FrancophonIA/ELRC3.0 huggingface dataset:
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Komisije (EU) br. 37/2010 navedeno da određivanje NDK-a nije nužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EZ) br. 470/2009 kada se primjenjuju kao u ovom veterinarskomedicinskom proizvodu.
English: These pharmacodynamic properties may be also relevant for equine umbilical cord derived MSCs (EUC-MSCs) but have not been demonstrated in proprietary studies conducted with the product.
Croatian: Ta farmakodinamička svojstva mogu biti važna i u slučaju mezenhimskih matičnih stanica dobivenih iz krvi pupkovine konja (EUC-MSCs), koja nisu utvrđena u vlasnički zaštićenim ispitivanjima provedenim s VMP-om.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE OUTER CARTON
Croatian: PODATCI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA
English: PACKAGE LEAFLET: HorStem suspension for injection for horses
Croatian: UPUTA O VMP-u: HorStem suspenzija za injekciju za konje
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na internetskim stranicama Europske agencije za lijekove: http://www.ema.europa.eu/.
English: To what extent EUC-MSCs from this product persist after intraarticular administration to horses is not known as no proprietary biodistribution studies have been conducted with HorStem.
Croatian: Nije poznato u kojoj su mjeri stanice EUC-MSC iz ovoga VMP-a postojane nakon intraartikularne primjene konjima, jer s HorStemom nisu provedena vlasnički zaštićena ispitivanja biološke raspodjele.
English: Moderate joint effusion with no associated lameness has been observed 24 hours after HorStem administration.
Croatian: Umjerena efuzija zgloba bez pridružene hromosti opažena je 24 sata poslije primjene HorStema.
English: In case of severe inflammation, administration of symptomatic treatment with NonSteroidal Anti-Inflammatory Drugs (NSAIDs) could be necessary.
Croatian: U slučaju teške upale može biti potrebno primijeniti asimptomatsku terapiju nesteroidnim protuupalnim lijekovima (NSAID).
English: Special warnings for each target species:
Croatian: Posebna upozorenja za svaku ciljnu vrstu životinja
English: Equine umbilical cord mesenchymal stem cells (EUC-MSCs)
Croatian: Mezenhimske matične stanice krvi iz pupkovine konja (EUC-MSCs)
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Route of administration:
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI)
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Croatian: Učestalost nuspojava određena je sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuje nuspojavu(e)) - česte (više od 1, ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1, ali manje od 10 životinja na 1000 tretiranih životinja)
English: Each vial contains:
Croatian: Jedan ml sadržava:
English: Route of administration: Intraarticular use.
Croatian: Put primjene: Intraartikularna primjena.
English: Intraarticular use.
Croatian: Intraartikularna primjena.
English: A single intraarticular injection of 1 ml (15x106 equine umbilical cord mesenchymal stem cells) into the affected joint.
Croatian: Jedna intraartikularna injekcija od 1 ml (15 x 106 mezenhimskih matičnih stanica krvi iz pupkovine konja) u zahvaćeni zglob.
English: ROUTE(S) OF ADMINISTRATION Intraarticular use
Croatian: 4. PUT(EVI) PRIMJENE Intraartikularna primjena
English: MARKETING AUTHORISATION HOLDER EquiCord-YMAS S.L.
Croatian: EquiCord-YMAS S.L.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA
English: FOR ANIMAL TREATMENT ONLY For animal treatment only.
Croatian: SAMO ZA PRIMJENU NA ŽIVOTINJAMA Samo za primjenu na životinjama.
English: The active substance, mesenchymal stem cells, is considered as not falling within the scope of the MRL regulation, as it is covered by the entry for stem cells in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009.
Croatian: Smatra se da djelatna tvar, mezenhimske matične stanice, ne spada u područje primjene uredbe o najvećim dopuštenim količinama rezidua (NDK), jer su matične stanice svrstane u popis tvari koje nisu obuhvaćene
English: TARGET SPECIES Horses
Croatian: 5. CILJNE VRSTE ŽIVOTINJA Konji
English: The product should only be administered by a veterinary surgeon.
Croatian: Ovaj proizvod smije primijeniti samo veterinar.
English: Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Croatian: Primijeniti samo nakon što odgovorni veterinar procijeni omjer koristi i rizika.
