FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/183/001 - 10 vials (1 ml) EU/2/15/183/002 - 50 vials (1 ml) EU/2/15/183/003 - 1 vial (10 ml)
Slovenian: EU/2/15/183/001 - 10 vial (1 ml) EU/2/15/183/002 - 50 vial (1 ml) EU/2/15/183/003 - 1 viala (10 ml)
English: A mild and transient increase in body temperature (≤ 1°C) has been observed very commonly in clinical studies for a few days after vaccination, with some pups showing less activity and/or a reduced appetite.
Slovenian: Rahlo in prehodno povišanje telesna temperature (≤ 1°C), ki je trajalo nekaj dni po cepljenju, so zelo pogosto opazili v kliničnih študijah, nekateri mladiči so bili manj aktivni in/ali so imeli zmanjšan apetit.
English: In case of ocular irritation seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: V primeru draženja oči takoj poiščite zdravniški nasvet in pokažite zdravniku navodilo ali ovojnino.
English: When mixed with Canigen vaccines containing canine parainfluenza virus strain Cornell at annual revaccination, it has been established that there is no interference with the anamnestic response induced by the injectable canine parainfluenza virus component.
Slovenian: Kadar se pri letni revakcinaciji to cepivo meša s cepivi Canigen, ki vsebujejo virus pasje parainfluence seva Cornell, je bilo ugotovljeno, da to ne vpliva na anamnestični odziv, ki ga sproži injicirana komponenta virusa pasje parainfluence.
English: Incompatibilities: Do not mix with any other veterinary medicinal products except the above mentioned vaccines.
Slovenian: Inkompatibilnosti Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicine razen z zgoraj navedenimi cepivi.
English: Shelf life after reconstitution of Canigen vaccines according to directions: 45 mins.
Slovenian: Rok uporabnosti po rekonstituciji Canigen cepiv skladno z navodili: 45 minut
English: België/Belgique/Belgien: VIRBAC,
Slovenian: België/Belgique/Belgien:
English: 4.4 Special warnings for each target species
Slovenian: 4.4 Posebna opozorila za vsako živalsko vrsto
English: For example, local swelling, which can be up to 5 cm in diameter and which may take over 5 weeks to completely disappear, may be observed at the site of injection.
Slovenian: Na primer, na mestu injiciranja lahko opazite lokalno oteklino z do 5 cm premera, ki lahko popolnoma izgine po več kot 5 tednih.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: - občasni (pri več kot1, toda manj kot 10 živalih od 1.000 zdravljenih živali) - redki (pri več kot 1 toda manj kot 10 živalih od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključujoč posamezne primere).
English: Do not mix with any other veterinary medicinal products except those mentioned in section 4.8.
Slovenian: Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini razen s tistimi, ki so navedena v poglavju 4.8. 6.3 Rok uporabnosti
English: Type I glass vial of 1 ml (1 dose) or 10 ml (10 doses) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Slovenian: Viala, steklo tipa I, po 1 ml (1 odmerek) ali 10 ml (10 odmerkov), zaprta z zamaškom iz halogenobutilne gume in zatesnjena z aluminijasto zaporko s šifro.
English: Bury St. Edmunds, Suffolk, IP30 9UP, Tel: + 44 (0) 1359 243243
Slovenian: Suffolk, IP30 9UP, Tel: + 44 (0) 1359 243243
English: Before use, ensure that the vaccine is at room temperature (15°C - 25°C).
Slovenian: Pred uporabo zagotovite, da je zdravilo na sobni temperaturi (15°C - 25°C).
English: The product information of the relevant Canigen vaccines should be consulted before administration of the mixed product.
Slovenian: Pred dajanjem mešanega cepiva je treba preučiti navodila ustreznih cepiv Canigen.
English: ADVICE ON CORRECT ADMINISTRATION Before use, ensure that the vaccine is at room temperature (15°C - 25°C).
Slovenian: Subkutano dajanje Pred uporabo zagotovite, da je cepivo na sobni temperaturi (15°C - 25°C).
