FrancophonIA/ELRC3.0 huggingface dataset:
English: RIXUBIS 250 IU powder and solvent for solution for injection RIXUBIS 500 IU powder and solvent for solution for injection RIXUBIS 1000 IU powder and solvent for solution for injection RIXUBIS 2000 IU powder and solvent for solution for injection RIXUBIS 3000 IU powder and solvent for solution for injection
Croatian: RIXUBIS 250 IU prašak i otapalo za otopinu za injekciju RIXUBIS 500 IU prašak i otapalo za otopinu za injekciju RIXUBIS 1000 IU prašak i otapalo za otopinu za injekciju RIXUBIS 2000 IU prašak i otapalo za otopinu za injekciju RIXUBIS 3000 IU prašak i otapalo za otopinu za injekciju
English: Week 26 (N=55)
Croatian: 26. tjedan (N=55)
English: The mean (± SD) and median dose of RIXUBIS in the per protocol analysis set (n=25) were 74.69±2.37 and 74.25 IU/kg, respectively, with a range of 71.27 to 79.38 IU/kg.
Croatian: Srednja vrijednost (± SD) i medijan doze lijeka RIXUBIS u obavljenoj analizi prema planu ispitivanja (n=25) iznosile su 74,69 ± 2,37, odnosno 74,25 IU/kg, uz raspon od 71,27 do 79,38 IU/kg.
English: Allergic type hypersensitivity reactions have been reported with RIXUBIS.
Croatian: Prijavljene su reakcije preosjetljivosti alergijskog tipa na RIXUBIS.
English: Excipients: sodium chloride, sucrose, calcium chloride, histidine, mannitol, polysorbate 80.
Croatian: Pomoćne tvari: natrijev klorid, saharoza, kalcijev klorid, histidin, manitol, polisorbat 80.
English: It is a vitamin K-dependent coagulation factor and it is synthesised in the liver.
Croatian: Radi se o koagulacijskom faktoru ovisnom o vitaminu
English: How to store RIXUBIS
Croatian: Kako čuvati RIXUBIS
English: Incremental recovery for RIXUBIS 30 minutes after infusion, paediatric patients < 6 years:
Croatian: Inkrementalni oporavak za RIXUBIS 30 minuta nakon infuzije, pedijatrijski bolesnici < 6 godina:
English: RIXUBIS Initial cross-over study (N=25)
Croatian: Početno ukriženo ispitivanje (N=25)
English: Incremental recovery for RIXUBIS 30 minutes after infusion, both paediatric age groups:
Croatian: Inkrementalni oporavak za RIXUBIS 30 minuta nakon infuzije, obje pedijatrijske dobne skupine:
English: RIXUBIS was administered by bolus infusions.
Croatian: Lijek RIXUBIS primijenjen je bolusnom infuzijom.
English: The potency (IU) is determined using the European Pharmacopoeia one stage clotting assay.
Croatian: Jačina (IU) je određena pomoću jednofaznog testa zgrušavanja krvi prema Europskoj farmakopeji.
English: Week 13 (N=68)
Croatian: 13. tjedan (N=68)
English: Calculated as (Cmax-baseline factor IX) divided by the dose in IU/kg, where Cmax is the maximal post-infusion factor IX measurement.
Croatian: Izračunat kao (Cmaks faktora IX na početku) podijeljen s dozom u IU/kg, gdje je Cmaks maksimalno mjerenje vrijednosti faktora IX nakon infuzije.
English: It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX.
Croatian: Potrebno je napomenuti da bolesnici s inhibitorima faktora IX mogu biti pod povećanim rizikom od anafilaksije kod kasnijeg izlaganja faktoru IX.
English: What RIXUBIS contains - The active substance is nonacog gamma (recombinant human coagulation Factor IX).
Croatian: Što RIXUBIS sadrži - Djelatna tvar je nonakog gama (rekombinantni ljudski faktor zgrušavanja IX).
English: Activated factor IX, in combination with activated factor VIII, activates factor X. Activated factor X converts prothrombin into thrombin.
Croatian: Aktivirani faktor IX, u kombinaciji s aktiviranim faktorom VIII, aktivira faktor X.
English: The powder is white to off-white.
Croatian: Prašak i otapalo za otopinu za injekciju Prašak je bijele ili gotovo bijele boje.
