natgillin/translations-raw huggingface dataset:
Anamnese med anafylaktisk (dvs. livstruende) reaktion på et eller flere af indholdsstofferne eller sporstoffer (ægge- og kyllingeproteiner, ovalbumin, kanamycin- og neomycinsulfat, formaldehyd og cetyltrimethylammoniumbromid (CTAB)) i denne vaccine.
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)) of this vaccine.
Navn og adresse på fremstilleren ansvarlig for batchfrigivelse
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
Injektionsvæske, suspension i fyldt injektionssprøjte.
PHARMACEUTICAL FORM AND CONTENTS Suspension for injection.
Blod og lymfesystem Forbigående trombocytopeni.
Transient thrombocytopenia.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics skal anvendes i overensstemmelse med de officielle anbefalinger.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics should be used in accordance with official recommendations.
Der er desuden indberettet følgende bivirkninger fra overvågning efter markedsføring af ikkeadjuverede trivalente vacciner i alle aldersgrupper og en MF59-adjuveret trivalent sæsonvaccine, hvis sammensætning ligner Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticss (overfladeantigen, inaktiveret, adjuveret med MF59C.1), som er godkendt til brug hos ældre forsøgspersoner på 65 år eller derover.
The following additional adverse events were reported from post-marketing surveillance with seasonal non-adjuvanted trivalent vaccines in all age groups and an MF59 seasonal adjuvanted trivalent vaccine with a composition similar to Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (surface antigen, inactivated, adjuvanted with MF59C.1) that is licensed for use in elderly subjects 65 years of age and older: Blood and lymphatic system disorders
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.
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.
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
General disorders and administration site conditions Very common: injection site swelling, injection site pain, injection site induration, injection site redness, fatigue
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.
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.
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).
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).
Bivirkningerne nedenfor er opstået under kliniske studier med Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics hos voksne, inklusive ældre:
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:
Seroprotektionsrate*, serokonverteringsrate* og serokonverteringsfaktor** for anti-HA antistof mod H5N1 A/Vietnam/1194/2004 målt ved SRH- assays var som følger:
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:
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
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.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics can cause side effects, although not everybody gets them.
Brug ikke Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics efter den udløbsdato, der står på pakningen.
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.
INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.5 ml
Seroprotektionsrate*, serokonverteringsrate* og serokonverteringsfaktor** for anti-HA antistof mod H5N1 A/Vietnam/1194/2004 hos de voksne målt ved SRH-assay var som følger:
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:
Serokonverterings faktor (95 % CI)°° * målt ved SRH-assay ≥ 25 mm ** geometriske middelratioer af SRH ° målt ved HI assay ≥ 40 °° geometriske middelratioer af HI
** geometric mean ratios of SRH ° measured by HI assay ≥ 40 °° geometric mean ratios of HI
Hud og subkutane væv Almindelig: svedsekretion
Skin and subcutaneous tissue disorders Common: sweating Uncommon: urticaria Rare: eye swelling
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics injektionsvæske, suspension i fyldt injektionssprøjte Præpandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret)
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)
Forekomsten af bivirkninger, der blev indberettet efter de enkelte vaccinationsdoser (dvs. 1., 2. eller booster-), var sammenlignelig og er anført efter frekvens som følger:
st nd or booster) were similar and are listed according to the following frequency:
A/Vietnam/1194/2004 (H5N1)-lignende stamme (NIBRG-14) 7,5 mikrogram** pr. 0,5 ml dosis
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.
A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Indehaver af markedsføringstilladelsen og fremstiller Novartis Vaccines and Diagnostics S.r.l.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Novartis Vaccines & Diagnostics S.r.l.
UDLØBSDATO
RELEASE
Mave-tarmlidelser såsom kvalme, opkastning, mavesmerter og diare.
Disorders of the gut such as nausea, vomiting, abdominal pain and diarrhoea.
• 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.
• 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,
Disse bivirkninger kan forekomme med Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
These side effects may occur with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
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.
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
Hævede lymfekirtler, hjertebanken, svaghed, smerte i arme/ben og hoste.
Swollen lymph nodes, palpitations, weakness, pain in the extremities and cough.
Vigtig information om nogle af de øvrige indholdsstoffer i Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Important information about some of the ingredients of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Studie V87P2 Voksne booster efter 2. dosis
Study V87P2 Adults booster after 2rd dose
Der foreligger ingen post-marketing overvågningsdata efter administration af Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
No post-marketing surveillance data are available following Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics administration.
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.
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.
Indsendelse af periodiske sikkerhedsopdateringsrapporter (PSURs), når Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics anvendes under en influenzapandemi:
PSUR submission when Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is used during an influenza pandemic:
Du bør ikke få Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics:
You should not receive Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics:
Præpandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret).
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted).
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)).
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)).
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.
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.
Serokonverteringsfaktor (95 % CI)** * målt ved SRH-assay ≥ 25 mm ** geometriske middelratioer af SRH
* measured by SRH assay ≥ 25 mm2 ** geometric mean ratios of SRH
Vær ekstra forsigtig med at bruge PREPANDEMIC INFLUENZA VACCINE (H5N1) (SURFACE ANTIGEN, INACTIVATED, ADJUVANTED) NOVARTIS VACCINES AND DIAGNOSTICS:
Take special care with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics:
Der er ingen data vedrørende samtidig administration af Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics og andre vacciner.
There are no data on co-administration of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics with other vaccines.
Præpandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret)
Prepandemic Influenza vaccine (H5N1) (surface antigen, inativated, adjuvanted)
Børn (3-<9 år)
Toddlers (6-<36 months) Children (3-<9 years) Adolescents (9-<18 years) N=91
Mave-tarm-kanalen Mave-tarmlidelser såsom kvalme, opkastning, mavesmerter og diare.
Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Der foreligger ingen data vedrørende brug af Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics under amning.
There are no data regarding the use of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics during breast-feeding.
Bivirkninger fra lægemiddelstudier hos børn (6 måneder til 17 år) Der er udført et lægemiddelstudier med samme vaccine hos børn.
Side effects from clinical study in children (6 months to 17 years of age)
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:
Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2
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.
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14)
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics injektionsvæske, suspension i fyldt injektionssprøjte.
NAME OF THE MEDICINAL PRODUCT Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics suspension for injection in pre-filled syringe.
Lægemidlets beskyttende virkning blev evalueret i frittemodellen gennem challenge med (eksponering af dyrene for) vira, der er homologe og heterologe med virusstammer.
Efficacy against challenge with virus homologous and heterologous to vaccine strains was evaluated in the ferret model.
7,5 mikrogram hæmagglutinin
7.5 micrograms** per 0.5 ml dose
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics indeholder
What Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics contains
Indgivelsesmåde
DIAGNOSTICS
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics er en injektionsvæske, suspension i fyldt injektionssprøjte.
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.
DET SKAL DU VIDE, FØR DU FÅR PREPANDEMIC INFLUENZA VACCINE (H5N1) (SURFACE ANTIGEN, INACTIVATED, ADJUVANTED) NOVARTIS VACCINES AND DIAGNOSTICS
Before you receive Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
SÅDAN FÅR DU PREPANDEMIC INFLUENZA VACCINE (H5N1) (SURFACE ANTIGEN, INACTIVATED, ADJUVANTED) NOVARTIS VACCINES AND DIAGNOSTICS
How to store Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
ETIKET TIL INJEKTIONSSPRØJTE
Gastrointestinal disorders
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E)
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Prepandemic Influenza vaccine (H5N1)
Eurartesim tages én gang dagligt i tre på hinanden følgende dage, på samme tidspunkt hver dag.
Eurartesim is taken once a day for three consecutive days, at the same time each day.
Det fås som tabletter (160 mg/20 mg; 320 mg/40 mg).
It is available as tablets (160 mg/20 mg; 320 mg/40 mg).
Det kan anvendes til voksne og børn på 6 måneder og derover, der vejer mindst 5 kg.
It can be used in adults and children aged 6 months and over and weighing 5 kg or more.
"Ukompliceret" betyder, at sygdommen ikke omfatter alvorlige, livstruende symptomer.
‘Uncomplicated' means the disease does not involve severe, life-threatening symptoms.
Tabletterne kan knuses og blandes med vand, hvis der er behov for det.
The tablets may be crushed and mixed with water if needed.
Dosis afhænger af patientens legemsvægt.
The dose is determined by the patient's body weight.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Eurartesim den 27. oktober 2011.
The European Commission granted a marketing authorisation valid throughout the European Union for Eurartesim on 27 October 2011.
Den fuldstændige EPAR for Eurartesim findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Eurartesim can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Det menes at virke ved at blokere et trin i parasittens metabolisme, der er nødvendigt for dens overlevelse.
It is thought to work by blocking a step in the parasite's metabolism needed for its survival.
Det er kemisk beslægtet med andre bredt tilgængelige lægemidler til behandling af malaria.
It is chemically related to other widely available medicines used to treat malaria.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Eurartesim.
This is a summary of the European public assessment report (EPAR) for Eurartesim.
CHMP bemærkede den potentielle risiko for forlænget QTc-interval og medtog begrænsninger i produktinformationen for at minimere risikoen for patienterne.
The CHMP noted the potential risk for QTc interval prolongation, and included restrictions in the product information to minimise the risk to patients.
Virksomheden vil også gennemføre en undersøgelse af Eurartesims indvirkning på hjertet.
The company will also complete a study on Eurartesim's effects on the heart.
Andre oplysninger om Eurartesim
Other information about Eurartesim
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.
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.
Artenimol er et derivat af det naturligt forekommende stof artemisinin.
Artenimol is a derivative of the naturally occurring substance artemisinin.
Tabletterne synkes med vand på tom mave mindst tre timer før eller efter et måltid.
The tablets are swallowed with water when the stomach is empty, at least three hours before or after a meal.
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.
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.
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.
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.
Eurartesim må ikke anvendes hos patienter med alvorlig malaria.
Eurartesim must not be used in patients with severe malaria.
De nærmere oplysninger om behandling med Eurartesim fremgår af indlægssedlen (også en del af EPAR), eller du kan kontakte din læge eller dit apotek.
For more information about treatment with Eurartesim, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Pakningen med Eurartesim skal indeholde anvisninger om, at lægemidlet skal tages mindst 3 timer før eller efter et måltid.
The Eurartesim carton is to include instructions to take the medicine at least 3 hours before or after food.
Malaria er en infektion, der forårsages af en parasit kaldet Plasmodium og spredes via stik fra en inficeret myg.
Malaria is an infection caused by a parasite known as Plasmodium and spread through the bite of an infected mosquito.
Selv om det ikke vides med nøjagtighed, hvordan det dræber parasitten, menes det, at det ødelægger parasittens membran.
Although the exact way in which it kills the parasite is not fully understood, it is believed to damage the parasite membrane.
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.
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.