FrancophonIA/ELRC3.0 huggingface dataset:
English: In a pharmacokinetic trial 6 children (age 1 to less than 6 years old) with congenital FXIII A-subunit deficiency were exposed to one single i.v.
Croatian: U ispitivanju farmakokinetike, 6 djece (u dobi od 1 do manje od 6 godina) s prirođenim nedostatkom A-podjedinice FXIII bilo je izloženo jednoj pojedinačnoj i.v. dozi lijeka NovoThirteen od 35 IU/kg.
English: Monitoring NovoThirteen activity levels using a standard FXIII activity assay is recommended.
Croatian: Preporučuje se nadziranje razina aktivnosti lijeka NovoThirteen pomoću standardnih testova za mjerenje aktivnosti FXIII.
English: Remove the protective paper from the vial adapter without taking the vial adapter out of the protective cap.
Croatian: Uklonite zaštitni papir s nastavka za bočicu, ali nemojte nastavak za bočicu izvaditi iz zaštitnog omota.
English: The dose volume for the reconstituted NovoThirteen diluted with 6 ml sodium chloride 0.9%, solution for injection can be calculated from this formula:
Croatian: Volumen doze lijeka NovoThirteen pripremljenog za primjenu i razrijeđenog sa 6 ml 0,9% otopine za injekciju natrijeva klorida može se izračunati pomoću ove formule:
English: The antibodies had no inhibitory action and the patients did not experience any adverse events or bleeding in association with these antibodies.
Croatian: Protutijela nisu imala inhibitorno djelovanje, a u bolesnika se nisu pojavili nikakvi štetni događaji ili krvarenja povezana s tim protutijelima.
English: The 6 patients below 6 years were investigated through a single dose pharmacokinetic phase 3b trial (F13CD-3760) and then, included in the long-term follow-up trial (F13CD-3835) assessing the safety and the efficacy of monthly replacement therapy with NovoThirteen.
Croatian: 6 bolesnika mlađih od 6 godina sudjelovalo je u ispitivanju faze 3b farmakokinetke pojedinačne doze (F13CD-3760), a potom su uključeni u dugotrajni nastavak ispitivanja (F13CD-3835) kako bi se procijenila sigurnost i djelotvornost mjesečnog nadomjesnog liječenja lijekom NovoThirteen.
English: To reconstitute and administer this product the following tools are needed: a 10 ml syringe or a syringe of a convenient size according to injection volume, alcohol swabs, the included vial adapter and an infusion set (tubing, butterfly needle).
Croatian: Za rekonstituciju i primjenu ovog lijeka potreban je sljedeći pribor: štrcaljka od 10 ml ili štrcaljka prikladne veličine u skladu s volumenom injiciranja, alkoholni tupferi, priloženi nastavak za bočicu i infuzijski set (cjevčica, leptirasta igla).
English: Reconstituted NovoThirteen is a clear, colourless solution.
Croatian: Rekonstituirani lijek NovoThirteen je bistra, bezbojna otopina.
English: In this last case your doctor will prescribe an alternative treatment to treat the bleeding.
Croatian: U slučaju da Vam je potrebno liječenje, liječnik će Vam propisati drugu terapiju za zaustavljanje krvarenja.
English: Non-neutralising antibodies Fibrin D-dimer increased
Croatian: Povišeni fibrinski D-dimeri
English: Side effects include:
Croatian: Nuspojave su sljedeće:
English: • Indication of the product
Croatian: • Indikaciju lijeka
English: The patient brochure, to be distributed to patients by the prescribers, should contain the following key elements and item:
Croatian: Propisivač treba bolesniku dati Brošuru za bolesnika koja treba sadržavati sljedeće ključne elemente i podatke:
English: In the F13CD-1725 extension trial F13CD-3720, the age-adjusted rate of bleeds that required treatment with a FXIII-containing product was estimated to be 0.021 bleeds per subject year with a 95% CI of [0.0062; 0.073] (model-based estimate corresponding to a mean age of the trial population of 31.0 years).
Croatian: U F13CD-1725 nastavku ispitivanja F13CD-3720, stopa krvarenja prilagođena dobi za koju je potrebno liječenje lijekovima koji sadrže FXIII procijenjeno je da iznosi 0,021 krvarenja ispitanik-godina sa 95% CI od [0,0062; 0,073] (procjena na temelju modela koji odgovara srednjoj dobi ispitivane populacije od 31,0 godine).
