FrancophonIA/ELRC3.0 huggingface dataset:
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujete z zdravnikom ali farmacevtom.
English: Prolonged bleeding, bleeding inside the head, bleeding in the eye, blood in the urine and/or purpura (red spots on the skin caused by bleeding underneath the skin) Rashes, itching, abnormal touch sensation
Slovenian: • podaljšan čas krvavitve, krvavitve v dihalih, krvavitve v očesu, kri v urinu in/ali purpura (rdeče pike na koži, ki nastajajo zaradi krvavitev pod kožo),
English: Driving and using machines Clopidogrel Teva Pharma B.V. is unlikely to affect your ability to drive or operate machinery.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Malo verjetno je, da bi zdravilo Klopidogrel Teva Pharma B.V.
English: Do not take Clopidogrel Teva Pharma B.V.
Slovenian: Ne jemljite zdravila Klopidogrel Teva Pharma B.V.
English: If you forget to take Clopidogrel Teva Pharma B.V.
Slovenian: Če ste pozabili vzeti zdravilo Klopidogrel Teva Pharma B.V.
English: You should continue taking Clopidogrel Teva Pharma B.V. for as long as your doctor has told you to take it.
Slovenian: morate jemati vse dokler vam ga vaš zdravnik predpisuje.
English: 30 tablets HDPE bottle:
Slovenian: HDPE steklenička po 30 tablet:
English: No clinically significant pharmacodynamic interactions were observed when clopidogrel was co administered with atenolol, nifedipine, or both atenolol and nifedipine.
Slovenian: Pri sočasni uporabi klopidogrela z atenololom, nifedipinom, ali z obema - atenololom in nifedipinom - niso opazili nobenih klinično pomembnih farmakodinamičnih interakcij.
English: Clopidogrel Teva Pharma B.V. 75 mg film-coated tablets clopidogrel
Slovenian: 75 mg filmsko obložene tablete klopidogrel
English: 30 tablets HDPE bottles:
Slovenian: HDPE stekleničke po 30 tablet:
English: The other ingredients in the tablet core are (see section 2 ‘Clopidogrel Teva Pharma B.V. contains lactose' and ‘Clopidogrel Teva Pharma B.V. contains hydrogenated castor oil') lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose (E463), crospovidone (type A), hydrogenated castor oil and sodium laurilsulfate, and in the film-coating are lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, iron oxide red (E172), iron oxide yellow (E172), indigo carmine aluminium lake (E132).
Slovenian: Pomožne snovi v filmski oblogi so: laktoza monohidrat, hipromeloza (E464), titanov dioksid (E171), makrogol 4000, rdeči železov oksid (E172), rumeni železov oksid (E172), indigotin (E132).
English: If you forget to take a dose of Clopidogrel Teva Pharma B.V., but don't remember within 12 hours of the missed dose, skip the missed dose and take the next tablet at the usual time.
Slovenian: in se nanj spomnite po več kot 12 urah, izpustite pozabljeni odmerek in naslednji odmerek vzemite ob običajnem času.
English: 100 tablets HDPE bottles:
Slovenian: HDPE stekleničke po 100 tablet:
English: If you forget to take a dose of Clopidogrel Teva Pharma B.V., but remember within 12 hours of the missed dose, take your tablet straight away and then take your next tablet at the usual time.
Slovenian: in se nanj spomnite do 12 ur od vašega običajnega časa jemanja, takoj vzemite tableto.
English: The recommended dose for ASA was 75 to 100 mg/day.
Slovenian: Priporočeni odmerek acetilsalicilne kisline je bil od 75 do 100 mg na dan. Bolnike so zdravili do 5 let.
English: How to take Clopidogrel Teva Pharma B.V.
Slovenian: Kako jemati zdravilo Klopidogrel Teva Pharma B.V.
English: Inflammation of the blood vessels, decrease in blood pressure Yellowing of the skin and whites of the eyes (jaundice) Bleeding in the lungs, throat, stomach or bowels, abdomen or joints Bleeding of post-operative wounds or other serious bleeds Severe abdominal pain with or without back pain, pain in the joints and muscular pain Diarrhoea
Slovenian: Bolezni prebavil krvavitev v prebavila, driska, bolečine v trebuhu, dispepsija želodčna razjeda in razjeda na dvanajstniku, gastritis, bruhanje, navzea, zaprtje, flatulenca retroperitonealna krvavitev krvavitev v prebavila in retroperitonealna krvavitev s smrtnim izidom, pankreatitis, kolitis (vključno z ulceroznim ali limfocitnim
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the placebo plus ASA group.
