FrancophonIA/ELRC3.0 huggingface dataset:
English: Similarly, combining t½ values at the Baseline Visit and the Repeat PK assessment gave an overall geometric mean t½ of 29.36 hours.
Croatian: Slično tome, udruživanje vrijednosti t1/2 kod početnog posjeta i ponovljene procjene FK dalo je ukupnu geometrijsku sredinu t1/2 od 29,36 sati.
English: The mean dose per infusion and total dose of Coagadex were 25.4 IU/kg and 30.4 IU/kg, respectively.
Croatian: Srednja doza po infuziji i ukupna doza lijeka Coagadex bile su 25,4 IU/kg, odnosno 30,4 IU/kg.
English: If any of these symptoms occur, they should be advised to discontinue use of the product immediately and contact their physician.
Croatian: treba ih savjetovati da odmah prekinu primjenu lijeka i obrate se svom liječniku.
English: Step 3: Turn the solvent vial upside down with the transfer device still attached.
Croatian: 3. korak: Okrenite bočicu s otapalom naopako s još uvijek pričvršćenom napravom za prijenos.
English: The mean (CV%) for area under the curve (AUC 0-144h) was 17.1 (21.0) IU.hr/mL.
Croatian: Srednja vrijednost (CV%) površine ispod krivulje (AUC0-144h) bila je 17,1 (21,0) IU. h/ml.
English: Of the 208 bleeding episodes treated with Coagadex, 187 bleeding episodes in 15 subjects were evaluated for efficacy.
Croatian: Coagadex, 187 epizoda krvarenja kod 15 ispitanika procijenjeno je za djelotvornost.
English: Powder vial: 250 IU or 500 IU of human coagulation factor X in a type I glass vial stoppered with a halobutyl rubber stopper, oversealed with a snap-off polypropylene cap and aluminium lacquered skirt.
Croatian: Bočica s praškom: 250 IU ili 500 IU ljudskog koagulacijskog faktora X u bočici od stakla tipa I, zatvorenoj čepom od halobutilne gume, prekrivenim aluminijskim lakiranim prstenom sa polipropilenskim zatvaračem.
English: Step 6: Immediately invert the vial of solution, which will be drawn into the syringe.
Croatian: 6. korak: Odmah preokrenite bočicu s otopinom, koja će se uvući u štrcaljku.
English: The study in young children (see section 5.1) measured incremental recovery at 30 min (IR30min) after the first dose and after the last dose in the study (approximately 6 months later) (see section 5.1) Combining IR30min values for FX:C at the baseline visit (n=9) and the Repeat PK assessment (n=9) gave an overall geometric mean IR of 1.74 (range 1.3-2.2) IU/dL per IU/kg administered (n=9).
Croatian: U ispitivanju s malom djecom (vidjeti dio 5.1) mjeren je prirast po jedinici doze (engl. incremental recovery, IR) 30 minuta nakon prve doze (IR30min) te nakon posljednje doze primljene u okviru ispitivanja (otprilike 6 mjeseci kasnije) (vidjeti dio 5.1) Kombinacijom vrijednosti IR30min za aktivnost faktora X na početku ispitivanja (n=9) i vrijednosti iz ponovljene farmakokinetičke procjene (n=9) dobivena je geometrijska sredina ukupnog prirasta po jedinici doze od 1,74 (raspon 1,3-2,2) IU/dl po primijenjenim IU/kg (n=9).
English: Step 5: Separate the empty solvent vial and blue part from the clear part by unscrewing anti-clockwise.
Croatian: 5. korak: Odvojite praznu bočicu otapala i plavi dio od prozirnog dijela odvrćući suprotno od kazaljke na satu.
English: EXP: Use within 1 hour of reconstitution.
Croatian: Rok valjanosti: Upotrijebiti unutar 1 sata nakon rekonstitucije otopine.
English: Six children (66.7%) remained free of bleeds during routine prophylaxis.
Croatian: Tijekom rutinske profilakse u šestero djece (66,7%) nije se pojavilo krvarenje.
English: For all surgical procedures, Coagadex was assessed as excellent (no post-operative bleeding, no requirement of blood transfusions, and blood loss was no more than ‘as expected') in controlling blood loss during and after surgery.
Croatian: bez potrebe za transfuzijom krvi, te gubitak krvi nije bio veći 'od očekivanog') u kontroli gubitka krvi tijekom i nakon operacije.