English: If you notice any side effects,, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli stranske učinke, tudi če ti niso že navedeni v navodilu za uporabo ali mislite,
English: Luxembourg/Luxemburg: VIRBAC,
Slovenian: Luxembourg/Luxemburg:
English: PACKAGE LEAFLET: Canigen L4 suspension for injection for dogs
Slovenian: NAVODILO ZA UPORABO Canigen L4 suspenzija za injiciranje za pse
English: 3550-7100 U1
Slovenian: 3550-7100 E1
English: 290-1000 U1
Slovenian: 290-1000 E1
English: 10x 1 ml (1 dose) 50x 1 ml (1 dose) 1x 10 ml (10 doses)
Slovenian: 50x 1 ml (1 odmerek) 1x 10 ml (10 odmerkov)
English: VIRBAC ESPAÑA S.A., Angel Guimerá 179-181, ES-8950 Esplugues de Llobregat, infocliente@virbac.es
Slovenian: ES-8950 Esplugues de Llobregat, infocliente@virbac.es
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Slovenian: NL-5831 AN Boxmeer
English: 1ère avenue 2065 m - L.I.D.,
Slovenian: 13ème rue - L.I.D.,
English: Pharmacotherapeutic group: Immunologicals for Canidae, inactivated bacterial vaccine.
Slovenian: Farmakoterapevtska skupina: Imunološka zdravila za pse, inaktivirano bakterijsko cepivo Oznaka ATC vet QI07AB01.
English: Plastic box with 10, or 50 vials of 1 ml Cardboard box with 1 vial of 10 ml
Slovenian: Plastična škatla z 10 ali 50 vialami po 1 ml Kartonska škatla z 1 vialo po10 ml
English: Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi tiomersal natrijev klorid kalijev klorid dinatrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
English: 1 ml and 10 ml vial
Slovenian: Viala po 1 ml in 10 ml
English: Vaccinate healthy animals only.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Cepite samo zdrave živali.
English: Administer two vaccinations of 1 dose (1 ml) of vaccine with an interval of 4 weeks to dogs from 6 weeks of age onwards.
Slovenian: Pse cepite od 6 tednov starosti dalje dvakrat s po 1 odmerkom (1 ml) cepiva z razmikom 4 tednov.
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with vaccines of the Canigen series from the same marketing authorisation holder (or national subsidiary) containing Bordetella bronchiseptica strain B-C2 and/or canine parainfluenza virus strain Cornell components for intranasal administration where authorised.
Slovenian: Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno dati isti dan, vendar ne mešano s cepivi serije Canigen za intranazalno dajanje istega imetnika dovoljenja za promet (krajevne podružnice), ki vsebujejo bakterijo Bordetella bronchiseptica seva B-C2 in/ali virus parainfluence seva Cornell za intranazalno dajanje, kjer so registrirani.
English: Special precautions for each target species: Vaccinate healthy animals only.
Slovenian: 4.5 Posebni previdnostni ukrepi Posebni previdnostni ukrepi za uporabo pri živalih Cepite samo zdrave živali.
English: 650-1300 U1
Slovenian: 650-1300 E1
English: Inactivated Leptospira strains: - L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12
Slovenian: Serološka skupina L. interrogans Canicola serovar Portland-vere (sev Ca-12-000)
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) See package leaflet.
Slovenian: KOLIČINA UČINKOVIN(E) Glej navodilo za uporabo.
English: For active immunisation of dogs against: - L. interrogans serogroup Canicola serovar Canicola to reduce infection and urinary excretion - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni to reduce infection and urinary excretion - L. interrogans serogroup Australis serovar Bratislava to reduce infection - L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang to reduce infection and urinary excretion
Slovenian: Za aktivno imunizacijo psov proti: - serološka skupina L. interrogans Canicola serovar Canicola za zmanjšanje okužbe in izločanja z urinom - serološka skupina L. interrogans Icterohaemorrhagiae serovar Copenhageni za zmanjšanje okužbe in izločanja z urinom
English: For simultaneous use with Canigen vaccines where authorised: 1 dose of a Canigen vaccine from the same marketing authorisation holder (or national subsidiary) containing canine distemper virus strain Onderstepoort, canine adenovirus type 2 strain Manhattan LPV3, canine parvovirus strain 154 and/or canine parainfluenza virus strain Cornell components should be reconstituted with 1 dose (1 ml) of Canigen L4.
Slovenian: Za sočasno dajanje s cepivi Canigen, kjer so registrirana: 1 odmerek cepiva Canigen istega imetnika dovoljenja za promet (ali krajevne podružnice), ki vsebuje virus pasje kuge seva Onderstepoort, pasji adenovirus seva Manhattan LPV3, pasji parvovirus seva 154 in/ali virus pasje parainfluence seva Cornell, je treba rekonstituirati z 1 odmerkom (1 ml) cepiva Canigen L4.
