FrancophonIA/ELRC3.0 huggingface dataset:
English: Vaccine virus genome is rarely detectable by RT-PCR in tonsils and lymph nodes for up to 63 days after vaccination and vaccine virus is very rarely detectable by virus isolation in tonsil for the first week after vaccination.
Croatian: Genom cjepnog virusa rijetko se otkriva pomoću RT-PCR u tonzilama i limfnim čvorovima do 63 dana nakon cijepljena, a cjepni virus se rijetko otkriva pomoću izolacije virusa u tonzilama u prvom tjednu nakon cijepljenja.
English: Name and address of the manufacturers of the biological active substance
Croatian: Naziv i adresa proizvođača biološki djelatnih tvari
English: Therefore, sows should not be vaccinated, due to the risk of birth of immunotolerant persistently infected offspring.
Croatian: Stoga se krmače ne smiju vakcinirati, zbog rizika od rađanja imunotolerantnih, trajno inficiranih potomaka.
English: Active substance: Lyophilisate:
Croatian: Djelatna tvar: Liofilizat:
English: DIVA efficiency depends on the performance of tests related to fitness for purpose in outbreak situations.
Croatian: Djelotvornost DIVA ovisi o performansi ispitivanja koja se odnosi na prikladnost za svrhu u situacijama izbijanja bolesti.
English: Shelf-life after reconstitution according to directions: use immediately.
Croatian: Rok valjanosti poslije rekonstitucije prema uputi: odmah upotrijebiti.
English: Persistently infected immunotolerant piglets represent a very high risk since they are shedding field virus and they cannot be identified serologically due to their seronegative status.
Croatian: Trajno inficirana imunotolerantna prasad predstavljaju vrlo visoki rizik jer izlučuju terenski virus, a ona se ne mogu serološki identificirati zbog svog seronegativnog statusa.
English: The recombinant vaccine virus has potential marker properties for use in DIVA (differentiation between field virus infected and solely vaccinated animals).
Croatian: Rekombinirani cjepni virus ima potencijalna svojstva markera za primjenu u DIVA (differentiation between field virus infected and solely vaccinated animals - razlikovanje životinja inficiranih terenskim virusom od cijepljenih životinja).
English: For active immunisation of pigs from 7 weeks of age onwards to prevent mortality and reduce infection and disease caused by classical swine fever virus (CSFV).
Croatian: Za aktivnu imunizaciju svinja u dobi od 7 tjedana starosti na dalje kako bi se spriječila smrtnost i smanjila infekcija i bolest uzrokovane virusom klasične svinjske kuge VKSK.
English: A single 1 ml dose should be administered to pigs from 7 weeks of age.
Croatian: Pojedinačnu dozu od 1 ml treba primijeniti svinjama u dobi od 7 tjedana.
English: Date of last renewal:
Croatian: Datum posljednjeg produljenja odobrenja:
English: Sodium chloride 9 mg/ml Water for injections q.s.p.
Croatian: Natrijev klorid 9 mg/ml Voda za injekcije q.s.p. 1 ml
English: Sodium chloride solution 9 mg/ml
Croatian: Otopina natrijevog klorida 9 mg/ml
English: Documentation provided for this vaccine supports that it is only to be used in an outbreak situation in herds within restricted control zones.
Croatian: Dokumentacija priložena uz ovo cjepivo podupire njegovu upotrebu samo tijekom izbijanja bolesti u stadima unutar ograničenih kontroliranih područja.
English: Serological DIVA concept has been shown in principle, while actual DIVA tools remain to be tested on large panels of samples from emergency vaccination in outbreak situations.
Croatian: Serološki DIVA koncept prikazan je u načelu, dok stvarni DIVA alati ostaju za testiranje na velikim panelima uzoraka kod hitnog cijepljenja u situacijama izbijanja bolesti.
English: Therefore, the decision to vaccinate breeding boars and piglets with maternally derived antibodies should be taken based on the actual outbreak case and associated control zones.
