FrancophonIA/ELRC3.0 huggingface dataset:
English: Maintenance dose: 300 mg or 4 mg/kg every 8 weeks
Croatian: Doza održavanja: 300 mg ili 4 mg/kg svakih 8 tjedana
English: Gather together the necessary items Included in the pack - one vial of Ilaris powder for solution for injection (keep refrigerated)
Croatian: Uključeno u pakiranje jedna bočica Ilaris praška za otopinu za injekciju (čuvati u hladnjaku)
English: Uric acid increases were not observed in clinical trials in non-gouty arthritis populations (see section 5.1).
Croatian: U drugom ispitivanju, među bolesnicima koji su započinjali liječenje ULT-om, nije zabilježena povećanja razine mokraćne kiseline Povišenja razine mokraćne kiseline nisu bila zabilježena u kliničkim ispitivanjima u populacijama bez uričnog artritisa (vidjeti dio 5.1).
English: If you have any questions, talk to your doctor, pharmacist or nurse.
Croatian: Ako imate bilo kakvih pitanja, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: If you have CAPS, TRAPS, HIDS/MKD, FMF or Still's disease (AOSD or SJIA), you may inject yourself with Ilaris after proper training, or a caregiver may inject it for you.
Croatian: Ako imate CAPS, TRAPS, HIDS/MKD, FMF ili Stillovu bolest (SBOD ili SJIA), možete si sami ubrizgavati Ilaris nakon odgovarajuće obuke, ili Vam ga može ubrizgavati njegovatelj.
English: Additional dose of 300 mg or 4 mg/kg can be considered
Croatian: Može se razmotriti dodatna doza od 300 mg ili 4 mg/kg
English: Multipack: 4 (4x1) vials.
Croatian: Prašak za otopinu za injekciju Višestruko pakiranje: 4 (4x1) bočice.
English: Apparent clearance per kg body weight (CL/F per kg) was comparable between the SJIA and CAPS population (0.004 l/d per kg).
Croatian: Prividni klirens po kg tjelesne težine (CL/F po kg) bio je usporediv između populacije sa SJIA-om i one sa CAPS-om (0,004 l/d po kg).
English: Do not touch the vial stoppers.
Croatian: Ne dirajte čep bočice.
English: If a full treatment response is subsequently achieved, the intensified dosing regimen of 300 mg or 4 mg/kg every 8 weeks should be maintained.
Croatian: Ako se naknadno postigne potpuni odgovor na liječenje, potrebno je održavati intenzivirani režim doziranja od 300 mg ili 4 mg/kg svakih 8 tjedana.
English: Also contains: mannitol, histidine, histidine hydrochloride monohydrate, polysorbate 80, water for injections.
Croatian: Također sadrži: manitol, histidin, histidinklorid hidrat, polisorbat 80, voda za injekcije.
English: The efficacy and safety profile in AOSD patients are expected to be similar to SJIA patients based on literature reports.
Croatian: Na osnovu izvješća iz literature očekuje se da su profili djelotvornosti i sigurnosti u bolesnika sa SBOD-om slični onima u bolesnika sa SJIA-om.
English: Clean the stoppers with the alcohol swab.
Croatian: Očistite čepove jastučićem natopljenim alkoholom.
English: Feeling dizzy, spinning sensation (dizziness or vertigo).
Croatian: Osjećaj omaglice, vrtnje (omaglica ili vrtoglavica).
English: Gouty arthritis
Croatian: Urični artritis
English: Maintenance dose 2 mg/kg every 4 weeks
Croatian: Doza održavanja od 2 mg/kg svaka 4 tjedna
English: The solution should be clear to opalescent and free of visible particles.
Croatian: Otopina treba biti bistra do opalescentna i bez vidljivih čestica.
English: If a full treatment response is subsequently achieved, the intensified dosing regimen of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) every 4 weeks should be maintained.
Croatian: Ako se naknadno postigne potpuni odgovor na liječenje, potrebno je održavati intenzivirani režim doziranja od 300 mg (ili 4 mg/kg za bolesnike s tjelesnom težinom ≤ 40 kg) svaka 4 tjedna.
English: Place the transfer needle in the sharps container.
Croatian: Odložite iglu za prijenos u spremnik za oštre predmete.
English: If you respond well enough to the third dose, your treatment will be continued at 600 mg or 8 mg/kg every 8 weeks.
