FrancophonIA/ELRC3.0 huggingface dataset:
English: Limited data was obtained from women who became pregnant during the course of clinical trials with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics or H1N1v vaccines adjuvanted with MF59C.1.
Danish: Der er opnået begrænsede data fra kvinder, der blev gravide under kliniske studier med Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (H5N1) og eller H1N1v-vacciner adjuveret med MF59C.1.
English: General disorders and administration site conditions Very common: injection site swelling, injection site pain, injection site induration, injection site redness, fatigue
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig: hævelse, smerte, induration og/eller rødme på injektionsstedet, træthed Almindelig: ekkymose på injektionsstedet, feber, utilpashed, kulderystelser Ikke almindelig: influenzalignende sygdom
English: Data obtained in adults showed that Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics can be given at the same time as nonadjuvanted seasonal influenza vaccines, with injections made into separate limbs.
Danish: Resultater fra studier med voksne viste, at Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics kan gives samtidig med ikke-adjuveret sæsoninfluenzavaccine, hvis indsprøjtningerne gives i to forskellige lemmer.
English: Therefore the data indicate that Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics may be co-administered with non-adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).
Danish: Data indikerer derfor, at Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics kan administreres samtidig med ikke-adjuverede sæsoninfluenzavacciner (ved injektion i modsatte ekstremiteter).
English: The side effects listed below have occurred with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics in clinical studies in adults, including the elderly:
Danish: Bivirkningerne nedenfor er opstået under kliniske studier med Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics hos voksne, inklusive ældre:
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 measured by SRH assays were as follows:
Danish: Seroprotektionsrate*, serokonverteringsrate* og serokonverteringsfaktor** for anti-HA antistof mod H5N1 A/Vietnam/1194/2004 målt ved SRH- assays var som følger:
English: The safety and efficacy of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics in subjects under 18 years of age have not yet been established.
Danish: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Like all medicines, Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics can cause side effects, although not everybody gets them.
Danish: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Do not use Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics after the expiry date which is stated on the carton and the label.
Danish: Brug ikke Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics efter den udløbsdato, der står på pakningen.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.5 ml
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 in the adults measured by SRH assay was as follows:
Danish: Seroprotektionsrate*, serokonverteringsrate* og serokonverteringsfaktor** for anti-HA antistof mod H5N1 A/Vietnam/1194/2004 hos de voksne målt ved SRH-assay var som følger:
English: ** geometric mean ratios of SRH ° measured by HI assay ≥ 40 °° geometric mean ratios of HI
Danish: Serokonverterings faktor (95 % CI)°° * målt ved SRH-assay ≥ 25 mm ** geometriske middelratioer af SRH ° målt ved HI assay ≥ 40 °° geometriske middelratioer af HI
English: Skin and subcutaneous tissue disorders Common: sweating Uncommon: urticaria Rare: eye swelling
Danish: Hud og subkutane væv Almindelig: svedsekretion
English: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics suspension for injection in pre-filled syringe Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Danish: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics injektionsvæske, suspension i fyldt injektionssprøjte Præpandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret)
English: st nd or booster) were similar and are listed according to the following frequency:
Danish: Forekomsten af bivirkninger, der blev indberettet efter de enkelte vaccinationsdoser (dvs. 1., 2. eller booster-), var sammenlignelig og er anført efter frekvens som følger:
English: A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14) 7.5 micrograms haemagglutinin Adjuvant: MF59C.1 oil composed of squalene, polysorbate 80 and sorbitan trioleate.
Danish: A/Vietnam/1194/2004 (H5N1)-lignende stamme (NIBRG-14) 7,5 mikrogram** pr. 0,5 ml dosis
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Novartis Vaccines & Diagnostics S.r.l.
Danish: Indehaver af markedsføringstilladelsen og fremstiller Novartis Vaccines and Diagnostics S.r.l.
English: RELEASE
Danish: UDLØBSDATO
English: Disorders of the gut such as nausea, vomiting, abdominal pain and diarrhoea.
Danish: Mave-tarmlidelser såsom kvalme, opkastning, mavesmerter og diare.