English: WITHDRAWAL PERIOD Withdrawal period(s): Zero days
Croatian: KARENCIJA Karencija(e): Nula dana
English: Trolox (6-hydroxyl-2,5,7,8- tetramethylchroman-2-carboxylic acid) Water for injections
Croatian: L-glutation kalijev klorid kalijev bikarbonat kalijev fosfat dekstroza saharoza manitol kalcijev klorid magnezijev klorid kalijev hidroksid natrijev hidroksid troloks (6-hidroksi-2,5,7,8- tetrametilkroman-2-karboksilna kiselina) voda za injekcije
English: Lactobionic acid
Croatian: adenozin dekstran-40 laktobionska kiselina
English: Method of administration:
Croatian: Način primjene::
English: 15x106 /ml Equine umbilical cord mesenchymal stem cells
Croatian: 15 x 106/ml mezenhimske matične stanice krvi iz pupkovine konja
English: STATEMENT OF ACTIVE SUBSTANCES Each vial contains:
Croatian: 2. SASTAV DJELATNIH TVARI Jedan ml sadržava:
English: PACKAGE SIZE One 1 ml vial.
Croatian: 4. VELIČINA PAKIRANJA Jedna bočica zapremnine od 1 ml
English: PHARMACOLOGICAL PROPERTIES
Croatian: FARMACEUTSKI PODATCI
English: AUTHORISATION
Croatian: Doziranje
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 15x106 /ml Equine umbilical cord mesenchymal stem cells
Croatian: 2. KOLIČINA DJELATNE(IH) TVARI 15 x 106/ml mezenhimske matične stanice krvi iz pupkovine konja
English: Common
Croatian: NUSPOJAVE
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: Active Substance: 15x106 Equine umbilical cord mesenchymal stem cells
Croatian: Djelatna tvar: 15 x 106/ml mezenhimske matične stanice krvi iz pupkovine konja.
English: To be administered only by a veterinary surgeon
Croatian: Smije primjenjivati samo veterinar.
English: • It looks damaged.
Croatian: • Izgleda oštećeno.
English: 1 GET READY
Croatian: 1 PRIPREMITE SE
English: Important points to know
Croatian: Važne stvari koje morate znati
English: You will hear a second loud click in about 5 to 10 seconds after the first one.
Croatian: Čut ćete drugi glasan klik približno 5 - 10 sekundi nakon prvoga.
English: - if you have an infection which your doctor thinks is important (for example, active tuberculosis).
Croatian: - ako imate infekciju koju Vaš liječnik smatra važnom (primjerice, aktivnu tuberkulozu)
English: 1f Prepare your skin.
Croatian: 1f Pripremite kožu.
English: Date of first authorisation: 25 April 2016
Croatian: Datum prvog odobrenja: 25. travnja 2016.
English: Your doctor will decide if and when you may restart the treatment:
Croatian: Vaš će liječnik odlučiti hoćete li i kada ponovno započeti liječenje:
English: However, the physician should ensure appropriate follow-up of patients.
Croatian: Međutim, liječnik se treba pobrinuti za odgovarajuće praćenje bolesnika.
English: DO NOT inject in the exact same spot every time.
Croatian: NEMOJTE injicirati lijek svaki put u isto mjesto.
English: Look out for infections and allergic reactions
Croatian: Pripazite na infekcije i alergijske reakcije
English: Air bubbles are not a problem in this type of injection.
Croatian: Mjehurići zraka nisu problem kod takve vrste injekcije.
English: Check the label.
Croatian: Provjerite naljepnicu.
English: Number of patients (%)
Croatian: Broj bolesnika (%)
English: If you have psoriatic arthritis you will first be given other medicines.
Croatian: Ako imate psorijatični artritis, prvo ćete primiti druge lijekove.
English: Such signs are listed under “Serious side effects” in section 4.
Croatian: Takvi su znakovi navedeni u odlomku "Ozbiljne nuspojave" u dijelu 4.
English: This will not harm you or affect your dose.
Croatian: To Vam neće naškoditi niti utjecati na dozu.
English: Other medicines and Taltz
Croatian: Drugi lijekovi i Taltz
English: Taltz that has been frozen must not be used.
Croatian: Taltz koji je bio zamrznut ne smije se primijeniti.
English: Week 52 Ixekizumab* Ustekinumab** Ixekizumab* Ustekinumab** Ixekizumab* Ustekinumab**
Croatian: 52. tjedan Iksekizumab* Ustekinumab** Iksekizumab* Ustekinumab** Iksekizumab* Ustekinumab**
English: Bottom/ End Needle minutes
Croatian: Donji dio / Kraj igle minuta
English: 1d Wash your hands before you inject your medicine.
Croatian: 1d Operite ruke prije nego što injicirate lijek.
English: Do not remove the pre-filled pen from your skin until you hear the second loud click.
Croatian: Nemojte odvojiti brizgalicu od kože prije nego što čujete drugi glasni klik.
