FrancophonIA/ELRC3.0 huggingface dataset:
English: ≥ 90% improvement
Croatian: Poboljšanje ≥ 90%
English: Higher degrees of clinical response (ACR50 and ACR70) were observed in all infliximab groups at 30 and 54 weeks compared with methotrexate alone.
Croatian: Opažen je veći stupanj kliničkog odgovora (ACR50 i ACR70) u svim skupinama bolesnika koji su primali infliksimab nakon 30 i 54 tjedana u odnosu na bolesnike koji su primali samo metotreksat.
English: • Abnormal values of a blood protein called ‘complement factor' which is part of the immune system.
Croatian: • odstupanja u vrijednostima proteina koji je prisutan u krvi, a zove se faktor komplementa i dio je imunološkog sustava
English: • In case you have received Remicade 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 Remicade za vrijeme trudnoće, važno je da o tome obavijestite pedijatra svog djeteta prije nego što Vaše dijete primi ikakvo cjepivo.
English: In case maintenance therapy is interrupted, and there is a need to restart treatment, use of a re-induction regimen is not recommended (see section 4.8).
Croatian: U slučaju da je terapija održavanja prekinuta, a potrebno je ponovno započeti liječenje, ne preporučuje se ponavljanje uvodnog režima liječenja (vidjeti dio 4.8).
English: • A reminder to patients to show the patient reminder card to all treating HCPs, including in conditions of emergency, and a message for HCPs that the patient is using Remicade
Croatian: • podsjetnik bolesnicima da karticu s podsjetnikom za bolesnika pokažu svim zdravstvenim radnicima koji ih liječe, uključujući i u hitnim slučajevima, te obavijest zdravstvenim radnicima da bolesnik uzima Remicade
English: Of the infliximab-treated patients who received at least one shortened infusion, infusion-related reactions occurred in 15% of patients and serious infusion reactions occurred in 0.4% of patients.
Croatian: Među bolesnicima liječenima infliksimabom koji su primili barem jednu infuziju u skraćenom trajanju, reakcije vezanu uz infuziju javile su se u njih 15%, dok su se ozbiljne reakcije na infuziju javile u 0,4% bolesnika.
English: • Eye problems including blurred or reduced vision, puffy eyes or sties
Croatian: • problemi s očima uključujući zamagljen ili oslabljen vid, natečene oči ili ječmenac
English: Reports of lupus and lupus-like syndromes, however, remain uncommon (see section 4.4).
Croatian: Ipak, učestalost prijavljivanja lupusa i sindroma nalik lupusu i dalje je manje česta (vidjeti dio 4.4.).
English: • Tell your doctor straight away if you have signs of an infection.
Croatian: • Odmah obavijestite liječnika ako se pojave znakovi infekcije.
English: Additionally, closure of all fistulae was achieved in 55% of infliximab-treated patients compared with 13% of placebo-treated patients (p = 0.001).
Croatian: Uz to, zatvaranje svih fistula postignuto je u 55% bolesnika liječenih infliksimabom, u odnosu na 13% bolesnika koji su primali placebo (p = 0,001).
English: DO NOT SHAKE.
Croatian: NE TRESITE BOČICU.
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 kliničkom ispitivanju REACH imala anafilaktičke reakcije koje nisu bile ozbiljne.
English: Do not dilute the reconstituted Remicade solution with any other diluent.
Croatian: Ne razrjeđujte rekonstituiranu otopinu lijeka Remicade niti s jednom drugom otopinom.
English: Subjects randomised Percentage ACR improvement Mean ± SD
Croatian: Broj randomiziranih ispitanika Postotak poboljšanja ACR odgovora
English: At baseline 27.4% of patients were receiving systemic corticosteroids, 14.2% of patients were receiving budesonide, and 54.3% of patients were receiving 5-ASA compounds.
Croatian: Na početku je 27,4% bolesnika primalo sustavne kortikosteroide, 14,2% bolesnika primalo je budezonid, a 54,3% bolesnika primalo je spojeve 5-ASA.
