FrancophonIA/ELRC3.0 huggingface dataset:
English: NovoEight 250 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Croatian: NovoEight 250 IU prašak i otapalo za otopinu za injekciju turoktokog alfa (humani koagulacijski faktor VIII (rDNK))
English: Each powder vial contains nominally 3000 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Croatian: Jedna bočica s praškom nominalno sadrži 3000 IU humanog koagulacijskog faktora VIII (rDNK), turoktokoga alfa.
English: NovoEight 2000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Croatian: NovoEight 2000 IU prašak i otapalo za otopinu za injekciju turoktokog alfa (humani koagulacijski faktor VIII (rDNK))
English: Table 6 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by BMI classesaOne-stage clotting assay - Mean (SD)
Croatian: Table 6 Farmakokinetički parametri jednokratne doze lijeka NovoEight (50 IU/kg) u skupinama prema ITM-ua - jednostupanjski test koagulacije - srednja vrijednost (SD) PK parametar
English: After reconstitution NovoEight contains approximately 750 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Croatian: Nakon rekonstitucije, NovoEight sadrži približno 750 IU/ml humanog koagulacijskog faktora VIII (rDNK), turoktokoga alfa.
English: NovoEight 500 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Croatian: NovoEight 500 IU prašak i otapalo za otopinu za injekciju turoktokog alfa (humani koagulacijski faktor VIII (rDNK))
English: • bleeding into joint spaces
Croatian: • upala vene • krvarenje u zglobne prostore
English: Each powder vial contains nominally 1000 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Croatian: Jedna bočica s praškom nominalno sadrži 1000 IU humanog koagulacijskog faktora VIII (rDNK), turoktokoga alfa.
English: Each powder vial contains nominally 500 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Croatian: Jedna bočica s praškom nominalno sadrži 500 IU humanog koagulacijskog faktora VIII (rDNK), turoktokoga alfa.
English: Vial adapter Protective cap
Croatian: Napomena o pomoćnim tvarima
English: Intravenous use Read the package leaflet before use
Croatian: Prije uporabe pročitajte uputu o lijeku.
English: After reconstitution NovoEight contains approximately 250 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Croatian: Nakon rekonstitucije, NovoEight sadrži približno 250 IU/ml humanog koagulacijskog faktora VIII (rDNK), turoktokoga alfa.
English: NovoEight 3000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Croatian: NovoEight 3000 IU prašak i otapalo za otopinu za injekciju turoktokog alfa (humani koagulacijski faktor VIII (rDNK))
English: NovoEight 1500 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Croatian: NovoEight 1500 IU prašak i otapalo za otopinu za injekciju turoktokog alfa (humani koagulacijski faktor VIII (rDNK))
English: After reconstitution NovoEight contains approximately 500 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Croatian: Nakon rekonstitucije, NovoEight sadrži približno 500 IU/ml humanog koagulacijskog faktora VIII (rDNK), turoktokoga alfa.
English: NovoEight is given as an injection into a vein.
Croatian: Kako se primjenjuje NovoEight NovoEight se primjenjuje injekcijom u venu (intravenski).
English: Adults (≥18 years) PTP
Croatian: Mlađa djeca (0 do <6 godina) PTP
English: NovoEight 1000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Croatian: NovoEight 1000 IU prašak i otapalo za otopinu za injekciju turoktokog alfa (humani koagulacijski faktor VIII (rDNK))
English: NovoEight 2000 IU EU/1/13/888/005
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/888/005
English: NovoEight 3000 IU EU/1/13/888/006
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/888/006
English: Each powder vial contains nominally 1500 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Croatian: Jedna bočica s praškom nominalno sadrži 1500 IU humanog koagulacijskog faktora VIII (rDNK), turoktokoga alfa.
English: NovoEight 1000 IU powder for solution for injection turoctocog alfa
Croatian: NovoEight 1000 IU prašak za otopinu za injekciju turoktokog alfa Za intravensku primjenu.
English: Fatigue, feeling hot, oedema peripheral, pyrexia
Croatian: Opći poremećaji i reakcije na mjestu primjene često reakcije na mjestu injiciranjac često pireksija, eritem na mjestu kateterizacije manje često umor, osjećaj vrućine, periferni edem, pireksija
English: NovoEight 2000 IU powder for solution for injection turoctocog alfa
Croatian: NovoEight 2000 IU prašak za otopinu za injekciju turoktokog alfa Za intravensku primjenu.