English: Based on FXIII activity measured by the Berichrom assay in patients with congenital FXIII deficiency, a geometric mean half-life of 11.8 days was estimated.
Croatian: mjerene Berichrom testom u bolesnika s prirođenim nedostatkom FXVIII, procijenjena geometrijska srednja vrijednost poluvijeka iznosila je 11,8 dana.
English: • If you have or have ever had a higher risk of blood clots forming (thrombosis), as NovoThirteen may increase the severity of a pre-existing blood clot.
Croatian: • Ako imate ili ste ikada imali povećan rizik od stvaranja krvnih ugrušaka (tromboze) jer
English: • The active substance is catridecacog (recombinant coagulation factor XIII: 2500 IU/3 ml, after reconstitution, corresponding to a concentration of 833 IU/ml.
Croatian: • Djelatna tvar je katridekakog (rekombinantni koagulacijski faktor XIII: 2500 IU/3 ml, nakon pripreme za primjenu, što odgovara koncentraciji od 833 IU/ml).
English: Dose volume in ml = 0.042 x subject bw (kg)
Croatian: Volumen doze u ml = 0,042 x TT bolesnika (kg)
English: Nervous system disorders Common (≥ 1/100 to < 1/10)
Croatian: Poremećaji živčanog sustava Često (≥ 1/100 do < 1/10)
English: In the event that inhibitors are suspected analysis for antibodies should be performed.
Croatian: U slučaju sumnje na inhibitore potrebno je odrediti prisutnost protutijela.
English: Your treatment with NovoThirteen should be initiated by a doctor experienced in the treatment of rare bleeding disorders.
Croatian: Kako primjenjivati NovoThirteen Liječenje lijekom NovoThirteen treba provoditi liječnik s iskustvom u liječenju rijetkih poremećaja krvarenja.
English: There is limited clinical experience in administering NovoThirteen to elderly patients with congenital FXIII deficiency.
Croatian: Kliničko iskustvo primjene lijeka NovoThirteen u starijih bolesnika s prirođenim nedostatkom FXIII je ograničeno.
English: In clinical studies, adverse reactions were more frequently reported in patients aged from 6 to less than 18 years old than in adults.
Croatian: U kliničkim ispitivanjima nuspojave su bile češće prijavljivane u bolesnika u dobi od 6 do manje od
English: Children above 6 years were investigated through the pivotal phase 3 trial (F13CD-1725) and the extension study (F13CD-3720) assessing the safety of monthly replacement therapy with NovoThirteen.
Croatian: Djeca starija od 6 godina sudjelovala su u pivotalnom ispitivanju faze 3 (F13CD-1725) te u nastavku ispitivanja (F13CD-3720) kako bi se procijenila sigurnost mjesečnog nadomjesnog liječenja lijekom
English: To dilute the reconstituted NovoThirteen the following tools are needed: a vial containing sodium chloride 0.9%, solution for injection, a 10 ml syringe and alcohol swabs.
Croatian: Za razrjeđivanje lijeka NovoThirteen pripremljenog za primjenu potreban je sljedeći pribor: bočica koja sadrži 0,9% otopinu za injekciju natrijeva klorida, štrcaljka od 10 ml i alkoholni tupferi.
English: A stabilisation of the thrombus might occur, resulting in increased risk of vessel occlusions.
Croatian: Može doći do stabilizacije tromba što povećava rizik od okluzija krvne žile.
English: Common (≥ 1/100 to < 1/10) Common (≥ 1/100 to < 1/10)
Croatian: Često (≥ 1/100 do < 1/10) Često (≥ 1/100 do < 1/10)
English: No effects on reproductive organs were noted in the repeated dose toxicity studies.
Croatian: U ispitivanjima toksičnosti ponovljenih doza nisu zabilježeni učinci na reproduktivne organe.
English: Congenital FXIII B-subunit deficiency
Croatian: Prirođeni nedostatak B-podjedinice FXIII
English: The crude bleeding rates in the two trials, F13CD-1725 and F13CD-3720, not adjusted for age, were 0.138 and 0.043 respectively, corresponding to a total of 13 bleeds over 223 subject-years and a pooled rate of 0.058.
