FrancophonIA/ELRC3.0 huggingface dataset:
English: After dilution: Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2°C to 8°C, or up to 12 hours below 25°C.
Danish: Efter fortynding: Der er påvist kemisk og fysisk stabilitet af den brugsklare infusionsvæske i op til 24 timer ved 2 °C til 8 °C og i op til 12 timer ved temperaturer under 25 °C.
English: LAL deficiency registry
Danish: LAL-mangel-register
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 10 ml VIAL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER 10 ml HÆTTEGLAS
English: • Information on how to manage patients experiencing severe hypersensitivity reactions including anaphylaxis.
Danish: • Information om, hvordan patienter, der oplever svære overfølsomhedsreaktioner, herunder anafylaksi, skal behandles.
English: Evaluated in patients with MEGE-MRI assessments performed (n = 32 for KANUMA; n = 25 for placebo).
Danish: Evalueret hos patienter, hvor MEGE-MRI-vurdering er udført (n=32 for KANUMA; n=25 for placebo).
English: LAL-CL03 was a multicentre, open-label, single-arm study of KANUMA in 9 patients with LAL deficiency with growth failure or other evidence of rapidly progressive disease prior to 6 months of age.
Danish: LAL-CL03 var et åbent, enkeltarmet multicenterstudie af KANUMA hos 9 patienter med LALmangel med væksthæmning eller andre tegn på hurtigt progredierende sygdom før 6-måneders alderen.
English: Based on these data, the pharmacokinetics of sebelipase alfa appeared to be nonlinear with a greater than dose-proportional increase in exposure observed between the 1 and 3 mg/kg dose.
Danish: Baseret på disse data syntes sebelipase alfas farmakokinetik at være non-lineær med en mere end dosisproportional stigning i eksponering imellem doserne 1 og 3 mg/kg.
English: Animal studies show no evidence of impaired fertility (see section 5.3).
Danish: Dyrestudier påviser ingen tegn på forringet fertilitet (se pkt.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Sebelipase alfa catalyses the lysosomal hydrolysis of cholesteryl esters and triglycerides to free cholesterol, glycerol and free fatty acids.
Danish: Sebelipase alfa katalyserer lysosomal hydrolyse af kolesterylestere og triglycerider til frit kolesterol, glycerol og frie fedtsyrer.
English: Four (4) of 65 patients in the open label period were dose escalated to 3 mg/kg once every other week based on clinical response.
Danish: Hos 4 ud af 65 patienter i den åbne periode blev dosis optrappet til 3 mg/kg én gang hver anden uge baseret på klinisk respons.
English: The safety objectives should focus on hypersensitivity reactions, particularly anti-drug antibodies development impacting response to drug.
Danish: Sikkerhedsmålene skal fokusere på overfølsomhedsreaktioner, særligt hvordan udvikling af antistoffer mod lægemidlet (anti-drug antibodies (ADA)) påvirker lægemiddelresponset.
English: Table 5: Recommended infusion volumes (1 mg/kg dose)* Weight range (kg)
Danish: Tabel 5: Anbefalede infusionsvolumener (1 mg/kg dosis)* Vægtinterval (kg)
English: In LAL-CL02, 5 of 35 evaluable children and adults (14%) who were administered KANUMA during the 20-week double-blind period of the study developed ADA.
Danish: I LAL-CL02 udviklede 5 ud af 35 evaluerbare børn og voksne (14 %), som fik administreret KANUMA under forsøgets 20 uger lange dobbeltblinde periode, ADA.
English: ADA titres decreased to undetectable levels during continued treatment in 3 of the 4 patients.
Danish: ADA-titrene faldt til under detektionsgrænsen under fortsat behandling hos 3 af de 4 patienter.
English: Hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with sebelipase alfa; see section 4.8.
Danish: Der er indberettet overfølsomhedsreaktioner, herunder anafylaksi, hos patienter, der blev behandlet med sebelipase alfa, se pkt.
English: You or your child may be monitored by your doctor or nurse for an additional hour after the infusion.
