FrancophonIA/ELRC3.0 huggingface dataset:
English: PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe.
Slovenian: suspenzija za injiciranje v napolnjeni injekcijski brizgi mlečno-bela tekočina
English: This section describes the clinical experience with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics following a two-dose administration and booster.
Slovenian: To poglavje opisuje klinične izkušnje s cepivom Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics po dajanju dveh odmerkov in obnovitvenega odmerka.
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:
Slovenian: Stopnja serozaščite*, deleţ serokonverzije* in faktor serokonverzije** za protitelo proti HA na H5N1 A/Vietnam/1194/2004 pri odraslih, izmerjeno s testom SRH, so bili kot sledi:
English: Intramuscular use
Slovenian: NAVODILO ZA UPORABO
English: Read all of this leaflet carefully before you start receive this vaccine.
Slovenian: Preden se cepite, natančno preberite navodilo!
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.
Slovenian: Podatki, pridobljeni pri odraslih, kaţejo, da se lahko cepivo Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics daje sočasno s sezonskimi cepivi proti gripi, ki ne vsebujejo adjuvansa, pri čemer se cepivi dajeta vsaka v svojo okončino.
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)
Slovenian: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics suspenzija za injiciranje v napolnjeni injekcijski brizgi prepandemsko cepivo proti gripi (H5N1) (s površinskimi antigeni, inaktivirano, z adjuvansom)
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.
Slovenian: Obstajajo omejeni podatki pri ţenskah, ki so v teku kliničnih preskušanj s cepivoma Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (H5N1) ali H1N1v z adjuvansom MF59C.1 zanosile.
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
Slovenian: V kliničnem preskušanju, v katerem so ocenili 4 različne reţime cepljenja pri 240 osebah, starih 18 do 60 let, kjer je drugi odmerek sledil bodisi 1, 2, 3 ali 6 tednov po prvem odmerku cepiva Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, so bili kriteriji SRH po CHMP doseţeni za vse reţime cepljenja po 3. tednih po 2. cepljenju.
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.
Slovenian: Izgled cepiva Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics in vsebina pakiranja Cepivo Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics je suspenzija za injiciranje v napolnjeni injekcijski brizgi.
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.
Slovenian: Kot vsa cepiva ima lahko tudi cepivo Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics neţelene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: A clinical trial (Study V87P1) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 312 healthy adults.
Slovenian: Pri 312 zdravih odraslih so izvedli klinično preskušanje (študija V87P1) s kombinacijo cepiva H5N1 in adjuvansa MF59C.1.
English: Two doses of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics were administered three weeks apart and a third dose 12 months following the first dose.
Slovenian: V časovnem presledku treh tednov so dali dva odmerka cepiva Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics in tretji odmerek 12 mesecev po prvem odmerku.
English: General disorders and administration site conditions Very common: injection site swelling, injection site pain, injection site induration, injection site redness, fatigue
Slovenian: Splošne teţave in spremembe na mestu aplikacije Zelo pogosti: oteklina na mestu injiciranja, bolečina na mestu injiciranja, zatrdlina na mestu injiciranja, rdečina na mestu injiciranja, utrujenost Pogosti: ekhimoza na mesto injiciranja, zvišana telesna temperatura, slabo počutje, tresavica Občasni: gripi podobna bolezen
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).
Slovenian: Zato podatki kaţejo, da se lahko cepivo Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics daje sočasno s sezonskimi cepivi proti gripi brez adjuvansa (vendar je treba cepivi injicirati v različni okončini).
English: These side effects may occur with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Slovenian: Ti neţeleni učinki se lahko pojavijo s cepivom Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
English: Study V87P13 21 days after 2nd dose N=66
Slovenian: Študija V87P13 21. dni po 2. odmerku n = 66
English: Study V87P13 21 days after 2nd dose N=143
Slovenian: Study V87P13 21. dni po 2. odmerku n = 143
English: Side effects from clinical study in children (6 months to 17 years of age)
Slovenian: Neţeleni učinki v kliničnih preskušanjih z otroki (6 mesecev do 17 let starosti) Pri otrocih so opravili klinično preskušanje z enakim cepivom.
