natgillin/translations-raw huggingface dataset:
Aflibercept bør seponeres hos patienter, der udvikler PRES (se pkt. 
Aflibercept should be discontinued in patients that develop PRES (see section 4.2).
ZALTRAP indeholder - Aktivt stof: aflibercept. 
• The active substance is aflibercept.
GI-perforation, inklusive dødelig GI-perforation, er blevet rapporteret hos patienter behandlet med aflibercept (se pkt. 
GI perforation including fatal GI perforation has been reported in patients treated with aflibercept (see section 4.8).
Den hyppigste grad 3-4 neutropeniske komplikation var forekomst af febril neutropeni hos 4,3 % af patienterne i ZALTRAParmen og hos 1,7 % i placeboarmen. 
The most common grade 3-4 neutropenic complication was the occurrence of febrile neutropenia in 4.3 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 1.7 % of patients treated with the placebo/FOLFIRI regimen.
4.2), antidiarrépræparater og rehydrering bør institueres efter behov. 
Dose modification of FOLFIRI regimen (see section 4.2), anti-diarrhoeal medicinal products, and rehydration as needed should be instituted.
Patienter med forudgående bevacizumab behandling eksklusive patienter med kun adjuverende (n (%)) 
Patients with no prior bevacizumab excluding adjuvant only (n ( %))
Rektal blødning Fistel (1) Aftøs stomatitis Hæmorroider Proktalgi Tandpine 
Rectal haemorrhage Fistula (1) Aphthous stomatitis Haemorrhoids Proctalgia Toothache
Patienter uden forudgående bevacizumab (n (%)) Median OS (95 % CI) (måneder) 
Patients with no prior bevacizumab (n (%)) Median OS (95 % CI) (months)
I det pivotale studie med mCRC-patienter blev der indberettet proteinuri (sammensat af kliniske data og laboratoriedata) hos 62,2 % af patienterne i ZALTRAP-armen og hos 40,7 % i placeboarmen. 
In the pivotal study of MCRC patients, proteinuria (compiled from clinical and laboratory data) was reported in 62.2 % patients treated with the ZALTRAP/FOLFIRI regimen compared to 40.7 % patients treated with the placebo/FOLFIRI regimen.
100 mg/4 ml 1 hætteglas 3 hætteglas 
100 mg / 4 ml 1 vial
Blod og lymfesystem Meget almindelig Leukopeni (2) Neutropeni (1),(2) Trombocytopeni (2) 
Leucopenia (2) Neutropenia (1),(2) Thrombocytopenia (2)
I det pivotale studie med mCRC-patienter er der rapporteret om hypertension (alle grader) hos 41,2 % af patienterne i ZALTRAP-armen og hos 10,7 % i placeboarmen. 
In the pivotal study of MCRC patients, hypertension (all grades) has been reported in 41.2 % of patients treated with ZALTRAP/FOLFIRI and 10.7 % of patients treated with placebo/FOLFIRI.
9/l (se pkt. 
/ L (see section 4.2).
Kompromitteret sårheling (1) 
Compromised wound healing (1)
Aflibercept bør seponeres hos patienter, der oplever en ATE (se pkt. 
Aflibercept treatment should be discontinued in patients who experience an ATE (see section 4.2).
En ml koncentrat til infusionsvæske, opløsning indeholder 25 mg aflibercept*. 
One ml of concentrate for solution for infusion contains 25 mg aflibercept*.
Dehydrering (alle grader) er observeret hos 9,0 % af patienterne i ZALTRAP-armen og hos 3,0 % i placeboarmen. 
Dehydration (all grades) has been observed in 9.0 % of patients treated with ZALTRAP/FOLFIRI and 3.0 % of patients treated with placebo/FOLFIRI.
• Svære overfølsomhedsreaktioner (inklusive bronkospasme, dyspnø, angioødem og anafylaksi) 
• Severe hypersensitivity reactions (including bronchospasm, dyspnoea, angioedema, and anaphylaxis) (see sections 4.3 and 4.4)
Patienter uden forudgående bevacizumab (n (%)) Median PFS (95 % CI) (måneder) 
Patients with no prior bevacizumab (n (%)) Median PFS (95 % CI) (months)
Hjerteinsufficiens og nedsat ejektionsfraktion 
Cardiac failure and ejection fraction decreased
I det pivotale studie med mCRC-patienter er der observeret diarré (alle grader) hos 69,2 % af patienterne i ZALTRAP-armen og hos 56,5 % i placeboarmen. 