Danish: Du eller dit barn vil måske blive overvåget i endnu en time efter infusionen.
English: Consequently, impaired liver function is not expected to affect the pharmacokinetics of sebelipase alfa.
Danish: Følgelig forventes nedsat leverfunktion ikke at påvirke sebelipase alfas farmakokinetik.
English: In the spleen, LAL deficiency results in splenomegaly, anemia, and thrombocytopenia.
Danish: I milten medfører LAL-mangel splenomegali, anæmi og trombocytopeni.
English: If you or your child has an infusion reaction you or your child may be given additional medicines to treat or help prevent future reactions.
Danish: Hvis du eller dit barn får en infusionsreaktion, vil du eller dit barn måske få supplerende lægemidler til behandling eller forebyggelse af reaktioner ved fremtidige infusioner.
English: There are no data from the use of sebelipase alfa in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af sebelipase alfa til gravide kvinder.
English: Your doctor or nurse will give KANUMA to you or your child by an infusion (drip) into a vein.
Danish: Din læge eller sundhedspersonalet vil give dig eller dit barn KANUMA ved infusion ind i en vene.
English: Table 1: Recommended infusion volumes (1 mg/kg dose)* Weight range (kg)
Danish: Tabel 1: Anbefalede infusionsvolumener (1 mg/kg dosis)* Vægtinterval (kg)
English: KANUMA contains sodium
Danish: KANUMA indeholder natrium
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 10 ml
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1 hætteglas med 10 ml
English: ADA titres decreased to undetectable levels during continued treatment in all patients.
Danish: ADA-titrene faldt til under detektionsgrænsen under fortsat behandling hos alle patienter.
English: If not used immediately, the diluted solution may be stored up to 24 hours at 2°C to 8°C or up to 12 hours below 25°C.
Danish: Hvis den ikke anvendes straks, kan infusionsvæsken opbevares i op til 24 timer ved 2 °C til 8 °C eller i op til 12 timer ved temperaturer under 25 °C.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/10 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 20 mg/10 ml
English: Consistent with what was observed in KANUMA-treated patients during the double-blind period, initiation of treatment with KANUMA during the open-label period produced rapid improvements in ALT levels and in lipid parameters including LDL-cholesterol and HDL-cholesterol levels.
Danish: I overensstemmelse med det, der blev observeret hos KANUMA-behandlede patienter i den dobbeltblinde periode, fremkaldte initiering af behandling med KANUMA i den åbne periode hurtigt forbedringer i ALAT-niveauer og i lipidparametre, herunder LDL-kolesterol- og HDL-kolesterolniveauer.
English: KANUMA treatment should be supervised by a healthcare professional experienced in the management of patients with LAL deficiency, other metabolic disorders, or chronic liver diseases.
Danish: Behandling med KANUMA skal superviseres af sundhedspersonale med erfaring i behandling af LAL-mangel, andre stofskiftesygdomme eller kroniske leversygdomme.
English: Dose escalation to 3 mg/kg once weekly was associated with additional improvements in weight gain, lymphadenopathy and serum albumin.
Danish: Dosistitrering til 3 mg/kg én gang ugentligt var forbundet med yderligere forbedringer i vægtstigning, lymfadenopati og serumalbumin.
English: In the liver, this accumulation leads to hepatomegaly, increased hepatic fat content, transaminase elevation signaling chronic liver injury, and progression to fibrosis, cirrhosis, and complications of end stage liver disease.
Danish: I leveren medfører denne akkumulering hepatomegali, forøget leverfedtindhold, aminotransferaseforhøjelse som tegn på kronisk leverskade og progression til fibrose, cirrose og komplikationer fra terminal leversygdom.
English: See Table 5 for recommended total infusion volumes by weight range.
Danish: Se tabel 5 for det anbefalede samlede infusionsvolumen efter vægtinterval.
English: Pack sizes: 1 vial containing 10 ml of concentrate.
Danish: Pakningsstørrelse: 1 hætteglas indeholdende 10 ml koncentrat.
English: The solution should be mixed gently, and not be shaken.