English: • if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to egg and, chicken protein, ovalbumin, formaldehyde,
Danish: • hvis du har haft en allergisk reaktion, som ikke er en pludselig, livstruende allergisk reaktion, over for en af de ingredienser, der findes i vaccinen, ægge- og kyllingeprotein, ovalbumin, formaldehyd, kanamycin og neomycinsulphat (antibiotika) eller cetyltrimethylammoniumbromid (CTAB) (se pkt.
English: These side effects may occur with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Danish: Disse bivirkninger kan forekomme med Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
English: In a clinical trial evaluating 4 different vaccination schedules in 240 subjects 18 to 60 years of age, where the second dose was after either 1, 2, 3 or 6 weeks after the first Prepandemic Influenza vaccine
Danish: I et klinisk studie, hvor 4 forskellige vaccinationsprogrammer blev evalueret hos 240 forsøgspersoner i alderen 18 til 60 år, og hvor den anden dosis blev givet enten 1, 2, 3 eller 6 uger efter den første Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics dosis, blev CHMP-kriterier for SRH opfyldt i alle vaccinationsprogramgrupper fra 3 uger efter den 2. vaccination.
English: Swollen lymph nodes, palpitations, weakness, pain in the extremities and cough.
Danish: Hævede lymfekirtler, hjertebanken, svaghed, smerte i arme/ben og hoste.
English: Important information about some of the ingredients of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
English: Study V87P2 Adults booster after 2rd dose
Danish: Studie V87P2 Voksne booster efter 2. dosis
English: No post-marketing surveillance data are available following Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics administration.
Danish: Der foreligger ingen post-marketing overvågningsdata efter administration af Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
English: Persistence of antibodies after primary vaccination in this population as assessed by HI, SRH, and MN tests reduced from 1/2 to 1/5th of their post-vaccination level at day 202 as compared to day 43 after completion of primary schedules as assessed by HI, SRH, and MN tests.
Danish: Persistens af antistoffer efter primær vaccination målt ved HI-, SRH- og MN-test var hos denne population reduceret til 1/2 til 1/5 i forhold til post-vaccinationsniveauet ved dag 202 sammenlignet med dag 43 efter gennemførelse af de primære vaccinationsprogrammer vurderet ved HI-, SRH- og MN-test. Op til 50 % af de ældre forsøgspersoner, der blev immuniseret med Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, udviste seroprotektion ved 6 måneder.
English: PSUR submission when Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is used during an influenza pandemic:
Danish: Indsendelse af periodiske sikkerhedsopdateringsrapporter (PSURs), når Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics anvendes under en influenzapandemi:
English: You should not receive Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics:
Danish: Du bør ikke få Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics:
English: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted).
Danish: Præpandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret).
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients and to residues (eggs and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)).
Danish: 4.3 vedrørende en anafylaktisk reaktion) over for det aktive stof, et eller flere af hjælpestofferne eller over for sporrester (ægge- og kyllingeprotein, ovalbumin, kanamycin og neomycinsulfat, formaldehyd og cetyltrimethylammoniumbromid (CTAB)).
English: Limited data was obtained from women who became pregnant with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics during the course of clinical trials.
Danish: Der er opnået begrænsede data fra kvinder, der blev gravide under kliniske studier med Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
English: * measured by SRH assay ≥ 25 mm2 ** geometric mean ratios of SRH
Danish: Serokonverteringsfaktor (95 % CI)** * målt ved SRH-assay ≥ 25 mm ** geometriske middelratioer af SRH
English: Take special care with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics:
Danish: Vær ekstra forsigtig med at bruge PREPANDEMIC INFLUENZA VACCINE (H5N1) (SURFACE ANTIGEN, INACTIVATED, ADJUVANTED) NOVARTIS VACCINES AND DIAGNOSTICS:
English: There are no data on co-administration of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics with other vaccines.
Danish: Der er ingen data vedrørende samtidig administration af Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics og andre vacciner.
English: Prepandemic Influenza vaccine (H5N1) (surface antigen, inativated, adjuvanted)
Danish: Præpandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret)
English: Toddlers (6-<36 months) Children (3-<9 years) Adolescents (9-<18 years) N=91
Danish: Børn (3-<9 år)
English: Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Danish: Mave-tarm-kanalen Mave-tarmlidelser såsom kvalme, opkastning, mavesmerter og diare.
English: There are no data regarding the use of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics during breast-feeding.
