FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of overdose, based on the pharmacological action of caplacizumab, there is the potential for an increased risk of bleeding.
Croatian: U slučaju predoziranja, na temelju farmakološkog djelovanja kaplacizumaba, postoji mogućnost za povećani rizik od krvarenja.
English: • If the kit was not stored at room temperature, allow the vial and the syringe to reach room temperature (15°C - 25°C) by letting them stand at room temperature for a few minutes.
Croatian: • Ako set nije bio čuvan na sobnoj temperaturi, pustite da bočica i injekcija dosegnu sobnu temperaturu (15°C - 25°C) tako što ćete ih ostaviti par minuta na sobnoj temperaturi.
English: In clinical studies, up to 9% of patients developed treatment-emergent anti-drug antibodies (ADA).
Croatian: U kliničkim ispitivanjima, do 9 % bolesnika razvilo je tijekom ispitivanja protutijela na lijek (engl. anti-drug antibodies, ADA).
English: *Bleeding events: see below
Croatian: *Događaji povezani s krvarenjem: vidjeti u nastavku
English: No impact on clinical efficacy was observed and no serious adverse events were found to be associated with these ADA responses.
Croatian: Nije uočen utjecaj na kliničku djelotvornost i nisu pronađeni ozbiljni štetni događaji koji bi bili povezani s tim ADA odgovorima.
English: • Do not use the kit if the packaging or the items in it are damaged in any way.
Croatian: • Nemojte upotrijebiti set ako su pakiranje ili sadržaj u njemu oštećeni.
English: Select a different injection site from the one you used on the previous day to help the skin to recover after the injection.'
Croatian: Odaberite različito mjesto primjene od mjesta kojeg ste koristili prethodni dan kako bi omogućili koži da se oporavi od injekcije.
English: The safety and efficacy of caplacizumab in the paediatric population have not yet been established.
Croatian: Sigurnost i djelotvornost kaplacizumaba kod pedijatrijske populacije nije još ustanovljena.
English: The median treatment duration with caplacizumab in the double blind period was 35 days.
Croatian: Medijan trajanja liječenja kaplacizumabom u dvostruko slijepom razdoblju bio je 35 dana.
English: Then, slowly push the plunger until a small amount of liquid comes out of the needle.
Croatian: Zatim lagano potisnite klip sve dok iz štrcaljke ne izađe mala količine tekućine.
English: All powder must be dissolved and the solution must be clear.
Croatian: Sav prašak mora biti otopljen, a otopina mora biti prozirna.
English: The solvent should be added slowly and mixed gently to avoid foaming of the solution.
Croatian: Otapalo se mora dodavati polagano i lagano miješati kako bi se izbjeglo stvaranje pjene.
English: Cablivi is for single use only.
Croatian: Cablivi je namijenjen samo za jednokratnu primjenu.
English: Preparing a dose of Cablivi for intravenous injection should be done in the same way as for a subcutaneous injection (see Instructions for Use, step 1 to 9, in section 3).
Croatian: Doza lijeka Cablivi za intravensku primjenu mora se pripremiti na isti način kao i za supkutanu primjenu (vidjeti upute za uporabu, koraci 1 do 9 u dijelu 3).
English: Characteristics in specific groups
Croatian: Svojstva u posebnim skupinama
English: After subcutaneous administration, caplacizumab is rapidly and almost completely absorbed (estimated F> 0.901) in the systemic circulation.
Croatian: Nakon supkutane primjene, kaplacizumab se brzo i gotovo u potpunosti apsorbirao (procjena je F>0,901) u sistemsku cirkulaciju.
English: In the population PK/PD model, renal function (CRCL) had a statistically significant effect resulting in limited increase in predicted exposure (AUCss) in severe renal impairment.
Croatian: U populacijiskom PK/PD modelu, funkcija bubrega (CRCL) imala je statistički značajan utjecaj koji je rezultirao ograničenim povećanjem predviđene izloženosti (AUCss) kod teškog oštećenja funkcije bubrega.