In the pivotal study of MCRC patients, diarrhoea (all grades) has been observed in 69.2 % of patients treated with ZALTRAP/FOLFIRI and 56.5 % of patients treated with placebo/FOLFIRI.
Kompromitteret sårheling 
Compromised wound healing
• rindende næse 
• runny nose
Performancestatus og komorbiditet 
Performance status and co-morbidities
Fertilitetshæming 
Impairment of fertility
Orofanryngeale smerter Rinorré 
Oropharyngeal pain Rhinorrhoea
Arteriel tromboemboli (1) Venøs tromboemboli (1) Blødning (1) 
Arterial thromboembolism (1) Venous thromboembolism (1) Haemorrhage (1)
Patienter med forudgående bevacizumab (n (%)) 
Patients with prior bevacizumab (n (%))
I det pivotale studie med mCRC-patienter blev der indberettet fistler (anale, enterovesikale, enterokutane, kolovaginale, intestinale) hos 9 ud af 611 patienter (1,5 %) i ZALTRAP-armen og hos 3 ud af 605 patienter (0,5 %) i placeboarmen. 
In the pivotal study of MCRC patients, fistulas (anal, enterovesical, enterocutaneous, colovaginal, intestinal sites) were reported in 9 of 611 patients (1.5 %) treated with the ZALTRAP/FOLFIRI
Stratificeret hazard-ratio (95 % CI) 
Stratified hazard ratio (95 % CI)
Svære overfølsomhedsreaktioner (inklusive bronkospasme, dyspnø, angioødem og anafylaksi) (se pkt. 
Severe hypersensitivity reactions (including bronchospasm, dyspnoea, angioedema, and anaphylaxis) (see sections 4.3 and 4.4)
Der er ikke gennemført formelle studier med ZALTRAP hos patienter med nedsat leverfunktion (se pkt. 
There have been no formal studies with ZALTRAP in patients with renal impairment (see section 5.2).
Ikke almindelig GI-perforation (1) 
GI perforation (1)
Grad 3 GI-fisteldannelse forekom hos 2 patienter, som blev behandlet med ZALTRAP (0,3 %), og hos en patient, som blev behandlet med placebo (0,2 %). 
Grade 3 GI fistula formation occurred in 2 patients treated with ZALTRAP (0.3 %) and in 1 placebo-treated patient (0.2 %).
Brug af anden medicin sammen med ZALTRAP Fortæl altid lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig. 
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Fisteldannelse, både fra GI-kanalen og udenfor GI-kanalen, er forekommet hos patienter, som blev behandlet med ZALTRAP. 
Fistula formation involving GI and non-GI sites has occurred in patients treated with ZALTRAP.
Grad 3-4 ATE forekom hos 1,7 % af de patienter, som blev behandlet med ZALTRAP, og hos 1,0 % af de placebobehandlede patienter (se pkt. 
Grade 3-4 ATE occurred in 1.7 % of patients treated with ZALTRAP and 1.0 % of patients treated with placebo (see section
Grad 3-4 blødning inklusive GI-blødning, hæmaturi og postoperativ blødning blev indberettet hos 2,9 % af patienterne i ZALTRAP-armen og hos 1,7 % i placeboarmen. 
Grade 3-4 haemorrhage including GI haemorrhage, haematuria, and post-procedural haemorrhage was reported in 2.9 % of patients receiving the ZALTRAP/FOLFIRI regimen compared with 1.7 % of patients receiving the placebo/FOLFIRI regimen.
I det pivotale studie med mCRC-patienter blev kompromitteret sårheling indberettet hos 3 af patienterne (0,5 %) i ZALTRAP-armen og hos 5 af patienterne (0,8 %) i placeboarmen. 
In the pivotal study for MCRC, compromised wound healing was reported in 3 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and 5 patients (0.8 %) treated with the placebo/FOLFIRI regimen.
Holdbarhed efter fortynding i infusionspose 
Shelf-life after dilution in the infusion bag
Et 8 ml hætteglas med koncentrat indeholder 200 mg aflibercept. 
One 8 ml vial of concentrate contains 200 mg aflibercept.
Det skal du vide, før du begynder at bruge ZALTRAP 
What you need to know before you are given ZALTRAP
I det pivotale studie med mCRC-patienter blev der indberettet neutropeni (alle grader) hos 67,8 % af patienterne i ZALTRAP-armen og hos 56,3 % i placeboarmen. 
