FrancophonIA/ELRC3.0 huggingface dataset:
English: In both studies concurrent use of stable doses of folic acid, oral corticosteroids (≤10 mg/day) and/or non-steroidal anti-inflammatory drugs (NSAIDs) was permitted.
Croatian: U oba je ispitivanja bila dopuštena istodobna primjena ustaljenih doza folatne kiseline, peroralnih kortikosteroida (≤ 10 mg na dan) i/ili nesteroidnih protuupalnih lijekova.
English: In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of infliximab, or modification of concomitant therapy.
Croatian: Bolesnici s povišenim ALT-om i AST-om u pravilu nisu imali simptoma, a odstupanja bi se smanjila ili vratila na normalne vrijednosti bilo s nastavkom ili prekidom davanja lijeka infliksimab ili modifikacijom istodobno primijenjenih lijekova.
English: • Tell your doctor before you are given Remsima if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
Croatian: • Prije nego počnete primati Remsima, obavijestite liječnika ako bolujete ili ste bolovali od limfoma (vrsta raka krvi) ili neke druge vrste raka.
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 premedikacija npr. antihistaminik, hidrokortizon i/ili paracetamol te se infuzija može usporiti 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: • Tell your doctor before you are given Remsima if you have an infection even if it is a very minor one.
Croatian: • Prije nego primite lijek Remsima, obavijestite svog liječnika ako imate neku infekciju, čak i ako je vrlo blaga.
English: In IMPACT and IMPACT 2, clinical responses were observed as early as week 2 and were maintained through week 98 and week 54 respectively.
Croatian: U ispitivanjima IMPACT i IMPACT 2 klinički su odgovor primijećen već u 2. tjednu i održali su se do 98. tjedna u ispitivanju IMPACT odnosno do 54. tjedna u ispitivanju IMPACT 2. Djelotvornost je potvrđena s ili bez istodobne primjene metotreksata.
English: a. Put the used syringe in an approved sharps disposal container immediately after use.
Croatian: Odložite iskorištenu brizgalicu u odobreni spremnik za oštre predmete odmah nakon primjene.
English: Elevations of aminotransferases were observed (ALT more common than AST) in a greater proportion of patients receiving infliximab than in controls, both when infliximab was given as monotherapy and when it was used in combination with other immunosuppressive agents.
Croatian: Povišene aminotransferaze (češće ALT nego AST) primijećene su u većem postotku u bolesnika koji su primali infliksimab nego u kontrolnim skupinama, kako pri primjeni lijeka infliksimab u monoterapiji, tako i pri primjeni u kombinaciji s drugim imunosupresivima.
English: Remsima contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Croatian: Remsima sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: c. Apply an adhesive bandage, if necessary.
Croatian: c. Postavite flaster ako je potrebno.
English: Significant improvements in health-related quality of life were also demonstrated as measured by the physical and mental component summary scores of the SF-36 in IMPACT 2.
Croatian: Dokazano je i značajno poboljšanje kvalitete života povezane sa zdravljem, mjereno ukupnim zbrojem rezultata fizičkih i mentalnih parametara u upitniku SF-36 u ispitivanju IMPACT 2. Psorijaza u odraslih bolesnika
English: c. Gently press a cotton ball or gauze over the injection site and apply an adhesive bandage, if necessary.
Croatian: c. Lagano pritisnite vatu ili gazu preko mjesta primjene i postavite flaster ako je potrebno.
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions (see section 6.3 above).
Croatian: Ako se ne primjeni odmah, trajanje i uvjeti čuvanja do primjene lijeka odgovornost su korisnika i ne bi trebali biti dulji od 24 sata na temperaturi od 2°C do 8°C, osim ukoliko rekonstitucija/razrjeđivanje nije provedeno u kontroliranim i validiranim aseptičkim uvjetima (vidjeti dio 6.3).
English: About the Remsima syringe Parts of the syringe (see Figure A):
Croatian: Remsima štrcaljki Dijelovi štrcaljke (vidjeti Sliku A):
English: Remsima is not likely to affect your ability to drive or use tools or machines.
Croatian: Nije vjerojatno da bi lijek Remsima mogao utjecati na Vašu sposobnost upravljanja vozilima i strojevima i rada sa alatima.
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 infliximab 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 infliksimaba kakve su se primjenjivale u bolesnika s reumatoidnim artritisom i onih s Crohnovom bolešću.
English: b. Gently press a cotton ball or gauze over the injection site and hold for 10 seconds.