Croatian: Stoga odluka o cijepljenju nerasta za rasplod i prasadi s materinjim antitijelima treba donijeti na temelju stvarnog izbijanja bolesti i povezanih kontroliranih zona.
English: 104.8* to 106.5 TCID**50
Croatian: 104,8* do 106,5 TCID**50
English: 104.8 to 106.5 TCID50
Croatian: 104,8 do 106,5 TCID50
English: L2 Freeze-drying Stabilizer composed as follows Dextran 40
Croatian: Sastav L2 stabilizatora za liofilizaciju: Dekstran 40
English: EXP {month/year} Once broached, use immediately.
Croatian: EXP {mjesec/godina} Jednom otvoreno, odmah upotrijebiti.
English: Type I hydrolytic glass vials containing 10 or 50 doses of lyophilisate and 10 or 50 ml of solvent.
Croatian: Bočice od hidrolitičkog stakla tip I koje sadrže 10 ili 50 doza liofilizata i 10 ili 50 ml otapala.
English: EXP {month/year} Once reconstituted use immediately.
Croatian: EXP {mjesec/godina} Jednom rekonstituiran, odmah upotrijebiti.
English: Challenge studies have shown lack of protection against transplacental transmission of CSFV.
Croatian: Testiranje ispitnim sojem virusa je pokazalo nedostatak zaštite od transplacentarnog prijenosa VKSK.
English: Studies in vaccinated breeding boars addressing potential shedding of virulent challenge virus in semen have not been conducted.
Croatian: Ispitivanja u cijepljenih nerasta za rasplod, koja se odnose na potencijalno izlučivanje virulentnog ispitnog soja virusa u sjemenu, nisu provedena.
English: Solvent: Clear colourless liquid
Croatian: Otapalo: bistra bezbojna tekućina
English: Specific derogation is required to use this vaccine in an outbreak situation.
Croatian: Za upotrebu ove vakcine u situacijama izbijanja bolesti potrebno je specifično odstupanje.
English: Challenge studies were conducted with the Koslov strain (genotype 1) of CSFV.
Croatian: Testiranja ispitnim sojem virusa provedena su sojem Koslov (genotip 1) VKSK.
English: RT-PCR tools could be used in outbreak situations to differentiate between the vaccine virus genome and those of fields strains based on sequences unique to the CP7_E2alf.
Croatian: RT-PCR alati mogu se koristiti u slučajevima izbijanja bolesti kako bi se razlikovao genom cjepnog virusa i genom terenskog soja na temelju sekvenci jedinstvenih za CP7_E2alf.
English: Basic vaccination A single 1 ml dose should be administered intramuscularly to pigs from 7 weeks of age.
Croatian: Pojedinačnu dozu od 1 ml treba primijeniti intramuskularno svinjama u dobi od 7 tjedana.
English: Reconstitute the lyophilisate aseptically with the solvent to obtain a suspension for injection.
Croatian: Aseptično rekonstituirajte liofilizat s otapalom kako bi dobili suspenziju za injekciju.
English: The vaccine has shown reduced protection in studies of piglets with maternally derived antibodies compared to studies of piglets without maternally derived antibodies.
Croatian: Cjepivo je u ispitivanjima prasadi s majčinskim antitijelima pokazalo smanjenu zaštitu u usporedbi s ispitivanjima prasadi bez materinjih antitijela.
English: Use of the vaccine in experimental studies in breeding boars has not revealed safety concerns.
Croatian: Upotreba cjepiva u eksperimentalnim ispitivanjima u nerasta za rasplod nije otkrila probleme vezane uz neškodljivost .
English: 6 BATCH NUMBER
Croatian: 6 BROJ PROIZVODNE SERIJE
English: Basic vaccination
Croatian: Osnovno cijepljenje
English: Serological DIVA tools based on detection of CSFV antibodies other than those raised against E2, such as Erns antibody detection should be able to differentiate between antibody responses against Erns-BVDV after solely herd vaccination with CP7_E2alf from responses against Erns-CSFV after natural field CSFV infection.