Slovenian: V študiji CLARITY je v skupini s klopidogrelom v kombinaciji z acetilsalicilno kislino prišlo do splošnega povečanja krvavitev v primerjavi s skupino s placebom v kombinaciji z acetilsalicilno kislino.
English: - Perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet.
Slovenian: - Perforirani pretisni omoti vsebujejo 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obložena tableta.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING BOTTLE LABEL (30 or 100 film-coated tablets)
Slovenian: ETIKETA STEKLENIČKE (30 in 100 filmsko obloženih tablet)
English: Monitoring for signs of hypersensitivity in patients with a known allergy to thienopyridines is advised.
Slovenian: Pri tistih bolnikih, ki so že kazali znake preobčutljivosti na druge tienopiridine, je treba spremljati znake preobčutljivosti na klopidogrel skozi celotno terapijo.
English: • moclobemide, medicine to treat depression.
Slovenian: • fluoksetin, fluvoksamin ali moklobemid, zdravila za zdravljenje depresije,
English: Reduced levels of certain white blood cells which increases the risk of infection (neutropenia) Vertigo (dizziness accompanied by a whirling sensation) Bleeding inside the abdomen
Slovenian: • zmanjšanje števila belih krvnih celic, zaradi česar je tveganje za okužbo večje (nevtropenija),
English: - Peelable perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet.
Slovenian: - Perforirani pretisni omoti, ki se odlepijo, vsebujejo 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obložena tableta.
English: - If you have any side effects, including any side effects not listed in this leaflet, talk your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg clopidogrel (as hydrobromide)
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (v obliki bromida).
English: See section 4
Slovenian: Glejte poglavje
English: + ASA treatment group compared to the placebo + ASA group (1.4% versus 0.8%, respectively).
Slovenian: V skupini s klopidogrelom + acetilsalicilno kislino je bilo več intrakranialnih krvavitev (1,4 %) kot v skupini s placebom + acetilsalicilno kislino (0,8 %).
English: Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland Tél/Tel: +49 731 402 02
Slovenian: Luxembourg/Luxemburg Teva Pharma Belgium S.A. Tél/Tel: +32 3 820 73 73
English: Cross reactions among thienopyridines
Slovenian: • Okvarjeno delovanje jeter
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Clopidogrel Teva Pharma B.V. 75 mg film-coated tablets clopidogrel oral use
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Klopidogrel Teva Pharma B.V.
English: Symptoms may include altered behaviour, headaches, coma, visual disturbances, seizures (fitting), kidney failure, fever, extreme tiredness, weakness, or bleeding into the stomach, bowels or skin (including small red spots or large bruised areas)
Slovenian: Simptomi lahko vključujejo spremembe vedenja, glavobole, komo, motnje vida, napade (krče), odpovedovanje ledvic,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON of peelable blisters (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet)
Slovenian: ZUNANJA OVOJNINA - pretisni omoti, ki se odlepijo (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obložena tableta)
English: Clopidogrel Teva Pharma B.V. with food and drink You can take Clopidogrel Teva Pharma B.V. with or without food.
Slovenian: s hrano in pijačo Zdravilo Klopidogrel Teva Pharma B.V.
English: INFORMATION IN BRAILLE Clopidogrel Teva Pharma B.V. 75 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Klopidogrel Teva Pharma B.V.
English: How to store Clopidogrel Teva Pharma B.V.
Slovenian: Shranjavenja zdravila Klopidogrel Teva Pharma B.V.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON of blisters (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet)
Slovenian: ZUNANJA ŠKATLICA za pretisne omote (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obložena tableta)
English: Ulcers in the stomach and small intestine, nausea, vomiting, constipation, flatulence (wind) and inflammation of the stomach leading to sickness, loss of appetite and discomfort after eating Reduction in blood platelets which makes bleeding or bruising more likely Blood disorders including a reduction in the number of white blood cells which makes infections more likely.
Slovenian: • razjede v želodcu in tankem črevesju, navzea, bruhanje, zaprtje, preveč plinov (vetrovi) in vnetje želodca, kar vodi do občutka slabosti, izgube apetita in nelagodja po hranjenju,
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 film-coated tablets
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
English: Clopidogrel Teva Pharma B.V. contains lactose.
Slovenian: Klopidogrel Teva Pharma B.V.
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Teva Pharma B.V. 75 mg film-coated tablets clopidogrel
Slovenian: 75 mg filmsko obložene tablete klopidogrel peroralna uporaba
English: Taste disorders
Slovenian: • motnje okušanja,
English: Further information on RoActemra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/RoActemra.
