natgillin/translations-raw huggingface dataset:
Patients given Opdivo survived on average for 7.5 months, compared with 5.1 months in patients given other treatments. 
Bolesnici koji su primili Opdivo živjeli su u prosjeku 7,5 mjeseci, u usporedbi s onima koji su primili drugu terapiju, čije je preživljenje bilo 5,1 mjesec.
Opdivo was used on its own and was compared with another cancer medicine (cetuximab, methotrexate or docetaxel) chosen by the treating doctor. 
Lijek Opdivo primijenjen je kao monoterapija te je uspoređen s drugim lijekom protiv raka (cetuksimabom, metotreksatom ili docetakselom) prema odabiru liječnika koji je propisivao terapiju.
Opdivo was investigated in one main study involving 361 adults with SCCHN whose cancer progressed despite previous treatment with platinum medicines. 
Lijek Opdivo ispitan je u jednom glavnom ispitivanju na 361 odrasloj osobi s SCCHN-om čiji je rak uznapredovao usprkos prethodnoj terapiji lijekovima s platinom.
Opdivo is used on its own in patients whose cancer is progressing despite treatment with platinum-based cancer medicines; 
Opdivo se primjenjuje kao monoterapija u bolesnika čiji se rak nastavio širiti usprkos terapiji lijekovima protiv raka na bazi platine;
Opdivo was investigated in one main study involving 270 adults with urothelial cancer whose cancer got worse or returned despite previous treatment with platinum medicines. 
Lijek Opdivo ispitan je u jednom glavnom ispitivanju na 270 odraslih osoba s karcinomom urotela čija se bolest pogoršala ili vratila usprkos prethodnoj terapiji lijekovima na bazi platine.
Urothelial cancer 
Karcinom urotela
How is Opdivo used? 
Kako se Opdivo primjenjuje?
Patients given Opdivo survived for 25.0 months, compared with 19.6 months for patients given everolimus. 
Bolesnici koji su primili lijek Opdivo živjeli su 25 mjeseci u usporedbi s onima koji su primili everolimus, čije je preživljenje bilo 19,6 mjeseci.
Side effects from Opdivo were considered manageable with appropriate measures and were outweighed by the benefits. 
Smatralo se da se nuspojave lijeka Opdivo mogu kontrolirati odgovarajućim mjerama te da su koristi od lijeka veće.
Date of first authorisation: 10/02/2015. 
Datum prvog odobrenja: 10/02/2015.
Council Directive 2001/89/EC and Commission Decision 2002/106 prohibit prophylactic vaccination within the European Union. 
Direktiva Vijeća 2001/89/EZ i Odluka Komisije 2002/106 zabranjuju profilaktička cijepljenja unutar Europske unije.
See section 4.4 
Vidjeti odjeljak 4.4.
According to Community Legislation on classical swine fever (Council Directive 2001/89/EC, as amended), in the European Union: 
Sukladno zakonodavstvu Zajednice o klasičnoj svinjskoj kugi (Direktiva Vijeća 2001/89/EZ, kako je izmijenjena i dopunjena), u Europskoj uniji:
6.2 Major Incompatibilities 
6.2 Glavne inkompatibilnosti
ADVICE ON CORRECT ADMINISTRATION 
SAVJET ZA ISPRAVNU PRIMJENU
EU/2/14/179/001 (10 doses) EU/2/14/179/002 (50 doses) 
EU/2/14/179/001 (10 doza) EU/2/14/179/002 (50 doza)
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009. 
Djelatna tvar biološkog podrijetla namijenjena za proizvodnju aktivnog imuniteta nije u okviru Uredbe (EZ) br 470/2009.
* min 100 PD50 ** Tissue culture infectious dose 
* min 100 PD50 ** Infektivna doza za tkivnu kulturu
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years. 
Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 2 godine.
Sorbitol 70% (solution) 
Sorbitol 70% (otopina)
After reconstitution, the suspension should be slightly pink clear liquid. 