Croatian: b. Lagano pritisnite vatu ili gazu preko mjesta primjene i držite oko 10 sekundi.
English: Table 1 Adverse reactions in clinical studies and from post-marketing experience of intravenous infliximab
Croatian: Tablica 1 Nuspojave u kliničkim ispitivanjima i nakon stavljanja intravenskog infliksimaba u promet
English: • That treatment with Remsima may increase the risks of serious infections/sepsis, opportunistic infections, tuberculosis, hepatitis B reactivation, and BCG breakthrough in infants with in utero exposure to infliximab, and when to seek attention from a HCP
Croatian: • napomenu da liječenje lijekom Remsima može povećati rizik od ozbiljnih infekcija/sepse, oportunističkih infekcija, tuberkuloze, reaktivacije hepatitisa B i probojne infekcije BCG-om u dojenčadi koja je bila izložena infliksimabu in utero, te kada je potrebno zatražiti medicinsku pomoć od zdravstvenog radnika • kontakt podatke liječnika koji je propisao lijek
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 14 days, 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 tijekom jednokratnog razdoblja od najviše 14 dana, ali ne izvan originalnog roka valjanosti.
English: The median AUCss in paediatric patients aged 2 years to less than 6 years was predicted to be approximately 40% lower than that in adults, although the number of patients supporting this estimate is limited.
Croatian: 2 do manje od 6 godina nego u odraslih, iako je broj bolesnika na kojemu se temelji ta procjena malen.
English: This will depend on your disease, weight and how well you respond to Remsima.
Croatian: Vašoj bolesti, tjelesnoj težini i odgovoru na liječenje.
English: Clean the injection site.
Croatian: Očistite mjesto primjene injekcije.
English: The primary endpoint was the proportion of patients who experienced a clinical response, defined as ≥50% reduction from baseline in the number of fistulae draining upon gentle compression on at least two consecutive visits (4 weeks apart), without an increase in the use of medicinal products or surgery for Crohn's disease.
Croatian: Primarna mjera ishoda bila je udio bolesnika koji su pokazali klinički odgovor, definiran kao ≥ 50%-tno smanjenje početnog broja fistula koje su se cijedile na lagani pritisak u najmanje dva uzastopna posjeta (u razmaku od 4 tjedna), bez povećanja doze lijekova za Crohnovu bolest ili kirurškog liječenja Crohnove bolesti.
English: Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia
Croatian: zatajenje srca (novonastalo ili pogoršanje postojećeg), aritmija, sinkopa,
English: c. With a quick and “dart-like” motion, insert the needle completely into the fold of the skin at a 45-degree angle.
Croatian: Brzim, kratkim pokretom, pod kutem od 45 stupnjeva ubodite iglu do kraja u nabor kože.
English: Note: Keep the syringe and sharps disposal container out of the sight and reach of children.
Croatian: Napomena: štrcaljku i spremnik za oštre predmete čuvajte izvan pogleda i dohvata djece.
English: The dose and the number of Remsima vials have to be calculated.
Croatian: Morate izračunati potrebnu dozu i broj bočica lijeka Remsima.
English: Hypotension, hypertension, ecchymosis, hot flush, flushing
Croatian: hipotenzija, hipertenzija, ekhimoza, navala vrućine, navale crvenila
English: From a microbiological point of view, the infusion solution should be administered immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions.
Croatian: S mikrobiološkog stajališta, infuzijsku otopinu treba primijeniti odmah; trajanje i uvjeti čuvanja do primjene lijeka odgovornost su korisnika i ne bi trebali biti dulji od 24 sata na temperaturi od 2°C do 8°C, osim ukoliko rekonstitucija/razrijeđivanje nije provedeno u kontroliranim i validiranim aseptičkim uvijetima.
English: Excipients: acetic acid, sodium acetate trihydrate, sorbitol, polysorbate 80, water for injections
Croatian: Pomoćne tvari: acetatna kiselina, natrijev acetat trihidrat, sorbitol, polisorbat 80, voda za injekciju
English: About the Remsima pen Parts of the pen (see Figure A):
Croatian: Remsima brizgalici Dijelovi brizgalice (vidjeti Sliku A):
English: PASI 75 response** * ITT-analysis where subjects with missing data were included as non-responders.
Croatian: * ITT-analiza, analiza svih bolesnika koje se namjeravalo liječiti; ispitanici za koje su nedostajali podaci bili uključeni kao oni u kojih nije nastupio odgovor.