Slovenian: Nadaljnje informacije o zdravilu RoActemra so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/RoActemra.
English: The pack will also include a patient alert card with key safety information for patients.
Slovenian: V izobraževalnem gradivu bo tudi opozorilna kartica s ključnimi varnostnimi informacijami za bolnika.
English: All patients were also treated with a corticosteroid, which was stopped after reducing the dose gradually over 6 or 12 months.
Slovenian: Vsi bolniki so prejeli tudi zdravljenje s kortikosteroidi, ki je bilo prekinjeno po postopnem zmanjševanju odmerka v 6 ali 12 mesecih.
English: RoActemra received a marketing authorisation valid throughout the EU on 16 January 2009.
Slovenian: Za zdravilo RoActemra je bilo 16. januarja 2009 izdano dovoljenje za promet, veljavno po vsej EU.
English: The European Medicines Agency decided that RoActemra's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je menila, da so koristi zdravila RoActemra večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of RoActemra?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila RoActemra?
English: Cytokine release syndrome (CRS)
Slovenian: Sindrom sproščanja citokinov (CRS)
English: RoActemra must not be used in patients who have an active, severe infection.
Slovenian: Zdravilo RoActemra se ne sme uporabljati pri bolnikih z aktivnimi, resnimi okužbami.
English: As for all medicines, data on the use of RoActemra are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila RoActemra stalno spremljajo.
English: Tocilizumab attaches to the receptor for a messenger molecule or ‘cytokine' called interleukin-6.
Slovenian: Tocilizumab se veže na receptor za sporočilno molekulo ali citokin, ki se imenuje interlevkin-6.
English: Other information about RoActemra:
Slovenian: Druge informacije o zdravilu RoActemra:
English: Almost 4,000 patients from these 5 studies went on to enter studies looking at the long-term effects of RoActemra treatment and results showed that response to RoActemra is maintained for at least 2 years.
Slovenian: Skoraj 4 000 bolnikov iz teh petih študij je nato sodelovalo v študijah, ki so proučevale dolgoročne učinke zdravljenja z zdravilom RoActemra, in rezultati so dokazali, da se odziv bolnikov na zdravilo RoActemra ohranja vsaj dve leti.
English: Why is RoActemra authorised in the EU?
Slovenian: Zakaj je bilo zdravilo RoActemra odobreno v EU?
English: Doctors should monitor patients carefully for signs of infection during treatment, and should prescribe RoActemra with caution in patients who have had recurring or long-term infections, or diseases that could increase the risk of infections, such as diverticulitis or diabetes.
Slovenian: Zdravniki morajo bolnike med zdravljenjem z zdravilom RoActemra pozorno spremljati zaradi znakov okužb in zdravilo predpisovati previdno pri bolnikih s ponavljajočimi ali dolgotrajnimi okužbami ali boleznimi, ki bi lahko povečale tveganje za pojav okužb, kakršni sta divertikulitis ali sladkorna bolezen.
English: Patients were allowed to continue treatment with methotrexate during the study.
Slovenian: Med študijo so lahko bolniki še naprej prejemali metotreksat.
English: The most serious side effects are serious infections, complications of diverticulitis (a disease affecting the gut) and hypersensitivity (allergic) reactions.
Slovenian: Najresnejši neželeni učinki so resne okužbe, zapleti divertikulitisa (bolezni, ki prizadene črevesje) in preobčutljivostne (alergijske) reakcije.
English: Side effects reported with RoActemra are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu RoActemra, se skrbno ovrednotijo in po potrebi sprejmejo ukrepi za zaščito bolnikov.
English: RoActemra can also be used in adults and children from 2 years of age for the treatment of severe or life-threatening cytokine release syndrome (CRS, a condition that can cause nausea, vomiting, pain and low blood pressure).
Slovenian: Zdravilo RoActemra se lahko prav tako uporablja pri odraslih in otrocih, starejših od dveh let, za zdravljenje hudega ali življenjsko nevarnega sindroma sproščanja citokinov (CRS, tj. bolezni, ki povzroča slabost, bruhanje, bolečine in nizek krvni tlak).
English: By preventing interleukin-6 attaching to its receptors, tocilizumab reduces the inflammation and other symptoms of these diseases.
Slovenian: Tocilizumab s preprečevanjem vezave interlevkina-6 na ustrezne receptorje zmanjša vnetje in druge simptome teh bolezni.