English: EXP
Croatian: Klip
English: Cough
Croatian: Nuspojava
English: NovoEight 1000 IU EU/1/13/888/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/888/003
English: Table 4 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by age - one stage clotting assay - Mean (SD)
Croatian: Tablica 4 Farmakokinetički parametri jednokratne doze lijeka NovoEight (50 IU/kg) po dobijednostupanjski test koagulacije - srednja vrijednost (SD) Parametar
English: (bromobutyl) and a syringe cap with a stopper (bromobutyl) - 1 plunger rod (polypropylene).
Croatian: i zatvaračem štrcaljke s čepom (brombutil)
English: Hypertension, lymphoedema, hyperaemia
Croatian: Krvožilni poremećaji manje često hipertenzija, limfedem, hiperemija često navale crvenila, površinski tromboflebitis
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva manje često ukočenost mišića i kostiju,
English: NovoEight 1500 IU EU/1/13/888/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/888/004
English: Date of first authorisation: 26 July 2018
Croatian: Datum prvog odobrenja: 26. srpanj 2018.
English: Children and adolescents Trazimera is not recommended for anyone under the age of 18 years.
Croatian: Djeca i adolescenti Trazimera se ne preporučuje osobama mlađima od 18 godina.
English: Appropriate aseptic technique should be used.
Croatian: Potrebno je primijeniti odgovarajuću aseptičku tehniku.
English: 88397 Biberach an der Riss Germany
Croatian: 88397 Biberach an der Riss Njemačka
English: Your doctor will closely supervise your therapy.
Croatian: Liječnik će pomno nadzirati Vašu terapiju.
English: Not known: frequency cannot be estimated from the available data
Croatian: Nepoznate: učestalost se ne može procijeniti iz dostupnih podataka
English: This medicinal product must not be mixed or diluted with other medicinal products except those mentioned under section 6.6.
Croatian: Lijek se ne smije miješati ni razrjeđivati s drugim lijekovima osim onih navedenih u dijelu 6.6.
English: Your doctor will prescribe a dose and treatment regimen that is right for you.
Croatian: Liječnik će Vam propisati dozu i režim liječenja koji Vama najviše odgovara.
English: * are summarized in Table 7.
Croatian: * prikazani su sažeto u Tablici 7.
English: The powder is a white cake.
Croatian: Prašak čini bijeli kolačić.
English: What Trazimera is and what it is used for
Croatian: Što je Trazimera i za što se koristi
English: Trazimera can cause breathing difficulties, especially when it is first given.
Croatian: Trazimera može izazvati poteškoće u disanju, osobito prilikom prve primjene.
English: What Trazimera looks like and contents of the pack
Croatian: Kako Trazimera izgleda i sadržaj pakiranja
English: The dose of Trazimera depends on your body weight.
Croatian: Potrebna doza lijeka Trazimera ovisi o Vašoj tjelesnoj težini.
English: Like all medicines, Trazimera can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Trazimera može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: • Your doctor will advise you of the risks and benefits of taking Trazimera during pregnancy.
Croatian: • Liječnik će Vam objasniti rizike i koristi primjene lijeka Trazimera tijekom trudnoće.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Croatian: Ako se lijek ne primijeni odmah, vrijeme i uvjeti čuvanja prije uporabe postaju odgovornost korisnika.
English: The loading dose should be administered as a 90-minute intravenous infusion.
Croatian: Udarnu dozu potrebno je primijeniti u 90-minutnoj intravenskoj infuziji.
English: The primary endpoint was overall survival which was defined as the time from the date of randomization to the date of death from any cause.
Croatian: Primarna mjera ishoda ispitivanja bila je ukupno preživljenje, utvrđeno kao vrijeme od dana randomizacije do dana smrti zbog bilo kojeg uzroka.
English: Other medicines and Trazimera
Croatian: Drugi lijekovi i Trazimera
English: Overexpression of HER2 is observed in 20%-30% of primary breast cancers.
Croatian: Povećana ekspresija HER2 uočena je u 20 %-30 % primarnih karcinoma dojke.
English: Trazimera may also be given once a week for metastatic breast cancer.
Croatian: Trazimera se također može davati jednom tjedno za metastatski rak dojke.
English: • dry eyes
Croatian: • suzne oči
English: There is no relevant use of Trazimera in the paediatric population.
Croatian: Nema relevantne primjene lijeka Trazimera u pedijatrijskoj populaciji.
English: The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions.
Croatian: Čuvanje lijeka nakon rekonstitucije i razrjeđivanja nije predviđeno, osim ukoliko ono nije obavljeno u kontroliranim i validiranim aseptičkim uvjetima.
