FrancophonIA/ELRC3.0 huggingface dataset:
English: Major bleeding was defined as any one of the following: intracranial, retroperitoneal, intraocular, access site haemorrhage requiring radiological or surgical intervention, ≥5 cm diameter haematoma at puncture site, reduction in haemoglobin concentration of ≥4 g/dl without an overt source of bleeding, reduction in haemoglobin concentration of ≥3 g/dl with an overt source of bleeding, re-operation for bleeding or use of any blood product transfusion.
Danish: Major blødning blev defineret som en af følgende: intrakraniel, retroperitoneal, intraokulær blødning eller blødning på punkturstedet, hvor radiologisk eller kirurgisk indgreb var nødvendigt, hæmatom ≥5 cm diameter på punkturstedet, reduktion af hæmoglobinkoncentrationen på ≥4 g/dl uden synlig blødningskilde, reduktion af hæmoglobinkoncentrationen på ≥3 g/dl med synlig blødningskilde, gentaget operation for blødning eller brug af ethvert blodprodukt til transfusion.
English: Angiox 250 mg powder for concentrate for solution for injection or infusion bivalirudin
Danish: Angiox 250 mg pulver til koncentrat til injektionsvæske eller infusionsvæske, opløsning bivalirudin
English: • When this treatment is finished, the infusion may go back to 0.25 mg/kg body weight per hour
Danish: • Når indgrebet er afsluttet, kan infusionshastigheden sættes ned igen til 0,25 mg/kg legemsvægt i timen i yderligere 4-12 timer.
English: Angiox 250 mg powder for concentrate for solution for injection or infusion.
Danish: Angiox 250 mg pulver til koncentrat til injektionsvæske eller infusionsvæske, opløsning.
English: Just prior to surgery, a 0.5 mg/kg bolus dose should be administered followed by a 1.75 mg/kg/h intravenous infusion for the duration of the surgery.
Danish: Umiddelbart før operation administreres en bolus på 0,5 mg/kg legemsvægt efterfulgt af intravenøs infusion på 1,75 mg/kg legemsvægt/time under hele operationsforløbet.
English: Currently available data are described in sections 5.1 and 5.2.
Danish: 5.1 og 5.2.
English: The recommended dose of bivalirudin for patients undergoing PCI is an intravenous bolus of 0.75 mg/kg body weight followed immediately by an intravenous infusion at a rate of 1.75 mg/kg body weight/hour for at least the duration of the procedure.
Danish: Til patienter, som skal have foretaget PCI, er den anbefalede dosis bivalirudin en intravenøs bolus på 0,75 mg/kg legemsvægt, direkte efterfulgt af intravenøs infusion af 1,75 mg/kg legemsvægt/time som minimum til afsluttet PCI.
English: Lyophilised powder: Do not store above 25C.
Danish: Efter fortynding: Må ikke opbevares ved temperaturer over 25 C.
English: 1 vial contains 250 mg bivalirudin.
Danish: 1 hætteglas indeholder 250 mg bivalirudin.
English: The ACT value is positively correlated with the dose and plasma concentration of bivalirudin administered.
Danish: Den farmakodynamiske virkning af bivalirudin kan vurderes ved måling af antikoagulationsaktivitet, herunder ACT. ACT-værdien er positivt korreleret med dosis og plasmakoncentrationen af den indgivne mængde bivalirudin.
English: (For full information on posology see section 4.2 of SmPC)
Danish: (Fuldstændige oplysninger om dosering findes i pkt.
English: Major bleeding was defined as the occurrence of any of the following: intracranial haemorrhage, retroperitoneal haemorrhage, blood loss leading to a transfusion of at least two units of whole blood or packed red blood cells, or bleeding resulting in a haemoglobin drop of more than 3 g/dl, or a fall in haemoglobin greater than 4 g/dl (or 12% of haematocrit) with no bleeding site identified.
Danish: Major blødning blev defineret som forekomst af: Intrakraniel blødning, retroperitoneal blødning, blodtab, som udløser transfusion af mindst to portioner fuldblod eller pakkede røde blodceller, eller blødning, som resulterer i et fald i hæmoglobinkoncentrationen på mere end 3 g/dl eller et fald i hæmoglobinkoncentrationen på mere end 4g/dl (eller 12 % i hæmatokrit), uden at der er identificeret en blødningskilde.
