FrancophonIA/ELRC3.0 huggingface dataset:
English: Keep this card with you for 4 months after your last dose of Inflectra, or in case of pregnancy, for at least 6 months after the birth of your baby.
Croatian: Nosite ovu karticu sa sobom još 4 mjeseca nakon posljednje doze lijeka Inflectra ili, u slučaju trudnoće, još najmanje 6 mjeseci nakon poroda.
English: • Inflammation in the eye that may cause changes in the vision, including blindness
Croatian: • upala oka koja može uzrokovati promjene u vidu, uključujući sljepoću
English: Inflectra will generally be stored by the health professionals at the hospital or clinic.
Croatian: Lijek Inflectra će uglavnom čuvati zdravstveni radnici u bolnici ili klinici.
English: • In some patients receiving infliximab, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
Croatian: • Moguće je da u nekih bolesnika koji primaju infliksimab tijelo ne proizvodi dovoljno krvnih stanica koje pomažu u borbi protiv infekcija ili zaustavljanju krvarenja.
English: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last infliximab treatment.
Croatian: Žene reproduktivne dobi moraju razmotriti uporabu odgovarajuće kontracepcije kako bi se spriječila trudnoća tijekom i do najmanje 6 mjeseci nakon primjene posljednje doze infliksimaba.
English: Care should be taken and patients should continue to be monitored when switching from one biologic to another, since overlapping biological activity may further increase the risk for adverse reactions, including infection.
Croatian: Potreban je oprez i kontinuirani nadzor bolesnika kod prelaska s jednog biološkog lijeka na drugi jer preklapanje biološke aktivnosti može dodatno povećati rizik od nuspojava, uključujući infekciju.
English: • Abnormal values of a blood protein called ‘complement factor' which is part of the immune system.
Croatian: • odstupanje od normalne vrijednosti bjelančevine u krvi poznate pod nazivom „faktor komplementa“ koja je dio imunološkog sustava.
English: It is important that you tell your baby's doctors and other healthcare professionals about your Inflectra use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis).
Croatian: Važno je obavijestiti pedijatra Vašeg djeteta i druge zdravstvene radnike o Vašem primanju lijeka Inflectra, tako da mogu odlučiti kada Vaše dijete treba primiti bilo koje cjepivo, uključujući živa cjepiva kao što je BCG (primjenjuje se za sprječavanje tuberkuloze).
English: Inflectra is a biosimilar medicinal product.
Croatian: Inflectra je biosličan lijek.
English: Currently available pharmacokinetic data are described in section 5.2 but no recommendation on a posology can be made in children younger than 6 years.
Croatian: Trenutno dostupni farmakokinetički podaci opisani su u dijelu 5.2 međutim nije moguće dati preporuku o doziranju u djece mlađe od 6 godina.
English: In REACH, 17.5% of randomised patients experienced 1 or more infusion reactions.
Croatian: U ispitivanju REACH ukupno je 17,5% randomiziranih bolesnika imalo jednu ili više reakcija na infuziju.
English: TNF alpha is involved in inflammatory processes of the body so blocking it can reduce the inflammation in your body.
Croatian: TNF-alfa sudjeluje u upalnim procesima u organizmu pa se njegovom blokadom može smanjiti upala u tijelu.
English: • Treatment with TNF blockers such as Inflectra may result in reactivation of hepatitis B virus in patients who carry this virus, which can be life-threatening in some cases.
Croatian: • Liječenje TNF-blokatorima kao što je Inflectra može izazvati ponovnu aktivaciju virusa hepatitisa B u bolesnika koji nose taj virus, što u nekim slučajevima može ugroziti život.
English: Do not use Inflectra if any of the above applies to you.
Croatian: Nemojte primiti lijek Inflectra ako se nešto od navedenog odnosi na Vas.
English: For storage conditions up to 25 °C before reconstitution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja na temperaturi do 25°C prije rekonstitucije lijeka vidjeti u dijelu 6.3.
