natgillin/translations-raw huggingface dataset:
Initiation of lacosamide treatment with a loading dose 
Začetek zdravljenja z lakozamidom z začetnim (polnilnim) odmerkom
Titanium dioxide (E171) Iron oxide red (E172) Iron oxide black (E172) Indigo carmine aluminum lake (E132) Lecithin (soya) 
Obloga tablete polivinilalkohol polietilenglikol smukec titanov dioksid (E171) rdeči železov oksid (E172) črni železov oksid (E172) indigotin (E132) lecitin (sojin)
Lacosamide Accord 50 mg film coated tablets: EU/1/17/1230/001-004 
Lacosamide Accord 50 mg filmsko obložene tablete EU/1/17/1230/001-004
Very common: may affect more than 1 in 10 people Headache; 
Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov glavobol; omotica ali siljenje na bruhanje (navzea); dvojni vid (diplopija).
Lacosamide Accord 150 mg film coated tablets: EU/1/17/1230/009-012 
Lacosamide Accord 150 mg filmsko obložene tablete EU/1/17/1230/009-012
What Lacosamide Accord is 
Kaj je zdravilo Lacosamide Accord
What Lacosamide Accord is used for 
Za kaj uporabljamo zdravilo Lacosamide Accord
This will be until you reach a maintenance dose between 100 mg and 200 mg twice a day. 
Zdravnik bo lahko povečal dnevni odmerek, razdeljen na dva odmerka, vsak teden za 50 mg, dokler ne boste dosegli vzdrževalnega odmerka med 100 mg in 200 mg dvakrat na dan.
OTHER Week 3 
DRUGI PODATKI 3. teden
Abnormalities in liver function tests have been observed in placebo-controlled trials with lacosamide in adult patients with partial-onset seizures who were taking 1 to 3 concomitant antiepileptic medicinal products. 
Pri odraslih bolnikih s parcialnimi napadi, ki so sočasno jemali 1 do 3 antiepileptike, so pri s placebom kontroliranih preskušanjih z lakozamidom opazili odstopanja od normalnih vrednosti preiskav jetrne funkcije.
Titanium dioxide (E171) Lecithin (soya) Iron oxide yellow (E172) 
Obloga tablete polivinilalkohol polietilenglikol smukec titanov dioksid (E171) lecitin (sojin) rumeni železov oksid (E172)
Treatment initiation pack (in adolescent and children weighing 50 kg or more and adults only) Lacosamide Accord 50 mg film-coated tablets 
Pakiranje za začetek zdravljenja (le za mladostnike in otroke, ki tehtajo 50 kg ali več, in odrasle) Lacosamide Accord 50 mg filmsko obložene tablete Lacosamide Accord 100 mg filmsko obložene tablete Lacosamide Accord 150 mg filmsko obložene tablete Lacosamide Accord 200 mg filmsko obložene tablete
Liver function test abnormal (2) 
Bolezni jeter, žolčnika in žolčevodov odstopanja od normalnih vrednosti preiskav jetrne funkcije(2),
Difficulties in coordinating your movements or walking. 
težave pri koordinaciji gibov ali hoje
Lacosamide Accord 200 mg film-coated tablets 
Lacosamide Accord 200 mg filmsko obložene tablete
Lacosamide Accord 50 mg Lacosamide Accord 100 mg Lacosamide Accord 150 mg Lacosamide Accord 200 mg film-coated tablets lacosamide 
Lacosamide Accord 50 mg Lacosamide Accord 100 mg Lacosamide Accord 150 mg Lacosamide Accord 200 mg filmsko obložene tablete lakozamid
Nystagmus 
Omotica
Balance disorder Memory impairment Cognitive disorder Somnolence Tremor 
Bolezni živčevja omotica glavobol motnje ravnotežja motnje spomina kognitivna motnja zaspanost tremor sinkopa(2) motnje koordinacije konvulzije(3)
Lacosamide Accord 150 mg film-coated tablets 
Lacosamide Accord 150 mg filmsko obložene tablete
Lacosamide Accord 100 mg film-coated tablets 
Lacosamide Accord 100 mg filmsko obložene tablete
Lacosamide Accord 50 mg film-coated tablets 
Lacosamide Accord 50 mg filmsko obložene tablete
the package marked ‘Week 3' contains 14 tablets of 150 mg, the package marked ‘Week 4' contains 14 tablets of 200 mg . 
teden' vsebuje 14 tablet po 150 mg,
In vitro data show that CYP2C9, CYP2C19 and CYP3A4 are capable of catalysing the formation of the Odesmethyl metabolite. 