English: Major bleeding rates for the intent-to-treat trial population are shown in Table 6.
Danish: Hyppigheden af major blødning hos ITT-populationen vises i Tabel 6.
English: After reconstitution 1 ml contains 50 mg bivalirudin.
Danish: Efter rekonstitution: 1 ml indeholder 50 mg bivalirudin.
English: • severe renal impairment (GFR<30 ml/min) and in dialysis-dependent patients.
Danish: • svært nedsat nyrefunktion (GFR <30 ml/min) samt hos dialyseafhængige patienter
English: In STEMI patients the infusion of 1.75 mg/kg body weight/hour should be continued for up to 4 hours post-PCI and continued at a reduced dose of 0.25 mg/kg body weight/hour for an additional 4 - 12 hours as clinically necessary (see section 4.4).
Danish: Hos STEMI-patienter bør infusionen med 1,75 mg/kg legemsvægt/time fortsættes i op til 4 timer efter PCI og med en reduceret dosis på 0,25 mg/kg legemsvægt /time i yderligere 4-12 timer, hvis det er klinisk relevant (se pkt.
English: The following data are based on a clinical study of bivalirudin in patients with STEMI undergoing primary PCI; 1,800 patients were randomised to bivalirudin alone, 1,802 were randomised to heparin plus GP IIb/IIIa inhibitor.
Danish: 1.800 patienter blev randomiseret til bivalirudin alene, mens 1.802 blev randomiseret til heparin plus GP IIb/IIIa-inhibitor.
English: or to hirudins
Danish: 6.1 eller over for hirudiner
English: After dilution 1 ml contains 5 mg bivalirudin.
Danish: Efter fortynding: 1 ml indeholder 5 mg bivalirudin.
English: - If you have any further questions, ask your doctor.
Danish: - Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: • 0.5 mg/kg body weight for the intravenous injection, followed by an infusion into vein of 1.75 mg/kg body weight, per hour for the duration of the PCI.
Danish: • 0,5 mg/kg legemsvægt som intravenøs indsprøjtning, efterfulgt af infusion (drop) i en vene på 1,75 mg/kg legemsvægt i timen så længe, PCI-behandlingen varer.
English: In STEMI patients the infusion of 1.75 mg/kg body weight/hour should be continued for up to 4 hours post-PCI and continued at a reduced dose of 0.25 mg/kg/h for an additional 4 - 12 hours as clinically necessary (see section 4.4).
Danish: Hos STEMI-patienter bør infusionen med 1,75 mg/kg legemsvægt/time fortsættes i op til 4 timer efter PCI og med en reduceret dosis på 0,25 mg/kg legemsvægt/time i yderligere 4-12 timer, hvis det er klinisk relevant (se pkt.
English: Hypersensitivity, including anaphylactic reaction and shock, including reports with fatal outcome
Danish: anafylaktiske reaktioner og shock, inkl.
English: • INR test (warfarin blood test result) increased (see Section 2, Other medicines and Angiox)
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer) • højere resultat af warfarinblodprøven (INR-test) (se punkt 2, Brug af anden medicin sammen med
English: 50 ml] of glucose solution or sodium chloride solution) 1 ml contains 5 mg bivalirudin.
Danish: Efter fortynding (blanding af 5 ml af den rekonstituerede opløsning i en infusionspose [samlet mængde på 50 ml] med glucoseopløsning eller natriumchloridopløsning) indeholder 1 ml 5 mg bivalirudin.
English: Other medicines and Angiox tell your doctor
Danish: Brug af anden medicin sammen med Angiox
English: Ear haemorrhage
Danish: Udslæt Urticaria
English: Haloperidol lactate
Danish: Haloperidollactat
English: For patients undergoing PCI, an additional intravenous bolus of 0.5 mg/kg bivalirudin was administered and the rate of intravenous infusion increased to 1.75 mg/kg/h.
