FrancophonIA/ELRC3.0 huggingface dataset:
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² single agent
Croatian: Tablični popis nuspojava kod karcinoma dojke za Docetaksel 100 mg/m² u monoterapiji
English: Docetaxel Teva is supplied as single-dose vials.
Croatian: Teva je dostupan u jednodoznim bočicama.
English: Primary G-CSF prophylaxis should be considered in patients who receive docetaxel, doxorubicin and cyclophosphamide (TAC) adjuvant therapy for breast cancer.
Croatian: U bolesnika koji primaju docetaksel, doksorubicin i ciklofosfamid (TAC) kao adjuvantnu terapiju u liječenju karcinoma dojke, treba razmotriti primarnu profilaksu s G-CSF.
English: Hazard ratio (95% CI) **p-value
Croatian: Omjer rizika (95% CI) **p-vrijednost
English: Fatigue (G3/4: 3.9%); Fluid retention (severe: 0.6%)
Croatian: vrućica (G3/4: 2,3%); retencija tekućine (teška/opasna po život: 1%)
English: Nausea (G3/4:13.9%);
Croatian: Poremećaji probavnog sustava mučnina (G 3/4: 13,9%);
English: Skin reaction (G3/4:
Croatian: retencija tekućine (G3/4:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Docetaxel Teva 20 mg/0.72 ml
Croatian: Otapalo za Docetaksel Teva 20 mg/0,72 ml
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Teva 20 mg/0.72 ml concentrate and solvent for solution for infusion
Croatian: Uputa o lijeku: Informacije za bolesnika Docetaksel Teva 20 mg/0,72 ml koncentrat i otapalo za otopinu za infuziju docetaksel
English: This vial contains 0.72 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.88 ml).
Croatian: 27,73 mg/ml (volumen punjenja 24,4 mg/0,88 ml).
English: Tabulated list of adverse reactions in head and neck cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Croatian: Tablični popis nuspojava za Docetaksel 75 mg/m2 u kombinaciji s cisplatinom i 5-fluorouracilom za terapiju karcinoma glave i vrata
English: Syncope (G3/4: 0%); Neurotoxicity (G3/4:
Croatian: (G3/4:0%); somnolencija (G3/4:
English: Fatigue/ weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
Croatian: Opći poremećaji i reakcije na mjestu primjene astenija (G3/4: 3%); pireksija (G3/4: 1%); umor/slabost (G3/4: 5%); periferni edem (G3/4: 1%)
English: No of positive nodes Overall
Croatian: Broj pozitivnih limfnih čvorova
English: G3/4 Blood bilirubin increased (< 5%);
Croatian: G3/4 povećanje bilirubina u krvi (<5%); G3/4 povećanje alkalne fosfataze u krvi (<4%);
English: in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm.
Croatian: Na kraju perioda praćenja (medijan vremena praćenja iznosio je 10 godina i 5 mjeseci), alopecija je i dalje bila prisutna u 3 bolesnika (0,6%) u TAC skupini, te u 1 bolesnika (0,2%) u FAC skupini.
English: Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Croatian: prsišta i sredoprsja epistaksa (G3/4: 0%); dispneja (G3/4: 0,6%); kašalj (G3/4: 0%)
English: Hypersensitivity (G3/4: 1.7%)
Croatian: proljev (G3/4: 1,7%)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: Česte nuspojave Manje česte nuspojave
English: Febrile neutropenia (G3/4: NA)
Croatian: vrućica (G3/4: ND);
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.88 ml (Fill: 3.40 ml)
Croatian: 2,88 ml (Punjenje 3,40 ml)
English: Nausea (G3/4: 3.3%);
Croatian: stomatitis (G3/4: 23,7%);
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Croatian: Tablični popis nuspojava za Docetaksel 75 mg/m² u kombinaciji s cisplatinom i 5-fluorouracilom u terapiji adenokarcinoma želuca
English: Lethargy (G3/4: 4.0%); Pyrexia (G3/4: 3.6%); Fluid retention (G3/4:
Croatian: Opći poremećaji i reakcije na mjestu primjene letargija (G3/4: 4,0%); pireksija (G3/4: 3,6%);
English: Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%)
Croatian: Poremećaji krvi i limfnog sustava neutropenija (G4: 54,2%); anemija (G3/4: 10,8%); trombocitopenija (G4: 1,7 %)
English: Diarrhoea (G3/4: Vomiting (G3/4: 0.6%)
Croatian: hipotenzija (G3/4: flebitis (G3/4: 0%)
English: Polysorbate 80
Croatian: Koncentrat polisorbat 80 etanol, bezvodni
English: What the solvent vial contains: Water for injections.