English: • Bacterial infections such as blood poisoning, abscess or infection of the skin (cellulitis)
Croatian: • bakterijske infekcije kao što su trovanje krvi, apsces ili infekcija kože (celulitis)
English: Psoriasis is an inflammatory disease of the skin.
Croatian: Psorijaza je upalna bolest kože.
English: Psoriatic arthritis, ankylosing spondylitis (Bechterew's disease), psoriasis, ulcerative colitis and Crohn's disease
Croatian: Psorijatični artritis, ankilozantni spondilitis (Bechterewljeva bolest), psorijaza, ulcerozni kolitis i Crohnova bolest
English: Week 54 Clinical Response
Croatian: 54. tjedan Klinički odgovor
English: Infliximab 5 mg/kg
Croatian: infliksimab 5 mg/kg
English: Children may receive some vaccines during treatment with Remicade but should not receive live vaccines while using Remicade.
Croatian: Tijekom liječenja lijekom Remicade djeca mogu primiti neka cjepiva, ali ne smiju primiti živa cjepiva za vrijeme primjene lijeka Remicade.
English: Infliximab inhibits the functional activity of TNF in a wide variety of in vitro bioassays.
Croatian: Infliksimab inhibira funkcionalno djelovanje TNFα u raznim vrstama bioloških pokusa in vitro.
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(s) (HCPs) treating the patient about on-going treatment with the product.
Croatian: Kartica će služiti i kao podsjetnik da se upišu datumi provedbe i ishodi specifičnih pretraga i kao pomoć bolesniku da zdravstvene radnike koji ga liječe upozna sa specifičnim informacijama u vezi s trenutnim liječenjem ovim lijekom.
English: Due to methodological limitations, a negative assay did not exclude the presence of antibodies to infliximab.
Croatian: Zbog ograničenja metode negativni rezultati testa ne isključuju prisutnost protutijela na infliksimab.
English: Improvement from baseline in HAQ averaged over time from week 30 to week 54
Croatian: Prosjek poboljšanja HAQ od početne vrijednosti tijekom razdoblja od 30. do 54. tjedna Prosječna vrijednost ± SD
English: Immunogenicity Antibodies to infliximab were detected in 3 (2.9%) paediatric patients.
Croatian: Protutijela na infliksimab otkrivena su u 3 pedijatrijska bolesnika (2,9%).
English: There have also been post-marketing reports of new onset heart failure, including heart failure in patients without known pre-existing cardiovascular disease.
Croatian: Također su nakon stavljanja lijeka u promet prijavljeni slučajevi novonastalog zatajenja srca, uključujući zatajenje srca u bolesnika u kojih prethodno nije bila utvrđena kardiovaskularna bolest.
English: Radiographs of hands and feet were collected at baseline, weeks 24 and 54.
Croatian: Radiološke snimke šaka i stopala načinjene su na početku ispitivanja te u 24. i 54. tjednu.
English: In a clinical study of patients with Crohn's disease (SONIC), infusion-related reactions occurred in 16.6% (27/163) of patients receiving infliximab monotherapy, 5% (9/179) of patients receiving infliximab in combination with AZA, and 5.6% (9/161) of patients receiving AZA monotherapy.
Croatian: U kliničkom ispitivanju bolesnika s Crohnovom bolešću (SONIC), reakcije vezane uz infuziju javile su se u 16,6% (27/163) bolesnika koji su primali monoterapiju infliksimabom, 5% (9/179) bolesnika koji su primali infliksimab u kombinaciji s AZA i 5,6% (9/161) bolesnika koji su primali AZA kao monoterapiju.
English: Concomitant stable doses of oral aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted.
Croatian: Dopuštala se istodobna primjena stabilnih doza peroralnih aminosalicilata, kortikosteroida i/ili imunomodulatora.
English: In a clinical study of patients with rheumatoid arthritis (ASPIRE), infusions were to be administered over 2 hours for the first 3 infusions.
Croatian: U kliničkom ispitivanju bolesnika s reumatoidnim artritisom (ASPIRE) prve 3 infuzije morale su se davati tijekom 2 sata.