Študija in vitro je pokazala, da se lakozamid v črevesju ne prenaša preko glikoproteina P. Podatki in vitro kažejo, da so encimi CYP2C9, CYP2C19 in CYP3A4 sposobni katalizirati nastanek O-desmetilnega presnovka.
Lacosamide Accord 50 mg film-coated tablets Lacosamide Accord 100 mg film-coated tablets Lacosamide Accord 150 mg film-coated tablets Lacosamide Accord 200 mg film-coated tablets lacosamide 
Lacosamide Accord 50 mg filmsko obložene tablete Lacosamide Accord 100 mg filmsko obložene tablete Lacosamide Accord 150 mg filmsko obložene tablete Lacosamide Accord 200 mg filmsko obložene tablete
This will be until you reach a maintenance dose between 100 mg and 300 mg twice a day. 
Zdravnik vam lahko poveča dnevni odmerek, razdeljen na dva odmerka, vsak teden za 50 mg Odmerek bo povečeval dokler ne boste dosegli vzdrževalnega odmerka med 100 mg in 300 mg dvakrat na dan.
Titanium dioxide (E171) Lecithin (soya) 
Obloga tablete polivinilalkohol polietilenglikol smukec titanov dioksid (E171) lecitin (sojin) indigotin (E132)
Other medicines and Lacosamide Accord 
Shranjevanje zdravila Lacosamide Accord
Lacosamide Accord 150 mg film-coated tablets lacosamide 
Lacosamide Accord 150 mg filmsko obložene tablete lakozamid
Lacosamide Accord 50 mg film-coated tablets lacosamide 
Lacosamide Accord 50 mg filmsko obložene tablete lakozamid
Lacosamide Accord 100 mg film-coated tablets lacosamide 
Lacosamide Accord 100 mg filmsko obložene tablete lakozamid
System organ class Very Common 
organski sistem zelo pogosti pogosti občasni neznana
Laboratory abnormalities 
Odstopanja od normalnih vrednosti laboratorijskih preiskav
Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention Noise in the ear such as buzzing, ringing or whistling Irritability, trouble sleeping, depression; 
Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov težave z ravnotežjem, tresenje (tremor), mravljinčenje (parestezija) ali mišični krči, pogosto padanje in modrice; težave s spominom, razmišljanjem ali iskanjem besed, zmedenost; hitri in nenadzorovani gibi oči (nistagmus), zamegljen vid; občutek "vrtenja" (vrtoglavica), občutek pijanosti; bruhanje, suha usta, zaprtost, prebavne motnje, vetrovi v želodcu ali črevesju, driska; zmanjšanje občutka ali občutljivosti, motnje izgovorjave, motnje pozornosti; hrup v ušesih, kot so brenčanje, zvonenje ali piskanje.
Blood and lymphatic disorders 
Bolniki z ledvično okvaro
Pink, oval, approximately 10.3 x 4.8 mm, coated tablets, debossed “L” on one side and “50” on other side. 
Lacosamide Accord 50 mg filmsko obložene tablete Rožnate, ovalne obložene tablete, velike približno 10,3 x 4,8 mm z vtisnjeno oznako ‘L' na eni strani in oznako ‘50' na drugi strani.
--P1 Live gEP-P tkP-P double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL: 10P6.3P - 10P7.3P CCIDR50 Rper 2 ml (gEP-P: deleted glycoprotein E; tkP-P: deleted thymidine kinase; CCID: cell culture infectious dose) 
--P1 Živ gEP-P tkP-P Goveji Herpes Virus vrste 1 (BoHV-1) z dvojno delecijo genov, sev CEDDEL: 10P6.3P - 10P7.3P CCIDR50
Packaging Content Package size Withdrawal period 
Vsebina Velikost pakiranja
Strength Pharmaceutical form 
Jakost Farmacevtska oblika Ciljna živalska vrsta
Lyophilisate: bottle (type I glass); solvent: bottle (type I glass or PET) 
(gEP-P: izbrisan glikoprotein E; tkP-P: izbrisana timidin kinaza; CCID: odmerek za infekcije celične kulture)
Route of administration 
Način uporabe Pakiranje
Target species 
Karenca
Solvent: 1 bottle 
R (2 ml)
This summary was last updated in March 2015. 
