FrancophonIA/ELRC3.0 huggingface dataset:
English: On 11 July 2012, the reference Member State, the Czech Republic, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Croatian: Na dan 11. srpnja 2012. referentna zemlja članica, Republika Češka, obavijestila je Europsku agenciju za lijekove da CMD(v) nije postigao sporazum u vezi lijeka te da je pitanje upućeno CVMP-u temeljem
English: STRENZEN 500/125 mg/g powder for use in drinking water for pigs contains amoxicillin and clavulanic acid as active ingredients and is intended for use in pigs for the treatment of respiratory tract infections caused by microorganisms susceptible to the combination amoxicillin/clavulanic acid i.e. Actinobacillus pleuropneumoniae, Pasteurella spp, Streptococcus spp.
Croatian: STRENZEN 500/125 mg/g prašak za uporabu u vodi za piće kod svinja sadrži amoksicilin i klavulansku kiselinu kao djelatne tvari i namijenjen je za uporabu kod svinja za liječenje infekcija dišnih putova uzrokovanih mikroorganizmima koji su osjetljivi na kombinaciju amoksicilina/klavulanske kiseline tj.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics and package leaflet in Annex III.
Croatian: Znanstveni zaključci navedeni su u Dodatku II, zajedno sa Sažetkom opisa svojstava lijeka i uputom o lijeku u Dodatku III.
English: Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of STRENZEN 500/125 mg/g powder for use in drinking water for pigs is positive.
Croatian: Na temelju procjene trenutačno dostupnih podataka, CVMP smatra da je profil koristi i rizika za lijek STRENZEN 500/125 mg/g prašak za uporabu u vodi za piće kod svinja pozitivan.
English: The applicant, Novartis Animal Health Inc., submitted an application for a decentralised procedure for STRENZEN 500/125 mg/g powder for use in drinking water for pigs and associated names.
Croatian: Podnositelj zahtjeva, Novartis Animal Health Inc., podnio je zahtjev za decentralizirani postupak za STRENZEN 500/125 mg/g prašak za uporabu u vodi za piće kod svinja i povezana imena.
English: Therefore, the Committee adopted by consensus a positive opinion on 10 April 2013 recommending the granting of a marketing authorisation for STRENZEN 500/125 mg/g powder for use in drinking water for pigs and associated names.
Croatian: Stoga je Odbor konsenzusom prihvatio pozitivno mišljenje 10. travnja 2013. i preporučio izdavanje odobrenja za stavljanje u promet lijeka STRENZEN 500/125 mg/g praška za uporabu u vodi za piće kod svinja i povezanih imena.
English: Opinion following an Article 33(4)1 referral for STRENZEN 500/125 mg/g powder for use in drinking water for pigs and associated names
Croatian: Članka 33(4)0F za lijek STRENZEN 500/125 mg/g prašak za uporabu u vodi za piće kod svinja i povezana imena
English: EMA/325274/2013
Croatian: Članka 33(4)
English: These differences should be taken into account when dosing.
Croatian: Ove se razlike trebaju uzeti u obzir kod doziranja.
English: Wash your hands before opening the pack
Croatian: Operite ruke prije otvaranja pakiranja.
English: None of these patients developed inhibitors.
Croatian: Nijedan od ovih bolesnika nije razvio inhibitore.
English: Do not use external heat.
Croatian: Nemojte koristiti vanjski izvor topline.
English: Tell your doctor as soon as possible.
Croatian: Čim prije obavijestite liječnika.
English: 5000 Davis Drive Research Triangle Park, NC 27709 USA
Croatian: 5000 Davis Drive Research Triangle Park, NC 27709
English: Preparation:
Croatian: Priprema:
English: How often you need an injection will depend on how well ELOCTA is working for you.
Croatian: Koliko često ćete trebati primati injekciju ovisit će o tome koliko dobro ELOCTA kod Vas djeluje.