Danish: Infusionsvæsken skal blandes forsigtigt og må ikke omrystes.
English: The recommended dose is 1 mg per kg body weight once every other week through a drip into a vein.
Danish: Den anbefalede dosis er 1 mg/kg én gang hver anden uge via drop ind i en vene.
English: At the time of initial ADA positivity, 3 patients were receiving a dose of 1 mg/kg once weekly and 1 patient was receiving a dose of 3 mg/kg once weekly.
Danish: På tidspunktet for første ADA-positivitet fik 3 patienter en dosis på 1 mg/kg én gang ugentligt, og 1 patient fik en dosis på 3 mg/kg én gang ugentligt.
English: Sixty-five of 66 patients entered the open-label period (up to 130 weeks) at a KANUMA dose of 1 mg/kg once every other week.
Danish: 65 ud af 66 patienter indtrådte i den åbne periode (op til 130 uger) med en KANUMA-dosis på 1 mg/kg én gang hver anden uge.
English: In a separate study in infants, one of five evaluable patients developed antibodies that inhibit in vitro enzyme activity and cellular uptake of the enzyme.
Danish: I et separat studie hos spædbørn udviklede en ud af fem evaluerbare patienter antistoffer, der hæmmer in vitro enzymaktivitet og cellulær optagelse af enzymet.
English: The active substance is sebelipase alfa.
Danish: Aktivt stof: Sebelipase alfa.
English: Very common Chills, hyperthermia, pyrexia b,
Danish: Kulderystelser, hypertermi, pyreksi b,
English: These reported signs and symptoms occurring in two or more patients included abdominal pain, agitation, chills, diarrhoea, eczema, hypertension, irritability, laryngeal oedema, nausea, oedema, pallor, pruritus, pyrexia/body temperature increased, rash, tachycardia, urticaria, and vomiting.
Danish: Disse indberettede tegn og symptomer, som forekom hos to eller flere patienter, omfattede abdominalsmerter, agitation, kulderystelser, diarré, eksem, hypertension, irritabilitet, laryngealt ødem, kvalme, ødem, bleghed, pruritus, pyreksi/forhøjet kropstemperatur, udslæt, takykardi, urticaria og opkastning.
English: Very common side effects reported in infants (1 to 6 months old) are: eyelid swelling agitation high blood pressure decreased muscle tone difficulty breathing wheezing paleness stuffy or swollen nose sneezing cough heartburn (reflux diseases)
Danish: Meget almindelige bivirkninger, som er indberettet for spædbørn (1 til 6 måneder gamle), er: hævede øjenlåg uro højt blodtryk muskelslaphed åndedrætsbesvær hvæsende vejrtrækning bleghed tilstoppet eller hævet næse nysen hoste halsbrand (sure opstød)
English: LAL deficiency is a genetic disease that leads to liver damage, high blood cholesterol, and other complications due to a build-up of certain types of fats (cholesteryl esters and triglycerides).
Danish: LAL-mangel er en arvelig sygdom, som medfører leverskade, forhøjet kolesterol i blodet og andre komplikationer på grund af ophobning af bestemte fedtstoffer (kolesterylestere og triglycerider).
English: In clinical studies, 21 of 106 (20%) KANUMA-treated patients, including 9 of 14 (64%) infants and 12 of 92 (13%) children and adults, experienced signs and symptoms either consistent with or that may be related to a hypersensitivity reaction.
Danish: I kliniske forsøg oplevede 21 ud af 106 (20 %) KANUMA-behandlede patienter, herunder 9 ud af 14 (64 %) spædbørn og 12 ud af 92 (13 %) børn og voksne, tegn og symptomer, der enten stemte overens med eller kunne være relateret til en overfølsomhedsreaktion.
English: Very common Respiratory distress, wheezing, cough, rhinitis, nasal congestion, sneezing
Danish: Vejrtrækningsbesvær, hvæsende vejrtrækning, hoste, rhinitis, nasal kongestion, nysen
English: KANUMA is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase (LAL) deficiency.
