FrancophonIA/ELRC3.0 huggingface dataset:
English: A significantly greater proportion of patients randomized to dupilumab + TCS achieved a rapid improvement in the pruritus NRS compared to placebo + TCS (defined as > 4-point improvement as early as week 2; p < 0.05) and the proportion of patients responding on the pruritus NRS continued to increase through the treatment period.
Croatian: Značajno je veći udio bolesnika randomiziranih za primanje kombinacije dupilumab + TKS u usporedbi s onima koji su primali placebo + TKS postigao brzo poboljšanje NRS rezultata za pruritus (koje se definiralo kao poboljšanje za ≥ 4 boda već u 2. tjednu; p < 0,05), a udio bolesnika s odgovorom prema NRS rezultatu za pruritus nastavio se povećavati tijekom čitavog razdoblja liječenja.
English: Gather supplies
Croatian: Supkutana primjena
English: QUEST study Dupilumab 200 mg Q2W
Croatian: Ispitivanje QUEST Dupilumab 200 mg svaka 2 tjedna
English: Do not put the pre-filled pen into direct sunlight.
Croatian: Nemojte izlagati napunjenu brizgalicu izravnoj sunčevoj svjetlosti.
English: There were greater reductions in exacerbations in subjects with higher baseline levels of type 2 inflammatory biomarkers such as blood eosinophils or FeNO (Table 6 and Table 7).
Croatian: Smanjenja stope egzacerbacija bila su veća u ispitanika s višim početnim vrijednostima bioloških biljega upale tipa 2, kao što su eozinofili u krvi ili FeNO (Tablica 6 i Tablica 7).
English: • hives
Croatian: • bedro
English: The parts of the Dupixent pre-filled syringe are shown in this picture.
Croatian: Dijelovi Dupixent unaprijed napunjene štrcaljke prikazani su na sljedećoj slici
English: For the 200 mg every other week dose, patients had a reduction in the rate of severe exacerbations that was consistent with adults.
Croatian: Smanjenje stope teških egzacerbacija uz dozu od 200 mg svaki drugi tjedan odgovaralo je onome zabilježenome u odraslih.
English: ≥300 cells/mcL
Croatian: ≥ 300 stanica/μl
English: ≥ 300 cells/mcL
Croatian: ≥300 stanica/μl
English: Figure 6: Mean Change from Baseline in Pre-Bronchodilator FEV1 (L) Over Time (Baseline
Croatian: Slika 6: Srednja vrijednost promjene početne vrijednosti FEV1 (l) prije primjene bronhodilatatora tijekom vremena (podskupine s početnim brojem eozinofila ≥ 150 i ≥ 300 stanica/μl te FeNO ≥ 25 ppb) u ispitivanju QUEST
English: Step 6: Clean
Croatian: 6. korak: Očistite mjesto injiciranja
English: EU/1/17/1229/009 1 pre-filled syringe with needle shield EU/1/17/1229/010 2 pre-filled syringes with needle shield
Croatian: EU/1/17/1229/009 1 napunjena štrcaljka sa zaštitnim pokrovom igle EU/1/17/1229/010 2 napunjene štrcaljke sa zaštitnim pokrovom igle
English: Do not shake the pre-filled syringe.
Croatian: Nemojte tresti napunjenu brizgalicu.
English: The co-primary endpoint was the proportion of patients with IGA 0 or 1 (“clear” or “almost clear”) least a 2-point improvement and the proportion of patients with EASI-75 (improvement of at least 75% in EASI), from baseline to week 16.
Croatian: Koprimarne mjere ishoda bile su udio bolesnika s IGA rezultatom 0 ili 1 („čisto“ ili „gotovo čisto“), postignutim smanjenjem za ≥ 2 boda te udio bolesnika s EASI-75 rezultatom (poboljšanje
English: Figure 2: Mean Change from Baseline in Pre-Bronchodilator FEV1 (L) Over Time (Baseline
Croatian: Slika 2: Srednja vrijednost promjene početne vrijednosti FEV1 (l) prije primjene bronhodilatatora tijekom vremena (podskupine s početnim brojem eozinofila ≥ 150 i ≥ 300 stanica/μl te FeNO ≥ 25 ppb) u ispitivanju QUEST
English: EU/1/17/1229/005 1 pre-filled syringe with needle shield EU/1/17/1229/006 2 pre-filled syringes with needle shield
Croatian: EU/1/17/1229/005 1 napunjena štrcaljka sa zaštitnim pokrovom igle EU/1/17/1229/006 2 napunjene štrcaljke sa zaštitnim pokrovom igle
English: The ACQ-5 and AQLQ(S) responder rate results in patients with elevated baseline biomarkers of type 2 inflammation in QUEST at week 52 are presented in Table 10.