English: Always use this medicine exactly as your doctor has told you (see section 7).
Croatian: Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik (pogledajte dio 7).
English: This is of importance particularly when changing the laboratory and/or reagent used in the assay.
Croatian: To je osobito važno pri promjeni laboratorija i/ili reagensa koji se koristi u testu.
English: Uncommon (PTPs)1 Very common (PUPs)1
Croatian: manje često (PTPs)1 vrlo često (PUPs)1
English: EXP Use within 6 hours after reconstitution.
Croatian: EXP Primijeniti unutar 6 sati nakon rekonstitucije.
English: Date removed from refrigerator:
Croatian: Datum uklanjanja iz hladnjaka:
English: Do not reuse equipment.
Croatian: Nemojte ponovno koristiti ovaj pribor.
English: Take your dose as soon as you remember and then resume your normal dosing schedule.
Croatian: Uzmite dozu čim se sjetite i potom nastavite uzimati doze prema uobičajenom rasporedu.
English: Check the name and strength of the package, to make sure it contains the correct medicine.
Croatian: Provjerite naziv i jačinu na pakiranju kako biste bili sigurni da sadrži pravi lijek.
English: If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Croatian: Ako se pojave takvi inhibitori, to će se stanje manifestirati kao nedostatan klinički odgovor.
English: SE-112 76 Stockholm Sweden
Croatian: SE-112 76 Stockholm Švedska
English: Your doctor will perform appropriate laboratory tests to make sure that you have adequate factor VIII levels in your blood.
Croatian: Vaš će liječnik provesti odgovarajuće laboratorijske testove kako bi se osiguralo da imate odgovarajuću razinu faktora VIII u krvi.
English: What ELOCTA is and what it is used for
Croatian: Što je ELOCTA i za što se koristi
English: QR code to be included+ http://www.elocta-instructions.com
Croatian: Uključiti QR kod + http://www.elocta-instructions.com
English: Store in a refrigerator (2°C - 8°C).
Croatian: Čuvati u hladnjaku (2 °C-8 °C).
English: See section 5.2 for pharmacokinetic data.
Croatian: Vidjeti dio 5.2 za farmakokinetičke podatke.
English: Your doctor may change your recommended injection rate to make it more comfortable for you.
Croatian: Liječnik Vam može promijeniti preporučenu brzinu ubrizgavanja kako bi Vam primjena bila ugodnija.
English: 12 to <18 years
Croatian: 12 do <18 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); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalosti su procijenjene prema sljedećoj konvenciji: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The specific activity of ELOCTA is 4000-10200 IU/mg protein.
Croatian: Specifična aktivnost lijeka ELOCTA je 4000-10 200 IU/mg proteina.
English: Therefore, factor VIII should be used during pregnancy and breast-feeding only if clearly indicated.
Croatian: Stoga se faktor VIII smije primjenjivati tijekom trudnoće i dojenja samo ako za to postoji jasna indikacija.
English: 79.2 % of first injections were rated as excellent or good by the patients.
Croatian: 79,2 % prvih injekcija ocijenjeno je kao odlično ili dobro od strane bolesnika.
English: Rarely, inhibitors may develop after the first 100 exposure days.
Croatian: U rijetkim se slučajevima inhibitori mogu razviti nakon prvih 100 dana izlaganja.
English: Dosing of up to 80 IU/kg and a dosing interval as short as 2 days was allowed and used in a limited number of patients.
Croatian: Doziranje do 80 IU/kg i interval doziranja od samo 2 dana bili su dopušteni i primijenjeni u ograničenog broja bolesnika.
English: Contents of the pack and other information What ELOCTA contains
Croatian: Sadržaj pakiranja i druge informacije Što ELOCTA sadrži
English: 6 to <12 years
Croatian: 6 do <12 godina
English: The time to peak activity is not expected to be delayed.
Croatian: Ne očekuje se da će vrijeme do vršne aktivnosti biti produljeno.