English: The solution should be colourless to light yellow and opalescent.
Croatian: Otopina mora biti bezbojna do svijetložuta i opalescentna.
English: Elevations of ALT ≥5 x Upper Limit of Normal (ULN) have been observed (see Table 2).
Croatian: Opažen je povišen ALT ≥ 5 puta iznad gornje granice normale (GGN) (vidjeti Tablicu 2).
English: 5 years at 2 °C - 8 °C.
Croatian: 5 godina na temperaturi 2°C-8°C.
English: • Inflamed liver caused by a problem with the immune system (autoimmune hepatitis)
Croatian: • upaljena jetra uzrokovana problemom s imunološkim sustavom (autoimuni hepatitis)
English: • Inflectra will be given to you by your doctor or nurse, in a hospital or clinic.
Croatian: • Lijek Inflectra će Vam dati Vaš liječnik ili medicinska sestra u bolnici ili klinici.
English: • Your doctor will also give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Inflectra.
Croatian: • Vaš liječnik će Vam dati i karticu s podsjetnikom za bolesnika, koja sadrži važne sigurnosne informacije kojih morate biti svjesni prije i tijekom liječenja lijekom Inflectra.
English: Before starting treatment with infliximab, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Croatian: Prije početka liječenja infliksimabom sve bolesnike treba provjeriti na aktivnu i neaktivnu ("latentnu") tuberkulozu.
English: • Provision to record the type, date, and result of TB screenings
Croatian: • pripremu za zabilježbu vrste, datuma i rezultata probirnih pregleda za tuberkulozu (TBC)
English: Forty-six percent of patients continued on stable doses of methotrexate (≤ 25 mg/week).
Croatian: Četrdeset i šest posto bolesnika nastavilo je primati ustaljene doze metotreksata (≤ 25 mg na tjedan).
English: Republic of Korea
Croatian: Republika Koreja
English: What you need to know before you use Inflectra
Croatian: Što morate znati prije nego počnete primjenjivati lijek Inflectra
English: • A statement that the brand name and batch number should be recorded
Croatian: • izjavu da je potrebno zabilježiti zaštićeni naziv i broj serije
English: Inflectra is produced in packs of 1, 2, 3, 4, or 5 vials.
Croatian: Inflectra je dostupna u pakiranjima koja sadrže 1, 2, 3, 4 ili 5 bočica.
English: Inflectra infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Croatian: Infuziju lijeka Inflectra moraju davati osposobljeni zdravstveni radnici koji su obučeni prepoznati bilo koji problem u vezi s infuzijom.
English: Your doctor may recommend temporarily stopping Inflectra.
Croatian: Liječnik Vam može preporučiti privremeni prekid liječenja lijekom Inflectra.
English: Significant improvements from baseline were demonstrated in DLQI (p<0.001) and the physical and mental component scores of the SF 36 (p<0.001 for each component comparison).
Croatian: Značajno poboljšanje u odnosu na početno stanje pokazalo se i u upitniku DLQI (p < 0,001) i u rezultatima na fizičkoj i mentalnoj komponenti upitnika SF-36 (p < 0,001 za svaku uspoređenu komponentu).
English: There were no serious infusion reactions, and 2 subjects in REACH had non-serious anaphylactic reactions.
Croatian: Ozbiljnih reakcija na infuziju nije bilo, a 2 su ispitanika u ispitivanju REACH imala anafilaktičke reakcije koje nisu bile ozbiljne.
English: Tell your doctor if you are using, have recently used or might use any other medicines, including any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis or medicines obtained without a prescription, such as vitamins and herbal medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i bilo koje druge lijekove za liječenje Crohnove bolesti, ulceroznog kolitisa, reumatoidnog artritisa, ankilozantnog spondilitisa, psorijatičnog artritisa ili psorijaze, ili lijekove koje ste nabavili bez recepta, poput vitamina i biljnih lijekova.