Croatian: Teva sadrži vodu za injekcije.
English: Best overall response (CR + PR) to study treatment [chemotherapy +/chemoradiotherapy] (%) (95%CI) ***p-value
Croatian: Najbolji ukupni odgovor (CR + PR) na liječenje tijekom studije [kemoterapija +/
English: Dysgeusia (G3/4: <1%); Paraesthesia (G3/4: <1%)
Croatian: dermatitis eritematozni osip (G 3/4: <1%) promjena boje nokta; oniholiza (G 3/4: 1%)
English: Solvent vial: water for injections.
Croatian: Teva je voda za injekcije.
English: Myalgia (severe: 1.4%) Arthralgia
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva mijalgija (teška: 1,4%) artralgija
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Docetaxel Teva 80 mg/2.88 ml concentrate contains 80 mg docetaxel.
Croatian: Jedana bočica s koncentratom Docetaksel Teva sadrži 80 mg/2,88 ml docetaksela.
English: Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe
Croatian: Poremećaji živčanog sustava periferna senzorna neuropatija (G3/4: 1,2%); disgeuzija (G3/4: 0%)
English: Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel 75 mg/m² single agent MedDRA system organ classes
Croatian: Tablični popis nuspojava kod karcinoma nemalih stanica pluća za Docetaksel 75 mg/m² u monoterapiji
English: Dry skin;
Croatian: kožna toksičnost
English: Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Croatian: Opći poremećaji i reakcije na mjestu primjene letargija (G3/4: 3,4%); pireksija (G3/4: 0,6%);
English: The solvent for Docetaxel Teva is water for injections.
Croatian: Docetaksel Teva otopine za infuziju
English: 2-year estimate (%) Hazard ratio (95% CI) *p-value
Croatian: Medijan preživljenja (mjeseci) (95% CI) dvogodišnja procjena (%) Omjer rizika (95% CI) *p-vrijednost
English: Anaemia (G3/4: 9.2%); Thrombocytopenia (G3/4: 5.2%)
Croatian: Poremećaji krvi i limfnog sustava neutropenija (G3/4: anemija (G3/4: 9,2%); trombocitopenija (G3/4: 5,2%)
English: The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin 75 mg/m2, as a 1-to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg /m2 per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Croatian: SCCHN), preporučena doza docetaksela iznosi 75 mg/m2 i daje se kao jednosatna intravenska infuzija na prvi dan, nakon čega slijedi cisplatin 100 mg/m2 primjenjen kao 30-minutna do 3 satna infuzija.
English: • chest tightness; difficulty in breathing
Croatian: • bol u trbuhu • probavne tegobe
English: Myalgia; Arthralgia; Pain in extremity; Bone pain; Back pain
Croatian: prsišta i sredoprsja epistaksa; bol u ždrijelu i grkljanu; nazofaringitis, dispneja; kašalj; rinoreja
English: Stomatitis (G3/4: 23.7%); Vomiting (G3/4: 14.3%)
Croatian: mučnina (G 3/4: 4%); povraćanje (G 3/4: 3%)
English: In a phase III study, 1,218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.
Croatian: Ispitivanje faze III provedeno je na 1218 bolesnika s neoperabilnim karcinomom nemalih stanica pluća stadija IIIB ili IV s KPS od 70% ili više, koji nisu ranije primali kemoterapiju za tu bolest.
English: At the median follow-up time of 77 months, overall survival (OS) was longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29).
Croatian: Pri medijanu vremena praćenja od 77 mjeseci ukupno ukupno preživljenje (OS) također je bilo duže u bolesnika u TAC skupini, uz 24% smanjenje rizika od smrti u usporedbi s bolesnicima u FAC skupini
English: Patients with operable node-negative breast cancer eligible to receive chemotherapy (GEICAM 9805) Data from a multi-centre open-label randomised trial support the use of Docetaxel for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Croatian: Docetaksel u kombinaciji s doksorubicinom i ciklofosfamidom: adjuvantno liječenje Bolesnici s operabilnim karcinomom dojke i pozitivnim limfnim čvorovima (TAX 316) Podaci iz multicentričnog, otvorenog, randomiziranog ispitivanja podupiru primjenu docetaksela za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i pozitivnim limfnim čvorovima te s
English: Myalgia (severe: 0.5%)
Croatian: (teška: 0,7%)
English: Anaemia (G3/4: 10.8%);
Croatian: povraćanje (G3/4: 0,8%);
English: Stomatitis (G3/4: 5.3%); Diarrhoea (G3/4: 4%);
Croatian: Poremećaji probavnog sustava stomatitis (G3/4: proljev (G 3/4: 4%);
English: Hand-foot syndrome (G3/4: Alopecia (G3/4: 6%);
Croatian: stomatitis (G3/4: proljev (G3/4: 6,2%);
English: Discard unused contents appropriately.
