FrancophonIA/ELRC3.0 huggingface dataset:
English: Cases of hepatitis B reactivation, including those with a fatal outcome, have been reported in rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis patients receiving rituximab.
Croatian: U bolesnika s reumatoidnim artritisom, granulomatozom s poliangiitisom i mikroskopskim poliangiitisom koji su primali rituksimab prijavljeni su slučajevi reaktivacije hepatitisa B, uključujući one sa smrtnim ishodom.
English: and 6
Croatian: 3 godine
English: Physician information
Croatian: KLINIČKI PODACI
English: How Ritemvia is given How it is given
Croatian: Kako se primjenjuje lijek Ritemvia Kako se Ritemvia primjenjuje
English: Ritemvia 100 mg concentrate for solution for infusion Rituximab
Croatian: Ritemvia 100 mg koncentrat za otopinu za infuziju rituksimab
English: PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS Ritemvia (Rituximab) Alert Card for patients with non-oncology diseases Why have I been given this card?
Croatian: Ritemvia (rituksimab) kartica s upozorenjima za bolesnike s neonkološkim bolestima
English: respiratory failure4
Croatian: zatajenje dišnog sustava4
English: Headache Dizziness
Croatian: I DOHVATA
English: Hypogammaglobulinaemia (IgG or IgM below the lower limit of normal) has been observed in RA patients treated with rituximab.
Croatian: U bolesnika s reumatoidnim artritisom liječenih rituksimabom zabilježena je hipogamaglobulinemija (IgG ili IgM ispod donje granice normalnih vrijednosti).
English: Cases of progressive multifocal leukoencephalopathy with fatal outcome have been reported following use of rituximab for the treatment of autoimmune diseases.
Croatian: Nakon primjene rituksimaba u liječenju autoimunih bolesti prijavljeni su slučajevi progresivne multifokalne leukoencefalopatije sa smrtnim ishodom.
English: Treatment difference (Rituximabcyclophosphamide)
Croatian: (rituksimabciklofosfamid)
English: B. PACKAGE LEAFLET
Croatian: Opservacijska Rituksimab skupina
English: The incidence of ADRs of all grades and grade 3/4 ADR was similar in elderly patients compared to younger patients (< 65 years).
Croatian: Stariji bolesnici (≥ 65 godina): Incidencija nuspojava svih stupnjeva i nuspojava stupnja 3/4 bila je slična u starijih i mlađih bolesnika
English: • short term increase in the amount of some types of anti-bodies in the blood (called immunoglobulins - IgM), chemical disturbances in the blood caused by break-down of dying cancer cells
Croatian: mučnina mjesta na vlasištu bez kose, zimica, glavobolja oslabljen imunitet - posljedica niskih razina protutijela zvanih „imunoglobulini“ (IgG) u krvi; imunoglobulini pomažu u zaštiti od infekcije
English: Kern Pharma, S.L.
Croatian: NAPP Pharmaceuticals Ltd.
English: • flushing or redness of the skin
Croatian: • crvenilo praćeno osjećajem vrućine ili crvenilo kože vrućica
English: Hypertension Flushing
Croatian: Krvožilni poremećaji hipertenzija navale crvenila
English: In a multicentre, single-arm trial, 58 patients with relapsed or chemoresistant low grade or follicular B cell NHL, who had achieved an objective clinical response to a prior course of rituximab, were re-treated with 375 mg/m2 of rituximab as intravenous infusion weekly for four doses.
Croatian: B-staničnim ne-Hodgkinovim folikularnim limfomom ili limfomom niskog stupnja malignosti, u kojih je postignut očekivan klinički odgovor na prethodno liječenje rituksimabom, ponovno liječeno rituksimabom u dozi od 375 mg/m2 putem intravenske infuzije jedanput tjedno tijekom četiri tjedna.
English: A higher proportion of patients receiving the original rituximab/MTX treatment also had no erosive progression over 56 weeks (Table 13).
Croatian: Također, tijekom tih 56 tjedana erozija nije napredovala u većem udjelu bolesnika koji su od početka liječeni rituksimabom i metotreksatom (Tablica 13).