English: In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of infliximab (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour.
Croatian: U pažljivo odabranih odraslih bolesnika koji su dobro podnijeli najmanje 3 početne dvosatne infuzije infliksimaba (faza uvodnog liječenja) te su sada na terapiji održavanja, može se razmotriti primjena daljnjih infuzija tijekom najmanje jednog sata.
English: What Inflectra contains
Croatian: Što Inflectra sadrži
English: Antinuclear antibodies (ANA)/Anti-double-stranded DNA (dsDNA) antibodies
Croatian: Antinuklearna protutijela (ANA)/protutijela protiv dvolančane DNK (dsDNK)
English: Autoantibody positive.
Croatian: pozitivan nalaz na autoprotutijela
English: Patients should be closely monitored and infliximab must not be continued in patients who develop new or worsening symptoms of heart failure (see sections 4.3 and 4.8).
Croatian: Bolesnike treba pomno nadzirati, a primjena infliksimaba ne smije se nastaviti u onih bolesnika u kojih se pojave novi ili pogoršaju postojeći simptomi zatajenja srca (vidjeti dijelove 4.3 i 4.8).
English: If these medicines do not work well enough, you will be given Inflectra which you will take with another medicine called methotrexate to:
Croatian: Ako ti lijekovi ne djeluju dovoljno dobro, dobit ćete lijek Inflectra, koji ćete koristiti s drugim lijekom koji se zove metotreksat kako bi se:
English: • Fast heart beat (tachycardia) or palpitations
Croatian: • ubrzano kucanje srca (tahikardija) ili palpitacije
English: • You will be monitored while you are given Inflectra and also for 1 to 2 hours afterwards.
Croatian: • Bit ćete pod nadzorom dok primate lijek Inflectra te 1 do 2 sata nakon toga.
English: You may receive some vaccines during treatment with Inflectra but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Inflectra because they may cause infections.
Croatian: Tijekom liječenja lijekom Inflectra možete primiti neka cjepiva, ali ne smijete primiti živa cjepiva (cjepiva koja sadrže živi, ali oslabljeni uzročnik zarazne bolesti) jer mogu prouzrokovati infekcije.
English: Of these patients, most were teenage boys or young men and most had either Crohn's disease or ulcerative colitis.
Croatian: Većina tih bolesnika bili su dječaci tinejdžeri ili mlađi muškarci te je većina imala ili Crohnovu bolest ili ulcerozni kolitis.
English: Infliximab should be administered intravenously over a 2 hour period.
Croatian: Infliksimab se primjenjuje intravenski tijekom razdoblja od 2 sata.
English: >40 weeks
Croatian: > 40 tjedana
English: Patients should be tested for HBV infection before initiating treatment with infliximab.
Croatian: Bolesnici se moraju testirati na HBV infekciju prije početka liječenja infliksimabom.
English: The moderate number of prospectively collected pregnancies exposed to infliximab resulting in live birth with known outcomes, including approximately 1,100 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Croatian: Prospektivno prikupljeni podaci o umjereno velikom broju trudnoća s poznatim ishodom tijekom kojih je žena bila izložena infliksimabu, a koje su završile rođenjem živog djeteta, uključujući približno 1100 trudnoća tijekom kojih je žena bila izložena infliksimabu tijekom prvog tromjesečja, ne ukazuju na porast stope malformacija u novorođenčadi.
English: Shortened infusions at doses >6 mg/kg have not been studied (see section 4.8).
Croatian: Nisu provedena ispitivanja s kraćim trajanjem infuzije kod doza > 6 mg/kg (vidjeti dio 4.8).
English: Since no preservative is present, it is recommended that the administration of the solution for infusion is to be started as soon as possible and within 3 hours of reconstitution and dilution.
Croatian: S obzirom da otopina za infuziju ne sadrži konzervanse, preporučuje se početi s primjenom što prije, a svakako u roku od 3 sata nakon rekonstitucije i razrjeđivanja.