English: All subjects had severe (factor IX level <1%) or moderately severe (factor IX level ≤2%) haemophilia B. Fifty-nine PTPs received RIXUBIS for prophylaxis.
Croatian: Svi ispitanici imali su tešku (razina faktora IX <1%) ili umjereno tešku (razina faktora IX ≤2%) hemofiliju B.
English: Median (range) Incremental recovery at Cmax (IU/dL:IU/kg)
Croatian: Srednja vrijednost±SD Medijan (raspon) Inkrementalni oporavak pri Cmaks (IU/dl:IU/kg)b
English: Kidney disorders (nephrotic syndrome) have been reported following high doses of Factor IX in haemophilia B patients with factor IX inhibitors and a history of allergic reactions.
Croatian: Bubrežni poremećaji (nefrotski sindrom) prijavljeni su nakon visokih doza faktora IX u bolesnika s hemofilijom B s inhibitorima faktora IX i povijesti alergijskih reakcija.
English: Connect the syringe to BAXJECT II (Fig. d).
Croatian: Spojite štrcaljku na uređaj BAXJECT II (Sl. d).
English: The requirements for submission of periodic safety update reports 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 and published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti lijeka (PSUR-evi) Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7.
English: Always use RIXUBIS exactly as your doctor has told you.
Croatian: Ako primijenite više lijeka RIXUBIS nego što ste trebali Uvijek primijenite RIXUBIS točno onako kako Vam je rekao Vaš liječnik.
English: Remove caps from powder and solvent vials.
Croatian: Uklonite zatvarače s bočica s praškom i otapalom.
English: RIXUBIS is administered by intravenous infusion (IV) after reconstitution of the powder with the provided solvent by your doctor or nurse.
Croatian: RIXUBIS se primjenjuje infuzijom u venu (i.v.) nakon što liječnik ili sestra pripreme prašak s priloženim otapalom.
English: Contents: 1 powder vial, 1 solvent vial, 1 BAXJECT II device
Croatian: Prašak i otapalo za otopinu za injekciju Sadržaj: 1 bočica s praškom, 1 bočica s otapalom, 1 BAXJECT II uređaj
English: Mean±SD Median (range)
Croatian: Srednja vrijednost±SD Medijan (raspon)
English: There are no or limited amount of data from the use of Factor IX in pregnant women.
Croatian: Podaci o primjeni faktora IX u trudnica ne postoje ili su ograničeni.
English: Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reactions.
Croatian: Nefrotski sindrom je prijavljen nakon pokušaja indukcije imunološke tolerancije u bolesnika s hemofilijom B s inhibitorima faktora IX i povijesti alergijskih reakcija.
English: Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors.
Croatian: Nefrotski sindrom je prijavljen nakon pokušaja indukcije imunološke tolerancije u bolesnika s hemofilijom B s inhibitorima faktora IX.
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor IX.
Croatian: Farmakoterapijska skupina: antihemoragici, faktor zgrušavanja krvi IX. ATK oznaka: B02BD04.
English: Patients who have specific mutations of their factor IX gene such as major deletion may be more likely to have factor IX inhibitors and an allergic reaction in the early period with any factor IX concentrate.
Croatian: Proizvodnjom faktora IX u tijelu upravlja gen za faktor IX. Za bolesnike koji imaju specifične mutacije svoga gena za faktor IX, kao što su veća delecija (brisanje), vjerojatnije je da će imati inhibitore faktora IX i alergijsku reakciju u ranom razdoblju s bilo kojim koncentratom faktora IX. Stoga će Vaš liječnik pomnije pratiti pokazujete li znakove alergijske reakcije ako je poznato da imate takvu mutaciju.
English: RIXUBIS 500 IU powder and solvent for solution for injection RIXUBIS 1000 IU powder and solvent for solution for injection RIXUBIS 2000 IU powder and solvent for solution for injection RIXUBIS 3000 IU powder and solvent for solution for injection nonacog gamma (recombinant human coagulation factor IX)
Croatian: RIXUBIS 500 IU prašak i otapalo za otopinu za injekciju RIXUBIS 1000 IU prašak i otapalo za otopinu za injekciju RIXUBIS 2000 IU prašak i otapalo za otopinu za injekciju RIXUBIS 3000 IU prašak i otapalo za otopinu za injekciju nonakog gama (rekombinantni ljudski faktor zgrušavanja IX)
English: For an incremental recovery of 0.7 IU/dL per IU/kg, the dose is calculated as follows:
Croatian: Za prirast po jedinici doze od 0,7 IU/dl na IU/kg, doza se izračunava na sljedeći način:
English: The median ABR on prophylaxis with RIXUBIS for all bleeds was 2.0, for spontaneous bleeds 0.0, and for joint bleeds 0.0.