English: Insert the needle at a 45-degree angle.
Croatian: Ubodite iglu pod kutom od 45 stupnjeva.
English: There is limited information in subjects aged ≥ 75 years.
Croatian: Ograničene su informacije o primjeni u ispitanika u dobi od ≥ 75 godina.
English: Make sure the lock ring is in the lock position.
Croatian: Provjerite da se prsten za zaključavanje nalazi u zaključanom položaju.
English: Such levels of neutropenia may persist, fluctuate or be transient.
Croatian: Takve razine neutropenije mogu biti trajne, fluktuirajuće ili prolazne.
English: Taltz must not be given to patients with active tuberculosis (TB).
Croatian: Taltz se ne smije davati bolesnicima s aktivnom tuberkulozom (TBC).
English: A. After you press the green injection button, you will hear 2 loud clicks.
Croatian: Nakon što pritisnete zeleni gumb za injekciju, čut ćete 2 glasna klika.
English: Always use this medicine exactly as your doctor or nurse has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik ili medicinska sestra.
English: Maintenance of Response at Week 60
Croatian: Održavanje odgovora u 60. tjednu
English: Taltz is for long-term treatment.
Croatian: Taltz je namijenjen za dugoročno liječenje.
English: Keep the Instructions for Use and refer to them as needed.
Croatian: Sačuvajte upute za uporabu i pročitajte ih po potrebi.
English: Week 24 data are presented in Table 9.
Croatian: Rezultati za 24. tjedan prikazani su u Tablici 9.
English: Your doctor or nurse will regularly monitor your condition to check that the treatment is having the desired effect.
Croatian: Vaš liječnik ili medicinska sestra redovito će nadzirati Vaše stanje kako bi provjerili ostvaruje li liječenje željeni učinak.
English: Q. What if I cannot push in the plunger?
Croatian: P. Što ako ne mogu potisnuti klip?
English: A. When your injection is complete:
Croatian: Kada je injekcija završena:
English: Pull the needle cap off and throw it away.
Croatian: Skinite zatvarač igle i bacite ga.
English: A. If the plunger is stuck or damaged:
Croatian: Ako je klip zapeo ili je oštećen:
English: Keep the base on your skin, and then turn the lock ring to the unlock position.
Croatian: Držite bazu položenom na koži, a zatim okrenite prsten za zaključavanje u otključan položaj.
English: You are now ready to inject.
Croatian: Sada ste spremni injicirati lijek.
English: There will be a loud click.
Croatian: Čut ćete glasan klik.
English: Use a reminder method such as notes in a calendar or diary to help you remember your next dose so that you avoid missing or repeating doses.
Croatian: Koristite podsjetnike poput napomena u kalendaru ili dnevniku da biste se lakše sjetili kada trebate primijeniti sljedeću dozu i tako izbjegli propuštanje ili ponavljanje doza.
English: - if you are allergic to ixekizumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na iksekizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Taltz reduces the signs and symptoms of the disease.
Croatian: Taltz ublažava znakove i simptome te bolesti.
English: Taltz can potentially cause serious side effects, including infections and allergic reactions.
Croatian: Taltz može izazvati ozbiljne nuspojave, uključujući infekcije i alergijske reakcije.
English: Guide to the parts
Croatian: Vodič kroz dijelove
English: Store in the original packaging in order to protect from light.
Croatian: Čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: Press the green injection button.
Croatian: Pritisnite zeleni gumb za injiciranje.
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC13
Croatian: Farmakoterapijska skupina: Imunosupresivi, inhibitori interleukina, ATK oznaka: L04AC13
English: 2 INJECT 2a
Croatian: 2 INJICIRAJTE 2a
English: Significance level only provided for endpoint that was pre-defined and multiplicity tested.
Croatian: Razina značajnosti osigurana je samo za mjeru ishoda koja je bila unaprijed definirana i višestruko testirana.
English: Quality of Life/Patient-Reported Outcomes
Croatian: Kvaliteta života/ishodi koje prijavljuju bolesnici
English: If you do not respond well enough to these medicines, you will be given Taltz to reduce the signs and symptoms of the disease.
Croatian: Ako ne odgovorite dovoljno dobro na te lijekove, primit ćete Taltz za ublažavanje znakova i simptoma bolesti.
English: Taltz can be used alone or with another medicine named methotrexate.
Croatian: Taltz se može koristiti sam ili zajedno s lijekom koji se zove metotreksat.
English: Ixekizumab belongs to a group of medicines called interleukin (IL) inhibitors.
