FrancophonIA/ELRC3.0 huggingface dataset:
English: 7% of the individuals with AD in clinical trials with IMVANEX experienced a flare-up or worsening of their skin condition during the course of the trial.
Danish: 7% af personerne med AD i kliniske studier med IMVANEX oplevede opblussen eller forværring af deres hudsygdom i løbet af studiet.
English: IMVANEX does not contain smallpox virus (Variola) and cannot spread or cause smallpox.
Danish: IMVANEX indeholder ikke koppevirus (Variola) og kan ikke sprede eller forårsage kopper.
English: IMVANEX may not fully protect all people who are vaccinated.
Danish: Det kan forekomme, at IMVANEX ikke helt beskytter alle personer, der vaccineres.
English: • abnormal sleep,
Danish: • unormal søvn,
English: • If your immune system is weakened you will receive two injections with the second injection no less than 28 days after the first.
Danish: • Hvis dit immunsystem er svækket, vil du få to injektioner, hvor den anden injektion gives ikke mindre end 28 dage efter den første.
English: Data have been generated in HIV infected individuals with CD4 counts ≥ 100 cells/µl and ≤ 750 cells/µl.
Danish: Der foreligger udelukkende data fra hiv-positive med CD4-tal på ≥ 100 celler/µl og ≤ 750 celler/µl.
English: Day 7/141
Danish: Dag 7/141
English: IMVANEX may trigger local rashes or more widespread eruptions.
Danish: IMVANEX kan udløse lokalt udslæt eller mere udbredt udslet.
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT • Risk Management Plan (RMP)
Danish: • Risikostyringsplan (RMP)
English: It is not known whether IMVANEX is excreted in human milk.
Danish: Det er ukendt, om IMVANEX udskilles i human mælk.
English: Therefore, concomitant administration of IMVANEX with other vaccines should be avoided.
Danish: Derfor skal samtidig administration af IMVANEX og andre vacciner undgås.
English: A protective immune response may not be elicited in all vaccinees.
Danish: Det kan forekomme, at et beskyttende immunrespons ikke udløses hos alle de vaccinerede.
English: IMVANEX should not be administered by intravascular injection.
Danish: IMVANEX må ikke administreres via intravaskulær injektion.
English: The safety and efficacy of IMVANEX in children below 18 years have not been established.
Danish: IMVANEXs sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Primary vaccination (individuals previously not vaccinated against smallpox): A first dose of 0.5 ml should be administered on an elected date.
Danish: Primær vaccination (personer, som ikke tidligere er vaccineret mod kopper) : Første dosis på 0,5 ml skal administreres på en udvalgt dato.
English: • swelling of the ankles, feet or fingers,
Danish: • hævede ankler, fødder eller fingre,
English: A dose of 0.5 ml is withdrawn into a syringe for injection.
Danish: En dosis på 0,5 ml trækkes op i injektionssprøjten.
English: For instructions on administration, see section 6.6.
Danish: Mht administrations instrukser, se pkt.
English: Do not use this vaccine after the expiry date which is stated on the label after Exp.
Danish: Brug ikke vaccinen efter den udløbsdato, der står på etiketten efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In the event of any damage to the vial, foreign particulate matter and/or variation of physical aspect being observed, discard the vaccine.
Danish: Hvis hætteglasset er beskadiget, hvis der er fremmedlegemer og/eller der observeres variation af fysiske aspekter, skal vaccinen bortskaffes.
English: This means that because of the lack of smallpox disease in the world it has not been possible to obtain complete information on this medicinal product.
Danish: Det betyder, at det på grund af manglende udbrud af kopper i verden ikke har været muligt at opnå fuldstændig dokumentation for lægemidlet.
English: Booster vaccination (individuals previously vaccinated against smallpox): There are inadequate data to determine the appropriate timing of booster doses.
Danish: Booster-vaccination (personer, som tidligere er vaccineret mod kopper) : Der foreligger utilstrækkelige data til at bestemme den hensigtsmæssige timing af booster-doser.
English: Smallpox vaccine (Live Modified Vaccinia Virus Ankara) This medicine is subject to additional monitoring.