Croatian: Serološki DIVA alati koji se temelje na otkrivanju antitijelaVKSK, različitih od onih izazvanih protiv E2, kao što je to otkrivanje Erns protutijela, trebali bi biti u mogućnosti razlikovati reakciju antitijela protiv Erns BVDV nakon cijepljenja stada sa CP7_E2alf od reakcije protiv Erns VKSK nakon infekcije s prirodnim terenskim virusom VKSK.
English: Serological DIVA tools based on detection of CSFV antibodies other than those raised against E2, such as Erns antibody detection should be able to differentiate between antibody responses after solely herd vaccination with CP7_E2alf from responses after natural field CSFV infection.
Croatian: Serološki DIVA alati koji se temelje na otkrivanju antitijela CSFV različitih, od onih izazvanih protiv E2 kao što je otkrivanje Erns protutijela trebali bi biti u mogućnosti razlikovati reakciju antitijela nakon cijepljenja stada sa CP7_E2alf od reakcije nakon infekcije s prirodnim terenskim virusom VKSK.
English: Pharmacotherapeutic group: live viral vaccines, live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene, ATC vet code: QI09AD04
Croatian: IMUNOLOŠKA SVOJSTVA Farmakoterapijska grupa: živa virusna cjepiva, živi rekombinirani virus goveđe virusne dijareje s deletiranim E2 genom, koji sadrži E2 gen klasične svinjske kuge ATC vet kod: QI09AD04 Za stimuliranje aktivnog imuniteta na virus klasične svinjske kuge
English: Cardboard box containing 1 vial with 50 doses of lyophilisate and 1 vial with 50 ml solvent.
Croatian: Kartonska kutija sadrži 1 bočicu s 50 doza liofilizata i 1 bočicu s 50 ml otapala.
English: Casein hydrolysate
Croatian: Hidrolizat kazeina
English: Lyophilisate
Croatian: NUSPOJAVE
English: Cardboard box containing 1 vial with 10 doses of lyophilisate and 1 vial with 10 ml solvent.
Croatian: Kartonska kutija sadrži 1 bočicu s 10 doza liofilizata i 1 bočicu s 10 ml otapala.
English: Live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene (CP7_E2alf)
Croatian: Živi rekombinirani virus goveđe virusne dijareje s deletiranim E2 genom koji sadrži E2 gen klasične svinjske kuge (CP7_E2alf)
English: Lyophilisate: Off-white pellet
Croatian: Liofilizat: peleta prljavo bijele boje
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance:
Croatian: 3. KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
English: 1ml
Croatian: i.m.
English: Lyophilisate and solvent for suspension for injection for pigs
Croatian: Liofilizat i otapalo za suspenziju za injekciju za svinje
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: Suvaxyn CSF Marker lyophilisate for suspension for injection for pigs
Croatian: Suvaxyn CSF Marker liofilizat za suspenziju za injekciju za svinje
English: PACKAGE LEAFLET: Suvaxyn CSF Marker lyophilisate and solvent for suspension for injection for pigs
Croatian: UPUTA O VMP: Suvaxyn CSF Marker liofilizat i otapalo za suspenziju za injekciju za svinje
English: Suvaxyn CSF Marker lyophilisate and solvent for suspension for injection for pigs
Croatian: Suvaxyn CSF Marker liofilizat i otapalo za suspenziju za injekciju za svinje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Boxes of 1 vial of 10 or 50 doses
Croatian: Kutija s 1 bočicom od 10 ili 50 doza
English: Lyophilisate: bromobutyl rubber stoppers and aluminium caps Solvent: chlorobutyl rubber stoppers and aluminium caps Cardboard box containing 1 vial with 10 doses of lyophilisate and 1 vial with 10 ml solvent.
Croatian: Liofilizat: bromobutilni gumeni čepovi i aluminijske kapice
English: The vaccine is a live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene.