Croatian: Medijan godišnje stope krvarenja s profilaksom uz RIXUBIS za sva krvarenja iznosio je 2,0, za spontana krvarenja 0,0, a za krvarenja zglobova 0,0. 24 ispitanika (42,9%) nije imalo krvarenja.
English: Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC.
Croatian: Prilikom primjene ovoga lijeka u bolesnika s bolešću jetre, bolesnika nakon operacije, novorođenčadi, ili bolesnika kod kojih postoji rizik od pojave trombotskih komplikacija ili diseminirane intravaskularne koagulacije, zbog potencijalnog rizika od trombotskih komplikacija potrebno je uvesti klinički nadzor ranih znakova trombotske i potrošne koagulopatije uz odgovarajuće biološko testiranje.
English: Week 5 All (N=23)
Croatian: 5. tjedan Svi (N=23)
English: Please, contact your doctor immediately if you experience such signs.
Croatian: Ako se pojave takvi znakovi odmah se javite svom liječniku.
English: For an incremental recovery of 0.9 IU/dL per IU/kg, the dose is calculated as follows:
Croatian: Za prirast po jedinici doze od 0,9 IU/dl na IU/kg, doza se izračunava na sljedeći način:
English: The calculation of the required dose of factor IX is based on the empirical finding that 1 International Unit factor IX per kg body weight raises the plasma factor IX activity by 0.9 IU/dL (range from 0.5 to 1.4 IU/dL) or 0.9% of normal activity in patients 12 years and older (further information see section 5.2).
Croatian: Izračun potrebne doze faktora IX temelji se na empirijskom nalazu da 1 internacionalna jedinica faktora IX po kg tjelesne težine povećava aktivnost faktora IX u plazmi za 0,9 IU/dl (raspon od 0,5 do 1,4 IU/dl) ili 0,9% normalne aktivnosti u bolesnika od 12 godina i starijih (za dodatne informacije vidjeti dio 5.2).
English: RIXUBIS is provided as a powder and solvent for solution for injection.
Croatian: Kako RIXUBIS izgleda i sadržaj pakiranja RIXUBIS dolazi kao prašak i otapalo za otopinu za injekciju.
English: 19 bleeds were non-joint (soft tissue, muscle, body cavity, intracranial and other) and 7 were joint bleeds of which 1 was a bleed into a target joint.
Croatian: Ukupno 26 epizoda krvarenja liječeno je lijekom RIXUBIS, od kojih su 23 bila krvarenja uzrokovana ozljedom, 2 spontana i 1 nepoznatog podrijetla. 19 krvarenja nije bilo u zglobovima (meko tkivo, mišić, tjelesna šupljina, intrakranijalno i drugo), a 7 je bilo krvarenje zglobova, od kojih je 1 bilo krvarenje u ciljni zglob.
English: Reconstituted medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Croatian: Rekonstituirane lijekove potrebno je vizualno pregledati prije primjene kako biste provjerili sadrže li bilo kakve strane čestice ili je došlo do promjene boje.
English: The calculation of the required dose of factor IX is based on the empirical finding that 1 International Unit (IU) factor IX per kg body weight raises the plasma factor IX activity by 0.7 IU/dL (range from 0.31 to 1.0 IU/dL) or 0.7% of normal activity in patients less than 12 years of age (further information see section 5.2).
Croatian: Izračun potrebne doze faktora IX temelji se na empirijskom nalazu da 1 internacionalna jedinica (IU) faktora IX po kg tjelesne težine povećava aktivnost faktora IX u plazmi za 0,7 IU/dl (raspon od 0,31 do 1,0 IU/dl) ili 0,7% normalne aktivnosti u bolesnika mlađih od 12 godina starosti (za dodatne informacije vidjeti dio 5.2).
