FrancophonIA/ELRC3.0 huggingface dataset:
English: An open-label, rollover, 96 week study is on-going to evaluate the long-term safety and efficacy of the combination regimen in both patient populations.
Croatian: U tijeku je otvoreno, prijelazno (engl. rollover) ispitivanje u trajanju od 96 tjedana u kojem se procjenjuju dugoročna sigurnost i djelotvornost kombiniranog režima u obje populacije bolesnika.
English: An appropriate dose for children under 6 years of age and weighing less than 25 kg cannot be achieved with Kalydeco tablets.
Croatian: Odgovarajuća doza u djece mlađe od 6 godina i tjelesne težine manje od 25 kg ne može se postići Kalydeco tabletama.
English: Each sachet is for single use only.
Croatian: Jedna vrećica samo je za jednokratnu primjenu.
English: Serious side effects include stomach (abdominal) ache and increased liver enzymes in the blood.
Croatian: Ozbiljne nuspojave uključuju bol u želucu (trbuhu) i povišene jetrene enzime u krvi.
English: 12- to 17-year-olds n = 97
Croatian: U dobi od 12 do 17 godina n = 97
English: Date of first authorisation: 23 July 2012 Date of latest renewal: 28 April 2017
Croatian: Datum posljednje obnove odobrenja: 28. travnja 2017.
English: In study 5, four patients with the G970R mutation were included.
Croatian: Ispitivanje 5 uključilo je četiri bolesnika s mutacijom G970R.
English: The magnitude of increase in exposure in these patients is unknown but is expected to be higher than that observed in patients with moderate hepatic impairment.
Croatian: Nije poznata veličina povećanja izloženosti u tih bolesnika, ali očekuje se da će biti veća nego ona opažena u bolesnika s umjerenim oštećenjem funkcije jetre.
English: Table 1: Dosing recommendations for concomitant use with moderate CYP3A inhibitors Day 1 Day 2 Day 3 Day 4*
Croatian: Tablica 1: Preporuke za doziranje kod istovremene primjene s umjerenim inhibitorima CYP3A 1. dan 2. dan 3. dan 4. dan*
English: Ivacaftor is approximately 99% bound to plasma proteins, primarily to alpha 1-acid glycoprotein and albumin.
Croatian: Približno je 99% ivakaftora vezano za proteine plazme, prvenstveno alfa 1-kiseli glikoprotein i albumin.
English: The frequency of adverse reactions is defined as follows: 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: Učestalost nuspojava definirana je na sljedeći način: 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 (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The exposure of ivacaftor increased approximately 2.5- to 4-fold when given with food containing fat.
Croatian: Izloženost ivakaftoru povećala se približno 2,5 do 4 puta kad se davao s hranom koja sadrži masti.
English: Kalydeco should only be prescribed by physicians with experience in the treatment of cystic fibrosis.
Croatian: Kalydeco smiju propisivati samo liječnici s iskustvom u liječenju cistične fibroze.
English: †† n = 3 for the analysis of absolute change in sweat chloride.
Croatian: †† n = 3 za analizu apsolutne promjene u koncentraciji klorida u znoju.
English: Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for your child.
Croatian: Pažljivo pročitajte cijelu uputu prije nego što Vaše dijete počne uzimati ovaj lijek jer sadrži važne podatke za Vaše dijete.
English: Other medicines and Kalydeco
Croatian: Drugi lijekovi i Kalydeco
English: • Kalydeco is not recommended for patients who have undergone an organ transplant.
Croatian: • Kalydeco se ne preporučuje za bolesnike kojima je presađen organ.
English: The tablets should not be chewed, crushed, or broken before swallowing.
Croatian: Tablete se prije gutanja ne smiju žvakati, drobiti ili lomiti.
English: † Reflects results from the one patient with the G551S mutation with data at the 8-week time point.
Croatian: † Pokazuje rezultate za jednog bolesnika s mutacijom G551S i podatke u vremenskoj točki od 8 tjedana.
