natgillin/translations-raw huggingface dataset:
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.
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
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 24. januar 2006 Dato for seneste fornyelse af tilladelsen: 26. januar 2011
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 January 2006
Som for alle genetiske lysosomale lidelser er det af altafgørende vigtighed, især i forbindelse med svære former, at påbegynde behandling så hurtigt som muligt, inden der optræder ikke-reversible kliniske manifestationer fra sygdommen.
As for all lysosomal genetic disorders, it is of primary importance, especially in severe forms, to initiate treatment as early as possible, before appearance of non-reversible clinical manifestations of the disease.
Læs denne indlægsseddel grundigt, inden du begynder at få medicinen, da den indeholder vigtige oplysninger.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Urin-GAGværdierne faldt med mere end 70 %, hvilket var samstemmende med resultaterne hos ældre patienter.
Urinary GAG levels decreased by more than 70%, consistent with results in older patients.
Hovedparten (42/59, 71 %) af patienterne oplevede mindst en bivirkning på lægemidlet.
The majority (42/59; 71%) of patients experienced at least one Adverse Drug Reaction.
Bivirkninger med ukendt hyppighed:
Other side effects with an unknown frequency:
Det er yderst vigtigt at behandle unge patienter i alderen <5 år, der lider af en svær form af sygdommen, endda skønt patienter <5 år ikke var inkluderet i det yderst betydningsfulde fase 3 studie.
A key issue is to treat children aged <5 years suffering from a severe form of the disease, even though children <5 years were not included in the pivotal phase 3 study.
Galsulfase er et protein, og det forventes at blive metabolisk degraderet via peptidhydrolyse.
Galsulfase is a protein and is expected to be metabolically degraded through peptide hydrolysis.
På grund af den lille patientpopulation klassificeres en bivirkning hos en enkelt patient som almindelig.
Due to the small patient population, an adverse reaction in a single patient is classified as common.
Denne medicin indeholder natrium
This medicine contains Sodium
Som ved ethvert intravenøst proteinlægemiddel er svære allergiske overfølsomhedsreaktioner mulige.
As with any intravenous protein medicinal product, severe allergic-type hypersensitivity reactions are possible.
Molekylet indeholder 6 N-linkede oligosaccharid modifikationssteder.
The molecule contains 6 N-linked oligosaccharide modification sites.
Håndtering i forbindelse med kompromitterede luftveje
Management of compromised airways
Da der kun er lidt erfaring med genoptagelse af behandlingen efter længere tids afbrydelse, skal der udvises forsigtighed på grund af den teoretiske øgede risiko for en overfølsomhedsreaktion.
As there is little experience on resumption of treatment following prolonged interruption, caution is to be used due to the theoretical increased risk of hypersensitivity reaction.
Opløsningen skal fortyndes yderligere, inden den kan infunderes.
The solution must be diluted further before it can be infused.
Administration af Naglazyme bør foretages på et passende klinisk sted, hvor genoplivningsudstyr til håndtering af medicinske nødsituationer er hurtigt tilgængeligt.
Administration of Naglazyme should be carried out in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available.
Vand til injektioner,
Water for injections
Følgende oplysninger er kun til læger og sundhedspersonale: Naglazyme må ikke blandes med andre lægemidler i samme infusion end med dem, der er anført nedenfor.
The following information is intended for medical or healthcare professionals only: Naglazyme should not be mixed with other medicinal products in the same infusion, except for those mentioned below.
Der vil blive indsamlet detaljerede oplysninger om klinisk status ved forsøgspersonens indtræden i forsøget samt på årlig basis i mindst 15 år.
Detailed clinical status information will be collected at study entry and on an annual basis for at least 15 years.
Andre målinger (urin-GAG, antistoffer) vil blive vurderet hyppigere.
Other measures (urinary GAG, antibodies) are assessed more frequently.
Rationalet for enzymsubstitutionsbehandling er at genoprette et niveau af enzymatisk aktivitet, som er tilstrækkeligt til at hydrolysere det akkumulerede substrat og til at forhindre yderligere akkumulation.
The rationale for enzyme replacement therapy is to restore a level of enzymatic activity sufficient to hydrolyze the accumulated substrate and to prevent further accumulation.
Behandling med Naglazyme viste forbedret, eller mangel på forværring af, facial dysmorfisme.
Treatment with Naglazyme showed improvement, or lack of worsening, of facial dysmorphism.
Advarsler og forsigtighedsregler - Hvis du bliver behandlet med Naglazyme, kan du få infusionsrelaterede reaktioner.
Warnings and precautions - If you are treated with Naglazyme, you may develop infusion-associated reactions.
Bivirkninger er opstillet i Tabel 1 efter systemorganklasse.
Adverse reactions are listed in Table 1 by System Organ Class.
Iværksættelse af positivt luftvejs-tryk (positive-airway pressure) under søvn samt potentiel trakeostomi i klinisk passende situationer bør ligeledes overvejes.
Institution of positive-airway pressure during sleep as well as potential tracheostomy in clinically appropriate situations should also be considered.
- Aktivt stof: Galsulfase.
- The active substance is galsulfase.
Infusionsreaktioner begyndte allerede i Uge 1 og så sent som i Uge 146 af Naglazyme-behandlingen og forekom under flere infusioner, men ikke altid i konsekutive uger.
Infusion reactions began as early as Week 1 and as late as Week 146 of Naglazyme treatment, and occurred during multiple infusions though not always in consecutive weeks.
Der skal udvises forsigtighed i forbindelse med håndtering og behandling af patienter med kompromitterede luftveje ved begrænsning af brugen eller omhyggelig monitorering af antihistamin og anden sedativ medicin.
