FrancophonIA/ELRC3.0 huggingface dataset:
English: Ask your doctor, pharmacist or nurse how to throw away medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Each pre-filled syringe contains 200 mg of dupilumab in 1.14 ml solution (175 mg/ml).
Slovenian: En napolnjen injekcijski peresnik vsebuje 200 mg dupilumaba v 1,14 ml raztopine (175 mg/ml).
English: • Do not heat the pre-filled pen.
Slovenian: • Napolnjenega injekcijskega peresnika ne segrevajte.
English: Rate Ratio (95%CI)
Slovenian: Razmerje obetov (95 % IZ)
English: The safety profile of dupilumab in these patients followed through week 16 was similar to the safety profile from studies in adults with atopic dermatitis.
Slovenian: ki so jih spremljali do 16. tedna, podobne kot v študijah pri odraslih z atopijskim dermatitisom.
English: EASI-50, % respondersc
Slovenian: EASI-50, % odzivnihc
English: Organ Class
Slovenian: Telesna masa
English: Rate of Severe Exacerbations in QUEST Defined by Baseline FeNO Subgroups
Slovenian: Delež hudih poslabšanj v QUEST, opredeljeno po podskupinah izhodiščnega deleža izdihanega dušikovega dioksida (diNO)
English: • Do not use the pre-filled pen if it has been damaged.
Slovenian: • Ne uporabite napolnjenega injekcijskega peresnika, če je poškodovan.
English: LS = least squares; SE = standard error a p-value < 0.0001 b p-value < 0.001 c p-value < 0.05
Slovenian: a Vrednost p < 0,0001 b Vrednost p < 0,001 c Vrednost p < 0,05
English: Dupixent 200 mg injection dupilumab
Slovenian: Dupixent 200 mg injekcijski peresnik dupilumab subkutana uporaba
English: Pre-filled syringe 300 mg - Multipack (without Blue Box)
Slovenian: Napolnjena injekcijska brizga 300 mg - Skupno pakiranje (brez podatkov za modro okence)
English: Mean ACQ-5 score (± SD)
Slovenian: Rezultati deležev odziva po ACQ-5
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
Slovenian: EU/1/17/1229/005 1 napolnjena injekcijska brizga s ščitnikom igle EU/1/17/1229/006 2 napolnjeni injekcijski brizgi s ščitnikom igle
English: Pre-filled syringe with needle shield 200 mg - Multipack (contains Blue Box)
Slovenian: Napolnjena injekcijska brizga s ščitnikom igle 200 mg - Skupno pakiranje (vključuje podatke za modro okence)
English: • 1 pre-filled syringe
Slovenian: • 1 napolnjen injekcijski peresnik
English: • Keep the syringe(s) out of the reach of children.
Slovenian: • Brizgo/brizge shranjujte nedosegljivo otrokom.
English: ≥ 150 and ≥ 300 cells/mcL and FeNO ≥ 25 ppb) Baseline Blood EOS ≥ 150 cells/mcL
Slovenian: Izhodiščna vrednost EOS v krvi ≥ 300 celic/mcl diNO ≥ 25 ppb
English: Other evaluated outcomes included the proportion of subjects with EASI-50 or EASI-90 (improvement of at least 50% or 90% in EASI from baseline respectively), reduction in itch as measured by the peak pruritus NRS, and percent change in the SCORAD scale from baseline to week 16.
Slovenian: 90 (izboljšanje EASI od izhodišča za vsaj 50 % oziroma 90 %), zmanjšanjem srbenja, merjeno znajvečjo oceno srbenja NRS, in odstotno spremembo na lestvici SCORAD od izhodišča do 16.
English: Pre-dose FEV1 (L) at baseline ± SD Mean percent predicted FEV1 at baseline (%)(± SD) % Reversibility (± SD)
Slovenian: Povprečni odstotek predvidenega FEV1 izhodiščno (%)(± std. odklon)
English: Pre-filled syringe 300 mg - Multipack (contains Blue Box)
Slovenian: Napolnjena injekcijska brizga 300 mg - Skupno pakiranje (vključuje podatke za modro okence)
English: Look at the medicine through the window on the pre-filled pen.
Slovenian: Skozi okence v napolnjenem injekcijskem peresniku preglejte zdravilo.
