natgillin/translations-raw huggingface dataset:
1 g/m2/hver 12. time på dag 1 til dag 3 
1 g/m2/every 12 hours on Day 1 to Day 3
Vedvarende trombocytopeni (Trombocytter < 100.000/mm 
Persistent thrombocytopenia (Platelets < 100,000/mm3 at the planned start date of the consolidation course)
In vitro viste N-acetyl-gamma-calicheamicin dimethylhydrazid og gemtuzumab ozogamicin lavt potentiale for at hæmme aktiviteten af UGT1A1, UGT1A4, UGT1A6, UGT1A9 og UGT2B7 ved klinisk relevante koncentrationer. 
In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide had a low potential to inhibit the activities of UGT1A1, UGT1A4, UGT1A6, UGT1A9, and UGT2B7 at clinically relevant concentrations.
Stomatitis omfatter følgende FT'er: slimhindeinflammation, orofaryngeale smerter, stomatitis, mundsår, mundsmerter, mundslimhindeblærer, aftøs stomatitis, sår på tungen, glossodyni, erytem på mundslimhinden, tungebetændelse og tungeblærer q. 
p. Stomatitis includes the following reported PTs: Mucosal inflammation, Oropharyngeal pain, Stomatitis, Mouth ulceration, Oral pain, Oral mucosal blistering, Aphthous stomatitis, Tongue ulceration, Glossodynia, Oral mucosal erythema, Glossitis#, and Oropharyngeal blistering#.
Der blev ikke observeret præ-neoplastiske eller neoplastiske læsioner hos aber ved op til ca. 115 gange human klinisk eksponering efter den tredje humane dosis på 3 mg/m baseret på 
There were no preneoplastic or neoplastic lesions observed in monkeys up to approximately 115 times the human clinical exposure after the third human dose of 3 mg/m2 based on AUC168).
In vitro havde N-acetyl-gamma-calicheamicin dimethylhydrazid og gemtuzumab ozogamicin lavt potentiale for at fremme CYP1A2-, CYP2B6- og CYP3A4-aktivitet ved klinisk relevante koncentrationer. 
In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide and gemtuzumab ozogamicin had a low potential to induce the activities of CYP1A2, CYP2B6, and CYP3A4 at clinically relevant concentrations.
Neutropenisk colitis Lever og galdeveje Meget almindelig Forhøjede transaminaser Hyperbilirubinæmi Almindelig 
Hepatobiliary disorders Very common Transaminases increasedq Hyperbilirubinaemiar
MYLOTARG 5 mg pulver til koncentrat til infusionsvæske, opløsning 
MYLOTARG 5 mg powder for concentrate for solution for infusion
Det indeholder 5 mg gemtuzumab ozogamicin. 
Each vial contains 5 mg of gemtuzumab ozogamicin.
9/l eller mere i perifert blod uden transfusion, anbefales op til to konsolideringsforløb med intravenøs DNR (60 mg/m på én dag (første forløb) eller 2 dage (andet forløb) i kombination med intravenøs AraC (1 g/m 2 pr. 12 timer, indgivet over 2 timer op til maksimaldosen på et hætteglas a 5 mg på dag 1). 
For patients experiencing a complete remission (CR) following induction, defined as fewer than 5% blasts in a normocellular marrow and an absolute neutrophil count (ANC) of more than 1.0 × 109 cells/L with a platelet count of 100 × 109/L or more in the peripheral blood in the absence of transfusion, up to 2 consolidation courses of intravenous DNR (60 mg/m2 for 1 day [first course] or 2 days [second course]) in combination with intravenous AraC (1 g/m2 per 12 hours, infused over 2 hours on Day 1 to Day 4) with intravenous MYLOTARG (3 mg/m2/dose infused over 2 hours up to a maximum dose of one 5 mg vial on Day 1) are recommended.