Danish: Koppevaccine (levende modificeret vaccinia virus Ankara) Dette lægemiddel er underlagt supplerende overvågning.
English: Immunisation should be carried out by subcutaneous injection, preferably into the upper arm (deltoid).
Danish: Immuniseringen skal udføres via subkutan injektion, helst i overarmen (musculus deltoideus).
English: If you have never been vaccinated against smallpox:
Danish: Hvis du aldrig er blevet vaccineret mod kopper:
English: This vaccine contains trace residues of gentamicin and benzonase.
Danish: Denne vaccine indeholder meget små restmængder af gentamicin og benzonase.
English: There are no data on the immune response to IMVANEX in other immunosuppressed individuals.
Danish: Ingen data foreligger med hensyn til immunresponset for IMVANEX hos andre immunosupprimerede personer.
English: Adverse reaction rates reported after either vaccination dose (1st, 2nd or booster) were similar.
Danish: Hyppigheden af bivirkninger, der blev rapporteret efter begge vaccinationsdoser (1., 2. eller booster), var sammenlignelige.
English: Seroconversion rates in Vaccinia-experienced healthy and special populations
Danish: Serokonversionsrater hos Vaccinia-erfarne raske og særlige populationer
English: 0.5 ml suspension in a vial (Type I glass) with stopper (bromobutyl rubber).
Danish: 0,5 ml suspension i et hætteglas (type I-glas) med prop af (brombutylgummi).
English: Immunogenicity and attenuation of take of ACAM2000 in healthy subjects
Danish: Immunogenicitet og svækkelse ved administration af ACAM2000 til raske forsøgspersoner
English: Animal studies did not reveal any evidence of impaired female and male fertility.
Danish: Dyreforsøg viste ingen evidens for nedsat fertilitet hos kvinder og mænd.
English: IMVANEX contains sodium
Danish: IMVANEX indeholder natrium
English: • if you have atopic dermatitis (see section 4).
Danish: • hvis du har atopisk dermatitis (se pkt.
English: IMVANEX is a vaccine used to prevent smallpox infection in adults.
Danish: IMVANEX er en vaccine, der anvendes til at forhindre en koppeinfektion hos voksne.
English: IMVANEX is available in pack containing 20 vials.
Danish: IMVANEX findes i pakninger indeholdende 20 hætteglas.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 20 VIALS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNING MED 20 HÆTTEGLAS
English: The safety of IMVANEX has been assessed in 20 clinical trials in which 5,261 Vaccinia-naïve individuals received two doses of no less than 5 x 107 Inf.U four weeks apart while 534 Vaccinia- and IMVANEX-experienced individuals received a single booster dose.
Danish: IMVANEXs sikkerhed er blevet vurderet i 20 kliniske studier, hvor 5.261 Vaccinia-naive personer fik to doser med ikke under 5 x 107 Inf.E med fire ugers mellemrum, mens 534 Vaccinia- og IMVANEXeksponerede personer fik en enkelt booster-dosis.
English: Sinusitis Conjunctivitis Influenza
Danish: Sinuitis Konjunktivitis Influenza
English: N Day 71
Danish: N Dag 71
English: Day 421
Danish: Dag 421
English: Day 281
Danish: Dag 281
English: If you get any of the following side effects, tell your doctor.
Danish: Hvis du oplever nogle af følgende bivirkninger, skal du fortælle det til lægen.
English: • The second injection will be given no less than 28 days after the first.
Danish: • Den anden injektion vil gives ikke mindre end 28 dage efter den første.
English: The use of this vaccine during pregnancy and breast-feeding is not recommended.
Danish: Denne vaccine bør ikke anvendes under graviditet og amning.
English: Immunocompromised patients (e.g. HIV infected, patients under immunosuppressive therapy) who have been previously vaccinated against smallpox should receive two booster doses.
Danish: Immunkompromitterede patienter (f.eks. med hiv-infektion, eller i immunosupprimerende behandling), som tidligere er blevet vaccineret mod kopper, skal have to booster-doser.
English: The second co-primary endpoint evaluated if vaccination with Imvanex (n = 165) prior to administration of ACAM2000 results in an attenuation of the cutaneous reaction to ACAM2000 (n = 161) as measured by maximum lesion area in mm2.