Croatian: Ako ste odgovorili dovoljno dobro na treću dozu, Vaše će se liječenje nastaviti pri dozi od 600 mg ili 8 mg/kg svakih 8 tjedana.
English: How to use Ilaris
Croatian: Kako primjenjivati Ilaris
English: The other ingredients are mannitol, histidine, histidine hydrochloride monohydrate, polysorbate 80, water for injections.
Croatian: Drugi sastojci su manitol, histidin, histidinklorid hidrat, polisorbat 80, voda za injekcije.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA BOČICU
English: The safety profile in AOSD patients is expected to be similar to SJIA patients based on literature reports.
Croatian: Na osnovu izvješća iz literature očekuje se da je sigurnosni profil u bolesnika sa SBOD-om sličan onom u bolesnika sa SJIA-om.
English: Gently pinch the skin up at the injection site.
Croatian: Lagano uhvatite kožu na mjestu primjene.
English: What Ilaris looks like and contents of the pack Ilaris is supplied as a solution for injection in a 2 ml glass vial.
Croatian: Ilaris se isporučuje kao otopina za injekciju u staklenoj bočici od 2 ml.
English: Gouty arthritis population
Croatian: Populacija s uričnim artritisom
English: Mixing Ilaris
Croatian: Miješanje Ilarisa
English: Laboratory abnormalities in SJIA patients
Croatian: Laboratorijske abnormalnosti u bolesnika sa SJIA-om Hematologija
English: - Tumour necrosis factor receptor associated periodic syndrome (TRAPS) - Hyperimmunoglobulin D syndrome (HIDS) also known as mevalonate kinase deficiency (MKD) - Familial Mediterranean fever (FMF): Ilaris is used to treat FMF.
Croatian: • Teške oblike obiteljskog autoinflamatornog sindroma povezanog s hladnoćom / obiteljske urtikarije povezane s hladnoćom koji imaju znakove i simptome izraženije nego hladnoćom uzrokovanog urtikarijskog kožnog osipa. - periodičnog sindroma povezanog s receptorom faktora nekroze tumora (TRAPS) - sindroma hiperimunoglobulina D (HIDS) koji se naziva i nedostatkom mevalonat kinaze (MKD) - obiteljske mediteranske groznice (FMF): Ilaris se koristi za liječenje FMF-a.
English: Ilaris 150 mg powder for solution for injection
Croatian: Ilaris 150 mg prašak za otopinu za injekciju
English: - Take off the cap from the withdrawal needle.
Croatian: - Skinite kapicu s igle za izvlačenje.
English: If you respond well enough to the second dose, your treatment will be continued with 300 mg or 4 mg/kg every 8 weeks.
Croatian: Ako ste dovoljno dobro odgovorili na drugu dozu, Vaše će se liječenje nastaviti s 300 mg ili 4 mg/kg svakih 8 tjedana.
English: One vial contains 150 mg canakinumab in 1 ml of solution.
Croatian: Jedna bočica sadrži 150 mg kanakinumaba u 1 ml otopine.
English: Choose an injection site on the upper thigh, abdomen, upper arm or buttocks.
Croatian: Odaberite mjesto na gornjem dijelu bedara, trbuhu, nadlaktici ili stražnjici.
English: It is colourless to slightly brownish-yellow.
Croatian: Bezbojna je do blago smećkasto-žuta.
English: Additional dose of 4 mg/kg can be considered
Croatian: Može se razmotriti dodatna doza od 4 mg/kg
English: • Familial Mediterranean fever (FMF).
Croatian: • obiteljska mediteranska groznica (engl.
English: How to store Ilaris
Croatian: Kako čuvati Ilaris
English: Maintenance dose 4 mg/kg every 8 weeks
Croatian: Doza održavanja 4 mg/kg svakih 8 tjedana
English: Each ml of solution contains 150 mg canakinumab.
Croatian: Svaki ml otopine sadrži 150 mg kanakinumaba.
English: Still's disease (AOSD and SJIA)
Croatian: Stillova bolest (SBOD i SJIA)
English: Ilaris 150 mg/ml injection canakinumab SC
Croatian: Ilaris 150 mg/ml injekcija kanakinumab s.c.
English: Ilaris 150 mg/ml solution for injection is supplied in a single-use vial for individual use.