Croatian: Neiskorišteni lijek treba odgovarajuće zbrinuti.
English: Further information on Vizimpro can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/vizimpro.
Croatian: Više informacija o lijeku Vizimpro nalazi se na internetskim stranicama Agencije: www.ema.europa.eu/medicines/human/EPAR/vizimpro.
English: Vizimpro is available as tablets (15, 30 and 45 mg).
Croatian: Lijek Vizimpro dostupan je u obliku tableta (od 15, 30 i 45 mg).
English: Vizimpro (dacomitinib)
Croatian: Vizimpro (dakomitinib)
English: The patient should normally take a 45-mg tablet once a day, at around the same time every day, for as long as they benefit from it and the side effects are tolerable.
Croatian: Bolesnik bi trebao uzimati tabletu od 45 mg jedanput na dan, otprilike u isto vrijeme svakoga dana, sve dok su vidljive koristi od lijeka i dok su nuspojave podnošljive.
English: Vizimpro (dacomitinib) EMA/89209/2019
Croatian: Vizimpro (dakomitinib) EMA/89209/2019
English: What measures are being taken to ensure the safe and effective use of Vizimpro?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vizimpro?
English: Before starting treatment, the presence of mutations in the EGFR gene should be confirmed by appropriate tests.
Croatian: Prije početka terapije trebalo bi odgovarajućim testovima ispitati prisutnost mutacija u genu EGFR.
English: Other information about Vizimpro
Croatian: Ostale informacije o lijeku Vizimpro
English: In lung cancer cells, EGFR is often overactive, causing uncontrolled growth of cancer cells.
Croatian: U stanicama raka pluća EGFR je često pretjerano aktivan, što uzrokuje nekontrolirani rast stanica raka.
English: The European Medicines Agency therefore decided that Vizimpro's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Vizimpro nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: By blocking EGFR, dacomitinib helps to reduce the growth and spread of the cancer.
Croatian: Blokiranjem EGFR-a dakomitinib pomaže usporiti rast i širenje raka.
English: What is Vizimpro and what is it used for?
Croatian: Što je Vizimpro i za što se primjenjuje?
English: Vizimpro can only be obtained with a prescription and treatment must be started and supervised by a doctor with experience in using cancer medicines.
Croatian: Vizimpro se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.
English: The most common side effects with Vizimpro (which may affect more than 1 in 5 people) are diarrhoea, rash, stomatitis (inflammation of the lining of the mouth), nail disorder, dry skin, loss of appetite, conjunctivitis (redness and discomfort in the eye), weight and hair loss, itching, elevated levels of transaminases (a sign of liver problems) and nausea (feeling sick).
Croatian: Najčešće nuspojave lijeka Vizimpro (mogu se pojaviti u više od 1 na 5 osoba) jesu proljev, osip, stomatitis (upala sluznice usne šupljine), poremećaji noktiju, suha koža, gubitak apetita, konjunktivitis (crvenilo i osjećaj nelagode u oku), gubitak težine i kose, svrbež, povišene razine transaminaza(znak problema s jetrom) i mučnina (slabost).
English: Side effects reported with Vizimpro are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Vizimpro pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Why is Vizimpro authorised in the EU?
Croatian: Zašto je Vizimpro odobren u EU-u?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vizimpro have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Vizimpro nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The active substance in Vizimpro, dacomitinib, belongs to a group of cancer medicine called tyrosine kinase inhibitor.
Croatian: Djelatna tvar u lijeku Vizimpro, dakomitinib, pripada skupini lijekova za liječenje raka zvanih inhibitori tirozin kinaze.
English: What are the risks associated with Vizimpro?
Croatian: Koji su rizici povezani s lijekom Vizimpro?
English: Vizimpro is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC) when the disease is advanced or has spread.
Croatian: Vizimpro je lijek protiv raka koji se primjenjuje za liječenje odraslih osoba s rakom pluća nemalih stanica (NSCLC) ako je bolest uznapredovala ili ako se proširila.
English: Although Vizimpro caused more side effects than gefitinib, these were considered manageable.
Croatian: Premda je lijek Vizimpro uzrokovao više nuspojava od gefitiniba, smatralo se da se one mogu kontrolirati.