Povzetek je bil nazadnje posodobljen marca 2015.
In the future, if the animals are exposed to these infections the immune system will be able to respond more quickly. 
Če so živali kasneje izpostavljene tem okužbam, se lahko imunski sistem nanje hitreje odzove.
It is typically transmitted through bites of infected animals. 
Običajno se prenaša z ugrizi okuženih živali.
Responses in puppies were lower than adult dogs in some cases, because of antibodies inherited from their mothers. 
Odzivi pri pasjih mladičih so bili v določenih primerih slabši kot pri odraslih psih, kar je posledica protiteles, ki so jih podedovali od mater.
The measures of effectiveness were clinical signs, body temperature and level of antibodies. 
Merila učinkovitosti so bili klinični znaki bolezni, telesna temperatura in raven protiteles.
The percentage of dogs with protective levels of antibodies for parvovirus ranged from 73 to 100%, for parainfluenza virus 73 to 97%, for leptospira 59 to 96% and for rabies virus 86 to 100%. 
Zaščitne ravni protiteles proti parvovirusu je razvilo od 73 do 100 % psov, proti virusu parainfluence od 73 do 97 % psov, proti leptospiri od 59 do 96 % psov in proti virusu stekline od 86 do 100 % psov.
The dogs were either vaccinated twice with a three or four week interval or they received a single annual booster vaccination. 
Psi so bili bodisi cepljeni dvakrat v razmiku od treh do štirih tednov bodisi so prejeli enkraten letni obnovitveni odmerek cepiva.
The effectiveness of Versican Plus DHPPi/L4R was initially investigated in a field study involving 129 dogs. 
Učinkovitost cepiva Versican Plus DHPPi/L4R so najprej raziskali v terenski študiji, v katero so vključili 129 psov.
The vaccine is given to puppies from eight to nine weeks of age as an injection, under the skin, and repeated once the puppies reach twelve weeks of age. 
Cepivo se daje pasjim mladičem, starim od osem do devet tednov, z injiciranjem v podkožje, cepljenje pa je treba ponoviti, ko so mladiči stari dvanajst tednov.
The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus DHPPi/L4R on 7 May 2014. 
Evropska komisija je dovoljenje za promet z zdravilom Versican Plus DHPPi/L4R, veljavno po vsej Evropski uniji, izdala 7. maja 2014.
The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus DHPPi/L4R is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination. 
Najpogostejši neželeni učinek cepiva Versican Plus DHPPi/L4R (opažen pri več kot 1 psu od 100) je kratkotrajna oteklina v velikosti do 5 cm, ki se lahko po cepljenju pojavi na mestu injiciranja.
The benefit-risk balance may be found in the scientific discussion module of this EPAR. 
Za razmerje med koristmi in tveganji glejte modul o znanstveni razpravi tega evropskega javnega poročila o oceni zdravila.
• canine adenovirus, which causes an acute liver infection that may produce signs of jaundice (yellowing of the skin and eyes); 
• pasjim adenovirusom tipa 1, ki povzroča akutno okužbo jeter, pri kateri se lahko pojavijo znaki zlatenice (porumenelost kože in oči);
Laboratory studies were conducted subsequently to determine the period of protection against distemper, canine adenovirus (type 1 and 2) and parvovirus. 
Zatem so bile izvedene laboratorijske študije za proučitev trajanja zaščite pred pasjo kugo, pasjim adenovirusom (tipa 1 in 2) ter parvovirusom.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus DHPPi/L4R exceed the risks for the approved indications and recommended that Versican Plus DHPPi/L4R be given a marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Versican Plus DHPPi/L4 večje od z njim povezanih tveganj, kadar se zdravilo uporablja za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
In these studies dogs were vaccinated twice with a three week interval and were challenged with canine distemper virus, canine adenovirus and canine parvovirus three years after the second vaccination. 
V teh študijah so bili psi cepljeni dvakrat v razmiku treh tednov, zatem pa so bili tri leta po drugem cepljenju izpostavljeni virusu pasje kuge, pasjega adenovirusa, pasjega parvovirusa.
When Versican Plus DHPPi/L4R is given to dogs the animals' immune system recognises the viruses and bacteria as ‘foreign' and makes antibodies against them. 
