FrancophonIA/ELRC3.0 huggingface dataset:
English: Infliximab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment at the week 24 primary endpoint as measured by change from baseline in total modified vdH-S score (mean ± SD score was 0.82 ± 2.62 in the placebo group compared with -0.70 ± 2.53 in the infliximab group; p<0.001).
Croatian: Sudeći prema promjeni u ukupnom rezultatu po van der Heijdeu modificiranoj Sharpovoj bodovnoj skali u odnosu na početno stanje (prosječan rezultat ± SD bio je 0,82 ± 2,62 u skupini koja je primala placebo, dok je u skupini koja je primala infliksimab iznosio -0,70 ± 2,53; p < 0,001), liječenje infliksimabom je u odnosu na placebo smanjilo brzinu napredovanja oštećenja perifernih zglobova, što je bila primarna mjera ishoda u 24. tjednu.
English: ** PASI 75 response for IMPACT not included due to low N; p<0.001 for infliximab vs. placebo at week 24 for IMPACT 2.
Croatian: Na temelju broja bolesnika s početnim PASI ≥ 2,5 u ispitivanju IMPACT i bolesnika s početnom zahvaćenošću kože psorijazom ≥ 3% BSA u ispitivanju IMPACT 2. ** Odgovor PASI 75 u ispitivanju IMPACT nije uključen zbog malog N; p < 0,001 za infliksimab u usporedbi s placebom u 24. tjednu ispitivanja IMPACT 2.
English: Mean ± SD
Croatian: Prosječna vrijednost ±SD
English: 1 Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
Croatian: Ankilozantni spondilitis Psorijatični artritis Plak psorijaza 1 Bolesnici u placebo skupini primali su metotreksat, dok su bolesnici u infliksimab skupini primali i infliksimab i metotreksat.
English: * p-values represent each infliximab treatment group vs. AZA monotherapy.
Croatian: (p < 0,001) * p-vrijednosti odnose se na usporedbu svake skupine koja je primala infliksimab sa skupinom koja je primala monoterapiju AZA.
English: • Tell your doctor straight away if you get symptoms of low blood counts during treatment with Inflectra.
Croatian: • Odmah obavijestite svog liječnika ako tijekom liječenja lijekom Inflectra dobijete simptome smanjenog broja krvnih stanica.
English: Cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis, have been observed in the post-marketing experience of infliximab.
Croatian: Nakon stavljanja infliksimaba u promet primijećeni su slučajevi žutice i neinfektivnog hepatitisa, koji je ponekad imao značajke autoimunog hepatitisa.
English: Mean ± SDd a p <0.001, for each infliximab treatment group vs control.
Croatian: Cijeljenje sluznice u 30. tjednu p < 0,001 za svaku skupinu liječenu infliksimabom u usporedbi s placebom.
English: 3 mg/kg given as an intravenous infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Croatian: Daje se doza od 3 mg/kg intravenskom infuzijom, a zatim slijede dodatne infuzije u dozi od 3 mg/kg 2. i 6. tjedna nakon prve infuzije te svakih 8 tjedana nakon toga.
English: Inflectra and Kineret should not be used together.
Croatian: Lijekovi Inflectra i Kineret ne smiju se istodobno uzimati.
English: Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate
Croatian: 6.1 Popis pomoćnih tvari saharoza polisorbat 80 natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat dihidrat
English: After reconstitution each mL contains 10 mg of infliximab.
Croatian: Nakon rekonstitucije, 1 ml sadrži 10 mg infliksimaba.
English: Sustained response (clinical response at both week 8 and week 30)a
Croatian: Održani odgovor (klinički odgovor i u
English: • you have heart failure that is moderate or severe.
Croatian: • ako imate umjeren ili težak stupanj zatajenja srca.
English: c HAQ = Health Assessment Questionnaire; greater values indicate less disability.
Croatian: HAQ = upitnik za procjenu zdravlja (engl.
English: • Skin problems such as blistering, warts, abnormal skin colouration or pigmentation, or swollen lips, or thickening of the skin, or red, scaly, and flaky skin
Croatian: • problemi s kožom kao što su mjehurići, bradavice, neprirodna boja kože ili pigmentacija,
English: The solution must not be used if opaque particles, discolouration, or other foreign particles are present.
Croatian: Otopina se ne smije primijeniti ako se u njoj pojave neprozirne ili kakve druge strane čestice ili ako promijeni boju.
English: Psychiatric disorders Common:
Croatian: Krvožilni poremećaji Često:
English: Appropriate empiric antifungal therapy should be considered while a diagnostic workup is being performed taking into account both the risk for severe fungal infection and the risks of antifungal therapy.