English: Co. Armagh BT63 5UA United Kingdom
Croatian: Armagh BT63 5UA Ujedinjeno Kraljevstvo
English: Duration of ivacaftor treatment (weeks)
Croatian: Trajanje liječenja ivakaftorom (tjedni)
English: No patients had elevations in total bilirubin.
Croatian: Nijedan bolesnik nije imao povišen ukupni bilirubin.
English: The confirmed R117H poly-T variant was 5T in 38 patients and 7T in 16 patients.
Croatian: Potvrđena varijanta poli-T R117H bila je 5T u 38 bolesnika i 7T u 16 bolesnika.
English: However, increased liver enzymes in the blood are more frequently seen in young children.
Croatian: Međutim, u mlađe djece češće su opaženi povišeni jetreni enzimi u krvi.
English: If more than 6 hours have passed since the time the dose is usually taken, the patient should be told to wait until the next scheduled dose.
Croatian: Ako je prošlo više od 6 sati od vremena kad se doza obično uzima, bolesniku treba reći da pričeka do sljedeće doze prema uobičajenom rasporedu.
English: Morning
Croatian: Ujutro
English: If you plan to breast-feed, ask your doctor for advice before taking Kalydeco.
Croatian: Ako planirate dojiti, upitajte liječnika za savjet prije uzimanja lijeka Kalydeco.
English: The MAH shall complete, within the stated timeframe, the below measures:
Croatian: Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere: Opis
English: If possible, have your medicine and this leaflet with you.
Croatian: Po mogućnosti ponesite sa sobom lijek i ovu uputu.
English: Whenever possible the phase of the poly-T variant identified with the R117H mutation should be determined as this may be informative in considering treatment of patients with an R117H mutation (see section 4.2).
Croatian: Kad god je to moguće, potrebno je utvrditi fazu varijante poli-T identificiranu kod mutacije R117H jer to može biti informativno kad se razmatra liječenje bolesnika s mutacijom R117H (vidjeti dio 4.2).
English: The granules are supplied in sachets.
Croatian: Granule su dostupne u vrećicama.
English: The apparent terminal half-life was approximately 12 hours following a single dose in the fed state.
Croatian: Prividni terminalni poluvijek eliminacije iznosio je približno 12 sati nakon jednokratne doze u sitom stanju.
English: Clinical studies of ivacaftor monotherapy did not include sufficient numbers of patients age 65 years and older to determine whether pharmacokinetic parameters are similar or not to those in younger adults.
Croatian: U klinička ispitivanja monoterapije ivakaftorom nije bio uključen dovoljan broj bolesnika u dobi od 65 i više godina da bi se moglo odrediti jesu li njihovi farmakokinetički parametri slični onima u mlađih odraslih osoba.
English: Study 1
Croatian: Ispitivanje 1
English: • Runny nose
Croatian: • curenje nosa
English: Evening
Croatian: Navečer
English: For all patients with a history of transaminase elevations, more frequent monitoring of liver function tests should be considered.
Croatian: U svih bolesnika s povišenjem transaminaza u anamnezi potrebno je razmotriti češće praćenje testova jetrene funkcije.
English: Due to its high intrinsic permeability and low likelihood of being excreted intact, co-administration of BCRP inhibitors is not expected to alter exposure of ivacaftor and M1-IVA, while any potential changes in M6-IVA exposures are not expected to be clinically relevant.
Croatian: Zbog njegove velike intrinzične permeabilnosti i male vjerojatnosti da se izluči nepromijenjen, ne očekuje se da će istodobna primjena inhibitora BCRP-a izmijeniti izloženost ivakaftoru i metabolitu M1-IVA, dok se za moguće promjene izloženosti metabolitu M6-IVA ne očekuje da će biti klinički važne.
English: M6 has less than one-fiftieth the potency of ivacaftor and is not considered pharmacologically active.
Croatian: M6 ima manje od jedne pedesetine jačine ivakaftora i ne smatra se farmakološki aktivnim.