Danish: Patienter der gik videre til en PCI fik en ekstra intravenøs bolus af bivalirudin på 0,5 mg/kg legemsvægt efterfulgt af en øget intravenøs -infusion op til 1,75 mg/kg legemsvægt/time.
English: Arm A UFH/enox +GP IIb/IIIa inhibitor (N=4,603)
Danish: UFH/enoxaparin + GP IIb/IIIa-inhibitor (N=
English: Patients with moderate renal impairment (GFR 30-59 ml/min) undergoing PCI (whether being treated with bivalirudin for ACS or not) should receive a lower infusion rate of 1.4 mg/kg/h.
Danish: Ved PCI (uanset om der er initieret behandling for AKS med bivalirudin) bør infusionshastigheden nedsættes til 1,4 mg/kg legemsvægt/time hos patienter med moderat nedsat nyrefunktion (GFR 30-59 ml/min).
English: Major bleeding
Danish: Major blødning
English: • Shortness of breath
Danish: • langsom puls (hjerterytme)
English: The following medicinal products should not be administered in the same intravenous line as bivalirudin since they result in haze formation, micro-particulate formation or gross precipitation; alteplase, amiodarone HCl, amphotericin B, chlorpromazine hydrochloride (HCl), diazepam, prochlorperazine edisylate, reteplase, streptokinase and vancomycin HCl.
Danish: Det drejer sig om alteplase, amiodaron HCI, amphotericin B, chlorpromazinhydrochlorid (HCI), diazepam, prochlorperazinedisylat, reteplase, streptokinase og vancomycin HCI.
English: In patients with mild or moderate renal insufficiency, the ACS dose (0.1 mg/kg bolus/0.25 mg/kg/h infusion) should not be adjusted.
Danish: Dosis ved AKS (0,1 mg/kg bolus/0,25 mg/kg legemsvægt/time infusion) skal ikke reduceres hos patienter med let til moderat nyreinsufficiens.
English: When bivalirudin is combined with a platelet inhibitor or an anti-coagulant medicine, clinical and biological parameters of haemostasis should be regularly monitored.
Danish: Kliniske og biologiske hæmostaseparametre skal måles regelmæssigt, når bivalirudin kombineres med en trombocythæmmer og et antikoagulerende lægemiddel.
English: If you have kidney problems, the dose of Angiox may need to be reduced.
Danish: Nedsat nyrefunktion: Hvis du har nedsat nyrefunktion, kan dosisnedsættelse være nødvendig.
English: Excipient
Danish: Ekkymose
English: Bival alone (N=2,911) %
Danish: (N=2.924) %
English: Quadruple endpoint Triple endpoint* Components: Death Myocardial Infarction Major bleeding** (based on nonTIMI criteria - see section 4.8) Urgent revascularisation * excludes major bleeding component.
Danish: Major blødning** (baseret på non-TIMI kriterier- se pkt.
English: Coronary stent thrombosis including reports with fatal outcome c
Danish: rapporter med letal udgang c
English: Dobutamine HCl
Danish: Dobutaminhydrochlorid
English: Coronary artery thrombosis,
Danish: Koronar stenttrombose, inkl.
English: Breastfeeding
Danish: Bivalirudin
English: - Each vial contains 250 mg bivalirudin.
Danish: Hvert hætteglas indeholder 250 mg bivalirudin.
English: The reconstituted/diluted solution should be inspected visually for particulate matter and discolouration.
Danish: Den rekonstituerede/fortyndede opløsning bør inspiceres visuelt for partikler og misfarvning både efter tilsætning af de 5 ml samt efter den endelige fortynding til 50 ml.
English: HOW TO STORE ANGIOX
Danish: Hvis du får for meget Angiox
English: Unplanned
Danish: Ufraktioneret
English: Gastrointestinal disorders
Danish: Gastrointestinal blødning (inkl.
English: Chest pain
Danish: Se pkt.
English: Cardiac disorders
Danish: Myokardieinfarkt
English: Ischaemic target vessel revascularisation Stroke
Danish: Iskæmi trods revaskularisering af det behandlede kar Apopleksi
English: Diluted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25C.
Danish: Den fortyndede opløsning kan opbevares i op til 24 timer ved 25 °C.
English: 6.3 Shelf life
Danish: 4.4. d. Pkt.
English: Diluted solution: Do not store above 25C.
Danish: Den fortyndede opløsning: Opbevares ved temperaturer under 25 C.
English: What Angiox looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Arteriovenous fistula,
Danish: Gingival blødning Kvalme
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the Member States
Danish: Bilag I Liste over lægemidlernes navne, lægemiddelformer, styrker, indgivelsesveje, indehavere af markedsføringstilladelser i medlemsstaterne
English: Member State (in EEA)
Danish: Medlemsstat EU/EEA
English: via Isonzo, 71 04100 Latina Italy
Danish: via Isonzo, 71 04100 Latina Italien
English: Pfizer Gyógyszerkereskedelmi Kft. Alkotás St 53
Danish: Pfizer Gyógyszerkereskedelmi Kft. Alkotás u. 53.
English: Pfizer ApS, Lautrupvang 8, 2750 Ballerup Denmark
Danish: Pfizer ApS, Lautrupvang 8, 2750 Ballerup Danmark
English: Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Vienna
Danish: Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Wien
English: 2909 LD, Capelle a/d Ijssel The Netherlands
Danish: Capelle a/d Ijssel Holland
English: Acipimox Olbetam 250 mg kemény kapszula
Danish: Olbetam 250 mg Kemény kapszula
English: Sandwich, Kent CT13 9NJ United Kingdom
Danish: Storbritannien Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ Storbritannien
English: Acipimox Olbetam 250 mg Capsules 250 mg capsule
Danish: Olbetam 250 mg Capsules
English: 1123 Budapest
Danish: Budapest Ungarn
English: Belgium PFIZER S.A. Boulevard de la Plaine 17 1050 Ixelles
Danish: Boulevard de la Plaine 17 1050 Ixelles
English: Marketing authorisaton holder INN Invented name
Danish: Indehaver af markedsføringstilladelsen
English: The Netherlands Pfizer B.V. Rivium Westlaan 142
Danish: Pfizer B.V.
English: Acipimox Olbetam - Kapseln
Danish: Olbetam - Kapseln 250 mg
English: Atlantic salmon (Salmo salar)
Danish: Atlantisk laks (Salmo salar)
English: EU (MA) number Invented name
Danish: EU (MA)nummer
English: Zero degree days
Danish: Nul graddage
English: Route of administration
Danish: Administration svej
English: Bag (ethyl vinyl acetate)
Danish: Pose (ethylvinylacetat)
English: Intramuscular use
Danish: Intramuskulær brug
English: Packaging Content Package size
Danish: Indhold Pakningss tørrelse
English: Strength Pharmaceutical form
Danish: (Sær)navn Styrke Lægemiddelform Dyrearter, som lægemidlet er beregnet til
English: Talk to your doctor first.
Danish: Tal med din læge først.
English: MA 01701 United States
Danish: MA 01701 USA
English: ATC code: A16AB04.
Danish: ATC kode: A16AB04.
English: Date of first authorisation: 03 August 2001 Date of last renewal: 03 August 2006
Danish: Dato for første tilladelse: 3. august 2001 Dato for sidste fornyelse: 3. august 2006
English: Results were similar between the two treatment groups.
Danish: Resultaterne var sammenlignelige i de to behandlingsgrupper.
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør produktet anvendes umiddelbart.
English: Genotoxic and carcinogenic potential are not expected.
Danish: Genotoksisk og karcinogent potentiale forventes ikke.
English: Antibody status should be regularly monitored.
Danish: Antistofstatus bør overvåges regelmæssigt.
English: The current medical standards for emergency treatment are to be observed.
Danish: De gældende medicinske standarder for akut behandling skal overholdes.
English: The educational pack should contain the following:
Danish: Pakken med uddannelsesmateriale skal indeholde følgende:
English: Studies with regard to other stages of the development have not been carried out.
Danish: Der er ikke gennemført undersøgelser med hensyn til andre udviklingstrin.
English: Your doctor may advise that you can be treated at home provided you meet certain criteria.
Danish: Din læge kan anbefale, at du bliver behandlet hjemme, hvis du opfylder visse kriterier.
English: The frequency of these reactions decreased over time.