Croatian: Cjepivo je živi rekombinirani virus goveđe virusne dijareje s deletiranim E2 genom, koji sadrži E2
English: To stimulate active immunity to Classical Swine Fever virus.
Croatian: gen klasične svinjske kuge.
English: Live recombinant CP7-E2Alf:
Croatian: KOLIČINA DJELATNIH TVARI Živi rekombinantni virus (CP7-E2Alf): 104,8 - 106,5 TCID50
English: Girona
Croatian: OBLIK
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vial label (10 and 50 doses)
Croatian: Etiketa bočice s liofilizatom (10 i 50 doza) NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
English: Solvent:
Croatian: Otapalo:
English: Pharmaceutical Products Ltd,
Croatian: S.M. Pharmaceutical Products Ltd,
English: 92931 Paris La Défense Cedex FRANCE
Croatian: 92931 Paris La Défense Cedex
English: Czech Republic
Croatian: Češka Republika
English: Diagonal, 67-69 08019 Barcelona Spain
Croatian: Diagonal, 67-69 08019 Barcelona ESPAÑA
English: IZ NOE-Sued, Strasse 7, Obj.58D/1/2.OG, 2355 Wiener Neudorf, Austria
Croatian: IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG 2355 Wiener Neudorf Austria
English: PHARMACEUTICAL INDUSTRY Proel Epam.
Croatian: PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS
English: ACTAVIS GROUP (ISLANDE) Reykjavikurvegur 76-78 220 Hafnarfjordur ISLANDE
Croatian: ACTAVIS GROUP (ISLANDE) Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland
English: Neo-Farmacêutica, S.A. Av. D. João II, Lote 1.02.2.1 D2º
Croatian: Neo-Farmacêutica, S.A. Av. D. João II, Lote 1.02.2.1 D-2º 1990-090 Lisboa Portugal
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for diacerin containing medicinal products
Croatian: Dodatak I Popis naziva, farmaceutskog(ih) oblika, jačine(a) lijek(ov)a, put(ev)a primjene, nositelja odobrenja u državama članicama
English: BROS EPE Avgis & Gallinis 15, n. Kifissia,
Croatian: Avgis & Gallinis 15, n.
English: RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92800 Puteaux FRANCE
Croatian: 11-15 Quai de Dion Bouton 92800 Puteaux France
English: VOCATE Pharmaceuticals S.A., Gounari 150, Glyfada 16674, Athens
Croatian: Gounari 150, Glyfada 16674, Athens Greece
English: PROTON PHARMA Anonymous Pharmaceutical Company, Achaias 4 and Trizoinias, Nea Kifissia 14564
Croatian: PROTON PHARMA Achaias 4 and Trizoinias, Nea Kifissia 14564 Greece
English: ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre FRANCE
Croatian: ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes PâturesParc d'Activités des Peupliers
English: ANGELINI PHARMA HELLAS Nea Kifissia 14564, Athens Greece
Croatian: ANGELINI PHARMA HELLAS Achaias and Troizinias, Nea Kifissia 14564, Athens Greece
English: ROTTAPHARM S.L.
Croatian: ROTTAPHARM S.L. Avda.
English: EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex
Croatian: A 12, rue Danjou 92517 Boulogne Billancourt Cedex
English: Via Meucci 36
Croatian: ABIOGEN PHARMA S.p.A. Via Meucci 36
English: 49, avenue Georges Pompidou 92300 Levallois-Perret FRANCE
Croatian: 92300 Levallois-Perret France
English: 15, boulevard Charles de Gaulle 92700 C olombes
Croatian: 15, boulevard Charles de Gaulle
English: MAZART 50 mg, gélule
Croatian: MAZART 50 mg, gélule 50 mg
English: SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini 75116 Paris FRANCE
Croatian: SUBSTIPHARM DEVELOPPEMENT 24, rue Erlanger 75016 Paris FRANCE
English: VERBORIL 50 mg Kapseln
Croatian: VERBORIL 50 mg Kapseln 50 mg
English: Menandrou 54, Athens, 10431 Greece
Croatian: Menandrou 54, Athens,
English: ABIOGEN PHARMA S.p.A.