English: If severe, sudden allergic reactions (anaphylactic reaction) occur, the injection must be stopped immediately.
Croatian: Ako nastane teška, iznenadna alergijska reakcija (anafilaktička reakcija), odmah se mora prekinuti davanje injekcije.
English: Non-clinical data reveal no special hazard for humans based on acute and repeated dose toxicity studies (which included assessments of local toxicity and safety pharmacology).
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju ispitivanja akutne toksičnosti i toksičnosti ponovljenih doza (koja su uključivala procjene lokalne toksičnosti i farmakologije sigurnosti primjene).
English: Other medicines and ELOCTA
Croatian: Drugi lijekovi i ELOCTA
English: If you stop using ELOCTA you may no longer be protected against bleeding or a current bleed may not stop.
Croatian: Ako prestanete primjenjivati lijek ELOCTA, možda više nećete biti zaštićeni od krvarenja ili trenutno krvarenje možda neće prestati.
English: If not used immediately, 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 lijeka u primjeni do uporabe su odgovornost korisnika.
English: No symptoms of overdose have been reported.
Croatian: Nisu prijavljeni simptomi predoziranja.
English: If you use more ELOCTA than you should
Croatian: Ako primijenite više lijeka ELOCTA nego što ste trebali
English: Frequency of doses (hours)/ Duration of therapy (days)
Croatian: Učestalost doziranja (sati) / trajanje terapije (dani)
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case (see section 5.2).
Croatian: Količinu koja će se primijeniti i učestalost primjene uvijek treba određivati ovisno o kliničkoj učinkovitosti u pojedinom slučaju (vidjeti dio 5.2).
English: Talk to your doctor, pharmacist or nurse before using ELOCTA.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite lijek ELOCTA.
English: The haemostatic response was rated by the physicians as excellent in 41 and as good in 3 of 44 major surgeries.
Croatian: Hemostatski odgovor ocijenjen je od strane liječnika kao odličan u 41 te kao dobar u 3 od ukupno 44 veće operacije.
English: After reconstitution, chemical and physical stability has been demonstrated for 6 hours when stored at room temperature (up to 30°C).
Croatian: Nakon rekonstitucije Nakon rekonstitucije, dokazana je kemijska i fizikalna stabilnost u trajanju od 6 sati kad se čuva na sobnoj temperaturi (do 30 °C).
English: What ELOCTA looks like and contents of the pack
Croatian: Kako ELOCTA izgleda i sadržaj pakiranja
English: Do not stop using ELOCTA without consulting your doctor.
Croatian: Nemojte prestati primjenjivati lijek ELOCTA bez savjetovanja s liječnikom.
English: From a microbiological point of view, the product should be used immediately after reconstitution.
Croatian: S mikrobiološkog gledišta, lijek treba primijeniti odmah nakon rekonstitucije.
English: Do not use this medicine if it has been stored at room temperature for longer than 6 months.
Croatian: Nemojte primjenjivati ovaj lijek ako se čuvao na sobnoj temperaturi dulje od 6 mjeseci.
English: 90.2 % of first injections were rated as excellent or good by the patients and their caregivers.
Croatian: 90,2 % prvih injekcija ocijenjeno je kao odlično ili dobro od strane bolesnika i njihovih njegovatelja.
English: • if you are allergic to efmoroctocog alfa or any other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na efmoroktokog alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: ELOCTA is used to replace the missing or deficient factor VIII.
Croatian: ELOCTA se primjenjuje da nadomjesti nedostatak ili manjkavost faktora VIII.
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Croatian: U takvim se slučajevima preporučuje kontaktirati specijalizirani centar za hemofiliju.
English: In case of anaphylactic shock, standard medical treatment for shock should be implemented.
Croatian: U slučaju anafilaktičkog šoka potrebno je provesti standardno medicinsko liječenje.