English: 10 ml (10 doses)
Slovenian: 1 ml (1 odmerek) 10 ml (10 odmerkov)
English: Plastic box with 10 or 50 vials of 1 ml (1 dose).
Slovenian: Velikosti pakiranj: Plastična škatla z 10 ali 50 vialami po 1 ml (1 odmerek)
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines of the Canigen series from the same marketing authorisation holder (or national subsidiary) containing canine distemper virus strain Onderstepoort, canine adenovirus type 2 strain Manhattan LPV3, canine parvovirus strain 154 and/or canine parainfluenza virus strain Cornell components for subcutaneous administration where authorised.
Slovenian: Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in daje s cepivi serije Canigen za subkutano dajanje istega imetnika dovoljenja za promet (ali krajevne podružnice), ki vsebujejo virus pasje kuge seva Onderstepoort, pasji adenovirus tipa 2 seva Manhattan LPV3, pasji parvovirus seva 154 in/ali virus pasje parainfluence seva Cornell za subkutano dajanje, kjer so registrirana.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po dajanju dvojnega odmerka cepiva niso opazili drugih neželenih učinkov razen tistih, ki so navedeni v poglavju 4.6.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Canigen L4
Slovenian: Canigen L4
English: In vitro and in vivo data in non-target species suggest that the vaccine may provide a degree of cross-protection against L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
Slovenian: Podatki in vitro in in vivo pri neciljnih živalskih vrstah kažejo, da cepivo lahko zagotovi določeno navzkrižno zaščito proti serološki skupini L. interrogans Icterohaemorrhagiae serovar
English: For simultaneous use with Canigen vaccines where authorised: 1 dose of a Canigen vaccine from the same marketing authorisation holder (or national subsidiary) containing canine distemper virus strain Onderstepoort, canine adenovirus type 2 strain Manhattan LPV3, canine parvovirus strain 154, and/or canine parainfluenza virus strain Cornell components should be reconstituted with 1 dose (1 ml) of Canigen L4.
Slovenian: Za sočasno dajanje s cepivi Canigen, kjer so registrirana: 1 odmerek cepiva Canigen istega imetnika dovoljenja za promet (ali krajevne podružnice), ki vsebuje virus pasje kuge seva Onderstepoort, pasji adenovirus tipa 2 seva Manhattan LPV3, pasji parvovirus seva 154 in/ali virus pasje parainfluence seva
English: Infections may be more likely in younger children.
Slovenian: Okužbe so bolj verjetne pri mlajših otrocih.
English: Further information on Benlysta can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/benlysta.
Slovenian: Nadaljnje informacije za zdravilo Benlysta so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/benlysta.
English: Patients should therefore be observed for several hours after at least the first two infusions.
Slovenian: Zato je treba vsaj po prvih dveh infuzijah bolnike opazovati nekaj ur.
English: The first three doses are given at two-week intervals.
Slovenian: Prvi trije odmerki se dajejo z dvotedenskimi presledki.
English: The Agency also noted the lack of effective alternative treatments for patients who have already tried standard treatments.
Slovenian: Agencija je tudi ugotovila, da učinkovita nadomestna zdravljenja za bolnike, ki so že preizkusili standardno zdravljenje, niso na voljo.
English: What measures are being taken to ensure the safe and effective use of Benlysta?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Benlysta?
English: Benlysta received a marketing authorisation valid throughout the European Union on 13 July 2011.
Slovenian: Za zdravilo Benlysta je bilo 13. julija 2011 izdano dovoljenje za promet, veljavno po vsej EU.
English: The European Medicines Agency decided that Benlysta's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Benlysta večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Benlysta is given to patients whose disease is still highly active despite standard treatment.
Slovenian: Zdravilo Benlysta se daje bolnikom, pri katerih je bolezen kljub standardnemu zdravljenju še vedno zelo dejavna.
English: Other information about Benlysta
Slovenian: Druge informacije o zdravilu Benlysta
English: As for all medicines, data on the use of Benlysta are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Benlysta stalno spremljajo.
English: After this, Benlysta is given once every four weeks.
Slovenian: Pozneje se zdravilo Benlysta daje enkrat na štiri tedne.
English: The company that markets Benlysta will provide further information on the safety of the medicine from a study and from a register of patients being followed up long-term.
Slovenian: Podjetje, ki trži zdravilo Benlysta, bo zagotovilo dodatne podatke o varnosti zdravila iz študije in registra bolnikov, ki se jih dolgoročno spremlja.