English: In patients undergoing surgery
Croatian: Bolesnici s planiranom kirurškom operacijom
English: The European Medicines Agency has deferred the obligation to submit the results of studies with caplacizumab in one or more subsets of the paediatric population with aTTP (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja kaplacizumaba u jednoj ili više podskupina pedijatrijske populacije s aTTP-om (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Based on a carcinogenicity risk assessment, dedicated studies were not deemed necessary.
Croatian: Na temelju procjene kancerogenog rizika, smatralo se da nisu potrebna ispitivanja s tom svrhu.
English: Foetal exposure to caplacizumab in primates and humans remains uncertain, as proteins lacking an Fc portion are not thought to freely pass the placental barrier.
Croatian: Izoženost fetusa kaplacizumabu kod primata i ljudi je i dalje je nejasna jer se smatra da proteini kojima nedostaje Fc dio ne prolaze slobodno placentnu membranu.
English: What Cablivi is and what it is used for
Croatian: Što je Cablivi i za što se koristi
English: Pharmacotherapeutic group: Other antithrombotic agents, ATC code: B01AX07.
Croatian: Farmakoterapijska skupina: Ostali antitrombotici, ATK oznaka: B01AX07.
English: No studies have been performed to evaluate the mutagenic potential of caplacizumab, as such tests are not relevant for biologicals.
Croatian: Nisu provedena ispitivanja za procjenu mutagenog potencijala kaplacizumaba, jer takva ispitivanja nisu relevantna za biološke lijekove.
English: If a patient is to undergo elective surgery or a dental procedure, the patient should be advised to inform the physician or dentist that they are using Cablivi, and treatment should be stopped at least 7 days before the planned intervention.
Croatian: Ako je za bolesnika planiran elektivni operativni ili stomatološki zahvat, bolesnika treba upozoriti da obavijesti liječnika ili stomatologa da uzima lijek Cablivi, a liječenje se mora prekinuti barem 7 dana prije planirane intervencije.
English: Please talk to your doctor before you stop the treatment because stopping it too early can cause your condition to come back.
Croatian: Razgovarajte s Vašim liječnikom prije nego prestanete s liječenjem jer prerani prestanak može uzrokovati povratak vaše bolesti.
English: In case of active, clinically significant bleeding, treatment with Cablivi should be interrupted.
Croatian: U slučaju aktivnog, klinički značajnog krvarenja liječenje lijekom Cablivi mora se prekinuti.
English: Do not use the vial if the green plastic cap is missing.
Croatian: Nemojte upotrebljavati bočicu na kojoj nedostaje zelena plastična kapica.
English: • have severely reduced liver function.
Croatian: • imate teško smanjenju funkciju jetre.
English: • are going to have an operation or dental treatment.
Croatian: • pripremate se za operaciju ili stomatološki zahvat.
English: Injections into the area around the navel should be avoided and consecutive injections should not be administered in the same abdominal quadrant.
Croatian: Potrebno je izbjegavati primjenu injekcija u područje oko pupka i ne smiju se davati uzastopno u isti abdominalni kvadrant.
English: - your doctor may ask you to continue daily treatment until the underlying signs of your disease are resolved
Croatian: - Vaš liječnik može tražiti da nastavite dnevno liječenje sve dok se postojeći znaci vaše bolesti ne povuku
English: To get the most benefit from your treatment, it is important to use Cablivi as prescribed and for as long as your doctor tells you to use it.
Croatian: Kako bi postigli najveću korist od liječenja, važno je da uzmete Cablivi onako kako je propisan i onoliko dugo koliko vam je rekao liječnik.
English: Use of Cablivi is not recommended during pregnancy.
Croatian: Cablivi se ne preporučuje tijekom trudnoće.
English: • Hold this skin fold during the entire injection.
Croatian: • Držite kožni nabor tijekom cjelog postupka injiciranja.