Croatian: Ilaris 150 mg/ml otopina za injekciju dostupna je u bočici za jednokratnu uporabu namijenjena individualnoj uporabi.
English: Clean the injection site with a new alcohol swab.
Croatian: Očistite mjesto primjene novim jastučićem natopljenim alkoholom.
English: Ilaris 150 mg/ml solution for injection
Croatian: Ilaris 150 mg/ml otopina za injekciju
English: Additional dose of 2 mg/kg can be considered
Croatian: Može se razmotriti dodatna doza od 2 mg/kg
English: • Severe forms of familial cold auto-inflammatory syndrome (FCAS) / familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash.
Croatian: Neonatalnu multisistemsku upalnu bolest (engl. neonatal-onset multisystem inflammatory disease, NOMID) / kronični infantilni neurokutani artikularni sindrom (engl. chronic infantile neurological, cutaneous, articular syndrome, CINCA), Teške oblike obiteljskog autoinflamatornog sindroma povezanog s hladnoćom (engl. familial cold autoinflammatory syndrome, FCAS) / obiteljske urtikarije povezane s hladnoćom (engl. familial cold urticaria, FCU) koji imaju znakove i simptome izraženije od hladnoćom uzrokovanog urtikarijskog kožnog osipa.
English: Primary endpoint (flare) Proportion of patients with disease flare in Part II
Croatian: Udio bolesnika s razbuktavanjem bolesti u II. dijelu
English: Ilaris 150 mg powder for solution for injection canakinumab
Croatian: Ilaris 150 mg prašak za otopinu za injekciju kanakinumab
English: There were 80 paediatric CAPS patients (2-17 years of age) who received canakinumab in the interventional studies.
Croatian: U intervencijska ispitivanja je bilo uključeno 80 pedijatrijskih bolesnika s CAPS-om koji su primali kanakinumab (u dobi od 2 do 17 godina).
English: TRAPS, HIDS/MKD and FMF: Adults, adolescents and children aged 2 years and older The recommended starting dose of canakinumab in TRAPS, HIDS/MKD and FMF patients is:
Croatian: TRAPS, HIDS/MKD i FMF: Odrasli, adolescenti i djeca u dobi od 2 i više godina Prepoučena početna doza kanakinumaba u bolesnika s TRAPS-om, HIDS/MKD-om i FMF-om iznosi: 150 mg za bolesnike s tjelesnom težinom > 40 kg 2 mg/kg za bolesnike s tjelesnom težinom ≥ 7,5 kg i ≤ 40 kg
English: Histidine hydrochloride monohydrate Polysorbate 80
Croatian: 6.1 Popis pomoćnih tvari saharoza histidin histidinklorid hidrat polisorbat 80
English: Gently push the plunger all the way down until air is in the vial.
Croatian: Lagano gurnite klip do kraja dok zrak ne bude u bočici.
English: Do not rub the injection area.
Croatian: Ne trljajte mjesto primjene.
English: Ilaris 150 mg powder for solution for injection is supplied in a single-use vial for individual use.
Croatian: Ilaris 150 mg prašak za otopinu za injekciju dostupan je u bočici za jednokratnu uporabu namijenjen individualnoj uporabi.
English: Also contains: sucrose, histidine, histidine hydrochloride monohydrate, polysorbate 80.
Croatian: Također sadrži: saharozu, histidin, histidinklorid hidrat, polisorbat 80.
English: Investigations Very common Creatinine renal clearance decreased Proteinuria Leukopenia
Croatian: Pretrage vrlo često smanjeni bubrežni klirens kreatinina proteinurija leukopenija često neutropenija manje često smanjeni broj trombocita
English: Primary endpoint (disease flare) - Proportion of patients who had index disease flare resolution at day 15 and did not experience a new flare during the remainder of the 16-week treatment period FMF
Croatian: - Udio bolesnika kod kojih se povuklo razbuktavanje osnovne bolesti do 15. dana i koji nisu imali novo razbuktavanje tijekom ostatka 16tjednog razdoblja liječenja
English: Cryopyrin-associated periodic syndromes
Croatian: Periodični sindromi povezani s kriopirinom
English: 9/l were also observed (see section 4.4).