English: Do not shake the pre-filled syringe.
Slovenian: Napolnjenega injekcijskega peresnika ne segrevajte.
English: • 2 pre-filled syringes
Slovenian: • 2 napolnjena injekcijska peresnika
English: Posology
Slovenian: Nalepka
English: • hives
Slovenian: SN)
English: Placebo QUEST study Dupilumab 200 mg Q2W
Slovenian: Placebo diNO ≥ 50 ppb Dupilumab 200 mg vsak drugi teden
English: Body Weight
Slovenian: Telo brizge
English: Pre-filled syringe with needle shield 200 mg - Multipack (without Blue Box)
Slovenian: Napolnjena injekcijska brizga s ščitnikom igle 200 mg - Skupno pakiranje (brez podatkov za modro okence)
English: Step 11: Remove
Slovenian: 11. korak: Izvlecite iglo
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.
Slovenian: Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: The parts of the Dupixent pre-filled syringe with needle shield are shown in this picture.
Slovenian: Ta slika prikazuje dele napolnjene injekcijske brizge zdravila Dupixent s ščitnikom igle.
English: EASI, LS mean % change from baseline (+/-SE)
Slovenian: povprečna % sprememba po mNK od izhodišča (+/
English: Pre-filled syringe with needle shield 300 mg - Multipack (contains Blue Box)
Slovenian: Napolnjena injekcijska brizga s ščitnikom igle 300 mg - Skupno pakiranje (vključuje podatke za modro okence)
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.
Slovenian: Hitro izboljšanje ocene srbenja NRS (opredeljeno kot izboljšanje za > 4 točke že 2. teden) je dosegel značilno večji delež bolnikov, ki so prejemali dupilumab + LKS, kot tistih, ki so prejemali placebo + LKS (p < 0,05), in delež bolnikov, ki so se odzvali glede na oceno srbenja NRS, se je med obdobjem zdravljenja še naprej povečeval.
English: e p-value <0.0001
Slovenian: e Vrednost p < 0,0001.
English: LS = least squares a In the primary analyses of the efficacy endpoints, patients who received rescue treatment or with missing data were considered non-responders.
Slovenian: 52. teden)b mNK = metoda najmanjših kvadratov aV primarnih analizah opazovanih dogodkov učinkovitosti so bili bolniki, ki so prejeli rešilno zdravljenje, in bolniki z manjkajočimi podatki, ocenjeni kot neodzivni.
English: Conjunctivitis Oral herpes
Slovenian: Pogosti konjunktivitis labialni herpes
English: In all three studies, patients received 1) an initial dose of 600 mg dupilumab (two 300 mg injections) on day 1, followed by 300 mg once every two weeks (Q2W); 2) an initial dose of 600 mg dupilumab on day 1, followed by 300 mg once weekly (QW); or 3) matching placebo.
Slovenian: 1. dan in nato 300 mg vsak drugi teden , (2) začetni odmerek 600 mg dupilumaba 1. dan in nato 300 mg vsak teden , ali (3) ujemajoč se placebo.
English: Do not twist the yellow cap off.
Slovenian: Rumenega pokrovčka ne sukajte, da bi ga sneli.
English: c Responder was defined as a patient with IGA 0 or 1 (“clear” or “almost clear”) with a reduction of
Slovenian: c Kot odzivni so bili opredeljeni bolniki z oceno IGA 0 ali 1 ("čisto" ali "skoraj čisto") z zmanjšanjem na lestvici IGA 0-4 za ≥ 2 točki.
English: Treatment-emergent ADA: QW: 1.2%; Q2W: 4.3%; Q4W: 6.0%; Q8W:
Slovenian: vsak teden: 1,2 %, vsak 2. teden: 4,3 %, vsak 4. teden: 6,0 %, vsak 8. teden: 11,7%.
English: Eosinophils ≥ 150 and ≥ 300 cells/mcL and FeNO ≥25 ppb) in QUEST
Slovenian: (izhodiščna vrednost eozinofilcev v krvi ≥ 150 in ≥ 300 celic/mcl in diNO ≥ 25 ppb)
English: ≥150 cells/mcL
Slovenian: ≥150 celic/mcL
English: ≥ 150 cells/mcL
Slovenian: ≥ 150 celic/mcl
English: • Read all of the instructions carefully before using the pre-filled pen.