English: Table 3 Adverse drug reactions occurring at 6-months in ≥ 5% of patients receiving rituximab for induction of remission of GPA and MPA, and at a higher frequency than the comparator group.
Croatian: Tablica 3 Nuspojave koje su u 6 mjeseci nastupile u ≥ 5 % bolesnika koji su primali lijek rituksimab za poticanje remisije GPA i
English: The overall incidence of IRRs in clinical trials was 23% with the first infusion and decreased with subsequent infusions.
Croatian: Ukupna incidencija reakcija povezanih s infuzijom u kliničkim ispitivanjima bila je 23 %
English: Please talk to your doctor or nurse if you have any questions about the information in this card.
Croatian: Ako imate bilo kakvih pitanja o informacijama u ovoj kartici, obratite se svom liječniku ili medicinskoj sestri.
English: At minimum this should include HBsAg-status and HBcAb-status.
Croatian: Potrebno je najmanje odrediti status HBsAg i HBcAb, a testiranje se može dopuniti i određivanjem drugih odgovarajućih biljega, sukladno lokalnim smjernicama.
English: Diarrhoea Dyspepsia Constipation
Croatian: Poremećaji probavnog sustava proljev dispepsija konstipacija
English: Patient's
Croatian: Liječnik
English: Eye disorders lacrimation disorder, conjunctivitis severe vision loss5
Croatian: konjunktivitis težak gubitak vida5
English: Manufacturer
Croatian: Mađarska Proizvođač
English: Non-Hodgkin's lymphoma and chronic lymphocytic leukaemia
Croatian: Ne-Hodgkinov limfom Folikularni ne-Hodgkinov limfom Kombinirano liječenje
English: Gastrointestinal perforation in some cases leading to death has been observed in patients receiving rituximab for treatment of non-Hodgkin's lymphoma.
Croatian: U bolesnika koji su primali rituksimab za liječenje ne-Hodgkinova limfoma zabilježene su gastrointestinalne perforacije, u nekim slučajevima sa smrtnim ishodom.
English: log-rank p value hazard ratio (95% CI) risk reduction
Croatian: (medijan) log-rang p-vrijednost omjer hazarda (95% CI) smanjenje rizika Sekundarna djelotvornost
English: Closely monitor patients with pre-existing cardiac conditions and those who experienced prior cardiopulmonary adverse reactions.
Croatian: Bolesnike s postojećim srčanim tegobama i one koji su ranije imali nuspojave na srcu i plućima treba strogo nadzirati.
English: Muscle weakness Musculoskeletal pain Pain in extremities
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva grčevi mišića artralgija bol u leđima mišićna slabost bol u kostima i mišićima bol u udovima
English: In the overall experience of rituximab repeat treatment over one year in rheumatoid arthritis, the proportions of patients with positive antibody titres against S. pneumoniae, influenza, mumps, rubella, varicella and tetanus toxoid were generally similar to the proportions at baseline.
Croatian: S. pneumoniae, influence, zaušnjaka, rubele, varičele i toksoida tetanusa općenito bili slični udjelima na početku liječenja.
English: Hyperkalaemia
Croatian: LDH-a, hipokalcijemija
English: • severe vision loss
Croatian: zatajenje bubrega težak gubitak vida
English: No serious IRRs were observed.
Croatian: Nisu opažene ozbiljne reakcije povezane s infuzijom.
English: Severe IRRs with fatal outcome have been reported in rheumatoid arthritis patients in the post-marketing setting.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi teških infuzijskih reakcija sa smrtnim ishodom u bolesnika s reumatoidnim artritisom.
English: Common
Croatian: American
English: The pharmacokinetic (PK) parameters in the anti-TNF inadequate responder population, following the same dosage regimen (2 × 1000 mg, IV, 2 weeks apart), were similar with a mean maximum serum concentration of 369 μg/mL and a mean terminal half-life of 19.2 days.
Croatian: inhibitorom su uz isti režim doziranja (2 x 1000 mg, intravenski, u razmaku od dva tjedna) bili slični,
English: Gastrointestinal dyspepsia, diarrhoea,
Croatian: dispneja, pojačan kašalj, rinitis astma,
English: Bronchitis Rhinitis
Croatian: obliterirajući bronhiolitis,
English: In a multicentre, single-arm trial, 37 patients with relapsed or chemoresistant, low grade or follicular B cell NHL received 375 mg/m2 of rituximab as intravenous infusion weekly for eight doses.