Croatian: Grube stope krvarenja u dva ispitivanja, koje nisu bile prilagođene dobi, iznosile su 0,138 za ispitivanje F13CD-1725, a 0,043 za ispitivanje F13CD-3720, što odgovara ukupno 13 krvarenja tijekom 223 ispitanik-godina, a objedinjena stopa iznosi 0,058.
English: What NovoThirteen is used for
Croatian: Za što se NovoThirteen koristi
English: Powder: Sodium chloride, sucrose, polysorbate 20, L-histidine, hydrochloric acid, sodium hydroxide Solvent: water for injections
Croatian: POPIS POMOĆNIH TVARI Prašak: natrijev klorid, saharoza, polisorbat 20, L-histidin, kloridna kiselina, natrijev hidroksid.
English: How to store NovoThirteen
Croatian: Kako čuvati NovoThirteen
English: Carefully draw exactly 6 ml sodium chloride 0.9%, solution for injection, into the 10 ml syringe.
Croatian: Pažljivo uvucite točno 6 ml 0,9% otopine za injekciju natrijeva klorida u štrcaljku od 10 ml.
English: Solvent: Water for injections
Croatian: Otapalo: voda za injekcije.
English: Instructions of how to dilute the reconstituted NovoThirteen
Croatian: Upute kako razrijediti lijek NovoThirteen pripremljen za primjenu
English: 3 of these patients discontinued the study due to the adverse reaction.
Croatian: 3 bolesnika su prekinula sudjelovanje u ispitivanju zbog prethodno navedene nuspojave.
English: Dose volume in millilitres = 0.042 x your body weight in kilograms.
Croatian: Volumen doze u mililitrima = 0,042 x Vaša tjelesna težina u kilogramima.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label for powder vial
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica za bočicu s praškom
English: Check the injection solution for particulate matter and for discolouration.
Croatian: Provjerite otopinu za injekciju na prisutnost vidljivih čestica i promjenu boje.
English: Pull the plunger to draw in a volume of air equal to the total amount of solvent in the solvent vial.
Croatian: Povucite klip kako biste uvukli volumen zraka jednak ukupnoj količini otapala u bočici s otapalom.
English: Patients known to have neutralising antibodies to FXIII should not be treated with NovoThirteen without close monitoring.
Croatian: Bolesnici za koje se zna da imaju neutralizirajuća protutijela na FXIII ne smiju biti liječeni lijekom
English: Remove the empty solvent vial by tipping the syringe with the vial adapter.
Croatian: Uklonite praznu bočicu s otapalom naginjanjem štrcaljke s nastavkom za bočicu.
English: When the FXIII Asubunit is bound to the FXIII B-subunit [A2B2], the half-life of the FXIII A-subunit [A2] is prolonged.
Croatian: FXIII veže uz B-podjedinicu FXIII [A2B2], poluvijek A-podjedinice FXIII [A2] se produljuje.
English: NovoThirteen 2500 IU powder and solvent for solution for injection catridecacog (recombinant coagulation factor XIII)
Croatian: NovoThirteen 2500 IU prašak i otapalo za otopinu za injekciju katridekakog (rekombinantni koagulacijski faktor XIII)
English: Powder and solvent for solution for injection 2500 IU powder in a vial, 3.2 ml solvent in a vial, 1 vial adapter
Croatian: Prašak i otapalo za otopinu za injekciju 2500 IU praška u bočici, 3,2 ml otapala u bočici,
English: Dilution of the reconstituted product with sodium chloride 0.9%, solution for injection
Croatian: Razrjeđivanje rekonstituiranog lijeka sa 0,9% otopinom za injekciju natrijeva klorida
English: • The risks of off-label use within FXIII congenital deficiency
Croatian: • Rizike vezane za primjenu u neodobrenoj indikaciji kod prirođenog nedostatka FXIII
English: Inhibitor formation to NovoThirteen therapy has not been detected in clinical trials.
Croatian: U kliničkim ispitivanjima nije zapaženo stvaranje inhibitora tijekom terapije lijekom NovoThirteen.
English: Dose volume in ml = 0.117 x body weight in kilograms.
Croatian: Volumen doze u ml = 0,117 x tjelesna težina u kilogramima.
English: NovoThirteen (A-subunit) binds to free human FXIII B-subunit resulting in a heterotetramer [rA2B2] with a similar half-life to endogenous [A2B2].