Slovenian: • Pred uporabo napolnjenega injekcijskega peresnika natančno in v celoti preberite navodila za uporabo.
English: Mean total IgE IU/mL (± SD) Mean baseline Eosinophil count (± SD) cells/mcL
Slovenian: (± std. odklon) celic/mcl % bolnikov z eozinofilci (EOS)
English: Specific metabolism studies were not conducted because dupilumab is a protein.
Slovenian: Dupilumab je beljakovina, zato specifičnih študij presnove niso izvedli.
English: CAFE study evaluated the efficacy of dupilumab compared to placebo during a 16-week treatment period, administered with concomitant TCS, in adult patients with AD who are not adequately controlled with, or are intolerant to, oral ciclosporin, or when this treatment is currently contraindicated or not medically advisable.
Slovenian: Študija CAFE je ocenjevala učinkovitost dupilumaba v primerjavi s placebom med 16-tedenskim obdobjem zdravljenja in s sočasno uporabo LKS.
English: Pre-filled syringe with needle shield 300 mg - Multipack (without Blue Box)
Slovenian: Napolnjena injekcijska brizga s ščitnikom igle 300 mg - Skupno pakiranje (brez podatkov za modro okence)
English: ≥ 300 cells/mcL
Slovenian: ≥300 celic/mcL
English: Dupixent 200 mg solution for injection in pre-filled syringe dupilumab
Slovenian: Dupixent 200 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku dupilumab
English: 300 mg Q2W Placebo
Slovenian: 200 mg vsak drugi teden Placebo
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.
Slovenian: Celotna ocena POEM in DLQI sta se od izhodišča do 52. tedna v primerjavi s placebom + LKS klinično pomembno zmanjšali (pri obeh je bilo to opredeljeno kot izboljšanje za ≥ 4 točke) pri večjem deležu prejemnikov 300 mg dupilumaba vsak drugi teden + LKS
English: Table 11: Effect of dupilumab on OCS dose reduction, VENTURE (Baseline Blood Eosinophil Levels
Slovenian: Preglednica 11: Učinek dupilumaba na zmanjšanje odmerka PKS, študija VENTURE
English: Step 9: Insert
Slovenian: 9. korak: Zabodite iglo
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.
Slovenian: Hitro izboljšanje ocene srbenja NRS (opredeljeno kot izboljšanje za ≥ 4 točke že 2. teden) je dosegel značilno večji delež bolnikov, ki so prejemali dupilumab, kot tistih, ki so prejemali placebo (p < 0,01), in delež bolnikov, ki so se odzvali glede na oceno srbenja NRS, se je med obdobjem zdravljenja še naprej povečeval.
English: Dupixent 300 mg solution for injection in pre-filled syringe
Slovenian: Dupixent 300 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: LS = least squares aIn the primary analyses of the efficacy endpoints, patients who received rescue treatment or with missing data were considered non-responders.
Slovenian: a V primarnih analizah opazovanih dogodkov učinkovitosti so bili bolniki, ki so prejeli rešilno zdravljenje, in bolniki z manjkajočimi podatki, ocenjeni kot neodzivni.
English: From baseline L (%)
Slovenian: Povprečna Δ po mNK od izhodišča l (%)
English: Dupixent 200 mg solution for injection in pre-filled syringe
Slovenian: Dupixent 200 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Dupixent 300 mg injection dupilumab
Slovenian: Dupixent 300 mg injekcijska brizga dupilumab subkutana uporaba
English: Figure 2: Mean Change from Baseline in Pre-Bronchodilator FEV1 (L) Over Time (Baseline
Slovenian: Slika 2: Povprečna sprememba FEV1 pred bronhodilatatorjem (l) od izhodišča skozi čas (izhodiščni eozinofilci ≥ 150 in ≥ 300 celic/mcl in diNO≥25 ppb ) v študiji QUEST
English: Lightly press a cotton ball or gauze on the injection site if you see any blood.
Slovenian: Če opazite nekaj krvi, s kosmom vate ali zložencem gaze rahlo pritisnite na mesto injiciranja.