Croatian: Uzimajući u obzir rizike teške gljivične infekcije kao i rizike antimikotičke terapije, treba razmotriti primjenu odgovarajuće empirijske antimikotičke terapije tijekom dijagnostičkog postupka.
English: Caution should be exercised in considering treatment of patients with increased risk for malignancy due to heavy smoking.
Croatian: U bolesnika koji imaju povećan rizik za razvoj maligne bolesti jer su teški pušači, mogućnost liječenja treba razmotriti uz oprez.
English: Inflectra is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1).
Croatian: Inflectra je indicirana za liječenje umjerene do teške plak psorijaze u odraslih bolesnika u kojih je druga sustavna terapija, uključujući ciklosporin, metotreksat ili psoralen ultraljubičastu
English: In patients treated with infliximab, an invasive fungal infection such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis should be suspected if they develop a serious systemic illness, and a physician with expertise in the diagnosis and treatment of invasive fungal infections should be consulted at an early stage when investigating these patients.
Croatian: U bolesnika liječenih infliksimabom u kojih se razvije ozbiljna sistemska bolest treba posumnjati na neku invazivnu gljivičnu infekciju poput aspergiloze, kandidijaze, pneumocistoze, histoplazmoze, kokcidioidomikoze ili blastomikoze.
English: • Tell your doctor straight away if you get symptoms of liver problems during treatment with Inflectra.
Croatian: • Odmah obavijestite svog liječnika ako tijekom liječenja lijekom Inflectra dobijete simptome problema s jetrom.
English: b Absence of any draining fistulas.
Croatian: Nisu prisutne fistule iz kojih se cijedi sadržaj.
English: A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and safety of long-term maintenance therapy versus re-treatment with an induction regimen of infliximab
Croatian: Provedeno je kliničko ispitivanje u bolesnika s umjerenom do teškom psorijazom kako bi se ocijenile djelotvornost i sigurnost dugotrajne terapije održavanja u odnosu na ponovno davanje uvodnog režima liječenja infliksimabom (najviše četiri infuzije u 0., 2., 6. i 14. tjednu) nakon ponovnog izbijanja bolesti.
English: If you are given too much Inflectra
Croatian: Ako primite više lijeka Inflectra nego što ste trebali
English: Inflectra.
Croatian: Cijepljenje
English: • Tell your doctor straight away if you get signs of infection during treatment with Inflectra.
Croatian: • Odmah obavijestite svog liječnika ako tijekom liječenja lijekom Inflectra dobijete simptome infekcije.
English: Infliximab Placebo 5 mg/kg 10 mg/kg Combined
Croatian: Placebo + MTX 3 mg/kg
English: • Tell your doctor straight away if you develop symptoms of lupus during treatment with Inflectra.
Croatian: • Odmah obavijestite svog liječnika ako tijekom liječenja lijekom Inflectra dobijete simptome lupusa.
English: In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, antituberculosis therapy should be considered before the initiation of infliximab.
Croatian: Treba razmotriti primjenu antituberkulozne terapije prije početka liječenja infliksimabom u bolesnika koji imaju brojne ili značajne čimbenike rizika za tuberkulozu, a rezultati testa na latentnu tuberkulozu su im negativni.
English: Discontinuation of infliximab therapy should be considered in patients with confirmed significant haematologic abnormalities.
Croatian: U bolesnika s potvrđenim značajnim hematološkim poremećajima treba razmotriti prekid liječenja infliksimabom.
English: • Infections of the vagina
Croatian: • infekcije rodnice
English: • Feeling numb or having a tingling feeling.
Croatian: • osjećaj utrnulosti i trnci.
English: 10 mg/kg q 4 wks
Croatian: 10 mg/kg
English: • Tell your doctor straight away if you get signs of TB during treatment with Inflectra.
Croatian: • Odmah obavijestite svog liječnika ako tijekom liječenja lijekom Inflectra dobijete simptome tuberkuloze.
English: For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of infliximab treatment should be carefully considered before initiation of infliximab therapy.
Croatian: Prije uvođenja infliksimaba treba pažljivo ocijeniti koristi i rizike liječenja infliksimabom u bolesnika koji su boravili ili putovali u područja za koja su karakteristične endemske invazivne gljivične infekcije kao što su histoplazmoza, kokcidioidomikoza ili blastomikoza.
English: • Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Inflectra.
Croatian: Odmah obavijestite svog liječnika ako tijekom liječenja lijekom Inflectra dobijete simptome neke bolesti živčanog sustava.
