotinine (bovine): 3000 KIU/ml
Norwegian Bokmål: Fibrinogen: 70-110 mg/ml Fibronektin: 2-9 mg/ml Trombin: 500 IE/ml Kalsiumklorid: 40 µmol/ml Faktor XIII: 10-50 IE/ml Aprotinin (bovint):
English: Beriplast P CombiSet Pulver und Lösungsmittel für einen
Norwegian Bokmål: Beriplast P Combi-Set Pulver und
English: Bottle 1: Total Proteins 100-130 mg/ml; dont clottable protein 75-115 mg/ml, Factor XIII 10-50 UI/ml; Plasminogen 0.04-0.12 mg/ml; Bottle 2: Aprotinin bovine 3000 UIK/ml (1.67 UPE/ml);
Norwegian Bokmål: Flaske 1: Proteiner totalt 100-130 mg/ml; koagulerbare proteiner 75115 mg/ml; faktor XIII 1050 IE/ml; plasminogen 0,040,12 mg/ml; flaske 2: Bovint aprotinin 3000 KIE/ml (1,67 EPU/ml); flaske 3: Humant trombin 500 IE/ml; proteiner 50 mg/ml; flaske 4: Humant trombin 4 IE/ml; proteiner 50 mg/ml; flaske 5: kalsiumklorid 40 µmol/ml
English: Slovak Republic CSL Behring GmbH, Emil-von-Behring-Strasse 76 35041 Marburg
Norwegian Bokmål: CSL Behring GmbH, Emil-von-Behring-Strasse 76
English: Fibrinogen: 90 mg/ml Coagulation factor XIII: 60 U/ml Aprotinin: 1000 KIU = 0,56 EPU Thrombin: 500 IU /ml Calcium chloride (dihydrate): 5,9 mg/ml
Norwegian Bokmål: Fibrinogen: 90 mg/ml Koagulasjonsfaktor XIII: 60 U/ml Aprotinin: 1000 KIU = 0,56 EPU Trombin : 500 IU /ml Kalsiumkloriddihydrat : 5,9 mg/ml
English: Proteins 50mg/ml; Bottle 4: Human Thrombin 4 UI/ml; Proteins 50mg/ml;
Norwegian Bokmål: Plasminogen 80 μg/ml Humant trombin 500 IE/ml Humant plasmaprotein 50 mg/ml
English: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 40 µmol/ml Factor XIII: 10 IU/ml
Norwegian Bokmål: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIE/ml Trombin: 500 IE/ml Kalsiumklorid: 40 µmol/ml Faktor XIII: 10 IE/ml
English: Fibrinogen: 75mg Human thrombin: 500 IU Aprotinin: 3000KIU Calcium chloride: 40 mcmol/ml
Norwegian Bokmål: Fibrinogen: 75 mg/ml Humant trombin: 500 IE/ml Aprotinin: 3000 KIE/ml Kalsiumklorid: 40 µmol/ml
English: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 40 µmol/ml
Norwegian Bokmål: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIE/ml Trombin: 500 IE/ml Kalsiumklorid: 40 µmol/ml
English: Fibrinogen: 90 mg/ml Factor XIII: 60 U/ml Aprotinin: 1000 KIU/ml Thrombin: 500 IU/ml Calcium Chloride: 5.9 mg/ml
Norwegian Bokmål: Fibrinogen: 90 mg/ml Koagulasjonsfaktor XIII: 60 U/ml Aprotinin: 1000 KIU/ml Trombin : 500 IU/ml Kalsiumklorid: 5.9 mg/ml
English: Fibrinogen: 90 mg/ml Factor XIII: 60 U/ml Aprotinin: 1000 UIC/ml Thrombin: 500 UI/ml Calcium chloride dihydrate: 5,9 mg/ml
Norwegian Bokmål: Fibrinogen: 90 mg/ml Koagulasjonsfaktor XIII: 60 U/ml Aprotinin: 1000 UIC/ml Trombin : 500 UI/ml Kalsiumkloriddihydrat : 5,9 mg/ml
English: IU/ml
Norwegian Bokmål: 3000 KIE/ml
English: Tissucol Duo (RVG
Norwegian Bokmål: Tisseel duo quick
English: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU/ml Thrombin: 4 IU/ml Calcium chloride: 40 µmol/ml
Norwegian Bokmål: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIE/ml Trombin: 4 IE/ml Kalsiumklorid: 40 µmol/ml
English: Tisseel Duo Quick Fibrinogen 90mg/ml Fibronectin 6mg/ml
Norwegian Bokmål: Humant fibrinogen 90,00 mg/ml
English: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU Thrombin: 500 UI/ML Calcium Chloride: 40 MMO LI/L Factor XIII ≤ 10 UI/ml
Norwegian Bokmål: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIE Trombin: 500 IE/ml Kalsiumklorid: 40 μmol/ml Faktor XIII ≤ 10 IE/ml
English: Fibrinogen: 90 mg/ml Coagulation factor XIII: 60 U/ml Aprotinin: 1000 KIU/ml=0.56 PEU/ml
Norwegian Bokmål: Fibrinogen: 90 mg/ml Koagulasjonsfaktor XIII: 60 U/ml Aprotinin:
English: Powder for sealant and Solution for sealant
Norwegian Bokmål: Pulver til vevslim og vevslim, oppløsning
English: Aprotinin 3000KIE/ml Coagulation Factor XIII 30IE/ml Plasminogen 80 μg/ml Thrombin human 500 IE/ml Calcium Chloride Dihydrate 40 μg/ml
Norwegian Bokmål: Aprotinin 3000 KIE/ml Humant trombin 500 IE/ml Kalsiumklorid 40 µmol/ml
English: Powder, solution and solvent for sealant
Norwegian Bokmål: Pulver, oppløsning og væske til vevslim
English: Bottle 5: calcium chloride 40 µmol/ml
Norwegian Bokmål: Humant trombin 4 IE^3/ml Kalsiumklorid 40 μmol/ml