English: The following side effects have been reported with Coagadex.
Croatian: Sljedeće nuspojave su prijavljene za lijek Coagadex.
English: Control of Bleeding Episodes
Croatian: Kontrola epizoda krvarenja
English: Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, United Kingdom For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, Ujedinjeno Kraljevstvo
English: BPL Bioproducts Laboratory GmbH Dornhofstraße, 63263 Neu-Isenburg Germany
Croatian: BPL Bioproducts Laboratory GmbH Dornhofstraße,63263 Neu-Isenburg
English: • Disconnect the filled syringe from the device.
Croatian: • Odvojite napunjenu štrcaljku od naprave.
English: The 250 IU and 500 IU presentations should be reconstituted using 2.5 mL and 5 mL water for injections, respectively.
Croatian: Pakiranje od 250 IU treba rekonstituirati s 2,5 ml, odnosno pakiranje od 500 IU s 5 ml vode za injekcije.
English: Volume of solvent
Croatian: Volumen otapala
English: BPL Bioproducts Laboratory GmbH 63263 Neu-Isenburg Germany
Croatian: BPL Bioproducts Laboratory GmbH 63263 Neu-Isenburg
English: Not more than 60 IU/kg daily should be administered in any age group.
Croatian: Ni u jednoj dobnoj skupini ne smije se primjenjivati više od 60 IU/kg dnevno.
English: For secondary prophylaxis against re-bleeding or short-term prophylaxis prior to anticipated physical activity or dental appointments: 30 IU/kg Coagadex should be injected and repeated as required.
Croatian: Za sekundarnu profilaksu protiv ponovnog krvarenja ili kratkoročnu profilaksu prije očekivane fizičke aktivnosti ili zakazanog pregleda kod zubara: potrebno je injicirati 30 IU/kg lijeka Coagadex, i ponoviti po potrebi.
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Croatian: Usprkos tome, kad se primjenjuju lijekovi pripremljeni od ljudske krvi ili plazme, ne može se u potpunosti isključiti mogućnost prijenosa uzročnika infekcija.
English: For secondary prophylaxis against re-bleeding or short-term prophylaxis prior to anticipated physical activity or dental appointments: 25 IU/kg Coagadex should be injected and repeated as required.
Croatian: Za sekundarnu profilaksu protiv ponovnog krvarenja ili kratkoročnu profilaksu prije očekivane fizičke aktivnosti ili zakazanog pregleda kod zubara: potrebno je injicirati 25 IU/kg lijeka Coagadex, i ponoviti po potrebi.
English: Trough levels of FX:C were measured during the first 6 weeks of the study to individualise the dosage regimen and to maintain a trough level of at least 5 IU/dL.
Croatian: Najniže razine aktivnosti faktora X mjerene su u prvih 6 tjedana ispitivanja kako bi se individualizirao režim doziranja i zadržala najniža koncentracija od najmanje 5 IU/dl.
English: For on-demand control of bleeding in children aged less than 12 years: 30 IU/kg Coagadex should be injected when the first sign of bleeding occurs.
Croatian: Za kontrolu epizoda krvarenja prema potrebi u djece mlađe od 12 godina: kada se pojavi prvi znak krvarenja potrebno je injicirati 30 IU/kg lijeka Coagadex.
English: Coagadex contains sodium
Croatian: Coagadex sadrži natrij
English: For minor surgery, a median of 2.5 infusions (range 1 to 4 infusions) and a median cumulative dose of 89 IU/kg (range 51 to 127 IU/kg) were used to maintain haemostasis.
Croatian: Za manje operativne zahvate, za održavanje hemostaze koristio se medijan od 2,5 infuzije (raspon 1 do 4 infuzije) i medijan kumulativne doze od 89 IU/kg (raspon 51 do 127 IU/kg).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 500 IU
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA OD 500 IU
English: Connect the syringe to the clear part of the transfer device and push the air into the vial.
Croatian: Spojite štrcaljku na prozirni dio naprave za prijenos i potisnite zrak u bočicu.
English: Median and mean doses per infusion in the four children less than 6 years of age were both 40.1 IU/kg (95% CI 30.70, 49.57) and in the five children 6 to 11 years of age inclusive, median dose was 39.6 IU/kg and mean dose was 37.7 IU/kg (95% CI: 23.42, 51.91).