English: België/Belgique/Belgien Pfizer SA/NV
Croatian: België/Belgique/Belgien Pfizer SA/NV Tél/Tel: + 32 2 554 62 11
English: Пфайзер Люксембург САРЛ, Клон България
Croatian: Pfizer Luxembourg SARL filialas Lietuvoje Tel.
English: One vial contains 100 mg of infliximab.
Croatian: Jedna bočica sadrži 100 mg infliksimaba.
English: Clinical Remission
Croatian: Prijavljivanje nuspojava
English: Inflectra should be visually inspected for particulate matter or discolouration prior to administration.
Croatian: Prije primjene lijeka Inflectra potrebno je vizualno provjeriti sadrži li čestice i je li promijenio boju.
English: Patients must be monitored closely for infections including tuberculosis before, during and after treatment with infliximab.
Croatian: Prije, tijekom i nakon liječenja infliksimabom bolesnike se mora pomno nadzirati kako bi se uočile infekcije, uključujući tuberkulozu.
English: Each Inflectra vial contains 100 mg infliximab.
Croatian: Jedna bočica lijeka Inflectra sadrži 100 mg infliksimaba.
English: Inflectra should be administered
Croatian: Lijek Inflectra treba primjenjivati:
English: It is recommended that paediatric patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating infliximab therapy.
Croatian: Prije početka terapije infliksimabom, preporučuje se po mogućnosti cijepiti pedijatrijske bolesnike u skladu s važećim programom cijepljenja.
English: • You should receive recommended vaccinations before starting Inflectra treatment.
Croatian: • Prije početka liječenja lijekom Inflectra trebate primiti sva preporučena cjepiva.
English: Further treatment with infliximab must not be given if a patient develops a serious infection or sepsis.
Croatian: Ako se u bolesnika razvije teška infekcija ili sepsa, liječenje infliksimabom ne smije se nastaviti.
English: Annex related to the Art. 127a Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States
Croatian: Dodatak vezan za članak 127a Uvjeti ili ograničenja vezani uz sigurnu i učinkovitu primjenu lijeka koji se imaju provesti u zemljama članicama
English: • Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) are provided with a prescriber kit containing the following: o Educational Health Care Professional's kit o Educational brochures for Patients o Patient cards o Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling.
Croatian: • Prije propisivanja (gdje je prikladno, i u skladu s nacionalnim regulatornim tijelom, izdavanja) svi zdravstveni djelatnici koji namjeravaju propisati (i izdati) prime Komplet za propisivača lijeka koji sadrži sljedeće:
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: The Member State shall agree the details of the Prescriber kit and a controlled distribution system with the Marketing Authorisation Holder (MAH) and must implement such programme nationally prior to launch to ensure that:
Croatian: Zemlje članice moraju osigurati da su provedeni svi uvjeti ili ograničenja vezani uz sigurnu i učinkovitu primjenu lijeka opisani niže: Zemlja članica će, s nositeljem odobrenja za stavljanje lijeka u promet, dogovoriti pojedinosti
English: If you take more Urorec than you should
Croatian: Ako uzmete više Urorec nego što ste trebali
English: Other medicines and Urorec
Croatian: Drugi lijekovi i Urorec
English: Difference (95 % CI) vs placebo
Croatian: Razlika (95 % CI) u odnosu na placebo
English: • If you have severe liver problems, you should not take Urorec, as it was not tested in this condition.
Croatian: • Ako imate teških tegoba s jetrom, ne biste smjeli uzimati Urorec, jer nije ispitan kod takvog stanja.
English: Talk to your doctor or pharmacist before taking Urorec
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Urorec.
English: Urorec does not treat prostate cancer.
Croatian: Urorec ne liječi rak prostate.
English: If you stop taking Urorec
Croatian: Ako prestanete uzimati Urorec
English: Ask your doctor whether or not you should postpone or temporarily stop taking Urorec when undergoing cataract surgery.
Croatian: Upitajte liječnika trebate li odgoditi ili privremeno prekinuti uzimanje lijeka Urorec ako idete na operaciju katarakte.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/01/2010
Croatian: Datum prvog odobrenja: 29/01/2010 Datum posljednje obnove odobrenja: 18/09/2014
English: Dizziness when standing up and occasionally fainting may occur when taking Urorec, particularly when starting treatment or if you are taking other medicines that lower blood pressure.
Croatian: Za vrijeme uzimanja lijeka Urorec mogu nastati omaglica pri ustajanju i povremeno nesvjestica, osobito na početku liječenja ili ako uzimate druge lijekove koji snižavaju krvni tlak.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Urorec in all subsets of the paediatric population in BPH (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Urorec u svim podskupinama pedijatrijske populacije u BHP (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If you have moderate kidney problems, your doctor will start Urorec with caution and possibly with a lower dose (see section 3 “Dose”).
