natgillin/translations-raw huggingface dataset:
N: number of patients evaluated; SE: Standard Error; ICU: Intensive Care Unit
N: število ocenjenih bolnikov; SE: standardna napaka
In clinical studies, bleeding events occurred in different body systems, independent of treatment duration.
V kliničnih študijah so se dogodki krvavitve pojavili v različnih telesnih sistemih, neodvisno od trajanja zdravljenja.
Characteristics in specific groups
Značilnosti za specifične skupine
The line can be flushed with 0.9% sodium chloride.
Linija se lahko izpere z 0,9-% natrijevim kloridom.
Half of the patients were experiencing their first episode of aTTP.
Polovica bolnikov je imela svojo prvo epizodo aTTP.
Contact your doctor immediately if any of the following serious side effects occur.
Takoj se obrnite na zdravnika, če se pojavi kateri od naslednjih resnih neželenih učinkov.
Side effects in a clinical study were reported with the following frequencies:
Neželene učinke v klinični študiji so poročali z naslednjimi pogostnostmi:
Frequencies are 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).
Pogostnosti neželenih učinkov so opredeljene kot: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1000), zelo redki (<1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
In patients with aTTP the central volume of distribution was estimated at 6.33 L.
Pri bolnikih z aTTP je ocenjen centralni volumen porazdelitve 6,33 l.
In case of active clinically significant bleeding, consider actions outlined in sections 4.4 and 4.9.
V primeru aktivne klinično pomembne krvavitve je treba razmisliti o ukrepih, opisanih v poglavjih 4.4 in 4.9.
Body weight was allometrically included in the model.
V model je bila alometrično vključena telesna masa.
Based on a carcinogenicity risk assessment, dedicated studies were not deemed necessary.
Na podlagi ocene tveganja za kancerogenost se smatra, da namenske študije niso potrebne.
Tell your doctor if you think you have had an overdose.
Zdravniku povejte, če menite, da ste dobili preveliki odmerek.
Step 2 - Before use
2. korak - Pred uporabo
Component of a multipack, cannot be sold separately.
Del večodmernega pakiranja, ločena prodaja ni možna.
Do not use if the expiry date has passed.
Ne uporabljajte, če je datum izteka roka uporabnosti potekel.
Very common, may affect more than 1 in 10 people
Zelo pogosti: lahko se pojavijo pri več kot 1 od 10 bolnikov
The most common serious adverse reaction was epistaxis.
Najpogostejši resni neželeni učinek je bila epistaksa.
In patients with coagulopathies
Pri bolnikih s koagulopatijami
In clinical studies, up to 9% of patients developed treatment-emergent anti-drug antibodies (ADA).
V kliničnih študijah so se pri do 9 % bolnikov razvila protitelesa proti zdravilu zaradi zdravljenja (ADA - anti-drug antibodies).
These clots can block blood vessels and damage the brain, heart, kidneys, or other organs.
Ti strdki lahko zamašijo krvne žile in poškodujejo možgane, srce, ledvice ali druge organe.
Number of days of Plasma Exchange (days)
Število dni izmenjave plazme (dnevi)
In case of active, clinically significant bleeding, treatment with Cablivi should be interrupted.
V primeru aktivne klinično pomembne krvavitve je treba zdravljenje z zdravilom Cablivi prekiniti.
The median treatment duration with caplacizumab in the double blind period was 35 days.
Mediano trajanje zdravljenja s kaplacizumabom v dvojno slepem obdobju je bilo 35 dni.
Active clinically significant bleeding
Aktivna klinično pomembna krvavitev
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).
Priprava odmerka zdravila Cablivi za intravensko injiciranje naj poteka na enak način kot za subkutano injiciranje (glejte navodilo za uporabo, korake 1 do 9, v poglavju 3).
Make sure the needle does not touch anything before the injection.
Prepričajte se, da se igla pred injiciranjem ničesar ne dotakne.
Never use the kit for another injection.
Nikoli ne uporabite istega kompleta za dve injekciji.
Biotransformation/Elimination
Biotransformacija in izločanje
In patients undergoing surgery
Pri bolnikih, ki bodo operirani
Transfer the entire volume of the reconstituted solution back to the glass syringe and immediately administer the entire volume of the syringe (see section 6.3).