Ko psi prejmejo cepivo Versican Plus DHPPi/L4R, imunski sistem živali viruse in bakterije prepozna kot „tujke“ ter začne proti njim tvoriti protitelesa.
• canine distemper, an infectious disease which is sometimes called hard pad since dogs can develop thickening of the skin on the foot pads, as well as runny nose, cough, fever, vomiting and diarrhoea, excessive salivation and in some cases fits; 
• pasjo kugo, tj. infekcijsko boleznijo, ki jo včasih imenujemo tudi bolezen trdih blazinic, saj se lahko pri psih pojavi odebeljena koža na blazinicah na šapah, poleg tega pa tudi izcedek iz smrčka, kašelj, povišana telesna temperatura, bruhanje in driska, čezmerno slinjenje ter v nekaterih primerih krči;
• rabies, a viral zoonotic (communicable to man) disease that affects the central nervous system (brain and spinal cord), leading to death. 
• steklino, tj. virusno zoonozo (prenaša se lahko na ljudi), ki prizadene osrednje živčevje (možgane in hrbtenjačo) ter povzroči smrt.
Versican Plus DHPPI/L4R is used to protect dogs against: 
Zdravilo Versican Plus DHPPi/L4R se uporablja za zaščito psov pred:
The field study showed that vaccination with Versican Plus DHPPi/L4R resulted in levels of antibodies that were sufficient to protect against canine distemper virus and canine adenovirus in all dogs. 
Terenska študija je pokazala, da so bile po cepljenju s cepivom Versican Plus DHPPi/L4R ravni protiteles pri vseh psih dovolj visoke za zaščito pred virusom pasje kuge in pasjim adenovirusom.
This will help protect them against distemper, adenovirus, parvovirosis, kennel cough, leptospirosis and rabies. 
To pomaga zaščititi pse pred kugo, adenovirusom, parvovirozo, kužnim kašljem, leptospirozo in steklino.
Versican Plus DHPPi/L4R is a veterinary vaccine that contains live attenuated (weakened) canine distemper virus, canine adenovirus type 2, canine parvovirus type 2b and canine parainfluenza virus type 2 as well as inactivated (killed) strains of Leptospira bacteria and rabies virus. 
Zdravilo Versican Plus DHPPi/L4R je cepivo za uporabo v veterinarski medicini, ki vsebuje živ atenuiran (oslabljen) virus pasje kuge, pasji adenovirus tipa 2, pasji parvovirus tipa 2b in virus pasje parainfluence tipa 2 ter inaktivirane (uničene) seve bakterij Leptospira in virus stekline.
• canine parainfluenza virus, the cause of kennel cough; 
• virusom pasje parainfluence, ki povzroča kužni kašelj;
Versican Plus DHPPi/L4R contains an adjuvant (aluminium hydroxide) to enhance the immune response. 
Cepivo Versican Plus DHPPi/L4R vsebuje adjuvans (aluminijev hidroksid), ki spodbuja imunski odziv.
• canine parvovirus disease, an infection that may severely affect puppies, resulting in lethargy, fever, vomiting and bloody diarrhoea; 
• boleznijo, ki jo povzroča pasji parvovirus, tj. okužbo, ki lahko močno prizadene pasje mladiče in povzroči letargijo, povišano telesno temperaturo, bruhanje in krvavo drisko;
Versican Plus DHPPi/L4R is a vaccine. 
Zdravilo Versican Plus DHPPi/L4R je cepivo.
Versican Plus DHPPi/L4R is available as a lyophilisate (freeze-dried pellet) with solvent for injection. 
Zdravilo Versican Plus DHPPi/L4R je na voljo v obliki liofilizata (pelet, posušenih v zamrznjenem stanju) z vehiklom za injiciranje.
Canine distemper, adenovirus, parvovirus, parainfluenza virus (live attenuated), canine leptospirosis, rabies (inactivated) vaccine 
cepivo proti pasji kugi, pasjemu adenovirusu, pasjemu parvovirusu, virusu pasje parainfluence (živo, atenuirano), pasji leptospirozi, virusu stekline (inaktivirano)
Annual revaccination is required for protection against parainfluenza virus, leptospirosis and rabies. 
Za zaščito pred virusom parainfluence, leptospirozo in steklino je ponovno cepljenje potrebno vsako leto.
What benefit has Versican Plus DHPPi/L4R shown during the studies? 
Kakšne koristi je zdravilo Versican Plus DHPPi/L4R izkazalo med študijami?