Croatian: (95% CI 30,70; 49,57), a u petero djece u dobi od 6 do uključivo 11 godina medijan doze bio je 39,6 IU/kg dok je srednja vrijednost doze bila 37,7 IU/kg (95% CI: 23,42; 51,91).
English: In a multicentre, open-label, non-randomised clinical trial to evaluate the pharmacokinetics, safety and efficacy of Coagadex, 16 subjects (aged 12 years and above) with moderate to severe hereditary factor X deficiency (FX:C < 5 IU/dL) received a dose of 25 IU/kg Coagadex to treat spontaneous, traumatic and menorrhagic bleeding episodes.
Croatian: sigurnosti i djelotvornosti lijeka Coagadex, 16 ispitanika (u dobi od 12 godina i više), s umjerenim do teškim nasljednim nedostatkom faktora X (FX:C <5 IU/dl) primalo je dozu od 25 IU/kg Coagadexa za liječenje epizoda spontanog, traumatskog i menstrualnog krvarenja.
English: When to inject Coagadex
Croatian: Kada injicirati Coagadex
English: Keep the vial in the outer carton to protect from light.
Croatian: Čuvati bočicu u vanjskom pakiranju radi zaštite od svjetlosti.
English: Step 1: Remove the cap from the powder vial and clean the top of the stopper with an alcohol swab.
Croatian: 1. korak: Skinite zatvarač s bočice praška i očistite vrh čepa vaticom natopljenom alkoholom.
English: - Solvent: water for injections.
Croatian: - Otapalo: voda za injekcije.
English: Perioperative Management (Adults and adolescents aged at least 12 years of age) Pre-surgery: calculate dose of Coagadex to raise plasma factor X levels to 70-90 IU/dL.
Croatian: Za perioperativno zbrinjavanje djece mlađe od 12 godina: Prije operativnog zahvata: izračunajte dozu lijeka Coagadex za porast razine faktora X u plazmi na 70-90 IU/dl.
English: A dose of 2000 IU Coagadex administered to a 70 kg patient should be expected to result in a peak post-infusion factor X increase of 2000 x {[2 IU/dL]/[IU/kg]}/[70 kg] = 57 IU/dL (i.e. 57% of normal)
Croatian: Sljedeći primjeri pretpostavljaju da je bolesnikova početna vrijednost razine faktora X < 1 IU/dl: Očekuje se da će doza od 2000 IU lijeka Coagadex primijenjena bolesniku od 70 kg nakon infuzije rezultirati vršnim porastom faktora X od 2000 x {[2 IU/dl]/[IU/kg]}/[70 kg] = 57 IU/dl (tj. 57 % normalne vrijednosti)
English: The following adverse reactions have been reported in clinical studies involving 27 patients treated with
Croatian: Sljedeće nuspojave prijavljene su u kliničkim ispitivanjima koja uključuju 27 bolesnika liječenih lijekom Coagadex.
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of rare bleeding disorders.
Croatian: 4.2 Doziranje i način primjene Liječenje treba započeti pod nadzorom liječnika iskusnog u liječenju rijetkih poremećaja hemostaze.
English: Elderly No dose adjustment is necessary.
Croatian: Nije potrebna prilagodba doze.
English: • Remove the cap from the powder vial and clean the top of the stopper with an alcohol swab.
Croatian: • Skinite zatvarač s bočice s praškom i očistite vrh čepa vaticom natopljenom alkoholom.
English: Combining IR values for FX:C at the baseline visit (n=16) and the Repeat PK assessment (n=15) gave an overall geometric mean IR of 2.07 IU/dL per IU/kg administered (n=31).
Croatian: Udruživanje vrijednosti prirasta po jedinici doze za aktivnost faktora X pri početnom posjetu (n=16) i ponovljenoj procjeni FK (n=15) dalo je ukupnu srednju geometrijsku vrijednost prirasta po jedinici doze od 2,07 IU/dl po IU/kg danog lijeka (n=31).
English: Fertility Animal reproduction studies have not been conducted with Coagadex.
Croatian: Plodnost Nisu provedena ispitivanja učinka na reprodukciju u životinja s lijekom Coagadex.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 250 IU
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA OD 250 IU
English: For major surgery, a median of 13 infusions (range 2 to 15 infusions) and a median cumulative dose of 181 IU/kg (range 45 to 210 IU/kg) were required to maintain haemostasis.