English: RoActemra is also used to treat adults with giant cell arteritis, a disease in which arteries, usually of the head, are swollen.
Slovenian: Zdravilo RoActemra se uporablja tudi za zdravljenje odraslih z velikoceličnim arteritisom, boleznijo, pri kateri so običajno otečene arterije v glavi.
English: The main measure of effectiveness was based on the number of patients whose CRS resolved within 14 days of the first dose of RoActemra, and who needed no more than two doses of the medicine, and no additional treatment other than corticosteroid medicines.
Slovenian: Glavno merilo učinkovitosti je temeljilo na številu bolnikov, pri katerih je bil sindrom CRS ozdravljen v 14 dneh od prejema prvega odmerka zdravila RoActemra in ki niso potrebovali več kot dveh odmerkov tega zdravila ter nobenega drugega zdravljenja razen kortikosteroidov.
English: For more information about using RoActemra, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila RoActemra glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: An overview of RoActemra and why it is authorised in the EU
Slovenian: Pregled zdravila RoActemra in zakaj je odobreno v EU
English: What are the risks associated with RoActemra?
Slovenian: Kakšna tveganja so povezana z zdravilom RoActemra?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of RoActemra have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila RoActemra upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: What benefits of RoActemra have been shown in studies?
Slovenian: Kakšne koristi je zdravilo RoActemra izkazalo v študijah?
English: The company that markets RoActemra must supply all doctors expected to prescribe the medicine with an educational pack containing important information on the safety and correct use of RoActemra.
Slovenian: Družba, ki trži zdravilo RoActemra, mora vsem zdravnikom, ki naj bi predpisovali to zdravilo, zagotoviti izobraževalno gradivo s pomembnimi informacijami o varni in pravilni uporabi zdravila RoActemra.
English: Juvenile idiopathic polyarthritis
Slovenian: Juvenilni idiopatski poliartritis
English: One year after starting treatment, 56% of patients treated with RoActemra once a week did not have symptoms compared with 14% patients receiving placebo.
Slovenian: Eno leto po začetku zdravljenja 56 % bolnikov, ki so se enkrat tedensko zdravili z zdravilom RoActemra, ni imelo simptomov bolezni v primerjavi s 14 % bolnikov, ki so prejemali placebo.
English: What is RoActemra and what is it used for?
Slovenian: Kaj je zdravilo RoActemra in za kaj se uporablja?
English: RoActemra is a medicine used to treat:
Slovenian: Zdravilo RoActemra se uporablja za zdravljenje:
English: CRS is a side effect of certain cancer treatments and RoActemra is used for CRS caused by chimeric antigen receptors (CAR) T-cell medicines.
Slovenian: Sindrom CRS je stranski učinek nekaterih vrst zdravljenja raka, pri čemer se zdravilo RoActemra uporablja za zdravljenje sindroma CRS, ki ga povzročajo zdravila s himernimi receptorji antigenov (CAR) celic T.
English: RoActemra is used in combination with methotrexate for these conditions but it can be used on its own in patients for whom methotrexate is inappropriate.
Slovenian: Zdravilo RoActemra se pri teh boleznih uporablja skupaj z metotreksatom, vendar se lahko pri bolnikih, za katere metotreksat ni primeren, uporablja samostojno.
English: The most common side effects (occurring in up to 1 patient in 10) with RoActemra are upper respiratory tract infections (nose and throat infection), nasopharyngitis (inflammation of the nose and throat), headache, hypertension (high blood pressure) and abnormal liver function tests.
Slovenian: Najpogostejši neželeni učinki zdravila RoActemra (ki se pojavijo pri več kot 1 bolniku od 10) so okužbe zgornjih dihal (okužbe nosu in grla), nazofaringitis (vnetje nosu in grla), glavobol, hipertenzija (povišan krvni tlak) in neobičajni rezultati testov delovanja jeter.
English: The active substance in RoActemra, tocilizumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific target (called an antigen) in the body.
Slovenian: Učinkovina v zdravilu RoActemra, tocilizumab, je monoklonsko protitelo, tj. vrsta beljakovine, ki je bila zasnovana tako, da prepozna specifično prijemališče (imenovano antigen) v telesu, in se veže nanj.
English: Studies show RoActemra is effective at reducing symptoms of several inflammatory conditions.
Slovenian: V študijah so dokazali, da je zdravilo RoActemra učinkovito pri zmanjševanju simptomov različnih vnetnih bolezni.
English: This messenger is involved with inflammation and is found at high levels in patients with rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis and CRS.
