natgillin/translations-raw huggingface dataset:
Akynzeo er et lægemiddel, der anvendes til at forebygge kvalme og opkastning hos voksne patienter med cancer, som modtager kemoterapi (lægemidler til behandling af cancer). 
Akynzeo is a medicine used to prevent nausea (feeling sick) and vomiting in adult patients with cancer who are receiving chemotherapy (medicines to treat cancer).
Hvis du ønsker praktisk vejledning om anvendelsen af Akynzeo, kan du læse indlægssedlen eller kontakte din læge eller dit apotek. 
For practical information about using Akynzeo, patients should read the package leaflet or contact their doctor or pharmacist.
Ved at anvende begge aktive stoffer sammen hjælper Akynzeo med til at tilvejebringe kontrol af både de umiddelbare og forsinkede faser af kvalme og opkastning, der indtræffer efter kemoterapi. 
By having both active substances together, Akynzeo helps provide control for both the immediate and delayed phases of nausea and vomiting than occur following chemotherapy.
Hvordan anvendes Akynzeo? 
How is Akynzeo used?
Palonosetron blokerer på den anden side 5HT3-receptorerne i tarmsystemet, som er ansvarlige for den umiddelbare fase (der indtræffer inden for de første 24 timer). 
receptors, which are found in the nervous system and are responsible for the delayed phase of nausea and vomiting (that occurs after the first 24 hours); palonosetron, on the other hand, blocks 5HT3 receptors in the gut, which are responsible for the immediate phase (that occurs within the first 24 hours).
Hvilke fordele viser undersøgelserne, at der er ved Akynzeo? 
What benefits of Akynzeo have been shown in studies?
Hvordan virker Akynzeo? 
How does Akynzeo work?
Netupitant virker ved at blokere neurokinin-1(NK1)-receptorerne, som findes i nervesystemet, og som er ansvarlige for den forsinkede kvalme- og opkastningsfase (der indtræffer efter de første 24 timer). 
Netupitant works by blocking neurokinin-1 (NK1)
MF (EU)-nummer (Særnavn) Navn 
MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administra
BILAG I Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, indgivelsesveje, indehavere af markedsføringstilladelser i medlemsstaterne 
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Kruczkowskiego 8 00-380 Warszawa Poland 
Kruczkowskiego 8 00-380 Warzawa Poland
Beriplast og tilhørende navne Medlemsstat (i EØS) 
Beriplast and associated names Member State (in EEA)
Artiss og tilhørende navne; Tisseel og tilhørende navne; Tissucol og tilhørende navne Medlemsstat (i EØS) 
Artiss and associated names; Tisseel and associated names; Tissucol and associated names Member State (in EEA)
Aprotinin 15000 KIE; 
Aprotinin 15000 KIU;
1221 Vienna 
A- 1221 Vienna Austria
Storbritannien Baxter Healthcare Limited, Caxton Way, 
United Kingdom Baxter Healthcare Limited, Caxton Way,
Luxembourg Baxter AG Industriestraße 67 