Croatian: AURORA PHARMACEUTICALS S.A.
English: ZONDAR 50 mg, gélule
Croatian: ZONDAR 50 mg, gélule 50 mg
English: 15, boulevard Charles de Gaulle 92700 Colombes FRANCE
Croatian: 92700 Colombes France
English: DIACEREIN /NORMA 50 mg capsule, hard
Croatian: DIACEREIN /NORMA 50 mg
English: G. Koronis Dilou 9, Peristeri, Attikis, 12134 Greece
Croatian: Dilou 9, Peristeri, Attikis,
English: DATE OF REVISION OF TEXT
Croatian: DATUM REVIZIJE TEKSTA
English: (pre- and postoperative)
Croatian: (pre- i postoperativno)
English: See your doctor immediately, if bleeding does not stop as expected.
Croatian: Odmah posjetite svog liječnika ako krvarenje ne prestaje kao što je očekivano.
English: This leaflet was last approved
Croatian: Ova uputa je zadnji put odobrena
English: Produced from the plasma of human donors.
Croatian: Proizvedeno iz plazme ljudskih darivatelja.
English: If you are unsure, you should discuss this with your doctor.
Croatian: Ako niste sigurni, razgovarajte o tome sa svojim liječnikom.
English: Instructions for use:
Croatian: Upute za uporabu:
English: The required dose is determined using the following formula:
Croatian: Potrebna doza određuje se korištenjem sljedeće formule:
English: Previously untreated patients
Croatian: Prethodno neliječeni bolesnici
English: No data are available.
Croatian: Podaci nisu dostupni.
English: Administer immediately.
Croatian: Odmah primijenite.
English: The other (serious and non-serious) adverse reactions were received by spontaneous reporting.
Croatian: Druge nuspojave (ozbiljne i one koje nisu ozbiljne) zaprimljene su spontanim prijavljivanjem.
English: Thrombin then converts fibrinogen into fibrin and a clot is formed.
Croatian: Trombin tada pretvara fibrinogen u fibrin te se oblikuje ugrušak.
English: The solution should not be too cold when it is administered.
Croatian: Otopina ne smije biti prehladna kad se primjenjuje.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, even those not prescribed.
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzimali ili biste mogli uzeti bilo koje druge lijekove, čak i one koje Vam nije propisao liječnik.
English: UNIQUE IDENTIFIER - 2D BARCODE 18.
Croatian: JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
English: In case of shock, standard medical treatment for shock should be implemented.
Croatian: U slučaju šoka potrebno je primijeniti standardno medicinsko liječenje šoka.
English: If you have the impression that the effect of Nonafact is too strong or too weak, talk to your doctor.
Croatian: Ako imate dojam da je učinak lijeka Nonafact prejak ili preslab, obratite se svom liječniku
English: Nonafact may be self-administered if it is an approved practice in your country and when you have been trained sufficiently.
Croatian: Nonafact si možete davati i sami ako je to odobreno u Vašoj državi i ako ste dovoljno uvježbani.
English: You should discuss the possible side effects with your doctor in order to know how to recognise them and what to do if they occur.
Croatian: Trebali biste razgovarati sa svojim liječnikom o mogućim nuspojavama kako biste ih naučili prepoznati i što učiniti u slučaju da se pojave.
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: Nuspojave su prikazane prema sljedećim kategorijama učestalosti: 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) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Croatian: Sljedeća tablica može se koristiti kao vodič za doziranje u slučajevima krvarenja i u kirurgiji:
English: Do not shake!
Croatian: Ne tresite!
English: Neutralising antibodies (Inhibitors)
Croatian: Neutralizirajuća protutijela (inhibitori)
English: This will show itself as an increased tendency to bleed.
Croatian: To će se ispoljiti kao povećana sklonost krvarenju.
English: Renewal of authorisation: 03 July 2006
Croatian: Datum posljednje obnove odobrenja: 3. srpnja 2006.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at a temperature of 21°C.