English: For storage conditions of the reconstituted medicinal product, see sections 6.3 and 6.6.
Croatian: Uvjete čuvanja rekonstituiranog lijeka vidjeti u dijelovima 6.3 i 6.6.
English: Trastuzumab 1 Year N=1702***
Croatian: Trastuzumab tijekom1 godine N =1702***
English: If you develop any signs of heart failure (inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Trazimera treatment.
Croatian: Ako se pojave znakovi zatajenja srca (srce nedostatno pumpa krv), možda ćete srčanu funkciju kontrolirati češće (svakih šest do osam tjedana), a možda ćete primati terapiju za zatajenje srca ili ćete morati prekinuti liječenje lijekom Trazimera.
English: The bag or bottle should be gently inverted to mix the solution in order to avoid foaming.
Croatian: Vrećicu ili bocu treba lagano okretati kako bi se otopina izmiješala bez stvaranja pjene.
English: These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with Trazimera.
Croatian: Ti lijekovi (ili neki drugi antraciklini) mogu oštetiti srčani mišić i povećati rizik od srčanih problema pri primjeni lijeka Trazimera.
English: Trazimera is a biosimilar medicinal product.
Croatian: Trazimera je biosličan lijek.
English: The efficacy results from the BCIRG 006 are summarized in Tables 9 and 10.
Croatian: Rezultati djelotvornosti iz ispitivanja BCIRG 006 sažeto su prikazani u Tablicama 9 i 10.
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8ºC in a refrigerator.
Croatian: Uvijek čuvajte ovaj lijek u zatvorenom originalnom pakiranju u hladnjaku na temperaturi od 2°C do 8°C.
English: The results of these simulations indicate that at least 95% of patients will reach concentrations that are <1 μg/mL (approximately 3% of the population predicted Cmin,ss, or about 97% washout) by 7 months.
Croatian: Rezultati tih simulacija ukazuju da će najmanje 95 % bolesnika postići koncentracije <1 μg/ml (približno 3% vrijednosti Cmin,ss predviđene za populaciju ili ispiranje od približno 97%) do 7. mjeseca.
English: Greater than 70% of patients enrolled exhibited 3+ overexpression.
Croatian: Više od 70 % uključenih bolesnica imalo je povećanu ekspresiju razine 3+.
English: Patients who develop asymptomatic cardiac dysfunction may benefit from more frequent monitoring (e.g., every 6 - 8 weeks).
Croatian: Bolesnicima koji razviju asimptomatsku disfunkciju srca mogli bi koristiti češći pregledi (primjerice, svakih 6-8 tjedana).
English: If you receive Trazimera in combination with chemotherapy, some of them may also be due to the chemotherapy.
Croatian: Ako primate lijek Trazimera u kombinaciji s kemoterapijom, neke od njih mogu biti i posljedica primljene kemoterapije.
English: Trazimera intravenous formulation is given as an intravenous infusion (“drip”) directly into your veins.
Croatian: Trazimera u intravenskoj formulaciji se primjenjuje intravenskom infuzijom („drip“) direktno u venu.
English: Concentration after reconstitution - 21 mg/mL
Croatian: Koncentracija nakon rekonstitucije - 21 mg/ml
English: • Heart problems can sometimes occur during treatment and occasionally after treatment has stopped and can be serious.
Croatian: • Ponekad se za vrijeme liječenja i katkad nakon prestanka liječenja mogu pojaviti srčani problemi koji mogu biti ozbiljni.
English: FP + H: Fluoropyrimidine/cisplatin + trastuzumab FP: Fluoropyrimidine/cisplatin Odds ratio
Croatian: FP + H: fluoropirimidin/cisplatin + trastuzumab FP: fluoropirimidin/cisplatin omjer izgleda
English: Trazimera may affect your ability to drive a car or operate machines.
Croatian: Trazimera može utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
English: After reconstitution with sterile water for injections the reconstituted solution is physically and chemically stable for 48 hours at 2°C - 8°C.
Croatian: Nakon rekonstitucije sa sterilnom vodom za injekcije rekonstituirana otopina je fizički i kemijski stabilna 48 sati na temperaturi 2-8°C.
English: Due to nonlinear elimination, total clearance increased with decreasing concentration.
Croatian: Zbog nelinearne eliminacije, ukupan se klirens povećavao sa smanjenjem koncentracije.
English: In general, CISH is considered positive if there are more than 5 copies of the HER2 gene per nucleus in greater than 50% of tumour cells.