The Netherlands Baxter AG Industriestraße 67
P 0,5 ml, 1 ml, 3 ml, powders and solvents for sealant 
BERIPLAST P 0.5 ml, 1 ml, 3 ml, powders and solvents for sealant Combi-Set
Grækenland CSL BEHRING 5 Hadjiyianni Mexi str, 11528-Athens 
CSL BEHRING 5 Hadjiyianni Mexi str, 11528-Athens Greece
Zona Industrial da Abrunheira - Edifício 10Sintra Business Park 2710-089 Sintra Portugal 
Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park
Protein i alt 200-260 mg; 
Total Protein 200-260 mg;
Protein i alt 500-650 mg; 
Total Protein 500-650 mg;
Humant fibrinogen (koagulerbart protein): 72-110 mg/ml 
Human fibrinogen (clottable protein): 72-110 mg/ml
Calciumchlorid: 40 µmol/ml 
Calcium chloride: 40 µmol/ml
Flaske 3: Humant thrombin 500 IE/ml; 
Bottle 3: Human Thrombin 500 IU/ml;
Faktor XIII 10-50 IE; 
Factor XIII 30 a.e
Komponent 2 
Component 2
2. komponent: Thrombin 500 IE/ml 
2nd Component: Thrombin 500 UI/ml
BAXTER, S.L.Polígono Industrial Sector 14 Pouet de Camilo, 2 46394 Ribarroja del Turia Valencia 
Polígono Industrial Sector 14 Pouet de Camilo, 2
Thrombin 1000 IE eller Thrombin 8 IE; Calciumchloriddihydrat 11,76 mg 
Thrombin 1000 IU or Thrombin 8 UI; Calcium Chlorid Dihydrate 11.76 mg
Combi-Set 0,5ml/1ml/3m l 
Beriplast P CombiSet 0,5ml/1ml/3ml
Thrombin 2500 IE eller Thrombin 20 IE; Calciumchloriddihydrat 29,4 mg 
Thrombin 2500 IU or Thrombin 20 UI; Calcium Chlorid Dihydrate 29.4 mg
Calciumchlorid: 40 µmol/ml Faktor XIII: ≤10 IE/ml 
Calcium chloride: 40 µmol/ml Factor XIII: 30 IU/ml
Komponent 1: 
Component 1:
Koagulerbart protein: 150-230 mg, hvoraf fibrinogen 140-220 mg; Plasmafibronectin 4-18 mg; 
Clottable protein: 150-230 mg, thereof Fibrinogen 140-220 mg; Plasma Fibronectin 4-18 mg; Factor XIII 20-100 UI;
Fibrinogen, humant 90,00 mg/ml Faktor XIII: 10,00 IE/ml Fibronectin: 5,50 mg/ml Plasminogen: 0,08 mg/ml Aprotinin 3000,0 KIE***/ml 
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
Koagulerbart protein: 375-575 mg, hvoraf fibrinogen 350-550 mg; Plasmafibronectin 10-45 mg; 
Clottable protein: 375-575 mg, thereof Fibrinogen 350-550 mg; Plasma Fibronectin 10-45 mg; Factor XIII 50-250 UI;
Thrombin S lyofiliseret: 500 IE/ml Thrombin L lyofiliseret: 4 IE/ml Calciumchlorid: 5,88 mg/ml 
Thrombin S lyophilized: 500 I.E/ml Thrombin L lyophilized: 4 I.E/ml Calcium chloride: 5,88 mg/ml
1. komponent: 
1st Component:
Komponent 2: 
Component 2:
Thrombin 500 IE eller Thrombin 4 IE; Calciumchloriddihydrat 5,88 mg 
Thrombin 500 IU or Thrombin 4 UI; Calcium Chlorid Dihydrate 5.88 mg
Kutan anvendelse 
Cutaneous Use
Thrombin (humant) 500 IE/ml Calciumchlorid: 5,88 mg/ml 
Thrombin (human) 500 I.E./ml Calcium chloride: 5,88 mg/ml
Proteiner 50 mg/ml; Flaske 4: Humant thrombin 4 IE/ml; Proteiner 50 mg/ml; Flaske 5: calciumchlorid 40 µmol/ml 
Proteins 50mg/ml; Bottle 4: Human Thrombin 4 UI/ml; Proteins 50mg/ml;