Croatian: 9/l također su bili zabilježeni
English: one 27 G x 0.5 inch (or similar, as available on the market) needle for injecting (“injection needle”) alcohol swabs clean, dry cotton swabs an adhesive plaster a proper disposal container for used needles, syringe and vial (sharps container)
Croatian: Nije uključeno u pakiranje jedna štrcaljka od 1,0 ml jedna igla (kao što je igla od 18 G ili 21 G x 50 mm ili slična, ovisno o tome što je dostupno na tržištu) za izvlačenje otopine iz bočice („igla za izvlačenje“). jedna 27 G x 13 mm (ili slična, ovisno o tome što je dostupno na tržištu) igla za injekciju („igla za injekciju“) jastučići natopljeni alkoholom čisti, suhi pamučni jastučići ljepljivi flaster odgovarajući spremnik za odlaganje upotrijebljenih igala, štrcaljki i bočica (spremnik za oštre predmete).
English: If you need another treatment with Ilaris, and got relief from the last dose, you must wait at least 12 weeks before the next dose.
Croatian: Ako Vam je potrebna još jedna terapija Ilarisom, a zadnja doza
English: Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including:
Croatian: Ilaris je indiciran za liječenje periodičnih sindroma povezanih s kriopirinom (engl.
English: It was estimated to be 0.17 l/d in a CAPS patient of body weight 70 kg and 0.11 l/d in a SJIA patient of body weight 33 kg. After accounting for body weight differences, no clinically significant differences in the pharmacokinetic properties of canakinumab were observed between CAPS and SJIA patients.
Croatian: Bilo je procijenjeno da iznosi 0,17 l/d u bolesnika s CAPS-om tjelesne težine od 70 kg te 0,11 l/d u bolesnika sa SJIA-om tjelesne težine od 33 kg.
English: Ilaris 150 mg/ml solution for injection canakinumab
Croatian: Ilaris 150 mg/ml otopina za injekciju kanakinumab
English: One vial contains 150 mg of canakinumab*.
Croatian: Jedna bočica sadrži 150 mg kanakinumaba*.
English: CI p-value, 1-sided p < 0.0001*
Croatian: Omjer hazarda u odnosu na triamcinolon acetonid CI p-vrijednost, jednostrana p<0,0001*
English: Treatment with canakinumab resulted in clinically relevant improvements in patients' physical function and quality of life.
Croatian: Ishodi povezani sa zdravljem i kvalitetom života u ispitivanjima G2305 i G2301 Liječenje kanakinumabom rezultiralo je klinički relevantnim poboljšanjima u tjelesnoj funkciji i kvaliteti života bolesnika.
English: Remove the syringe and withdrawal needle from the vial.
Croatian: Izvadite štrcaljku i iglu za izvlačenje iz bočice.
English: Keep your doctor informed of your condition and any symptoms before you use or are given Ilaris (see section 2).
Croatian: Obavijestite svog liječnika o svom stanju i svim simptomima prije nego što upotrijebite ili dobijete Ilaris (vidjeti dio 2).
English: Clean the rubber stopper of the vial with an alcohol swab.
Croatian: Očistite gumeni čep bočice s jastučićem natopljenim alkoholom.
English: Malignancy events have been reported in patients treated with canakinumab.
Croatian: Kod bolesnika liječenih kanakinumabom zabilježene su zloćudne bolesti.
English: One vial of powder contains 150 mg canakinumab.
Croatian: Jedna bočica praška sadrži 150 mg kanakinumaba.
English: Pull the plunger all the way down to the 1.0 ml mark, filling the syringe with air. Insert the needle into the water vial through the centre of the rubber stopper.
Croatian: Povucite klip štrcaljke sve do oznake za 1,0 ml tako da se štrcaljka napuni zrakom.
English: Tumour necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) and familial Mediterranean fever (FMF) The recommended starting dose of Ilaris is: - Adults and children aged 2 years or more
Croatian: Periodični sindrom povezan s receptorom faktora nekroze tumora (TRAPS), sindrom hiperimunoglobulina D (HIDS)/nedostatak mevalonat kinaze (MKD) i obiteljska mediteranska groznica (FMF)
English: A total of 243 CAPS patients (85 paediatric patients aged ≥ 2 to ≤ 17 years and 158 adult patients aged ≥ 18 years) were treated with canakinumab in routine clinical practice in a long-term registry study (mean of 3.8 years of canakinumab exposure).