Croatian: Po strukturi je identičan humanoj A-podjedinici FXIII [A2]. NovoThirteen (A-podjedinica) veže se na slobodnu B-podjedinicu humanog FXIII stvarajući heterotetramer [rA2B2] s poluvijekom sličnim endogenom [A2B2].
English: The diluted solution is a clear, colourless solution.
Croatian: Razrijeđena otopina je bistra, bezbojna otopina.
English: In plasma, FXIII circulates as a heterotetramer [A2B2] composed of 2 FXIII A-subunits and 2 FXIII Bsubunits held together by strong non-covalent interactions.
Croatian: U plazmi FXIII cirkulira kao heterotetramer [A2B2] sastavljen od 2 A-podjedinice FXIII i
English: NovoThirteen contains sodium This medicine contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free'.
Croatian: Sadržaj natrija Lijek sadrži manje od 1 mmol (23 mg) natrija po injekciji, tj. zanemarive količine natrija.
English: The preparation should be administered as a slow bolus intravenous injection at a rate not higher than 2 ml/minute.
Croatian: Pripravak se primjenjuje polaganom intravenskom bolus injekcijom brzinom injiciranja ne većom od
English: Bring the powder and solvent vials to a temperature not above 25°C by holding them in the hands.
Croatian: pustite da temperatura bočica s praškom i otapalom dosegne temperaturu ne višu od 25°C.
English: Click the vial adapter, still attached to the syringe onto the powder vial.
Croatian: Pričvrstite nastavak za bočicu, koji je još uvijek pričvršćen na štrcaljku, na bočicu s praškom.
English: For children weighing less than 24 kg the reconstituted NovoThirteen should be further diluted with 6 ml of sodium chloride 0.9%, solution for injection to be able to handle the dosing of small children.
Croatian: U djece koja imaju manje od 24 kg, NovoThirteen pripremljen za primjenu dodatno treba razrijediti sa 6 ml 0,9% otopine za injekciju natrijeva klorida kako bi se provelo doziranje u male djece.
English: Dose volume in millilitres = 0.117 x body weight in kilograms.
Croatian: Volumen doze u mililitrima = 0,117 x tjelesna težina u kilogramima.
English: The medicinal product contains less than 1 mmol sodium (23 mg) per injection, indicating that it is essentially ‘sodium free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po injekciji, tj. zanemarive količine natrija.
English: INFORMATION IN BRAILLE NovoThirteen
Croatian: 16. PODACI NA BRAILLEOVOM PISMU
English: Patients with hepatic impairment have not been studied.
Croatian: Nisu provedena ispitivanja u bolesnika s oštećenjem jetre.
English: Safely dispose of the syringe, vial adapter, infusion set and vials.
Croatian: Oprezno zbrinite štrcaljku, nastavak za bočicu, infuzijski set i bočice.
English: However, if the paediatric patient weighs less than 24 kg, the reconstituted NovoThirteen should be further diluted with 6 ml of sodium chloride 0.9%, solution for injection to handle the dosing of small children (see section 6.6 ‘Special precautions for disposal and other handling - Use in the paediatric population').
Croatian: Međutim, ako pedijatrijski bolesnik ima manje od 24 kg, rekonstituirani NovoThirteen treba dodatno razrijediti sa 6 ml 0,9% otopine za injekciju natrijeva klorida kako bi se provelo doziranje u male djece (vidjeti dio 6.6 ‘Posebne mjere za zbrinjavanje i druga rukovanja lijekom - Primjena u pedijatrijskoj populaciji').
English: In case a dilution of the reconstituted NovoThirteen is needed proceed to the section ‘Dilution of the reconstituted product with sodium chloride 0.9%, solution for injection'.
Croatian: Ako NovoThirteen pripremljen za primjenu treba razrijediti prijeđite na dio ‘Razrjeđivanje lijeka pripremljenog za primjenu sa 0,9% otopinom za injekciju natrijeva klorida'.
English: NovoThirteen user instructions
Croatian: Upute za uporabu lijeka NovoThirteen
English: What NovoThirteen contains
Croatian: NovoThirteen sadrži natrij
English: Push the plunger slowly to inject the solvent into the powder vial.
Croatian: Potisnite lagano klip kako biste otapalo ubrizgali u bočicu s praškom.
English: After dilution proceed to the step ‘Injecting the solution'.
Croatian: Nakon razrjeđivanja prijeđite na korak ʻInjiciranje otopine'.
English: The enzymatic activity resides with the FXIII A-subunit.