English: The calculation of the required dose of factor IX is based on the empirical finding that 1 International Unit factor IX per kg body weight raises the plasma factor IX activity by 0.7 IU/dL (range from 0.31 to 1.0 IU/dL) or 0.7% of normal activity in patients less than 12 years of age (further information see section 5.2).
Croatian: Izračun potrebne doze faktora IX temelji se na empirijskom nalazu da 1 internacionalna jedinica faktora IX po kg tjelesne težine povećava aktivnost faktora IX u plazmi za 0,7 IU/dl (raspon od 0,31 do 1,0 IU/dl) ili 0,7% normalne aktivnosti u bolesnika mlađih od 12 godina starosti (za dodatne informacije vidjeti dio 5.2).
English: Early haemarthrosis, muscle bleeding or oral bleeding
Croatian: Rana hemartroza, krvarenje u mišiću ili usnoj šupljini
English: Week 5 All (N=12)
Croatian: 5. tjedan Svi (N=12)
English: (inhibitors) against your medicine, as inhibitors may develop together with allergies.
Croatian: Vaš liječnik će možda napraviti i krvne pretrage kako bi provjerio jeste li razvili protutijela koja neutraliziraju aktivnost (inhibitore) Vašeg lijeka, jer se inhibitori mogu razviti zajedno s alergijama.
English: Problems from exaggerated blood clotting (thromboembolic episodes) have not been observed with this product, but may occur with any factor IX products.
Croatian: Problemi zbog pretjeranoga zgrušavanja krvi (tromboembolijske epizode) nisu zabilježene uz ovaj lijek, ali se mogu pojaviti s bilo kojim lijekom koji sadrži faktor IX. Oni mogu uključivati srčani udar, krvne ugruške u venama ili krvne ugruške u plućima.
English: Solvent: sterilised water for injections
Croatian: Otapalo: sterilizirana voda za injekcije
English: Median (range) Cmax (IU/dL) Mean±SD
Croatian: Srednja vrijednost±SD Medijan (raspon) Cmaks (IU/dl)
English: Fig. b
Croatian: Sl. b
English: Life-threatening haemorrhages.
Croatian: Krvarenja opasna po život.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI ZA PRAŠAK
English: PK (ED 1) All (N=12)
Croatian: FK (1. dan izloženosti) Svi (N=12)
English: Week 5 All (N=11)
Croatian: 5. tjedan Svi (N=11)
English: PK (ED 1) All (N=22)
Croatian: FK (1. dan izloženosti) Svi (N=22)
English: Week 26 All (N=10)
Croatian: 26. tjedan Svi (N=10)
English: Median (range) Half-life (hr) Mean±SD
Croatian: Srednja vrijednost ±SD Medijan (raspon) Poluvijek (h)
English: Week 26 All (N=21)
Croatian: 26. tjedan Svi (N=21)
English: Week 26 All (N=11)
Croatian: 26. tjedan Svi (N=11)
English: PK (ED 1) All (N=10)
Croatian: FK (1. dan izloženosti) Svi (N=10)
English: Major surgery
Croatian: Veliki kirurški zahvat
English: Week 13 All (N=21)
Croatian: 13. tjedan Svi (N=21)
English: 1 vial: 3000 IU nonacog gamma, approx. 600 IU/ml after reconstitution with 5 ml solvent.
Croatian: 1 bočica: 3000 IU nonakoga gama, približno 600 IU/ml nakon pripreme s 5 ml otapala.
English: Week 13 All (N=11)
Croatian: 13. tjedan Svi (N=11)
English: 1 vial: 250 IU nonacog gamma, approx. 50 IU/ml after reconstitution with 5 ml solvent.
Croatian: 1 bočica: 250 IU nonakoga gama, približno 50 IU/ml nakon pripreme s 5 ml otapala.
English: 1 vial: 500 IU nonacog gamma, approx. 100 IU/ml after reconstitution with 5 ml solvent.
Croatian: 1 bočica: 500 IU nonakoga gama, približno 100 IU/ml nakon pripreme s 5 ml otapala.
English: RIXUBIS 500 IU powder for injection nonacog gamma
Croatian: RIXUBIS 500 IU prašak za injekciju nonakog gama i.v. primjena
English: Median (range) Clearance (dL/(kg.hr)) Mean±SD
Croatian: Srednja vrijednost±SD Medijan (raspon) Klirens (dl/(kg.h))
English: Week 13 All (N=10)
Croatian: 13. tjedan Svi (N=10)
English: Factor IX is a normal constituent of human blood necessary for effective blood clotting.