Celotno količino rekonstituirane raztopine prenesite nazaj v stekleno brizgo, nato pa ves volumen brizge takoj aplicirajte (glejte poglavje 6.3).
Date of first authorisation: 31 August 2018
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 31. avgust 2018
In the absence of compatibility studies, Cablivi must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti zdravila Cablivi ne smemo mešati z drugimi zdravili.
• 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.
• Če komplet ni bil shranjen pri sobni temperaturi, dovolite, da dosežeta viala in injekcijska brizga sobno temperaturo (15 °C - 25 °C) tako, da ju nekaj minut pustite stati na sobni temperaturi.
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.
Da bi imeli od zdravljenja kar največ koristi, je pomembno, da zdravilo Cablivi uporabljate, kot je predpisano in tako dolgo, kot vam naroči zdravnik.
This is a rare blood clotting disorder in which clots form in small blood vessels.
To je redka motnja strjevanja krvi, pri kateri v majhnih krvnih žilah nastajajo strdki.
Baseline disease characteristics were typical of aTTP.
Izhodiščne značilnosti bolezni so bile tipične za aTTP.
All powder must be dissolved and the solution must be clear.
Ves prašek mora biti raztopljen, raztopina pa mora biti bistra.
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”.
Učinkovitost in varnost kaplacizumaba pri odraslih, ki so imeli epizodo aTTP, sta bili ugotovljeni v 2 randomiziranih, nadzorovanih študijah: študija faze III ALX0681-C301 "HERCULES" in študija faze II ALX-0681-2.1/10 "TITAN".
Pharmacotherapeutic group: Other antithrombotic agents, ATC code: B01AX07.
Farmakoterapevtska skupina: drugi antitrombotiki, oznaka ATC: B01AX07.
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).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s kaplacizumabom za eno ali več podskupin pediatrične populacije s aTTP (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
• Do not use the kit if the packaging or the items in it are damaged in any way.
• Pakiranja ali predmetov v njem ne uporabljajte, če so kakor koli poškodovani.
After subcutaneous administration, caplacizumab is rapidly and almost completely absorbed (estimated F> 0.901) in the systemic circulation.
Po subkutanem dajanju se kaplacizumab hitro in skoraj povsem absorbira (ocenjen F> 0,901) v sistemski cirkulaciji.
For each injection, use a fresh kit package to prepare the injection solution.
Za vsako injekcijo uporabite pakiranje s svežim kompletom za pripravo raztopine za injiciranje.
• have severely reduced liver function.
• imate močno zmanjšano delovanje jeter.
The doctor will say when you can start your treatment again.
Zdravnik vam bo povedal, kdaj lahko zdravljenje nadaljujete.
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.
V populacijskem modelu FK/FD je imelo delovanje ledvic (CRCL) statistično značilen učinek, ki se je odražal v manjšem povečanju napovedane izpostavljenosti (AUCss) pri hudi okvari ledvic.
No studies have been performed to evaluate the mutagenic potential of caplacizumab, as such tests are not relevant for biologicals.
Študij za ocenitev mutagenega potenciala kaplacizumaba niso opravili, saj ti testi niso pomembni za biološka zdravila.
Your doctor may decide to keep you under closer observation or change your treatment.
Zdravnik se lahko odloči, da vas bo skrbno spremljal ali zamenjal zdravljenje.
Your doctor will decide how you should be treated.
Zdravnik se bo odločil, kako se boste zdravili.
The reconstituted solution is clear, colourless, or slightly yellowish.
Rekonstituirana raztopina je bistra, brezbarvna ali nekoliko rumenkasta.
In the clinical studies of patients with TTP, those with renal impairment did not show additional risk of adverse events.
V kliničnih študijah bolnikov s TTP bolniki z ledvično okvaro niso imeli dodatnega tveganja za neželene učinke.
* Caplacizumab is a humanised bivalent Nanobody produced in Escherichia coli by recombinant DNA technology.
* Kaplacizumab je humanizirano bivalentno nanotelo, izdelano v Escherichia coli s tehnologijo rekombinantne DNA.
In case of overdose, based on the pharmacological action of caplacizumab, there is the potential for an increased risk of bleeding.