Croatian: Stope bolesnika koji su na početku ispitivanja QUEST imali povišene vrijednosti bioloških biljega upale tipa 2 i koji su u 52. tjednu ostvarili odgovor prema upitnicima ACQ-5 i AQLQ(S) prikazane su u Tablici 10.
English: Eczema herpeticum was reported in < 1 % of the dupilumab groups and in < 1 % of the placebo group in the 16-week atopic dermatitis monotherapy studies.
Croatian: U 16-tjednim ispitivanjima monoterapije kod atopijskog dermatitisa herpetični ekcem prijavljen je u < 1% bolesnika liječenih dupilumabom i < 1% onih koji su primali placebo.
English: EASI, LS mean % change from baseline (+/-SE)
Croatian: EASI, LS srednja vrijednost % promjene od početne vrijednosti (+/-SE)
English: Step 9: Insert
Croatian: 9. korak: Ubodite iglu
English: Do not put the yellow cap back on the pre-filled pen after you have removed it.
Croatian: Nakon što ga skinete, nemojte vraćati žuti zatvarač na napunjenu brizgalicu.
English: There were greater reductions in exacerbations in subjects with higher baseline levels of type 2 inflammatory biomarkers such as blood eosinophils or FeNO (Table 12 and Table 13).
Croatian: Smanjenja stope egzacerbacija bila su veća u ispitanika s višim početnim vrijednostima bioloških biljega upale tipa 2, kao što su eozinofili u krvi ili FeNO (Tablica 12 i Tablica 13).
English: Pre-filled pen 200 mg
Croatian: Napunjena brizgalica od 200 mg
English: Pre-filled syringe with needle shield 200 mg - Multipack (contains Blue Box)
Croatian: Napunjena štrcaljka od 200 mg sa zaštitnim pokrovom igle - višestruko pakiranje (sadrži plavi okvir)
English: Do not use this medicine if you notice that the medicine is cloudy, discoloured, or has particles in it. Do not throw away any medicines via wastewater or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: Atopic dermatitis patients with comorbid asthma
Croatian: Bolesnici s atopijskim dermatitisom i istodobnom astmom
English: Pre-filled syringe with needle shield 200 mg - Multipack (without Blue Box)
Croatian: Napunjena štrcaljka od 200 mg sa zaštitnim pokrovom igle - višestruko pakiranje (bez plavog okvira)
English: A significantly greater proportion of patients randomized to dupilumab achieved a rapid improvement in the pruritus NRS compared to placebo (defined as ≥ 4-point improvement as early as week 2; p < 0.01) and the proportion of patients responding on the pruritus NRS continued to increase through the treatment period.
Croatian: Značajno je veći udio bolesnika randomiziranih za primanje dupilumaba u usporedbi s onima koji su primali placebo postigao brzo poboljšanje NRS rezultata za pruritus (koje se definiralo kao poboljšanje za ≥ 4 boda već u 2. tjednu; p < 0,01), a udio bolesnika s odgovorom prema NRS rezultatu za pruritus nastavio se povećavati tijekom čitavog razdoblja liječenja.
English: Dupixent 300 mg solution for injection in pre-filled syringe
Croatian: Dupixent 300 mg otopina za injekciju u napunjenoj štrcaljki
English: • 1 pre-filled pen
Croatian: • 1 napunjena brizgalica
English: A significantly greater proportion of patients randomised to dupilumab achieved a rapid improvement in the pruritus NRS compared to placebo (defined as >4-point improvement as early as week 4; nominal p<0.001) and the proportion of patients responding on the pruritus NRS continued to increase through the treatment period (see Figure 1).
Croatian: Značajno veći udio bolesnika randomiziranih u skupinu koja je primala dupilumab postigao je brz napredak u NRS rezultatu za pruritus (definiran kao poboljšanje za ≥ 4 boda već do 4. tjedna; nominalno p<0,001) u usporedbi s placebom te se udio bolesnika s odgovorom prema NRS rezultatu za pruritus nastavio povećavati tijekom čitavog razdoblja liječenja (vidjeti sliku 1).