Andre lægemidlers virkning på gemtuzumab ozogamicin N-acetyl-gamma-calicheamicin dimethylhydrazid metaboliseres in vitro primært via non-enzymatisk reduktion. 
In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide is primarily metabolised via nonenzymatic reduction.
Baseret på en analyse af potentielle risikofaktorer hos voksne patienter, der fik MYLOTARG som monoterapi, var der hos patienter, som fik en HSCT før eksponering for gemtuzumab ozogamicin, 2,6 gange større sandsynlighed (95 % CI: 1,448-4,769) for at udvikle VOD sammenlignet med patienter, som ikke fik HSCT før gemtuzumab ozogamicin-behandling. 
Based on an analysis of potential risk factors, adult patients who received MYLOTARG as monotherapy, patients who had received an HSCT prior to gemtuzumab ozogamicin exposure were 2.6 times more likely (95% CI: 1.448, 4.769) to develop VOD compared to patients without HSCT prior to treatment with gemtuzumab ozogamicin; patients who had received an HSCT following treatment with gemtuzumab ozogamicin were 2.9 times more likely (95% CI: 1.502, 5.636) to develop VOD compared to patients without HSCT following treatment with gemtuzumab ozogamicin; and patients who had moderate/severe hepatic impairment at baseline were 8.7 times more likely (95% CI: 1.879, 39.862) to develop VOD compared to patients without moderate/severe hepatic impairment at baseline.
Infusion med MYLOTARG bør udføres under tæt klinisk overvågning, inkl. 
Infusion of MYLOTARG should be performed under close clinical monitoring, including pulse, blood pressure, and temperature.
• har eller har haft leverproblemer: MYLOTARG kan under eller efter behandlingen, forårsage en potentiel livstruende tilstand hvor blodårerne i leveren beskadiges og blokeres af blodpropper. 
• have or ever had liver problems: MYLOTARG may cause, during or after treatment, a potentially life-threatening condition called hepatic venoocclusive disease, in which the blood vessels in the liver become damaged and obstructed by blood clots which may include fluid retention, rapid weight gain, increased liver size (which may be painful), and ascites (excessive accumulation of fluid in the abdominal cavity).
Under induktionsfasen havde 109 (83,2 %) og 99 (75,6 %) patienter restitution af trombocyttal til henholdsvis 50.000/mm 3 og 100.000/mm 3. 
During the induction phase, 109 (83.2%) and 99 (75.6%) patients had platelet recovery to counts of 50,000/mm3 and 100,000/mm3, respectively.
Efter rekonstitution indeholder hvert hætteglas 1 mg/ml gemtuzumab ozogamicin. 
After reconstitution each vial contains 1 mg/mL gemtuzumab ozogamicin.
Antal hændelser, n (%) Median EFS i måneder [95 % CI] 
Number of events, n (%) Median RFS in months [95% CI]a
Budd-Chiaris syndrom Hud og subkutane væv Meget almindelig 
Skin and subcutaneous tissue disorders Very common Rashu
Trombocytopeni omfatter følgende FT'er: Nedsat antal trombocytter og trombocytopeni*. 
b. Thrombocytopenia includes the following reported PTs: Platelet count decreased and Thrombocytopenia*.
Brug af anden medicin sammen med MYLOTARG Fortæl lægen eller sundhedspersonalet, hvis du tager anden medicin for nylig har taget anden medicin eller planlægger at tage anden medicin. 
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Gennemsnitstiden for bedring af trombocyttallene til 50.000/mm 3 og 100.000/mm 3 var henholdsvis 32 og 35 dage. 
The median times to platelet recovery to counts of 50,000/mm3 and 100,000/mm3 were 32 and 35 days, respectively.
Hos patienter med hyperleukocytisk AML bør leukoreduktion med hydroxyurea eller leukaferese overvejes for at reducere antallet af perifere hvide blodlegemer til under 30.000/mm 
In patients with hyperleukocytic AML, leukoreduction should be considered with hydroxyurea or leukapheresis to reduce the peripheral WBC count to below 30,000/mm3 prior to administration of MYLOTARG to reduce the risk of inducing TLS (see section 4.2).