V primeru prevelikega odmerjanja obstaja na podlagi farmakološkega delovanja kaplacizumaba možnost večjega tveganja za krvavitve.
• Check the content of the syringe.
• Preverite vsebino injekcijske brizge.
No impact on clinical efficacy was observed and no serious adverse events were found to be associated with these ADA responses.
Vpliva na klinično učinkovitost niso opazili in niso ugotovili, da bi bili s temi odzivi ADA povezani resni neželeni dogodki.
Do not try to inject Cablivi until you have been taught how to do so by a healthcare professional.
Zdravila Cablivi si ne poskušajte injicirati, dokler vas zdravstveni delavec ni podučil, kako naj to počnete.
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.
Vse klinične študije s kaplacizumabom so pokazale hitro znižanje ravni RIPA in/ali RICO po začetku zdravljenja, s povrnitvijo na izhodiščne ravni v 7 dneh po prekinitvi.
Long or excessive bleeding.
Dolga ali močna krvavitev.
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.
Pri zdravih prostovoljcih, ki so prejemali 10 mg kaplacizumaba subkutano enkrat na dan, so največjo koncentracijo opazili 6-7 ur po odmerku, stanje dinamičnega ravnovesja pa je bilo doseženo po prvem dajanju, z minimalno akumulacijo.
In studied populations; gender, age, blood group and race did not affect the pharmacokinetics of caplacizumab.
V preučevanih populacijah spol, starost, krvna skupina in rasa niso vplivali na farmakokinetiko kaplacizumaba.
Then, slowly push the plunger until a small amount of liquid comes out of the needle.
Nato počasi pritiskajte na bat, da iz igle izteče majhna količina tekočine.
The safety and efficacy of caplacizumab in the paediatric population have not yet been established.
Varnost in učinkovitost kaplacizumaba pri pediatrični populaciji nista bili dokazani.
If not used immediately, in-use storage times and conditions are the responsibility of user.
Če uporabnik zdravila ne uporabi takoj, je sam odgovoren za čas in pogoje shranjevanja pred uporabo.
• 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
• krvavitev v možganih, na kar kaže hud glavobol s hitrim pojavom, bruhanje, zmanjšana raven zavesti, zvišana telesna temperatura, včasih epileptični napadi in togost vratu ali bolečina v vratu
Your doctor may ask you to stop the treatment.
Morda vam bo zdravnik naročil, da prekinete zdravljenje.
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:
Imetnik dovoljenja za promet bo zagotovil, da bodo v vseh državah članicah, kjer bo zdravilo Cablivi na trgu, vsi bolniki/negovalci, ki bodo predvidoma uporabljali zdravilo Cablivi, prejeli sledečo opozorilno kartico, ki bo vsebovala sledeča ključna opozorila:
Patients or caregivers may inject the medicinal product after proper training in the subcutaneous injection technique.
Bolniki ali skrbniki lahko zdravilo injicirajo sami, če so se ustrezno izurili v tehniki subkutanega injiciranja.
• Make sure you have a disposal container at hand.
• Prepričajte se, da imate pri roki vsebnik za odpadke.
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.
Pred prihodom zdravila Cablivi na trg v posamezni državi članici mora imetnik dovoljenja za promet (MAH) s pristojnim nacionalnim organom uskladiti vsebino in obliko opozorilne kartice bolnika, vključno s komunikacijskimi mediji, načinom distribucije in morebitnimi drugimi vidiki.
INFORMATION IN BRAILLE Cablivi
PODATKI V BRAILLOVI PISAVI Cablivi
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.
Izpostavljenost ploda kaplacizumabu je pri primatih in ljudeh negotova, saj prevladuje mnenje, da beljakovine brez dela Fc ne morejo prosto prehajati skozi posteljico.
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.
V primeru ponovitve v obdobju spremljanja (tj. po koncu zdravljenja s študijskim zdravilom) študijskega zdravila niso ponovno uvedli, ponovni pojav pa so zdravili s standardno nego.
• Insert the full length of the needle into the skin fold at an angle as shown in the illustration.
• Celotno dolžino igle pod kotom vstavite v kožno gubo, kot prikazuje ilustracija.
• injection site reactions: rash, itching and bleeding
• reakcije na mestu injiciranja: izpuščaj, srbečica in krvavitev
The most frequent adverse reactions in clinical trials were epistaxis, headache and gingival bleeding.