Croatian: Kod većih operativnih zahvata za održavanje hemostaze bio je potreban medijan od 13 infuzija (raspon 2 do 15 infuzija) i medijan kumulativne doze od 181 IU/kg (raspon 45 do 210 IU/kg).
English: Sodium Content
Croatian: Sadržaj natrija
English: Dose (IU) = body weight (kg) x desired factor X rise (IU/dL or % of normal) x 0.6 OR Increase in factor X level (IU/dL or % of normal) = [total dose (IU)/body weight (kg)] x 1.7
Croatian: Doza (IU) = tjelesna težina (kg) x željeni porast faktora X (IU/dl ili % normalne vrijednosti) x 0,6 ILI Porast razine faktora X (IU/dl ili % normalne vrijednosti) = [ukupna doza (IU) / tjelesna težina (kg)] x 1,7
English: If you forget to use Coagadex
Croatian: Ako ste zaboravili primijeniti Coagadex
English: Your medicine must only be dissolved in the solvent provided with the product.
Croatian: Vaš se lijek smije otopiti samo u otapalu koje je isporučeno s lijekom.
English: Coagadex contains traces of human proteins other than factor X. Patients should be informed of the early signs of hypersensitivity reactions including angioedema, infusion site inflammation (e.g. burning, stinging, erythema), chills, cough, dizziness, fever, flushing, generalised urticaria, headache, hives, hypotension, lethargy, musculoskeletal pains, nausea, pruritus, rash, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing.
Croatian: Bolesnike treba informirati o ranim znakovima reakcija preosjetljivosti uključujući angioedem, upalu na mjestu infuzije (npr. žarenje, peckanje, eritem), zimicu, kašalj, omaglicu, vrućicu, navale crvenila, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, bolove u mišićima i kostima, mučninu, pruritus, osip, nemir, tahikardiju, stezanje u prsištu, trnce, povraćanje, piskanje pri disanju.
English: Keep this medicine out of the sight and reach of children.
Croatian: I DOHVATA DJECE Čuvati izvan pogleda i dohvata djece.
English: • Separate the empty solvent vial and blue part from the clear part by unscrewing anti-clockwise.
Croatian: • Odvojite praznu bočicu otapala i plavi dio od prozirnog dijela odvrćući suprotno od kazaljke na satu.
English: If you stop using Coagadex
Croatian: Ako prestanete primjenjivati Coagadex
English: Coagadex is indicated in all age groups
Croatian: Coagadex je inidiciran za primjenu u svim dobnim skupinama.
English: Also contains: Powder vial: citric acid, sodium hydroxide, disodium phosphate dihydrate, sodium chloride, sucrose.
Croatian: Bočica s praškom: citratna kiselina, natrijev hidroksid, natrijev hidrogenfosfat dihidrat, natrijev klorid, saharoza.
English: • Each individual bleed should be judged on its own severity
Croatian: • Treba procijeniti težinu svakog pojedinog krvarenja.
English: 1 vial 250 IU powder 1 vial 2.5 mL water for injections 1 Transfer Device (Mix2Vial)
Croatian: 1 bočica s praškom od 250 IU 1 bočica s 2,5 ml vode za injekcije 1 naprava za prijenos (Mix2Vial)
English: Solvent Water for injections
Croatian: Otapalo Voda za injekcije
English: Dose (IU) = body weight (kg) x desired factor X rise (IU/dL or % of normal) x 0.5 OR Increase in factor X level (IU/dL or % of normal) = [total dose (IU)/body weight (kg)] x 2
Croatian: Doza (IU) = tjelesna težina (kg) x željeni porast faktora X (IU/dl ili % normalne vrijednosti) x 0,5 ILI Porast razine faktora X (IU/dl ili % normalne vrijednosti) = [ukupna doza (IU)/tjelesna težina (kg)] x 2
English: List of adverse reactions (ADRs) in 27 treated subjects MedDRA System Organ Class
Croatian: Popis nuspojava u 27 liječenih ispitanika
English: • Connect the syringe to the clear part of the transfer device and push the air in the syringe into the vial.
Croatian: • Spojite štrcaljku na prozirni dio naprave za prijenos i potisnite zrak iz štrcaljke u bočicu.