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: 1 vial 2 vials 3 vials 4 vials 5 vials
Croatian: 1 bočica 2 bočice 3 bočice 4 bočice 5 bočica
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
English: For the two initial intravenous infusions, 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 prve dvije intravenske infuzije može dati premedikacija npr. antihistaminik, hidrokortizon i/ili paracetamol te se infuzija može usporiti 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: b all infliximab doses given in combination with methotrexate and folate with some on corticosteroids and/or NSAIDs c p <0.001, for each infliximab treatment group vs. control d greater values indicate more joint damage.
Croatian: b sve doze infliksimaba davale su se u kombinaciji s metotreksatom i folatima, a u nekim slučajevima i s kortikosteroidima i/ili nesteroidnim protuupalnim lijekovima c p < 0,001 za svaku skupinu liječenu infliksimabom u usporedbi s kontrolnom skupinom d veće vrijednosti znače jače oštećenje zgloba e HAQ = upitnik za procjenu zdravlja (engl.
English: If these medicines do not work well enough, you will be given Remsima which you will take with another medicine called methotrexate to:
Croatian: Ako ti lijekovi ne djeluju dovoljno dobro, dobit ćete Remsima, koji ćete koristiti u kombinaciji s drugim lijekom koji se zove metotreksat kako bi se: • umanjili znakovi i simptomi bolesti
English: The analysis of other efficacy endpoints showed that efficacy profile of Remsima subcutaneous formulation compared to Remsima intravenous formulation in RA patients was generally comparable in terms of disease activity measured by DAS28 (CRP and ESR) and ACR response up to Week 54.
Croatian: Analiza drugih mjera ishoda djelotvornosti pokazala je da je profil djelotvornosti supkutane formulacije u odnosu na intravensku formulaciju lijeka Remsima u bolesnika s reumatoidnim artritisom općenito usporediv u smislu aktivnosti bolesti mjereno DAS28 (CRP (engl.
English: Week 22 137 (78.7%) 139 (84.2%) 90 (51.7%) 85 (51.5%) 49 (28.2%) 46 (27.9%)
Croatian: 6. tjedan 103 (59,2%) 107 (64,8%) 45 (25,9%) 47 (28,5%) 18 (10,3%) 19 (11,5%) 22. tjedan 137 (78,7%) 139 (84,2%) 90 (51,7%) 85 (51,5%) 49 (28,2%) 46 (27,9%) 54. tjedan 125 (71,8%)a 132 (80,0%) 101 (58,0%)a 108 (65,5%) 68 (39,1%)a 77 (46,7%)
English: Secondary endpoints included the proportion of patients in clinical remission at week 4 (CDAI <150) and clinical response over time.
Croatian: Sekundarne mjere ishoda obuhvaćale su udio bolesnika u kliničkoj remisiji nakon 4 tjedna liječenja (CDAI < 150) te održanost kliničkog odgovora tijekom vremena.
English: Proportions of Patients Achieving Clinical Response According to the ACR Criteria ACR20
Croatian: Udjeli bolesnika koji su postigli klinički odgovor na temelju ACR kriterija
English: In the re-treatment arm, 4% (8/219) of patients experienced a serious infusion reaction versus <1% (1/222) on maintenance therapy.
Croatian: U skupini u kojoj je ponovljena uvodna shema liječenja ozbiljnu reakciju na infuziju razvilo je 4% (8/219) bolesnika u odnosu na < 1% bolesnika (1/222) koji su primali terapiju održavanja.
English: Infliximabb
Croatian: infliksimabb
English: Gather the supplies for the injection.
Croatian: Priredite pribor za davanje injekcije.
English: Table 7 Effects on response rate, data from ACCENT II (Week-14 responders)
Croatian: Učinci na stopu odgovora, podaci iz ACCENT II (bolesnici s odgovorom u 14. tjednu)
English: Remsima is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Međutim, Remsima se razrijeđuje u 0,9%-tnoj (9 mg/ml) otopini natrijeva klorida za infuziju.
English: In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 patients-years (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported.
Croatian: što predstavlja ukupno 6234 bolesnik-godina (3210 bolesnika), prijavljeno je 5 slučajeva limfoma i 38
English: This medicine contains 45 mg sorbitol in each 120 mg dose.
Croatian: Remsima sadrži 45 mg sorbitola u jednoj dozi od 120 mg.
English: Choose an injection site (see Figure C).
Croatian: Izaberite mjesto primjene injekcije (vidjeti Sliku C).