English: Patients randomised EASI-75, % responders EASI, LS mean % change from baseline (+/- SE) Pruritus NRS, LS mean % change from baseline (+/- SE)
Slovenian: EASI, povprečna odstotna sprememba od izhodišča po mNK (+/-SN) SCORAD, povprečna odstotna sprememba od izhodišča po mNK (+/-SN) Ocena srbenja NRS, povprečna % sprememba po mNK od izhodišča (+/- SN) Ocena srbenja NRS (izboljšanje za ≥ 4 točke),
English: Placebo Dupilumab 300 mg Q2W
Slovenian: Placebo Dupilumab300 mg vsak drugi teden
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).
Slovenian: Hitro izboljšanje ocene srbenja NRS (opredeljeno kot izboljšanje za ≥ 4 točke že 4. teden, nominalna vrednost p < 0,001) je dosegel značilno večji delež bolnikov, randomiziranih na dupilumab, kot randomiziranih na placebo, in delež bolnikov, ki so se odzvali glede na oceno srbenja NRS, se je med obdobjem zdravljenja še naprej povečeval (glejte sliko 1).
English: The parts of the Dupixent pre-filled syringe are shown in this picture.
Slovenian: Ta slika prikazuje dele napolnjenega injekcijskega peresnika Dupixent.
English: Figure 6: Mean Change from Baseline in Pre-Bronchodilator FEV1 (L) Over Time (Baseline
Slovenian: Slika 6: Povprečna sprememba FEV1 pred bronhodilatatorjem (l) od izhodišča skozi čas (izhodiščni eozinofilci ≥ 150 in ≥ 300 celic/mcl in diNO ≥ 25 ppb) v študiji QUEST
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).
Slovenian: Hitro izboljšanje ocene srbenja NRS (opredeljeno kot izboljšanje za ≥ 4 točke že 4. teden, nominalna vrednost p < 0,001) je dosegel značilno večji delež bolnikov, randomiziranih na dupilumab, kot randomiziranih na placebo, in delež bolnikov, ki so se odzvali glede na oceno srbenja NRS, se je med obdobjem zdravljenja še naprej povečeval (glejte sliko 5).
English: cp-value =0.0001
Slovenian: bp-value <0,0001 cp-value =0,0001 dp-value =0,0002
English: Figure 1: Proportion of adolescent patients with ≥4-point improvement on the pruritus NRS in AD-1526 studya (FAS)b a In the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered non-responders.
Slovenian: izboljšala za ≥ 4 točkea (celotni nabor za analizo)b a V primarnih analizah opazovanih dogodkov učinkovitosti so bili preiskovanci, ki so prejeli rešilno zdravljenje, in preiskovanci z manjkajočimi podatki ocenjeni kot neodzivni.
English: • 6 pre-filled pens
Slovenian: • 6 napolnjenih injekcijskih peresnikov
English: Multipack: 3 (3 packs of 1) pre-filled syringes with needle shield Multipack: 6 (3 packs of 2) pre-filled syringes with needle shield
Slovenian: Skupno pakiranje: 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg s ščitnikom igle
English: 76580 LE TRAIT,
Slovenian: 1051 Boulevard Industriel, 76580 LE TRAIT, FRANCIJA
English: ACQ-5 Dupilumab 200 mg Q2W Placebo
Slovenian: ACQ-5 Dupilumab 200 mg vsak drugi teden
English: • Do not shake the syringe at any time.
Slovenian: • Brizge nikoli ne pretresajte.
English: Dupixent 200 mg solution for injection in a pre-filled syringe with needle shield dupilumab
Slovenian: Dupixent 200 mg raztopina za injiciranje v napolnjeni injekcijski brizgi s ščitnikom igle dupilumab
English: Lung Function
Slovenian: Delovanje pljuč
English: Dupixent 300 mg solution for injection in a pre-filled syringe with needle shield dupilumab
Slovenian: Dupixent 300 mg raztopina za injiciranje v napolnjeni injekcijski brizgi s ščitnikom igle dupilumab
English: In asthma clinical trials, dupilumab treatment markedly decreased FeNO and circulating concentrations of eotaxin-3, total IgE, allergen specific IgE, TARC, and periostin in asthma subjects relative to placebo.
Slovenian: V kliničnih preskušanjih pri astmi je zdravljenje z dupilumabom pri bolnikih z astmo v primerjavi s placebom izrazito znižalo delež izdihanega dušikovega oksida (diNO) ter koncentracije eotaksina-3,
English: There were greater improvements in FEV1 in the subjects with higher baseline levels of type 2 inflammatory biomarkers such as blood eosinophils or FeNO (Table 8 and Table 9).
Slovenian: Pri bolnikih s povišanimi izhodiščnimi vrednostmi bioloških označevalcev vnetja tipa 2 kot so eozinofilci ali diNO v krvi, (preglednica 8 in preglednica 9), je prišlo do večjega izboljšanja vrednosti FEV1.
English: • Change the injection site for each injection.
Slovenian: • Vsakič, ko zdravilo injicirate, uporabite drugo mesto injiciranja.
English: This medicine contains less than 1 mmol sodium (23 mg) per 200 mg dose, i.e., it is essentially “sodium-free”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na 200-mg odmerek; to pomeni, da je praktično "brez natrija".
English: Dupixent 300 mg solution for injection in a pre-filled syringe dupilumab
Slovenian: Dupixent 300 mg raztopina za injiciranje v napolnjeni injekcijski brizgi dupilumab
English: (≥ 4-point improvement)
Slovenian: ≥ 4 točke), %
English: The safety of dupilumab was assessed in a study of 250 patients 12 to 17 years of age with moderate-to-severe atopic dermatitis (AD-1526).
Slovenian: randomizirani, dvojno slepi, s placebom nadzorovani študiji (AD-1526) pri 251 mladostnikih z zmernim do hudim atopijskim dermatitisom (AD), starih od 12 do 17 let, ki so imeli oceno IGA
English: This medicine contains less than 1 mmol sodium (23 mg) per 300 mg dose, i.e., it is essentially “sodium-free”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na 300-mg odmerek; to pomeni, da je praktično "brez natrija".
English: • Do not shake the pre-filled pen at any time.
Slovenian: • Napolnjenega injekcijskega peresnika nikoli ne pretresajte.
English: Placebo Dupilumab 300 mg Q2W 124 0.39 (0.27, 0.558)
Slovenian: Zdravilo Dupixent 300 mg V2T + LKS, primarna analiza (n = 89) Placebo + LKS, primarna analiza (N = 264)
English: There were greater improvements in FEV1 in the subjects with higher baseline levels of type 2 inflammatory biomarkers such as blood eosinophils or FeNO (Table 14 and Table 15).
Slovenian: Pri bolnikih s povišanimi izhodiščnimi vrednostmi bioloških označevalcev vnetja tipa 2 kot so eozinofilci ali diNO v krvi (preglednica 14 in preglednica 15), je prišlo do večjega izboljšanja vrednosti FEV1.
English: In both monotherapy studies (SOLO 1 and SOLO 2), both dupilumab 300 mg Q2W and 300 mg QW groups significantly improved patient-reported symptoms and the impact of AD on sleep and healthrelated quality of life as measured by POEM and DLQI total scores, respectively, at 16 weeks compared to placebo.
Slovenian: teden kot v odmerku 300 mg vsak teden v primerjavi s placebom po 16 tednih značilno izboljšalo simptome po navedbi bolnikov ter vpliv AD na spanje in zdravstveno kakovost življenja (merjeno s celotno oceno POEM oz. indeksom DLQI).
English: EXPIRY DATE
Slovenian: Datum izteka roka uporabnosti
English: Table 8: Mean Change from Baseline in Pre-Bronchodilator FEV1 at Week 12 in DRI12544 and
Slovenian: Preglednica 8: Povprečna sprememba vrednosti FEV1 pred uporabo bronhodilatatorja od izhodišča do 12. tedna v študijah DRI12544 in QUEST (izhodiščne vrednosti eozinofilci v krvi ≥ 150 in ≥ 300 celic/mcl)
English: EU/1/17/1229/011 3 pre-filled syringes with needle shield (3 packs of 1) EU/1/17/1229/012 6 pre-filled syringes with needle shield (3 packs of 2)
Slovenian: EU/0/00/0000/011 3 napolnjene injekcijske brizge s ščitnikom igle (3 pakiranja po 1) EU/0/00/0000/012 6 napolnjenih injekcijskih brizg s ščitnikom igle (3 pakiranja po 2)
English: In the 16-week atopic dermatitis monotherapy clinical studies, serious infections were reported in 1.0 % of patients treated with placebo and 0.5 % of patients treated with dupilumab.