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.
Slovenian: V primerjavi z ravnmi protiteles, pridobljenimi 43. dan po zaključku primarnega reţima cepljenja, so bile ravni protiteles 202. dan zmanjšane za 1/5 do 1/2 glede na predhodne ravni, izmerjene s testi HI, SRH in MN. Do 50 % starejših oseb, imuniziranih s cepivom Prepandemic Influenza vaccine (H5N1)
English: Disorders of the gut such as nausea, vomiting, abdominal pain and diarrhoea.
Slovenian: Črevesne motnje kot so navzea, bruhanje, bolečine v trebuhu in diareja.
English: Water for injections.
Slovenian: suspenzija za injiciranje
English: MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serije
English: Study V87P2 Adults booster after 2rd dose
Slovenian: Študija V87P2 odrasli obnovitev po 2. odmerku
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.
Slovenian: Cepiva Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in ovojnini.
English: Two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HA/dose adjuvanted) were administered three weeks apart to 156 healthy adults.
Slovenian: V 3-tedenskem presledku so 156 zdravih odraslih oseb cepili s cepivom, ki je vsebovalo H5N1 (A/Vietnam/1194/2004; 7,5 µg HA/odmerek z adjuvansom).
English: Important information about some of the ingredients of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Slovenian: Pomembne informacije o nekaterih sestavinah cepiva Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
English: Take special care with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics:
Slovenian: Bodite posebno pozorni pri uporabi cepiva Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics:
English: PSUR submission when Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is used during an influenza pandemic:
Slovenian: Predloţitev PSUR za cepivo Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics med pandemijo gripe:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.5 ml
Slovenian: VSEBINA, IZRAŢENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
English: Post-marketing surveillance
Slovenian: Spremljanje v obdobju trţenja
English: Marketing Authorisation Holder Novartis Vaccines and Diagnostics S.r.l.
Slovenian: Imetnik dovoljenja za promet z zdravilom Novartis Vaccines and Diagnostics S.r.l.
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:
Slovenian: Neţeleni učinki, opisani v nadaljevanju, so se pojavili po cepljenju odraslih oseb in starostnikov s cepivom Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics v kliničnih študijah:
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,
Slovenian: • če ste imeli kakršnakoli alergijsko reakcijo, ki ni bila nenadna, ţivljenje ogroţajoča, na katerokoli sestavino cepiva, na jajčne in piščančje beljakovine, na ovalbumin, formaldehid, kanamicinsulfat in neomicinsulfat (antibiotika) ali cetiltrimetilamonijev bromide (CTAB) (glejte poglavje 6, Dodatne informacije).
English: ** geometric mean ratios of SRH ° measured by HI assay ≥ 40 °° geometric mean ratios of HI
Slovenian: Faktor serokonverzije (95-odstotni IZ)** * izmerjeno s testom SRH ≥ 25 mm ** razmerja geometričnih srednjih vrednosti za SRH ° izmerjeno s testom HI ≥ 40 °° razmerja geometričnih srednjih vrednosti za HI
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.
Slovenian: Sev* virusa influence s površinskimi antigeni (hemaglutinin in nevraminidaza): sevu A/Vietnam/1194/2004 (H5N1) podobnega seva (NIBRG-14) 7,5 mikrogramov** na 0,5 ml odmerek * razmnoţen v jajcih ** izraţeno v mikrogramih hemaglutinina
English: st nd or booster) were similar and are listed according to the following frequency:
Slovenian: Stopnje neţelenih učinkov, o katerih so poročali po kateremkoli odmerku cepljenja (tj. 1., 2. ali obnovitvenem) so bile podobne in so naštete v skladu z naslednjo pogostnostjo:
English: There are no data on co-administration of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics with other vaccines.
Slovenian: Podatkov o sočasni uporabi cepiva Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics z drugimi cepivi ni.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR SYRINGE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2
Slovenian: Stopnja serozaščite*, stopnja serokonverzije* in factor serokonverzije** za protitelesa proti HA na sev H5N1 A/turkey/Turkey/05 po 2. odmerku pri odraslih, starih od 18 do 60 let, izmerjeno s testoma SRH in HI, so bili kot sledi:
English: What Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is and what it is used for 2.