Croatian: RIXUBIS sadrži djelatnu tvar nonakog gama i lijek je s faktorom zgrušavanja (koagulacije) IX. Faktor IX normalni je sastojak ljudske krvi nužan za učinkovito zgrušavanje krvi.
English: RIXUBIS 250 IU powder for injection nonacog gamma
Croatian: RIXUBIS 250 IU prašak za injekciju nonakog gama i.v. primjena
English: Treatment was individualised based on the severity, cause and site of bleed The majority (23; 88,5%) were treated with 1-2 infusions.
Croatian: Većina (23; 88,5%) liječeno je 1-2 infuzijama.
English: 1 vial: 2000 IU nonacog gamma, approx. 400 IU/ml after reconstitution with 5 ml solvent.
Croatian: 1 bočica: 2000 IU nonakoga gama, približno 400 IU/ml nakon pripreme s 5 ml otapala.
English: Patients less than 12 years:
Croatian: Bolesnici mlađi od 12 godina: liječenje prema potrebi
English: RIXUBIS 250 IU powder and solvent for solution for injection One vial contains nominally 250 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 50 IU/ml after reconstitution with 5 ml solvent.
Croatian: RIXUBIS 250 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 250 IU nonakoga gama, rekombinantnog koagulacijskog faktora IX, ljudskog (rDNK), što odgovara koncentraciji od 50 IU/ml nakon rekonstitucije s 5 ml otapala.
English: 1 vial: 1000 IU nonacog gamma, approx. 200 IU/ml after reconstitution with 5 ml solvent.
Croatian: 1 bočica: 1000 IU nonakoga gama, približno 200 IU/ml nakon pripreme s 5 ml otapala.
English: RIXUBIS 250 IU powder and solvent for solution for injection nonacog gamma (recombinant human coagulation factor IX)
Croatian: RIXUBIS 250 IU prašak i otapalo za otopinu za injekciju nonakog gama (rekombinantni ljudski koagulacijski faktor IX)
English: RIXUBIS 2000 IU powder and solvent for solution for injection One vial contains nominally 2000 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 400 IU/ml after reconstitution with 5 ml solvent.
Croatian: RIXUBIS 2000 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 2000 IU nonakoga gama, rekombinantnog koagulacijskog faktora IX, ljudskog (rDNK), što odgovara koncentraciji od 400 IU/ml nakon rekonstitucije s 5 ml otapala.
English: RIXUBIS 500 IU powder and solvent for solution for injection One vial contains nominally 500 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 100 IU/ml after reconstitution with 5 ml solvent.
Croatian: RIXUBIS 500 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 500 IU nonakoga gama, rekombinantnog koagulacijskog faktora IX, ljudskog (rDNK), što odgovara koncentraciji od 100 IU/ml nakon rekonstitucije s 5 ml otapala.
English: RIXUBIS 3000 IU powder and solvent for solution for injection One vial contains nominally 3000 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 600 IU/ml after reconstitution with 5 ml solvent.
Croatian: RIXUBIS 3000 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 3000 IU nonakoga gama, rekombinantnog koagulacijskog faktora IX, ljudskog (rDNK), što odgovara koncentraciji od 600 IU/ml nakon rekonstitucije s 5 ml otapala.
English: RIXUBIS 500 IU powder and solvent for solution for injection nonacog gamma (recombinant human coagulation factor IX)
Croatian: RIXUBIS 500 IU prašak i otapalo za otopinu za injekciju nonakog gama (rekombinantni ljudski koagulacijski faktor IX)
English: RIXUBIS 2000 IU powder for injection nonacog gamma
Croatian: RIXUBIS 2000 IU prašak za injekciju nonakog gama i.v. primjena
English: RIXUBIS 1000 IU powder for injection nonacog gamma
Croatian: RIXUBIS 1000 IU prašak za injekciju nonakog gama i.v. primjena
English: Lot:
Croatian: SERIJA:
English: RIXUBIS 3000 IU powder for injection nonacog gamma
Croatian: RIXUBIS 3000 IU prašak za injekciju nonakog gama i.v. primjena
English: Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX.