Danish: KANUMA er indiceret til langvarig enzymerstatningsterapi (ERT) hos patienter i alle aldre med lysosomal sur lipase (LAL)-mangel.
English: Sebelipase alfa is similar to the naturally occurring enzyme lysosomal acid lipase (LAL), which the body uses to breakdown fats.
Danish: Sebelipase alfa ligner det naturligt forekommende enzym lysosomal sur lipase (LAL), som nedbryder fedt i kroppen.
English: During the covariate analysis of the population pharmacokinetics model for sebelipase alfa, age, body weight, and sex were not found to have a significant influence on CL and Vc of sebelipase alfa.
Danish: Kovariatanalysen af den populationsfarmakokinetiske model for sebelipase alfa viste, at alder, kropsvægt og køn ikke har væsentlig indflydelse på sebelipase alfas clearance og centrale fordelingsvolumen.
English: The diluted solution should be administered to patients using a low-protein binding infusion set equipped with an in-line, low-protein binding 0.2 μm filter, with a surface area of greater than 4.5 cm2
Danish: Den fortyndede infusionsvæske skal administreres til patienter ved brug af et infusionssæt med lav proteinbinding og med et in-line 0,2 μm filter med lav proteinbinding og så vidt muligt et overfladeareal på over 4,5 cm for at undgå tilstopning af filteret.
English: There is limited information on the impact of anti-drug antibodies on sebelipase alfa pharmacokinetics.
Danish: Der er begrænsede oplysninger om indvirkningen af anti-drug antistoffer på sebelipase alfas farmakokinetik.
English: Anxietyc, insomnia
Danish: Almindelig Angst c, insomnia
English: If the infusion reaction is severe, your doctor may stop KANUMA infusion and start giving you or your child appropriate medical treatment.
Danish: Hvis infusionsreaktionen er alvorlig, vil din læge måske standse KANUMA-infusionen og give dig eller dit barn relevant behandling.
English: Table 1: Adverse reactions reported in infants c receiving KANUMA
Danish: Tabel 1: Bivirkninger indberettet for spædbørn c, der fik KANUMA
English: If you or your child experiences a severe infusion reaction like this, seek immediate medical attention.
Danish: Hvis du eller dit barn oplever en kraftig infusionsreaktion som denne, skal du straks kontakte en læge.
English: If the infusion reaction is severe, your doctor may stop the infusion of KANUMA in the vein and start giving appropriate medical treatment.
Danish: Hvis infusionsreaktionen er alvorlig, vil din læge måske standse infusionen af KANUMA i din vene og give relevant behandling.
English: Two patients were determined to be positive for antibodies that inhibit in vitro enzyme activity and cellular uptake of the enzyme.
Danish: To patienter blev bestemt positive for antistoffer, der hæmmer in vitro enzymaktivitet og cellulær optagelse af enzymet.
English: Based on a noncompartmental analysis of data from adults (LAL-CL01/LAL-CL-04), the pharmacokinetics of sebelipase alfa appeared to be nonlinear with a greater than dose-proportional increase in exposure observed between the 1 and 3 mg/kg dosages.
Danish: Baseret på en ikke-kompartmental analyse af data fra voksne (LALCL01/LAL-CL-04) syntes sebelipase alfas farmakokinetik at være ikke-lineær med en større end dosisproportional stigning i eksponering imellem doserne 1 og 3 mg/kg.
English: It is used to treat patients of all ages with lysosomal acid lipase deficiency (LAL deficiency).
Danish: Det bruges til at behandle patienter i alle aldre med lysosomal sur lipase-mangel (LAL-mangel).