Croatian: U objedinjenim podacima iz tri ispitivanja 39 bolesnika s relapsirajućim ili kemorezistentnim proširenim ne-Hodgkinovim limfomom (promjer jedne lezije ≥ 10 cm) niskog stupnja malignosti ili folikularnim B-staničnim ne-Hodgkinovim limfomom je primilo rituksimab u dozi od 375 mg/m2
English: Ritemvia is used for the treatment of patients with moderate to severe pemphigus vulgaris.
Croatian: c) običnog pemfigusa Ritemvia se primjenjuje za liječenje bolesnika s umjerenim do teškim običnim pemfigusom.
English: A small number of cases of hepatitis B reactivation, some with fatal outcome, have been reported in granulomatosis with polyangiitis and microscopic polyangiitis patients receiving rituximab in the postmarketing setting.
Croatian: U bolesnika s granulomatozom s poliangiitisom i mikroskopskim poliangiitisom koji su primali rituksimab nakon njegova stavljanja u promet prijavljen je malen broj slučajeva reaktivacije hepatitisa B,
English: Diluted product
Croatian: Razrijeđen lijek
English: Duration of response* Disease free survival (DFS)** Time to new treatment
Croatian: TTF - vrijeme do prestanka učinka liječenja (engl.
English: Dyspnoea
Croatian: Cijepljenje
English: Respiratory, thoracic and mediastinal disorders bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis asthma, bronchiolitis obliterans, lung disorder, hypoxia interstitial lung disease7
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja bronhospazam4, bolest dišnog sustava, bol u prsnom košu,
English: NAPP Pharmaceuticals Ltd. Tel: +44 1223 424444
Croatian: Tel: +44 1223 424444
English: Clinical laboratory findings
Croatian: Odstupanja laboratorijskih nalaza
English: Tel: +386 1 519 29 22
Croatian: OPH Oktal Pharma d.o.o. Tel: +386 1 519 29 22
English: • respiratory failure
Croatian: Srčani poremećaji
English: Always take your medicines exactly as your doctor has told you.
Croatian: Uvijek uzmite lijekove točno onako kako Vam je rekao liječnik.
English: When this happens, it is called ‘response'.
Croatian: Kada se to dogodi, tada se to naziva „odgovorom na liječenje“.
English: • at least every month after that for as long as you are taking Imnovid.
Croatian: • najmanje svaki mjesec nakon toga onoliko dugo koliko uzimate Imnovid.
English: Overall Survival was the key secondary study endpoint.
Croatian: Ukupno preživljenje bilo je ključni sekundarni ishod ispitivanja.
English: Children and adolescents Imnovid is not recommended for use in children and young people under 18 years.
Croatian: Djeca i adolescenti Imnovid se ne preporučuje za uporabu u djece i mladih ispod 18 godina.
English: Talk to your doctor about the best method of contraception for you.
Croatian: Razgovarajte s liječnikom o najboljoj metodi kontracepcije za Vas.
English: Imnovid works in a number of different ways:
Croatian: Imnovid djeluje na brojne različite načine:
English: Multiple myeloma generally cannot be cured.
Croatian: Multipli mijelom se uglavnom ne može izliječiti.
English: What Imnovid is and what it is used for
Croatian: Što je Imnovid i za što se koristi
English: You and your partner should use effective methods of contraception while taking this medicine.
Croatian: Vi i Vaš partner trebate koristiti učinkovite metode kontracepcije dok uzimate taj lijek.
English: • Increased blood pressure.
Croatian: • povišen krvni tlak
English: If you take more Imnovid than you should
Croatian: Ako uzmete više Imnovida nego što ste trebali
English: • Take Imnovid at about the same time each day.
Croatian: • Uzimajte Imnovid otprilike u isto vrijeme svakoga dana.
English: Based on these results, the observed effects were attributed to the treatment of females.
Croatian: Na temelju tih rezultata, opaženi učinci pripisani su liječenju ženki.