Croatian: Ako imate umjerene tegobe s bubrezima, Vaš liječnik će započeti liječenje lijekom Urorec s oprezom i možda u manjoj dozi (pogledajte dio 3 „Doza “).
English: This effect disappears after discontinuation of Urorec.
Croatian: Ovaj učinak nestaje nakon prestanka uzimanja lijeka Urorec.
English: By blocking these receptors, it causes smooth muscle in these tissues to relax.
Croatian: Blokiranjem ovih receptora, Urorec uzrokuje opuštanje glatkih mišića u tim tkivima.
English: If you have severe kidney problems, you should not take Urorec.
Croatian: Ako imate teške tegobe s bubrezima, ne biste smjeli uzimati Urorec.
English: What you need to know before you take Urorec Do not take Urorec if you are allergic to silodosin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Urorec ako ste alergični na silodozin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: If you forget to take Urorec
Croatian: Ako ste zaboravili uzeti Urorec
English: • Since a benign enlargement of the prostate and prostate cancer may present the same symptoms, your doctor will check you for prostate cancer before starting treatment with Urorec.
Croatian: • Kako dobroćudno povećanje prostate i rak prostate mogu imati iste simptome, liječnik će Vas pregledati na rak prostate prije nego što počnete uzimati Urorec.
English: Urorec belongs to a group of medicines called alpha1A-adrenoreceptor blockers.
Croatian: Urorec pripada skupini lijekova koji se zovu blokatori alfa1A-adrenergičkih receptora.
English: What Urorec is and what it is used for
Croatian: Što je Urorec i za što se koristi
English: Urorec may cause complications during a cataract surgery (eye surgery because of cloudiness of the lens, see section “Warnings and precautions”).
Croatian: Urorec može prouzročiti komplikacije tijekom operacije katarakte (operacija oka zbog zamućenosti leće, pogledajte dio „Upozorenja i mjere opreza“).
English: • If you are undergoing eye surgery because of cloudiness of the lens (cataract surgery), it is important that you immediately inform your eye specialist that you are using or have previously used Urorec.
Croatian: • Ako idete na operaciju oka zbog zamućenja leće (operacija katarakte), važno je da odmah obavijestite svog specijalistu za liječenje očnih bolesti da uzimate ili da ste prije uzimali
English: For special patient populations, one capsule of Urorec 4 mg daily is recommended (see below).
Croatian: Kod posebnih populacija bolesnika, preporučuje se jedna kapsula lijeka Urorec 4 mg na dan (vidjeti niže).
English: Urorec is available in packs containing 5, 10, 20, 30, 50, 90, 100 capsules.
Croatian: Urorec je dostupan u pakiranjima od 5, 10, 20, 30, 50, 90, 100 kapsula.
English: It is important that you immediately inform your eye specialist if you are using or have previously used Urorec.
Croatian: Važno je da odmah obavijestite svog specijalistu za očne bolesti ako uzimate ili ste prethodno uzimali
English: Urorec is used in adult men to treat the urinary symptoms associated with benign enlargement of the prostate (prostatic hyperplasia), such as:
Croatian: Urorec se primjenjuje u odraslih muškaraca za liječenje urinarnih simptoma povezanih s dobroćudnim povećanjem prostate (hiperplazija prostate), kao što su:
English: PharmaSwiss EOOD Тел.
Croatian: PharmaSwiss EOOD
English: Urorec may reduce the amount of sperm, and so could temporarily affect your ability to father a child.
Croatian: Urorec može smanjiti količinu sperme, stoga bi mogao privremeno utjecati na vašu sposobnost začeća.
English: • medicines for epilepsy or rifampicin (a medicine to treat tubercolosis), since the effect of Urorec may be reduced.
Croatian: • lijekove protiv epilepsije ili rifampicin (lijek za liječenje tuberkuloze), budući da mogu smanjiti učinak lijeka Urorec.
English: • medicines which lower blood pressure (in particular, medicines called alpha1-blockers, such as prazosin or doxazosin) as there may be the potential risk that the effect of these medicines is increased whilst taking Urorec.
Croatian: • lijekove koji snižavaju krvni tlak (osobito lijekove koji se zovu blokatori alfa1-receptora, kao što su prazosin ili doksazosin), jer postoji mogući rizik od pojačanog učinka tih lijekova za vrijeme uzimanja lijeka Urorec.
English: How to take Urorec
Croatian: Kako uzimati Urorec
English: • If you have ever fainted or felt dizzy when suddenly standing up, please inform your doctor before taking Urorec.