Slovenian: KAJ JE CEPIVO PREPANDEMIC INFLUENZA VACCINE (H5N1) (SURFACE ANTIGEN, INACTIVATED, ADJUVANTED) NOVARTIS VACCINES AND DIAGNOSTICS IN ZA KAJ GA UPORABLJAMO
English: Possible side effects
Slovenian: MOŢNI NEŢELENI UČINKI
English: inactivated, adjuvanted) Novartis Vaccines and Diagnostics may be administered but a protective immune response may not be elicited.
Slovenian: • v prisotnosti imunske pomanjkljivosti se cepivo Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics lahko daje, vendar ni nujno, da bo doseţen zaščitni imunski odziv.
English: How Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is given
Slovenian: KAKO SE DAJE CEPIVO PREPANDEMIC INFLUENZA VACCINE (H5N1) (SURFACE ANTIGEN, INACTIVATED, ADJUVANTED) NOVARTIS VACCINES AND DIAGNOSTICS
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni krvi in limfatičnega sistema Prehodna trombocitopenija
English: Study V87P3 21 days after 2
Slovenian: Študija V87P3 21. dni po 2. odmerku n = 30
English: General disorders and administration site conditions Asthenia.
Slovenian: Splošne teţave in spremembe na mestu aplikacije atenija
English: (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics dose, SRH CHMP criteria were achieved in all the vaccine schedule groups after 3 weeks from the 2nd vaccination.
Slovenian: (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, je bilo v šestem mesecu serozaščitenih.
English: nd dose
Slovenian: IME ZDRAVILA
English: Rare: Convulsions, eye swelling and anaphylaxis.
Slovenian: Krči, oteklost oči in anafilaksa
English: Systemic
Slovenian: GMR
English: What Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics contains
Slovenian: Kaj vsebuje cepivo Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
English: It is available as tablets (160 mg/20 mg; 320 mg/40 mg).
Slovenian: Na voljo je v obliki tablet (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.
Slovenian: Uporablja se lahko pri odraslih in otrocih, starejših od šest mesecev, ki tehtajo 5 kg ali več.
English: The tablets may be crushed and mixed with water if needed.
Slovenian: Tablete se lahko po potrebi zdrobijo in zmešajo z vodo.
English: Eurartesim is taken once a day for three consecutive days, at the same time each day.
Slovenian: Zdravilo Eurartesim se jemlje enkrat na dan tri zaporedne dni ob isti uri.
English: ‘Uncomplicated' means the disease does not involve severe, life-threatening symptoms.
Slovenian: „Nezapletena“ pomeni, da se pri bolezni ne pojavljajo hudi, življenjsko nevarni simptomi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Eurartesim on 27 October 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Eurartesim, veljavno po vsej Evropski uniji, izdala 27. oktobra 2011.
English: The dose is determined by the patient's body weight.
Slovenian: Odmerek je odvisen od bolnikove telesne mase.
English: It is chemically related to other widely available medicines used to treat malaria.
Slovenian: Kemično je povezan z drugimi široko dostopnimi zdravili za zdravljenje malarije.
English: The company will also complete a study on Eurartesim's effects on the heart.
Slovenian: Družba bo tudi izvedla študijo o učinkih zdravila Eurartesim na srce.
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.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Eurartesim je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The tablets are swallowed with water when the stomach is empty, at least three hours before or after a meal.
Slovenian: Tablete je treba pogoltniti z vodo na prazen želodec vsaj tri ure pred ali po obroku.
English: Other information about Eurartesim
Slovenian: Druge informacije o zdravilu Eurartesim
English: This is a summary of the European public assessment report (EPAR) for Eurartesim.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Eurartesim.
English: For more information about treatment with Eurartesim, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Eurartesim preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
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.