Neutropeni Anæmi Leukopeni 
Febrile neutropenia
Virkning på co-administrerede kemoterapeutiske midler Baseret på farmakokinetiske (PK) populationsanalyser forventes det ikke, at kombinationen med gemtuzumab ozogamicin og hydroxyurea, DNR og AraC vil forårsage klinisk meningsfulde PKændringer af disse stoffer. 
Based on population pharmacokinetic (PK) analyses, the combination of gemtuzumab ozogamicin with DNR and AraC is not predicted to cause clinically meaningful changes in the PK of these agents.
Hvis den rekonstituerede opløsning ikke kan anvendes med det samme, kan den opbevares i det oprindelige hætteglas i op til 18 timer i køleskab (2 °C - 8 °C) efter anbrud og ikke over 6 timer ved stuetemperatur (under 25 °C). 
If the product cannot be used immediately, the diluted solution may be stored up to 18 hours in a refrigerator (2°C-8°C) from the time of initial vial puncture with not more than 6 hours at room temperature (below 25°C).
35 mg/m 2/dag på dag 1 til dag 2 
35 mg/m2/day on Day 1 to Day 2
I et randomiseret studie (COG AAML0531), der evaluerede standard kemoterapi alene eller kombineret med MYLOTARG hos 1.063 nyligt diagnosticerede børn med AML (93,7 % af patienterne var <18 år) og unge (6,3 % af patienterne), hvor gennemsnitsalderen var 8,9 år (interval: 029 år). 
In a randomised study (COG AAML0531) that evaluated standard chemotherapy alone or combined with MYLOTARG in 1,063 newly diagnosed children with AML (93.7% of patients < 18 years of age), and young adults (6.3% of patients); mean age was 8.9 years (range: 0-29 years), patients with de novo AML were randomly assigned to either standard 5-course chemotherapy alone or to the same chemotherapy with 2 doses of MYLOTARG (3 mg/m2/dose) administered once in induction Course 1 and once in intensification Course 2.
Under konsolideringsfase 2 havde 80 (97,6 %) og 70 (85,4 %) patienter restitution af trombocyttal til henholdsvis 50.000/mm 3 og 100.000/mm 3. 
During the consolidation 2 phase, 80 (97.6%) and 70 (85.4%) patients had a platelet recovery to counts of 50,000/mm3 and 100,000/mm3, respectively.
Ikke-fraktioneret MYLOTARG 
Non-fractionatedb MYLO TARG
Hvis en patient udvikler symptomer på anafylaksi, herunder alvorlige respiratoriske symptomer, eller klinisk signifikant hypotension, skal seponering af behandlingen alvorligt overvejes (se pkt. 
Discontinuation of treatment should be strongly considered for patients who develop signs or symptoms of anaphylaxis, including severe respiratory symptoms or clinically significant hypotension (see section 4.2).
Under konsolideringsfase 1 havde 92 (94,8 %) og 71 (73,2 %) patienter forbedret trombocyttal til henholdsvis 50.000/mm 3 og 100.000/mm 
During the consolidation 1 phase, 92 (94.8%) and 71 (73.2%) patients had a platelet recovery to counts of 50,000/mm3 and 100,000/mm3, respectively.
Infusionsrelateret reaktion omfatter følgende indberettede FT'er: Infusionsrelateret reaktion, urticaria, hypersensitivitet, bronkospasme, overfølsomhed over for lægemidler og urticaria på injektionssted i. 
h. Infusion related reaction includes the following reported PTs: Infusion related reaction, Urticaria, Hypersensitivity,
• Smerter i mave/underliv 
• Pain in the abdomen
Træthed omfatter følgende indberettede FT'er: udmattelse, slaphed, sløvhed og utilpashed. 
y. Fatigue includes the following reported PTs: Fatigue, Asthenia, Lethargy, and Malaise.