English: Infusion reactions and hypersensitivity
Croatian: Reakcije vezane uz infuziju i preosjetljivost
English: • Collections of immune cells resulting from an inflammatory response (granulomatous lesions)
Croatian: • nakupljanje imunosnih stanica kao posljedica upalnog odgovora (granulomatozne lezije)
English: In psoriatic arthritis patients who received 5 mg/kg with and without methotrexate, antibodies occurred overall in 15% of patients (antibodies occurred in 4% of patients receiving methotrexate and in 26% of patients not receiving methotrexate at baseline).
Croatian: U bolesnika s psorijatičnim artritisom koji su primali dozu od 5 mg/kg s ili bez metotreksata, protutijela su se pojavila u ukupno 15% bolesnika (protutijela su se pojavila u 4% bolesnika koji su primali metotreksat i u 26% bolesnika koji nisu početno primali metotreksat).
English: Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology.
Croatian: Infliksimab je kimerično humano-mišje monoklonsko protutijelo IgG1 proizvedeno na mišjim hibridomskim stanicama tehnologijom rekombinantne DNK.
English: A ≥ 50% reduction from baseline in the number of draining fistulas over a period of ≥ 4 weeks.
Croatian: Smanjenje početnog broja fistula iz kojih se cijedi sadržaj za ≥ 50% tijekom razdoblja od ≥ 4 tjedna.
English: Table 6 Percent of patients achieving corticosteroid-free clinical remission at week 26, SONIC
Croatian: Tablica 6 Postotak bolesnika koji su postigli kliničku remisiju bez kortikosteroida u 26. tjednu, SONIC Monoterapija AZA
English: • Changes in how your liver works, increase in liver enzymes (shown in blood tests)
Croatian: • poremećaj funkcije jetre, povišene vrijednosti jetrenih enzima (što se vidi iz nalaza pretraga krvi)
English: If you forget or miss an appointment to receive Remicade, make another appointment as soon as possible.
Croatian: Ako ste zaboravili ili propustili infuziju lijeka Remicade Ako ste zaboravili ili propustili doći na infuziju lijeka Remicade, dogovorite novi pregled što je prije moguće.
English: The safety and efficacy of re-administration after a Remicade-free interval of more than 16 weeks has not been established.
Croatian: Sigurnost i djelotvornost ponovne primjene, ako je razdoblje u kojemu se Remicade nije davao bilo dulje od 16 tjedana, nisu ustanovljene.
English: A response was observed within 2 weeks, with a maximum response at 4 weeks.
Croatian: Odgovor na liječenje zabilježen je u roku od dva tjedna, a najjači je bio u 4. tjednu.
English: If a patient has an inadequate response or loses response after this period, consideration may be given to increase the dose step-wise by approximately 1.5 mg/kg, up to a maximum of 7.5 mg/kg every 8 weeks.
Croatian: Ako nakon tog razdoblja odgovor bolesnika na terapiju više nije odgovarajući ili se odgovor izgubi, može se razmotriti postupno povećavanje doze za približno 1,5 mg/kg do najviše doze od 7,5 mg/kg svakih 8 tjedana.
English: Population pharmacokinetic analysis based on data obtained from patients with ulcerative colitis (N = 60), Crohn's disease (N = 112), juvenile rheumatoid arthritis (N = 117) and Kawasaki disease (N = 16) with an overall age range from 2 months to 17 years indicated that exposure to infliximab was dependent on body weight in a non-linear way.
Croatian: Populacijska farmakokinetička analiza na temelju podataka prikupljenih u bolesnika s ulceroznim kolitisom (N = 60), Crohnovom bolešću (N = 112), juvenilnim reumatoidnim artritisom (N = 117) i Kawasakijevom bolešću (N = 16), u ukupnom rasponu dobi od 2 mjeseca do 17 godina, pokazala je da izloženost infliksimabu nelinearno ovisi o tjelesnoj težini.
English: • A type of blood cancer (lymphoma)
Croatian: • vrsta raka krvi (limfom)
English: • Do not breast-feed when you are being treated with Remicade or for 6 months after your last treatment with Remicade.
Croatian: • Nemojte dojiti dok se liječite lijekom Remicade niti 6 mjeseci nakon posljednje doze lijeka Remicade.
English: Remicade is not likely to affect your ability to drive or use tools or machines.