Croatian: Općenito, CISH se smatra pozitivnim ako postoji više od pet kopija HER2 gena po jezgri u više od 50 % tumorskih stanica.
English: As animal reproduction studies are not always predictive of human response, trastuzumab should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the foetus.
Croatian: Budući da se na temelju ispitivanja provedenih na životinjama ne može pouzdano predvidjeti odgovor kod ljudi, primjenu trastuzumaba u trudnoći treba izbjegavati osim ako je moguća korist za majku veća od moguće opasnosti za fetus.
English: Do not administer as an intravenous push or bolus.
Croatian: Ne primjenjujte je kao intravensku injekciju ili bolus.
English: Serious reactions have been treated successfully with supportive therapy such as oxygen, beta- agonists, and corticosteroids.
Croatian: Ozbiljne reakcije uspješno su liječene suportivnom terapijom, primjerice kisikom, beta-agonistima i kortikosteroidima.
English: It may take up to 7 months for Trazimera to be removed from your body.
Croatian: Može biti potrebno i do 7 mjeseci da se Trazimera ukloni iz Vašeg tijela.
English: Therefore, these patients should not be treated with trastuzumab (see section 4.3).
Croatian: Te se bolesnike zato ne smije liječiti trastuzumabom (vidjeti dio 4.3).
English: One vial contains either:
Croatian: Jedna bočica sadrži:
English: Trazimera should only be given by a doctor or nurse.
Croatian: Lijek Trazimera smije primijeniti samo liječnik ili medicinska sestra.
English: Duration of Response, Median months
Croatian: Trajanje odgovora, medijan u mjesecima
English: In this section, the following categories of frequency have been used: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: U ovom dijelu, za prikaz nuspojava prema učestalosti korišteni su sljedeći kriteriji: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko
English: Instructions for Reconstitution:
Croatian: Upute za rekonstituciju:
English: Do not stop using this medicine without talking to your doctor first.
Croatian: Nemojte prestati primati lijek Trazimera ako o tome prethodno niste razgovarali sa svojim liječnikom.
English: These events may occur as part of an infusion-related reaction or with a delayed onset.
Croatian: Ti se nuspojave mogu javiti kao dio infuzijskih reakcija ili s odgođenim nastupom.
English: In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, trgovački naziv i broj serije primijenjenog lijeka moraju se jasno evidentirati.
English: Chemo + Trastuzumab (n=115)
Croatian: Kemoterapija + trastuzumab (n=115)
English: No. patients with event
Croatian: Broj bolesnica s događajem
English: Trazimera may have a minor influence on the ability to drive or use machines (see section 4.8).
Croatian: Trazimera može imati manji utjecaj na sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio 4.8).
English: The bioactivity of D7D and the clinical impact of the elevation of this metabolite was unclear.
Croatian: Nije bila razjašnjena bioaktivnost metabolita D7D, ni klinički značaj povećanih koncentracija toga metabolita.
English: If a pregnant woman is treated with trastuzumab, or if a patient becomes pregnant while receiving trastuzumab or within 7 months following the last dose of trastuzumab, close monitoring by a multidisciplinary team is desirable.
Croatian: Ako se trastuzumabom liječi trudnicu, ili ako bolesnica zatrudni tijekom liječenja trastuzumabom ili unutar 7 mjeseci nakon posljednje doze trastuzumaba, poželjno je pažljivo praćenje od strane multidisciplinarnog tima.
English: Treatment with Trazimera alone or with a taxane may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer).
Croatian: Liječenje lijekom Trazimera samim ili u kombinaciji s taksanom može utjecati na srce, osobito ako ste nekada već uzimali antracikline (taksani i antraciklini su dvije vrste lijekova koji se koriste za liječenje raka).
English: Your doctor may prescribe Trazimera for the treatment of breast and gastric cancer when: • You have early breast cancer, with high levels of a protein called HER2.
Croatian: Vaš liječnik Vam može propisati lijek Trazimera za liječenje raka dojke i želuca ako: • bolujete od ranog raka dojke s visokom razinom proteina koji se zove HER2.
English: What you need to know before you are given Trazimera
Croatian: Što morate znati prije nego počnete primati lijek Trazimera
English: As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during Trazimera therapy and for 7 months after the last dose.
Croatian: Budući da se humani IgG1 izlučuje u majčino mlijeko u ljudi, a nema spoznaja o mogućem štetnom učinku na novorođenče, žene ne bi smjele dojiti tijekom liječenja lijekom Trazimera ni 7 mjeseci nakon posljednje doze lijeka.