English: • injection site reactions: rash, itching and bleeding
Croatian: • reakcije na mjestu primjene: osip, svrbež i krvarenje
English: For each injection, use a fresh kit package to prepare the injection solution.
Croatian: Za svaku injekciju upotrijebite paket s novim setom za pripremu injekcije s otopinom.
English: In healthy volunteers receiving 10 mg caplacizumab subcutaneoulsy once daily, the maximum concentration was observed at 6-7 hours post-dose and steady-state was reached following the first administration, with minimal accumulation.
Croatian: U zdravih dobrovoljaca koji su primili 10 mg kaplacizumaba supkutano jednom dnevno, najviša koncentracija uočena je 6-7 sati nakon primjenjene doze, a stanje dinamičke ravnoteže postignuto je nakon prve primjene uz minimalnu akumulaciju.
English: • Remove the plastic flip-off cap from the vial.
Croatian: • Uklonite plastičnu flip-off kapicu s bočice.
English: * Caplacizumab is a humanised bivalent Nanobody produced in Escherichia coli by recombinant DNA technology.
Croatian: * kaplacizumab je humanizirano bivalentno nanotijelo proizvedeno u bakteriji Escherichia coli rekombinantnom DNK-a tehnologijom.
English: Do not use the medicine if you see any cloudiness, clumps or anything else that looks abnormal.
Croatian: Nemojte primijeniti ovaj lijek ako uočite da je mutan, sadrži grudice ili bilo što drugo što se čini neuobičajeno.
English: • bleeding in brain as evidenced by severe headache of rapid onset, vomiting, decreased level of consciousness, fever, sometimes seizures and neck stiffness or neck pain
Croatian: • krvarenje u mozgu očitovano naglom pojavom teške glavobolje, povraćanjem, smanjenjem razine svijesti, vrućicom, ponekad napadima i ukočenošću ili boli u vratu
English: After absorption, caplacizumab binds to the target and distributes to well perfused organs.
Croatian: Nakon apsorpcije, kaplacizumab se veže na svoj ciljni protein i distribuira do dobro perfundiranih organa.
English: In the clinical development program, caplacizumab has been administered daily for up to 65 days.
Croatian: U kliničkom razvojnom programu kaplacizumab se primjenjivao dnevno u trajanju do 65 dana.
English: The MAH shall ensure that in each Member State where Cablivi is marketed, all patients/carers who are expected to use Cablivi are provided with the following patient alert card which shall contain the following key message:
Croatian: Nositelj odobrenja mora osigurati da u svakoj državi članici na čijem se tržištu lijek Cablivi nalazi, svi bolesnici i njihovi skrbnici za koje se očekuje da će koristiti Cablivi imaju dostupnu karticu s upozorenjima za bolesnike koja sadrži sljedeću ključnu poruku:
English: • Check the content of the syringe.
Croatian: • Provjerite sadržaj štrcaljke.
English: Tell your doctor if you think you have had an overdose.
Croatian: Obavijestite svog liječnika ako mislite da ste se predozirali.
English: • Immediately after the injection, move the needle safety shield over the needle, until it clicks into place.
Croatian: • Odmah nakon injektiranja, pomaknite sigurnosnu zaštitu preko igle sve dok ne klikne na svoje mjesto.
English: The patient should also notify the physician who supervises the treatment with Cablivi about the planned procedure.
Croatian: Bolesnik također mora obavijestiti liječnika koji nadzire liječenje lijekom Cablivi o planiranom zahvatu.
English: Number of days of Plasma Exchange (days)
Croatian: Broj dana izmjene plazme (dani)
English: Do not try to inject Cablivi until you have been taught how to do so by a healthcare professional.
Croatian: Nemojte pokušati primijeniti injekciju lijeka Cablivi dok vas zdravstveni radnik nije naučio kao da to učinite.
