FrancophonIA/ELRC3.0 huggingface dataset:
English: Infusion site pain
Croatian: Eritem na mjestu infuzije
English: Sucrose
Croatian: Saharoza
English: How to store Coagadex
Croatian: Moguće nuspojave Kako čuvati Coagadex
English: Reconstitution time is less than 2 minutes.
Croatian: Vrijeme rekonstitucije je manje od 2 minute.
English: Therefore, these findings were not considered to be adverse.
Croatian: Stoga se ovi rezultati nisu smatrali štetnima.
English: Dry powder: 3 years
Croatian: Suhi prašak: 3 godine
English: Do not use Zinforo if any of the above applies to you.
Croatian: Nemojte primjenjivati Zinforo ako se bilo što od gore navedenoga odnosi na Vas.
English: • The other ingredient is arginine.
Croatian: • Drugi sastojak je arginin.
English: Resistant (R>)
Croatian: Rezistentan (R>)
English: • If you have ever had fits (seizures or convulsions)
Croatian: • ako ste ikada imali napadaje (napadaje ili konvulzije)
English: Dose is based on CrCL.
Croatian: Doza se temelji na CrCL.
English: Calculated using the Cockcroft-Gault formula for adults.
Croatian: Izračunato korištenjem Cockcroft-Gaultove formule za odrasle.
English: After dilution:
Croatian: Nakon razrjeđivanja:
English: Overall, the safety profile in these 227 patients was similar to that observed in the adult population.
Croatian: Sveukupno, sigurnosni profil u ovih 227 bolesnika bio je sličan onom zabilježenom u odrasloj populaciji.
English: Gram-negative micro-organisms • Fusobacterium spp.
Croatian: Gram-negativni mikroorganizmi • Fusobacterium spp.
English: • Sudden swelling of your lips, face, throat or tongue; a severe rash; and, swallowing or breathing problems.
Croatian: • iznenadno oticanje usana, lica, grla ili jezika; težak osip; otežano gutanje ili disanje.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se ne upotrijebi odmah, vrijeme čuvanja u uporabi i uvjeti prije uporabe odgovornost su korisnika.
English: Tell your doctor straight away if you get these symptoms as you may need urgent medical treatment:
Croatian: Odmah obavijestite svog liječnika ako dobijete neki od sljedećih simptoma jer će Vam možda biti potrebno hitno liječenje:
English: If the level of your red blood cells fall your doctor may check to see if these antibodies have caused this.
Croatian: Ako razina Vaših crvenih krvnih stanica padne, Vaš liječnik može provjeriti jesu li to uzrokovala ta protutijela.
English: The hospital will dispose of any waste materials safely.
Croatian: Bolnica će ukloniti bilo koji otpadni materijal na siguran način.
English: • If you have kidney problems (your doctor may have to prescribe a lower dose)
Croatian: • ako imate tegoba s bubrezima (liječnik će možda morati propisati manju dozu lijeka)
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as a result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Date of first authorisation: 23 August 2012 Date of the latest renewal: 24 April 2017
Croatian: Datum posljednje obnove odobrenja: 24. travnja 2017.
English: The chemical and physical in-use stability has been demonstrated for up to 24 hours at 2-8 °C.
Croatian: Dokazana je kemijska i fizikalna stabilnost lijeka u primjeni u trajanju do 24 sata na temperaturi od 2 - 8°C.
English: From a microbiological point of view, the medicinal product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek se mora odmah upotrijebiti.
English: ≥ 15 to ≤ 30
Croatian: ≥ 15 do ≤ 30
English: • Bleeding or bruising more than usual.
Croatian: • krvarenje ili stvaranje modrica više nego inače.
English: Store below 30 °C.
Croatian: Čuvati na temperaturi ispod 30°C.
English: Frequency categories are derived according to the following conventions: 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), not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti definirane su na slijedeći 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), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Carcinogenicity studies have not been conducted.
Croatian: Nisu provedena istraživanja kancerogenosti.
English: Zinforo is used to treat children (from birth) and adults with:
Croatian: Zinforo se koristi za liječenje djece (od rođenja) te odraslih koji imaju:
English: Paediatric population As with adults, the interaction potential is expected to be low in paediatrics.
Croatian: Pedijatrijska populacija Kao i kod odraslih, očekuje se niska mogućnost interakcija u pedijatrijskoj populaciji.
English: The usual recommended dose for children depends on the age and weight of the child and is given every 8 or 12 hours.