Nakon rekonstitucije, suspenzija mora biti svijetlo ružičasta bistra tekućina.
10 doses 50 doses 
10 doza 50 doza
The virus is grown in porcine cells. 
Virus se uzgaja na stanicama svinje.
Camprodon s/n “La Riba”, 17813 Vall de Bianya 
Camprodon s/n “La Riba”, 17813 Vall de Bianya Girona
Onset of immunity: 14 days after vaccination Duration of immunity: at least 6 months after vaccination 
Početak imunosti: 14 dana nakon cijepljenja Trajanje imunosti: najmanje 6 mjeseci nakon cijepljenja.
Dulbecco's Modified Eagle culture medium (DMEM) 
Dulbeccov modificirani Eagleov medij (DMEM)
Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP {month/year}. 
Ne koristite ovaj veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi i kutiji poslije EXP {mjesec/godina}
a) the use of classical swine fever vaccines is prohibited. 
a) uporaba cjepiva protiv klasične svinjske kuge je zabranjena.
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
Pomoćne tvari (uključujući adjuvanse) navedene u odjeljku 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1. dodatka Uredbe Komisije (EU) br. 37/2010 naznačeno da se za njih ne zahtjeva određivanje NDK (MRL) ili nisu obuhvaćene odredbama Uredbe (EZ) br. 470/2009 kada se koriste u ovom veterinarsko-medicinskom proizvodu.
DIVA tests: 
DIVA ispitivanja:
b) the manipulation, manufacture, storage, supply, distribution and sale of classical swine fever vaccines must be carried out under supervision and in accordance with the eventual instructions established by the competent authority of the Member State. 
b) rukovanje, proizvodnja, skladištenje, opskrba, distribucija i prodaja cjepiva klasične svinjske kuge mora se provoditi pod nadzorom i u skladu s eventualnim uputama koje je izdalo nadležno tijelo države članice.
If you notice any side effects, whether or not listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.. 
Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj uputi o VMP ili mislite da veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog veterinara.
Shedding of vaccine virus has however not been detected but cannot be excluded. 
Izlučivanje cjepnog virusa, međutim, nije otkriveno, ali se ne može isključiti.
However, the use of vaccines may be authorised in the framework of an emergency vaccination plan, implemented by the competent authority of a Member State following confirmation of disease, in accordance with Community Legislation on control and eradication of classical swine fever. 
Međutim, primjena cjepiva može se odobriti u okviru plana hitnog cijepljenja, koje provodi nadležno tijelo države članice po utvrđivanju bolesti, u skladu sa zakonodavstvom Zajednice o kontroli i iskorjenjivanju klasične svinjske kuge.
Limited studies in young pigs support protection against CSF1045 (genotype 2, Germany 2009) and CSF1047 (genotype 2, Israel 2009) field strains. 
Ograničena ispitivanja u mlade prasadi pružaju zaštitu protiv KSG1045 (genotip 2, Njemačka 2009) i KSG1047 (genotip 2, Izrael 2009) terenskih sojeva virusa.
Solvent for Suvaxyn CSF Marker 
Otapalo za Suvaxyn CSF Marker
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 
U slučaju nehotičnog samoinjiciranja odmah potražiti pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
c) special provisions regulate the movement of pigs from areas where classical swine fever vaccine is being or has been used and the processing or marking of pig meat from vaccinated pigs. 
c) posebne odredbe reguliraju kretanje svinja iz područja gdje se primjenjuje ili se primijenilo cjepivo protiv klasične svinjske kuge te obradu i označavanje svinjskog mesa cijepljenih svinja.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu). 
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
Keep out of the sight and reach of children. 
I DOSEGA DJECE” Čuvati izvan pogleda i dosega djece.
Diagnostic tools targeted to detection of antibody responses could enable DIVA strategies. 
Dijagnostički alati namjenjeni za otkrivanje reakcije antitijela mogu omogućiti DIVA strategije.
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. 
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.