English: Why is Benlysta authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Benlysta odobreno v EU?
English: What benefits of Benlysta have been shown in studies?
Slovenian: Kakšne koristi zdravila Benlysta so se pokazale v študijah?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Benlysta 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 Benlysta upoštevati zdravstveni delavci in bolniki, so prav tako vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The medicine may cause infusion and hypersensitivity reactions as well as infections, but is generally well tolerated.
Slovenian: Zdravilo lahko povzroča infuzijske in preobčutljivostne reakcije ter okužbe, vendar ga bolniki na splošno dobro prenašajo.
English: An overview of Benlysta and why it is authorised in the EU
Slovenian: Pregled zdravila Benlysta in zakaj je odobreno v EU
English: Side effects reported with Benlysta are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Benlysta, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What are the risks associated with Benlysta?
Slovenian: Kakšna tveganja so povezana z zdravilom Benlysta?
English: Results from a main study involving 93 children aged 5 to 17 years with active SLE showed that Benlysta was distributed in the body in a similar way as in adults and could be expected to have similar benefits.
Slovenian: Rezultati glavne študije, v katero je bilo vključenih 93 otrok, starih od pet do 17 let, z aktivnim sistemskim eritematoznim lupusom, so pokazali, da je bilo zdravilo Benlysta v telesu razporejeno podobno kot pri odraslih, zato je pričakovati, da bo imelo podobne koristi.
English: The doctor may interrupt or stop treatment if the patient develops reactions linked to the infusion (such as rash, itchiness and difficulty breathing) or hypersensitivity (allergic) reactions which may be severe and life-threatening and can develop several hours after Benlysta is given.
Slovenian: Zdravnik lahko prekine ali zaustavi zdravljenje, če se pri bolniku pojavijo reakcije, povezane z infuzijo (npr. izpuščaji, srbenje in težave z dihanjem), ali preobčutljivostne (alergijske) reakcije, ki so lahko resne in življenjsko nevarne ter se lahko pojavijo nekaj ur po prejemu zdravila Benlysta.
English: When Benlysta is given as an infusion into a vein, the recommended dose is 10 mg per kilogram body weight given over one hour.
Slovenian: Kadar se zdravilo Benlysta daje v obliki infuzije v veno, je priporočeni odmerek 10 mg na kilogram telesne mase v obdobju ene ure.
English: Benlysta is available as a powder (120 mg and 400 mg) that is made up into a solution for infusion (drip) into a vein; it is also available as a pre-filled pen and pre-filled syringe (200 mg) for injection under the skin.
Slovenian: Zdravilo Benlysta je na voljo v obliki praška (120 mg in 400 mg) za pripravo raztopine za infundiranje (kapalne infuzije) v veno; na voljo je tudi v napolnjenih peresnikih in napolnjenih injekcijskih brizgah (200 mg) za injiciranje pod kožo.
English: Benlysta is a medicine used as an add-on treatment in patients aged 5 years and older with systemic lupus erythematosus (SLE), a disease in which the immune system (the body's natural defences) attacks normal cells and tissues, causing inflammation and organ damage.
Slovenian: Benlysta je zdravilo, ki se uporablja kot dodatno zdravilo pri bolnikih, starejših od pet let, s sistemskim eritematoznim lupusom (SLE), tj. boleznijo, pri kateri imunski sistem (naravna obramba telesa) napada normalne celice in tkiva ter povzroča vnetje in okvaro organov.
English: Patients may inject Benlysta themselves once they have been properly trained, if the doctor considers this appropriate.
Slovenian: Bolniki si lahko po ustreznem usposabljanju zdravilo Benlysta injicirajo sami, če zdravnik meni, da je to primerno.
English: What is Benlysta and what is it used for?
Slovenian: Kaj je zdravilo Benlysta in za kaj se uporablja?
English: For more information about using Benlysta, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Benlysta glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: All infusions with Benlysta, and the first injection under the skin, should be given in a place where these reactions can be managed immediately if they occur.
Slovenian: Vse infuzije zdravila Benlysta in prvi dve podkožni injekciji je treba dajati v ustanovah, v katerih je nemudoma na voljo vse potrebno za obvladovanje takšnih reakcij.
English: Benlysta can only be obtained with a prescription and treatment should only be started and supervised by a doctor who has experience in the diagnosis and treatment of SLE.