× 3) til standard induktions-kemoterapi til patienter med tidligere ubehandlet de novo AML resulterede i en statistisk signifikant og klinisk meningsfuld forbedring af EFS. 
The trial met its primary objective of demonstrating that MYLOTARG added in fractionated doses (3 mg/m2 × 3) to standard induction chemotherapy for patients with previously untreated de novo AML resulted in a statistically significant and clinically meaningful improvement in EFS.
Anæmi omfatter følgende indberettede FT'er: Anæmi og nedsat hæmoglobin. 
d. Anaemia includes the following reported PTs: Anaemia and Haemoglobin decreased.
• Dårlig fordøjelse 
Nausea Stomatitisp
Hazard ratio [95 % CI] p-værdi 
Hazard ratio [95% CI] c p-valued
Hazard ratio [95% CI] p-værdi 
Hazard ratio [95% CI]c p-valued
Skema 2. 
Table 2.
9/l for neutrofile) varierede fra 42 til 48 dage for trombocytter og fra 30 til 37 dage for neutrofile i de tilfælde, hvor den blev analyseret. 
e: Where analysed, median recovery (defined as 20 x 109/L or 50 x 109/L for platelets and 0.5 x 109/L for neutrophils) ranged from 42-48 days for platelets and 30-37 days for neutrophils.
• Symptomer på forstørret lever, som kan være at maven vokser 
• Signs of an enlarged liver (hepatomegaly), such as an enlarged belly
Der er ikke udført formelle PK-studier af gemtuzumab ozogamicin hos patienter med nedsat nyrefunktion. 
No formal PK studies of gemtuzumab ozogamicin have been conducted in patients with renal impairment.
Udsæt MYLOTARG indtil bedring af totalbilirubin er ≤ 2 × ULN, og ASAT og ALAT er ≤ 2,5 × ULN før hver dosis. 
Postpone MYLOTARG until recovery of total bilirubin to ≤ 2 × ULN and AST and ALT to
Cytogenetik (ugunstig), N Antal dødsfald, n (%) Median OS i måneder [95% CI] Hazard ratio [95% CI] p-værdi 
Cytogenetics (unfavourable), N Number of deaths, n (%) Median OS in months [95% CI]a Hazard ratio [95% CI]b p-valuec
Blødning omfatter blødning i centralnervesystemet (3,1 %), øvre gastrointestinal blødning (33,6 %) nedre gastrointestinal blødning (17,6 %), subkutan blødning (60,3 %), anden blødning (64,9 %) og næseblod (62,6 %). 
(5.3%), Bacterial infection (9.2%), Gastrointestinal infection (8.4%), Skin infection (2.3%), and Other infections b. Haemorrhage includes Central nervous system haemorrhage (3.1%), Upper gastrointestinal haemorrhage (33.6%), Lower gastrointestinal haemorrhage (17.6%), Subcutaneous haemorrhage (60.3%), Other haemorrhage (64.9%), and Epistaxis (62.6%).
Under konsolideringsfase 2 af behandlingen havde 80 (97,6 %) patienter forbedret neutrofiltallet til 500/mm 3, og 79 (96,3 %) patienter forbedrede tallet til 1.000/mm Gennemsnitstiden for bedring af neutrofiltallene til ANC på 500/mm 3 og 1.000/mm 3 var henholdsvis 
In the consolidation 2 phase of therapy, 80 (97.6%) patients had neutrophil recovery to counts of 500/mm3, and 79 (96.3%) patients recovered to counts of 1,000/mm3.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) 
Post-marketing (frequency category unknown)
ELN (god/intermediær), N Antal hændelser, n (%) Median EFS i måneder [95% CI] 
ELN (favourable/intermediate), N Number of events, n (%) Median EFS in months [95% CI]a
Anvendelse ved AML med ugunstige cytogenetiske forandringer I analyse af subgrupper i ALFA-0701 blev EFS ikke forbedret ved tilføjelsen af MYLOTARG til standard kombinationskemoterapi hos patienter, der havde ugunstig risiko-cytogenetik. 