Croatian: Iksekizumab pripada skupini lijekova koji se zovu inhibitori interleukina (IL).
English: Clean your skin with an alcohol wipe.
Croatian: Očistite kožu vatom natopljenom alkoholom.
English: Women of childbearing potential should use an effective method of contraception during treatment and for at least 10 weeks after treatment.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu metodu kontracepcije tijekom liječenja i još najmanje 10 tjedana po njegovu završetku.
English: Clinical response at 12 weeks
Croatian: Klinički odgovor u 12. tjednu
English: Wait 30 minutes to let the syringe warm to room temperature before you use it.
Croatian: Pričekajte 30 minuta da se štrcaljka ugrije na sobnu temperaturu prije nego što je upotrijebite.
English: DO NOT touch the needle.
Croatian: NEMOJTE dodirivati iglu.
English: Your doctor will decide how much Taltz you need and for how long.
Croatian: Vaš će liječnik odlučiti koliko lijeka Taltz Vam je potrebno i koliko dugo ga trebate primjenjivati.
English: A. This is not necessary, but it may help you keep the pre-filled pen steady and firm against your skin.
Croatian: Nije potrebno, ali možda ćete tako lakše držati napunjenu brizgalicu nepomičnom i čvrsto pritisnutom uz kožu.
English: No apparent association between the presence of neutralising antibodies and impact on drug concentration or efficacy was observed.
Croatian: Nije opažena jasna povezanost između prisutnosti neutralizirajućih protutijela i utjecaja na koncentraciju lijeka ili djelotvornost.
English: No data are available on the response to live vaccines; there are insufficient data on response to inactive vaccines (see section 5.1).
Croatian: Nema podataka o odgovoru na živa cjepiva; nema dovoljno podataka o odgovoru na inaktivirana cjepiva (vidjeti dio 5.1).
English: After proper training in subcutaneous injection technique, patients may self-inject Taltz if a healthcare professional determines that it is appropriate.
Croatian: Nakon adekvatne obuke o tehnici supkutanog injiciranja, bolesnici mogu sami injicirati Taltz ako zdravstveni radnik utvrdi da je to prikladno.
English: However, the data concerning immunisation were insufficient to conclude on an adequate immune response to these vaccines following administration of Taltz.
Croatian: Međutim, podaci o imunizaciji nisu bili dostatni za zaključak o dovoljno dobrom imunom odgovoru na ta cjepiva nakon primjene lijeka Taltz.
English: A. It is normal to sometimes have air bubbles in the syringe.
Croatian: O. Normalno je da se u štrcaljki ponekad nalaze mjehurići zraka.
English: Some patients with initially partial response may subsequently improve with continued treatment beyond 20 weeks.
Croatian: Nekim bolesnicima koji na početku ostvare djelomičan odgovor stanje se može naknadno poboljšati nastavkom liječenja i nakon 20 tjedana.
English: to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Croatian: (≥ 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).
English: - if you are receiving any other treatment for psoriasis (such as immunosuppressant or phototherapy with ultraviolet light) or for psoriatic arthritis.
Croatian: - ako primate bilo koje drugo liječenje za psorijazu (poput imunosupresiva ili fototerapije ultraljubičastim svjetlom) ili za psorijatični artritis.
English: • Your doctor, pharmacist or nurse may help you decide where on your body to inject your dose.
Croatian: • Vaš liječnik, ljekarnik ili medicinska sestra mogu Vam pomoći odlučiti u koji ćete dio tijela injicirati dozu.
English: What Taltz is and what it is used for
Croatian: Što je Taltz i za što se koristi
English: If you stop treatment, symptoms of psoriasis or psoriatic arthritis may come back.
Croatian: Ako prekinete liječenje, simptomi psorijaze ili psorijatičnog artritisa mogu se vratiti.
English: If you have forgotten to inject a dose of Taltz, talk to your doctor.
Croatian: Ako zaboravite injicirati dozu lijeka Taltz, obratite se svom liječniku.
English: Q. What if I heard more than 2 clicks during my injection-2 loud clicks and a soft one.
Croatian: Što ako sam čuo više od 2 klika tijekom injekcije - 2 glasna i jedan tiši.
English: • DO NOT continue to use the syringe.
Croatian: • NEMOJTE nastaviti koristiti tu štrcaljku.
English: DO NOT use any heat sources to warm the medicine, for example: a microwave, hot water, or direct sunlight.
Croatian: NEMOJTE koristiti nikakve izvore topline da biste ugrijali lijek, primjerice: mikrovalnu pećnicu, vruću vodu ili izravnu sunčevu svjetlost.
English: You should not stop using Taltz without speaking to your doctor first.