English: You must keep using all other medicines you use, unless your doctor tells you to stop using any.
Croatian: Morate nastaviti uzimati sve druge lijekove, osim ako Vam liječnik kaže da ih prestanete uzimati.
English: It is a weak inhibitor of CYP3A and P-gp and a potential inhibitor of CYP2C9.
Croatian: On je slabi inhibitor CYP3A i P-glikoproteina (P-gp) i mogući inhibitor CYP2C9.
English: • Nausea or vomiting
Croatian: • mučnina ili povraćanje
English: If a dose is missed within 6 hours of the time it is usually taken, the patient should be told to take it as soon as possible and then take the next dose at the regularly scheduled time.
Croatian: Ako je od propuštene doze prošlo manje od 6 sati od vremena kad se obično uzima, bolesniku treba reći da je uzme čim prije i da zatim uzme sljedeću dozu prema uobičajenom rasporedu.
English: • Cardiac glycosides such as digoxin, used for the treatment of mild to moderate congestive heart failure and an abnormal heart rhythm called atrial fibrillation
Croatian: • Srčani glikozidi kao što je digoksin, koji se primjenjuju za liječenje blagog do umjerenog kongestivnog zatajenja srca i poremećenog srčanog ritma koji se zove fibrilacija atrija.
English: • Kalydeco (alone or in combination with tezacaftor/ivacaftor) should only be used if you have one of the mutations in the CFTR gene indicated in section 1 (What Kalydeco is and what it is used for).
Croatian: • Kalydeco se (sam ili u kombinaciji s tezakaftorom/ivakaftorom) smije primjenjivati samo ako imate jednu od mutacija u genu CFTR navedenih u dijelu 1 (Što je Kalydeco i za što se koristi).
English: Ivacaftor decreased survival and lactation indices and caused a reduction in pup body weights.
Croatian: Ivakaftor je smanjio indekse preživljenja i laktacije i uzrokovao smanjenje tjelesne težine mladunčadi.
English: Ivacaftor is extensively metabolised in humans.
Croatian: Ivakaftor se opsežno metabolizira u ljudi.
English: • Changes in the type of bacteria in mucus
Croatian: • promjene u vrsti bakterija u sluzi
English: Important information about the contents of Kalydeco
Croatian: Važne informacije o sastojcima lijeka Kalydeco
English: Ivacaftor may inhibit CYP2C9.
Croatian: Ivakaftor može inhibirati CYP2C9.
English: Ivacaftor had an effect on fertility in rats (see section 5.3).
Croatian: Ivakaftor je utjecao na plodnost u štakora (vidjeti dio 5.3).
English: Due to mutations in the CFTR gene (see below), chloride movement is reduced in those with cystic fibrosis (CF).
Croatian: Zbog mutacija u genu CFTR (pogledajte niže), kretanje klorida je smanjeno u osoba s cističnom fibrozom (CF).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Kalydeco in one or more subsets of the paediatric population in cystic fibrosis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Kalydeco u jednoj ili više podskupina pedijatrijske populacije u cističnoj fibrozi (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Adults (≥ 18 years old) n = 389
Croatian: Odrasli u dobi od ≥ 18 godina n = 389
English: • if you are allergic to ivacaftor or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na ivakaftor ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Pharmacotherapeutic group: Other respiratory system products, ATC code: R07AX02
Croatian: Farmakoterapijska skupina: drugi lijekovi za dišni sustav, ATK oznaka: R07AX02
English: Patients in study 7 were aged 2 to less than 6 years (mean age 3 years).
Croatian: Bolesnici u ispitivanju 7 bili su u dobi od 2 do manje od 6 godina (srednja vrijednost dobi: 3 godine).
English: Kalydeco contains lactose.
Croatian: Kalydeco sadrži laktozu.
English: Your doctor will decide whether to recommend that you stop breast-feeding or for you to stop ivacaftor therapy.