English: Reconstituted products should be inspected visually for particulate matter and discolouration prior to administration.
Croatian: Rekonstituirane lijekove prije primjene treba vizualno provjeriti na pojavu čestica ili promjenu boje.
English: Quantity of Coagadex
Croatian: Količina lijeka Coagadex
English: • Repeat this step with the vial of solvent.
Croatian: • Ponovite ovaj korak s bočicom otapala.
English: There are no data available on routine prophylaxis in paediatric patients aged >12 to <18 years.
Croatian: Nema dostupnih podataka o rutinskoj profilaksi u pedijatrijskih bolesnika u dobi
English: Sodium hydroxide (for pH adjustment) Disodium phosphate dihydrate Sodium chloride
Croatian: Natrijev hidrogenfosfat dihidrat Natrijev klorid
English: The median prophylactic dose per infusion per subject was 39.60 IU/kg (mean 38.76 IU/kg), and ranged from 18.0 to 47.3 IU/kg.
Croatian: (srednja vrijednost 38,76 IU/kg), a raspon je iznosio od 18,0 do 47,3 IU/kg.
English: 1 vial 500 IU powder 1 vial 5 mL water for injections 1 Transfer Device (Mix2Vial)
Croatian: 1 bočica s praškom od 500 IU 1 bočica s 5 ml vode za injekcije 1 naprava za prijenos (Mix2Vial)
English: How to use Coagadex
Croatian: Kako primjenjivati Coagadex
English: Method of administration Intravenous use.
Croatian: Intravenska primjena.
English: No pharmacokinetic studies have been conducted but there is no anticipated effect of gender or hepatic function on the pharmacokinetic profile of Coagadex.
Croatian: Farmakokinetička ispitivanja nisu provedena, ali ne predviđa se učinak spola ili jetrene funkcije na farmakokinetički profil lijeka Coagadex.
English: 1 powder vial
Croatian: 1 bočicu s praškom
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 2.5 mL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA BOČICU OD 2,5 ml
English: No pharmacokinetic studies have been conducted but there is no anticipated effect of age on the pharmacokinetic profile of Coagadex.
Croatian: Farmakokinetička ispitivanja nisu provedena, ali ne predviđa se učinak dobi na farmakokinetički profil lijeka Coagadex.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Bol u leđima
English: 1 vial 250 IU human coagulation factor X powder for solution for injection 1 vial 2.5 mL water for injections
Croatian: 1 bočica s 250 IU ljudskog koagulacijskog faktora X kao praška za otopinu za injekciju 1 bočica s 2,5 ml vode za injekcije
English: 1 vial 500 IU human coagulation factor X powder for solution for injection 1 vial 5 mL water for injections
Croatian: 1 bočica s 500 IU ljudskog koagulacijskog faktora X kao praška za otopinu za injekciju 1 bočica s 5 ml vode za injekcije
English: Prophylaxis of Bleeding Episodes
Croatian: Profilaksa epizoda krvarenja
English: Before injection, look at the solution.
Croatian: Prije uporabe pročitajte uputu o lijeku.
English: Virus safety
Croatian: Sigurnost s obzirom na virusne infekcije
English: • Immediately invert the vial of solution, which will be drawn into the syringe.
Croatian: • Odmah preokrenite bočicu s otopinom, koja će se uvući u štrcaljku.
English: Step 2: Place the blue end of the transfer device on the solvent vial and push straight down until the spike penetrates the rubber stopper and snaps into place.
Croatian: 2. korak: Stavite plavi kraj naprave za prijenos na bočicu s otapalom i pritisnite ga prema dolje sve dok šiljak ne probije gumeni čep i sjedne na svoje mjesto.
English: sodium hydroxide and sucrose (see section 2 for further information about ingredients).
Croatian: - Drugi sastojci su: citratna kiselina, natrijev hidrogenfosfat dihidrat, natrijev klorid, natrijev hidroksid i saharoza (vidjeti dio 2 za dodatne informacije o sastojcima).
English: Coagadex to raise plasma factor X levels to 70-90 IU/dL.
Croatian: Prije operativnog zahvata: izračunajte dozu lijeka Coagadex za porast razine faktora X u plazmi na 70-90 IU/dl.
English: • Turn the solvent vial upside down with the device still attached.
Croatian: • Okrenite bočicu s otapalom naopako s još uvijek pričvršćenom napravom.