Croatian: Nije vjerojatno da bi Remicade mogao utjecati na Vašu sposobnost upravljanja vozilima i strojevima i rada sa alatima.
English: Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
Croatian: Analiza je temeljena na bolesnicima s psorijazom noktiju na početku ispitivanja (81,8% bolesnika).
English: Patients were followed up to 26 weeks.
Croatian: Bolesnici su praćeni tijekom sljedećih 26 tjedana.
English: Clinical experience shows that host defence against infection is compromised in some patients treated with infliximab.
Croatian: Kliničko iskustvo je pokazalo narušenost obrane domaćina protiv infekcije u nekih bolesnika liječenih infliksimabom.
English: At baseline 53% of patients were receiving immunomodulator therapy (6-MP, AZA and/or MTX) and 62% of patients were receiving corticosteroids.
Croatian: Na početku ispitivanja je 53% bolesnika primalo terapiju imunomodulatorima (6-MP, AZA i/ili MTX), a 62% je primalo kortikosteroide.
English: Patients did not receive any concomitant immunosuppressant therapy.
Croatian: Bolesnici nisu istodobno primali terapiju imunosupresivima.
English: • Blood test result showing ‘antibodies' against your own body.
Croatian: • infekcije rodnice • nalazi krvnih pretraga koji ukazuju na prisutnost 'protutijela' na vlastito tijelo
English: The reduction in incidence of colectomy was also examined in another randomised, double-blind study (C0168Y06) in hospitalised patients (n = 45) with moderately to severely active ulcerative colitis who failed to respond to intravenous corticosteroids and who were therefore at higher risk for colectomy.
Croatian: Smanjena incidencija kolektomije ispitivana je i u drugom randomiziranom, dvostruko slijepom kliničkom ispitivanju (C0168Y06) u hospitaliziranih bolesnika (n = 45) sa umjerenim do teškim, aktivnim ulceroznim kolitisom koji nisu odgovorili na intravensko liječenje kortikosteroidima i koji su stoga imali veći rizik za kolektomiju.
English: • Store in a refrigerator (2 °C - 8 °C).
Croatian: • Čuvati u hladnjaku (2°C - 8°C).
English: The proportion of subjects achieving clinical remission at week 10 was 58.9% (66/112).
Croatian: Udio ispitanika koji su postigli kliničku remisiju u 10. tjednu iznosio je 58,9% (66/112).
English: For storage conditions up to 25 °C before reconstitution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja prije rekonstitucije lijeka, na temperaturi do 25°C, vidjeti u dijelu 6.3.
English: Please read the Remicade ‘Package Leaflet' carefully before you start using this medicine.
Croatian: Pažljivo pročitajte uputu o lijeku za lijek Remicade prije nego počnete primati ovaj lijek.
English: Studies have not been performed in patients with liver or renal disease.
Croatian: Nisu provedena ispitivanja u bolesnika s bolešću jetre ili bubrega.
English: ≥ 75% improvement
Croatian: Poboljšanje ≥ 75%
English: • These infections may be serious and include tuberculosis, infections caused by viruses, fungi, bacteria, or other organisms in the environment and sepsis that may be life-threatening.
Croatian: • Te infekcije mogu biti ozbiljne, a uključuju tuberkulozu, virusne infekcije, gljivične infekcije, bakterijske infekcije ili infekcije uzrokovane drugim mikroorganizmima iz okoliša te sepsu, koja može ugroziti život.
English: 19 weeks
Croatian: 19 tjedana
English: Almost all patients had also received medicines containing azathioprine or 6-mercaptopurine in addition to TNF-blockers.
Croatian: Skoro svi bolesnici također su uzimali lijekove koji sadrže azatioprin ili 6-merkaptopurin s TNF-blokatorom.
English: Infections occurred in 68% (41/60) of children receiving 3 mg/kg over 52 weeks, 65% (37/57) of children receiving infliximab 6 mg/kg over 38 weeks and 47% (28/60) of children receiving placebo over 14 weeks (see section 4.4).