English: Dupixent 200 mg solution for injection in pre-filled syringe
Croatian: Dupixent 200 mg otopina za injekciju u napunjenoj štrcaljki
English: A significantly greater proportion of patients randomised to dupilumab achieved a rapid improvement in the pruritus NRS compared to placebo (defined as >4-point improvement as early as week 4; nominal p<0.001) and the proportion of patients responding on the pruritus NRS continued to increase through the treatment period (see Figure 5).
Croatian: Značajno veći udio bolesnika randomiziranih u skupinu koja je primala dupilumab postigao je brz napredak u NRS rezultatu za pruritus (definiran kao poboljšanje za ≥ 4 boda već do 4. tjedna; nominalno p<0,001) u usporedbi s placebom te se udio bolesnika s odgovorom prema NRS rezultatu za pruritus nastavio povećavati tijekom čitavog razdoblja liječenja (vidjeti sliku 5).
English: Dupixent 300 mg solution for injection in a pre-filled syringe dupilumab
Croatian: Dupixent 300 mg otopina za injekciju u napunjenoj štrcaljki dupilumab
English: (> 4-point improvement)
Croatian: (vidjeti dio 4.4).
English: Step 8: Pinch
Croatian: 8. korak: Uhvatite nabor
English: Baseline Blood EOS ≥ 300 cells/mcL
Croatian: Broj eozinofila u krvi ≥ 300 stanica/μl
English: Number of patients with HADS-anxiety ≥ 8 or HADSdepression ≥ 8 at baseline Patients achieving HADS-anxiety and HADSdepression < 8,
Croatian: U post-hoc analizi podskupine bolesnika koji su na početku ispitivanja imali HADS podrezultat za tjeskobu ili HADS podrezultat za depresiju ≥ 8 (granična vrijednost za tjeskobu ili depresiju), HADS rezultat za tjeskobu i HADS rezultat za depresiju < 8 u
English: Very rare cases of serum sickness/serum sickness-like reactions have been reported in the atopic dermatitis development program following the administration of dupilumab.
Croatian: U razvojnom programu lijeka kod atopijskog dermatitisa prijavljeni su vrlo rijetki slučajevi serumske bolesti/reakcija nalik na serumsku bolest nakon primjene dupilumaba (vidjeti dio 4.8).
English: The recommended dose of dupilumab for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week administered as subcutaneous injection.
Croatian: Preporučena doza dupilumaba za odrasle i adolescente (u dobi od 12 ili više godina) je: • početna doza od 400 mg (dvije injekcije od 200 mg), nakon čega se primjenjuje doza od 200 mg svaki drugi tjedan, supkutanom injekcijom.
English: Pre-filled syringe with needle shield 300 mg - Multipack (contains Blue Box)
Croatian: Napunjena štrcaljka od 300 mg sa zaštitnim pokrovom igle - višestruko pakiranje (sadrži plavi okvir)
English: Package leaflet: Information for the user Dupixent 300 mg solution for injection in pre-filled syringe dupilumab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Dupixent 300 mg otopina za injekciju u napunjenoj štrcaljki dupilumab
English: • the Dupixent pre-filled syringe
Croatian: • Dupixent napunjenu štrcaljku • 1 vaticu natopljenu alkoholom*
English: A. Check expiration date
Croatian: OKS-a ili izlazak iz ispitivanja
English: Pre-filled syringe with needle shield 300 mg - Multipack (without Blue Box)
Croatian: Napunjena štrcaljka od 300 mg sa zaštitnim pokrovom igle - višestruko pakiranje (bez plavog okvira)
English: Patients randomised EASI-75, % responders EASI, LS mean % change from baseline (+/- SE) Pruritus NRS, LS mean % change from baseline (+/- SE)
Croatian: boda), % bolesnika s odgovorom BSA, LS srednja vrijednost % promjene od početne vrijednosti (+/- SE)
English: Package leaflet: Information for the user Dupixent 200 mg solution for injection in pre-filled syringe dupilumab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Dupixent 200 mg otopina za injekciju u napunjenoj štrcaljki dupilumab
English: N Responder rate %
Croatian: EASI, LS srednja vrijednost %
English: Dupixent 200 mg solution for injection in pre-filled syringe dupilumab
Croatian: Dupixent 200 mg otopina za injekciju u napunjenoj brizgalici dupilumab
English: Also at baseline the mean Eczema Area and Severity Index (EASI) score was 35.5, the baseline weekly averaged pruritus Numerical Rating Scale (NRS) was 7.6, the baseline mean SCORing Atopic Dermatitis (SCORAD) score was 70.3, the baseline mean Patient Oriented Eczema Measure (POEM) score was 21.0, and the baseline mean Children Dermatology
Croatian: Također, početna srednja vrijednost indeksa proširenosti i težine ekcema (EASI) iznosila je 35,5, početni tjedni prosječni rezultat za pruritus na brojčanoj ocjenskoj ljestvici (engl.