Croatian: ≥18 godina) primala kanakinumab u rutinskoj kliničkoj praksi (srednja vrijednost perioda izloženosti kanakinumabu bila je 3,8 godina).
English: Upper abdominal pain.
Croatian: Bol u gornjem dijelu trbuha.
English: How much Ilaris to use Cryopyrin-associated periodic syndromes (CAPS) The recommended starting dose of Ilaris is: - Adults and children aged 4 years or more
Croatian: Preporučena početna doza Ilarisa je: - Odrasli i djeca u dobi od 2 i više godina
English: Recap the transfer needle as instructed by your healthcare provider or pharmacist.
Croatian: Vratite kapicu na iglu za prijenos prema uputama zdravstvenog djelatnika ili ljekarnika.
English: One vial contains 150 mg canakinumab.
Croatian: Jedna bočica sadrži 150 mg kanakinumaba.
English: Recap the withdrawal needle as instructed by your healthcare provider or pharmacist.
Croatian: Vratite kapicu na iglu za izvlačenje prema uputama zdravstvenog djelatnika ili ljekarnika.
English: CAPS: Adults, adolescents and children aged 2 years and older The recommended starting dose of canakinumab for CAPS patients is: Adults, adolescents and children ≥ 4 years of age:
Croatian: CAPS: Odrasli, adolescenti i djeca u dobi od 2 i više godina Preporučena početna doza kanakinumaba za bolesnike s CAPS-om je: Odrasli, adolescenti i djeca u dobi od ≥4 godine: 150 mg za bolesnike s tjelesnom težinom >40 kg 2 mg/kg za bolesnike s tjelesnom težinom ≥15 kg i ≤40 kg 4 mg/kg za bolesnike s tjelesnom težinom ≥7,5 kg i <15 kg Djeca u dobi od 2 do <4 godine: 4 mg/kg za bolesnike s tjelesnom težinom ≥7,5 kg
English: Renal impairment
Croatian: Stillova bolest
English: In the overall SJIA programme, transient decreases in absolute neutrophil count (ANC) to less than 1 x 109/l were reported in 12 patients (6.0%).
Croatian: U cjelokupnom programu za SJIA-u zabilježena su prolazna smanjenja apsolutnog broja neutrofila (ABN) na manje od 1 x 10
English: Powder for solution for injection
Croatian: Prašak za otopinu za injekciju 1 bočica
English: Ilaris is injected every 8 weeks as a single dose.
Croatian: Svakih 8 tjedana ubrizgava se jedna doza.
English: Platelets
Croatian: Serija
English: Uncap the injection needle.
Croatian: Skinite kapicu s igle za injekciju.
English: The other ingredients are: sucrose, histidine, histidine hydrochloride monohydrate, polysorbate
Croatian: Drugi sastojci su: saharoza, histidin, histidinklorid hidrat, polisorbat 80.
English: Urinary tract infection
Croatian: Sindrom hiperimunoglobulina
English: Ilaris is also indicated for the treatment of:
Croatian: Ilaris je također indiciran za liječenje sljedećih bolesti: Stillova bolest
English: Pull the plunger of the syringe all the way down to the 1.0 ml mark, filling the syringe with air. Insert the syringe needle into the vial of Ilaris solution through the centre of the rubber stopper.
Croatian: Umetnite iglu štrcaljke u bočicu Ilaris otopine kroz središte gumenog čepa.
English: • Risk management plan(RMP)
Croatian: • Plan upravljanja rizikom(RMP)
English: The results did not support the second method.
Croatian: Rezultati ne podržavaju drugi način primjene.
English: The active components are made from human blood.
Croatian: Djelatni sastojci se rade iz ljudske krvi.
English: Read all of this leaflet carefully.
Croatian: Pažljivo pročitajte cijelu uputu.
English: Use only undamaged packages.
Croatian: Koristite samo neoštećena pakiranja.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGO(A)POSEBNO(A)UPOZORENJE(A), AKO JE POTREBNO
English: TachoSil is not recommended for use in children below age 18 years due to insufficient data on safety and efficacy.
Croatian: TachoSil se ne preporučuje primjenjivati kod djece mlađe od 18 godina jer su podaci o sigurnosti i djelotvornosti nedostatni.
English: Find out which size of TachoSil is needed.