English: Prophylaxis regimens:
Croatian: Profilaktički režimi:
English: ELOCTA is prepared by recombinant technology without addition of any human- or animal-derived components in the manufacturing process.
Croatian: ELOCTA je proizvedena rekombinantnom tehnologijom bez dodavanja ikakvih sastojaka ljudskog ili životinjskog podrijetla u procesu proizvodnje.
English: If you are not sure what to do, ask your doctor or pharmacist.
Croatian: Ako niste sigurni što učiniti, upitajte svog liječnika ili ljekarnika.
English: Minor surgery including tooth extraction
Croatian: Kirurgija Manji kirurški zahvat uključujući vađenje zuba
English: Your doctor will calculate your dose of ELOCTA (in International Units or “IU”) depending on your individual needs for factor VIII replacement therapy and on whether it is used for prevention or treatment of bleeding.
Croatian: Vaš će liječnik izračunati dozu lijeka ELOCTA (u međunarodnim jedinicama ili “IU”), koja će ovisiti o Vašim osobnim potrebama za nadomjesnom terapijom faktorom VIII i o tome primjenjuje li se za sprječavanje ili za liječenje krvarenja.
English: Adverse reactions were monitored for a total of 893.72 subject-years.
Croatian: Nuspojave su praćene za ukupno 893,72 ispitanik-godina.
English: If preferred, you may use one of the plasters (G) provided in the pack to hold the plastic wings of the needle in place at the injection site.
Croatian: Ako želite, možete uporabiti jedan od flastera (G) priloženih u pakiranju kako biste pričvrstili plastična krilca igle na mjesto davanja injekcije.
English: Please safely dispose of the used needle, any unused solution, the syringe and the empty vial in an appropriate medical waste container as these materials may hurt others if not disposed of properly.
Croatian: Molimo da na siguran način odbacite uporabljenu iglu, svu neprimijenjenu otopinu, štrcaljku i praznu bočicu u odgovarajući spremnik za medicinski otpad, jer se drugi mogu ozlijediti ovim priborom ako ga se ne zbrine na odgovarajući način.
English: A placental transfer study in mice was conducted (see section 5.3).
Croatian: Provedeno je ispitivanje prijenosa kroz placentu u miševa (vidjeti dio 5.3).
English: In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk.
Croatian: U bolesnika s postojećim kardiovaskularnim čimbenicima rizika, zamjenska terapija FVIII-om može povećati kardiovaskularni rizik.
English: 12 adolescent subjects age 12 up to 18 years were included in the adult study population on prophylactic treatment.
Croatian: 12 ispitanika adolescenata u dobi od 12 do 18 godina bilo je uključeno u ispitivanu populaciju odraslih na profilaktičkom liječenju.
English: Studies to investigate genotoxicity, carcinogenicity, toxicity to reproduction or embryo-foetal development have not been conducted.
Croatian: Ispitivanja kojima bi se istražila genotoksičnost, kancerogeni potencijal, reproduktivna i embriofetalna razvojna toksičnost nisu provedena.
English: In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Croatian: Općenito, sve bolesnike liječene koagulacijskim faktorom VIII treba pažljivo pratiti na razvoj inhibitora odgovarajućim kliničkim pregledima i laboratorijskim testovima.
English: Activated factor X converts prothrombin into thrombin.
Croatian: Aktivirani faktor X pretvara protrombin u trombin.
English: If you are on a controlled sodium diet see section 2.
Croatian: Ako ste na dijeti s ograničenim unosom natrija, pogledajte dio 2.
English: 1 In some patients and circumstances the dosing interval can be prolonged up to 36 hours.
Croatian: 1 U nekih bolesnika i u nekim okolnostima, vremenski razmak između doziranja može se produljiti na 36 sati.
English: For adolescents of 12 years of age and above, the dose recommendations are the same as for adults.
Croatian: U adolescenata u dobi od 12 i više godina preporuke za doziranje iste su kao i u odraslih.