Danish: Der foreligger ingen data vedrørende brug af Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics under amning.
English: Side effects from clinical study in children (6 months to 17 years of age)
Danish: Bivirkninger fra lægemiddelstudier hos børn (6 måneder til 17 år) Der er udført et lægemiddelstudier med samme vaccine hos børn.
English: Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2
Danish: Seroprotektionsrate*, serokonverteringsrate* og serokonverteringsfaktor** for anti-HA antistoffer mod H5N1 A/turkey/Turkey/05 efter den 2. dosis hos voksne på 18-60 år målt ved SRH-assay og HIassay var som følger:
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14)
Danish: Influenzavirus-overfladeantigener (hæmagglutinin og neuraminidase)* fra stammen: A/Vietnam/1194/2004 (H5N1)-lignende stamme (NIBRG-14) 7,5 mikrogram** pr. 0,5 ml dosis * dyrket i æg ** udtrykt som mikrogram hæmagglutinin.
English: NAME OF THE MEDICINAL PRODUCT Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics suspension for injection in pre-filled syringe.
Danish: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics injektionsvæske, suspension i fyldt injektionssprøjte.
English: Efficacy against challenge with virus homologous and heterologous to vaccine strains was evaluated in the ferret model.
Danish: Lægemidlets beskyttende virkning blev evalueret i frittemodellen gennem challenge med (eksponering af dyrene for) vira, der er homologe og heterologe med virusstammer.
English: 7.5 micrograms** per 0.5 ml dose
Danish: 7,5 mikrogram hæmagglutinin
English: What Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics contains
Danish: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics indeholder
English: DIAGNOSTICS
Danish: Indgivelsesmåde
English: What Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics looks like and contents of the pack Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a suspension for injection in a pre-filled syringe.
Danish: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics er en injektionsvæske, suspension i fyldt injektionssprøjte.
English: Before you receive Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Danish: DET SKAL DU VIDE, FØR DU FÅR PREPANDEMIC INFLUENZA VACCINE (H5N1) (SURFACE ANTIGEN, INACTIVATED, ADJUVANTED) NOVARTIS VACCINES AND DIAGNOSTICS
English: How to store Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Danish: SÅDAN FÅR DU PREPANDEMIC INFLUENZA VACCINE (H5N1) (SURFACE ANTIGEN, INACTIVATED, ADJUVANTED) NOVARTIS VACCINES AND DIAGNOSTICS
English: Gastrointestinal disorders
Danish: ETIKET TIL INJEKTIONSSPRØJTE
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Prepandemic Influenza vaccine (H5N1)
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E)
English: Eurartesim is taken once a day for three consecutive days, at the same time each day.
Danish: Eurartesim tages én gang dagligt i tre på hinanden følgende dage, på samme tidspunkt hver dag.
English: It is available as tablets (160 mg/20 mg; 320 mg/40 mg).
Danish: Det fås som tabletter (160 mg/20 mg; 320 mg/40 mg).
English: It can be used in adults and children aged 6 months and over and weighing 5 kg or more.
Danish: Det kan anvendes til voksne og børn på 6 måneder og derover, der vejer mindst 5 kg.
English: ‘Uncomplicated' means the disease does not involve severe, life-threatening symptoms.
Danish: "Ukompliceret" betyder, at sygdommen ikke omfatter alvorlige, livstruende symptomer.
English: The tablets may be crushed and mixed with water if needed.
Danish: Tabletterne kan knuses og blandes med vand, hvis der er behov for det.
English: The dose is determined by the patient's body weight.
Danish: Dosis afhænger af patientens legemsvægt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Eurartesim on 27 October 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Eurartesim den 27. oktober 2011.
English: The full EPAR for Eurartesim can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Eurartesim findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is thought to work by blocking a step in the parasite's metabolism needed for its survival.
Danish: Det menes at virke ved at blokere et trin i parasittens metabolisme, der er nødvendigt for dens overlevelse.
English: It is chemically related to other widely available medicines used to treat malaria.
Danish: Det er kemisk beslægtet med andre bredt tilgængelige lægemidler til behandling af malaria.
English: This is a summary of the European public assessment report (EPAR) for Eurartesim.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Eurartesim.
English: The CHMP noted the potential risk for QTc interval prolongation, and included restrictions in the product information to minimise the risk to patients.