English: Key elements to be included
Croatian: Glavni elementi koje je potrebno uključiti
English: See also section 4 “Possible side effects”).
Croatian: Pogledajte također dio 4. „Moguće nuspojave“).
English: However, treatment can reduce the signs and symptoms of the disease, or make them disappear for a period of time.
Croatian: Međutim, liječenje može smanjiti znakove i simptome bolesti i učiniti da oni na neko vrijeme nestanu.
English: You may also experience an uneven heartbeat.
Croatian: Možete osjetiti i neujednačene otkucaje srca.
English: Day (of 21-day cycle)
Croatian: Dan (21-dnevnog ciklusa)
English: Your partner should also tell her doctor straight away.
Croatian: Vaša partnerica također treba odmah obavijestiti svojega liječnika.
English: Note: CI=Confidence interval.
Croatian: Napomena: CI = interval pouzdanosti.
English: 30 September 2021
Croatian: 30. rujna 2021.
English: Your doctor should ask you to have a blood test:
Croatian: Liječnik će od Vas zatražiti da obavite pretrage krvi:
English: Imnovid hard capsules should be taken orally at the same time each day.
Croatian: Imnovid tvrde kapsule treba uzimati peroralno u isto vrijeme svakoga dana.
English: Your doctor should check whether you have ever had hepatitis B infection.
Croatian: Liječnik mora provjeriti jeste li ikada imali infekciju hepatitisom B.
English: • you have ever had blood clots in the past.
Croatian: • Ako ste ikad prije imali krvne ugruške.
English: Final clinical study report:
Croatian: Završni izvještaj o kliničkom ispitivanju:
English: • if you are allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6).
Croatian: • Ako ste alergični na pomalidomid ili bilo koji drugi sastojak tog lijeka (navedeni u dijelu 6).
English: Each cycle lasts 28 days (4 weeks).
Croatian: Svaki ciklus traje 28 dana (4 tjedna).
English: Before starting the treatment, you should tell your doctor if you are able to become pregnant, even if you think this is unlikely.
Croatian: Prije početka liječenja trebate obavijestiti svojega liječnika možete li zatrudnjeti, čak i ako mislite da to nije vjerojatno.
English: The difference in OS between the two treatment arms was statistically significant (p < 0.001).
Croatian: Razlika u ukupnom preživljenju između dvije terapijske skupine bila je statistički značajna (p<0,001).
English: What you need to know before you take Imnovid
Croatian: Što morate znati prije nego počnete uzimati Imnovid
English: In these studies, monkeys exhibited greater sensitivity to pomalidomide effects than rats.
Croatian: U tim su ispitivanjima majmuni pokazali veću osjetljivost na učinke pomalidomida nego štakori.
English: The capsules should not be opened, broken or chewed (see section 6.6).
Croatian: Kapsule se ne smiju otvarati, lomiti ili žvakati (vidjeti dio 6.6).
English: Action should be taken to try to minimise all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Croatian: Treba poduzeti mjere kako bi se smanjili svi promjenjivi čimbenici rizika (npr. pušenje, hipertenzija i hiperlipidemija).
English: • Do not take this medicine if you are pregnant or could become pregnant.
Croatian: • Nemojte uzimati taj lijek ako ste trudni ili biste mogli zatrudnjeti.
English: Follow CBC*** weekly.
Croatian: Tjedno pratiti KKS***.
English: • The need to avoid fetal exposure
Croatian: • potreba za izbjegavanjem fetalne izloženosti
English: • You can take the capsules either with or without food.
Croatian: • Kapsule možete uzeti s hranom ili bez nje.
English: WARNING: Risk of severe birth defects.
Croatian: UPOZORENJE: Rizik od teških prirođenih oštećenja.
English: If you forget to take Imnovid on a day when you should, take your next capsule as normal the next day.
Croatian: Ako ste zaboravili uzeti Imnovid na dan kad ste to trebali učiniti, sljedeću kapsulu uzmite u uobičajeno vrijeme sljedećega dana.
English: • High blood levels of sugar.
Croatian: • visoke razine šećera u krvi
English: Date of first authorisation: 05 August 2013 Date of latest renewal: 11 July 2018
Croatian: Datum posljednje obnove odobrenja: 11. srpnja 2018.