English: • The doctor will decide your dose and how often you will be given Inflectra.
Croatian: • Liječnik će odrediti koju dozu lijeka Inflectra ćete primati i koliko često.
English: Patients may be pre-treated with e.g. an antihistamine, hydrocortisone and/or paracetamol to prevent mild and transient effects.
Croatian: Bolesnicima se prije infuzije može dati antihistaminik, hidrokortizon i/ili paracetamol kako bi se spriječili blagi i prolazni učinci.
English: • Children and adults taking Inflectra may have an increased risk of developing lymphoma or another cancer.
Croatian: • Djeca i odrasli koji uzimaju lijek Inflectra mogu imati povećan rizik za razvoj limfoma ili neke druge vrste raka.
English: In children (6 years of age or older) treated for Crohn's disease or ulcerative colitis, the recommended dose is the same as for adults.
Croatian: Preporučena doza u djece (starosti 6 ili više godina) za liječenje Crohnove bolesti ili ulceroznog kolitisa je ista kao i doza koja je preporučena za odrasle.
English: Pharmacotherapeutic group: immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB02.
Croatian: Farmakoterapijska skupina: imunosupresivi, inhibitori faktora nekroze tumora alfa (TNFα), ATK oznaka: L04AB02
English: If you forget or miss an appointment to receive Inflectra, make another appointment as soon as possible.
Croatian: Ako ste zaboravili ili propustili doći na infuziju lijeka Inflectra, dogovorite novi pregled što je prije moguće.
English: Concurrent use of stable doses of conventional therapies was permitted, and 83% of patients continued to receive at least one of these therapies.
Croatian: Bila je dozvoljena istodobna primjena konvencionalnih lijekova u ustaljenoj dozi te je 83% bolesnika nastavilo primati najmanje jedan od tih lijekova.
English: At single doses of 3, 5, or 10 mg/kg, the median Cmax values were 77, 118 and 277 micrograms/mL, respectively.
Croatian: Pri jednokratnim dozama od 3, 5 odnosno 10 mg/kg, medijan Cmax iznosio je 77, 118 odnosno 277 mikrograma/ml.
English: Currently available data are described in sections 4.8 and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8 i 5.2 međutim nije moguće dati preporuku o doziranju.
English: Chemical and physical in use stability of the diluted solution has been demonstrated for up to 28 days at 2 °C - 8 °C and for an additional 24 hours at 25 C after removal from refrigeration.
Croatian: Dokazana je kemijska i fizikalna stabilnost razrijeđene otopine do 28 dana na temperaturi od 2°C do 8°C i tijekom dodatna 24 sata nakon vađenja iz hladnjaka na temperaturi od 25°C.
English: Inflectra should only be used in children if they are being treated for Crohn's disease or ulcerative colitis.
Croatian: Inflectra se smije primjenjivati u djece samo ako se liječe od Crohnove bolesti ili ulceroznog kolitisa.
English: >54 weeks
Croatian: > 54 tjedna
English: Placebo (Week 16)
Croatian: Placebo (16. tjedan)
English: • Tell your doctor if you have had treatment with medicines containing infliximab in the past and are now starting Inflectra treatment again.
Croatian: • Obavijestite svog liječnika ako ste se u prošlosti već liječili lijekovima koji sadrže infliksimab i sada ponovno započinjete liječenje lijekom Inflectra.
English: If you feel tired, dizzy, or unwell after having Inflectra, do not drive or use any tools or machines.
Croatian: Ako se nakon primjene lijeka Inflectra osjećate umorno, imate omaglicu ili se osjećate loše, nemojte voziti ni rukovati alatima i strojevima.
English: * Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology.
Croatian: * Infliksimab je kimerno ljudsko-mišje monoklonsko protutijelo IgG1 proizvedeno na mišjim hibridoma stanicama tehnologijom rekombinantne DNK.