In the pivotal study of MCRC patients, neutropenia (all grades) has been reported in 67.8 % of patients treated with ZALTRAP/FOLFIRI and 56.3 % of patients treated with placebo/FOLFIRI.
Grad 3-4 GIperforation forekom hos 0,8 % af de patienter, som blev behandlet med ZALTRAP, og hos 0,2 % af de patienter, som blev behandlet med placebo (se pkt. 
Grade 3-4 GI perforation events occurred in 0.8 % of patients treated with ZALTRAP and 0.2 % of patients treated with placebo (see section 4.4).
De hyppigst rapporterede bivirkninger (alle grader, ≥20 % forekomst) med mindst 2 % højere forekomst for ZALTRAP/FOLFIRI-regimet end for placebo/FOLFIRI-regimet var, med faldende frekvens: leukopeni, diarré, neutropeni, proteinuri, forhøjet aspartataminotransferase (ASAT), 
The most common adverse reactions (all grades, ≥ 20 % incidence) reported at least 2 % greater incidence for the ZALTRAP/FOLFIRI regimen as compared to the placebo/FOLFIRI regimen in order of decreasing frequency were leucopenia, diarrhoea, neutropenia, proteinuria, increased aspartate aminotransferase (AST), stomatitis, fatigue, thrombocytopenia, increased alanine aminotransferase (ALT), hypertension, weight loss, decreased appetite, epistaxis, abdominal pain, dysphonia, increased serum creatinine, and headache (see Table 1).
I det pivotale studie med mCRC-patienter blev der rapporteret alle grader af VTE hos 9,3 % af patienterne i ZALTRAP-armen og hos 7,3 % i placeboarmen. 
In the pivotal study of MCRC patients, all grades VTE occurred in 9.3 % of patients treated with the ZALTRAP/FOLFIRI regimen and 7.3 % of patients treated with the placebo/FOLFIRI regimen.
611 patienter blev behandlet med ZALTRAP 4 mg/kg hver anden uge (en cyklus), og 605 patienter blev behandlet med placebo/FOLFIRI. 
The safety of ZALTRAP in combination with FOLFIRI was evaluated in 1,216 patients previously treated for metastatic colorectal cancer, of which 611 patients were treated with ZALTRAP 4 mg/kg every two weeks (one cycle) and 605 patients were treated with placebo/FOLFIRI in a phase III study.
Kompromitteret sårheling i grad 3 blev indberettet hos 2 af patienterne (0,3 %) i ZALTRAP-armen og hos ingen af patienterne i placeboarmen. 
Grade 3 compromised wound healing was reported in 2 patients (0.3 %) treated with the ZALTRAP/FOLFIRI regimen and in none of the patients treated with the placebo/FOLFIRI regimen.
I det pivotale studie med mCRC-patienter er der rapporteret om svære overfølsomhedsreaktioner hos 0,3 % af patienterne i ZALTRAP-armen og hos 0,5 % i placeboarmen (se pkt. 
In the pivotal study of MCRC patients, severe hypersensitivity reactions have been reported in 0.3 % of patients treated with the ZALTRAP/FOLFIRI regimen and 0.5 % of patients treated with the placebo/FOLFIRI regimen (see section 4.4).
Et 4 ml hætteglas med koncentrat indeholder 100 mg aflibercept. 
One 4 ml vial of concentrate contains 100 mg aflibercept.
Arteriel tromboemboli (1) Venøs tromboemboli (1) 
Arterial thromboembolism (1) Venous thromboembolism (1)
Venøs tromboemboli 
Venous thromboembolic events
I det pivotale studie med mCRC-patienter blev der indberettet GI-perforation (alle grader) hos 3 ud af 611 patienter i ZALTRAP-armen og hos 3 ud af 605 patienter i placeboarmen. 
In the pivotal study of MCRC patients, GI perforation (all grades) was reported in 3 of 611 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and 3 of 605 patients (0.5 %) treated with the placebo/FOLFIRI regimen.
I det pivotale studie med mCRC-patienter blev der indberettet blødningsepisoder (alle grader) hos 37,8 % af patienterne i ZALTRAP-armen og hos 19,0 % i placeboarmen. 
In the pivotal study of MCRC patients, episodes of bleeding/haemorrhage (all grades) was reported in 37.8 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 19.0 % of patients treated with the placebo/FOLFIRI regimen.