Name and address of the manufacturers of the biological active substance 
Naziv i adresa proizvođača biološki djelatnih tvari
Therefore, sows should not be vaccinated, due to the risk of birth of immunotolerant persistently infected offspring. 
Stoga se krmače ne smiju vakcinirati, zbog rizika od rađanja imunotolerantnih, trajno inficiranih potomaka.
Active substance: Lyophilisate: 
Djelatna tvar: Liofilizat:
DIVA efficiency depends on the performance of tests related to fitness for purpose in outbreak situations. 
Djelotvornost DIVA ovisi o performansi ispitivanja koja se odnosi na prikladnost za svrhu u situacijama izbijanja bolesti.
Shelf-life after reconstitution according to directions: use immediately. 
Rok valjanosti poslije rekonstitucije prema uputi: odmah upotrijebiti.
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. 
Trajno inficirana imunotolerantna prasad predstavljaju vrlo visoki rizik jer izlučuju terenski virus, a ona se ne mogu serološki identificirati zbog svog seronegativnog statusa.
The recombinant vaccine virus has potential marker properties for use in DIVA (differentiation between field virus infected and solely vaccinated animals). 
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).
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). 
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.
A single 1 ml dose should be administered to pigs from 7 weeks of age. 
Pojedinačnu dozu od 1 ml treba primijeniti svinjama u dobi od 7 tjedana.
Date of last renewal: 
Datum posljednjeg produljenja odobrenja:
Sodium chloride 9 mg/ml Water for injections q.s.p. 
Natrijev klorid 9 mg/ml Voda za injekcije q.s.p. 1 ml
Sodium chloride solution 9 mg/ml 
Otopina natrijevog klorida 9 mg/ml
Documentation provided for this vaccine supports that it is only to be used in an outbreak situation in herds within restricted control zones. 
Dokumentacija priložena uz ovo cjepivo podupire njegovu upotrebu samo tijekom izbijanja bolesti u stadima unutar ograničenih kontroliranih područja.
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. 
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.
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. 
Stoga odluka o cijepljenju nerasta za rasplod i prasadi s materinjim antitijelima treba donijeti na temelju stvarnog izbijanja bolesti i povezanih kontroliranih zona.
104.8* to 106.5 TCID**50 
104,8* do 106,5 TCID**50
104.8 to 106.5 TCID50 
104,8 do 106,5 TCID50
L2 Freeze-drying Stabilizer composed as follows Dextran 40 
Sastav L2 stabilizatora za liofilizaciju: Dekstran 40
EXP {month/year} Once broached, use immediately. 
EXP {mjesec/godina} Jednom otvoreno, odmah upotrijebiti.
Type I hydrolytic glass vials containing 10 or 50 doses of lyophilisate and 10 or 50 ml of solvent. 
Bočice od hidrolitičkog stakla tip I koje sadrže 10 ili 50 doza liofilizata i 10 ili 50 ml otapala.
EXP {month/year} Once reconstituted use immediately. 
EXP {mjesec/godina} Jednom rekonstituiran, odmah upotrijebiti.
Challenge studies have shown lack of protection against transplacental transmission of CSFV. 
Testiranje ispitnim sojem virusa je pokazalo nedostatak zaštite od transplacentarnog prijenosa VKSK.
Studies in vaccinated breeding boars addressing potential shedding of virulent challenge virus in semen have not been conducted. 
Ispitivanja u cijepljenih nerasta za rasplod, koja se odnose na potencijalno izlučivanje virulentnog ispitnog soja virusa u sjemenu, nisu provedena.
Solvent: Clear colourless liquid 
Otapalo: bistra bezbojna tekućina
Specific derogation is required to use this vaccine in an outbreak situation. 
Za upotrebu ove vakcine u situacijama izbijanja bolesti potrebno je specifično odstupanje.
Challenge studies were conducted with the Koslov strain (genotype 1) of CSFV. 
Testiranja ispitnim sojem virusa provedena su sojem Koslov (genotip 1) VKSK.