Croatian: Enzimatsko djelovanje svojstveno je za A-podjedinicu FXIII.
English: Gently swirl the vial to mix the solution.
Croatian: Nježno vrtite bočicu kako biste izmiješali otopinu.
English: It is not recommended to use NovoThirteen and recombinant coagulation factor VIIa (another blood clotting factor) together.
Croatian: Ne preporučuje se istodobna primjena lijeka NovoThirteen i rekombinantnog koagulacijskog faktora
English: If the paediatric patient weighs less than 24 kg, the reconstituted NovoThirteen should be diluted with 6 ml of sodium chloride 0.9%, solution for injection to be able to handle the dosing of small children (see section 4.2 ‘Posology and method of administration - Paediatric population').
Croatian: Ako pedijatrijski bolesnik ima manje od 24 kg, rekonstituirani NovoThirteen treba razrijediti sa 6 ml 0,9% otopine za injekciju natrijeva klorida kako bi se provelo doziranje u male djece (vidjeti dio 4.2 ‘Doziranje i način primjene - Pedijatrijska populacija').
English: Pull the plunger to draw the solvent into the syringe.
Croatian: Povucite klip kako biste otapalo uvukli u štrcaljku.
English: In the event of either being observed, discard the medicinal product.
Croatian: Ako zapazite bilo što od navedenog, lijek bacite u otpad.
English: • Summary of Product Characteristics.
Croatian: • Sažetak opisa svojstava lijeka.
English: NAME OF THE MEDICINAL PRODUCT NovoThirteen 2500 IU powder and solvent for solution for injection catridecacog (rDNA factor XIII)
Croatian: NovoThirteen 2500 IU prašak i otapalo za otopinu za injekciju katridekakog (rDNK faktor XIII)
English: NAME OF THE MEDICINAL PRODUCT NovoThirteen 2500 IU powder and solvent for solution for injection
Croatian: NovoThirteen 2500 IU prašak i otapalo za otopinu za injekciju
English: Injection site pain
Croatian: Injiciranje otopine
English: NovoThirteen should be inspected visually for extraneous (for any foreign) particulate matter and discoloration prior to administration.
Croatian: NovoThirteen treba prije primjene vizualno ispitati na prisutnost vidljivih čestica i promjenu boje.
English: NovoThirteen contains the active substance catridecacog, which is identical to human coagulation factor XIII, an enzyme necessary for blood clotting.
Croatian: NovoThirteen sadrži djelatnu tvar katridekakog, koji je istovjetan humanom koagulacijskom faktoru
English: One vial contains catridecacog (recombinant coagulation factor XIII) (rDNA) 2500 IU per 3 ml, after reconstitution corresponding to a concentration of 833 IU/ml.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 2500 IU katridekakoga (rekombinantni koagulacijski faktor XIII) (rDNK) u 3 ml, što nakon rekonstitucije odgovara koncentraciji od 833 IU/ml.
English: Upon activation, the FXIII A-subunit dissociates from the FXIII B-subunit and thereby exposes the active site of the FXIII A-subunit.
Croatian: Nakon aktiviranja, A-podjedinica FXIII odvaja se od B-podjedinice
English: Slowly inject the 6 ml sodium chloride 0.9%, solution for injection, into the reconstituted NovoThirteen vial.
Croatian: Polako ubrizgajte 6 ml 0,9% otopine za injekciju natrijeva klorida u bočicu rekonstituiranog lijeka
English: Hold the syringe with the solvent vial upside down.
Croatian: Držite štrcaljku s bočicom s otapalom okrenutom naopako.
English: • Warning of the difference of both posology and concentration between NovoThirteen and other
Croatian: • Upozorenje vezano za razliku u doziranju i koncentraciji lijeka NovoThirteen u odnosu na druge lijekove koji sadrže FXIII.
English: (bw) once monthly, administered as an intravenous bolus injection.
Croatian: (Preporučena doza lijeka NovoThirteen je 35 IU/kg tjelesne težine (TT) jednom mjesečno, primijenjena intravenski bolus injekcijom.
English: Attach the vial adapter to the solvent vial (water for injections).
Croatian: Pričvrstite nastavak za bočicu na bočicu s otapalom (voda za injekcije).
English: What NovoThirteen looks like and contents of the pack NovoThirteen is supplied as a powder and solvent for solution for injection (2500 IU powder in a vial and 3.2 ml solvent in a vial, with a vial adapter).