Najpogostejši neželeni učinki v kliničnih preskušanjih so bili epistaksa, glavobol in krvavitev dlesni.
If a recurrence occurred while on study drug treatment, patients were switched to open-label caplacizumab.
Če se je v času zdravljenja s študijskim zdravilom pojavila ponovitev, so bolniki prešli na odprto zdravljenje s kaplacizumabom.
• to mitigate the risk of serious bleeding episode particularly in emergency situations (e.g. accident) to inform physicians about the medical blockage of the von Willebrand Factor.
• da bi zmanjšali tveganje za resne krvavitve, posebej v nujnih stanjih (kot je npr. nezgoda), mora bolnik oz. njegov negovalec obvestiti zdravnika o blokadi von Willebrandovega faktorja, povzročeni s tem zdravilom.
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.
Bolniku, ki ima načrtovan operativni ali zobozdravstveni poseg, je treba svetovati, da morajo zdravnika ali zobozdravnika obvestiti o uporabi zdravila Cablivi, zdravljenje pa morajo vsaj 7 dni pred načrtovanim posegom prekiniti.
Please talk to your doctor before you stop the treatment because stopping it too early can cause your condition to come back.
Preden prenehate uporabljati zdravilo, se pogovorite z zdravnikom, saj lahko prezgodnja prekinitev povzroči vrnitev bolezni.
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Z mikrobiološkega stališča velja, da je treba zdravilo uporabiti takoj, razen če metoda rekonstitucije izločuje tveganje mikrobne kontaminacije.
• first dose - 1 vial injected into a vein by a healthcare professional - the medicine will be given before starting plasma exchange
• prvi odmerek - 1 viala, ki vam jo v veno injicira zdravstveni delavec - zdravilo se daje pred začetkom izmenjave plazme
• Do not use the syringe if this white cap is missing, loose or damaged.
• Injekcijske brizge ne uporabljajte, če bela zaporka manjka, je zrahljana ali poškodovana.
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).
Če ob koncu tega obdobja obstajajo očitni dokazi nerazrešene bolezni imunskega sistema, je priporočljivo optimirati imunosupresijski režim in nadaljevati dnevno subkutano dajanje 10 mg kaplacizumaba, dokler se znaki osnovne bolezni imunskega sistema ne razrešijo (npr. trajna normalizacija ravni aktivnosti ADAMTS13).
Treatment with caplacizumab resulted in a statistically significant reduction in time to platelet count response (p<0.01).
Zdravljenje s kaplacizumabom je povzročilo statistično značilno zmanjšanje časa do odziva števila trombocitov (p < 0,01).
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.
Za bolnike, zdravljene s kaplacizumabom, je bilo 1,55-krat bolj verjetno, da so na kateri koli časovni točki dosegli odziv števila trombocitov, v primerjavi z bolniki, zdravljenimi s placebom.
For instructions on reconstitution of Cablivi before administration, see section 6.6.
Za navodila glede rekonstitucije zdravila Cablivi pred dajanjem glejte poglavje 6.6.
Cablivi contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
Zdravilo Cablivi vsebuje natrij To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‛brez natrija'.
In the clinical development program, caplacizumab has been administered daily for up to 65 days.
Med programom kliničnega razvoja so kaplacizumab dajali dnevno do 65 dni.
• have a bleeding disorder such as haemophilia.
• imate motnjo strjevanja krvi, kot je hemofilija.
• Go to step 10 to inject caplacizumab under the skin of the belly.
• Pojdite na 10. korak za injiciranje kaplacizumaba pod kožo na trebuhu.
• are going to have an operation or dental treatment.
• imate načrtovan kirurški ali zobozdravstveni poseg.
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).
Čeprav so izkušnje s kaplacizumabom pri starejših omejene, ni znakov, ki bi kazali, da je treba za starejše bolnike odmerek prilagoditi ali uporabiti posebne previdnostne ukrepe (glejte poglavje 5.2).
Higher levels of von Willebrand factor antigen, such as in patients with aTTP, increase the fraction of drug-target complex retained in the circulation.
Večje ravni antigena von Willebrandovega faktorja, kot pri bolnikih z aTTP, povečajo frakcijo kompleksa zdravilo-tarčno mesto, ki se ohrani v cirkulaciji.