Slovenian: Ta sporočilna molekula sodeluje pri povzročanju vnetja in je prisotna v visokih ravneh pri bolnikih z revmatoidnim artritisom, sistemskim juvenilnim idiopatskim artritisom, juvenilnim idiopatskim poliartritisom, velikoceličnim arteritisom in sindromom sproščanja citokinov.
English: RoActemra can only be obtained with a prescription and treatment should be started by a doctor who has experience in the diagnosis and treatment of the relevant condition.
Slovenian: Predpisovanje in izdaja zdravila RoActemra je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem zadevne bolezni.
English: The other study, which compared RoActemra injected under the skin with RoActemra given by infusion, showed that RoActemra injected under the skin was no less effective in achieving a response after 6 months.
Slovenian: Druga študija, v kateri so primerjali injiciranje zdravila RoActemra pod kožo z dajanjem zdravila z infuzijo, je pokazala, da zdravilo, injicirano v podkožje, po šestih mesecih ni bilo nič manj učinkovito pri doseganju odziva.
English: • adults with moderate to severe active rheumatoid arthritis whose previous treatments with disease modifying antirheumatic drugs (DMARDs), such as methotrexate or medicines known as tumour necrosis factor (TNF) blockers, have not worked well or were not tolerated;
Slovenian: • zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih, katerih predhodno zdravljenje z imunomodulirajočimi antirevmatičnimi zdravili (zdravili iz skupine DMARD), kot je metotreksat, ali zdravili, znanimi kot zaviralci tumorje nekrotizirajočega faktorja (TNF), ni bilo dovolj uspešno oziroma takšnega zdravljenja niso prenašali;
English: The fifth study involving 673 patients showed that patients receiving RoActemra on its own were more likely to respond than those taking methotrexate on its own.
Slovenian: V peti študiji, ki je zajela 673 bolnikov, so dokazali, da je obstajala pri bolnikih, ki so prejemali samo zdravilo RoActemra, večja verjetnost, da se bodo nanj odzvali, kot pri bolnikih, ki so jemali samo metotreksat.
English: In the fourth study, which included 498 patients who had an inadequate response to TNF blockers, patients receiving RoActemra with methotrexate were around 9 times more likely to respond than those receiving placebo with methotrexate.
Slovenian: V četrti študiji pri 498 bolnikih, ki se niso zadostno odzvali na zaviralce tumorje nekrotizirajočega faktorja, so se bolniki, ki so prejemali zdravilo RoActemra z metotreksatom, približno devetkrat pogosteje odzvali na zdravljenje kot bolniki, ki so prejemali placebo z metotreksatom.
English: In this study 85% (64 out of 75) patients treated with RoActemra responded to treatment and no longer had fever after 3 months, compared with 24% (9 out of 37) patients receiving placebo.
Slovenian: V tej študiji se je 85 % (64 od 75) bolnikov, zdravljenih z zdravilom RoActemra, odzvalo na zdravljenje in po treh mesecih niso imeli več povišane telesne temperature v primerjavi s 24 % (9 od 37) bolnikov, ki so prejemali placebo.
English: In severe rheumatoid arthritis not previously treated with methotrexate, RoActemra given by infusion was investigated in one main study involving 1,162 patients.
Slovenian: Pri hudem revmatoidnem artritisu, ki še ni bil zdravljen z metotreksatom, so zdravilo RoActemra, dano z infundiranjem, raziskovali v eni glavni študiji, v katero je bilo vključenih 1 162 bolnikov.
English: RoActemra is available as a solution to be injected under the skin and as a concentrate for making a solution for infusion (drip) into a vein.
Slovenian: Zdravilo RoActemra je na voljo v obliki raztopine za injiciranje pod kožo in koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: • adults with severe rheumatoid arthritis that is getting worse in patients who have not been previously treated with a medicine called methotrexate;
Slovenian: • hudega, slabšajočega se revmatoidnega artritisa pri odraslih bolnikih, ki se predhodno niso zdravili z metotreksatom;
English: RoActemra given by injection under the skin was investigated in two studies involving 1,918 patients with moderate to severe rheumatoid arthritis where previous treatment with DMARD had not worked well.
Slovenian: Zdravilo RoActemra, ki se injicira pod kožo, so raziskovali tudi v dveh študijah, pri katerih je sodelovalo 1 918 bolnikov z zmernim ali hudim revmatoidnim artritisom, pri katerih predhodno zdravljenje z zdravilom is skupine DMARD ni bilo učinkovito.