English: Dupilumab 300 mg Q2W N=81
Croatian: Dupixent 200 mg ili 300 mg svaka 2 tjedna (N=82) Placebo (N=85)
English: Race was not found to be associated with any clinically meaningful impact on the systemic exposure of dupilumab by population PK analysis.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, rasa se ne povezuje s klinički važnim utjecajem na sistemsku izloženost dupilumabu.
English: Placebo Dupilumab 300 mg Q2W
Croatian: Placebo Dupilumab 300 mg svaka 2 tjedna
English: Remove
Croatian: Cijepljenje
English: Hepatic impairment
Croatian: Herpetični ekcem
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 200 mg dose, i.e. essentially “sodium-free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi od 200 mg, tj. zanemarive količine natrija.
English: The ACQ-5 and AQLQ(S) responder rate results in patients with elevated baseline biomarkers of type 2 inflammation in QUEST at week 52 are presented in Table 16.
Croatian: Stope bolesnika koji su na početku ispitivanja QUEST imali povišene vrijednosti bioloških biljega upale tipa 2 i koji su u 52. tjednu ostvarili odgovor prema upitnicima ACQ-5 i AQLQ(S) prikazane su u Tablici 14.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 300 mg dose, i.e. essentially “sodium-free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi od 300 mg, tj. zanemarive količine natrija.
English: Package leaflet: Information for the user Dupixent 200 mg solution for injection in pre-filled pen dupilumab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Dupixent 200 mg otopina za injekciju u napunjenoj brizgalici dupilumab
English: Dupilumab 300 mg QW+TCS
Croatian: Dupilumab 300 mg svaka 2 tjedna + TKS
English: Mean exacerbations in previous year ± SD 2.17 (2.14) High dose ICS use (%)a
Croatian: Ispitanici koji nikada nisu pušili (%) Srednja vrijednost broja egzacerbacija u prethodnih godinu dana ± SD Visoka doza IKS-a (%)a
English: Dupixent 200 mg solution for injection in a pre-filled syringe with needle shield dupilumab
Croatian: Dupixent 200 mg otopina za injekciju u napunjenoj štrcaljki sa zaštitnim pokrovom igle dupilumab
English: • Do not place the pre-filled pen into direct sunlight.
Croatian: • Nemojte izlagati napunjenu brizgalicu izravnoj sunčevoj svjetlosti
English: Talk to your doctor, pharmacist or nurse before using Dupixent:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Dupixent: Dupixent nije lijek za hitno ublažavanje simptoma i ne smije se koristiti za liječenje iznenadnog napadaja astme.
English: Dupixent 300 mg solution for injection in a pre-filled syringe with needle shield dupilumab
Croatian: Dupixent 300 mg otopina za injekciju u napunjenoj štrcaljki sa zaštitnim pokrovom igle dupilumab
English: Mean FeNO ppb (± SD)
Croatian: Srednja vrijednost ukupnog IgE-a, IU/ml (± SD)
English: In DRI12544 and QUEST studies, the proportion of patients who discontinued treatment due to adverse events was 4.3% of the placebo group, 3.2% of the dupilumab 200 mg Q2W group, and 6.1% of the dupilumab 300 mg Q2W group.
Croatian: iznosio je 4,3% u skupini koja je primala placebo, 3,2% u skupini koja je primala dupilumab 200 mg svaka 2 tjedna te 6,1% u skupini koja je primala dupilumab 300 mg svaka 2 tjedna.
English: Clinically significant increases in pre-bronchodilator FEV1 were observed at week 12 for DRI12544 and QUEST.