Slovenian: Družba, ki trži zdravilo Eurartesim, bo vsem zdravnikom, za katere se pričakuje, da bodo predpisovali ali uporabljali zdravilo Eurartesim, posredovala izobraževalno gradivo s pomembnimi informacijami o pravilni uporabi zdravila, vključno s seznamom zdravil, s katerimi se zdravilo Eurartesim ne sme dajati, da se zmanjša tveganje za podaljšanje intervala QTc.
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.
Slovenian: Ne smejo ga uporabljati bolniki, ki imajo ali pri katerih obstaja tveganje za podaljšanje intervala QTc ali srčne aritmije (nestabilnega srčnega ritma) in tisti, ki jemljejo zdravila, ki lahko vplivajo na srčni ritem.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eurartesim have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Eurartesim upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: The CHMP noted the potential risk for QTc interval prolongation, and included restrictions in the product information to minimise the risk to patients.
Slovenian: CHMP je upošteval možno tveganje za podaljšanje intervala QTc in za zmanjšanje tveganja za bolnike v informacije o zdravilu vključil omejitve.
English: Malaria is an infection caused by a parasite known as Plasmodium and spread through the bite of an infected mosquito.
Slovenian: Malarija je okužba, ki jo povzroča parazit, imenovan plazmodij, in se prenaša z ugrizom okuženega komarja.
English: What benefit has Eurartesim shown during the studies?
Slovenian: Kakšne koristi je zdravilo Eurartesim izkazalo med študijami?
English: Although the exact way in which it kills the parasite is not fully understood, it is believed to damage the parasite membrane.
Slovenian: Čeprav natančen mehanizem delovanja, s katerim zdravilo uniči parazit, še ni popolnoma znan, se domneva, da poškoduje njegovo membrano.
English: Eurartesim must not be used in patients with severe malaria.
Slovenian: Ne sme se uporabljati pri bolnikih s hudo malarijo.
English: The Eurartesim carton is to include instructions to take the medicine at least 3 hours before or after food.
Slovenian: Ovojnina zdravila Eurartesim mora vsebovati navodilo, da se zdravilo daje vsaj tri ure po hrani ali pred njo.
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.
Slovenian: Najpogostejši neželeni učinki zdravila Eurartesim pri odraslih (opaženi pri 1 do 10 bolnikih od 100) so anemija (nizko število rdečih krvnih celic), glavobol, podaljšanje intervala QTc (sprememba električne aktivnosti srca, ki lahko povzroči življenjsko nevaren nenormalen srčni ritem), tahikardija (pospešen srčni utrip), oslabelost in povišana telesna temperatura.
English: What measures are being taken to ensure the safe use of Eurartesim?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Eurartesim?
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.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The Committee noted that Eurartesim meets World Health Organization recommendations for P. falciparum malaria treatment by offering a new alternative artemisinin combination therapy containing two active substances which work in different ways.
Slovenian: Odbor je ugotovil, da zdravilo Eurartesim izpolnjuje priporočila Svetovne zdravstvene organizacije za zdravljenje malarije P. falciparum, saj ponuja novo alternativno kombinirano zdravljenje z artemizininom, ki vsebuje dve zdravilni učinkovini, ki delujeta na različna načina.
English: Therefore, the Committee concluded that the benefits of Eurartesim outweigh its risks and recommended that it be granted marketing authorisation.
Slovenian: Zato je CHMP zaključil, da so koristi zdravila Eurartesim večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Eurartesim piperaquine tetraphosphate / artenimol
Slovenian: Eurartesim piperakin tetrafosfat/artenimol
English: Artenimol is a derivative of the naturally occurring substance artemisinin.
Slovenian: Artenimol je derivat naravne snovi artemizinin.
English: The active substances in Eurartesim, piperaquine tetraphosphate and artenimol, are antimalarial substances which kill the P. falciparum parasite.
Slovenian: Zdravilni učinkovini v zdravilu Eurartesim, piperakin tetrafosfat in artenimol, sta antimalarika, ki ubijeta parazit P. falciparum.
English: The main measure of effectiveness was the proportion of patients who were cured 63 days after treatment.
Slovenian: Glavno merilo učinkovitosti je bil odstotek bolnikov, ki so bili po 63 dneh zdravljenja ozdravljeni.