English: The most frequent serious side effects are diarrhoea, interstitial lung disease (disorders causing scarring in the lungs), rash and loss of appetite.
Croatian: Najčešće ozbiljne nuspojave jesu proljev, intersticijska bolest pluća (poremećaji koji uzrokuju ožiljke na plućima), osip i gubitak apetita.
English: As for all medicines, data on the use of Vizimpro are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Vizimpro kontinuirano se prate.
English: Vizimpro contains the active substance dacomitinib.
Croatian: Vizimpro sadrži djelatnu tvar dakomitinib.
English: involving 452 patients with EGFR mutations, patients given Vizimpro lived on average for around 15 months without their disease getting worse, compared with 9 months for those given gefitinib.
Croatian: U jednom glavnom ispitivanju kojim su bila obuhvaćena 452 bolesnika s mutacijama EGFR-a, bolesnici koji su uzimali lijek Vizimpro živjeli su u prosjeku oko 15 mjeseci bez pogoršanja bolesti, u usporedbi s 9 mjeseci u bolesnika koji primali gefitinib.
English: An overview of Vizimpro and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Vizimpro i zašto je odobren u EU-u
English: Vizimpro is used on its own and only in patients with certain mutations (changes) in the gene for a protein called epidermal growth factor receptor (EGFR).
Croatian: Lijek Vizimpro primjenjuje se kao monoterapija te samo u bolesnika koji imaju određene mutacije (promjene) u genu za protein pod nazivom receptor epidermalnog čimbenika rasta (EGFR).
English: For more information about using Vizimpro, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Vizimpro pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Patients taking Vizimpro lived for an extra 6 months without their disease getting worse compared with those taking gefitinib.
Croatian: Bolesnici koji su uzimali Vizimpro živjeli su šest mjeseci dulje bez pogoršanja bolesti u odnosu na bolesnike koji su uzimali gefitinib.
English: How does Vizimpro work?
Croatian: Kako djeluje Vizimpro?
English: Vizimpro has been shown to be more effective than gefitinib (another medicine for non-small cell lung cancer) at prolonging the time patients lived without their disease getting worse.
Croatian: Lijek Vizimpro pokazao se učinkovitijim od gefitiniba (drugog lijeka za liječenje raka pluća nemalih stanica) u produljenju razdoblja tijekom kojeg su bolesnici živjeli bez pogoršanja bolesti.
English: What benefits of Vizimpro have been shown in studies?
Croatian: Koje su koristi od lijeka Vizimpro utvrđene u ispitivanjima?
English: Vizimpro was shown to significantly improve the length of time patients lived without their disease getting worse.
Croatian: Pokazalo se da lijek Vizimpro znatno produljuje razdoblje tijekom kojeg bolesnici žive bez pogoršanja bolesti.
English: For the full list of side effects and restrictions of Vizimpro, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja vezanih uz primjenu lijeka Vizimpro potražite u uputi o lijeku.
English: How is Vizimpro used?
Croatian: Kako se Vizimpro primjenjuje?
English: - if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
Croatian: - ako ste ikad imali tuberkulozu ili ako ste bili u bliskom kontaktu s nekim tko ima ili je imao tuberkulozu.
English: 3 days.
Croatian: 3 godine
English: It may take about 4 weeks or longer until you start to feel an improvement in your condition.
Croatian: Mogu biti potrebna oko 4 tjedna ili dulje da biste ste se počeli osjećati bolje.
English: If possible, take your tablets or the box with you to show the doctor.
Croatian: Ako je moguće, uzmite tablete ili kutiju kako biste ih pokazali liječniku.
English: The tablets are packed in bottles.
Croatian: Tablete su pakirane u bočice.
English: For more information on these, please read section 4 (Possible side effects).
Croatian: Za daljnje informacije molimo pročitajte dio 4 (Moguće nuspojave).
English: If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose.
Croatian: Ako ste zaboravili uzeti dozu lijeka, uzmite je čim se sjetite, osim ako se ne približava vrijeme kad morate uzeti sljedeću dozu.
English: After this, most patients need a dose of:
Croatian: Nakon toga, doza za većinu bolesnika iznosi:
English: If you are affected, do not drive, or use machines.
Croatian: Ako se to dogodi, nemojte voziti ili upravljati strojevima.
English: In such cases patients should refrain from driving cars and using machines.
Croatian: U tim slučajevima bolesnici trebaju izbjegavati upravljanje vozilima i rad sa strojevima.