Grækenland BAXTER HELLAS LTD 3 Metsovou str, 
BAXTER HELLAS LTD 3 Metsovou str, 14121-N Irakleio, Athens
2. komponent: 
2nd Component:
Pulver, opløsning og solvens til vævsklæber 
Powder, solution and solvent for sealant
Human fibrinogen: 90 mg Koagulationsfaktor XIII: 60 UI Aprotinin: 1000 KUI Trombin: 7,6 mg Calcium chloride: 5,9 mg 
Human fibrinogen: 90 mg Coagulation factor XIII: 60 UI Aprotinin: 1000 KUI Trombin: 7,6 mg Calcium chloride: 5,9 mg
Fibrinogen: 72-110 mg/ml Aprotinin: 3000 KIE/ml Thrombin: 500 IE/ml i 45-55 mg protein i alt 
Fibrinogen: 72-110mg/ml Aprotinin: 3000KIU/ml Thrombin: 500 IU/ml in 45-55mg total protein
Flaske 1: Proteiner i alt 100-130 mg/ml; koagulerbart protein 75-115 mg/ml, Faktor XIII 10-50 IE/ml; Plasminogen 0,04-0,12 mg/ml; Flaske 2: Bovint aprotinin 3000 KIE/ml (1,67 PEU/ml); 
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);
Sprøjte TISSUCOL-APROTININ: Proteiner i alt 100-130 mg/ml; koagulerbart protein 75-115 mg/ml, heraf fibrinogen 70-110 mg/ml og plasmafibronectin 2-9 mg/ml; Faktor XIII 10-50 IE/ml; Plasminogen 0,040,12 mg/ml; Aprotinin 3000 KIE/ml (1,67 PEU/ml); Sprøjte THROMBINCALCIUMCHLORID: Proteiner 50 mg/ml; Thrombin 500 IE/ml; calciumchlorid 40 µmol/ml 
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
Fibrinogen: 70-110 mg/ml Plasmafibronectin (CIG): 2-9 mg/ml Faktor XIII: 10-50 E/ml Plasminogen: 0,04-0,12 mg/ml 
Fibrinogen: 70-110mg/ml Plasmafibronectin (CIG): 2-9mg/ml Factor XIII: 10-50 U/ml Plasminogen: 0.04 - 0.12mg/ml
Combi-Set 1: fibrinogen: 90 mg/ml Koagulationsfaktor XIII: 60 U/ml aprotinin: 1000 KIU/ml = 0,56 PEU/ml 
Combi-Set 1: fibrinogen: 90 mg/ml coagulation factor XIII: 60 U/ml aprotinin: 1000 KIU/ml=0.56 PEU/ml
Plasminogen 0,08-0,24 mg; 
Plasminogen 0.08-0.24 mg; Aprotinin 6000 KIU;
Faktor XIII ≤10 IE/ml Aprotinin: 3000 KIE/ml Humant thrombin: 500 IE/ml Calciumchlorid: 40 μmol/ml 
Factor XIII ≤ 10 UI/ml Aprotinin: 3000 UIK/ml Human Thrombin: 500 UI/ml Calcium chloride: 40 μmol/ml
Plasminogen 0,04-0,12 mg; 
UI/ml; Plasminogen 0.04-0.12 mg/ml;
Fibrinogen: 90 mg/ml Koagulationsfaktor XIII: 60 U/ml Aprotinin: 1000 KIU/ml = 0,56 PEU/ml 
Fibrinogen: 90 mg/ml Coagulation factor XIII: 60 U/ml Aprotinin: 1000 KIU/ml=0.56 PEU/ml
Koagulerbart protein: 75-115 mg, hvoraf fibrinogen 70-110 mg; Plasmafibronectin 2-9 mg; 
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;
Humant fibrinogen (72-110 mg/ml) Faktor xiii (≤10 IE) Aprotinin (3000 KIE2/ml) Humant thrombin (500 IE3/ml) Calciumchlorid (40 mikromol/ml) 
Human fibrinogen (72-110 mg/ml) Factor xiii (≤10 UI) Aprotinin (3000 KUI2/ml) Human thrombin (500 UI3/ml) Calcium chloride (40micromol/ml)
Human fibrinogen: 90 mg/ml Koagulationsfaktor XIII: 60 e/ml Aprotinin: 1000 EIK/ml Thrombin: 7,6 mg/ml Calcium chloride: 5,9 mg/ml 
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