Croatian: Uobičajena preporučena doza za djecu ovisi o dobi i tjelesnoj težini djeteta te se primjenjuje svakih 8 ili 12 sati.
English: Infusion related reactions (such as phlebitis) can be managed by prolonging the infusion duration.
Croatian: Reakcije povezane s infuzijom (kao što je flebitis) mogu se rješavati produljenjem trajanja infuzije.
English: Staphylococcus aureus Streptococcus pneumoniae Streptococcus Groups A, B, C, G
Croatian: Staphylococcus aureus Streptococcus pneumoniae Streptococcus skupine A, B, C, G
English: The total time interval between starting reconstitution and completing preparation of the intravenous infusion should not exceed 30 minutes.
Croatian: Ukupno vrijeme od početka rekonstitucije koncentrata do završetka pripreme intravenske infuzije ne smije biti dulje od 30 minuta.
English: • If you are allergic to ceftaroline fosamil or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na ceftarolinfosamil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: The usual recommended dose for adults is 600 mg every 12 hours.
Croatian: Uobičajena preporučena doza za odrasle je 600 mg svakih 12 sati.
English: Zinforo will be given to you by a doctor or nurse.
Croatian: Zinforo će Vam dati liječnik ili medicinska sestra.
English: • Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus)
Croatian: • skupina Streptococcus anginosus (obuhvaća S. anginosus, S. intermedius i S. constellatus)
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7 Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: > 30 to ≤ 50
Croatian: > 30 do ≤ 50
English: This may impair your ability to drive or operate machinery.
Croatian: To može umanjiti Vašu sposobnost da upravljate vozilima ili rukujete strojevima.
English: Once removed from refrigeration to room temperature, the diluted product must be used within 6 hours.
Croatian: Kad se izvadi iz hladnjaka na sobnu temperaturu, razrijeđeni lijek se mora upotrijebiti u roku od 6 sati.
English: Clostridium difficile-associated disease (CDAD) and severe hypersensitivity reactions may also occur.
Croatian: Clostridium difficileassociated disease, CDAD) i teške reakcije preosjetljivosti također se mogu pojaviti.
English: The kidney was the primary target organ of toxicity in both the monkey and rat.
Croatian: Bubreg je bio primarni ciljni organ za toksičnost i u majmuna i u štakora.
English: In this situation, you should not take medicines that stop or slow bowel movement.
Croatian: U tom slučaju ne smijete uzimati lijekove koji zaustavljaju ili usporavaju rad crijeva.
English: Caution is advised when treating such patients.
Croatian: U liječenju takvih bolesnika savjetuje se oprez.
English: • Changes in a blood test called a ‘Coombs test' commonly seen in patients receiving this type of antibiotic.
Croatian: • Promjene u nalazu krvne pretrage koja se zove "Coombsov test" uobičajene su u bolesnika koji se liječe ovom vrstom antibiotika.
English: Infusion volumes for paediatric patients will vary according to the weight of the child.
Croatian: Volumeni infuzije u pedijatrijskih bolesnika razlikovat će se ovisno o tjelesnoj težini djeteta.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8ºC, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne upotrijebi odmah, vrijeme čuvanja u uporabi i uvjeti prije uporabe odgovornost su korisnika te ne bi smjeli biti dulji od 24 sata na temperaturi od 2°C do 8°C, osim ako se rekonstitucija/razrjeđivanje provelo u kontroliranim i validiranim aseptičkim uvjetima.
English: Each vial is for single use only.
Croatian: Svaka bočica je samo za jednokratnu uporabu.
English: If a severe allergic reaction occurs during treament with Zinforo, the medicinal product should be discontinued and appropriate measures taken.
Croatian: Ako tijekom liječenja lijekom Zinforo nastupi teška alergijska reakcija, mora se prekinuti primjenu lijeka i poduzeti odgovarajuće mjere.
English: From a microbiological point of view, the medicinal product should be used immediately unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Croatian: S mikrobiološkog stajališta, lijek se mora odmah upotrijebiti, osim ako su rekonstitucija i razrjeđivanje provedeni u kontroliranim i validiranim aseptičkim uvjetima.
English: The medicinal product is supplied in packs of 10 vials.
Croatian: Lijek se isporučuje u pakiranjima od 10 bočica.
English: You may experience fever, flu-like symptoms, sore throat, or any other infection which may be serious.
Croatian: Može se javiti vrućica, simptomi nalik gripi, grlobolja ili bilo koja druga infekcija koja može biti ozbiljna.