Danish: Det andet co-primære endepunkt evaluerede om vaccination med Imvanex (n = 165) før administration af ACAM2000 fører til en svækkelse af den kutane reaktion på ACAM2000 (n = 161), målt ved det maksimale læsionsområde i mm2.
English: Two doses of IMVANEX given at a 7-day interval showed lower immune responses and slightly more local reactogenicity than two doses given at a 28-day interval.
Danish: Ved indgift af to doser IMVANEX i et interval på 7 dage, blev der fundet lavere immunrespons og lidt mere udtalt lokal reaktogenicitet sammenlignet med indgift i et interval på 28 dage.
English: If you have previously been vaccinated against smallpox:
Danish: Hvis du tidligere er blevet vaccineret mod kopper:
English: Body temperature increased Pyrexia
Danish: Øget kropstemperatur Pyreksi
English: As seen with traditional smallpox vaccines, a significant reduction in both mortality and morbidity (viral load, weight loss, number of pox lesions, etc.) compared to non-vaccinated controls was demonstrated for NHP vaccinated with IMVANEX.
Danish: I lighed med traditionelle koppevacciner blev der fundet en signifikant reduktion i både mortalitet og morbiditet (viral belastning, vægttab, antal koppesår osv.) sammenlignet med ikke-vaccinerede kontroller observeret for NHP'er, der blev vaccineret med IMVANEX.
English: Imvanex was compared to ACAM2000 (a 'second generation' live attenuated smallpox vaccine produced in cell culture and licenced in the United States of America) in a randomized, open-label non-inferiority clinical trial in healthy adults (US military personnel) aged 18 to 42 years and who were naïve to smallpox vaccine (Study POX-MVA-006).
Danish: IMVANEX blev sammenlignet med ACAM2000 (en 'andengenerations' levende svækket koppevaccine fremstillet i cellekultur og godkendt i USA) i et randomiseret, åbent klinisk noninferioritetsstudie hos raske voksne (amerikansk militærpersonale) i alderen 18 til 42 år, som var naive med hensyn til koppevaccine (studie POX-MVA-006).
English: A second dose of 0.5 ml should be administered no less than 28 days after the first dose.
Danish: Anden dosis på 0,5 ml skal administreres senest 28 dage efter den første dosis.
English: In a non-placebo controlled clinical trial that compared the safety of IMVANEX in individuals with AD to healthy individuals, individuals with AD reported erythema (61.2%) and swelling (52.2%) at the injection site with a higher frequency than healthy individuals (49.3% and 40.8%, respectively).
Danish: I et ikke-placebokontrolleret klinisk studie, der sammenlignede sikkerheden af IMVANEX hos personer med AD med raske personer, rapporterede personerne med AD om erytem (61,2%) og hævelse (52,2%) på injektionsstedet med en større hyppighed end de raske personer (hhv. 49,3% og 40,8%).
English: Name and address of the manufacturer(s) of the biological active substance(s) Bavarian Nordic A/S
Danish: Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer) Bavarian Nordic A/S
English: 1 dose (0.5 ml) has a titre of no less than 5 x 107 Inf.U (Inf.U = infectious units)
Danish: 1 dosis (0,5 ml) har et titer på ikke under 5 x 107 Inf.E (Inf.E = infektiøse enheder)
English: Pale milky coloured homogeneous suspension.
Danish: Lys, mælkefarvet homogen suspension.
English: Events of rash after vaccination (related cases observed in 0.4% of subjects) with IMVANEX tend to occur within the first days after vaccination, are mild to moderate in intensity and usually resolve without sequelae.
Danish: Tilfældemed udslæt efter vaccination (relaterede tilfælde observeret hos 0,4% af personerne) med IMVANEX har tendens til at opstå i løbet af de første dage efter vaccinationen, er lette til moderate i intensitet og forsvinder normalt uden sequelae.
English: Dispose of in accordance with local requirement.
Danish: Bortskaffes i henhold til lokale retningslinjer.