In subgroup analyses in ALFA-0701, the addition of MYLOTARG to standard combination chemotherapy did not improve EFS in the subgroup of patients having adverse-risk cytogenetics (HR 1.11; 95% CI: 0.63, 1.95).
Forlænget protrombintid Forlænget aktiveret partiel tromboplastin-tid 
Neutrophils decreased Hyperglycaemia Aspartate aminotransferase (AST) increas ed Prothrombin time increased Activated partial thromboplastin time prolonged Alkaline phosphatase increased
Hætteglasset er ravfarvet type 1-glas med en prop af butylgummi og flip off-hætte med krympeforsegling. 
Amber Type 1 glass vial, with butyl rubber stopper and crimp seal with flip-off cap containing 5 mg gemtuzumab ozogamicin.
Cytogenetik (god/intermediær), N Antal hændelser, n (%) Median EFS i måneder [95% CI] 
Cytogenetics (favourable/intermediate), N Number of events, n (%) Median EFS in months [95% CI]a
Der er ikke udført formelle PK-studier af gemtuzumab ozogamicin hos patienter med nedsat leverfunktion. 
No formal PK studies of gemtuzumab ozogamicin have been conducted in patients with hepatic impairment.
Cytogenetik (ugunstig), N Antal hændelser, n (%) Median EFS i måneder [95% CI] Hazard ratio [95% CI] p-værdi 
Cytogenetics (unfavourable), N Number of events, n (%) Median EFS in months [95% CI]a Hazard ratio [95% CI]b p-valuec
Cytogenetik (god/intermediær), N Antal dødsfald, n (%) Median OS i måneder [95% CI] 
Cytogenetics (favourable/intermediate), N Number of deaths, n (%) Median OS in months [95% CI]a
ELN (dårlig/ugunstig), N Antal hændelser, n (%) Median EFS i måneder [95% CI] Hazard ratio [95% CI] p-værdi 
ELN (poor/adverse), N Number of events, n (%) Median EFS in months [95% CI]a Hazard ratio [95% CI]b p-valuec
ELN (god/intermediær), N Antal dødsfald, n (%) Median OS i måneder [95% CI] 
ELN (favourable/intermediate), N Number of deaths, n (%) Median OS in months [95% CI]a
• Mundbetændelse 
• Mouth inflammation
60 mg/m 2/dag på dag 1 til dag 2 
60 mg/m2/day on Day 1 to Day 2
6.6) indeholder den koncentrerede opløsning 1 mg/ml gemtuzumab ozogamicin. 
After reconstitution (see section 6.6), the concentrated solution contains 1 mg/mL gemtuzumab ozogamicin.
Forkortelser: AML= akut myeloid leukæmi; CI=konfidenceinterval; ELN=European LeukaemiaNet; mITT=modificeret intent-to-treat; n=antal; N=antal; ; NE=ikke estimerbart; OS=Samlet overlevelse. 
Abbreviations: AML=acute myeloid leukaemia; CI=confidence interval; ELN=European LeukaemiaNet; mITT=modified intent-to-treat; n=number; N=number; NE=not estimable; OS=Overall Survival a. Median estimated by Kaplan-Meier method; CI based on the Brookmeyer and Crowley Method with log-log transformation.
Ødem omfatter følgende indberettede FT'er: ødem, ansigtsødem, perifert ødem, ansigtshævelse, generaliseret ødem og periorbitalt ødem. 
x. Oedema includes the following reported PTs: Oedema, Face oedema, Oedema peripheral, Swelling face, Generalised oedema, and Periorbital oedema.
Gulsot 
Leukopeniae
ANC på 500/mm 3 og 1.000/mm 3 var 25 dage. 