English: Fibrinogen: 70-110mg/ml Plasmafibronectin (CIG): 2-9mg/ml Factor XIII: 10-50 U/ml Plasminogen: 0.04 - 0.12mg/ml
Norwegian Bokmål: Fibrinogen: 70-110 mg/ml Plasmafibronektin (CIG): 29 mg/ml
English: The following side effects have also been reported:
Norwegian Bokmål: Følgende bivirkninger er også rapportert:
English: Adopted at the 8-11 January 2018 PRAC
Norwegian Bokmål: Vedtatt 8.-11- januar 2018 PRAC
English: Respiratory system
Norwegian Bokmål: Respirasjonssystemet
English: Frequency ‘not known': Non-mechanical intestinal obstruction
Norwegian Bokmål: Frekvens ‘ikke kjent': Ikke-mekanisk intestinal obstruksjon
English: Questioning the patient with regard to possible pulmonary dysfunctions, if necessary lung function test.
Norwegian Bokmål: Respirasjonssystemet Questioning the patient with regard to possible pulmonary dysfunctions, if necessary lung function test.
English: Dulaglutide - Gastrointestinal stenosis and obstruction (EPITT no 18931)
Norwegian Bokmål: Dulaglutid - Gastrointestinal stenose og obstruksjon (EPITT nr. 18931)
English: Not known: frequency cannot be estimated from the available data Increased urine output
Norwegian Bokmål: Ikke kjent: frekvens kan ikke anslås ut ifra tilgjengelige data Økt urinering
English: Frequency ‘not known'
Norwegian Bokmål: Frekvens ‘ikke kjent'
English: Patients should be informed of the risk of pneumonitis and advised to contact their doctor immediately should they develop persistent cough or dyspnoea.
Norwegian Bokmål: Pasienter bør informeres om risiko for pneumonitt og rådes til å kontakte lege umiddelbart ved utvikling av vedvarende hoste eller dyspné.
English: The following side effects have also been reported: Frequency not known (cannot be estimated from the available data): bleeding from the lungs
Norwegian Bokmål: Følgende bivirkninger er også rapportert: Ikke kjent (kan ikke anslås ut i fra tilgjengelige data): blødning i lungene
English: Many of the patients in whom these occurred had underlying risk factors for the development of renal events including dehydration or pre-existing hypertension or diabetes.
Norwegian Bokmål: Mange av pasientene hadde underliggende risikofaktorer for utvikling av nyreskade, som dehydrering, hypertensjon eller diabetes.
English: Frequency not known (cannot be estimated from the available data): bleeding from the lungs* *(has been reported for methotrexate used in patients with underlying rheumatologic disease).
Norwegian Bokmål: Ikke kjent (kan ikke anslås ut i fra tilgjengelige data): blødning i lungene* *(er blitt rapportert hos pasienter som bruker metotreksat og som har en underliggende revmatologisk sykdom)
English: Pemetrexed - Nephrogenic diabetes insipidus (EPITT no
Norwegian Bokmål: Pemetreksed - Nefrogen diabetes insipidus (EPITT nr.
English: Thirst and increased water consumption Hypernatraemia - increased sodium in blood
Norwegian Bokmål: Hypernatremi - økt natriuminnhold i blod
English: Uncommon cases of acute renal failure have been reported with pemetrexed alone or in association with other chemotherapeutic agents (see section 4.4).
Norwegian Bokmål: Tilfeller av akutt nyresvikt er rapportert med frekvens «mindre vanlig» der pemetreksed er brukt alene eller sammen med andre kjemoterapeutiske midler (se avsnitt 4.4).
English: If you develop any of the following side effects, contact your doctor immediately: - inflammation of the lungs (symptoms may be general illness, dry, irritating cough, shortness of breath, breathlessness at rest, chest pain, or fever) - spitting or coughing blood
Norwegian Bokmål: Kontakt lege umiddelbart dersom du opplever følgende symptomer: - lungebetennelse (symptomer på dette kan være generell uvelhet, tørr, irriterende hoste, kortpustethet, andpustenhet ved hvile, brystsmerter eller feber) - spytter eller hoster opp blod
English: Bowel obstruction - a severe form of constipation with additional symptoms such as stomach ache, bloating or vomiting
Norwegian Bokmål: Tarmobstruksjon - en alvorlig form for forstoppelse med tilleggssymptomer som magesmerter, oppblåst mage eller oppkast.