Humant fibrinogen 91 mg/ml Human faktor XIII 10 IE/ml Bovint aprotinin 3000 KIE/ml Humant thrombin 500 IE/ml Calciumchlorid (40 mikromol/ml) 
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
enhed/ml Koagulationsfaktor XIII 30 mg/ml Plasminogen 80 μg/ml Thrombin, humant 500 IE/ml Plasmaprotein, humant 50 mg/ml Calciumchloriddihydrat 40 μg/ml 
Aprotinin 3000KIE/ml Coagulation Factor XIII 30IE/ml Plasminogen 80 μg/ml Thrombin human 500 IE/ml Calcium Chloride Dihydrate 40 μg/ml
Humant fibrinogen 72-110 mg/ml Aprotinin 3000 KIE/ml Humant thrombin 500 IE/ml Calciumchlorid 40 µmol/ml 
Human fibrinogen 72-110 mg/ml Aprotinin 3000 KIU/ml Human Thrombin 500 IU/ml Calcium Chloride 40 µmol/ml
Fibrinogen: 90 mg/ml Aprotinin (bovint): 1000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 5,9 mg/ml Koagulationsfaktor XIII: 60 U/ml 
Fibrinogen: 90 mg/ml Aprotinin (bovine): 1000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 5,9 mg/ml Factor XIII: 60 U/ml
Fibrinogen: 70-110 mg/ml Koagulationsfaktor XIII: 10-50 IE/ml Plasmafibronectin: 2-9 mg/ml Aprotinin (bovint): 3000 KIE/ml 
Fibrinogen:70-110 mg/ml Coagulation factor XIII: 10-50 I.E./ml Plasmafibronectin: 2-9 mg/ml Aprotinin (bovin): 3000 KIE/ml
Humant fibrinogen 91 mg/ml Aprotinin 3000 KIE/ml Humant thrombin 4 IE/ml Calciumchlorid 40 µmol/ml 
Human fibrinogen 91 mg/ml Aprotinin 3000 KIU/ml Human Thrombin 4 IU/ml Calcium Chloride 40 µmol/ml
Topisk 
Sealant
Fibrinogen: 70-110 mg/ml Plasmafibronectin: 2-9 mg/ml Koagulationsfaktor XIII: 10-50 IE/ml Aprotininopløsning: 3000 KIE/ml 
Fibrinogen: 70 - 110 mg/ml Plasmafibronectin: 2 - 9 mg/ml Coagulation factor XIII: 10 - 50 I.E/ml Aprotininsolution: 3000 KIE/ml
Fibrinogen: 70-110 mg/ml Fibronectin: 2-9 mg/ml Thrombin: 500 IE/ml Calciumchlorid: 40 µmol/ml Faktor XIII: 10-50 IE/ml Aprotinin (bovint): 3000 KIE/ml 
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
Fibrinogen: 90 mg/ml Koagulationsfaktor XIII: 60 U/ml Aprotinin: 1000 KIU = 0,56 EPU Thrombin: 500 IU/ml Calciumchloriddihydrat : 5,9 mg/ml 
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
Humant fibrinogen: 72-110 mg/ml Faktor xiii: ≤10 IE Aprotinin: 3000 KIE2/ml Humant thrombin: 500 IE3/ml Calciumchlorid: 40 micromol/ml 
Human fibrinogen: 72-110 mg/ml Factor xiii: ≤10 UI Aprotinin: 3000 KU12/ml Human thrombin: 500 UI3/ml Calcium chloride: 40 micromol/ml
Humant fibrinogen: 72-110 mg/ml Aprotinin: 3000 KIE/ml Humant thrombin: 4 IE/ml Calciumchlorid: 40 μmol/ml 
Human Fibrinogen: 72-110 mg/ml Aprotinin: 3000 KIU/ml Human Thrombin: 4 IU/ml Calcium Chloride: 40 μmol/ml
Humant fibrinogen: 91 mg1/ml Aprotinin: 3000 KIE2/ml Humant thrombin: 500 IE3/ml Calciumchlorid: 40 µmol/ml 
Human Fibrinogen: 91 mg1/ml Aprotinin: 3000 KIU2/ml Human Thrombin: 500 IU3/ml Calcium Chloride: 40 µmol/ml