English: Hypersensitivity reactions Serious and occasionally fatal hypersensitivity reactions are possible (see sections 4.3 and 4.8).
Croatian: Reakcije preosjetljivosti Moguće su ozbiljne, ponekad i smrtonosne reakcije preosjetljivosti (vidjeti dijelove 4.3 i 4.8).
English: There was a 33% increase in AUC0-∞ in the elderly that was mainly attributable to age-related changes in renal function.
Croatian: Zabilježen je porast od 33% AUC0-∞ u starijih osoba, koji se uglavnom mogao pripisati dobno uvjetovanim promjenama bubrežne funkcije.
English: Overall, the adverse events reported in these studies were consistent with the known safety profile for Zinforo.
Croatian: Sveukupno, štetni događaji prijavljeni u ovim ispitivanjima bili su u skladu s poznatim sigurnosnim profilom lijeka Zinforo.
English: However, the frequency of rash in the subgroup of Asian patients receiving Zinforo every 8 hours was very common (18.5%).
Croatian: Međutim, učestalost osipa u podskupini azijskih bolesnika koji su primali lijek Zinforo svakih 8 sati bila je vrlo česta (18,5%).
English: Renal changes were not reversible but were reduced in severity following a 4 week recovery period.
Croatian: Promjene na bubrezima nisu bile reverzibilne, ali se njihova težina smanjila nakon 4-tjednog razdoblja oporavka.
English: The powder must be reconstituted with water for injections and the resulting concentrate must then be immediately diluted prior to use.
Croatian: Prašak se mora rekonstituirati vodom za injekcije, a dobiveni koncentrat se zatim mora odmah razrijediti.
English: Creatinine shows how well your kidneys are working.
Croatian: Kreatinin pokazuje kako rade bubrezi.
English: Furthermore, in vivo micronucleus assays in rat and mouse were negative.
Croatian: Nadalje, mikronukleusni testovi in vivo u štakora i miševa bili su negativni.
English: These may be signs of a severe allergic reaction (anaphylaxis) and may be lifethreatening;
Croatian: To mogu biti znakovi teške alergijske reakcije (anafilaksije) i mogu biti opasni po život.
English: How Zinforo works Zinforo works by killing certain bacteria, which can cause serious infections.
Croatian: Kako djeluje Zinforo Zinforo djeluje tako što ubija određene bakterije koje mogu uzrokovati ozbiljne infekcije.
English: After reconstitution: The reconstituted vial should be diluted immediately.
Croatian: Nakon rekonstitucije: Rekonstituirana bočica se mora odmah razrijediti.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Zinforo 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 Zinforo uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Arginine
Croatian: Arginin
English: Alternatively they are stable for up to 24 hours under refrigerated storage.
Croatian: Osim toga, stabilna je do 24 sata ako se čuva u hladnjaku.
English: Once the intravenous solution is prepared with diluents listed in section 6.6 it should be administered within 6 hours of preparation.
Croatian: Nakon što se intravenska otopina pripremi pomoću otapala navedenih u dijelu 6.6, mora se primijeniti u roku od 6 sati od pripreme.
English: Lab Test
Croatian: Laboratorijske pretrage
English: As a precautionary measure, it is preferable to avoid the use of Zinforo during pregnancy unless the clinical condition of the woman requires treatment with an antibiotic with Zinforo's antibacterial profile.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Zinforo tijekom trudnoće, osim ako kliničko stanje žene ne zahtijeva liječenje antibiotikom koji ima antibakterijski profil kakav ima Zinforo.
English: Approximate ceftaroline concentration (mg/mL)
Croatian: Približna koncentracija ceftarolina (mg/ml)
English: The mean terminal elimination half-life of ceftaroline in healthy adults is approximately 2.5 hours.
Croatian: Srednja vrijednost terminalnog poluvremena eliminacije ceftarolina u zdravih odraslih osoba iznosi približno 2,5 sata.
English: Studies have shown that Zinforo solutions for infusion are stable for up to 6 hours at room temperature.
Croatian: Ispitivanja su pokazala da je Zinforo otopina za infuziju stabilna do 6 sati na sobnoj temperaturi.
English: Mix gently to reconstitute and check to see that the contents have dissolved completely.
Croatian: Tijekom rekonstitucije pažljivo miješajte otopinu i provjerite da li se sadržaj u potpunosti otopio.