Croatian: • Ako ste ikad izgubili svijest ili osjetili omaglicu pri naglom ustajanju, obavijestite o tome svog liječnika prije nego što počnete uzimati Urorec.
English: There is no relevant use of Urorec in the paediatric population for the indication of benign prostatic hyperplasia (BPH).
Croatian: Nema relevantne primjene lijeka Urorec u pedijatrijskoj populaciji za indikaciju benigne hiperplazije prostate (BPH).
English: • antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV-AIDS (such as ritonavir) or medicines used after transplants to prevent organ rejection (such as cyclosporin) because these medicines can increase the blood concentration of Urorec.
Croatian: • lijekove protiv gljivica (kao što su ketokonazol ili itrakonazol), lijekove koji se primjenjuju kod HIV-a/SIDA-e (kao što je ritonavir) ili lijekove koji se koriste nakon presađivanja organa da bi se spriječilo njegovo odbacivanje (kao što je ciklosporin), zato što ti lijekovi mogu povećati koncentraciju lijeka Urorec u krvi.
English: Urorec has minor or moderate influence on the ability to drive and use machines.
Croatian: Urorec malo do umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Over 800 patients with moderate to severe symptoms of BPH (International Prostate Symptom Score, IPSS, baseline value ≥13) received silodosin 8 mg once daily in two Phase III placebo-controlled clinical studies conducted in the United States and in one placebo- and active-controlled clinical study conducted in Europe.
Croatian: Više od 800 bolesnika s umjerenim do jakim simptomima BHP (Međunarodni indeks simptoma prostate, IPSS; početna vrijednost ≥ 13) primilo je silodozin od 8 mg jedanput na dan, u dva placebom kontrolirana klinička ispitivanja Faze III koja su se provela u Sjedinjenim Američkim Državama i jednom kliničkom ispitivanju s placebom i aktivnom kontrolom provedenima u Europi.
English: In a Phase IV clinical trial performed in Europe, with a mean baseline IPSS total score of 18.9 points, 77.1%were responders to silodosin (as assessed by a change from baseline in the IPSS total score of at least 25%).
Croatian: U kliničkom ispitivanju Faze IV provedenom u Europi, s prosječnim početnim ukupnim IPSS rezultatom od 18,9 bodova, 77,1 % bolesnika odgovorilo je na terapiju silodozinom (što je procijenjeno na temelju promjene ukupnog IPSS rezultata od najmanje 25 % od početne vrijednosti).
English: • The treatment with Urorec may lead to an abnormal ejaculation (decrease in the amount of semen released during sex) that may temporarily affect male fertility.
Croatian: • Liječenje lijekom Urorec može dovesti do poremećaja ejakulacije (smanjenja količine sjemena koje se oslobađa u spolnom odnosu), što može privremeno narušiti plodnost u muškarca.
English: Urorec is not intended for use by women.
Croatian: Lijek Urorec nije namijenjen za primjenu u žena.
English: There is inadequate information about the safe use of silodosin in association with other α-adrenoreceptor antagonists.
Croatian: Nema odgovarajućih podataka o sigurnosti primjene silodozina s drugim antagonistima α-adrenergičkih receptora.
English: • medicines used for treating problems in getting or keeping an erection (such as sildenafil or tadalafil), since the concomitant use with Urorec might lead to a slight decrease in blood pressure.
Croatian: • lijekove koji se primjenjuju u liječenju otežanog postizanja i održavanja erekcije (kao što su sildenafil ili tadalafil), budući da istovremeno uzimanje lijeka Urorec može dovesti do sniženja krvnog tlaka.
English: For this purpose Urorec 4 mg hard capsules are available.
Croatian: U tu su svrhu dostupne tvrde kapsule Urorec od 4 mg.
English: Österreich Haemo Pharma GmbH Tel: + 43 2689 31160
Croatian: Haemo Pharma GmbH Tel: + 43 2689 31160
English: Yellow iron oxide (E172) (4 mg capsules only)
Croatian: Ovojnica kapsule želatina titanijev dioksid (E171) željezov oksid, žuti (E172) (samo kapsule od 4 mg)
English: The recommended dose is one capsule of Urorec 8 mg daily.
Croatian: Preporučena doza je jedna kapsula lijeka Urorec 8 mg na dan.
English: The use in patients with severe renal impairment (CLCR < 30 mL/min) is not recommended (see sections 4.4 and 5.2).
Croatian: Ne preporučuje se primjena u bolesnika s teškim oštećenjem funkcije bubrega (CLcr <30 ml/min) (vidjeti dijelove 4.4 i 5.2).