Caution must be exercised in the management and treatment of patients with compromised airways by limitation or careful monitoring of antihistamine and other sedative medicinal product use.
Adskillige patienter har modtaget deres totale dosis Naglazyme ved cirka to gange den anbefalede infusionshastighed tilsyneladende uden hændelser.
Several patients have received their total dose of Naglazyme at approximately twice the recommended infusion rate without apparent adverse events.
Sikkerheden og effekten af Naglazyme hos patienter over 65 år er ikke påvist, og der kan ikke anbefales et alternativt doseringsregimen til disse patienter.
The safety and efficacy of Naglazyme in patients older than 65 years has not been established, and no alternative dose regimen can be recommended in these patients.
Almindelige bivirkninger har en hyppighed på 1/100 til <1/10.
Common reactions have a frequency of 1/100 to <1/10.
Hvis disse reaktioner opstår, anbefales det øjeblikkeligt at afbryde behandlingen med Naglazyme og initiere passende behandling.
If these reactions occur, immediate discontinuation of Naglazyme is recommended and appropriate medical treatment should be initiated.
Det forhindrede ikke progression af skeletal dysplasi og udvikling af brok, og det forhindrede ikke progression af corneal opacitet.
It did not prevent the progression of skeletal dysplasia and development of hernias and did not prevent the progression of corneal clouding.
De ophobes i mange af kroppens væv, hvilket forårsager symptomerne af MPS VI.
They accumulate in many tissues in the body, which causes the symptoms of MPS VI.
Middel ( SD) eliminationshalveringstiden (t1/2) var 22,8 ( 10,7) minutter ved uge 24.
The mean ( SD) elimination half-life (t1/2) was 22.8 ( 10.7) minutes at Week 24.
Efter intravenøs infusion fjernes galsulfase hurtigt fra kredsløbet og optages af celler ind i lysosomer, højst sandsynlig via mannose-6 fosfat receptorer.
After intravenous infusion, galsulfase is rapidly removed from the circulation and taken up by cells into lysosomes, most likely via mannose-6 phosphate receptors.
Det anbefales, at den fortyndede Naglazyme opløsning administreres til patienterne ved brug af et infusionssæt, der er udstyret med et 0,2 µm in-line filter.
It is recommended that the diluted Naglazyme solution be administered to patients using an infusion set equipped with a 0.2 µm in-line filter.
Dette enzym kan erstatte det naturlige enzym, som mangler hos patienter med MPS VI.
This can replace the natural enzyme which is lacking in MPS VI patients.
Det vides ikke, hvorvidt galsulfase udskilles i modermælk, og derfor bør amning ophøre under behandling med Naglazyme.
It is not known whether galsulfase is excreted in milk, therefore breast-feeding should be stopped during Naglazyme treatment.
Dette lægemiddel indeholder et gensplejset (rekombinant) enzym, der kaldes galsulfase.
This medicine contains a recombinant enzyme called galsulfase.
BILAG II A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN C. SÆRLIGE FORPLIGTELSER, SOM SKAL OPFYLDES AF INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OF THE MARKETING AUTHORISATION C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Infusionen kan genoptages med en reduktion i infusionshastighed til 50% - 25% af den hastighed, ved hvilken reaktionen opstod.
The infusion can be restarted with a reduction of the infusion rate to 50% - 25% of the rate at which the reaction occurred.
En kort opdatering vil blive indsendt som del af de årlige revurderinger.
A brief update will be submitted as part of the Annual Reassessments.
Prøver for totalt antistof vil blive indsamlet med specifikke intervaller.
Samples for total antibody will be collected at specific intervals.
Med hensyn til mikrobiologisk sikkerhed bør Naglazyme anvendes omgående.
From a microbiological safety point of view, Naglazyme should be used immediately.
Patienter, som ved baseline kunne gå mere end 5 meter (m) men mindre end 250 m på 6 minutter i en 12 minutters gangtest eller mindre end 400 m ved 12 minutters tidspunktet, blev rekrutteret i studiet.
Patients who could walk more than 5 meters (m) but less than 250 m in 6 minutes of a 12 Minute Walk test or less than 400 m at the 12 minute time point at baseline were enrolled in the study.
Bivirkninger, som er indberettet i perioden efter markedsføring, er inkluderet med frekvenskategorien ”ukendt”.
Adverse reactions reported during the Post Marketing period are included at a frequency category of “unknown”.
Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet, som er beskrevet i Modul 1.8.1 i markedsføringstilladelsen, er på plads og fungerer, før og mens produktet markedsføres.
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation , is in place and functioning before and whilst the product is on the market.
Når der anvendes 100 ml poser, kan Naglazyme volumenet tilføres direkte til infusionsposen.
When using 100 ml bags, the volume of Naglazyme may be added directly to the infusion bag.
Evaluere sikkerheden og effekten af Naglazyme hos 10 børn under 5 år,
Evaluate the safety and efficacy of Naglazyme in 10 children less than
Evaluere virkningen af Naglazyme på graviditet og amning
Evaluate the effect of Naglazyme on pregnancy and lactation.
Renal elimination af galsulfase betragtes som en mere ubetydelig clearance-rute (se pkt.
Renal elimination of galsulfase is considered a minor pathway for clearance (see section 4.2).
I tilfælde af en enkelt svær IAR bør infusionen standses, indtil symptomerne ophører, og behandling med antihistaminer og paracetamol bør overvejes.
In case of a single severe IAR, the infusion should be stopped until the symptoms are resolved and treatment with antihistamines and paracetamol should be considered.