The median time to neutrophil recovery to ANC of 500/mm3 and 1,000/mm3 was 25 days.
Blødning omfatter det centrale nervesystem (5,1%), øvre gastrointestinal blødning (21,3 %), nedre gastrointestinal blødning (15,2 %), subkutan blødning (28,5 %), anden blødning (32,9 %) og næseblod (28,5 %). 
Lower gastrointestinal haemorrhage (15.2%), Subcutaneous haemorrhage (28.5%), Other haemorrhage (32.9%), and
Fraktioneret b 
Haemorrhage*b
Rat e 
s r.o.
2-årig EFS-sandsynlighed [95 % CI] 3-årig EFS-sandsynlighed [95 % CI] Hazard ratio [95 % CI] p-værdi 
Number of events, n (%) Median EFS in months [95% CI]a, 2-year EFS probability[95% CI]b 3-year EFS probability [95% CI]b
Pulver til koncentrat til infusionsvæske, opløsning 1 hætteglas 
PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial
• Forstoppelse 
• Fatigue
Udslæt 
Ratec
Forhøjet alkalisk fosfatase Forhøjet alaninamino-transferase (ALAT) 
Alanine aminotransferase (ALT) increased Blood bilirubin increased Hyperuricaemia
50.000/mm 3 og 100.000/mm 3 var henholdsvis 34 og 35 dage. 
The median times to platelet recovery to counts of 50,000/mm3 and 100,000/mm3 were 34 and 35 days, respectively.
eksfolierende dermatitis #, lægemiddeludslæt, allergikløe #, og erytematøst udslæt 
Bronchospasm, Drug hypersensitivity, and Injection site urticaria#.
• Hvert hætteglas indeholder 5 mg gemtuzumab ozogamicin. 
• Each vial contains 5 mg gemtuzumab ozogamicin.
Vaskulære sygdomme Meget almindelig Blødning 
Gastrointestinal disorders Very common Vomiting
• Hudkløe 
• Chills
Blod og lymfesystem Meget almindelig Febril neutropeni Trombocytopeni 
Blood and lymphatic system disorders Very common
MYLOTARG 5 mg pulver til koncentrat gemtuzumab ozogamicin i.v. 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MYLOTARG 5 mg powder for concentrate gemtuzumab ozogamicin
Udslæt omfatter følgende indberettede FT'er: udslæt, allergisk dermatitis #, blæredannende dermatitis, kontakteksem, 
u. Rash includes the following reported PTs: Rash, Dermatitis#, Dermatitis allergic#, Dermatitis bullous, Dermatitis contact, Dermatitis exfoliative#, Drug eruption, Pruritus allergic# and Rash erythematous#, Rash macular#, Rash maculo papular, Rash papular, Rash pruritic, Rash vesicular#.
• Kvalme 
• Indigestion
yderligere information om dosisændringer. 
Dose modification for adverse reactions
Venookklusiv leversygdom 
Hepatic impairment
Der er ikke udført PK-studier af gemtuzumab ozogamicin hos patienter med svært nedsat nyrefunktion. 
The PK of gemtuzumab ozogamicin has not been studied in patients with severe renal impairment.
Det kan være nødvendigt med dosisafbrydelse eller permanent seponering af MYLOTARG ved visse bivirkninger (se pkt. 
Management of some adverse reactions may require dose interruptions or permanent discontinuation of MYLOTARG (see sections 4.4 and 4.8).
9/l eller 50 x 10 
≤ 2.5 × ULN.
Interstitiel lungebetændelse Mave-tarm-kanalen Meget almindelig Opkastning 
Vascular disorders Very common Haemorrhage*k Hypotensionl Hypertensionm
Lever og galdeveje Almindelig 
Unopened vial
Organklasse Hyppighed 
Multi-organ failure*
• Blødning 
• Bleeding
INFORMATION I BRAILLESKRIFT 
Common Pancytopeniaf Lymphopeniag
Dette inkluderer 2 timers infusion og 1 time til at opnå stuetemperatur (under 25°C), hvis opløsningen har været nedkølet. 