English: infection of the urinary system swelling of the eyelids temporary increased cholesterol or triglyceride (fats) levels in the blood fast heartbeat anxiety sleeplessness dizziness low blood pressure redness in face shortness of breath swelling of the throat diarrhoea stomach ache stomach bloating nausea hives rash itching red swollen skin increased menstrual bleeding shivers chest discomfort swelling tiredness hardened area around the infusion site fever
Danish: urinvejsinfektion hævede øjenlåg midlertidigt forhøjede niveauer af kolesterol og/eller triglycerider (fedtstoffer) i blodet hurtig puls angst søvnløshed svimmelhed lavt blodtryk rødme i ansigtet kortåndethed hævelse af halsen diarré mavesmerter oppustet mave kvalme nældefeber udslæt kløe rød, hævet hud kraftigere menstruationsblødning kulderystelser ubehag i brystet hævelse træthed hårdt område omkring infusionsstedet feber
English: See Table 1 for recommended total infusion volumes by weight range.
Danish: Se tabel 1 for det anbefalede samlede infusionsvolumen efter vægtinterval.
English: No patients developed antibodies that inhibited in vitro enzyme activity and one patient developed antibodies that inhibited cellular uptake of the enzyme in vitro.
Danish: Ingen af patienterne udviklede antistoffer, der hæmmer in vitro enzymaktiviteten, men én patient udviklede antistoffer, der hæmmer den cellulære optagelse af enzymet in vitro.
English: The data in Table 2 describe adverse reactions reported in children and adults who received sebelipase alfa in clinical studies at a dose of 1 mg/kg once every other week.
Danish: Dataene i tabel 2 beskriver bivirkninger indberettet for børn og voksne, der fik sebelipase alfa i kliniske forsøg i en dosis på 1 mg/kg én gang hver anden uge.
English: The recommended starting dose in infants (< 6 months of age) presenting with rapidly progressive LAL deficiency is 1 mg/kg administered as an intravenous infusion once weekly.
Danish: Den anbefalede startdosis til spædbørn (< 6 måneder) med hurtigt progredierende LAL-mangel er 1 mg/kg som intravenøs infusion én gang ugentligt.
English: Because it is a recombinant human protein, sebelipase alfa is an unlikely candidate for cytochrome P450 mediated or other drug-drug interactions.
Danish: Da sebelipase alfa er et rekombinant humant protein, er det usandsynlig, at det er involveret i CYP-medierede eller andre lægemiddelinteraktioner.
English: The recommended dose in children and adults who do not present with rapidly progressive LAL deficiency prior to 6 months of age is 1 mg/kg administered as an intravenous infusion once every other week.
Danish: Den anbefalede dosis til børn og voksne, der ikke udviser hurtigt progredierende LAL-mangel før 6månedersalderen, er 1 mg/kg som intravenøs infusion én gang hver anden uge.
English: Marketing Authorisation Holder Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret France
Danish: Indehaver af markedsføringstilladelsen Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret Frankrig
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION KANUMA 2 mg/ml sterile concentrate sebelipase alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) KANUMA 2 mg/ml sterilt koncentrat sebelipase alfa
English: Deficient LAL enzyme activity results in the lysosomal accumulation of cholesteryl esters and triglycerides.
Danish: Manglende LAL-enzymaktivitet medfører lysosomal akkumulering af kolesterylestere og triglycerider.
English: Trisodium citrate dihydrate Citric acid monohydrate Human serum albumin Water for injections
Danish: Trinatriumcitratdihydrat Citronsyremonohydrat Humant serumalbumin Vand til injektionsvæsker
English: LAL enzyme activity leads to reductions in liver fat content and transaminases, and enables metabolism of cholesteryl esters and triglycerides in the lysosome, leading to reductions in lowdensity lipoprotein (LDL) cholesterol and non-high-density lipoprotein (HDL) cholesterol, triglycerides, and increases in HDL cholesterol.
Danish: Erstatning af LALenzymaktiviteten medfører fald i leverfedtindhold og transaminaser og muliggør metabolisering af kolesterylestere og triglycerider i lysosomet, hvorved lavdensitetslipoprotein (LDL)-kolesterol, ikkehøjdensitetslipoprotein (ikke-HDL)-kolesterol og triglycerider falder, og HDL-kolesterol stiger.
English: KANUMA has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique.
Danish: KANUMA skal fortyndes med 9 mg/ml (0,9 %) natriumchlorid infusionsvæske ved brug af aseptisk teknik.