English: While using Inflectra you should not receive live vaccines.
Croatian: Dok uzimate lijek Inflectra ne smijete primati živa cjepiva.
English: Only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 1.2 micrometre or less) should be used.
Croatian: Smije se rabiti isključivo pribor za infuziju s "in-line", sterilnim, nepirogenim filtrom male sposobnosti vezanja proteina (veličina pora 1,2 mikrometra ili manje).
English: Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g. BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
Croatian: Primjena terapijskih infektivnih agenasa, poput živih atenuiranih bakterija, u druge svrhe (npr. intravezikalna instilacija BCG-a za liječenje raka) mogla bi dovesti do kliničkih infekcija, uključujući diseminirane infekcije.
English: In a 1-year clinical study with repeated infusions in patients with Crohn's disease (ACCENT I study), the incidence of serum sickness-like reactions was 2.4%.
Croatian: U jednogodišnjem kliničkom ispitivanju u kojemu se ispitivalo ponovljeno davanje infuzije bolesnicima s Crohnovom bolešću (kliničko ispitivanje ACCENT I), incidencija reakcija nalik serumskoj bolesti iznosila je 2,4%.
English: Upon removal from refrigerated storage, Inflectra must not be returned to refrigerated storage.
Croatian: Nakon što se izvadi iz hladnjaka, Inflectra se ne smije vratiti u hladnjak radi čuvanja.
English: The efficacy of infliximab through week 54 was assessed in the ACT 1 study.
Croatian: Djelotvornost infliksimaba tijekom 54 tjedana ispitivala se u kliničkom ispitivanju ACT 1.
English: Table 8 Effects on clinical response, clinical remission and mucosal healing at Weeks 8 and 30.
Croatian: Tablica 8 Učinci na klinički odgovor, kliničku remisiju i cijeljenje sluznice u 8. i 30. tjednu.
English: Patients may be pre-treated with e.g. an antihistamine, hydrocortisone and/or paracetamol and infusion rate may be slowed in order to decrease the risk of infusion-related reactions especially if infusion-related reactions have occurred previously (see section 4.4).
Croatian: Bolesnicima se prije infuzije može dati antihistaminik, hidrokortizon i/ili paracetamol te se brzina infuzije može smanjiti kako bi se smanjio rizik od reakcija vezanih uz infuziju, osobito ako je bolesnik prethodno imao reakcije vezane uz infuziju (vidjeti dio 4.4).
English: There is insufficient information regarding the concomitant use of infliximab with other biological therapeutics used to treat the same conditions as infliximab.
Croatian: Nema dovoljno podataka o istodobnoj primjeni infliksimaba s drugim biološkim lijekovima koji se primjenjuju za liječenje istih stanja kao i infliksimab.
English: • Tell your doctor before you are given Inflectra if you have or have ever had a problem that affects your nervous system.
Croatian: • Obavijestite svog liječnika prije nego što počnete primati lijek Inflectra ako imate ili ste imali neki problem koji je zahvaćao Vaš živčani sustav.
English: If you received Inflectra while pregnant, giving BCG vaccine (used to prevent tuberculosis) to your baby within 6 months after birth may result in infection with serious complications, including death.
Croatian: Ako ste tijekom trudnoće primali lijek Inflectra, primjena BCG cjepiva (primjenjuje se za sprječavanje tuberkuloze) Vašem djetetu unutar 6 mjeseci od rođenja može dovesti do ozbiljnih komplikacija, uključujući smrt.
English: Immunogenicity Antibodies to infliximab were detected in 3 (2.9%) paediatric patients.
Croatian: Imunogenost Protutijela protiv infliksimaba otkrivena su u 3 pedijatrijska bolesnika (2,9%).
English: Do not dilute the reconstituted Inflectra solution with any other diluent.
Croatian: Ne razrjeđujte rekonstituiranu otopinu lijeka Inflectra niti s jednom drugom otopinom.