If not used immediately, store at room temperature (below 25°C) for up to 6 hours, which includes the 2-hour infusion time and 1 hour, if needed, to allow the refrigerated diluted solution to equilibrate to room temperature (below 25°C).
Hypertension 
Immunogenicity
Veno-okklusiv leversygdom 
Abdominal paino
Dyspepsi 
Dilution
Infusionen gives gradvist over 2 timer. 
• Infuse the diluted solution for 2 hour.
Dette sammendrag blev sidst ajourført i 09-2007. 
This summary was last updated in 09-2007.
Markedsføringstilladelsen blev fornyet den 14. august 2002 og den 14. august 2007. 
The marketing authorisation was renewed on 14 August 2002 and 14 August
Der er ingen kendte bivirkninger ved testen. 
There are no known side effects of the test.
Dette betyder, at det indeholder 13C, en sjælden form af kulstofatomet, i stedet for kulstof-12 (12C), som er den mest almindelige form i naturen. 
This means that it contains 13C, a rare form of the carbon atom, instead of carbon-12 (12C), the form that is the most common in nature.
Hos børn i alderen 3-11 år skal 'testmåltidet' bestå af 100 ml ren appelsinjuice. 
In children aged three to 11 years, the ‘test meal' should be 100 ml of pure orange juice.
Dette mærkede kuldioxid kan måles af specialiserede laboratorier ved brug af en teknik, som kaldes massespektrometri. 
This labelled carbon dioxide can be measured by specialised laboratories using a technique called mass spectrometry.
Hvis du ønsker yderligere oplysninger om grundlaget for CHMP's anbefalinger, kan du læse de faglige drøftelser (også en del af denne EPAR). 
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Hvis patienten kaster op under testen, skal testen dog gentages, men tidligst den efterfølgende dag. 
However, if the patient vomits during the test, the test will need to be done again, but not until at least the following day.
Pulveret er det aktive stof 13C-urea (45 mg til børn eller 75 
The powder is the active substance 13C-urea (45 mg for children or 75 mg for adults).
Hvis der ikke er mærket kuldioxid i udåndingsluften, betyder det, at der ikke er bakterier i maven eller tolvfingertarmen. 
If there is no labelled carbon dioxide in the breath, this means there are no bacteria in the stomach or duodenum.
Endelig skal patienten 30 minutter efter at have drukket opløsningen indsamle endnu to prøver af udåndingsluften. 
Finally, 30 minutes after drinking the solution, the patient collects a further two breath samples.
Hvis der er mærket kuldioxid i den prøve med udåndingsluft, som er taget efter 30 minutter (et positivt resultat), betyder det, at patienten har en infektion med H. pylori. 
If there is labelled carbon dioxide in the breath sample after 30 minutes (a positive test), this means that the patient is infected with H. pylori.
Herefter skal patienten indtage et 'testmåltid' (enten 200 ml ren appelsinjuice eller 1 g citronsyre opløst i 200 ml vand) efterfulgt af Helicobacter Test INFAI opløst i vand. 
The patient then takes a ‘test meal' (either 200 ml of pure orange juice or 1 g of citric acid dissolved in 200 ml water), followed by the solution of Helicobacter Test INFAI dissolved in water.
Helicobacter Test INFAI blev undersøgt i fire undersøgelser, hvor i alt 561 voksne patienter medvirkede, og i én undersøgelse med 335 børn og unge. 
Helicobacter Test INFAI has been tested in four studies in adult patients involving a total of 561 patients and one study in 335 children and adolescents.
Den fås i form af en beholder med et pulver, som skal blandes til en opløsning, der kan drikkes. 
It is available as a jar containing a powder to be made up into a solution for drinking.