Cablivi is available in
Zdravilo Cablivi je na voljo v
Step 1 - Cleaning
1. korak - Čiščenje
It must be visually inspected for particulate matter.
Vizualno jo je treba pregledati, da ne vsebuje delcev.
Cablivi has no or negligible influence on the ability to drive and use machines.
Zdravilo Cablivi nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
If a dose of Cablivi is missed, it can be administered within 12 hours.
Izpuščeni odmerek zdravila Cablivi je možno dati v roku 12 ur.
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.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Caplacizumab is a humanised bivalent Nanobody that consists of two identical humanised building blocks (PMP12A2hum1), genetically linked by a three-alanine linker, targeting the A1-domain of von Willebrand factor and inhibiting the interaction between von Willebrand factor and platelets.
Kaplacizumab je humanizirano bivalentno nanotelo, sestavljeno iz dveh identičnih humaniziranih gradnikov (PMP12A2hum1), ki sta genetsko povezana z veznim tri-alaninskim elementom, in cilja domeno A1 von Willebrandovega faktorja ter zavira medsebojno delovanje med von Willebrandovim faktorjem in trombociti.
In this case, your doctor or healthcare provider will train you or your caregiver on how to use Cablivi.
V tem primeru bo zdravnik ali zdravstveni delavec vas ali vašega negovalca usposobil za dajanje zdravila Cablivi.
The effects of caplacizumab on fertility in humans are unknown.
Učinki kaplacizumaba na plodnost pri ljudeh niso znani.
After absorption, caplacizumab binds to the target and distributes to well perfused organs.
Po absorpciji se kaplacizumab veže na tarčno mesto in porazdeli po dobro prekrvljenih organih.
Do not use the medicine if you see any cloudiness, clumps or anything else that looks abnormal.
Zdravila ne uporabljajte, če je motno, opazite grudice ali kako drugače ne zgleda normalno.
They were again treated for the duration of daily plasma exchange and for 30 days thereafter.
Ponovno so jih zdravili ves čas dnevne izmenjave plazme in nato še 30 dni po tem.
In this double-blind, placebo-controlled study, patients with an episode of aTTP were randomised 1:1 to receive either caplacizumab or placebo in addition to daily plasma exchange and immunosuppression.
V tej dvojno slepi, s placebom nadzorovani študiji, so bolnike z epizodo aTTP randomizirali v razmerju 1:1 za prejemanje kaplacizumaba ali placeba, kot dodatek dnevni izmenjavi plazme in imunosupresiji.
6.5 Nature and contents of container
6.5 Vrsta ovojnine in vsebina prašek
Cablivi may be stored at a temperature not above 25 °C for a single period of up to 2 months, but not beyond the expiry date.
Zdravilo Cablivi lahko shranjujete pri temperaturi do 25 °C za enkratno obdobje do 2 mesecev, vendar ne dlje kot je rok uporabnosti.
• bleed excessively during treatment.
• med zdravljenjem pretirano krvavite.
• a white powder for solution for injection in a glass vial, and
• bel prašek za raztopino za injiciranje v stekleni viali in
Upon repeated administration of caplacizumab, a decrease of 30-50% in von Willebrand factor antigen levels was observed in clinical studies, reaching a maximum within 1-2 days of treatment.
Po ponavljajočem dajanju kaplacizumaba so v kliničnih študijah opazili 30-50% znižanje ravni antigena von Willebrandovega faktorja, ki je doseglo maksimum v 1 do 2 dneh zdravljenja.
Name and address of the manufacturer of the biological active substance Richter-Helm BioLogics GmbH & Co. KG Dengelsberg
Ime in naslov izdelovalca biološke učinkovine Richter-Helm BioLogics GmbH & Co.
Step 11 - Prepare injection site for injection under the skin
11. korak - Priprava mesta injiciranja za injiciranje pod kožo
Allow the vial with connected syringe to stand on a surface for 5 minutes at room temperature.
Viala s priključeno brizgo naj na površini 5 minut stoji pri sobni temperaturi.
Common, may affect up to 1 in 10 people
Pogosti: lahko se pojavijo pri največ 1 od 10 bolnikov
Solvent Water for injections
vehikel voda za injekcije