Croatian: Infekcije su se javile u 68% djece (41/60) koja su primala infliksimab u dozi od 3 mg/kg tijekom 52 tjedna, u 65% djece (37/57) koja su primala infliksimab u dozi od 6 mg/kg tijekom 38 tjedana i u 47% djece (28/60) koja su primala placebo tijekom 14 tjedana (vidjeti dio 4.4).
English: In the psoriasis studies, delayed hypersensitivity reactions occurred early in the treatment course.
Croatian: U ispitivanjima psorijaze reakcije kasne preosjetljivosti događale su se u ranoj fazi liječenja.
English: Analysis of lamina propria mononuclear cells obtained by biopsy of the intestinal mucosa showed that infliximab treatment caused a reduction in the number of cells capable of expressing TNF and interferon.
Croatian: Analiza mononuklearnih stanica u lamini propriji, dobivenih biopsijom sluznice crijeva, pokazala je da je liječenje infliksimabom dovelo do smanjenja broja stanica koje mogu izraziti TNFα i interferon .
English: Calculate the dose and the number of Remicade vials needed.
Croatian: Izračunajte dozu i potreban broj bočica lijeka Remicade.
English: PGA of cleared (0) or minimal (1)
Croatian: PGA čist (0) ili minimalan (1)
English: Appropriate screening tests (e.g. tuberculin skin test, chest X-ray, and/or Interferon Gamma Release Assay), should be performed in all patients (local recommendations may apply).
Croatian: U svih bolesnika treba provesti odgovarajuće pretrage (npr. kožni tuberkulinski test, rendgen pluća i/ili test oslobađanja interferona gama) (sukladno lokalnim preporukama).
English: Low blood counts
Croatian: Smanjen broj krvnih stanica
English: Re-administration for Crohn's disease and rheumatoid arthritis If the signs and symptoms of disease recur, Remicade can be re-administered within 16 weeks following the last infusion.
Croatian: Ako se ponovno pojave znakovi i simptomi bolesti, Remicade se može ponovno primijeniti u roku od 16 tjedana od zadnje infuzije.
English: Table 1 lists ADRs based on experience from clinical studies as well as adverse reactions, some with fatal outcome, reported from post-marketing experience.
Croatian: Tablici 1 navedene su nuspojave koje se temelje na iskustvu iz kliničkih ispitivanja kao i nuspojave prijavljene nakon stavljanja lijeka u promet, od kojih su neke imale smrtni ishod.
English: In group 2, starting with the week 36 infusion, patients who had a BASDAI ≥ 3 at 2 consecutive visits, received 7.5 mg/kg infliximab every 6 weeks thereafter through week 96.
Croatian: U skupini 2, nakon infuzije u 36. tjednu, bolesnici koji su imali BASDAI ≥ 3 na dva uzastopna pregleda primali su dozu od 7,5 mg/kg infliksimaba svakih 6 tjedana do 96. tjedna.
English: In the 6 mg/kg group, 2 out of 57 patients had a serious infusion reaction, one of whom had a possible anaphylactic reaction (see section 4.4).
Croatian: U skupini koja je primala dozu od 6 mg/kg, 2 od 57 bolesnika imala su ozbiljnu reakciju na infuziju, od kojih se u jednog moglo raditi o anafilaktičkoj reakciji (vidjeti dio 4.4).
English: • This medicine can also be stored in the original carton outside of refrigerated storage up to a maximum of 25 °C for a single period of up to six months, but not beyond the original expiry date.
Croatian: • Ovaj se lijek također može čuvati u originalnom pakiranju izvan hladnjaka na temperaturi do najviše 25°C neprekinuto tijekom razdoblja od najviše 6 mjeseci, ali ne izvan originalnog roka valjanosti.
English: • Low blood counts, including a severely decreased number of white blood cells
Croatian: • smanjen broj krvnih stanica, uključujući značajno smanjenje broja bijelih krvnih stanica
English: • Tell your doctor before you are given Remicade if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.
Croatian: • Prije nego primite Remicade, obavijestite svog liječnika ako ste ikad živjeli ili putovali u područja u kojima su česte infekcije histoplazmoza, kokcidioidomikoza ili blastomikoza.