Croatian: Liječnik će odlučiti hoće li Vam preporučiti da prestanete dojiti ili da prestanete uzimati terapiju ivakaftorom.
English: Kalydeco monotherapy in adults, adolescents, and children aged 6 years and older and weighing 25 kg or more
Croatian: Monoterapija lijekom Kalydeco u odraslih, adolescenata i djece u dobi od 6 i više godina i tjelesne težine od 25 kg ili više
English: The use of inhaled hypertonic sodium chloride was not permitted.
Croatian: Primjena hipertonične otopine natrijevog klorida za inhalaciju nije bila dopuštena.
English: The exact mechanism leading ivacaftor to potentiate the gating activity of normal and some mutant CFTR forms in this system has not been completely elucidated.
Croatian: Točan mehanizam zbog kojega ivakaftor pojačava otvaranje kanala u normalnim i nekim mutiranim oblicima CFTR-a u ovom sustavu još nije potpuno razjašnjen.
English: 4 individual wallets with 14 sachets per wallet
Croatian: 4 pojedinačna pretinca s 14 vrećica po pretincu
English: Exposures in 6- to 11-year-olds are predictions based on simulations from the population PK model using data obtained for this age group.
Croatian: Izloženosti u dobnoj skupini od 6 do 11 godina predviđene su na temelju simulacija iz modela populacijske farmakokinetike pri čemu su se koristili podaci dobiveni za ovu dobnu skupinu.
English: Patients receiving Kalydeco in combination with tezacaftor/ivacaftor should be told not to take more than one dose of either tablet at the same time.
Croatian: Bolesnicima koji primaju Kalydeco u kombinaciji s tezakaftorom/ivakaftorom treba reći da ne uzimaju istovremeno više od jedne doze jedne ili druge tablete.
English: • Severe liver problems: the use is not recommended but your child's doctor will decide if it is appropriate for your child to use this medicine in which case the dose (as indicated in the table above) must be reduced to one sachet every other day.
Croatian: • Teški problemi s jetrom: primjena se ne preporučuje, ali djetetov će liječnik odlučiti je li prikladno primjenjivati ovaj lijek Vašem djetetu i u tom će slučaju doza (navedena u tablici iznad)
English: If this is not possible, give it within the following hour after mixing.
Croatian: Ako to nije moguće, dajte mu ga u roku od jednog sata nakon što ste ga pomiješali s hranom ili tekućinom.
English: Ivacaftor may cause dizziness (see section 4.8) and, therefore, patients experiencing dizziness should be advised not to drive or use machines until symptoms abate.
Croatian: Ivakaftor može uzrokovati omaglicu (vidjeti dio 4.8), pa stoga bolesnicima koji osjete omaglicu treba savjetovati da ne upravljaju vozilima i strojevima dok se simptomi ne povuku.
English: No specific antidote is available for overdose with ivacaftor.
Croatian: Nije dostupan specifični antidot za predoziranje ivakaftorom.
English: In part B of study 8, the primary endpoint of safety was evaluated through 24 weeks (see section 4.8).
Croatian: U dijelu B ispitivanja 8, mjera primarnog ishoda sigurnosti primjene procjenjivana je tijekom 24 tjedna (vidjeti dio 4.8).
English: Potential for ivacaftor to interact with transporters
Croatian: Mogućnost interakcije ivakaftora s prijenosnicima
English: Give Kalydeco to your child for as long as your child's doctor recommends.
Croatian: Nastavite davati Kalydeco svom djetetu onoliko dugo koliko to preporučuje djetetov liječnik.
English: The granules are packed in a Biaxially Oriented Polyethylene Terephthalate/Polyethylene/Foil/Polyethylene (BOPET/PE/Foil/PE) sachet.
Croatian: Granule su pakirane u vrećici od biaksijalno orijentiranog polietilen tereftalata/polietilena/folije/polietilena (BOPET/PE/Foil/PE).
English: Available pharmacokinetic data in animals have shown excretion of ivacaftor into the milk of lactating female rats.