Fibrinogen: 90 mg/ml Koagulationsfaktor XIII: 60 U/ml Aprotinin: 1000 KIU/ml Thrombin: 500 IU/ml Calcium Chloride: 5,9 mg/ml 
Fibrinogen: 90 mg/ml Factor XIII: 60 U/ml Aprotinin: 1000 KIU/ml Thrombin: 500 IU/ml Calcium Chloride: 5.9 mg/ml
Fibrinogen: 90 mg/ml Koagulationsfaktor XIII: 60 U/ml Aprotinin: 1000 UIC/ml Thrombin: 500 UI/ml Calciumchloriddihydrat : 5,9 mg/ml 
Fibrinogen: 90 mg/ml Factor XIII: 60 U/ml Aprotinin: 1000 UIC/ml Thrombin: 500 UI/ml Calcium chloride dihydrate: 5,9 mg/ml
Fibrinogen: 91 mg/ml Aprotinin: 3000 KIE/ml Thrombin: 500 IE/ml Calciumchlorid: 40 µmol/ml Faktor XIII: 10 IE/ml 
Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 40 µmol/ml Factor XIII: 10 IU/ml
Fibrinogen: 75 mg/ml Humant thrombin: 500 IE/ml Aprotinin: 3000 KIE/ml Calciumchlorid: 40 µmol/ml 
Fibrinogen: 75mg Human thrombin: 500 IU Aprotinin: 3000KIU Calcium chloride: 40 mcmol/ml
Fibrinogen: 91 mg/ml Aprotinin: 3000 KIE/ml Thrombin: 500 IE/ml Calciumchlorid: 40 µmol/ml 
Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 40 µmol/ml
Fibrinogen: 91 mg/ml Aprotinin: 3000 KIE/ml Thrombin: 4 IE/ml Calciumchlorid: 40 µmol/ml 
Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU/ml Thrombin: 4 IU/ml Calcium chloride: 40 µmol/ml
Humant fibrinogen 91 mg/ml Aprotinin 3000 KIE/ml (bovint) Humant thrombin, 4 IE^3/ml Calciumchlorid (40 mikromol/ml) 
Human Fibrinogen 91 mg/ml Aprotinum INN 3000 KIU/ml (bovine) Human Thrombin 4 ae^3/ml Calcium Chloride 40 micromol/ml
Humant fibrinogen: 110 mg/ml Aprotinin: 3750 KIE/ml Humant thrombin: 5 IE/ml Calciumchlorid: 44 µmol/ml 
Human fibrinogen: 110mg/ml Aprotinin: 3750KIU/ml Human thrombin: 6.5IU/ml Calcium chloride: 44mcmol/ml
Tisseel-opløsning per mlFibrinogen 90 mg Fibronectin 5,5 mg Faktor XIII 30 IE Aprotinin (bovint) 3000 KIE Plasminogen 80 mikrogram Thrombinopløsning per ml Humant thrombin 500 IE Calciumchlorid 40 mikromol 
Aprotinin (bovel) 3000 KIU Plasminogen 80 microgram Thrombin solution per ml Human thrombin 500 ae Calcium chloridum 40 micromol
Humant fibrinogen: 91 mg/ml Aprotinin: 3000 KIE2/ml Humant thrombin: 4 IE3/ml Calciumchlorid: 40 micromol/ml 
Human fibrinogen: 91 mg/ml Aprotinin: 3000 KUI2/ml Human thrombin: 4 UI3/ml Calcium chloride: 40 mmol/ml
Humant fibrinogen: 72-110 mg/ml Aprotinin: 3000 KIE/ml Humant thrombin: 500 IE/ml Calciumchlorid: 40 μmol/ml 
Human Fibrinogen: 72/110 mg/ml Aprotinin:3000 KIU/ml Human Thrombin: 500 IU/ml Calcium Chloride: 40 μmol/ml
Fibrinogen: 91 mg/ml Aprotinin: 3000 KIE Thrombin: 500 IE/ml Calciumchlorid: 40 μmol/ml Faktor XIII ≤10 IE/ml 
Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU Thrombin: 500 UI/ML Calcium Chloride: 40 MMO LI/L Factor XIII ≤ 10 UI/ml
Humant fibrinogen: 91 mg1/ml Aprotinin: 3000 KIE2/ml Humant thrombin: 4 IE3/ml Calciumchlorid: 40 μmol/ml 
Human Fibrinogen: 91mg1/ ml Aprotinin: 3000 KIU2/ml Human Thrombin: 4IU3/ml Calcium Chloride:40μmol/ml
Baxter B.V. 