English: Coagadex 250 IU powder and solvent for solution for injection.
Croatian: Coagadex 250 IU prašak i otapalo za otopinu za injekciju.
English: Coagadex 500 IU powder and solvent for solution for injection.
Croatian: Coagadex 500 IU prašak i otapalo za otopinu za injekciju.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 5 mL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA BOČICU OD 5 ml
English: 1 solvent vial of 5 mL water for injections
Croatian: 1 napravu za prijenos 1 bočicu otapala s 5 ml vode za injekcije
English: • Peel back the top of the transfer device package but leave the device in the package.
Croatian: • Odlijepite pokrov s pakiranja naprave za prijenos, ali ostavite napravu u pakiranju.
English: Posology
Croatian: Pakiranja
English: Solvent vial: 2.5 mL or 5 mL solution in a type I glass vial sealed with a halobutyl rubber stopper and an overseal.
Croatian: Bočica s otapalom: 2,5 ml ili 5 ml otapala u bočici od stakla tipa
English: Solvent vial: water for injections.
Croatian: Bočica s otapalom: voda za injekcije.
English: BATCH NUMBER>
Croatian: 13. BROJ SERIJE
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 250 IU
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA BOČICU OD 250 IU
English: 1 solvent vial of 2.5 mL water for injections
Croatian: 1 napravu za prijenos 1 bočicu otapala s 2,5 ml vode za injekcije
English: Signs of these may include skin rash (including hives), tingling, flushing, nausea, vomiting, headache, cough, wheezing, tightness of the chest, chills, fast heart rate, dizziness, lethargy, restlessness, swelling of the face, tightness of the throat, discomfort at the site of injection.
Croatian: piskanje pri disanju, stezanje u prsnom košu, zimicu, ubrzane srčane otkucaje, omaglicu, letargiju, nemir, oticanje lica, stezanje u grlu, neugodu na mjestu injekcije.
English: Peel back the top of the transfer device package but leave the device in the package.
Croatian: Odlijepite pokrov s pakiranja naprave za prijenos, ali ostavite napravu u pakiranju.
English: Place the clear end of the transfer device on the powder vial and push straight down until the spike penetrates the rubber stopper and snaps into place.
Croatian: Stavite proziran kraj naprave za prijenos na bočicu s praškom i pritisnite ga prema dolje sve dok šiljak ne probije gumeni čep i sjedne na svoje mjesto.
English: • Place the blue end of the transfer device on the solvent vial and push straight down until the spike penetrates the rubber stopper and snaps into place.
Croatian: • Stavite plavi kraj naprave za prijenos na bočicu s otapalom i pritisnite ga prema dolje sve dok šiljak ne probije gumeni čep i sjedne na svoje mjesto.
English: • Place the clear end of the transfer device on the powder vial and push straight down until the spike penetrates the rubber stopper and snaps into place.
Croatian: • Stavite proziran kraj naprave za prijenos na bočicu s praškom i pritisnite ga prema dolje sve dok šiljak ne probije gumeni čep i sjedne na svoje mjesto.
English: For i.v.
Croatian: PRILOG III.
English: Coagadex 250 IU powder for solution for injection human coagulation factor X
Croatian: Coagadex 250 IU prašak za otopinu za injekciju ljudski koagulacijski faktor X
English: Coagadex 500 IU powder for solution for injection human coagulation factor X
Croatian: Coagadex 500 IU prašak za otopinu za injekciju ljudski koagulacijski faktor X
English: In a clinical study of Coagadex in subjects with severe or moderate factor X deficiency (basal FX:C <5 IU/dL), the pharmacokinetics of Coagadex were assessed in 16 subjects after administration of a nominal dose of 25 IU/kg.
Croatian: (bazalna aktivnost faktora X <5 IU/dl), farmakokinetika lijeka Coagadex ocijenjena je kod 16
English: Coagadex 250 IU powder and solvent for solution for injection human coagulation factor X
Croatian: Coagadex 250 IU prašak i otapalo za otopinu za injekciju ljudski koagulacijski faktor X
English: Coagadex 500 IU powder and solvent for solution for injection human coagulation factor X
Croatian: Coagadex 500 IU prašak i otapalo za otopinu za injekciju ljudski koagulacijski faktor X
English: Adverse reaction
Croatian: NAČIN PRIMJENE