English: Two clinical studies have demonstrated that IMVANEX is able to boost a pre-existing immunological memory response, induced by either licensed smallpox vaccines a long time ago or two years after IMVANEX.
Danish: To kliniske studier har vist, at IMVANEX er i stand til at booste et eksisterende immunologisk hukommelsesrespons, induceret af enten tidligere godkendte koppevaccineindgivet for lang tid siden eller ved boostning to år efter IMVANEX.
English: Swirl the vial gently before use for at least 30 seconds.
Danish: Hætteglasset hvirvles forsigtigt før brug i mindst 30 sekunder.
English: IMVANEX is provided as a suspension for injection in a vial (0.5 ml).
Danish: IMVANEX leveres som en injektionsvæske, suspension i et hætteglas (0,5 ml).
English: ELISA = enzyme-linked immunosorbent assay; GMT= geometric mean titre; N = number of subjects in the specific study group; PRNT = plaque reduction neutralisation test; SCR = seroconversion rate.
Danish: ELISA = enzyme-linked immunosorbent assay, GMT= geometric mean titre (geometrisk gennemsnitstiter); N = antallet af personer i de specifikke studiegrupper; PRNT = plaque reduction neutralisation test, SCR = seroconversion rate (serokonversionsrate.
English: Package leaflet: Information for the user IMVANEX suspension for injection
Danish: Indlægsseddel: Information til brugeren IMVANEX injektionsvæske, suspension
English: A total of 433 subjects were randomized in a 1 : 1 ratio to receive either two doses of Imvanex followed by a single dose of ACAM2000 at four weeks intervals or to receive a single dose of ACAM2000.
Danish: I alt blev 433 forsøgspersoner randomiseret i forholdet 1:1 til enten at få to doser Imvanex, efterfulgt af en enkeltdosis af ACAM2000 med 4 ugers intervallet, eller at få en enkeltdosis af ACAM2000.
English: The Vaccinia-naïve study population included healthy individuals as well as individuals with HIV infection and AD who received 2 doses of IMVANEX 4 weeks apart.
Danish: Den Vaccinia-naive studiepopulation omfattede raske personer, samt personer med hiv-infektion og AD, der fik 2 doser IMVANEX med 4 ugers mellemrum.
English: Pain in extremity Arthralgia
Danish: Smerter i ekstremiteter Artralgi
English: The following general symptoms were reported more frequently in individuals with AD compared to healthy individuals: headache (33.1% vs. 24.8%), myalgia (31.8% vs. 22.3%), chills (10.7% vs. 3.8 %), nausea (11.9% vs. 6.8%), and fatigue (21.4% vs. 14.4%).
Danish: De følgende generelle symptomer blev rapporteret hyppigere hos personer med AD, sammenlignet med de raske personer: hovedpine (33,1% vs. 24,8%), myalgi (31,8% vs. 22,3%), kulderystelser (10,7% vs. 3,8%), kvalme (11,9% vs. 6,8%) og træthed (21,4% vs. 14,4%).
English: Non-human primate (NHP) studies have demonstrated that vaccination with IMVANEX induced a comparable immune response and protective efficacy to traditional smallpox vaccines used to eradicate smallpox and protected NHP from severe disease associated with a lethal challenge of monkeypox virus.
Danish: Studier med ikke-humane primater (non-human primates, NHP) har vist, at vaccination med IMVANEX inducerede et sammenligneligt immunrespons og en beskyttende virkning som traditionelle koppevacciner, der blev anvendt til at udslette kopper og beskytte NHP'er fra svær sygdom forbundet med dødelig provokation med monkeypox-virus.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with IMVANEX in all subsets of the paediatric population for prevention of smallpox infection by active immunisation against smallpox infection and disease (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med IMVANEX i alle undergrupper af den pædiatriske population til forebyggelse af koppeinfektion ved aktiv immunisering mod koppeinfektion og -sygdom (se pkt.
English: If you forget to receive IMVANEX
Danish: Hvis du har glemt at få IMVANEX
English: Hyperhidrosis Ecchymosis Night sweats Subcutaneous nodule Angioedema
Danish: Urticaria Hyperhidrose Ekkymose Nattesved Subkutan knude Angioødem
English: • swelling of the face, mouth and throat,
Danish: • hævelse af ansigt, mund og hals,
English: The protective efficacy of IMVANEX against smallpox has not been studied.