Danish: CHMP bemærkede den potentielle risiko for forlænget QTc-interval og medtog begrænsninger i produktinformationen for at minimere risikoen for patienterne.
English: The company will also complete a study on Eurartesim's effects on the heart.
Danish: Virksomheden vil også gennemføre en undersøgelse af Eurartesims indvirkning på hjertet.
English: Other information about Eurartesim
Danish: Andre oplysninger om Eurartesim
English: The company that markets Eurartesim will provide all doctors expected to prescribe or use Eurartesim with an educational pack containing important information on the correct use of the medicine, including a checklist of the medicines that Eurartesim must not be given with, to reduce the risk of QTc interval prolongation.
Danish: Den virksomhed, der markedsfører Eurartesim, vil give alle læger, som forventes at ordinere eller anvende Eurartesim, undervisningsmateriale indeholdende vigtig information om den korrekte brug af lægemidlet, herunder en tjekliste med lægemidler, som Eurartesim ikke må gives sammen med, for at reducere risikoen for forlænget QTc-interval.
English: Artenimol is a derivative of the naturally occurring substance artemisinin.
Danish: Artenimol er et derivat af det naturligt forekommende stof artemisinin.
English: The tablets are swallowed with water when the stomach is empty, at least three hours before or after a meal.
Danish: Tabletterne synkes med vand på tom mave mindst tre timer før eller efter et måltid.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Eurartesim.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Eurartesim skal anvendes.
English: It must not be used in patients who have or are at risk of QTc interval prolongation or cardiac arrhythmias (unstable heart rhythm) or who are taking medicines that can affect heart rhythm.
Danish: Det må ikke anvendes hos patienter, der har eller har risiko for at få forlænget QTc-interval eller hjertearytmi (ustabil hjerterytme), eller som indtager lægemidler, der kan påvirke hjerterytmen.
English: Eurartesim must not be used in patients with severe malaria.
Danish: Eurartesim må ikke anvendes hos patienter med alvorlig malaria.
English: For more information about treatment with Eurartesim, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: De nærmere oplysninger om behandling med Eurartesim fremgår af indlægssedlen (også en del af EPAR), eller du kan kontakte din læge eller dit apotek.
English: The Eurartesim carton is to include instructions to take the medicine at least 3 hours before or after food.
Danish: Pakningen med Eurartesim skal indeholde anvisninger om, at lægemidlet skal tages mindst 3 timer før eller efter et måltid.
English: Malaria is an infection caused by a parasite known as Plasmodium and spread through the bite of an infected mosquito.
Danish: Malaria er en infektion, der forårsages af en parasit kaldet Plasmodium og spredes via stik fra en inficeret myg.
English: Although the exact way in which it kills the parasite is not fully understood, it is believed to damage the parasite membrane.
Danish: Selv om det ikke vides med nøjagtighed, hvordan det dræber parasitten, menes det, at det ødelægger parasittens membran.
English: In adults, the most common side effects with Eurartesim (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), headache, QTc interval prolongation (an alteration of the electrical activity of the heart, which can cause a life-threatening abnormality of heart rhythm), tachycardia (rapid heartbeat), weakness, and fever.
Danish: Hos voksne er de hyppigst forekommende bivirkninger ved Eurartesim (set hos mellem 1 og 10 patienter ud af 100) anæmi (lavt antal røde blodlegemer), hovedpine, forlænget QTc-interval (en ændring i den elektriske aktivitet i hjertet, som kan forårsage en livstruende abnormalitet i hjerterytme), takykardi (hurtig puls), svaghed og feber.
English: Therefore, the Committee concluded that the benefits of Eurartesim outweigh its risks and recommended that it be granted marketing authorisation.
Danish: Udvalget konkluderede derfor, at fordelene ved Eurartesim opvejer risiciene, og udvalget anbefalede udstedelse af markedsføringstilladelse for Eurartesim.
English: In children, the most common side effects with Eurartesim (seen in more than 1 patient in 10) were influenza (flu), cough and fever.
Danish: Hos børn var de hyppigste bivirkninger ved Eurartesim (set hos flere end 1 ud af 10 patienter) influenza, hoste og feber.
English: Eurartesim piperaquine tetraphosphate / artenimol
Danish: Eurartesim piperaquintetrafosfat/artenimol