The laboratory studies showed the period of protection to be three years for canine distemper, canine adenovirus and canine parvovirus. 
Laboratorijske študije so pokazale, da traja obdobje zaščite pred pasjo kugo, pasjim adenovirusom in pasjim parvovirusom tri leta.
The canine distemper virus, canine adenovirus, canine parvovirus and canine parainfluenza virus in Versican Plus DHPPi/L4R are alive but they have been attenuated (weakened) so that they do not cause disease; they are combined with killed (inactivated) strains of Leptospira bacteria and rabies virus. 
Virus pasje kuge, pasji adenovirus, pasji parvovirus in virus pasje parainfluence v cepivu Versican Plus DHPPi/L4R so živi, vendar so atenuirani (oslabljeni), tako da ne povzročajo bolezni.
Other information about Versican Plus DHPPi/L4R: 
Druge informacije o zdravilu Versican Plus DHPPi/L4R:
What is the risk associated with Versican Plus DHPPi/L4R? 
Kakšna tveganja so povezana z zdravilom Versican Plus DHPPi/L4R?
Why has Versican Plus DHPPi/L4R been approved? 
Zakaj je bilo zdravilo Versican Plus DHPPi/L4R odobreno?
For revaccination, a single dose of Versican Plus DHPPi/L4R is required every three years for distemper, canine adenovirus (type 1 and 2) and parvovirus. 
Za zaščito pred pasjo kugo, pasjim adenovirusom (tipa 1 in 2) ter pasjim parvovirusom je vsaka tri leta potrebno ponovno cepljenje z enkratnim odmerkom cepiva Versican Plus DHPPi/L4R.
What is Versican Plus DHPPi/L4R? 
Kaj je zdravilo Versican Plus DHPPi/L4R?
How has Versican Plus DHPPi/L4R been studied? 
Kako je bilo zdravilo Versican Plus DHPPi/L4R raziskano?
• leptospirosis, a bacterial disease that may be transmitted via infected urine and result in bleeding, hepatitis (inflammation of the liver) and jaundice or nephritis (kidney inflammation); 
• leptospirozo, tj. bakterijsko boleznijo, ki se lahko prenaša z okuženim urinom in povzroči krvavitve,
What is Versican Plus DHPPi/L4R used for? 
Za kaj se zdravilo Versican Plus DHPPi/L4R uporablja?
How does Versican Plus DHPPi/L4R work? 
Kako zdravilo Versican Plus DHPPi/L4R deluje?
This summary was last updated in 03-2007. 
Ta povzetek je bil nazadnje posodobljen 03-2007.
It is used to treat adults with the following diseases: 
Uporablja se pri zdravljenju odraslih z naslednjimi boleznimi:
The European Commission granted a marketing authorisation valid throughout the European Union for Trudexa to Abbott Laboratories Ltd. on 1 September 2003. 
Evropska komisija je dovoljenje za promet z zdravilom Trudexa, veljavno po vsej Evropski uniji, odobrila družbi Abbott Laboratories Ltd. dne 1. septembra 2003.
Other information about Trudexa: 
Druge informacije o zdravilu Trudexa:
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TRUDEXA EPAR summary for the public 
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) TRUDEXA Povzetek EPAR za javnost
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in the body. 
Monoklonsko protitelo je vrsta protitelesa (vrsta beljakovine), ki je bilo zasnovano za prepoznavanje in vezanje na določeno strukturo (imenovano antigen), ki jo najdemo na določenih celicah telesa.
It is available as a solution for injection in a vial, pre-filled syringe or pre-filled pen, all containing 40 mg of adalimumab. 
Na voljo je kot raztopina za injiciranje v viali, napolnjeni injekcijski brizgi ali napolnjenem injekcijskem peresniku, vse oblike pa vsebujejo po 40 mg adalimumaba.
For more information, see the Package Leaflet. 
Za več informacij si oglejte Navodilo za uporabo.
Patients who take Trudexa must be given the special alert card that summarises the safety information about the medicine. 
Bolniki, ki prejemajo zdravilo Trudexa, morajo dobiti posebno opozorilno izkaznico, ki povzema varnostne podatke o zdravilu.
The medicines were taken alone or in combination with another anti-inflammatory medicine such as methotrexate. 
Zdravilo so dajali samostojno ali v povezavi z drugim protivnetnim zdravilom, kot je metotreksat.