English: Animal studies conducted in rat and rabbit do not indicate harmful effects with respect to reproductive toxicity at exposures similar to therapeutic concentrations.
Croatian: Ispitivanja na životinjama provedena u štakora i kunića ne ukazuju na štetne učinke na reproduktivnu toksičnost pri izloženostima sličnima terapijskim koncentracijama.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Croatian: Moraju se uzeti u obzir službene preporuke o primjerenoj primjeni antibakterijskih lijekova.
English: Do not use this medicine during pregnancy unless your doctor has told you to.
Croatian: Ovaj lijek se ne smije primjenjivati u trudnoći, osim ako to nije preporučio liječnik.
English: Renal cortical cysts were oberved in all groups, including controls, on PND50.
Croatian: Kortikalne ciste bubrega primijećene su u svim skupinama, uključujući kontrolnu skupinu na PND50.
English: Treatment of overdose should follow standard medical practice;
Croatian: Predoziranje se mora liječiti sukladno standardnoj medicinskoj praksi.
English: If ceftaroline is commenced before susceptibility test results are available then local information on the risk of encountering organisms that express these enzymes should be taken into consideration.
Croatian: Ako se ceftarolin uvede prije nego što budu dostupni rezultati testova osjetljivosti, moraju se uzeti u obzir lokalni podaci o riziku pojave organizama koji produciraju te enzime.
English: The most common adverse reactions occurring in ≥ 3% of approximately 3242 patients treated with Zinforo in clinical studies were diarrhoea, headache, nausea, and pruritus, and were generally mild or moderate in severity.
Croatian: Najčešće nuspojave koje su se javile u ≥ 3% od otprilike 3242 bolesnika liječenih lijekom Zinforo u kliničkim ispitivanjima bile su proljev, glavobolja, mučnina i svrbež, a uglavnom su bile blage ili umjerene težine.
English: Ceftaroline is neither a substrate, nor an inhibitor of renal uptake transporters (OCT2, OAT1, and OAT3) in vitro.
Croatian: Ceftarolin nije ni supstrat, niti inhibitor bubrežnih unosnih transportnih proteina (OCT2, OAT1 i OAT3) in vitro.
English: Zinforo should not be mixed with or physically added to solutions containing other drugs.
Croatian: Zinforo se ne smije miješati niti fizički dodavati u otopine koje sadrže druge lijekove.
English: Pyrexia, infusion site reactions (erythema, phlebitis, pain)
Croatian: Pireksija, reakcije na mjestu infuzije (eritem, flebitis, bol)
English: It is given as a drip into a vein lasting 5 to 60 minutes if you receive the usual dose or 120 minutes if you receive an increased dose.
Croatian: Primjenjuje se u venu infuzijom u trajanju od 5 do 60 minuta ako primate uobičajenu dozu ili 120 minuta ako primate povećanu dozu.
English: Zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults(see sections 4.4 and 5.1):
Croatian: Zinforo je indiciran za liječenje sljedećih infekcija u novorođenčadi, dojenčadi, djece, adolescenata i odraslih (vidjeti dijelove 4.4 i 5.1):
English: Calculated using the Schwartz formula for paediatric patients (in mL/min/1.73 m
Croatian: Izračunato korištenjem Schwartzove formule za pedijatrijske bolesnike (u ml/min/1,73 m
English: Infer susceptibility from susceptibility to benzylpenicillin.
Croatian: Zaključuje se o osjetljivosti prema osjetljivosti na benzilpenicilin.
English: However, when ceftaroline was administered throughout pregnancy and lactation, there was no effect on pup weight or growth.
Croatian: Međutim, kada se ceftarolin primjenjivao tijekom graviditeta i laktacije, nije bilo učinaka na težinu i rast mladunčadi.
English: CrCL should be closely monitored and the dose adjusted according to changing renal function.
Croatian: CrCL treba pomno pratiti i dozu prilagoditi promjenama bubrežne funkcije.
English: Do not use Zinforo:
Croatian: Nemojte primjenjivati Zinforo:
English: Other important toxicologic findings noted in the rat and monkey included histopathologic changes in the bladder and spleen.
Croatian: Ostali važni toksikološki nalazi opaženi u štakora i majmuna obuhvaćajli su patohistološke promjene na mokraćnom mjehuru i slezeni.
English: * Calculated using the Schwartz formula (in mL/min/1.73 m2) for paediatric patients.
Croatian: Izračunato korištenjem Schwartzove formule (u ml/min/1,73 m2) za pedijatrijske bolesnike.