English: If you develop any of the following side effects, contact your doctor immediately: - inflammation of the lungs (symptoms may be general illness, dry, irritating cough, shortness of breath, breathlessness at rest, chest pain, or fever) - spitting or coughing blood* *(has been reported for methotrexate used in patients with underlying rheumatologic disease)
Norwegian Bokmål: Kontakt lege umiddelbart dersom du opplever følgende symptomer: - lungebetennelse (symptomer på dette kan være generell uvelhet, tørr, irriterende hoste, kortpustethet, andpustenhet ved hvile, brystsmerter eller feber) - spytter eller hoster opp blod* *(er blitt rapportert hos pasienter som bruker metotreksat og som har en underliggende revmatologisk sykdom)
English: Acute or chronic interstitial pneumonitis, often associated with blood eosinophilia, may occur and deaths have been reported.
Norwegian Bokmål: Akutt eller kronisk interstitiell pneumonitt, ofte forbundet med eosinofili i blodet, kan opptre, og dødsfall er rapportert.
English: For methotrexate-containing medicinal products with both nononcologic and oncologic indications
Norwegian Bokmål: For metotreksat-holdige legemidler med både ikke-onkologiske og onkologiske indikasjoner
English: Respiratory, thoracic and mediastinal disorders Not known: Epistaxis, Pulmonary alveolar haemorrhage
Norwegian Bokmål: Sykdommer i respirasjonsorganer, thorax og mediastinum Ikke kjent: Epistakse, Pulmonal alveolær blødning
English: Serious renal events, including acute renal failure, have been reported with pemetrexed alone or in association with other chemotherapeutic agents.
Norwegian Bokmål: Alvorlig nyreskade som akutt nyresvikt, er rapportert ved bruk av pemetreksed alene eller sammen med andre kjemoterapeutiske midler.
English: For methotrexate-containing medicinal products with oncologic indications
Norwegian Bokmål: For metotreksat-holdige legemidler med onkologiske indikasjoner
English: For methotrexate-containing medicinal products with non-oncologic indications
Norwegian Bokmål: For metotreksatholdige legemidler med ikke-onkologiske indikasjoner
English: Symptoms typically include dyspnoea, cough (especially a dry nonproductive cough), thoracic pain and fever for which patients should be monitored at each follow-up visit.
Norwegian Bokmål: Typiske symptomer omfatter dyspné, hoste (spesielt ikke-produktiv tørrhoste), brystsmerter og feber.
English: Methotrexate - Pulmonary alveolar haemorrhage (EPITT no 18850)
Norwegian Bokmål: Metotreksat - Pulmonal alveolær blødning (EPITT nr.
English: MD: entire risk period.
Norwegian Bokmål: MD: hele risikoperioden.
English: SC In ovo
Norwegian Bokmål: s.c. in ovo
English: The vaccine is now ready for use.
Norwegian Bokmål: Vaksinen er nå klar til bruk.
English: The usual aseptic precautions should be applied to all preparation and administration procedures.
Norwegian Bokmål: Vanlige aseptiske forholdsregler skal brukes ved alle forberedelser og administrasjons prosedyrer.
English: Date of first authorisation: 22/08/2017
Norwegian Bokmål: Dato for første markedsføringstillatelse: 22/08/2017
English: Chickens and embryonated chicken eggs.
Norwegian Bokmål: Kylling og befruktede kylling egg.
English: ATCvet code: QI01AD16.
Norwegian Bokmål: ATC vet-kode: QI01AD.
English: Do not thaw in hot water or ice cold water.
Norwegian Bokmål: Skal ikke tines i varmt vann eller iskaldt vann.
English: Suspension: off-red to red suspension.
Norwegian Bokmål: Suspensjon: rødlig til rød suspensjon.
English: However, precautionary measures have to be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Norwegian Bokmål: Det må likevel tas forholdsregler for å unngå direkte eller indirekte kontakt mellom vaksinerte kyllinger og kalkuner.
English: Control of correct storage:
Norwegian Bokmål: Kontroll av korrekt oppbevaring:
English: Preparation of the vaccine:
Norwegian Bokmål: Klargjøring av vaksinen:
English: 29160 Intervet Lane PO Box 318, Millsboro Delaware 19966-0318
Norwegian Bokmål: 29160 Intervet Lane PO Box 318, Millsboro Delaware 19966-0318 USA
English: If you notice any serious effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Norwegian Bokmål: Hvis du legger merke til noen bivirkninger, også slike som ikke allerede er nevnt i dette pakningsvedlegget, eller du tror at legemidlet ikke har virket, bør dette meldes til din veterinær.
English: please note; the sentence ‘for animal treatment only' will only appear in the English and will not be translated
Norwegian Bokmål: Setningen «For animal treatment only.» vil kun være på engelsk, og vil ikke oversettes til norsk.