English: The therapeutic effect usually starts after 4 to 6 weeks and may further improve up to 4 to 6 months.
Croatian: Terapijski učinak obično počinje nakon 4 do 6 tjedana, a može se dalje poboljšavati sljedećih 4 do 6 mjeseci.
English: Date of first authorisation: 29 November 2010 Date of latest renewal: 19 June 2015
Croatian: Datum posljednje obnove: 19. lipnja 2015.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Pharmacokinetic data in elderly (>65 years) are limited but consistent with pharmacokinetics in younger adults.
Croatian: Podaci o farmakokinetici u starijih bolesnika (>65 godina) ograničeni su, ali odgovaraju farmakokinetici mlađih odraslih osoba.
English: In addition, an updated RMP should be submitted:
Croatian: Nadalje, nadopunjen RMP treba biti dostavljen
English: Leflunomide ratiopharm is not recommended for use in children and adolescents below 18 years of age.
Croatian: Leflunomid ratiopharm se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina.
English: There have been reports of chronic overdose in patients taking Leflunomide ratiopharm at daily doses up to five times the recommended daily dose, and reports of acute overdose in adults and children.
Croatian: Postoje izvješća o kroničnom predoziranju bolesnika koji su uzimali Leflunomid ratiopharm u dozama do pet puta većima od preporučene dnevne doze, kao i izvješća o akutnom predoziranju u odraslih i djece.
English: If you take more Leflunomide ratiopharm than you should, contact your doctor or get other medical advice.
Croatian: Ako uzmete više Leflunomida ratiopharm nego što ste trebali, obratite se svom liječniku ili zatražite savjet nekog drugo liječnika.
English: Do not take Leflunomide ratiopharm if you are, or think you may be pregnant.
Croatian: Nemojte uzimati Leflunomid ratiopharm ako ste trudni ili mislite da biste mogli biti trudni.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: The efficacy of Leflunomide ratiopharm in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III).
Croatian: Djelotvornost Leflunomida ratiopharm u liječenju reumatoidnog artritisa pokazala se u 4 kontrolirana ispitivanja (1 u fazi II i 3 u fazi III).
English: severe infections, including sepsis which may be fatal
Croatian: teške infekcije, uključujući sepsu koja može biti smrtonosna
English: Some patients may even still feel further improvements after 4 to 6 months of therapy.
Croatian: Određeni bolesnici mogu i nakon 4 do 6 mjeseci liječenja osjetiti dodatna poboljšanja.
English: Leflunomide ratiopharm can occasionally cause some problems with your blood, liver, lungs or nerves in your arms or legs.
Croatian: Leflunomid ratiopharm može povremeno uzrokovati probleme s krvi, jetrom, plućima ili živcima u rukama ili nogama.
English: Leflunomide ratiopharm is not recommended for use in patients below 18 years since efficacy and safety in juvenile rheumatoid arthritis (JRA) have not been established (see sections 5.1 and 5.2).
Croatian: Leflunomid ratiopharm se ne preporučuje bolesnicima mlađima od 18 godina jer djelotvornost i sigurnost primjene kod juvenilnog reumatoidnog artritisa (JRA) nisu ustanovljene (vidjeti dijelove 5.1. i 5.2.).
English: Your doctor will also check your blood pressure regularly as Leflunomide ratiopharm can cause an increase in blood pressure.
Croatian: Liječnik će Vam također redovito kontrolirati krvni tlak jer Leflunomid ratiopharm može uzrokovati njegovo povećanje.
English: Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma level laboratory testing
Croatian: Liječnici i bolesnici trebaju biti upoznati s postojanjem ad hoc savjetodavne službe za pružanje informacije o laboratorijskim pretragama koncentracije leflunomida u plazmi.
English: This may be reduced to a few weeks by taking certain medicines which speed up removal of Leflunomide ratiopharm from your body.
Croatian: To se razdoblje može smanjiti na nekoliko tjedana uzimanjem određenih lijekova koji mogu ubrzati uklanjanje lijeka Leflunomid ratiopharm iz tijela.
English: The tablets must be swallowed whole with sufficient amounts of liquid.
Croatian: Tablete se moraju progutati cijele s dovoljnom količinom tekućine.
English: In a carcinogenicity study in rats, leflunomide did not show carcinogenic potential.
Croatian: U ispitivanjima kancerogenosti u štakora, leflunomid se nije pokazao kancerogenim.
English: • Patients with serious infections (see section 4.4).
Croatian: • Bolesnici s ozbiljnim infekcijama (vidjeti dio 4.4.)