Croatian: Dostupni farmakokinetički podaci kod životinja pokazali su da se ivakaftor izlučuje u mlijeko ženki štakora tijekom laktacije.
English: M1 has approximately one-sixth the potency of ivacaftor and is considered pharmacologically active.
Croatian: M1 ima približno jednu šestinu jačine ivakaftora i smatra se farmakološki aktivnim.
English: • Moderate liver problems: the dose may be reduced to one half of the indicated dose in the table above, that is one sachet once daily.
Croatian: • Umjereni problemi s jetrom: dozu se može sniziti na polovicu doze navedene u tablici iznad, tj.
English: The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: Treatment differencea
Croatian: Terapijska razlikaa
English: Ciprofloxacin
Croatian: Ciprofloksacin
English: Animals studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na reprodukciju (vidjeti dio 5.3).
English: The pharmacokinetics of ivacaftor are generally linear with respect to time or dose ranging from 25 mg to 250 mg.
Croatian: Farmakokinetika ivakaftora uglavnom je linearna s obzirom na vrijeme i dozu, u rasponu od 25 mg do 250 mg.
English: Not all pack sizes may be marketed
Croatian: Na tržištu se ne moraju nalaziti sve veličine pakiranja.
English: • Kalydeco (alone or in combination with tezacaftor/ivacaftor) is not recommended if you have undergone an organ transplant.
Croatian: • Kalydeco se (sam ili u kombinaciji s tezakaftorom/ivakaftorom) ne preporučuje ako Vam je presađen organ.
English: Other forms of this medicine (granules in sachet) are more suitable for children under 6 years of age; ask your doctor or pharmacist.
Croatian: Za djecu mlađu od 6 godina pogodniji su drugi oblici ovog lijeka (granule u vrećici); upitajte svog liječnika ili ljekarnika.
English: CI: confidence interval; NA: not analysed due to low incidence of events a Treatment difference = effect of ivacaftor - effect of placebo b CFQ-R: Cystic Fibrosis Questionnaire-Revised is a disease-specific, health-related quality-of-life measure for CF.
Croatian: CI: interval pouzdanosti; NA: nije analizirano zbog male incidencije događaja a Terapijska razlika = učinak ivakaftora - učinak placeba b CFQ-R: Revidirani upitnik za cističnu fibrozu; služi za procjenu kvalitete života povezanu sa zdravljem isključivo u oboljelih od CF-a.
English: What Kalydeco looks like and contents of the pack
Croatian: Kako Kalydeco izgleda i sadržaj pakiranja
English: Give the missed dose if less than 6 hours have passed since the time your child missed the dose.
Croatian: Dajte propuštenu dozu ako je prošlo manje od 6 sati od vremena kad je Vaše dijete trebalo uzeti dozu.
English: The primary endpoint of safety was evaluated through week 24 (see section 4.8).
Croatian: Mjera primarnog ishoda sigurnosti primjene bila je procijenjena do 24. tjedna (vidjeti dio 4.8).
English: Kalydeco has minor influence on the ability to drive or use machines.
Croatian: Kalydeco malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The mean overall post-baseline value was 76.0% and 83.7%, respectively.
Croatian: Nakon početka, sveukupna srednja vrijednost iznosila je 76,0% odnosno 83,7%.
English: In three of four patients the change in the sweat chloride test was < 5 mmol/L and this group did not demonstrate a clinically relevant improvement in FEV1 after 8 weeks of treatment.
Croatian: U tri od četiri bolesnika promjena rezultata testa koncentracije klorida u znoju iznosila je < 5 mmol/l i ta skupina nije pokazala klinički važno poboljšanje vrijednosti FEV1 nakon 8 tjedana liječenja.
English: Following multiple oral dose administrations of ivacaftor, the exposure of ivacaftor generally increased with dose from 25 mg every 12 hours to 450 mg every 12 hours.
Croatian: Nakon peroralne primjene višestrukih doza ivakaftora, izloženost ivakaftoru obično se povećavala s povećanjem doze, od 25 mg svakih 12 sati do 450 mg svakih 12 sati.
English: Always give your child this medicine exactly as your child's doctor has told you to.
Croatian: Uvijek djetetu dajte ovaj lijek točno onako kako Vam je rekao djetetov liječnik.
English: Evening Dose
Croatian: Večernja doza
English: Dosing intervals should be modified according to clinical response and tolerability (see sections 4.4 and 5.2).
Croatian: Interval doziranja treba prilagoditi prema kliničkom odgovoru i podnošljivosti (vidjeti dijelove 4.4 i 5.2).
English: All 5 patients had maximum ALT or AST levels > 8 x ULN, which returned to baseline levels following interruption of dosing with ivacaftor granules.
Croatian: Svih 5 bolesnika imalo je maksimalne razine ALT ili AST > 8 puta GGN, koje su se vratile na početne razine nakon prekida primjene granula ivakaftora.
English: Clinical studies of ivacaftor in combination regimen with tezacaftor did not include patients over 75 years of age.
Croatian: U klinička ispitivanja ivakaftora u kombiniranom režimu s tezakaftorom nisu bili uključeni bolesnici stariji od 75 godina.
English: The G970R mutation causes a splicing defect resulting in little-to-no CFTR protein at the cell surface which may explain the results observed in subjects with this mutation in study 5 (see Pharmacodynamic effects and Clinical efficacy data).
Croatian: Mutacija G970R uzrokuje defekt u prekrajanju s posljedicom da na površini stanice gotovo ili uopće nema proteina CFTR, što može objasniti rezultate opažene u ispitanika s tom mutacijom u ispitivanju 5 (vidjeti podatke u „Farmakodinamički učinci“ i „Klinička djelotvornost“).
English: CFQ-R respiratory domain score (points)
Croatian: Rezultat upitnika CFQ-R u respiratornoj domeni (bodovi)
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of ivacaftor in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni ivakaftora u trudnica ograničeni (manje od 300 trudnoća).
English: • Herbal medicines such as St. John's wort (Hypericum perforatum)
Croatian: • Biljni lijekovi, kao što je gospina trava (Hypericum perforatum).
English: For patients with moderate hepatic impairment (Child-Pugh Class B), the dose should be reduced (see Table 2).
Croatian: U bolesnika s umjerenim oštećenjem funkcije jetre (Child-Pugh stadij B) dozu je potrebno sniziti (vidjeti tablicu 2).
English: Following resolution of transaminase elevations, the benefits and risks of resuming treatment should be considered (see section 4.8).
Croatian: Nakon normalizacije vrijednosti transaminaza potrebno je razmotriti koristi i rizike nastavka liječenja (vidjeti dio 4.8).
English: Ivacaftor is a substrate of CYP3A4 and CYP3A5.
Croatian: Ivakaftor je supstrat CYP3A4 i CYP3A5.
English: Your doctor will do some blood tests to check your liver before and during treatment, particularly during the first year and especially if your blood tests showed high liver enzymes in the past.
Croatian: Liječnik će napraviti neke krvne pretrage da Vam provjeri funkciju jetre prije i tijekom liječenja, osobito tijekom prve godine liječenja te posebno ako ste nekad prije imali povišene jetrene enzime na krvnim pretragama.
English: Ivacaftor was associated with slight decreases of the seminal vesicle weights, a decrease of overall fertility index and number of pregnancies in females mated with treated males and significant reductions in number of corpora lutea and implantation sites with subsequent reductions in the average litter size and average number of viable embryos per litter in treated females.
Croatian: Ivakaftor je bio povezan s blagim sniženjem težine sjemenskih mjehurića, sniženjem ukupnog indeksa plodnosti i broja trudnoća u ženki parenih s liječenim mužjacima i značajnim smanjenjem broja žutih tijela i mjesta implantacije s posljedičnim smanjenjem prosječne veličine okota i prosječnog broja preživjelih embrija po okotu u liječenih ženki.