Danish: Den beskyttende virkning af IMVANEX mod kopper er ikke blevet undersøgt.
English: Seroconversion in Vaccinia-experienced individuals was defined as at least a two-fold increase in base titres following a single vaccination with IMVANEX.
Danish: Serokonversion hos Vaccinia-erfarne personer var defineret som en mindst to gange stigning i basistitre efter en enkelt vaccination med IMVANEX.
English: S+ % GMT S+ % GMT
Danish: S+ % GMT S+ % GMT S+ % GMT
English: (≥1/100 to <1/10)
Danish: (≥1/100 til <1/10)
English: Seroconversion rates in Vaccinia-naïve healthy and special populations
Danish: Serokonversionsrater hos Vaccinia-naive raske og særlige populationer
English: Swirl gently before use.
Danish: Hvirvles forsigtigt rundt før anvendelse.
English: The first co-primary endpoint compared vaccinia-specific neutralizing antibody responses at the peak visits (Day 42 after first vaccination for Imvanex where the subjects received two doses according to the standard vaccination schedule and Day 28 for ACAM2000).
Danish: Det første co-primære endepunkt sammenlignede vaccine-specifikt neutraliserende antistofrespons ved peak-besøgene (dag 42 efter første vaccination for IMVANEX, hvor personerne fik to doser i henhold til standard-vaccinationsskemaet og dag 28 for ACAM2000).
English: At day 13-15, the median maximum lesion area for subjects who were administered ACAM2000 was 75mm2 (95% CI 69.0, 85.0) and for those who received Imvanex it was 0.0 (95% CI 0.0, 2.0).
Danish: Ved dag 13-15 var det mediane maksimale læsionsområde for forsøgspersoner, der fik administreret ACAM2000 75 mm2 (95 % CI: 69,0; 85,0), og for de forsøgspersoner, der fik Imvanex var det 0,0 (95 % CI: 0,0; 2,0).
English: Appetite disorder
Danish: Appetitforstyrrelser
English: The vaccine should be allowed to reach room temperature before use.
Danish: Vaccinen skal bringes til stuetemperatur før brug.
English: IMVANEX should be avoided during breastfeeding unless it is considered that the possible benefit in terms of preventing smallpox would outweigh the potential risk.
Danish: IMVANEX bør undgås under amning, medmindre det overvejes, at den mulige fordel med hensyn til forebyggelse af kopper vil opveje den mulige risiko.
English: 1 Produced in chick embryo cells
Danish: 1 Fremstillet i celler fra kyllingeembryoer
English: 20 single dose vials.
Danish: 20 enkeltdosis-hætteglas
English: Imvanex induced a peak neutralizing antibody geometric mean titer (GMT) of 153.5 (n = 185; 95% CI 134.3, 175.6), which was noninferior to the GMT of 79.3 (n = 186; 95% CI 67.1, 93.8) obtained after scarification with ACAM2000.
Danish: Imvanex inducerede et maksimalt neutraliserende geometrisk gennemsnitligt antistoftiter (geometric mean titer, GMT) på 153,5 (n = 185, 95 % CI: 134,3; 175,6), hvilket var non-inferiort til GMT på 79,3 (n = 186, 95 % CI: 67,1; 93,8), som blev opnået efter skarifikation med ACAM2000.
English: In case of any particles and/or abnormal appearance, the vaccine should be discarded.
Danish: Hvis der er partikler, og/eller hvis suspensionen ser unormal ud, skal vaccinen bortskaffes.
English: • sinus infection,
Danish: • sinusinfektion,
English: Talk to your doctor or nurse before receiving IMVANEX:
Danish: Kontakt lægen eller sundhedspersonalet, før du får IMVANEX:
English: 2 doses of IMVANEX Licensed smallpox vaccine
Danish: 2 doser IMVANEX Godkendt koppevaccine
English: Limited data on long-term immunogenicity covering a period of 24 months following primary vaccination of Vaccinia-naïve individuals with IMVANEX are currently available as shown below:
Danish: De foreliggende begrænsede data om længevarende immunogenicitet, dækkende en periode på 24 måneder efter primær vaccination af Vaccinia-naive personer med IMVANEX er vist herunder:
English: Once the frozen vaccine has been thawed, IMVANEX is a pale milky coloured homogeneous suspension for injection.