Danish: Hyppigheden af disse reaktioner faldt med tiden.
English: Because this condition is slowly progressive, early detection and treatment is critical to achieve the best outcomes.
Danish: Idet denne tilstand er langsomt progredierende, kan tidlig påvisning og behandling være afgørende for at opnå de bedste resultater.
English: Lower dosing regimens have been used in clinical studies.
Danish: Regimer med lavere doser har været anvendt i kliniske studier.
English: For the purpose of this table, ≥1% is defined as reactions occurring in 2 or more patients.
Danish: I dette skema er ≥1 % defineret som reaktioner, der opstår hos 2 eller flere patienter.
English: The majority of these reactions can be attributed to the formation of IgG antibodies and/or complement activation.
Danish: Hovedparten af disse reaktioner kan tilskrives dannelsen af IgG antistoffer og/eller komplement-aktivering.
English: You may need to be given additional medicines to prevent such reactions from occurring.
Danish: Du har muligvis brug for yderligere medicin for at forhindre sådanne reaktioner.
English: Adverse reaction terminology is based upon the Medical Dictionary for Regulatory Activities (MedDRA)
Danish: Bivirkningsterminologien er baseret på Medical Dictionary for Regulatory Activities (MedDRA)
English: Not known (frequency cannot be estimated from the available data):
Danish: Ikke kendt (kan ikke vurderes ud fra tilgængelige data)
English: Package sizes: 1, 5 and 10 vials per carton.
Danish: Pakningsstørrelser: 1, 5 og 10 hætteglas pr. karton.
English: It is supplied as a powder which will be mixed with sterile water before it is given (see information for Health Care Professionals at the end of this leaflet).
Danish: Det leveres som et pulver, der blandes med sterilt vand, inden det indgives (se information til læger og sundhedspersonale til sidst i denne indlægsseddel).
English: Please contact your doctor if you would like to be treated at home.
Danish: Tal med din læge, hvis du gerne vil behandles hjemme.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products in the same infusion.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler i samme infusionsvæske.
English: Adverse reactions only reported during the Post Marketing period are also included in the table below at a frequency category of “not known” (cannot be estimated from the available data).
Danish: Bivirkninger, der kun blev rapporteret i perioden efter markedsføring, er inkluderet i tabellen nedenfor i kategorien ”ikke kendt” (kan ikke estimeres ud fra forhåndenværende data).
English: This was achieved in 47 of the 49 patients (96%) with available information at month 6, and in 8 of the 8 patients (100%) with available information at the end of the study (up to a total of 5 years of treatment).
Danish: Dette blev opnået i 47 ud af 49 patienter (96 %), om hvilke der er informationer til rådighed efter 6 måneder, og hos 8 ud af 8 patienter (100 %), om hvilke der er informationer til rådighed ved studiets afslutning (op til i alt 5 års behandling).
English: The net effect of these changes after seroconversion was an increase in exposure of 2- to 3-fold based on AUC and Cmax.
Danish: Nettoeffekten af disse ændringer efter serokonvertering var en eksponeringsforøgelse på 2-3 gange, baseret på AUC og Cmax.
English: No unexpected safety issues were encountered in patients with an increase in exposure after seroconversion.
Danish: Der blev ikke observeret nogen uventede sikkerhedsproblemer hos patienter, som oplevede en eksponeringsforøgelse efter serokonvertering.
English: It is characterised by the deficiency of α-galactosidase.
Danish: Den er karakteriseret ved utilstrækkelig α-galaktosidase.
English: Although no specific study has been conducted to assess the effect on the neurological signs and symptoms, the results also indicate that patients may achieve reduced pain and enhanced quality of life upon enzyme replacement therapy.
Danish: Selvom der ikke er udført specifikke studier for at vurdere effekten på neurologiske tegn og symptomer, indikerer resultaterne også at patienterne kan opnå smertereduktion og forbedret livskvalitet under erstatningsbehandling med enzymer.
English: Fabry disease is an inherited heterogeneous and multisystemic progressive disease, that affects both males and females.
Danish: Fabrys sygdom er en nedarvet heterogen og multisystemisk progressiv sygdom, der rammer både mænd og kvinder.