ZALTRAP 25 mg/ml koncentrat til infusionsopløsning aflibercept 
ZALTRAP 25 mg / ml concentrate for solution for infusion aflibercept
Grad 3-4 fistler forekom hos 0,2 % af de patienter, som blev behandlet med ZALTRAP, og 0,1 % af de patienter, som blev behandlet med placebo (se pkt. 
Grade 3-4 fistula occurred in 0.2 % of patients treated with ZALTRAP and 0.1 % of patients treated with placebo (see section 4.4).
Hændelser af grad 3-4 forekom hos 11 patienter (1,8 %) i ZALTRAP-armen og hos 3 patienter (0,5 %) i placeboarmen. 
Grade 3-4 events occurred in 11 patients (1.8 %) treated with the ZALTRAP/FOLFIRI regimen and 3 patients (0.5 %) treated with the placebo/FOLFIRI regimen.
Neutropeni i grad 3-4 forekom hos 36,7 % af patienterne i ZALTRAP-armen og hos 29,5 % i placeboarmen. 
Grade 3-4 neutropenia was observed in 36.7 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 29.5 % patients treated with the placebo/FOLFIRI regimen.
Lungeemboli forekom hos 4,6 % af patienterne i ZALTRAP-armen og hos 3,5 % i placeboarmen. 
Pulmonary embolism occurred in 4.6 % of patients treated with the ZALTRAP/FOLFIRI regimen and 3.5 % of patients treated with the placebo/FOLFIRI regimen.
Aflibercept bør seponeres hos patienter, der udvikler fistel (se pkt. 
Aflibercept treatment should be discontinued in patients who develop fistula (see section 4.2).
VTE i grad 3-4 forekom hos 7,9 % af patienterne i ZALTRAP-armen og hos 6,3 % i placeboarmen. 
Grade 3-4 VTE occurred in 7.9 % of patients treated with the ZALTRAP/FOLFIRI regimen and in 6.3 % of patients treated with the placebo/FOLFIRI regimen.
Diarré i grad 3-4 blev indberettet hos 19,3 % af patienterne i ZALTRAP-armen og hos 7,8 % i placeboarmen. 
Grade 3-4 diarrhoea was reported in 19.3 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 7.8 % of patients treated with the placebo/FOLFIRI regimen.
Aflibercept bør seponeres hos patienter, der oplever GI-perforation (se pkt. 
Aflibercept treatment should be discontinued in patients who experience GI perforation (see section 4.2).
Grad 3-4 kompromitteret sårheling forekom hos 0,2 % af patienterne i ZALTRAP-armen og hos ingen af patienterne i placeboarmen (se pkt. 
Grade 3-4 compromised wound healing occurred in 0.2 % of patients treated with ZALTRAP and none of patients treated with placebo (see section 4.4).
Et hætteglas med 8 ml koncentrat indeholder 200 mg aflibercept. 
One vial of 8 ml of concentrate contains 200 mg of aflibercept.
Abdominalsmerter Øvre mavesmerter 
Abdominal pain Abdominal pain upper
Et hætteglas med 4 ml koncentrat indeholder 100 mg aflibercept. 
One vial of 4 ml of concentrate contains 100 mg of aflibercept.
Vaskulære sygdomme Meget almindelig Hypertension (1) Blødning (1) 
Hypertension (1) Haemorrhage (1)
Grad 3-4 neutropenisk infektion/sepsis forekom hos 1,5 % af patienterne i ZALTRAP-armen og hos 1,2 % i placeboarmen (se pkt. 
Grade 3-4 neutropenic infection/sepsis occurred in 1.5 % of patients treated with the ZALTRAP/FOLFIRI regimen and 1.2 % of patients treated with the placebo/FOLFIRI regimen (see section 4.4).
Nefrotisk syndrom forekom hos 2 patienter (0,5 %) i ZALTRAP-armen og hos ingen patienter i placeboarmen. 
Nephrotic syndrome occurred in 2 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen compared to none of the patients treated with the placebo/FOLFIRI regimen.
På tværs af de tre placebokontrollerede, kliniske fase III-studier (populationer med kolorektal-, pankreas- og lungecancer) var forekomsten af nefrotisk syndrom 0,5 % for patienter behandlet med ZALTRAP og 0,1 % for patienter behandlet med placebo (se pkt. 
Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of nephrotic syndrome was 0.5 % of patients treated with ZALTRAP and 0.1 % of patients treated with placebo (see section 4.4).
Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt. 
Hypersensitivity to aflibercept or to any of the excipients listed in section 6.1.
På tværs af de tre placebokontrollerede, kliniske fase III studier (populationer med kolorektal-, pankreas- og lungecancer) var forekomsten af VTE (alle grader) 7,1 % for patienter behandlet med ZALTRAP, og 7,1 % for patienter behandlet med placebo. 
Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of VTE (all grades) was 7.1 % for patients treated with ZALTRAP and 7.1 % for patients treated with placebo.
Nedsat nyrefunktion 
Dyspnoea Epistaxis Dysphonia
På tværs af de tre placebokontrollerede, kliniske fase III-studier (populationer med kolorektal-, pankreas- og lungecancer) var forekomsten af ATE (alle grader) 2,3 % for patienter behandlet med ZALTRAP, og 1,7 % for patienter behandlet med placebo. 
Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of ATE (all grades) was 2.3 % for patients treated with ZALTRAP and 1.7 % for patients treated with placebo.
Epistaxis 
Dyspnoea Epistaxis
• mavesmerter 
• Severe haemorrhage
Proteinuri i grad 3-4 forekom hos 7,9 % af patienterne i ZALTRAP-armen og hos 1,2 % i placeboarmen. 
Grade 3-4 proteinuria occurred in 7.9 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 1.2 % of patients treated with the placebo/FOLFIRI regimen.
På tværs af de tre placebokontrollerede, kliniske fase III-studier (populationer med kolorektal-, pankreas- og lungecancer) var forekomsten af GI-perforation (alle grader) 0,8 % for patienter behandlet med ZALTRAP og 0,3 % for placebobehandlede patienter. 
Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of GI perforation (all grades) was 0.8 % for patients treated with ZALTRAP and 0.3 % for patients treated with placebo.
• 8 ml koncentrat i et 10 ml gennemsigtigt borsilikathætteglas (type I) forseglet med en flangeprop med flip-off hætte, og indsat forseglingsskive med overtræk. 
• 8 ml of concentrate in a 10 ml clear borosilicate glass vial (type I) sealed by a flanged stopper with flip-off cap and inserted coated sealing disc.
På tværs af de tre placebokontrollerede, kliniske fase III-studier (populationer med kolorektal-, pankreas- og lungecancer) var forekomsten af kompromitteret sårheling (alle grader) 0,5 % for patienter behandlet med ZALTRAP og 0,4 % for placebobehandlede patienter. 
Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of compromised wound healing (all grades) was 0.5 % for patients treated with ZALTRAP and 0.4 % for patients treated with placebo.
• 4 ml koncentrat i et 5 ml gennemsigtigt borsilikathætteglas (type I) forseglet med en flangeprop med flip-off hætte, og indsat forseglingsskive med overtræk. 
• 4 ml of concentrate in a 5 ml clear borosilicate glass vial (type I) sealed by a flanged stopper with flip-off cap and inserted coated sealing disc.
Grad 3-4 GI-perforation forekom hos alle 3 patienter (0,5 %) i ZALTRAP-armen, og hos 2 patienter (0,3 %) i placeboarmen. 
Grade 3-4 GI perforation events occurred in all 3 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and in 2 patients (0.3 %) treated with the placebo/FOLFIRI regimen.
• vægttab 
• toothache
På tværs af de tre placebokontrollerede, kliniske fase III-studier (populationer med kolorektal-, pankreas- og lungecancer) var forekomsten af fisteldannelse (alle grader) 1,1 % for patienter behandlet med ZALTRAP og 0,2 % for placebobehandlede patienter. 
Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of fistula (all grades) was 1.1 % for patients treated with ZALTRAP and 0.2 % for patients treated with placebo.
5-FU-bolus og -infusionsdosis ligeledes reduceres med 20 %. 
If severe diarrhoea recurs on a subsequent cycle, the 5-FU bolus and infusion dose should also be reduced by 20 %.
ZALTRAP 25 mg/ml koncentrat til infusionsvæske, opløsning 
ZALTRAP 25 mg/ml concentrate for solution for infusion
Fisteldannelse 
Fistula formation
Koncentrat til infusionsvæske, opløsning (sterilt koncentrat) Koncentratet er en klar, farveløs til lysegul opløsning. 
Concentrate for solution for infusion (sterile concentrate).