In all five studies, the main measure of effectiveness was the change in symptoms after 6 months to a year of treatment. 
Glavno merilo učinkovitosti v vseh petih raziskavah je bila sprememba simptomov po šestih mesecih do enega leta zdravljenja.
For both diseases, the patients had had an inadequate response to previous therapy, and the main measure of effectiveness was the change in symptoms after 12 weeks of treatment. 
V primeru obeh bolezni so se bolniki pred tem neustrezno odzvali na prejšnje oblike zdravljenja, glavno merilo učinkovitosti pa je bila sprememba simptomov po 12 tednih zdravljenja.
Trudexa has been studied in five studies including almost 2,900 patients with moderate to severe rheumatoid arthritis. 
Zdravilo Trudexa so raziskovali v petih raziskavah, ki so vključevale skoraj 2900 bolnikov z zmernim do hudim revmatoidnim artritisom.
In studies of Trudexa, the most common side effects (seen in more than 1 patient in 10) were upper respiratory infection (colds) and injection site reactions (including pain, swelling, redness or pruritus [itching]). 
V raziskavah zdravila Trudexa so bili najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) vnetje zgornjih dihal (prehladi) in reakcije na mestu vbrizganja (vključno z bolečino, otekanjem, rdečino ali srbenjem).
The recommended dose of Trudexa is 40 mg given every 2 weeks as a single subcutaneous injection (under the skin). 
Priporočeni odmerek zdravila Trudexa znaša 40 mg vsake dva tedna v obliki ene same podkožne injekcije.
The greatest reductions were seen in the studies examining Trudexa as an add-on to methotrexate: in the two studies taken together, around two thirds of the patients adding 40 mg Trudexa every 2 weeks had at least a 20% reduction in symptoms after 6 months, compared to a quarter of those adding placebo. 
Največja zmanjšanja so opazili pri raziskavah, v katerih so raziskovali zdravilo Trudexa kot dodatek zdravljenju z metotreksatom: v dveh raziskavah skupaj sta po šestih mesecih približno dve tretjini bolnikov, ki so kot dodatno zdravljenje prejemali 40 mg zdravila Trudexa vsake dva tedna, pokazali 20 % zmanjšanje jakosti simptomov, v primerjavi s četrtino tistih bolnikov, ki so kot dodatek prejemali placebo.
The fifth study included 799 patients, none of whom had taken methotrexate in the past, and compared the combination of Trudexa and methotrexate to methotrexate or Trudexa alone. 
Peta raziskava je vključevala 799 bolnikov, ki v preteklosti še niso prejemali metotreksata, v raziskavi pa so primerjali kombinacijo zdravila Trudexa in metotreskata s samostojnim dajanjem metotreksata ali zdravila Trudexa.
What benefit has Trudexa shown during the studies? 
Kakšne koristi je zdravilo Trudexa izkazalo med raziskavami?
By blocking TNF, adalimumab improves the inflammation and other symptoms of the diseases. 
Z zaviranjem TNF učinkovina adalimumab izboljša stanje vnetij in druge simptome bolezni.
Trudexa should not be used in people who may be hypersensitive (allergic) to adalimumab or any of the other ingredients. 
Zdravila Trudexa ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) adalimumab ali katerokoli drugo sestavino zdravila.
The committee recommended that Trudexa be given marketing authorisation. 
Odbor je zato priporočil odobritev dovoljenja za promet z zdravilom Trudexa.
Some patients with rheumatoid arthritis who are taking Trudexa without methotrexate may benefit from taking this dose every week. 
Nekaterim bolnikom z revmatoidnim artritisom, ki prejemajo samo zdravilo Trudexa brez metotreksata, lahko koristi isti odmerek, apliciran enkrat na teden.
• rheumatoid arthritis (an immune system disease causing inflammation of the joints). 
• revmatoidnim artritisom (bolezen imunskega sistema, ki povzroča vnetje sklepov).
The Committee for Medicinal products for Human Use (CHMP) decided that Trudexa's benefits are greater than its risks for treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in adults when other treatments have been inadequate. 
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da so koristni učinki zdravila Trudexa večji od z njim povezanih tveganj pri zdravljenju zmernega do hudega revmatoidnega artritisa, psoriatičnega artritisa in ankilozirajočega spondilitisa pri odraslih, če se druge oblike zdravljenja niso izkazale za primerne.