Danish: Efter den frosne vaccine er optøet, er IMVANEX en lys, mælkefarvet, homogen injektionsvæske, suspension.
English: Do not re-freeze a vial once it has been thawed.
Danish: Et hætteglas må ikke nedfryses igen, efter det har været optøet.
English: Other medicines or vaccines and IMVANEX
Danish: Brug af anden medicin eller andre vacciner sammen med IMVANEX
English: However, it is possible that if you experience any of the side effects listed in section 4, then some of these may affect your ability to drive or use machines (e.g. dizziness).
Danish: 4, er det dog muligt, at nogle af disse kan påvirke din evne til at føre motorkøretøj eller betjene maskiner (f.eks. svimmelhed).
English: In the absence of compatibility studies, this vaccine must not be mixed with other vaccines.
Danish: Da der ikke foreligger studier over eventuelle uforligeligheder, må denne vaccine ikke blandes med andre vacciner.
English: N Day 01
Danish: N Dag 01
English: The second booster vaccination should be given no less than 28 days after the first dose.
Danish: Den anden booster-vaccination bør gives senest 28 dage efter den første dosis.
English: Prior vaccination with IMVANEX may modify the cutaneous response (‘take') to subsequently administered replication-competent smallpox vaccine resulting in a reduced or absent take.
Danish: Tidligere vaccination med IMVANEX kan modificere det kutane respons ('optagelsen') af en efterfølgende administreret replikations-kompetent koppevaccine, og føre til en nedsat eller udebleven optagelse.
English: Hejreskovvej 10 A, Kvistgård, 3490, Denmark
Danish: Hejreskovvej 10 A, Kvistgård, 3490, Danmark
English: Modified Vaccinia Ankara - Bavarian Nordic Live virus1 no less than 5 x 107 Inf.U * *infectious units
Danish: Modificeret vaccinia Ankara - Bavarian Nordic levende virus1 ikke mindre end 5 x 107 Inf.E * *infektiøse enheder
English: As a precautionary measure the use of IMVANEX should be avoided during pregnancy unless it is considered that the possible benefit in terms of preventing smallpox would outweigh the potential risk.
Danish: For en sikkerheds skyld bør IMVANEX undgås under graviditeten, medmindre det overvejes, at den mulige fordel med hensyn til forebyggelse af kopper vil opveje den mulige risiko.
English: SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE OMSTÆNDIGHEDER
English: Contents of the pack and other information What IMVANEX contains
Danish: Pakningsstørrelser og yderligere oplysninger IMVANEX indeholder:
English: (≥1/10,000 to
Danish: (≥1/10.000 til
English: What you need to know before you receive IMVANEX You must not receive IMVANEX:
Danish: Det skal du vide, før du begynder at få IMVANEX Du må ikke få IMVANEX:
English: • white blood cell count increased.
Danish: • øget antal hvide blodlegemer.
English: • swelling of the face and neck.
Danish: • hævelse af ansigt eller hals
English: The active substance is Modified Vaccinia Ankara - Bavarian Nordic Live virus1, no less than 5 x 107 Inf.U* *infectious units
Danish: Aktivt stof: modificeret vaccinia Ankara - Bavarian Nordic levende virus1 ikke mindre end 5 x 107 Inf.E* *infektiøse enheder
English: Seroconversion rates in Vaccinia-naïve individuals were defined as appearance of antibody titers equal or greater than the assay cut-off value following receipt of two doses of IMVANEX.
Danish: Serokonversionsrater hos Vaccinia-naive personer blev defineret som fremkomsten af antistoftitre, der var lig med eller større end analysens afskæringsværdi, efter de fik to doser IMVANEX.
English: • nerve disorder causing weakness, tingling or numbness,
Danish: • nerveforstyrrelser, der forårsager svaghed, prikkende fornemmelse eller følelsesløshed,