Slovenian: Predpisovanje in izdaja zdravila Benlysta je le na recept, zdravljenje z njim pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem sistemskega eritematoznega lupusa.
English: Another study involved 836 adult patients with active SLE, who received add-on Benlysta as an injection under the skin once a week for a year.
Slovenian: Dodatna študija je vključevala 836 odraslih bolnikov z aktivnim sistemskim eritematoznim lupusom, ki so eno leto prejemali zdravilo Benlysta kot dodatno zdravilo v obliki podkožne injekcije enkrat na teden.
English: The most common side effects with Benlysta (which may affect more than 1 in 10 people) are bacterial infections, such as bronchitis (infection in the lungs) and infection of the urinary tract (structures that produce or carry urine), diarrhoea and nausea (feeling sick).
Slovenian: Najpogostejši neželeni učinki zdravila Benlysta (ki se lahko pojavijo pri več kot 1 od 10 oseb) so bakterijske okužbe, kot sta bronhitis (okužba pljuč) in okužba sečil (struktur, ki proizvajajo ali prenašajo urin), driska in navzeja (siljenje na bruhanje).
English: For the full list of side effects and restrictions of Benlysta, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Benlysta glejte navodilo za uporabo.
English: In adults, Benlysta can also be given as a 200-mg injection under the skin, once a week.
Slovenian: Pri odraslih se lahko zdravilo Benlysta daje tudi v obliki 200-miligramske podkožne injekcije enkrat na teden.
English: In SLE, some of these antibodies attack the body's own cells and organs instead (autoantibodies).
Slovenian: Pri sistemskem eritematoznem lupusu pa ta protitelesa napadajo lastne celice in organe telesa (avtoprotitelesa).
English: By blocking the action of BLyS, belimumab reduces the life span of B lymphocytes, thereby reducing the inflammation and organ damage that occur in SLE.
Slovenian: Belimumab z zaviranjem delovanja beljakovine BLyS skrajšuje življenjsko dobo limfocitov B ter tako zmanjšuje vnetje in okvaro organov, ki se pojavljajo pri sistemskem eritematoznem lupusu.
English: The Agency considered that Benlysta, used as an add-on treatment, reduced disease activity in SLE.
Slovenian: Evropska agencija za zdravila je menila, da zdravilo Benlysta, kadar se uporablja kot dodatno zdravilo, zmanjšuje bolezensko dejavnost pri sistemskem eritematoznem lupusu.
English: The active substance in Benlysta, belimumab, is a monoclonal antibody, a protein that has been designed to attach to and block a protein called BLyS which helps B lymphocytes to live longer.
Slovenian: Učinkovina v zdravilu Benlysta, belimumab, je monoklonsko protitelo, tj. beljakovina, ki je bila zasnovana tako, da se veže na beljakovino BLyS, ki limfocitom B podaljšuje preživetje, in jo zavira.
English: SLE can affect almost any organ in the body, and is thought to involve a type of white blood cell called B lymphocytes.
Slovenian: Sistemski eritematozni lupus lahko prizadene skoraj vsak organ v telesu, domneva pa se, da je v njegov nastanek vpletena vrsta belih krvnih celic, imenovanih limfociti B. Te običajno tvorijo protitelesa, ki pomagajo v boju proti okužbam.
English: How is Benlysta used?
Slovenian: Kako se zdravilo Benlysta uporablja?
English: The study showed that disease activity decreased in 61% of patients treated with Benlysta, compared with 48% of patients given placebo.
Slovenian: Študija je pokazala, da se je bolezenska dejavnost zmanjšala pri 61 % bolnikov, ki so prejemali zdravilo Benlysta, in pri 48 % bolnikov, ki so prejemali placebo.
English: In the second study, disease activity decreased in 58% of patients treated with Benlysta, compared with 44% of patients who were given placebo.
Slovenian: V drugi študiji se je bolezenska dejavnost zmanjšala pri 58 % bolnikov, ki so prejemali zdravilo Benlysta, in pri 44 % bolnikov, ki so prejemali placebo.
English: In the first study, disease activity decreased in 43% of patients treated with Benlysta, compared with 34% of patients who were given placebo.
Slovenian: V prvi študiji se je bolezenska dejavnost zmanjšala pri 43 % bolnikov, ki so prejemali zdravilo Benlysta, in pri 34 % bolnikov, ki so prejemali placebo.
English: Benlysta contains the active substance belimumab.
Slovenian: Zdravilo Benlysta vsebuje učinkovino belimumab.