English: A decision must be made whether to discontinue breastfeeding or to abstain/discontinue from therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti treba li prestati s dojenjem ili prestati s liječenjem / suzdržati se od liječenja, uzimajući pritom u obzir korist dojenja za dijete i korist liječenja za ženu.
English: • Go to step 10 to inject caplacizumab under the skin of the belly.
Croatian: • Idite na 10. korak kako bi injektirali kaplacizumab pod kožu trbuha.
English: As a precautionary measure, it is preferable to avoid the use of Cablivi during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Cablivi tijekom trudnoće.
English: While experience with the use of caplacizumab in the elderly is limited, there is no evidence to suggest that dose adjustment or special precautions are needed for elderly patients (see section 5.2).
Croatian: Iako su podaci o primjeni kaplacizumaba u starijih osoba ograničeni, nema dokaza koji bi upućivali da je potrebna prilagodba doze ili posebne mjere opreza za starije bolesnike (vidjeti dio 5.2).
English: The efficacy and safety of caplacizumab in adults experiencing an episode of aTTP were established in 2 randomised, controlled studies: Phase III study ALX0681-C301 “HERCULES” and Phase II study ALX-0681-2.1/10 “TITAN”.
Croatian: Djelotvornost i sigurnost kaplacizumaba u odraslih s epizodama aTTP-a ustanovljene su u 2 randomizirana kontrolirana ispitivanja: ALX0681-C301 „HERCULES“ ispitivanju faze III i ALX0681-2.1/10 „TITAN“ ispitivanju faze II.
English: • a white powder for solution for injection in a glass vial, and
Croatian: • bijeli prašak za otopinu za injekciju u staklenoj bočici i
English: Ablynx NV Technologiepark 21 9052 Zwijnaarde Belgium
Croatian: Ablynx NV Technologiepark 21 9052 Zwijnaarde Belgija
English: Do not use this medicine after the expiry date stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza oznake EXP.
English: • Carefully remove the needle protection cap from the needle and throw it away.
Croatian: • Pažljivo uklonite zaštitnu kapicu s igle i bacite je.
English: In case of recurrence during the follow up period (i.e. after all study drug treatment had been stopped), there was no re-initiation of study drug and the recurrence was to be treated according to the standard of care.
Croatian: U slučaju ponavljanja bolesti tijekom razdoblja praćenja (tj. nakon što je prestala primjena svih lijekova), nije bilo ponovne primjene ispitivanog lijeka i ponovljena bolest se liječila u skladu sa standardima liječenja.
English: Treatment with caplacizumab resulted in a statistically significant reduction in time to platelet count response (p<0.01).
Croatian: Liječenje kaplacizumabom rezultiralo je statistički značajnim smanjenjem vremena do odgovora u broju trombocita (p<0,01).
English: • Use the second alcohol pad to clean the injection site you have chosen.
Croatian: • Upotrijebite novi jastučić natopljen alkoholom kako bi očistili mjesto injekcije koje ste izabrali.
English: • Holding the syringe in your hand, break off the white cap with your other hand.
Croatian: • Dok držite štrcaljku u jednoj ruci, drugom rukom odlomite bijelu kapicu.
English: Patients treated with caplacizumab were 1.55 times more likely to achieve platelet count response at any given time point, compared to patients treated with placebo.
Croatian: Bolesnici liječeni kaplacizumabom imali su 1,55 puta veću vjerojatnost da postignu odgovor u broju trombocita u bilo kojoj zadanoj vremenskoj točki u odnosu na bolesnike koji su primili placebo.
English: Patients or caregivers may inject the medicinal product after proper training in the subcutaneous injection technique.
Croatian: Bolesnici ili njegovatelji mogu injcirati lijek nakon odgovarajuće edukacije o pravilnoj primjeni supkutane injekcije.
English: What you need to know before you use Cablivi
Croatian: Što morate znati prije nego počnete primjenjivati Cablivi
English: For instructions on reconstitution of Cablivi before administration, see section 6.6.