English: After 54 weeks of treatment, both doses of infliximab + methotrexate resulted in statistically significantly greater improvement in signs and symptoms compared to methotrexate alone as measured by the proportion of patients achieving ACR20, 50 and 70 responses.
Croatian: Nakon 54 tjedana liječenja u obje skupine bolesnika koji su primali infliksimab + metotreksat došlo je do statistički značajnog poboljšanja simptoma i znakova bolesti u odnosu na bolesnike koji su primali samo metotreksat, mjereno udjelom bolesnika koji su postigli odgovor ACR20, 50 i 70.
English: Inflectra contains the active substance infliximab, which is of human and mouse origin.
Croatian: Inflectra sadrži djelatnu tvar infliksimab koja je ljudskog i mišjeg podrijetla.
English: Patients with ACR20 response/Patients evaluated (%) Total score d
Croatian: Bolesnici s odgovorom ACR20/ evaluirani bolesnici (%) Ukupan broj bodova d (van der
English: • In case you have received Inflectra while you were pregnant, it is important that you inform your baby's doctor about it before your baby receives any vaccine.
Croatian: • U slučaju da ste primali Inflectru za vrijeme trudnoće, važno je da o tome obavijestite pedijatra svog djeteta prije nego što Vaše dijete primi ikakvo cjepivo.
English: Infliximab should be used with caution in patients with mild heart failure (NYHA class I/II).
Croatian: Infliksimab treba davati uz oprez bolesnicima s blagim zatajenjem srca (NYHA stupanj I/II).
English: • Some patients receiving infliximab have developed symptoms of an immune system disorder called lupus.
Croatian: • Neki bolesnici koji su primali infliksimab razvili su simptome poremećaja imunološkog sustava koji se zove lupus.
English: Infusion-related reaction, pain.
Croatian: reakcije vezane uz infuziju, bol
English: • Small red or purple spots caused by bleeding under the skin
Croatian: • male crvene ili ljubičaste pjege nastale zbog krvarenja pod kožom
English: The card is aimed at both serving as a reminder to record the dates and outcomes of specific tests and to facilitate the patient sharing of special information with healthcare professionals (HCPs) treating the patient about on-going treatment with the product.
Croatian: Kartica služi kao podsjetnik na zabilježbu datuma i rezultata određenih testova te olakšava bolesniku dijeljenje posebnih informacija sa zdravstvenim radnicima koji liječe bolesnika trenutnom terapijom lijekom.
English: If you are 65 years of age or older, you have a greater risk.
Croatian: Taj je rizik veći ako imate 65 ili više godina.
English: Events (some fatal) of myocardial ischaemia/infarction and arrhythmia have been reported, some in close temporal association with infusion of infliximab, cerebrovascular accidents have also been reported in close temporal association with infusion of infliximab.
Croatian: Prijavljeni su događaji (neki sa smrtnim ishodom) ishemije/infarkta miokarda i aritmije, od kojih su neki bili vremenski usko povezani s infuzijom infliksimaba; prijavljeni su i cerebrovaskularni incidenti vremenski usko povezani s infuzijom infliksimaba.
English: In C0168T72, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever,
Croatian: U ispitivanju C0168T72 najčešće nuspojave bile su infekcije gornjih dišnih puteva, faringitis, bol u abdomenu, vrućica i glavobolja.
English: If these medicines or treatments do not work well enough, you will be given Inflectra to reduce the signs and symptoms of your disease.
Croatian: Ako ti lijekovi ili postupci ne djeluju dovoljno dobro, dobit ćete lijek Inflectra kako bi se umanjili znakovi i simptomi bolesti.
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor).
Croatian: Sve bolesnike treba upozoriti da odmah potraže liječničku pomoć ako razviju znakove i simptome koji ukazuju na krvnu diskraziju (npr. tvrdokorna vrućica, modrice, krvarenje, bljedilo).