Croatian: Analize unaprijed specificiranih podskupina u ispitivanjima DRI12544 i QUEST
English: Table 8: Mean Change from Baseline in Pre-Bronchodilator FEV1 at Week 12 in DRI12544 and
Croatian: Tablica 8: Srednja vrijednost promjene FEV1 prije primjene bronhodilatatora od početka ispitivanja do 12. tjedna u ispitivanjima DRI12544 i QUEST (podskupine s početnim brojem eozinofila u krvi ≥ 150 i ≥ 300 stanica/μl) Terapija
English: EASI-75, % respondersd
Croatian: Randomizirani bolesnici EASI-75, % bolesnika s odgovorom
English: A larger proportion of patients administered dupilumab 300 mg Q2W + TCS and 300 mg QW + TCS had clinically meaningful reductions in POEM and DLQI total score (each defined as ≥ 4-point improvement) from baseline to week 52 compared to the placebo + TCS.
Croatian: U usporedbi s kombinacijom placebo + TKS, veći udio bolesnika koji su primali dupilumab 300 mg svaka 2 tjedna + TKS i dupilumab 300 mg svaki tjedan + TKS ostvario je klinički važna smanjenja ukupnog POEM i DLQI
English: RENSSELAER
Croatian: Egzacerbacije
English: Q2W
Croatian: CYP2C9.
English: • 2 pre-filled pens
Croatian: • 2 napunjene štrcaljke
English: Table 14: Mean Change from Baseline in Pre-Bronchodilator FEV1 at Week 12 in DRI12544 and
Croatian: Tablica 14: Srednja vrijednost promjene FEV1 prije primjene bronhodilatatora od početka ispitivanja do 12. tjedna u ispitivanjima DRI12544 i QUEST (podskupine s početnim brojem eozinofila u krvi ≥ 150 i ≥ 300 stanica/μl) Terapija
English: Table 4: Efficacy results of dupilumab monotherapy at week 16 (FAS)
Croatian: Tablica 4: Rezultati za djelotvornost monoterapije dupilumabom u 16. tjednu.
English: Hold firmly
Croatian: I DOHVATA
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava vrlo rijetko anafilaktička reakcija
English: How to store Dupixent 6.
Croatian: Moguće nuspojave 5. Kako čuvati Dupixent
English: NRS increased by ≥ 3 points from baseline to week 35 in the subset of patients with peak pruritus NRS ≤ 7 at baseline, n (%) †P< 0.05, *P< 0.01, **P< 0.001, ***P≤ 0.0001
Croatian: †P < 0,05, *P < 0,01, **P < 0,001, ***P ≤ 0,0001
English: Pruritus NRS
Croatian: FAS populacija iz
English: Gender was not found to be associated with any clinically meaningful impact on the systemic exposure of dupilumab determined by population PK analysis.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, spol se ne povezuje s klinički važnim utjecajem na sistemsku izloženost dupilumabu.
English: EN
Croatian: HR
English: With Respect to “Pregnancy”
Croatian: Vezano uz “Trudnoću”
English: <Available pharmacodynamic/toxicological data in animals have shown excretion of {Active substance}/metabolites in milk (for details see 5.3).>
Croatian: <Dostupni farmakodinamičski/toksikološki podaci u životinja pokazuju da se {djelatna tvar}/metaboliti izlučuju u mlijeko (za detalje vidjeti 5.3).>
English: <A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from {Invented name} therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.>
Croatian: <Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom {Zaštićeno ime} uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.>
English: {Invented name} is contraindicated <during pregnancy><during {trimester} of pregnancy> [this case is a strict contraindication] (see section 4.3).
Croatian: Lijek {Zaštićeno ime} je kontraindiciran <tijekom trudnoće><u {tromjesečju} trudnoće> [ovaj slučaj je apsolutna kontraindikacija] (vidjeti dio 4.3).
English: With Respect to “Lactation”
Croatian: Vezano uz “Dojenje”
English: {Invented name} can be used during pregnancy.
Croatian: {Zaštićeno ime} se može koristiti u trudnoći.
English: [E.g. medicinal products for which negligible systemic exposure/negligible pharmacodynamic systemic activity has been demonstrated in clinical situation]
Croatian: [Npr. Lijek za koji je sistemska izloženost zanemariva/ u kliničkim uvjetima pokazana zanemariva sistemska aktivnost ]
English: [9] <No effects during pregnancy are anticipated, since systemic exposure to {Active substance} is negligible.>
Croatian: [9] <Ne očekuju se učinci tijekom trudnoće, budući da je sistemska izloženost {djelatna tvar} zanemariva.>
English: <The effect of {Active substance} on newborns/infants is unknown.> [or] <There is insufficient information on the effects of {Active substance} in newborns/infants.>>
Croatian: <Učinak {djelatna tvar} na novorođenčad/dojenčad nije poznat.> [ili] <Nema dovoljno podataka o učinku {djelatna tvar} na novorođenčad/dojenčad.>>
English: [1]<Based on human experience [specify] {Active substance} causes <congenital malformations [specify] when administered during pregnancy.> [or] <harmful pharmacological effects during pregnancy and/or on the fetus/newborn child.>
Croatian: [1]<Na temelju iskustava u ljudi [specificirati] {djelatna tvar} uzrokuje <kongenitalne malformacije [specificirati] ukoliko ako se primjenjuje tijekom trudnoće.> [ili] <štetne farmakološke učinke tijekom trudnoće i/ili na fetus/novorođenče.>
English: <{Invented name} <is contraindicated during breast-feeding (see section 4.3)> [or] <should not be used during breast-feeding>.>
Croatian: <Lijek {Zaštićeno ime}<je kontraindiciran tijekom dojenja (vidjeti dio 4.3)> [ili] <se ne bi trebao primjenjivati tijekom dojenja>.>
English: <No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to {Active substance} is negligible.>
Croatian: <Ne očekuju se učinci na dojenu novorođenčad/dojenčad budući da je sistemska izloženost dojilja {djelatna tvar} zanemariva.>
English: {Invented name} is not recommended <during pregnancy><during {trimester} of pregnancy> and in women of childbearing potential not using contraception.>
Croatian: Ne preporučuje se koristiti lijek {Zaštićeno ime} <tijekom trudnoće><u {tromjesečju} trudnoće> niti u žena reproduktivne dobi koje ne koriste kontracepciju.>
English: <Breast-feeding should be discontinued during treatment with {Invented name}.>
Croatian: <Dojenje treba prekinuti za vrijeme liječenja lijekom {Zaštićeno ime}.>
English: <{Active substance}/metabolites are excreted in human milk to such an extent that effects on the breastfed newborns/infants are likely.>
Croatian: <{Djelatna tvar}/metaboliti se izlučuju u majčino mlijeko u tolikoj mjeri da su učinci na dojenu novorođenčad/dojenčad vjerojatni.>
English: <{Active substance}/metabolites have not been identified in plasma of breastfed newborns/infants of treated mothers.>
Croatian: <{Djelatna tvar}/metaboliti nisu nađeni u plazmi dojene novorođenčadi/dojenčadi liječenih majki.>
English: [5] <There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of {Active substance} in pregnant women.
Croatian: [5] <Nema podataka ili su podaci o primjeni {djelatna tvar} u trudnica ograničeni (manje od 300 trudnoća).
English: <{Active substance}/metabolites are excreted in human milk, but at therapeutic doses of {Invented name} no effects on the breastfed newborns/infants are anticipated.>
Croatian: <{Djelatna tvar}/metaboliti se izlučuju u majčino mlijeko, ali se pri terapijskoj dozi lijeka {Zaštićeno ime} ne očekuju učinci na dojenu novorođenčad/dojenčad.>
English: <There is insufficient information on the excretion of {Active substance}/metabolites in animal milk.>
Croatian: <Nema dovoljno podataka o izlučivanju {djelatna tvar}/metabolita u mlijeko životinja.>
English: [3] <No effects of {Active substance} have been shown in breastfed newborns/infants of treated mothers.>
Croatian: [3] <Nisu opaženi učinci {djelatna tvar} u dojene novorođenčadi/dojenčadi liječenih majki.>
English: <{Active substance}/metabolites are not excreted in human milk.>
Croatian: <{Djelatna tvar}/metaboliti se ne izlučuju u majčino mlijeko.>
English: [4] <There are no or limited amount of data from the use of {Active substance} in pregnant women.
Croatian: [4] <Nema podataka ili su podaci o primjeni {djelatna tvar} u trudnica ograničeni.
English: {Invented name} should not be used <during pregnancy><during {trimester} of pregnancy> unless the clinical condition of the woman requires treatment with {Active substance}.
Croatian: {Zaštićeno ime} se ne smije primjenjivati <tijekom trudnoće><u {tromjesečju} trudnoće> osim ako kliničko stanje žene ne zahtijeva liječenje {djelatna tvar}.