Croatian: Za upute o rekonstituciji lijeka Cablivi prije primjene vidjeti dio 6.6.
English: • first dose - 1 vial injected into a vein by a healthcare professional - the medicine will be given before starting plasma exchange
Croatian: • prva doza - 1 bočica primijenjena injekcijom u venu od strane zdravstvenog radnika - lijek će se dati prije početka izmjene plazme
English: Step 1 - Cleaning
Croatian: Korak 1 - Čišćenje
English: • Gently pinch the cleaned skin between your thumb and forefinger to make a fold.
Croatian: • Nježno uhvatit očišćenu kožu između palca i kažiprsta kako bi napravili nabor
English: The reconstituted solution is clear, colourless, or slightly yellowish.
Croatian: Rekonstituirana otopina je prozirna, bezbojna ili blago žućkasta.
English: • have a bleeding disorder such as haemophilia.
Croatian: • imate poremećaj zgrušavanja krvi kao što je hemofilija.
English: Leave the adapter in its opened plastic packaging.
Croatian: Ostavite nastavak u otvorenom plastičnom pakiranju.
English: All clinical studies with caplacizumab demonstrated rapid decreases in RIPA and/or RICO levels after the start of the treatment, with recovery to baseline levels within 7 days of discontinuation.
Croatian: Sva klinička ispitivanja s kaplacizumabom pokazala su brzo smanjenje razina RIPA i/ili RICO-a nakon početka liječenja s povratkom na početne razine unutar 7 dana od prestanka primjene lijeka.
English: Side effects in a clinical study were reported with the following frequencies:
Croatian: Nuspojave su u kliničkom ispitivanju prijavljene sa sljedećom učestalošću:
English: The most frequent adverse reactions in clinical trials were epistaxis, headache and gingival bleeding.
Croatian: Najčešće nuspojave u kliničkim ispitivanjima bile su epistaksa, glavobolja i krvarenje iz desni.
English: They were again treated for the duration of daily plasma exchange and for 30 days thereafter.
Croatian: Ponovno su liječeni tijekom razdoblja trajanja izmjene plazme i 30 dana nakon toga.
English: Your doctor will decide if it can be postponed or if you should stop Cablivi before your surgery or dental treatment.
Croatian: Vaš liječnik će odlučiti može li se zahvat odgoditi ili morate prestati uzimati Cablivi prije operacije ili stomatološkog zahvata.
English: Subsequent doses are to be administered via subcutaneous injection in the abdomen.
Croatian: Sljedeće doze potrebno je primjenjivati supkutanom injekcijom u području abdomena.
English: The results indicated exposure to caplacizumab in dams and, to a much lesser extent, foetuses, with no reported effects on foetal development.
Croatian: Rezultati su pokazali izloženost kaplacizumabu kod ženki i u mnogo manjoj mjeri kod fetusa bez prijavljenih učinaka na fetalni razvoj.
English: In this case, your doctor or healthcare provider will train you or your caregiver on how to use Cablivi.
Croatian: U tom slučaju, liječnik ili zdravstveni radnik će Vas ili Vašeg njegovatelja educirati kako primijeniti Cablivi.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Croatian: Detaljnije informacije dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Other medicines and Cablivi Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: • Insert the full length of the needle into the skin fold at an angle as shown in the illustration.
Croatian: • Umetnite punu duljinu igle u kožni nabor pod kutom kako je prikazano na crtežu.
English: • subsequent doses: - 1 vial once daily as a subcutaneous injection (under the skin of the belly) - the subcutaneous injection will be given after each daily plasma exchange - after the daily plasma exchange finishes, your treatment with Cablivi will continue for at least 30 days with injection of 1 vial once daily.
Croatian: • sljedeće doze: - 1 bočica jednom dnevno primijenjena kao potkožna (supkutana) injekcija (primjena pod kožu u predjelu trbuha) - potkožna injekcija primijenit će se nakon svake dnevne izmjene plazme - nakon što se liječenje dnevnim izmjenama plazme završi, liječenje lijekom Cablivi će se nastaviti najmanje 30 dana primjenom 1 bočice potkožnom injekcijom jednom dnevno.