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. 
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.
Basic vaccination A single 1 ml dose should be administered intramuscularly to pigs from 7 weeks of age. 
Pojedinačnu dozu od 1 ml treba primijeniti intramuskularno svinjama u dobi od 7 tjedana.
Reconstitute the lyophilisate aseptically with the solvent to obtain a suspension for injection. 
Aseptično rekonstituirajte liofilizat s otapalom kako bi dobili suspenziju za injekciju.
The vaccine has shown reduced protection in studies of piglets with maternally derived antibodies compared to studies of piglets without maternally derived antibodies. 
Cjepivo je u ispitivanjima prasadi s majčinskim antitijelima pokazalo smanjenu zaštitu u usporedbi s ispitivanjima prasadi bez materinjih antitijela.
Use of the vaccine in experimental studies in breeding boars has not revealed safety concerns. 
Upotreba cjepiva u eksperimentalnim ispitivanjima u nerasta za rasplod nije otkrila probleme vezane uz neškodljivost .
6 BATCH NUMBER 
6 BROJ PROIZVODNE SERIJE
Basic vaccination 
Osnovno cijepljenje
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. 
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.
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. 
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.
Pharmacotherapeutic group: live viral vaccines, live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene, ATC vet code: QI09AD04 
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
Cardboard box containing 1 vial with 50 doses of lyophilisate and 1 vial with 50 ml solvent. 
Kartonska kutija sadrži 1 bočicu s 50 doza liofilizata i 1 bočicu s 50 ml otapala.
Casein hydrolysate 
Hidrolizat kazeina
Lyophilisate 
NUSPOJAVE
Cardboard box containing 1 vial with 10 doses of lyophilisate and 1 vial with 10 ml solvent. 
Kartonska kutija sadrži 1 bočicu s 10 doza liofilizata i 1 bočicu s 10 ml otapala.
Live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene (CP7_E2alf) 
Živi rekombinirani virus goveđe virusne dijareje s deletiranim E2 genom koji sadrži E2 gen klasične svinjske kuge (CP7_E2alf)
Lyophilisate: Off-white pellet 
Liofilizat: peleta prljavo bijele boje
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance: 
3. KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
Lyophilisate and solvent for suspension for injection for pigs 
Liofilizat i otapalo za suspenziju za injekciju za svinje
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČI BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
Suvaxyn CSF Marker lyophilisate for suspension for injection for pigs 
Suvaxyn CSF Marker liofilizat za suspenziju za injekciju za svinje
PACKAGE LEAFLET: Suvaxyn CSF Marker lyophilisate and solvent for suspension for injection for pigs 
UPUTA O VMP: Suvaxyn CSF Marker liofilizat i otapalo za suspenziju za injekciju za svinje
Suvaxyn CSF Marker lyophilisate and solvent for suspension for injection for pigs 
Suvaxyn CSF Marker liofilizat i otapalo za suspenziju za injekciju za svinje
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Boxes of 1 vial of 10 or 50 doses 
Kutija s 1 bočicom od 10 ili 50 doza
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. 
Liofilizat: bromobutilni gumeni čepovi i aluminijske kapice
The vaccine is a live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene. 
Cjepivo je živi rekombinirani virus goveđe virusne dijareje s deletiranim E2 genom, koji sadrži E2
To stimulate active immunity to Classical Swine Fever virus. 
gen klasične svinjske kuge.
Live recombinant CP7-E2Alf: 
KOLIČINA DJELATNIH TVARI Živi rekombinantni virus (CP7-E2Alf): 104,8 - 106,5 TCID50
Girona 
OBLIK
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vial label (10 and 50 doses) 
Etiketa bočice s liofilizatom (10 i 50 doza) NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
Solvent: 
Otapalo:
Pharmaceutical Products Ltd, 
S.M. Pharmaceutical Products Ltd,
Czech Republic 
Češka Republika
PHARMACEUTICAL INDUSTRY Proel Epam. 
PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS
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 
Dodatak I Popis naziva, farmaceutskog(ih) oblika, jačine(a) lijek(ov)a, put(ev)a primjene, nositelja odobrenja u državama članicama
BROS EPE Avgis & Gallinis 15, n. Kifissia, 
Avgis & Gallinis 15, n.
ROTTAPHARM S.L. 
ROTTAPHARM S.L. Avda.
EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex 
A 12, rue Danjou 92517 Boulogne Billancourt Cedex
Via Meucci 36 
ABIOGEN PHARMA S.p.A. Via Meucci 36
Menandrou 54, Athens, 10431 Greece 
Menandrou 54, Athens,
ABIOGEN PHARMA S.p.A. 
AURORA PHARMACEUTICALS S.A.
DATE OF REVISION OF TEXT 
DATUM REVIZIJE TEKSTA
(pre- and postoperative) 
(pre- i postoperativno)
See your doctor immediately, if bleeding does not stop as expected. 
Odmah posjetite svog liječnika ako krvarenje ne prestaje kao što je očekivano.
This leaflet was last approved 
Ova uputa je zadnji put odobrena
Produced from the plasma of human donors. 
Proizvedeno iz plazme ljudskih darivatelja.
If you are unsure, you should discuss this with your doctor. 
Ako niste sigurni, razgovarajte o tome sa svojim liječnikom.
Instructions for use: 
Upute za uporabu:
The required dose is determined using the following formula: 
Potrebna doza određuje se korištenjem sljedeće formule:
Previously untreated patients 
Prethodno neliječeni bolesnici
No data are available. 
Podaci nisu dostupni.
Administer immediately. 
Odmah primijenite.
The other (serious and non-serious) adverse reactions were received by spontaneous reporting. 
Druge nuspojave (ozbiljne i one koje nisu ozbiljne) zaprimljene su spontanim prijavljivanjem.
Thrombin then converts fibrinogen into fibrin and a clot is formed. 
Trombin tada pretvara fibrinogen u fibrin te se oblikuje ugrušak.
The solution should not be too cold when it is administered. 
Otopina ne smije biti prehladna kad se primjenjuje.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, even those not prescribed. 
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.
UNIQUE IDENTIFIER - 2D BARCODE 18. 
JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
In case of shock, standard medical treatment for shock should be implemented. 
U slučaju šoka potrebno je primijeniti standardno medicinsko liječenje šoka.
If you have the impression that the effect of Nonafact is too strong or too weak, talk to your doctor. 
Ako imate dojam da je učinak lijeka Nonafact prejak ili preslab, obratite se svom liječniku
Nonafact may be self-administered if it is an approved practice in your country and when you have been trained sufficiently. 
Nonafact si možete davati i sami ako je to odobreno u Vašoj državi i ako ste dovoljno uvježbani.
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. 
Trebali biste razgovarati sa svojim liječnikom o mogućim nuspojavama kako biste ih naučili prepoznati i što učiniti u slučaju da se pojave.
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) 
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).
The following table can be used to guide dosing in bleeding episodes and surgery: 
Sljedeća tablica može se koristiti kao vodič za doziranje u slučajevima krvarenja i u kirurgiji:
Do not shake! 
Ne tresite!
Neutralising antibodies (Inhibitors) 
Neutralizirajuća protutijela (inhibitori)
This will show itself as an increased tendency to bleed. 
To će se ispoljiti kao povećana sklonost krvarenju.
Renewal of authorisation: 03 July 2006 
Datum posljednje obnove odobrenja: 3. srpnja 2006.
Chemical and physical in-use stability has been demonstrated for 3 hours at a temperature of 21°C. 
Nakon rekonstitucije: Kemijska i fizikalna stabilnost u primjeni je dokazana tijekom 3 sata na temperaturi od 21°C.
They will then ensure that factor IX is administered to you, should this prove necessary. 
Oni će tada osigurati da Vam se da faktor IX, ako se pokaže potreba za tim.