Croatian: Ne smijete prestati primjenjivati Taltz bez prethodnog razgovora sa svojim liječnikom.
English: Its colour may vary from colourless to slightly yellow.
Croatian: Boja mu može varirati od bezbojne do žućkaste.
English: If you think you may be allergic, ask your doctor for advice before using Taltz.
Croatian: Ako mislite da ste biste mogli biti alergični, obratite se svom liječniku za savjet prije nego što primijenite Taltz.
English: You must look out for signs of these conditions while you are using Taltz.
Croatian: Morate pripaziti na znakove tih stanja dok primjenjujete Taltz.
English: This was related primarily to early delivery or maternal neglect of offspring, common findings in nonhuman primate studies, and considered clinically irrelevant.
Croatian: To je prvenstveno bilo povezano s preuranjenim okotom ili majčinim zanemarivanjem mladunčadi, što su česti nalazi u ispitivanjima s nehumanoidnim primatima i ne smatraju se klinički značajnima.
English: • The pre-filled pen contains glass parts.
Croatian: • Napunjena brizgalica sadrži staklene dijelove.
English: Talk to your doctor, nurse or pharmacist before using Taltz:
Croatian: Obratite se svom liječniku, medicinskoj sestri ili ljekarniku prije nego primijenite Taltz:
English: Patients in all treatment groups with an inadequate response at week 16 received rescue therapy (modification to background therapy).
Croatian: Bolesnici u svim liječenim skupinama koji nisu ostvarili dovoljno dobar odgovor u 16. tjednu primili su spasonosnu (rescue) terapiju (prilagodba osnovne terapije).
English: Via Gramsci 731/733 50019 Sesto Fiorentino (FI) Italy.
Croatian: Via Gramsci 731/733 50019 Sesto Fiorentino (FI) Italija
English: If you have received more Taltz than you should or the dose has been given sooner than prescribed, inform your doctor.
Croatian: Ako ste primili više lijeka Taltz nego što ste trebali ili ako ste dozu primili prije nego što je propisano, obavijestite o tome svog liječnika.
English: Clear base
Croatian: Prozirna baza
English: Serious hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Ozbiljna preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Ixekizumab does not bind to ligands IL-17B, IL-17C, IL-17D, IL-17E or IL-17F.
Croatian: Iksekizumab se ne vezuje za ligande IL-17B, IL-17C, IL-17D, IL-17E ni IL-17F.
English: If such an infection develops, monitor carefully and discontinue Taltz if the patient is not responding to standard therapy or the infection becomes serious.
Croatian: Ako se razvije takva infekcija, potrebno je pažljivo nadzirati bolesnika i prekinuti liječenje lijekom Taltz ako bolesnik ne odgovara na standardnu terapiju ili ako infekcija postane ozbiljna.
English: Non-clinical studies have not been conducted to evaluate the carcinogenic or mutagenic potential of ixekizumab.
Croatian: Nisu provedena neklinička ispitivanja kojima bi se ocijenio kancerogeni ili mutageni potencijal iksekizumaba.
English: ACR20 Responders, %
Croatian: Bolesnici s odgovorom ACR20, %
English: Patients had at least moderate plaque psoriasis (defined as sPGA score of ≥ 3 and being candidates for phototherapy and/or systemic therapy) for at least 6 months.
Croatian: Bolesnici su imali najmanje umjerenu plak psorijazu (definiranu kao sPGA rezultat ≥ 3 i bili su kandidati za fototerapiju i/ili sistemsku terapiju) tijekom najmanje 6 mjeseci.
English: You may have slight bleeding.
Croatian: Može doći do blagog krvarenja.
English: The average bioavailability of ixekizumab after subcutaneous administration was 54 % to 90 % across analyses.
Croatian: Prosječna bioraspoloživost iksekizumaba nakon supkutane primjene bila je od 54% do 90% u svim analizama.
English: In developmental toxicity studies, ixekizumab was shown to cross the placenta and was present in the blood of offspring for up to 6 months of age.
Croatian: Ispitivanja razvojne toksičnosti pokazala su da iksekizumab prolazi kroz placentu i da je prisutan u krvi mladunčadi do dobi od 6 mjeseci.
English: Cases of new or exacerbations of Crohn's disease and ulcerative colitis have been reported.
Croatian: Prijavljeni su slučajevi razvoja ili pogoršanja Crohnove bolesti i ulceroznog kolitisa.
English: DO NOT rub the injection site, as this may cause bruising.
Croatian: NEMOJTE trljati mjesto injiciranja jer to može dovesti do nastanka modrica.