English: Abdominal pain, nausea
Croatian: bol u abdomenu, mučnina
English: The safety and efficacy of Remsima subcutaneous therapy in children aged below 18 years of age have not yet been established.
Croatian: Sigurnost i djelotvornost supkutane primjene lijeka Remsima nisu utvrđeni u djece mlađe od 18 godina.
English: In psoriatic arthritis, short term treatment with infliximab reduced the number of T-cells and blood vessels in the synovium and psoriatic skin.
Croatian: U bolesnika s psorijatičnim artritisom kratkotrajno liječenje lijekom infliksimab smanjilo je broj T-stanica i krvnih žila u sinovijalnoj membrani i koži zahvaćenoj psorijazom.
English: Note: Keep the pen and sharps disposal container out of the sight and reach of children.
Croatian: Napomena: brizgalicu i spremnik za oštre predmete čuvajte izvan pogleda i dohvata djece.
English: Remsima IV 3 mg/kgb (N=174)
Croatian: Remsima i.v. 3 mg/kgb (N=174)
English: Before treatment with Remsima
Croatian: Prije liječenja lijekom Remsima
English: Transient visual loss occurring during or within 2 hours of infusion
Croatian: prolazan gubitak vida koji se javlja tijekom ili do 2 sata nakon infuzije
English: • The other ingredients are acetic acid, sodium acetate trihydrate, sorbitol, polysorbate 80 and water for injections.
Croatian: • Pomoćne tvari su acetatna kiselina, natrij acetat trihidrat, sorbitol, polisorbat 80, voda za injekcije.
English: • Other skin problems such as erythema multiforme, blisters and peeling skin, or boils (furunculosis)
Croatian: • drugi problemi s kožom kao što su multiformni eritem, mjehurići na koži i ljuštenje kože ili gnojni čirevi (furunkuloza)
English: Other special populations
Croatian: Druge posebnpopulacij Starije osobe
English: • Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur followed by infusions of 5 mg/kg every 8 weeks (see ‘Re-administration' below and section 4.4).
Croatian: • terapija održavanja: dodatne infuzije u dozi od 5 mg/kg svakih 8 tjedana ili • ponovna primjena: infuzija u dozi od 5 mg/kg ako se ponovno pojave znakovi i simptomi bolesti, nakon čega slijede infuzije u dozi od 5 mg/kg svakih 8 tjedana (vidjeti "Ponovna primjena" u daljnjem tekstu i dio 4.4).
English: Remsima and Kineret should not be used together.
Croatian: Remsima i Kineret ne smiju se istodobno uzimati.
English: All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g. persistent cough, wasting/weight loss, low-grade fever) appear during or after infliximab treatment.
Croatian: Sve bolesnike treba uputiti da se jave liječniku ako se tijekom ili nakon liječenja infliksimabom pojave znakovi/simptomi koji bi mogli ukazivati na tuberkulozu (npr. perzistirajući kašalj, gubitak tjelesne težine, subfebrilnost).
English: Conjunctivitis
Croatian: konjunktivitis
English: Clinical remission at Week 8a Clinical remission at Week 30a Sustained remission(in remission at both Week 8 and Week 30)a
Croatian: Održana remisija (u remisiji i u 8. i u 30. tjednu)a
English: The vast majority of infliximab cases have occurred in patients with Crohn's disease or ulcerative colitis and most were reported in adolescent or young adult males.
Croatian: Velika većina ovih slučajeva među bolesnicima liječenim infliksimabom pojavila se u bolesnika s Crohnovom bolešću ili ulceroznim kolitisom a većinom su prijavljeni u adolescenata ili mlađih odraslih muškaraca.
English: Remsima contains sodium
Croatian: Remsima sadrži natrij
English: Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFα but not to lymphotoxin α (TNFβ).
Croatian: Infliksimab je kimerično ljudsko-mišje monoklonsko protutijelo koje se vezuje s velikim afinitetom za topive i transmembranske oblike faktora nekroze tumora alfa (TNFα), ali ne i za limfotoksin alfa (TNFβ).
English: Your doctor may recommend temporarily stopping Remsima.