Croatian: Nakon rekonstitucije: Kemijska i fizikalna stabilnost u primjeni je dokazana tijekom 3 sata na temperaturi od 21°C.
English: They will then ensure that factor IX is administered to you, should this prove necessary.
Croatian: Oni će tada osigurati da Vam se da faktor IX, ako se pokaže potreba za tim.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet podnosit će periodička izvješća o neškodljivosti za ovaj lijek u skladu sa zahtjevima definiranim u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: Contents of pack and other information
Croatian: Sadržaj pakiranja i druge informacije
English: If you have to undergo surgery or have a tooth extracted, inform your doctor or dentist that you have factor IX deficiency.
Croatian: Ako trebate na operaciju ili vađenje zuba, obavijestite svog liječnika ili zubara da imate nedostatak faktora IX.
English: Paediatric population The listed warnings and precautions apply both to adults and children.
Croatian: Pedijatrijska populacija Navedena upozorenja i mjere opreza primjenjuju se na odrasle i djecu.
English: Nonafact contains sodium chloride
Croatian: Nonafact sadrži natrijev klorid
English: The specific activity of Nonafact is approximately 200 IU/mg protein.
Croatian: Specifična aktivnost lijeka Nonafact je približno 200 IU/mg proteina.
English: Viral safety
Croatian: Virusna sigurnost
English: For safety information with respect to transmissible agents, see 4.4.
Croatian: Za sigurnosne informacije obzirom na prenosive uzročnike, vidjeti dio 4.4.
English: These are conditions that increase your risk of developing internal blood clots.
Croatian: Ovo su uvjeti koji povećavaju opasnost od stvaranja unutarnjih krvnih ugrušaka.
English: If you are allergic to human coagulation factor IX or to any of the ingredients of this medicine (listed in section 6).
Croatian: Ako ste alergični na ljudski koagulacijski faktor IX ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Nonafact is given to you by your doctor or nurse.
Croatian: Nonafact će Vam dati liječnik ili medicinska sestra.
English: Once dissolved, the product should be used immediately (at least within 3 hours).
Croatian: Nakon otapanja lijek se treba odmah primijeniti (unutar 3 sata).
English: It is recommended that the rate of administration should not exceed 2 ml/min.
Croatian: Preporučuje se da brzina primjene ne prelazi 2 ml/min.
English: Talk to your doctor or pharmacist or nurse before using Nonafact.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije primjene lijeka Nonafact.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Croatian: UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
English: BATCH NUMBER Lot: {number}
Croatian: BROJ SERIJE Lot: {broj}
English: Cardiovascular events
Croatian: Kardiovaskularni događaji
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Croatian: U tim slučajevima preporučuje se obratiti se specijaliziranom centru za hemofiliju.
English: Factor IX level required (%) (IU/dl)
Croatian: Potrebna razina faktora IX (%) (IU/dl)
English: In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
Croatian: U nekim slučajevima, osobito u mlađih bolesnika, mogu biti potrebni kraći intervali doziranja ili veće doze.
English: Where necessary, mild allergic reactions, such as hives, can be treated with antihistamines (medicinal products which counteract allergies).
Croatian: Po potrebi, blage alergijske reakcije, poput koprivnjače, mogu se liječiti antihistaminicima (lijekovi koji suzbijaju alergije).
English: Degree of bleeding / Type of surgical procedure
Croatian: Stupanj krvarenja / Vrsta kirurškog postupka
English: Do not use this medicine after the expiry date which is stated on the label and carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji.
English: In each of these situations, the benefit of treatment with Nonafact should be weighed against the risk of these complications.
Croatian: U svakoj od ovih situacija potrebno je procijeniti korist liječenja lijekom Nonafact u odnosu na rizik od pojave ovih komplikacija.
English: If you are allergic to mouse protein or have had any reactions to mouse protein.
Croatian: Ako ste alergični na mišje proteine ili ste imali bilo kakve reakcije na mišje proteine.