English: This medicinal product contains 33 mg sodium per vial and is administered in sodium chloride 9 mg/ml (0.9%) solution for infusion (see section 6.6).
Danish: Dette lægemiddel indeholder 33 mg natrium pr. hætteglas og administreres i 9 mg/ml (0,9 %) natriumchloridinfusionsvæske (se pkt.
English: The data in Table 1 describe adverse reactions reported in infants who received KANUMA in clinical studies at doses up to 3 mg/kg weekly.
Danish: Dataene i tabel 1 beskriver bivirkninger indberettet for spædbørn, der fik KANUMA i kliniske forsøg i doser på op til 3 mg/kg ugentligt.
English: Preparation of the sebelipase alfa infusion KANUMA should be prepared and used according to the following steps.
Danish: Klargøring af sebelipase alfa-infusionen KANUMA skal klargøres og anvendes i henhold til nedenstående trin. Der skal anvendes aseptisk teknik.
English: Transient hypercholesterolaemia, transient hypertriglyceridaemia
Danish: Almindelig Forbigående hyperkolesterolæmi, forbigående hypertriglyceridæmi
English: There is a lack of data in patients with renal impairment.
Danish: Der mangler data for patienter med svært nedsat leverfunktion.
English: Each ml of concentrate contains 2 mg sebelipase alfa.
Danish: Hver ml koncentrat indeholder 2 mg sebelipase alfa.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 28 August 2015
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Clear to slightly opalescent, colourless to slightly coloured solution.
Danish: Klar til svagt opaliserende, farveløs til svagt farvet opløsning.
English: Each vial contains 20 mg of sebelipase alfa in 10 ml (2 mg/ml).
Danish: Hvert hætteglas indeholder 20 mg sebelipase alfa i 10 ml (2 mg/ml).
English: As a precautionary measure, it is preferable to avoid use of sebelipase alfa during pregnancy.
Danish: For en sikkerheds skyld bør sebelipase alfa undgås under graviditet.
English: e. Up to 10 ml of solution should be slowly withdrawn from each vial and diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: e. Op til 10 ml koncentrat skal langsomt trækkes ud af hvert hætteglas og fortyndes med 9 mg/ml (0,9 %) natriumchlorid infusionsvæske.
English: Renal elimination of sebelipase alfa is considered a minor pathway for clearance.
Danish: Elimination via nyrerne betragtes som mindre betydningsfuld for clearance af sebelipase alfa.
English: Final study report expected of Kanuma (in particular hypersensitivity reactions, including anaphylaxis, and anti-drug antibodies development potentially impacting response to drug) according to agreed protocol.
Danish: Endelig studierapport forventes i januar med hensyn til overfølsomhedsreaktioner, herunder anafylaksi, og den potentielle indvirkning af antistoffer mod lægemidlet (anti-drug antibodies (ADA)) på lægemiddelresponset) i henhold til den aftalte protokol.
English: Urinary tract infection
Danish: Almindelig Urinvejsinfektion
English: Three patients of 106 (3%) patients treated with KANUMA, including 1 of 14 (7%) infants and 2 of 92 (2%) children and adults, in clinical studies experienced signs and symptoms consistent with anaphylaxis.
Danish: I kliniske forsøg oplevede tre patienter ud af 106 (3 %) patienter, der blev behandlet med KANUMA, herunder 1 ud af 14 (7 %) spædbørn og 2 ud af 92 (2 %) børn og voksne, tegn og symptomer, der stemte overens med anafylaksi.
English: If you or your child experiences symptoms like these, seek immediate medical attention.
Danish: Hvis du eller dit barn får symptomer som disse, skal du straks kontakte en læge.
English: dry heaving diarrhoea hives rash vomiting itching raised rash red swollen skin fever swelling chills rapid breathing not enough oxygen in the blood fast heartbeat irritability
Danish: opkastningsfornemmelse diarré nældefeber udslæt opkastning kløe hævet udslæt rød, hævet hud feber hævelse kulderystelser hurtig vejrtrækning for lidt ilt i blodet hurtig puls irritabilitet