English: The compatibility of Zinforo with other medicines has not been established.
Croatian: Nije utvrđena kompatibilnost lijeka Zinforo s drugim lijekovima.
English: • More enzymes produced by your liver (as shown in blood tests)
Croatian: • povećano stvaranje jetrenih enzima (vidljivo je iz rezultata krvnih pretraga)
English: • Anaemia
Croatian: • anemija
English: Ceftaroline can be removed by haemodialysis; over a 4 hour dialysis period, approximately 74% of a given dose was recovered in the dialysate.
Croatian: Ceftarolin se može ukloniti hemodijalizom; tijekom razdoblja 4-satne dijalize otprilike 74% primjenjene doze se pojavilo u dijalizatu.
English: A course of treatment usually lasts for 5 to 14 days for skin infections and 5 to 7 days for pneumonia.
Croatian: Ciklus liječenja obično traje 5 do 14 dana za infekcije kože, a 5 do 7 dana za upalu pluća.
English: Diarrhoea, nausea, vomiting, abdominal pain
Croatian: Proljev, mučnina, povraćanje, bolovi u abdomenu
English: The MAH shall perform the 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: Posology (mg/infusion)
Croatian: Doziranje (mg/infuziji)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Croatian: 5 SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: 60/every 8 hours
Croatian: 60/svakih 8 sati
English: • An increase in the level of creatinine in your blood.
Croatian: • povišena razina kreatinina u krvi.
English: It belongs to a group of medicines called ‘cephalosporin antibiotics.'
Croatian: On pripada skupini lijekova koji se zovu „cefalosporinski antibiotici“.
English: Increased transaminases
Croatian: Povišene transaminaze
English: When stored as recommended, the product potency is not affected.
Croatian: Ako se čuva kako je preporučeno, nema utjecaja na djelovanje lijeka.
English: As with other beta-lactam antimicrobial agents, the percent time above the minimum inhibitory concentration (MIC) of the infecting organism over the dosing interval (%T > MIC) has been shown to be the parameter that best correlates with the efficacy of ceftaroline.
Croatian: Kao i kod drugih beta-laktamskih antimikrobnih lijekova, pokazalo se da je postotak vremena iznad minimalne inhibitorne koncentracije (MIK) za uzročnika infekcije tijekom intervala doziranja (%T > MIK) parametar koji najbolje korelira s djelotvornošću ceftarolina.
English: What Zinforo is and what it is used for What you need to know before you use Zinforo How to use Zinforo
Croatian: Što je Zinforo i za što se koristi Što morate znati prije nego počnete primjenjivati Zinforo
English: In such circumstance, the discontinuation of therapy with ceftaroline fosamil and the use of supportive measures together with the administration of specific treatment for Clostridium difficile should be considered.
Croatian: U takvim se okolnostima mora razmotriti prekid liječenja ceftarolin fosamilom te primjenu potpornih mjera zajedno s primjenom specifičnog liječenja protiv Clostridium difficile.
English: One or more of these mechanisms may co-exist in a single bacterial isolate.
Croatian: U jednom bakterijskom izolatu može istodobno biti prisutan jedan ili više od tih mehanizama.
English: Anaemia, leucopenia, neutropenia, thrombocytopenia, prothrombin time (PT) prolonged, activated partial thromboplastin time (aPTT) prolonged, international normalized ratio (INR) increased
Croatian: Anemija, leukopenija, neutropenija, trombocitopenija, produljeno protrombinsko vrijeme (PV), produljeno aktivirano parcijalno tromboplastinsko vrijeme (aPTV), povećanje međunarodnog normaliziranog omjera (INR)
English: The available clinical data cannot substantiate efficacy against penicillin non-susceptible strains of S. pneumoniae.
Croatian: Dostupni klinički podaci ne mogu potkrijepiti djelotvornost protiv sojeva S. pneumoniae neosjetljivih na penicilin.
English: > 30 to ≤ 50 400 mg c/every 12 hours
Croatian: > 30 do ≤ 50 400 mg c/svakih 12 sati
English: Neonates from birth to < 2 months
Croatian: Novorođenčad od rođenja do < 2 mjeseca
English: Animal studies with ceftaroline fosamil do not indicate harmful effects with respect to fertility (see section 5.3).
Croatian: Ispitivanja ceftarolinfosamila u životinja ne ukazuju na štetne učinke na plodnost (vidjeti dio 5.3).