English: In the 3 mg/kg Remicade group, 4 out of 60 patients had a serious infusion reaction and 3 patients reported a possible anaphylactic reaction (2 of which were among the serious infusion reactions).
Croatian: U skupini koja je primala dozu od 3 mg/kg lijeka Remicade, 4 od 60 bolesnika imala su ozbiljnu reakciju na infuziju dok su 3 bolesnika prijavila moguću anafilaktičku reakciju (od kojih su 2 bile među ozbiljnim reakcijama na infuziju).
English: If patients are re-treated after a prolonged period, they must be closely monitored for signs and symptoms of delayed hypersensitivity.
Croatian: Kada se liječenje ponavlja nakon dulje stanke, bolesnici se moraju pomno nadzirati zbog mogućih znakova i simptoma reakcija kasne preosjetljivosti.
English: Additional histological studies provided evidence that treatment with infliximab reduces the infiltration of inflammatory cells into affected areas of the intestine and the presence of inflammation markers at these sites.
Croatian: Dodatna histološka istraživanja pružila su dokaze da liječenje infliksimabom smanjuje infiltraciju upalnih stanica u zahvaćena područja crijeva te prisutnost upalnih biljega na tim mjestima.
English: There are insufficient data on the incidence of delayed hypersensitivity reactions after Remicade-free intervals of more than 1 year but limited data from clinical studies suggest an increased risk for delayed hypersensitivity with increasing Remicade-free interval (see section 4.4).
Croatian: Nema dovoljno podataka o incidenciji reakcija kasne preosjetljivosti nakon prekida davanja lijeka Remicade u trajanju duljem od jedne godine, ali ograničeni podaci iz kliničkih ispitivanja ukazuju na povećanje rizika od kasne preosjetljivosti što je dulje razdoblje u kojemu se lijek ne primjenjuje (vidjeti dio 4.4).
English: • Tell your doctor if you think you might be at risk of contracting hepatitis B.
Croatian: • Obavijestite svog liječnika ako mislite da postoji rizik da se zarazite virusom hepatitisa B.
English: In an exploratory clinical study involving patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 adult patients were treated with Remicade at doses similar to those used in rheumatoid arthritis and Crohn's disease.
Croatian: U eksplorativnom kliničkom ispitivanju u bolesnika sa srednje teškim do teškim KOPB-om koji su bili aktivni ili bivši pušači, 157 odraslih bolesnika liječilo se sličnim dozama lijeka Remicade kakve su se primjenjivale u bolesnika s reumatoidnim artritisom i onih s Crohnovom bolešću.
English: Furthermore, improved quality of life as measured by IBDQ was observed with infliximab.
Croatian: Osim toga, primijećeno je da je infliksimab poboljšao kvalitetu života mjerenu pomoću upitnika IBDQ.
English: • Infection due to a live vaccine because of a weakened immune system.
Croatian: • infekcija uzrokovana primjenom živog cjepiva zbog oslabljenog imunološkog sustava
English: A reduction in the rate of the progression of structural joint damage (erosions and joint space narrowing) was observed in all infliximab groups at 54 weeks (Table 3).
Croatian: Smanjenje brzine napredovanja strukturnog oštećenja zglobova (erozije i sužavanje zglobnog prostora) primijećeno je nakon 54 tjedna u svim skupinama bolesnika koji su primali infliksimab (Tablica 3).
English: Ask your doctor to record the type and date of last screening(s) for tuberculosis (TB) below: Test
Croatian: Zamolite liječnika da ovdje zabilježi vrstu i datum posljednjeg testiranja na tuberkulozu (TBC):
English: Immunogenicity Antibodies to infliximab were detected in 4 (7.7%) patients through week 54.
Croatian: Protutijela na infliksimab su do kraja 54. tjedna otkrivena u 4 bolesnika (7,7%).
English: In patients who develop HBV reactivation, Remicade should be stopped and effective antiviral therapy with appropriate supportive treatment should be initiated.
Croatian: U bolesnika u kojih se ponovno aktivira HBV treba prekinuti primjenu lijeka Remicade te uvesti djelotvorne antivirusne lijekove uz odgovarajuće suportivno liječenje.
English: In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered medicinal product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati.