FrancophonIA/ELRC3.0 huggingface dataset:
English: Sections 6.3 (shelf life), 6.4 (special precautions for storage) 6.5 (nature and contents of container) and 6.6 (Special precautions for disposal and other handling) have been updated in line with the recommendation for multi-use of the 800 ug ampoule.
Croatian: Odjeljci 6.3. (rok trajanja), 6.4. (posebne mjere pri čuvanju lijeka), 6.5. (vrsta i sadržaj spremnika) i
English: The package leaflet has been amended to reflect the changes of the SmPC
Croatian: Uputa o lijeku Uputa o lijeku izmijenjena je kako bi odražavala izmjene sažetka opisa svojstava lijeka.
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC
Croatian: • Odbor je razmotrio upućivanje u skladu s člankom 30.
English: The MAH stated that nebulisation is able to deliver drugs to paranasal sinuses while nasal sprays are not.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet zaključio je da lijekovi putem atomizacije mogu dospjeti do paranazalnih sinusa, dok to nije moguće primjenom sprejeva za nos.
English: Maintenance treatment of asthma
Croatian: Trajanje terapije Astma i piskanje
English: Section 1, (name of the medicial product) Sections 2 (qualitative and quantitative composition), 6.1 (list of excipients), and 6.2 (incompatibilities) have been updated with minor changes to be in line with QRD template.
Croatian: Odjeljak 1. (naziv lijeka), odjeljci 2. (kvalitativni i kvantitativni sastavi), 6.1. (popis pomoćnih tvari) i
English: On review of all available data including post marketing safety data the CHMP concluded that a maximum of 3200 ug daily dose of BDP in adults and adolescents, which is in line with the current recommendation in Germany, Ireland and Greece and of a maximum of 1600 ug daily dose in children, which is in line with the current recommendation in France, is acceptable.
Croatian: Nakon revizije svih dostupnih podataka, uključujući podatke o sigurnosti primjene nakon izdavanja odobrenja za stavljanje lijeka u promet, Odbor za lijekove za humanu uporabu (CHMP) zaključio je da je prihvatljiva maksimalna doza beklometazon dipropionata 3 200 ug u odraslih osoba i adolescenata,
English: Following the negative position of the CHMP on the broad indication, the MAH proposed a narrowed one "symptomatic treatment of recurrent wheezing in preschool children" that was agreed with some changes.
Croatian: „simptomatsko liječenje ponavljajućeg piskanja u djece predškolske dobi” koje je dogovoreno uz određene promjene.
English: • The committee considered the divergences identified in the notification for Clenil and associated names, as well as the remaining sections of the product information.
Croatian: Direktive 2001/83/EZ • Odbor je razmotrio utvrđene različitosti u prijavi za lijek Clenil i povezane nazive te preostale odjeljke informacija o lijeku.
English: nBDP is also indicated in allergic and idiopathic rhinitis, inflammatory and allergic affections of the nasal cavities and of the rhino-pharyngeal tract.
Croatian: Atomizator beklometazon dipropionat (nBDP) također se primjenjuje za liječenje alergijskog ili idiopatskog rinitisa, upalnih i alergijskih afekcija nosnih šupljina i rinofaringealnog trakta.
English: Paediatric age range
Croatian: Raspon dobi pedijatrijske populacije
English: Other sections of the SmPC
Croatian: Ostali odjeljci u sažetku opisa svojstava lijeka
English: • local infections
Croatian: • lokalne infekcije
English: These studies did not reveal any safety concerns for humans.
Croatian: Ta ispitivanja nisu pokazala nikakve sigurnosne rizike za ljude.
English: The following symptoms could be an early warning of these reactions:
Croatian: Sljedeći simptomi mogu biti rano upozorenje za ove reakcije:
English: No adverse events were reported.
Croatian: Nije bilo prijavljenih štetnih događaja.
English: Parameters (units)
Croatian: Parametri (jedinice)
English: Date of first authorisation: 22 November 2018
Croatian: Datum prvog odobrenja: 22. studeni 2018.
English: • heart disease or you are at risk of heart disease.
Croatian: • imate bolest srca ili rizik za bolesti srca.
English: The molecular weight of the protein is approximately 234 kDa.
Croatian: Molekularna težina proteina približno je 234 kDa.
English: The effect on fertility in humans is unknown.
Croatian: Utjecaj na plodnost u ljudi nije poznat.
English: The chemical and physical in-use stability after reconstitution has been demonstrated for 3 hours at room temperature.
Croatian: Kemijska i fizikalna stabilnost lijeka nakon rekonstitucije dokazana je za razdoblje od 3 sata pri sobnoj temperaturi.
English: 80-100 (pre- and post-operative)
Croatian: 80 - 100 (prije i poslije operacije)
English: Rarely, inhibitors may develop after the first 50 exposure days.
Croatian: U rijetkim se slučajevima inhibitori mogu razviti nakon prvih 50 dana izloženosti.
English: Ninety nine of 110 patients (90%) remained on the assigned regimen.
Croatian: Devedeset devet od 110 bolesnika (90 %) ostalo je na dodijeljenom režimu.
English: Do not use Jivi if you are
Croatian: Nemojte primjenjivati Jivi ako ste
English: What Jivi is and what it is used for
Croatian: Što je Jivi i za što se koristi
English: This study has been performed in compliance with the agreed Paediatric Investigation Plan.
Croatian: Ovo ispitivanje provedeno je u skladu s dogovorenim Planom pedijatrijskog ispitivanja.
English: *AUC calculated for a dose of 60 IU/kg
Croatian: *AUC izračunata za dozu od 60 IU/kg
English: Always use this medicine exactly as described in this leaflet and as your doctor or pharmacist has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako Vam je rekao liječnik ili ljekarnik.
English: • Store in a refrigerator.
Croatian: • Čuvati u hladnjaku.
English: This medicine must not be mixed with other injections.
Croatian: Ovaj lijek se ne smije miješati s drugim injekcijama.
English: Final study report should be submitted by 31 December
Croatian: Završno izvješće ispitivanja mora se predati do 31. prosinca 2028.
English: These may be signs of a rare severe sudden allergic reaction to this medicine.
Croatian: To mogu biti znakovi rijetke teške iznenadne alergijske reakcije na lijek.
English: Other medicines and Jivi
Croatian: Drugi lijekovi i Jivi
English: Determine the point of injection and clean the skin.
Croatian: Odredite mjesto ubrizgavanja i očistite kožu.
English: There is limited experience in patients ≥ 65 years.
Croatian: Iskustva s bolesnicima ≥ 65 godina su ograničena.
English: Single dose only.
Croatian: Samo jedna doza.
English: Repeat injection every 24-48 hours.
Croatian: Ponoviti injekciju svaka 24 - 48 sati.
English: The most serious side effects are allergic reactions or severe allergic reaction.
Croatian: Najozbiljnije nuspojave su alergijske reakcije ili teška alergijska reakcija.
English: The implications of any potential risk to affected patients with a hypersensitivity reaction to pegylated proteins are unknown.
Croatian: Posljedice bilo kojeg mogućeg rizika za bolesnike s reakcijom preosjetljivosti na pegilirane proteine nisu poznate.
English: Hemostasis was assessed as good or excellent in all available cases.
Croatian: Hemostaza je u svim dostupnim slučajevima procijenjena kao dobra ili odlična.
English: Be sure that the powder is completely dissolved.
Croatian: Provjerite da se prašak u potpunosti otopio.
English: The medicinal product must be prepared for injection under aseptic conditions.
Croatian: Lijek se mora pripremiti za injekciju u aseptičkim uvjetima.
English: The listed warnings and precautions apply both to adults and adolescents.
Croatian: Navedena upozorenja i mjere opreza vrijede kako za odrasle, tako i za adolescente.
English: The clinical effect of factor VIII is the most important element in evaluating the effectiveness of treatment.
Croatian: Klinički učinci faktora VIII najvažniji su element za procjenu učinkovitosti liječenja.
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Croatian: Napomena: ABR se ne može uspoređivati kod različitih koncentrata faktora i različitih kliničkih ispitivanja.
English: Every 24 hours, at least 1 day, until healing is achieved.
Croatian: Svaka 24 sata, najmanje jedan dan, do zacjeljivanja.
English: It is recommended that every time you use Jivi, you note down the name and batch number of the product.
Croatian: Preporučuje se da svaki put kad primjenjujete Jivi zapišete naziv i broj serije lijeka.
English: An extension study included patients completing the main study.
Croatian: Nastavak ispitivanja uključio je bolesnike koji su završili glavno ispitivanje.
English: At the end of this period the product should not be put back in the refrigerator, but should be used or discarded.
Croatian: Na kraju tog razdoblja lijek se ne smije vratiti natrag u hladnjak, nego se mora iskoristiti ili baciti.
English: The primary efficacy variable was annualized bleed rate (ABR).
Croatian: Primarna varijabla djelotvornosti bila je anualizirana stopa krvarenja (engl. annualized bleed rate, ABR).
English: What is in this leaflet What Jivi is and what it is used for What you need to know before you use Jivi How to use Jivi
Croatian: Što se nalazi u ovoj uputi Što je Jivi i za što se koristi Što morate znati prije nego počnete primjenjivati Jivi Kako primjenjivati Jivi
English: It is produced by recombinant technology without addition of any human- or animal-derived components in the manufacturing process.
Croatian: Proizvodi se rekombinantom tehnologijom bez dodavanja sastojaka ljudskog ili životinjskog porijekla tijekom procesa proizvodnje.
English: Additional 34 minor surgeries were performed in 19 patients.
Croatian: Dodatno su provedena 34 manja kirurška zahvata u 19 bolesnika.
English: For overweight patients, the maximum dose per injection for prophylaxis should not be higher than approximately 6000 IU.
Croatian: Za bolesnike s prekomjernom tjelesnom težinom maksimalna doza po injekciji za profilaksu ne smije biti veća od približno 6000 IU.
English: What Jivi looks like and contents of the pack
Croatian: Kako Jivi izgleda i sadržaj pakiranja
English: Specifically, no residual radioactivity was detected in the brain, indicating that the radio-labelled compound did not cross the blood brain barrier.
Croatian: Naročito nije bilo rezidualne radioaktivnosti u mozgu, što upućuje na to da radiološki obilježena komponenta nije prešla krvno-moždanu barijeru.
English: In 3 of 44 patients (7%), loss of drug effect was combined with hypersensitivity reactions (see section 4.4).
Croatian: U 3 od 44 (7 %) bolesnika gubitak učinka lijeka bio je kombiniran s reakcijama preosjetljivosti (vidjeti dio 4.4).
English: In such cases, it is recommended that a specialized haemophilia centre be contacted.
Croatian: U takvim se slučajevima preporučuje kontaktirati specijalizirani centar za hemofiliju.
English: The maximum rate is 2.5 mL per minute.
Croatian: Najveća brzina davanja je 2,5 ml u minuti.
English: It may be necessary to adjust the individual dosing at patient level in order to attain satisfactory clinical results.
Croatian: Može biti potrebno prilagoditi dozu svakom bolesniku individualno kako bi se postigli zadovoljavajući klinički rezultati.
English: Jivi is produced without the addition of any human or animal derived protein in the cell culture process, purification, PEGylation or final formulation.
Croatian: Jivi je proizveden bez dodavanja bilo kojeg proteina ljudskog ili životinjskog porijekla tijekom postupka dobivanja u staničnoj kulturi, pročišćavanja, pegilacije ili završne formulacije.
English: Sixty one subjects (83.6%) completed the main study and 59 patients continued in the optional extension study.
Croatian: Šezdeset i jedan ispitanik (83,6 %) završio je glavno ispitivanje, a 59 bolesnika nastavilo je sudjelovati u ponuđenom nastavku ispitivanja.
English: What you need to know before you use Jivi
Croatian: Što morate znati prije nego počnete primjenjivati Jivi
English: Ensure that no blood enters the syringe
Croatian: Provjerite da u štrcaljku ne ulazi krv.
English: The required dose of Jivi is determined using the following formula:
Croatian: Potrebna doza lijeka Jivi određuje se sljedećom formulom:
English: The requirements for submission of PSURs 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 web-portal.
Croatian: Zahtjevi za podnošenje PSUR-eva 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 objavljenim na europskom internetskom portalu za lijekove.
English: Final study protocol should be submitted within 3 months after CHMP Opinion.
Croatian: Završni protokol ispitivanja mora se predati unutar 3 mjeseca od Mišljenja CHMPa.
English: Therefore, factor VIII should be used during pregnancy and breast-feeding only if clearly indicated.
Croatian: Stoga se faktor VIII u trudnoći i tijekom dojenja smije primjenjivati samo ako za to postoje jasne indikacije.
English: All treatment decisions for identifying appropriate prophylactic treatment regimens should be guided by clinical judgement based on individual patient characteristics and treatment response.
Croatian: Sve odluke pri određivanju odgovarajućeg profilaktičkog režima liječenja trebaju se voditi kliničkom procjenom temeljenom na značajkama pojedinog bolesnika i odgovoru na liječenje.
English: Table 1: Guide for dosing in bleeding episodes and surgery for adolescents and adults
Croatian: Tablica 1: Vodič za doziranje u epizodama krvarenja i kod kirurških zahvata u adolescenata i odraslih
English: Adolescent population
Croatian: Adolescentska populacija
English: Talk to your doctor or pharmacist if you have
Croatian: Obratite se svom liječniku ili ljekarniku ako
English: • one vial adapter (with integrated filter)
Croatian: • jedan nastavak za bočicu (s integriranim filtrom)
English: Jivi was evaluated in pharmacology, single and repeated dose as well as juvenile toxicity studies in rats and rabbits.
Croatian: Jivi je procijenjen u ispitivanjima farmakologije, toksičnosti jednokratnih i ponovljenih doza, kao i juvenilne toksičnosti u štakora i zečeva.
English: • allergic to damoctocog alfa pegol or any of the other ingredients of this medicine (listed in section 6).
Croatian: • alergični na damoktokog alfa pegol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: No symptoms of overdose have been reported.
Croatian: Nisu zabilježeni simptomi predoziranja.
English: Dose based on bodyweight may require adjustment in overweight patients.
Croatian: Doza koja se bazira na tjelesnoj težini može zahtijevati prilagodbu u bolesnika s prekomjernom težinom.
English: Median time on study was 713 days with a median of 131 exposure days (range: 1 to 309 days).
Croatian: Medijan vremena u ispitivanju bio je 713 dana s medijanom od 131 dana izloženosti (raspon: 1 - 309 dana).
English: The speed of injection should be based on your comfort, but should not be faster than 2.5 mL per minute.
Croatian: Brzinu injekcije trebate odrediti na temelju razine ugodnosti, ali ne bi trebala biti veća od 2,5 ml po minuti.
English: Jivi should be used within 3 hours after reconstitution.
Croatian: Jivi se mora upotrijebiti u roku od 3 sata nakon pripreme za primjenu.
English: The use of Jivi in children below 12 years is not indicated (see section 4.2, for information on paediatric use).
Croatian: Primjena lijeka Jivi u djece mlađe od 12 godina nije indicirana (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: It is not for use in children younger than 12 years of age.
Croatian: Nije za primjenu u djece mlađe od 12 godina.
English: Frequencies have been evaluated according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Croatian: Učestalosti su procijenjene na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100).
English: Incremental recovery was determined in 131 patients at several time points.
Croatian: Oporavak po jedinici doze (engl. incremental recovery) utvrđen je u 131 bolesnika u nekoliko vremenskih točki.
English: The dose of factor VIII units is measured in International Units (IU).
Croatian: Doza faktora VIII mjeri se u međunarodnim jedinicama (IU).
English: If this happens your medicine may stop working properly and you may experience persistent bleeding.
Croatian: Ako se to dogodi, lijek može prestati djelovati i može doći do krvarenja koje ne prestaje.
English: Keep the medicine in its original package in order to protect from light.
Croatian: Lijek čuvajte u originalnom pakiranju radi zaštite od svjetlosti.
English: The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
Croatian: Kompleks faktora VIII/von Willebrandova faktora sastoji se od dvije molekule (faktora VIII i von Willebrandova faktora) različitih fizioloških funkcija.
English: Based on patient clinical characteristics the dose can also be 60 IU/kg every 7 days or 30-40 IU/kg two times per week (see sections 5.1 and 5.2).
Croatian: Na temelju kliničkih značajki bolesnika, doza također može biti 60 IU/kg svakih 7 dana ili 30-40 IU/kg dva puta tjedno (vidjeti dijelove 5.1 i 5.2).
English: If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja rekonstituiranog lijeka prije primjene odgovornost su korisnika.
English: Uncommon (PTPs)*
Croatian: manje često (PTP)*
English: The immune response was accompanied by a clinical hypersensitivity reaction after 4 injections of Jivi.
Croatian: Imunološki odgovor bio je popraćen kliničkom reakcijom preosjetljivosti nakon 4 injekcije lijeka Jivi.
English: A single unconfirmed positive result of a low titre of factor VIII inhibitor (1.7 BU/mL) was reported in one adult patient following a surgery.
Croatian: Zabilježen je samo jedan nepotvrđen pozitivan rezultat niskog titra inhibitora FVIII (1,7 BU/ml) u jednog odraslog bolesnika nakon kirurškog zahvata.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness required in the individual case.
Croatian: Količinu koju treba primijeniti i učestalost primjene uvijek treba prilagoditi postizanju kliničke učinkovitosti potrebne u pojedinom slučaju.
English: This date should never exceed the expiry date printed on the outer carton.
Croatian: Taj datum nikad ne smije biti dulji od datuma isteka roka valjanosti otisnutog na vanjskom pakiranju.
English: Jivi is for single use only.
Croatian: Jivi je namijenjen samo za jednokratnu upotrebu.
English: If this happens, you should contact your doctor immediately.
Croatian: Ako se to dogodi, odmah se morate obratiti liječniku.
English: From a microbiological point of view the product should be used immediately after reconstitution.
Croatian: S mikrobiološkog stajališta, lijek se nakon rekonstitucije treba odmah primijeniti.
English: Blood and lymphatic system disorders FVIII inhibition
Croatian: Poremećaji krvi i limfnog sustava inhibicija FVIII
English: Pharmacotherapeutic group: antihaemorrhagics: blood coagulation factor VIII, ATC code: B02BD02.
Croatian: Farmakoterapijska skupina: antihemoragici: krvni koagulacijski faktor VIII, ATK oznaka: B02BD02.
English: • burning and stinging at the application site
Croatian: • pečenje i bockanje na mjestu primjene
English: If you forget to use Jivi
Croatian: Ako ste zaboravili primijeniti Jivi
English: A total of 121 subjects received treatment during the extension study with a median duration of 464 days.
Croatian: Ukupno je 121 ispitanik primao lijek tijekom nastavka ispitivanja, a medijan trajanja terapije iznosio je 464 dana.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue the use of the medicinal product immediately and contact their physician.
Croatian: Ako se pojave simptomi preosjetljivosti, bolesnicima treba savjetovati da odmah prekinu primjenu lijeka i obrate se svom liječniku.
English: At least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
Croatian: Najmanje jedan dan, dok se ne zaustavi epizoda krvarenja na koje upućuje bol ili do zacjeljenja.