English: White lyophilised powder or cake.
Croatian: Liofilizirani prašak ili kolačić bijele boje.
English: Patients experiencing infusion-related symptoms (see section 4.4) should be advised not to drive and use machines until symptoms abate.
Croatian: Bolesnicima u kojih su se razvili simptomi izazvani infuzijskom reakcijom (vidjeti dio 4.4) treba savjetovati da ne upravljaju vozilima i strojevima dok se simptomi ne povuku.
English: If the first dose is well tolerated the next doses may be given over 30 minutes (see section 2 under “Warnings and precautions”).
Croatian: U slučaju dobrog podnošenja prve doze, sljedeće se doze mogu primijeniti u infuziji trajanja 30 minuta (pogledajte dio 2. pod "Upozorenja i mjere opreza").
English: defined as absence of any invasive cancer both in the breast and axillary nodes
Croatian: definiran kao izostanak invazivnoga raka i u dojci i u aksilarnim čvorovima
English: Observation N=1697***
Croatian: N=1697***
English: Experience of concurrent administration of trastuzumab with low dose anthracycline regimens is currently limited to two trials (MO16432 and BO22227).
Croatian: Iskustvo s istodobnom primjenom trastuzumaba i protokola s niskim dozama antraciklina zasada je ograničeno na dva ispitivanja (MO16432 i BO22227).
English: If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab.
Croatian: Ako je moguće, uputno je izbjegavati primjenu antraciklinske terapije do 7 mjeseci nakon prestanka primjene trastuzumaba.
English: For instructions on reconstitution of Trazimera intravenous formulation before administration, see section 6.6.
Croatian: Za upute o rekonstituciji lijeka Trazimera u intravenskoj formulaciji prije primjene vidjeti dio 6.6.
English: Patients should be observed for at least six hours after the start of the first infusion and for two hours after the start of the subsequent infusions for symptoms like fever and chills or other infusion-related symptoms (see sections 4.4 and 4.8).
Croatian: Bolesnike je potrebno promatrati najmanje 6 sati nakon početka prve infuzije te 2 sata nakon početka svake sljedeće infuzije kako bi se uočili simptomi poput vrućice i zimice ili drugi simptomi koji su vezani uz primjenu infuzije (vidjeti dijelove 4.4 i 4.8).
English: - following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).
Croatian: - nakon kirurškog zahvata, kemoterapije (neoadjuvantne ili adjuvantne) i radioterapije (ako su provedeni) (vidjeti dio 5.1)
English: In the adjuvant treatment setting, trastuzumab was investigated in 4 large multicentre, randomised, trials.
Croatian: U adjuvantnom je liječenju trastuzumab ispitivan u 4 velika multicentrična, randomizirana ispitivanja:
English: Women of childbearing potential should be advised to use effective contraception during treatment with Trazimera and for 7 months after treatment has concluded (see section 5.2).
Croatian: Ženama reproduktivne dobi potrebno je preporučiti učinkovitu kontracepciju tijekom terapije lijekom Trazimera i 7 mjeseci nakon prestanka liječenja (vidjeti dio 5.2).
English: The European Medicines Agency has waived the obligation to submit the results of studies with trastuzumab in all subsets of the paediatric population for breast and gastric cancer (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja trastuzumaba u svim podskupinama pedijatrijske populacije za rak dojke i želuca (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Median follow-up 12 months* Median follow-up 8 years**
Croatian: Medijan praćenja 8 godina**
English: For early breast cancer, metastatic breast cancer and metastatic gastric cancer, Trazimera is given every 3 weeks.
Croatian: Za rani rak dojke, metastatski rak dojke i metastatski rak želuca, Trazimera se primjenjuje svaka 3 tjedna.
English: During a Trazimera infusion, chills, fever and other flu like symptoms may occur.
Croatian: Za vrijeme infuzije lijeka Trazimera mogu se pojaviti zimica, vrućica i drugi simptomi nalik gripi.
English: Do not breast-feed your baby during Trazimera therapy and for 7 months after the last dose of Trazimera as Trazimera may pass to your baby through your breast milk.
Croatian: Nemojte dojiti dijete za vrijeme terapije lijekom Trazimera ni 7 mjeseci nakon posljednje doze lijeka, jer se Trazimera preko Vašeg mlijeka može prenijeti na Vaše dijete.
English: Denotes adverse reactions that are reported largely in association with Infusion-related reactions.
Croatian: Označava nuspojave koje su uglavnom prijavljivane u vezi s reakcijama izazvanima infuzijom.