Croatian: Odredite kolika veličina Tachosila je potrebna.
English: Intestinal obstruction (in abdominal surgeries)
Croatian: Intestinalna opstrukcija (u abdominalnoj kirurgiji)
English: 9 DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA
English: UNIQUE IDENTIFIER -2D BARCODE
Croatian: 17. JEDINSTVENI IDENTIFIKATOR -2D BARKOD
English: Read this before you open the package: TachoSil comes in sterile packages and therefore it is important:
Croatian: Pročitajte ovo prije otvaranja pakiranja: TachoSil dolazi u sterilnom pakiranju i zato je važno:
English: Single dose toxicity studies in different species of animals have shown no signs of acute toxic effects.
Croatian: Ispitivanja toksičnosti jednokratnih doza kod različitih životinjskih vrsta nisu pokazale znakove akutnih toksičnih učinaka.
English: 4.7 Effects on ability to drive and use machines
Croatian: 4.7 Utjecaj na sposobnost upravljanjavozilima i rada na strojevima
English: If these symptoms occur, the administration has to be discontinued immediately.
Croatian: Ako se pojave takvi simptomi, primjenu treba odmah prekinuti.
English: Such substances should be removed to the greatest possible extent before applying the sealant.
Croatian: Takve tvari treba prije nanošenja ljepila ukloniti u najvećoj mogućoj mjeri.
English: Open the inner sterile package and remove the matrix.
Croatian: Otvorite unutarnje sterilno pakiranjei izvadite matricu.
English: Do not store above 25 °C.
Croatian: Ne čuvati na temperaturi iznad 25C.
English: This leaflet was last revised in {month/YYYY}
Croatian: Ova uputa je zadnji puta revidirana u {mjesec GGGG}
English: From the experience in humans there have been isolated cases where remnants were observed as coincidental findings with no signs of functional impairment.
Croatian: U iskustvu kod ljudi bilo je izoliranih slučajeva kad su zaostaci opaženi kao slučajni nalaz, bez znakova funkcionalnih smetnji.
English: Like all medicines, this medicine can cause side effects although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se neće javiti kod svakoga.
English: Do not resterilise.
Croatian: Nemojte ponovno sterilizirati.
English: Anaphylactic shock, Hypersensitivity
Croatian: Anafilaktički šok, preosjetljivost
English: Once the package is opened, post-sterilisation is not possible.
Croatian: Kad se jednom otvori, naknadna sterilizacija nije moguća.
English: There is no residual product which needs to be removed; the entire matrix is dissolved (resorbed).
Croatian: Nema ostataka lijeka koje treba ukloniti;čitavamatricase razgrađuje (resorbira).
English: UNIQUE IDENTIFIER -HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR -PODACI ČITLJIVI LJUDSKIM OKOM
English: The frequency of all of the events listed below has been categorised as not known (cannot be estimated from the available data).
Croatian: Učestalost svih dolje navedenih događaja kategorizirana je kao nepoznata (ne može se procijeniti iz dostupnih podataka).
English: This is followed by the fibrinogen-thrombin reaction which initiates the last phase of physiological blood coagulation.
Croatian: To je popraćeno reakcijom fibrinogen-trombin koja započinje zadnju fazu fiziološke koagulacije krvi.
English: Date of first authorisation: 8 June 2004 Date of latest renewal: 30 April 2009
Croatian: Datum posljednje obnove odobrenja: 30. travnja 2009.
English: See section 6.6 for more detailed instructions.
Croatian: Za detaljnije upute vidjeti dio 6.6.
English: A-4020 Linz, Austria
Croatian: A-4020 Linz, Austrija
English: Due to practical reasons (comparison to standard surgical and standard haemostatic treatment), blinding was not possible in the TachoSil trials.
Croatian: Zbog praktičnih razloga (usporedba sa standardnim kirurškim i standardnim hemostatskim liječenjem) slijepa kontrola nije bila moguća u ispitivanjima TachoSila.
English: No evidence of local intolerability has been observed in animal studies.
Croatian: U ispitivanjima na životinjama nisu uočeni dokazi lokalne nepodnošljivosti.
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
Croatian: Ova uputa o lijeku je dostupna na svim EU/EEA jezicima na internetskoj stranici Europske agencije za lijekove.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Prilikomsvake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).