English: An instructional video on how to prepare and administer ELOCTA is available by scanning the QR code with a smartphone or via the website.
Croatian: Videu s uputama o tome kako pripremiti i primijeniti lijek ELOCTA možete pristupiti skeniranjem QR koda pomoću pametnog telefona ili pomoću internetske stranice
English: Factor VIII is a protein produced naturally in the body and is necessary for the blood to form clots and stop bleeding.
Croatian: Faktor VIII je protein koji se prirodno stvara u tijelu i neophodan je za stvaranje krvnih ugrušaka i zaustavljanje krvarenja.
English: In comparison with adolescents and adults, children less than 12 years of age may have a higher clearance and a shorter half-life which is consistent with observations of other coagulation factors.
Croatian: U usporedbi s adolescentima i odraslima, djeca mlađa od 12 godina mogu imati viši klirens i kraći poluvijek eliminacije, što je dosljedno opažanjima za druge faktore zgrušavanja krvi.
English: Paediatric population The listed warnings and precautions apply both to adults, children and adolescents.
Croatian: Pedijatrijska populacija Navedena upozorenja i mjere opreza odnose se kako na odrasle tako i na djecu i adolescente.
English: The total number of exposure days was 80,848 with a median of 294 (range 1-735) exposure days per subject.
Croatian: Ukupni broj dana izloženosti iznosio je 80 848, uz medijan od 294 (raspon: 1-735) dana izloženosti po ispitaniku.
English: ELOCTA can be used in children and adolescents of all ages.
Croatian: Lijek ELOCTA se može primjenjivati u djece i adolescenata svih uzrasta.
English: The Fc region of human immunoglobulin G1 binds to the neonatal Fc receptor.
Croatian: Fc regija ljudskog imunoglobulina G1 veže se za neonatalni Fc receptor.
English: After reconstitution, if the product is not used within 6 hours, it must be discarded.
Croatian: Nakon rekonstitucije, ako se ne primijeni u roku od 6 sati, lijek se mora odbaciti.
English: If you cannot use the prepared ELOCTA solution immediately, it should be used within 6 hours.
Croatian: Ako ne možete odmah primijeniti pripremljenu otopinu lijeka ELOCTA, treba je primijeniti u roku od 6 sati.
English: Administration (Intravenous injection):
Croatian: Primjena (injekcija u venu):
English: Weekly prophylaxis: 65 IU/kg
Croatian: Tjedna profilaksa: 65 IU/kg
English: The dose may be adjusted based on patient response in the range of 25 to 65 IU/kg (see section 5.1 and 5.2).
Croatian: Ta se doza može prilagoditi na temelju odgovora bolesnika u rasponu od 25 do 65 IU/kg (vidjeti dijelove 5.1 i 5.2).
English: The rate of administration should be determined by the patient's comfort level and should not exceed 10 mL/min.
Croatian: Brzinu primjene treba odrediti prema razini ugode u bolesnika i ne smije biti veća od 10 ml/min.
English: Contents of the pack and other information Instructions for preparation and administration
Croatian: Sadržaj pakiranja i druge informacije Upute za pripremu i primjenu
English: If ELOCTA has been stored in a refrigerator, allow the vial of ELOCTA (A) and the syringe with solvent (B) to reach room temperature before use.
Croatian: Ako se ELOCTA čuvala u hladnjaku, dopustite da bočica lijeka ELOCTA (A) i štrcaljka s otapalom (B) postignu sobnu temperaturu prije primjene.
English: Out of 153 subjects who completed Study I, 150 were enrolled onto Study III (extension study).
Croatian: Od 153 ispitanika koja su završila Ispitivanje I, njih 150 bilo je uključeno u Ispitivanje III (nastavak ispitivanja).
English: In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered.
Croatian: U bolesnika s visokim razinama inhibitora, terapija faktorom VIII možda neće biti učinkovita pa treba razmotriti druge terapijske mogućnosti.