Croatian: Liječnik Vam može preporučiti privremeni prekid liječenja lijekom
English: Pulmonary oedema, bronchospasm, pleurisy, pleural effusion
Croatian: edem pluća, bronhospazam, pleuritis, pleuralni izljev
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primjeni odmah, trajanje i uvjeti čuvanja do primjene lijeka odgovornost su korisnika i ne bi trebali biti dulji od 24 sata na temperaturi od 2°C - 8°C, osim ukoliko rekonstitucija/razrjeđivanje nije provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: Rheumatoid arthritis1
Croatian: Reumatoid ni artritis1
English: • A rare blood cancer affecting mostly young men (hepatosplenic T-cell lymphoma)
Croatian: • rijedak rak krvnih stanica koji se najčešće javlja u mlađih muškaraca (hepatosplenički limfom
English: b n = 292. c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
Croatian: c Analiza je temeljena na bolesnicima s psorijazom noktiju na početku ispitivanja (81,8% bolesnika).
English: Remsima IV 3 mg/kga (N=174)
Croatian: Remsima i.v. 3 mg/kga (N=174)
English: • Tell your doctor before you are using Remsima if you are a carrier of hepatitis B or have ever had it.
Croatian: • Prije nego počnete primati lijek Remsima, obavijestite svog liječnika ako ste nositelj virusa hepatitisa B ili ste ikad imali hepatitis B.
English: The primary endpoint was the proportion of patients who experienced a clinical response, defined as a decrease in CDAI by ≥70 points from baseline at the 4-week evaluation and without an increase in the use of medicinal products or surgery for Crohn's disease.
Croatian: Primarnu mjeru ishoda ispitivanja činio je udio bolesnika koji su pokazali klinički odgovor, definiran kao smanjenje CDAI za ≥ 70 bodova u odnosu na početne vrijednosti nakon 4 tjedna, bez povećanja doza lijekova koji se daju u Crohnovoj bolesti ili kirurškog liječenja Crohnove bolesti.
English: 3.4 (1.3)b a Two-sided 95% CI for difference in the mean change from baseline for DAS28 (CRP) at Week 22 was well above the pre-defined non-inferiority margin of -0.6 b Remsima IV was switched to Remsima SC at Week 30
Croatian: DAS28 (CRP) u 22. tjednu bio je znatno iznad prethodno definirane margine neinferiornosti od -0,6 b Prijelaz s Remsima i.v. na Remsima s.c. u 30. tjednu
English: During treatment with Remsima
Croatian: Tijekom liječenja lijekom Remsima
English: • you have tuberculosis (TB) or another serious infection such as pneumonia or sepsis (serious bacterial infection of the blood),
Croatian: • ako imate tuberkulozu (TBC) ili neku drugu ozbiljnu infekciju kao što je upala pluća ili sepsa
English: The efficacy of infliximab intravenous formulation was assessed in two multicentre, randomised, double-blind, pivotal clinical studies: ATTRACT and ASPIRE.
Croatian: Djelotvornost intravenske formulacije infliksimaba ispitivana je u dva multicentrična, randomizirana, dvostruko slijepa, pivotalna klinička ispitivanja: ATTRACT i ASPIRE.
English: Consult your healthcare provider if you have questions about using the Remsima pen.
Croatian: Obratite se svom liječniku ako imate pitanja u vezi primjene Remsima brizgalice.
English: Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, ATTRACT
Croatian: Učinci na ACR20, strukturna oštećenja zglobova i funkcionalnu sposobnost u 54. tjednu,
English: The ASPIRE study evaluated responses at 54 weeks in 1,004 methotrexate naive patients with early (≤3 years disease duration, median 0.6 years) active rheumatoid arthritis (median swollen and tender joint count of 19 and 31, respectively).
Croatian: U ispitivanju ASPIRE ocjenjivali su se odgovori na terapiju nakon 54 tjedna u 1004 bolesnika s aktivnim reumatoidnim artritisom (medijan broja otečenih zglobova 19, a osjetljivih zglobova 31) u ranoj fazi (trajanje bolesti ≤ 3 godine, medijan 0,6 godina), koji nisu prethodno liječeni metotreksatom.
English: Remsima 120 mg injection infliximab
Croatian: Remsima 120 mg injekcija infliksimab
English: Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis
Croatian: perforacija crijeva, stenoza crijeva, divertikulitis, pankreatitis, heilitis
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PRE-FILLED SYRINGE WITH AUTOMATIC NEEDLE GUARD
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA NAPUNJENU ŠTRCALJKU S AUTOMATSKIM ŠTITNIKOM IGLE
English: Information regarding switching patients from the subcutaneous formulation to the intravenous formulation of Remsima is not available.
Croatian: Nama dostupnih podataka o prijelazu s davanja supkutane formulacije na davanje intravenske formulacije lijeka Remsima.