Slovenian: 1,0 % bolnikov, ki so prejemali placebo, in pri 0,5 % bolnikov, zdravljenih z dupilumabom.
English: Life Quality Index (CDLQI) was 13.6.
Slovenian: Dermatitis) 70,3, izhodiščna povprečna ocena POEM (Patient Oriented Eczema Measure) 21,0 in izhodiščni povprečni indeks CDLQI (Children Dermatology Life Quality Index) 13,6.
English: It contains 200 mg of Dupixent for injection under the skin (subcutaneous injection).
Slovenian: Dupixent za injiciranje pod kožo (subkutana injekcija).
English: Placebo Dupilumab 300 mg Q2W 310 0.43 (0.35, 0.54)
Slovenian: Zdravilo Dupixent 300 mg V2T, primarna analiza (n = 233) Placebo, primarna analiza (N = 236)
English: Atopic dermatitis patients with comorbid asthma
Slovenian: Atopijski dermatitis Odrasli z atopijskim dermatitisom
English: FeNO ≥ 50 ppb
Slovenian: Placebo diNO ≥ 50 ppb
English: Table 14: Mean Change from Baseline in Pre-Bronchodilator FEV1 at Week 12 in DRI12544 and
Slovenian: Preglednica 14: Povprečna sprememba vrednosti FEV1 pred uporabo bronhodilatatorja od izhodišča do 12. tedna v študijah DRI12544 in QUEST (izhodiščne vrednosti eozinofilci v krvi ≥ 150 in ≥ 300 celic/mcl)
English: Vistor hf.
Slovenian: Pokrovček igle
English: EN
Slovenian: SL
English: With Respect to “Pregnancy”
Slovenian: Nanašajoč se na “Nosečnost”
English: {Invented name} is contraindicated <during pregnancy><during {trimester} of pregnancy> [this case is a strict contraindication] (see section 4.3).
Slovenian: Zdravilo {Lastniško ime} je kontraindicirano <med nosečnostjo><med {trimester} nosečnosti> [this case is a strict contraindication] (glejte poglavje 4.3).
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.>
Slovenian: <Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom {Lastniško ime}, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.>
English: [9] <No effects during pregnancy are anticipated, since systemic exposure to {Active substance} is negligible.>
Slovenian: [9] <Ne pričakuje se učinkov na nosečnost, ker je sistemska izpostavljenost {zdravilna učinkovina} zanemarljiva.>
English: With Respect to “Lactation”
Slovenian: Nanašajoč se na “Dojenje”
English: <Available pharmacodynamic/toxicological data in animals have shown excretion of {Active substance}/metabolites in milk (for details see 5.3).>
Slovenian: <Razpoložljivi farmakodinamični/toksikološki podatki pri živalih kažejo na izločanje {zdravilna učinkovina}/presnovkov v mleko (za podrobnosti glejte poglavje 5.3).>
English: <{Invented name}<is contraindicated during breast-feeding (see section 4.3)> [or] <should not be used during breast-feeding>.>
Slovenian: <Zdravilo {Lastniško ime} <je kontraindicirano med dojenjem (glejte poglavje 4.3)> [or] <se med dojenjem ne sme uporabljati>.>
English: {Invented name} can be used during pregnancy.
Slovenian: Zdravilo {Lastniško ime} se lahko uporablja med nosečnostjo.
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.>
Slovenian: [1]<Na podlagi izkušenj pri ljudeh [specify] {zdravilna učinkovina} povzroča <kongenitalne malformacije [specify], če jo jemljejo nosečnice.> [or] <škodljive farmakološke učinke na nosečnico oziroma zarodek/novorojenca.>
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.>>
Slovenian: <Učinek {zdravilna učinkovina} na dojene novorojence/otroke ni znan.> [or] <Podatki o učinku {zdravilne učinkovine} na dojene novorojence/otroke so nezadostni.>>
English: {Invented name} can be used during breast-feeding.
Slovenian: Zdravilo {Lastniško ime} se lahko uporablja med dojenjem.