Croatian: Bolesnici s hemofilijom B mogu razviti neutralizirajuća protutijela (inhibitore) na faktor IX. Ako se pojave takvi inhibitori, to će se stanje očitovati kao nedostatan klinički odgovor.
English: RIXUBIS 3000 IU powder and solvent for solution for injection nonacog gamma (recombinant human coagulation factor IX)
Croatian: RIXUBIS 3000 IU prašak i otapalo za otopinu za injekciju nonakog gama (rekombinantni ljudski koagulacijski faktor IX)
English: RIXUBIS 2000 IU powder and solvent for solution for injection nonacog gamma (recombinant human coagulation factor IX)
Croatian: RIXUBIS 2000 IU prašak i otapalo za otopinu za injekciju nonakog gama (rekombinantni ljudski koagulacijski faktor IX)
English: Median (range) Mean residence time (hr) Mean±SD
Croatian: Srednja vrijednost±SD Medijan (raspon) Srednje vrijeme zadržavanja (h) Srednja vrijednost±SD Medijan (raspon)
English: RIXUBIS 1000 IU powder and solvent for solution for injection One vial contains nominally 1000 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 200 IU/ml after reconstitution with 5 ml solvent.
Croatian: RIXUBIS 1000 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 1000 IU nonakoga gama, rekombinantnog koagulacijskog faktora IX, ljudskog (rDNK), što odgovara koncentraciji od 200 IU/ml nakon rekonstitucije s 5 ml otapala.
English: - If you get any side effects, talk to your doctor, or pharmacist.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: RIXUBIS 1000 IU powder and solvent for solution for injection nonacog gamma (recombinant human coagulation factor IX)
Croatian: RIXUBIS 1000 IU prašak i otapalo za otopinu za injekciju nonakog gama (rekombinantni ljudski koagulacijski faktor IX)
English: If you get any side effects, talk to your doctor or, pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Surgery
Croatian: Kirurški zahvat
English: Reconstitution and administration
Croatian: Priprema i primjena
English: 70 or more
Croatian: 70 ili više
English: • heart attack in the last 3 to 6 months;
Croatian: • srčani udar u zadnjih 3 do 6 mjeseci;
English: ATC code: N01BB58
Croatian: ATK oznaka: N01BB58
English: Your dentist knows how to throw away medicines no longer used.
Croatian: Vaš stomatolog zna kako baciti lijekove koji se više ne koriste.
English: • are more than 70 years old.
Croatian: • stariji ste od 70 godina;
English: • have or have had any heart problem
Croatian: • imate ili ste imali bilo kakvih problema sa srcem;
English: SN: {number} <NN: {number} >
Croatian: PC: {broj} SN: {broj} <NN: {broj}>
English: This medicine contains two active substances:
Croatian: Ovaj lijek sadrži dvije djelatne tvari:
English: It also decreases bleeding during surgery.
Croatian: Također smanjuje krvarenje tijekom kirurškog zahvata.
English: • X is usually used for simple and short dental procedures
Croatian: • X se obično koristi za jednostavne i kratke stomatološke zahvate
English: Elderly patients:
Croatian: Stariji bolesnici:
English: The pKa of articaine has been estimated at 7.8.
Croatian: Vrijednost pKa artikaina procijenjena je na 7,8.
English: If you are given more X / Y than you should
Croatian: Ako Vam je primijenjeno više X/Y nego što je trebalo biti
English: If only a portion of a cartridge is used, the remainder must be discarded.
Croatian: Ako se iskoristi samo dio uloška, ostatak se mora baciti.
English: There is no experience of the use of articaine in pregnant women, except during childbirth.
Croatian: Nema iskustva s primjenom artikaina u trudnica, osim tijekom porođaja.
English: No difference was observed in pharmacodynamic properties between the adult and the paediatric population.
Croatian: Nije uočena razlika u farmakodinamičkim svojstvima između odrasle i pedijatrijske populacije.
English: Serious adverse reactions are generally systemic.
Croatian: Ozbiljne nuspojave općenito su sistemske.
English: Binding to γ-globulin (8.6-23.7%) was much lower.
Croatian: Vezanje na γ-globulin (8,6 - 23,7 %) bilo je daleko niže.
English: The rate of injection should be very slow (1 ml/min).
Croatian: Ubrizgavanje treba biti vrlo sporo (1 ml/min).