Dehydrering i grad 3-4 blev indberettet hos 4,3 % af patienterne i ZALTRAP-armen og hos 1,3 % i placeboarmen (se pkt. 
Grade 3-4 dehydration was reported in 4.3 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 1.3 % of patients treated with the placebo/FOLFIRI regimen (see section 4.4).
• tandpine 
• stomach pain
Almindeligt (kan påvirke op til 1 ud af 10 personer) - disse abnorme rørlignende forbindelser eller passager kan for eksempel dannes mellem tarmen og huden. 
• Connections or passageways inside the body between internal organs and skin or other tissues (also called ‘fistula'): Common (may affect up to 1 in 10 people) - these abnormal tube-like connections or passageways can form for example, between the gut and your skin.
Fortæl omgående lægen eller sygeplejersken, hvis du får disse symptomer under eller kort efter en infusion af ZALTRAP. 
Tell your doctor or nurse straight away if you have any of these signs during or soon after an infusion of ZALTRAP.
Meget almindelig Hovedpine Almindelig 
Hepatobiliary disorders Very common
Orofanryngeale smerter 
Hepatic impairment
Nederland sanofi-aventis Netherlands B.V. 
Deutschland Sanofi-Aventis Deutschland GmbH
du kan få brug for at læse den igen. 
You may need to read it again.
MedDRA Foretrukken term 
MedDRA Preferred Term
Hver infusion vil tage cirka fire timer. 
Each infusion will take approximately 4 hours.
Væksten forblev normal over denne begrænsede opfølgningsperiode. 
Growth rate remained normal over this limited follow-up period.
Som resultat af dette bliver disse stoffer ikke nedbrudt og forarbejdet af kroppen, som de burde. 
As a result, these substances do not get broken down and processed by the body as they should.
Der blev observeret forbedret hørelse i mindst ét øre hos alle fire forsøgspersoner. 
Improved hearing was noted in at least one ear for all four subjects.
Peri- og postnatal toksicitet er ikke blevet undersøgt. 
Peri- and post-natal toxicity has not been investigated.
Modul 5 - klinisk 
Module 5 - Clinical
Særlige forpligtelser: 
Specific Obligations:
Den endelige forsøgsrapport under denne CSP vil blive indsendt senest den 31. juli 2020. 
The final study report under this CSP will be submitted by 31 July 2020.
Dosis baseres på din vægt. 
The dose you receive is based on your body weight.
Selv om undersøgelsen var begrænset af det meget lille antal patienter, der var rekrutteret, er konklusionerne fra dette studie følgende: 
Although limited by the very small number of patients that were enrolled, the conclusions that can be drawn from this study are the following:
Uåbnede hætteglas: 3 år. 
Unopened vials: 3 years.
Flere tiltag vil blive implementeret til vurdering af Naglazyme dosen. 
Several measures will be implemented to assess the Naglazyme dose.
Genotoksicitet og karcinogenicitet forventes ikke. 
Genotoxic and carcinogenic potential are not expected.
Farmakokinetikparametre hos fase 1 patienter har været stabile over lang tid (gennem mindst 194 uger). 
Pharmacokinetic parameters in Phase 1 patients have remained stable over the long term (through at least 194 weeks).
ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC 
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Din læge eller sygeplejerske vil give dig Naglazyme. 
Your doctor or nurse will administer Naglazyme to you.
Lægen vil muligvis endvidere give dig supplerende medicin til behandling af eventuelle allergiske reaktioner. 
Your doctor may also give you additional medicines to manage any allergic reactions.
Beskrivelse: 
Description:
Polysorbat 80, 
Polysorbate 80
53/54 patienter (98 %) var positive for IgG-antistoffer over for galsulfase. 
53/54 patients (98%) were positive for IgG antibodies to galsulfase.
Med hensyn til mikrobiologisk sikkerhed bør produktet anvendes omgående. 
From a microbiological safety point of view, the product is to be used immediately.
Inden for CSP vil der blive gennemført sub-studier, der skal: 
Substudies will be conducted within the CSP that will:
• Dårlige reflekser 
• Poor reflexes
Der er ingen evidens for særlige overvejelser, når Naglazyme administreres til den pædiatriske population. 
There is no evidence for special considerations when Naglazyme is administered to the paediatric population.
Håndtering af infusionsrelaterede reaktioner 
Management of infusion-associated reactions
Anafylaksi, shock 
Anaphylaxis, shock