English: Prior to launch of Cablivi in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the patient alert card, including communication media, distribution modalities, and any other aspects, with the National Competent Authority.
Croatian: Prije stavljanja u promet lijeka Cablivi u svakoj državi članici, nositelj odobrenja mora dogovoriti s nadležnim nacionalnim tijelom sadržaj i oblik kartice s upozorenjima za bolesnike, uključujući sredstva komunikacije, način distribucije te sve ostale aspekte programa.
English: Target inhibition
Croatian: Inhibicija ciljnog proteina
English: Do not remove the syringe from the vial.
Croatian: Nemojte uklanjati štrcaljku iz bočice.
English: Cablivi has no or negligible influence on the ability to drive and use machines.
Croatian: Cablivi ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Close monitoring for signs and symptoms of bleeding is recommended.
Croatian: Preporuča se strogo praćenje na znakove i simptome krvarenja. (vidjeti dio 4.4).
English: If a dose of Cablivi is missed, it can be administered within 12 hours.
Croatian: Ako se propusti doza lijeka Cablivi, on se može primijeniti unutar sljedećih 12 sati.
English: Higher levels of von Willebrand factor antigen, such as in patients with aTTP, increase the fraction of drug-target complex retained in the circulation.
Croatian: Više razine antigena von Willebrandovog faktora, kao što je to slučaj kod bolesnika s aTTP-om povećavaju udio kompleksa lijek-ciljni protein zadržanog u cirkulaciji.
English: Treatment with Cablivi is started by a doctor experienced in blood disorders.
Croatian: Liječenje lijekom Cablivi započinje liječnik s iskustvom u liječenju poremećaja krvi.
English: In the absence of compatibility studies, Cablivi must not be mixed with other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima.
English: Cablivi can be intravenously administered by connecting the prepared syringe to standard Luer locks of IV lines or using a suitable needle.
Croatian: Cablivi se može primijeniti intravenski priključivanjem pripremljene štrcaljke na standardni Luer lock na i.v. liniji ili pomoću prikladne igle.
English: In the clinical studies of patients with TTP, those with renal impairment did not show additional risk of adverse events.
Croatian: U kliničkim ispitivanjima bolesnika s TTP-om, bolesnici s oštećenjem funkcije bubrega nizu pokazali dodatni rizik od štetnih događaja.
English: INFORMATION IN BRAILLE Cablivi
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Cablivi
English: If more than 12 hours have passed since the dose was to have been given, the missed dose should NOT be administered and the next dose should be administered per the usual dosing schedule.
Croatian: Ako je prošlo više od 12 sati od kad je doza trebala biti primijenjena, propuštena doza NE SMIJE se primijeniti, a sljedeću dozu treba primijeniti po uobičajenom rasporedu.
English: Cablivi may be stored at room temperature (not above 25 °C) for a single period of up to 2 months.
Croatian: Cablivi se može čuvati na sobnoj temperaturi (ne iznad 25 °C) u jednokratnom razdoblju do 2 mjeseca.
English: Content :
Croatian: Sadržaj:
English: If at the end of this period there is evidence of unresolved immunological disease, it is recommended to optimise the immunosupression regimen and continue daily subcutaneous administration of 10 mg of caplacizumab until the signs of underlying immunological disease are resolved (e.g. sustained normalisation of ADAMTS13 activity level).
Croatian: Ako na kraju ovog razdoblja postoje dokazi koji upućuju da se imunološka bolest nije povukla, preporučuje se prilagođavanje imunosupresivnog liječenja i nastavak dnevne primjene 10 mg kaplacizumaba supkutano sve dok se znakovi osnovne imunološke bolesti ne povuku (npr. održana normalizacija razine aktivnosti ADAMTS13).