Croatian: NovoThirteen dolazi u obliku praška i otapala za otopinu za injekciju (2500 IU praška u bočici i
English: Once attached, remove the protective cap from the vial adapter.
Croatian: Nakon što pričvrstite nastavak za bočicu, uklonite s njega zaštitni omot.
English: The product is reconstituted using the vial adapter included.
Croatian: Lijek se rekonstituira pomoću priloženog nastavka za bočicu.
English: One patient was treated on demand in a phase 3b extension study (F13CD-3720).
Croatian: U nastavku ispitivanja faze 3b (F13CD-3720) jedan je bolesnik liječen prema potrebi.
English: If the patient weighs less than 24 kg, the reconstituted NovoThirteen should be diluted with 6 ml of sodium chloride 0.9%, solution for injection (refer to the section Use in the paediatric population for further detailed instructions on the dilution step).
Croatian: Ako bolesnik ima tjelesnu težinu manju od 24 kg, rekonstituirani NovoThirteen treba biti razrijeđen sa 6 ml 0,9% otopine za injekciju natrijeva klorida (za detaljne upute o postupku razrjeđivanja vidjeti dio Primjena u pedijatrijskoj populaciji).
English: Musculoskeletal and connective tissue disorders Common (≥ 1/100 to < 1/10)
Croatian: Opći poremećaji i reakcije na mjestu primjene Često (≥ 1/100 do < 1/10)
English: Contact your doctor if you have injected more NovoThirteen than you have been instructed.
Croatian: Ako ste injicirali više lijeka NovoThirteen nego što Vam je propisano, obratite se svom liječniku.
English: METHOD AND ROUTE OF ADMINISTRATION Intravenous use
Croatian: NAČIN I PUT PRIMJENE LIJEKA
English: Screw the syringe tightly onto the vial adapter on the solvent vial.
Croatian: Čvrsto navijte štrcaljku na nastavak za bočicu na bočici s otapalom.
English: 21 patients were between the age of 6 to less than 18 years old and 6 patients were less than 6 years old (total of 986 exposures of NovoThirteen in paediatric subjects (less than 18 years old).
Croatian: 21 bolesnik bio je u dobi između 6 do manje od 18 godina, a 6 bolesnika bilo je mlađe od 6 godina
English: How to store NovoThirteen Contents of the pack and other information.
Croatian: Kako NovoThirteen izgleda i sadržaj pakiranja
English: Renal insufficiency Patients with renal insufficiency requiring dialysis have not been studied in clinical trials.
Croatian: Bubrežna insuficijencija Nisu provedena klinička ispitivanja u bolesnika s bubrežnom insuficijencijom koji se liječe dijalizom.
English: Date of first authorisation: 31 July 2013
Croatian: Datum prvog odobrenja: 31. srpnja 2013.
English: These symptoms may be a sign of a serious allergic reaction.
Croatian: Ovi simptomi mogu biti znak ozbiljne alergijske reakcije.
English: Special population:
Croatian: Posebna populacija:
English: Efficacy in animals
Croatian: Djelotvornost u životinja
English: No case of overdose has been reported.
Croatian: Nije zabilježen nijedan slučaj predoziranja.
English: In this case, your doctor will postpone the vaccination until you are feeling better.
Croatian: U tom će Vam slučaju liječnik odgoditi cijepljenje dok ne budete bolje.
English: Seroconversion by ELISA and PRNT were as follows:
Croatian: Serokonverzije u testovima ELISA i PRNT bile su sljedeće:
English: Swirl gently before use.
Croatian: Nježno vrtite prije uporabe.
English: ACAM2000 was administered via scarification.
Croatian: ACAM2000 je bio primijenjen skarifikacijom.
English: The use of this vaccine should be in accordance with official recommendations.
Croatian: Ovo se cjepivo treba primijeniti u skladu sa službenim preporukama.
English: • if you are ill with a high temperature.
Croatian: • ako ste bolesni i imate visoku tjelesnu temperaturu.
English: Tell your doctor or nurse if you are taking or have recently taken any other medicines or if you have recently received any other vaccine.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako uzimate ili nedavno ste uzeli bilo koje druge lijekove ili ako ste nedavno primili neko drugo cjepivo.
English: Gently swirl for at least 30 seconds.
Croatian: Nježno vrtjeti najmanje 30 sekundi.