English: • That the patient should not give pomalidomide to any other person
Croatian: • da bolesnik ne smije davati pomalidomid bilo kojoj drugoj osobi
English: The systemic exposure (AUC) of pomalidomide increases in an approximately linear and dose proportional manner.
Croatian: Sustavna izloženost (AUC) pomalidomida povećava se približno linearno i proporcionalno s porastom doze.
English: • certain antidepressants such as fluvoxamine.
Croatian: • određene antidepresive kao što je fluvoksamin.
English: Patients should be advised to report febrile episodes promptly.
Croatian: Bolesnicima treba savjetovati da što prije prijave febrilne epizode.
English: When treated males on this study were mated with untreated females, all uterine parameters were comparable to the controls.
Croatian: Kad su se liječeni mužjaci iz ovog ispitivanja parili s neliječenim ženkama, svi uterini parametri bili su usporedivi s kontrolama.
English: If you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and will provide you with this confirmation.
Croatian: Ako možete zatrudnjeti, Vaš liječnik će uz svaki recept zabilježiti da su poduzete potrebne mjere i dati Vam tu potvrdu.
English: Based on Cox proportional hazards model.
Croatian: Na temelju Coxovog modela proporcionalnih hazarda.
English: Each cycle lasts 21 days (3 weeks).
Croatian: Svaki ciklus traje 21 dan (3 tjedna).
English: • you have a high total amount of tumour throughout the body, including your bone marrow.
Croatian: • Ako imate veliku ukupnu količinu tumora u tijelu, uključujući koštanu srž.
English: • National or other applicable specific arrangements for a prescription for pomalidomide to be dispensed
Croatian: • nacionalne i druge primjenjive specifične dogovore za recept za izdavanje pomalidomida
English: • each time your doctor writes a prescription for you, he will ensure you understand the necessary measures that have to be taken to prevent pregnancy.
Croatian: • Svaki put kad Vam liječnik napiše recept, provjerit će jeste li razumjeli neophodne mjere koje se moraju poduzeti kako bi se spriječila trudnoća.
English: Dosing is continued or modified based upon clinical and laboratory findings (see section 4.4).
Croatian: Doziranje se nastavlja ili mijenja na temelju kliničkih i laboratorijskih nalaza (vidjeti dio 4.4).
English: Two sided 95% CIb
Croatian: dvostrani 95% CIb
English: This medicine is related to thalidomide and belongs to a group of medicines which affect the immune system (the body's natural defences).
Croatian: Ovaj je lijek srodan talidomidu i pripada skupini lijekova koji utječu na imunosni sustav (prirodna obrana organizma).
English: If you forget to take Imnovid
Croatian: Ako ste zaboravili uzeti Imnovid
English: Duration of the treatment with Imnovid You should continue the cycles of treatment until your doctor tells you to stop.
Croatian: Trajanje liječenja Imnovidom Cikluse liječenja ponavljajte sve dok Vam liječnik ne kaže da prestanete.
English: • Need for effective contraception and definition of effective contraception
Croatian: • potreba za djelotvornom kontracepcijom i definicijom djelotvorne kontracepcije
English: It is important to note that patients with multiple myeloma treated with pomalidomide may develop additional types of cancer, therefore your doctor should carefully evaluate the benefit and risk when you are prescribed this medicine.
Croatian: Važno je napomenuti da bolesnici s multiplim mijelomom liječeni pomalidomidom mogu razviti dodatne vrste raka, stoga Vaš liječnik treba pomno procijeniti dobrobit i rizik kada Vam propisuje taj lijek.
English: • She understands the expected teratogenic risk to the unborn child
Croatian: • žena razumije očekivani teratogeni rizik za nerođeno dijete
English: • Feeling down (depressed mood).
Croatian: • osjećaj potištenosti (depresivno raspoloženje)
English: If you suffer from liver or kidney problems your doctor will check your condition very carefully whilst you are receiving this medicine.
Croatian: Ako imate tegobe s jetrom ili bubrezima, liječnik će vrlo pažljivo provjeravati Vaše stanje dok uzimate taj lijek.
English: Other medicines and Imnovid
Croatian: Drugi lijekovi i Imnovid
English: If this happens to you, do not drive or operate tools or machinery.
Croatian: Ako Vam se to dogodi, nemojte voziti ni rukovati alatima ili strojevima.
English: However, if you are over 75, the recommended starting dose is 10 mg per day.
Croatian: Međutim, ako imate više od 75 godina, preporučena početna doza iznosi 10 mg na dan.
English: • Loss of consciousness, fainting.
Croatian: • gubitak svijesti, nesvjestica
English: Do not increase the number of capsules you take to make up for not taking Imnovid the previous day.
Croatian: Nemojte povećati broj kapsula koje ćete uzeti kako biste nadoknadili dozu Imnovida koju niste uzeli prethodnog dana.
English: • After completing each 3-week cycle, start a new one.
Croatian: • Nakon završetka svakog 3-tjednog ciklusa, započnite novi.
English: Infection was the most common non haematological toxicity.
Croatian: Infekcija Infekcija je bila najčešća nehematološka toksičnost.
English: You must follow the Imnovid Pregnancy Prevention Programme.
Croatian: Morate se pridržavati Programa prevencije trudnoće za Imnovid.
English: There is no relevant use of pomalidomide in children aged 0-17 years for the indication of multiple myeloma.
Croatian: Nema relevantne primjene pomalidomida u djece u dobi od 0 do 17 godina za indikaciju multiplog mijeloma.
English: Pomalidomide should only be resumed after a thorough evaluation of the benefits and the risks.
Croatian: S primjenom pomalidomida se može nastaviti samo nakon temeljite procjene koristi i rizika.
English: • Sore or dry mouth.
Croatian: • bolna ili suha usta
English: • After completing each 4-week cycle, start a new one.
Croatian: • Nakon završetka svakog 4-tjednog ciklusa, započnite novi.
English: Direct Healthcare Professional Communications (Prior to Launch)
Croatian: Pisma zdravstvenim radnicima (prije početka izdavanja)
English: Summary of overall efficacy data are presented in Table 10 using a cut-off date of 26 Oct 2017.
Croatian: Sažetak ukupnih podataka djelotvornosti prikazan je u tablici 10 do datuma prestanka prikupljanja podataka 26. listopada 2017.
English: Do not apply pressure on the centre of the capsule as this can cause it to break.
Croatian: Nemojte kapsulu pritisnuti na sredini jer je tako možete slomiti.
English: Pomalidomide must not be taken during pregnancy, since a teratogenic effect is expected.
Croatian: Pomalidomid se ne smije uzimati u trudnoći jer se očekuje teratogeni učinak.
English: Patients must avoid situations where dizziness or confusion may be a problem and not to take other medicinal products that may cause dizziness or confusion without first seeking medical advice.
Croatian: Bolesnici moraju izbjegavati situacije u kojima bi omaglica ili konfuzija mogle predstavljati teškoću te ne smiju uzimati druge lijekove koji mogu prouzročiti omaglicu ili konfuziju ako prije toga nisu zatražili savjet liječnika.
English: Genotoxicity/carcinogenicity
Croatian: Genotoksičnost/kancerogenost
English: In the event of overdose, supportive care is advised.
Croatian: U slučaju predoziranja preporučuje se potporno liječenje.
English: No metabolites were present at >10% relative to parent or total radioactivity in plasma.
Croatian: Nije bilo prisutnih metabolita u postotku većem od >10% u odnosu na prekursor ili ukupnu radioaktivnost u plazmi.
English: Cycle 1 to 8
Croatian: Od 1. do 8. ciklusa
English: This requirement includes women of childbearing potential who practice absolute and continuous abstinence.
Croatian: Taj zahtjev uključuje žene reproduktivne dobi koje primjenjuju apsolutnu i neprekidnu apstinenciju.
English: Regardless of the subgroup evaluated, PFS was generally consistent with that observed in the ITT population for both treatment groups.
Croatian: Bez obzira na procjenjivanu podskupinu, PFS je većinom bio u skladu s onim u analizi ITT populacije u obje terapijske skupine.
English: Men Imnovid passes into human semen.
Croatian: Muškarci Imnovid prelazi u ljudsko sjeme.