English: If you are treated with Fabrazyme, you may develop infusion associated reactions.
Danish: Hvis du bliver behandlet med Fabrazyme, kan du udvikle infusionsrelaterede reaktioner.
English: Fabry disease
Danish: Fabrys sygdom
English: These reported symptoms resemble the natural course of Fabry disease.
Danish: Disse symptomer ligner de naturlige symptomer på Fabrys sygdom.
English: Infusion of Fabrazyme at home may be considered for patients who are tolerating their infusions well.
Danish: Infusion af Fabrazyme i hjemmet kan overvejes for patienter, der tolererer infusionerne godt.
English: Dose and infusion rate should remain constant while at home, and not be changed without supervision of a healthcare professional.
Danish: Dosis og infusionshastighed skal forblive konstant under hjemmebehandlingen og må ikke ændres uden lægelig supervision.
English: - Regular review of the administration by the patient and/or caregiver needs to be performed to ensure maintenance of optimal practice.
Danish: - Der skal regelmæssigt føres tilsyn med patientens og/eller plejepersonalets administration af behandlingen for at sikre opretholdelse af optimal praksis.
English: Fabrazyme pharmacokinetics was also evaluated in two paediatric studies.
Danish: Farmakokinetikken for Fabrazyme blev også evalueret i to pædiatriske studier.
English: Patients with advanced renal disease
Danish: Patienter med fremskreden nyresygdom
English: Fabrazyme is supplied as a white to off-white powder.
Danish: Fabrazyme leveres som et hvidt til off-white pulver.
English: Fabrazyme should not be used during pregnancy unless clearly necessary.
Danish: Fabrazyme bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: An infusionassociated reaction is any side effect occurring during the infusion or until the end of the infusion day (see section 4).
Danish: En infusionsrelateret reaktion er en bivirkning, der opstår under infusion eller ved infusionsdagens afslutning (se punkt 4).
English: This result was consistent across renal, cardiac and cerebrovascular events.
Danish: Dette resultat var konsistent over nyre-, hjerte- og cerebrovaskulære hændelser.
English: Do not use filter needles and avoid foaming.
Danish: Anvend ikke nåle med filter og undgå skumdannelse.
English: In some patients initially treated at the recommended dose, and whose dose was later reduced for an extended period, some symptoms of Fabry disease were reported more frequently.
Danish: Hos nogle patienter, der til at starte med blev behandlet med den anbefalede dosis, men hvor dosis senere blev reduceret i en længere periode, blev nogle af symptomerne på Fabrys sygdom oftere rapporteret.
English: Infusion associated reactions consisted most often of fever and chills.
Danish: Infusionsrelaterede reaktioner bestod oftest af feber og kuldegysninger.
English: Plasma GL-3 levels rapidly normalised with treatment and remained normal through 5 years.
Danish: Plasma-GL3-niveauer normaliseredes ved behandling og forblev normale i 5 år.
English: However, at the lower dose, IgG antibodies may play a role with respect to GL-3 clearance in some patients.
Danish: Ved den lavere dosis kan IgG antistoffer spille en rolle med hensyn til GL-3 clearance hos visse patienter.
English: Your doctor may decide to lower the infusion rate or give you additional medicines to prevent such reactions from occurring.
Danish: Lægen kan beslutte at nedsætte infusionshastigheden eller give dig andre lægemidler for at forhindre, at disse reaktioner opstår.
English: Infusion associated reactions
Danish: Infusionsrelaterede reaktioner
English: As with any intravenous protein medicinal product, allergic-type hypersensitivity reactions are possible.
Danish: Som ved ethvert lægemiddel indeholdende protein er der mulighed for overfølsomhedsreaktioner af allergisk art.
English: If you have missed an infusion of Fabrazyme, please contact your doctor.
Danish: Hvis du har sprunget en infusion med Fabrazyme over, bedes du kontakte din læge.
English: Subsequent infusions may need to occur in a clinical setting.
Danish: Efterfølgende infusioner skal muligvis ske på hospital eller klinik.
English: No clinical studies have been performed in children 0-4 years old.
Danish: Der er ikke udført kliniske studier hos børn fra 0-4 år.