English: EU/1/18/1324/001 - 1 x (Jivi 250 IU) EU/1/18/1324/002 - 1 x (Jivi 500 IU) EU/1/18/1324/003 - 1 x (Jivi 1000 IU) EU/1/18/1324/004 - 1 x (Jivi 2000 IU) EU/1/18/1324/005 - 1 x (Jivi 3000 IU) EU/1/18/1324/006 - 30 x (Jivi 250 IU) EU/1/18/1324/007 - 30 x (Jivi 500 IU) EU/1/18/1324/008 - 30 x (Jivi 1000 IU) EU/1/18/1324/009 - 30 x (Jivi 2000 IU) EU/1/18/1324/010 - 30 x (Jivi 3000 IU)
Croatian: EU/1/18/1324/001 - 1 x (Jivi 250 IU) EU/1/18/1324/002 - 1 x (Jivi 500 IU) EU/1/18/1324/003 - 1 x (Jivi 1000 IU) EU/1/18/1324/004 - 1 x (Jivi 2000 IU) EU/1/18/1324/005 - 1 x (Jivi 3000 IU) EU/1/18/1324/006 - 30 x (Jivi 250 IU) EU/1/18/1324/007 - 30 x (Jivi 500 IU) EU/1/18/1324/008 - 30 x (Jivi 1000 IU) EU/1/18/1324/009 - 30 x (Jivi 2000 IU)
English: Hemostasis during 20 major surgeries in 17 patients was evaluated in the surgery part.
Croatian: Hemostaza tijekom 20 velikih kirurških zahvata u 17 bolesnika ocjenjivana je u kirurškom dijelu.
English: The most frequently reported adverse reactions in clinical trials in PTPs were headache, cough and pyrexia.
Croatian: Najčešće prijavljene nuspojave u kliničkim ispitivanjima u prethodno liječenih bolesnika bile su glavobolja, kašalj i pireksija.
English: Repeat injection every 8 to 24 hours until threat is resolved.
Croatian: Ponoviti injekciju svakih 8 do 24 sata dok se ne ukloni opasnost.
English: • bacteria in the blood
Croatian: • bakterije u krvi
English: Required units = body weight (kg) x desired factor VIII rise (% or IU/dL) x reciprocal of observed recovery (i.e. 0.5 for recovery of 2.0%).
Croatian: Potreban broj jedinica = tjelesna težina (kg) x željeni porast faktora VIII (% ili IU/dl) x recipročna vrijednost vidljivog oporavka (npr. 0,5 za oporavak od 2,0 %).
English: A significant decrease in the risk of an immune response to PEG was observed with an increase in age.
Croatian: Uočeno je značajno smanjenje rizika od imunološkog odgovora na PEG s porastom dobi.
English: Immune response to polyethylene glycol (PEG)
Croatian: Imunološki odgovor na polietilenglikol (PEG)
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Croatian: Sljedeća tablica može poslužiti kao vodič za doziranje u epizodama krvarenja i kod kirurških zahvata:
English: Very common (may affect more than 1 in 10 people): • headache
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba): • glavobolja
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 IU factor VIII per kg body weight raises the plasma factor VIII activity by 1.5-2.5 % of normal activity.
Croatian: Izračun potrebne doze faktora VIII temelji se na empirijskim nalazima da 1 IU faktora VIII po kg tjelesne težine povećava aktivnost faktora VIII u plazmi za 1,5-2,5 % normalne aktivnosti.
English: Single dose studies in rats with the radio-labelled PEG moiety showed that there was no indication of retention or irreversible binding of radioactivity in the animal body.
Croatian: Ispitivanja jednokratnih doza u štakora s radiološki obilježenim PEG dijelom pokazala su da nema naznaka zadržavanja ili ireverzibilnog vezanja radioaktivnosti u tijelu životinja.
English: The dose and duration of substitution therapy depends on the severity of the factor VIII deficiency, the location and extent of the bleeding and on the patient's clinical condition.
Croatian: Doza i trajanje nadomjesne terapije ovise o težini nedostatka faktora VIII, o mjestu i opsegu krvarenja te o kliničkom statusu bolesnika.
English: The specific activity of Jivi is approximately 10000 IU/mg protein.
Croatian: Specifična aktivnost lijeka Jivi približno je 10 000 IU/mg proteina.