BAXTER, S.L.
Humant fibrinogen: 110 mg/ml Aprotinin: 3000 KIE/ml Humant thrombin: 500 IE/ml Calciumchlorid: 40 µmol/ml 
Human fibrinogen: 110mg/ml Aprotinin: 3000KU/ml Human thrombin: 500 iu/ml Calcium chloride: 40mcmol/ml
CSL Behring GmbH, Emil-von-Behring-Strasse 7 
Slovak Republic CSL Behring GmbH, Emil-von-Behring-Strasse 76 35041 Marburg
Tisseel (RVG 35050/1/2) Fibrinogen: 91 mg/ml Aprotinin (syntetisk): 3000 KIE/ml Thrombin: 500 IE/ml 
TISSEEL LYO Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU/ml Thrombin: 500 IU/ml
Sprøjte TISSUCOL-APROTININ: Proteiner i alt 100-130 mg/ml; koagulerbart protein 75-115 mg/ml, heraf fibrinogen 70-110 mg/ml og plasmafibronectin 2-9 mg/ml; Faktor XIII 10-50 IE/ml; Plasminogen 0,04-0,12 mg/ml; Aprotinin 3000 KIE/ml (1,67 PEU/ml); Sprøjte THROMBINCALCIUMCHLORID: Proteiner 50 mg/ml; Thrombin 500 IE/ml; calciumchlorid 40 µmol/ml 
Tissucol Duo 500 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
Følgende bivirkninger er også blevet rapporteret: 
The following side effects have also been reported:
Vedtaget på PRAC's møde 8.-11. januar 2018 
Adopted at the 8-11 January 2018 PRAC
Ikke kendt: hyppigheden kan ikke estimeres ud fra forhåndenværende data Øget urinproduktion 
Not known: frequency cannot be estimated from the available data Increased urine output
Hvis du oplever symptomer på blodigt spyt eller blodig hoste, bør du kontakte din læge med det samme. 
If you experience symptoms of spitting or coughing up blood you should contact your doctor immediately.
Patienterne skal informeres om risikoen for pneumonitis og tilrådes straks at kontakte lægen, hvis de får vedvarende hoste eller dyspnø. 
Patients should be informed of the risk of pneumonitis and advised to contact their doctor immediately should they develop persistent cough or dyspnoea.
Dulaglutid - Gastrointestinal stenose og obstruktion (EPITT nr. 18931) 
Dulaglutide - Gastrointestinal stenosis and obstruction (EPITT no 18931)
Hyppighed "ikke kendt" 
Frequency ‘not known'
Følgende bivirkninger er også blevet rapporteret: Hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data): blødning i lungerne 
The following side effects have also been reported: Frequency not known (cannot be estimated from the available data): bleeding from the lungs
Symptomerne omfatter typisk dyspnø, hoste (især tør, uproduktiv hoste), brystsmerter og feber, som patienterne skal spørges om ved hvert kontrolbesøg. 
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.
Pemetrexed - Nefrogen diabetes insipidus (EPITT nr. 
Pemetrexed - Nephrogenic diabetes insipidus (EPITT no
Hyppighed "ikke kendt": Ikke-mekanisk tarmobstruktion 
Frequency ‘not known': Non-mechanical intestinal obstruction
Der er rapporteret om tilfælde af akut blødning i lungerne hos patienter med underliggende reumatologiske lidelser ved brug af methotrexat. 
Acute bleeding from the lungs in patients with underlying rheumatologic disease has been reported with methotrexate.
Tarmobstruktion - en svær form for forstoppelse med yderligere symptomer som f.eks. mavesmerter, oppustethed eller opkastning 
Bowel obstruction - a severe form of constipation with additional symptoms such as stomach ache, bloating or vomiting
Der kan opstå akut eller kronisk interstitiel pneumonitis, ofte forbundet med eosinofili, og dødelige tilfælde er rapporteret. 
Acute or chronic interstitial pneumonitis, often associated with blood eosinophilia, may occur and deaths have been reported.
Hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data): blødning i lungerne* *(er indberettet ved anvendelse af methotrexat hos patienter med underliggende reumatologisk sygdom). 
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).
Vurdering af luftveje 
Assessment of respiratory system
Patienten skal udspørges om eventuelle lungedysfunktioner. 
Questioning the patient with regard to possible pulmonary dysfunctions, if necessary lung function test.
Luftveje, thorax og mediastinum Ikke kendt: Epistaxis, pulmonal alveolær blødning 
Respiratory, thoracic and mediastinal disorders Not known: Epistaxis, Pulmonary alveolar haemorrhage
For methotrexat-holdige lægemidler med både ikke-onkologiske og onkologiske indikationer 
For methotrexate-containing medicinal products with both nononcologic and oncologic indications
Øget koncentration af natrium i blodet (hypernatriæmi) 
Thirst and increased water consumption Hypernatraemia - increased sodium in blood
Ikke kendt: Epistaxis, pulmonal alveolær blødning* *(er indberettet ved anvendelse af methotrexat i reumatologiske og relaterede indikationer) 
Respiratory, thoracic and mediastinal disorders Not known: Epistaxis, Pulmonary alveolar haemorrhage* *(has been reported for methotrexate used in rheumatologic and related indications)
For methotrexat-holdige lægemidler med onkologiske indikationer 
For methotrexate-containing medicinal products with oncologic indications
For methotrexat-holdige lægemidler med ikke-onkologiske indikationer 
For methotrexate-containing medicinal products with non-oncologic indications
Methotrexat - Pulmonal alveolær blødning (EPITT nr. 
Methotrexate - Pulmonary alveolar haemorrhage (EPITT no 18850)
− betændelse i lungerne (symptomerne kan være generel sygdomsfølelse, tør, generende hoste, 
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
Luftveje 
Respiratory system
Mave-tarm-kanalen 
Gastrointestinal disorders
MD: hele risikoperioden. 
MD: entire risk period.
s.c. In ovo 
SC In ovo
Vaccinen er nu klar til brug. 
The vaccine is now ready for use.
ATCvet-kode: QI01AD. 
ATCvet code: QI01AD16.
Dato for første markedsføringstilladelse: 22/08/2017 
Date of first authorisation: 22/08/2017
Officiel batchfrigivelse af kontrolmyndighed er krævet for dette produkt. 
Official control authority batch release is required for this product.
Vær opmærksom på, at sætningen “Til dyr” kun vil stå på engelsk og ikke vil blive oversat 
please note; the sentence ‘for animal treatment only' will only appear in the English and will not be translated
Sædvanlige aseptiske forholdsregler skal benyttes ved fremstillings- og administrationsprocedurer. 
The usual aseptic precautions should be applied to all preparation and administration procedures.
Suspension: rødlig til rød suspension. 
Suspension: off-red to red suspension.
Imidlertid skal der tages forholdsregler for at undgå direkte eller indirekte kontakt mellem vaccinerede kyllinger og kalkuner. 
However, precautionary measures have to be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Sikkerhedsstudier har vist, at stammen er sikker for kalkuner. 
Safety trials have shown that the strain is safe for turkeys.
Kontrol af korrekt opbevaring: 
Control of correct storage:
Det aktive stof, som principielt er af biologisk oprindelse, hvis formål er at udvikle aktiv immunitet, falder ikke inden for anvendelsesområdet af Forordning (EF) nr. 470/2009. 
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Fremstilling af vaccinen: 
Preparation of the vaccine:
Enhver, som har til hensigt at fremstille, indføre, besidde, sælge, levere og anvende dette veterinære lægemiddel skal forinden rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik, da disse aktiviteter kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til nationale lovgivning. 
Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Det anbefales højst at håndtere 5 ampuller (fra kun en stav) ad gangen. 
It is recommended to handle a maximum of 5 ampoules (from one cane only) at a time.
1 PFU: plaquedannende enheder. 
1 PFU - plaque forming units.
En 3-dobbelt overdosis blev testet in ovo, og blev vurderet som sikker. 
A 3-fold overdose was tested in ovo, which was regarded as safe.