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII, ATC code: B02BD02
Croatian: Farmakoterapijska skupina: antihemoragici, faktor zgrušavanja krvi VIII, ATK oznaka: B02BD02
English: Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X on phospholipid surfaces.
Croatian: Aktivirani faktor VIII djeluje kao kofaktor za aktivirani faktor IX, koji ubrzava konverziju faktora X u aktivirani faktor X na fosfolipidnim površinama.
English: How ELOCTA works
Croatian: Kako ELOCTA djeluje
English: The factor VIII/von Willebrand factor complex consists of 2 molecules (factor VIII and von Willebrand factor) with different physiological functions.
Croatian: Mehanizam djelovanja Kompleks faktora VIII/von Willebrandovog faktora sastoji se od 2 molekule (faktora VIII i von Willebrandovog faktora) s različitim fiziološkim funkcijama.
English: ELOCTA should not be mixed with other solutions for injection or infusion.
Croatian: ELOCTA se ne smije miješati s drugim otopinama za injekciju ili infuziju.
English: The dose of ELOCTA is calculated depending on your body weight and the factor VIII levels to be achieved.
Croatian: Doza lijeka ELOCTA izračunava se ovisno o Vašoj tjelesnoj težini i razinama faktora VIII koje treba postići.
English: Do not use beyond the expiry date printed on the vial or six months after removing the carton from refrigeration, whichever is earlier.
Croatian: Nemojte primjenjivati lijek nakon isteka roka valjanosti otisnutog na bočici ili šest mjeseci nakon uklanjanja kutije iz hladnjaka, što god bude ranije.
English: The Table 2 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Croatian: Tablica 2 u nastavku u skladu je s klasifikacijom organskih sustava prema MedDRA (SOC i razina preporučenog pojma).
English: Required units = body weight (kg) x desired factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL)
Croatian: Potrebne jedinice = tjelesna težina (kg) x željeni porast faktora VIII (%) (IU/dl) x 0,5 (IU/kg po IU/dl)
English: No interactions of human coagulation factor VIII (rDNA) with other medicinal products have been reported.
Croatian: Nisu zabilježene interakcije ljudskog faktora zgrušavanja krvi VIII (rDNK) s drugim lijekovima.
English: Pharmacokinetic parameters after 50 IU/kg dose of ELOCTA are presented in Tables 3 and 4.
Croatian: Farmakokinetički parametri nakon doze lijeka ELOCTA od 50 IU/kg prikazani su u tablicama 3 i 4.
English: After this time, the prepared ELOCTA should be discarded.
Croatian: Nakon tog vremena pripremljeni lijek ELOCTA treba odbaciti.
English: • There is a small chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ELOCTA.
Croatian: - Postoji mala vjerojatnost da razvijete anafilaktičku reakciju (jaka, iznenadna alergijska reakcija) na lijek ELOCTA.
English: It is produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line without the addition of any exogenous human- or animal-derived protein in the cell culture process, purification or final formulation.
Croatian: Proizveden je tehnologijom rekombinantne DNK u staničnoj liniji bubrega ljudskog embrija (HEK) bez dodavanja ikakvog egzogenog proteina ljudskog ili životinjskog podrijetla tijekom postupka kultiviranja stanica, pročišćavanja ili konačne formulacije.
English: For children below the age of 12, more frequent or higher doses may be required (see section 5.1).
Croatian: U djece mlađe od 12 godina može biti potrebno učestalije doziranje ili primjena viših doza (vidjeti dio 5.1).
English: In a placental transfer study, ELOCTA has been shown to cross the placenta in small amounts in mice.
Croatian: U ispitivanju placentarnog prijenosa pokazalo se da lijek ELOCTA prelazi placentu u malim količinama u miševa.
English: Table 1 can be used to guide dosing in bleeding episodes and surgery:
Croatian: Tablica 1 može služiti kao smjernica za doziranje u slučajevima krvarenja i kirurških zahvata: