FrancophonIA/ELRC3.0 huggingface dataset:
English: 4.6 Fertility, pregnancy and lactation [the wording below should be inserted in the relevant section]
Croatian: 4.6 Plodnost, trudnoća i dojenje [Riječi u nastavku treba unijeti u odgovarajući dio]
English: Healthcare professionals are asked to report any suspected adverse reactions.
Croatian: Od zdravstvenih djelatnika traži se da prijave svaku sumnju na nuspojavu za ovaj lijek.
English: 4.4 Special warnings and precautions for use [the wording below should be inserted in the relevant section]
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi [Riječi u nastavku treba unijeti u odgovarajući dio]
English: See the end of section 4 for how to report side effects.
Croatian: Za postupak prijavljivanja nuspojava pogledajte dio 4.
English: 4.2 Posology and method of administration [the wording below should be inserted in the relevant section]
Croatian: 4.2 Doziranje i način primjene [Riječi u nastavku treba unijeti u odgovarajući dio]
English: Possible side effects [the wording below should be inserted in the relevant section]
Croatian: Moguće nuspojave [Riječi u nastavku treba unijeti u odgovarajući dio]
English: Before starting, the hands should be washed.
Croatian: Prije početka, potrebno je oprati ruke.
English: Currently available data are described in section 4.8, 5.1 and 5.2.
Croatian: Trenutno dostupni podaci opisani su u dijelu 4.8, 5.1 i 5.2.
English: Contact your doctor immediately:
Croatian: Odmah se obratite svom liječniku:
English: • If you have or have ever had liver damage.
Croatian: • Ako imate ili ste ikada imali oštećenje jetre.
English: The risk to humans is not known.
Croatian: Nije poznat rizik za ljude.
English: The potency of this medicinal product is expressed in international units (IU).
Croatian: Potentnost ovog lijeka izražena je u internacionalnim jedinicama (IU).
English: Always use an aseptic technique.
Croatian: Uvijek primjenjujte aseptičku tehniku.
English: Your doctor will explain what might happen if you stop treatment and discuss other options with you.
Croatian: Liječnik će Vam objasniti što bi se moglo dogoditi ako prestanete s liječenjem te s Vama razgovarati o drugim mogućnostima.
English: Important information
Croatian: Važna informacija
English: • The importance of collecting safety data and how to enrol patients in the PASS and other registries
Croatian: • Važnost skupljanja sigurnosnih podataka i kako uključiti bolesnike u PASS i druge registre
English: Your dose will depend on your body weight.
Croatian: Doza lijeka ovisit će o Vašoj tjelesnoj težini.
English: The final content, format and distribution modalities of both documents should be agreed with the national competent authority in each Member State.
Croatian: Konačan sadržaj, format i način na koji će oba dokumenta biti podijeljena trebaju biti dogovoreni s nacionalnim nadležnim tijelom u svakoj zemlji članici.
English: The calculation of the correction factor 0.117 is related to the exact quantity of the product and not the nominal value of the product.
Croatian: Izračun faktora korekcije od 0,117 povezan je s točnom količinom lijeka, a ne s nominalnom vrijednosti lijeka.
English: If you stop using NovoThirteen, you are not protected against bleeding.
Croatian: Ako prestanete primjenjivati NovoThirteen, niste zaštićeni od krvarenja.
English: Your doctor may adapt the dose if this is deemed necessary.
Croatian: Liječnik Vam može promijeniti dozu ako smatra da je to neophodno.
English: Use in small children
Croatian: Primjena u male djece
English: MARKETING AUTHORISATION NUMBER EU/1/12/775/001
Croatian: EU/1/12/775/001
English: If you are pregnant or breast-feeding, or if you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primijenite ovaj lijek.
English: This means your body may be more prone to infections
Croatian: To znači da ćete možda biti osjetljiviji na infekcije.
English: The antibodies disappeared in the 6-month follow up.
Croatian: Protutijela su nestala u šestomjesečnom periodu praćenja.
English: • Distribution and use of the patient brochure and the need to ensure that the patient has read and understood the brochure
Croatian: • Podjela i upotreba brošure za bolesnika i potreba da se osigura da je bolesnik pročitao i razumio brošuru
English: • If you experience an allergic reaction to NovoThirteen.
Croatian: • Ako dobijete alergijsku reakciju na NovoThirteen.
English: After dilution proceed to step H.
Croatian: Nakon razrjeđivanja prijeđite na korak H.
English: If the caps are loose or missing, do not use the vials.
Croatian: Ako zatvarači nisu pričvršćeni ili nedostaju, bočice nemojte koristiti.
English: Leucopenia and aggravated neutropenia
Croatian: Leukopenija i pogoršana neutropenija
English: Animal reproductive or developmental toxicity studies have not been performed.
Croatian: Ispitivanja reproduktivne i razvojne toksičnosti na životinja nisu provedena.
English: The Marketing Authorisation Holder must implement this educational plan nationally, prior to marketing.
Croatian: Nositelj odobrenja mora implementirati ovaj edukacijski plan na nacionalnoj razini prije stavljanja lijeka na tržište.
English: If a larger dose is needed, repeat the procedure in a separate syringe until the required dose is reached.
Croatian: Ako je potrebna veća doza, postupak treba ponoviti s drugom štrcaljkom dok se ne dobije potrebna doza.
English: Also, on-demand treatment is followed in a noninterventional post-authorisation safety study (NN1841-3868).
Croatian: Također, liječenje prema potrebi praćeno je u neintrevencijskom ispitivanju sigurnosti primjene lijeka nakon dobivanja odobrenja (NN1841-3868).
English: • What to do in the event of incorrect storage, thrombosis or embolism
Croatian: • Što učiniti u slučaju nepravilnog čuvanja, tromboze ili embolije
English: • How to recognise the potential side effects (thrombosis and embolism)
Croatian: • Kako prepoznati moguće nuspojave (trombozu i emboliju)
English: The dilution should be performed in accordance with aseptic rules.
Croatian: Razrjeđivanje treba provesti u skladu s aseptičkim pravilima.
English: • Development of antibodies against factor XIII which have no influence on the effect of the drug.
Croatian: • Razvoj protutijela na faktor XIII, bez utjecaja na učinak lijeka.
English: • A drop in the number of some types of white blood cells.
Croatian: • Pad broja nekih vrsta bijelih krvnih stanica.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or within 60 days as a result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno u roku od 60 dana kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: DK-2880 Bagsværd
Croatian: DK-2880 Bagsværd Danska
English: The dose volume for small children can then be calculated by using the below formula:
Croatian: Volumen doze za malu djecu se tada može izračunati pomoću dolje navedene formule:
English: Inhibitor formation:
Croatian: Stvaranje inhibitora:
English: The mean t½ of FXIII was approximately 15 days (range: 10 to 25 days).
Croatian: Srednja vrijednost t ½ FXIII bila je otprilike 15 dana (raspon: 10 do 25 dana).
English: Talk to your doctor before using NovoThirteen:
Croatian: Obratite se svom liječniku prije nego primijenite NovoThirteen:
English: 4 patients received at least 2 doses of NovoThirteen.
Croatian: Sva 4 bolesnika primila su najmanje 2 doze lijeka NovoThirteen.
English: Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology and repeated dose toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju ispitivanja sigurnosne farmakologije i toksičnosti ponovljenih doza.
English: Frequency categories are defined 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: Za učestalost pojavljivanja korištena je sljedeća kategorizacija: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100), rijetko (≥ 1/10 000 do < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: NovoThirteen should be injected at a rate not higher than 2 ml/minute.
Croatian: NovoThirteen treba injicirati brzinom ne većom od 2 ml/minuti.
English: You should only use the prescribed dose calculated by your doctor from this formula considering that the usual dose and the concentration of NovoThirteen are different from those of the other products which contain factor XIII.
Croatian: Smijete primijeniti samo propisanu dozu koju je Vaš liječnik izračunao na temelju ove formule, imajući u vidu da su uobičajena doza i koncentracija lijeka NovoThirteen različiti od drugih lijekova koji sadrže faktor XIII.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03 September 2012
Croatian: Datum prvog odobrenja: 3. rujna 2012.
English: Genotoxic potential or carcinogenicity has not been studied since rFXIII is an endogenous protein.
Croatian: Genotoksičnost ili kancerogenost nisu ispitivani budući je rFXIII endogeni protein.
English: The physician brochure should contain the following key elements and item:
Croatian: Brošura za liječnika treba sadržavati sljedeće ključne elemente i podatke:
English: No treatment requiring bleeding episodes have been detected in patients below 6 years during 17 years of cumulative follow-up, representing a total of 214 doses.
Croatian: Nije bilo epizoda krvarenja koje su zahtijevale liječenje u bolesnika mlađih od 6 godina tijekom 17 godina kumulativnog praćenja, što je bilo ukupno 214 doza.
English: OTHER Novo Nordisk A/S
Croatian: Novo Nordisk A/S
English: Bring the powder and solvent vials to a temperature not above 25°C, by holding them in the hands until they feel as warm as your hands.
Croatian: Pustite da temperatura bočica s praškom i otapalom dosegne temperaturu ne višu od 25°C, držeći ih u rukama sve dok ne osjetite da su tople kao i Vaše ruke.
English: Remove the plastic caps from the 2 vials.
Croatian: Odstranite plastične zatvarače s obje bočice.
English: The injections are given once a month (every 28 ± 2 days).
Croatian: Injekcije se daju jednom mjesečno (svakih 28 dana
English: Inject air into the vial by pushing the plunger until you feel a clear resistance.
Croatian: Ubrizgajte zrak u bočicu potiskujući klip sve dok ne osjetite otpor.
English: NovoThirteen is given as an injection into a vein.
Croatian: NovoThirteen se daje kao injekcija u venu.
English: There are no human data on potential effects on fertility.
Croatian: Nema podataka u ljudi o mogućim učincima na plodnost.
English: Side effects in children:
Croatian: Nuspojave u djece:
English: The specific activity of NovoThirteen is approximately 165 IU/mg protein.
Croatian: NovoThirteen je približno 165 IU/mg proteina.
English: Increased levels of activated NovoThirteen may increase the risk of thrombosis.
Croatian: Povišene razine aktiviranog lijeka NovoThirteen mogu povećati rizik od tromboze.
English: NovoThirteen can be used for all age groups.
Croatian: NovoThirteen se može primjenjivati u svim dobnim skupinama.
English: If you are not sure, ask your doctor before using this medicine.
Croatian: Ako niste sigurni, prije primjene ovog lijeka pitajte svog liječnika.
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3) as NovoThirteen has not been studied in pregnant animals.
Croatian: Ispitivanja na životinjama su nedostatna za konačan zaključak o reproduktivnoj toksičnosti (vidjeti dio 5.3) budući da NovoThirteen nije bio ispitivan na gravidnim životinjama.
English: As NovoThirteen contains a recombinant protein it may cause allergic reactions including anaphylactic reactions.
Croatian: Budući da NovoThirteen sadrži rekombinantni protein, može uzrokovati alergijske reakcije uključujući anafilaktičke reakcije.
English: NovoThirteen has been shown to have the same pharmacodynamic properties in plasma as endogenous FXIII.
Croatian: NovoThirteen je pokazao da ima ista farmakodinamička svojstva u plazmi kao endogeni FXIII.
English: In the reported cases of NovoThirteen overdose up to 2.3 times, no clinical symptoms have been observed.
Croatian: U prijavljenim slučajevima predoziranja lijekom NovoThirteen u kojima je doza bila 2,3 puta veća, nisu primijećeni nikakvi klinički simptomi.
English: Until further results are available, alternative treatment should be considered in such situations.
Croatian: Dok nisu dostupni dodatni podaci, u takvim situacijama potrebno je razmotriti zamjensko liječenje.
English: Use in children and adolescents (weighing more than 24 kg) NovoThirteen can be used in children and adolescents in the same way as in adults.
Croatian: Primjena u djece i adolescenata (tjelesne težine veće od 24 kg) NovoThirteen se u djece i adolescenata može primjenjivati na isti način kao i u odraslih.
English: Pharmacotherapeutic group: Antihaemorrhagics, Blood Coagulation factor, ATC code: B02BD11.
Croatian: Farmakoterapijska skupina: Antihemoragici, faktor zgrušavanja krvi, ATK oznaka: B02BD11.
English: The on-demand treatment of acute bleeds or breakthrough bleeds with NovoThirteen was allowed per protocol in the late phase clinical development programme.
Croatian: Liječenje akutnih krvarenja ili probojnih krvarenja lijekom NovoThirteen prema potrebi bilo je dozvoljeno po protokolu, u kasnoj fazi programa kliničkog razvoja.
English: • How to safely store, handle, reconstitute and administer the product
Croatian: • Kako sigurno čuvati, rukovati, rekonstituirati i primijeniti lijek
English: Based on the non-clinical study (see section 5.3) it is not recommended to combine NovoThirteen and recombinant activated FVII (rFVIIa).
Croatian: Na temelju nekliničkih ispitivanja (vidjeti dio 5.3) ne preporučuje se kombiniranje lijeka NovoThirteen i rekombinantnog aktiviranog FVII (rFVIIa).
English: The suggested dose of 35 IU/kg has shown to be appropriate to provide haemostatic coverage in this young population.
Croatian: Predložena doza od 35 IU/kg pokazala se odgovarajućom za postizanje hemostaze u ovoj mladoj populaciji.
English: Inhibitors may be suspected in the event of lack of therapeutic response which is observed as bleeding or demonstrated by laboratory findings including FXIII activity that fails to reach expected levels.
Croatian: Na inhibitore se može sumnjati u slučaju nedostatnog terapijskog odgovora što se očituje krvarenjima ili potvrđenim laboratorijskim nalazima, uključujući aktivnost FXIII koja nije dosegla očekivanu razinu.
English: The signs may include: hives, itching, swelling, difficulty breathing, low blood pressure (signs include paleness and coldness of skin, rapid heartbeat), feeling dizzy and sweating.
Croatian: Znakovi mogu biti: koprivnjača, svrbež, oticanje, otežano disanje, niski krvni tlak (znakovi uključuju blijedu i hladnu kožu, ubrzane otkucaje srca), osjećaj omaglice i znojenje.
English: The powder is white and the solvent is clear and colourless.
Croatian: Prašak je bijele boje, a otapalo je bistro i bezbojno.
English: Incorrect storage of the product after reconstitution must be avoided as it may result in loss of sterility and in increased levels of non-proteolytically activated NovoThirteen.
Croatian: Nepravilno čuvanje lijeka nakon rekonstitucije mora se izbjegavati jer to može rezultirati gubitkom sterilnosti i povišenjem razina neproteolitički aktiviranog lijeka NovoThirteen.
English: Clean the rubber stoppers on the vials with alcohol swabs and allow them to dry before use.
Croatian: Očistite gumene čepove na bočicama alkoholnim tupferima i pričekajte da se osuše prije uporabe.
English: The excretion of rFXIII in milk has not been studied in animals.
Croatian: Izlučivanje rFXIII u mlijeko nije bilo ispitivano na životinjama.
English: • If you experience bleeding during your treatment with NovoThirteen occurring spontaneously and/or requiring treatment.
Croatian: • Ako tijekom terapije lijekom NovoThirteen dođe do krvarenja koje se javilo spontano i/ili koje zahtijeva liječenje.
English: In case of any questions ask your doctor or nurse.
Croatian: U slučaju bilo kakvih pitanja obratite se svom liječniku ili medicinskoj sestri.
English: The four events of non-neutralising antibodies occurred in patients below the age of 18 (age 8, 8, 14 and 16).
Croatian: Četiri slučaja pojave ne-neutralizirajućih protutijela primijećena su u bolesnika mlađih od 18 godina (8, 8, 14 i 16 godina).
English: FXIII is a pro-enzyme (pro-transglutaminase), which is activated by thrombin in the presence of Ca2+.
Croatian: FXIII je proenzim (pro-transglutaminaza), kojeg aktivira trombin u prisutnosti Ca2+.
English: The results of standard coagulation tests are normal, as it is the quality of the clot that is affected.
Croatian: Rezultati standardnih testova zgrušavanja su normalni kao i kvaliteta ugruška.
English: Thromboembolic risk:
Croatian: Rizik od tromboembolija:
English: Do not stop using NovoThirteen without talking to your doctor.
Croatian: Ne prekidajte s primjenom lijeka NovoThirteen bez razgovora sa svojim liječnikom.
English: The usual dose is 35 IU for each kilogram of body weight.
Croatian: Uobičajena doza je 35 IU po kilogramu tjelesne težine.
English: A clot solubility assay is widely used as an indicator of FXIII deficiency, but the assay is qualitative, and when performed correctly the test is positive only when the FXIII activity in the sample is close to zero.
Croatian: Ispitivanje topivosti ugruška uvelike se koristi kao indikator nedostatka FXIII, ali analiza je kvalitativna, a ako se ispravno provede test je pozitivan samo ako je aktivnost FXIII u uzorku blizu nule.
English: For more information see section ‘NovoThirteen user instructions - Instructions of how to dilute the reconstituted NovoThirteen'.
Croatian: Za više informacija pogledajte dio ‘Upute za uporabu lijeka NovoThirteen - upute kako razrijediti lijek NovoThirteen pripremljen za primjenu.
English: At present there are no markers that can quantitatively assess the in vivo pharmacodynamics of FXIII.
Croatian: Trenutno ne postoje testovi koji mogu kvantitativno procijeniti farmakodinamiku FXIII in vivo.
English: If you use more NovoThirteen than you should
Croatian: Ako primijenite više lijeka NovoThirteen nego što ste trebali
English: The MAH should ensure harmonisation between terminology used in the brochures and the product information.
Croatian: Nositelj odobrenja mora uskladiti terminologiju u brošurama i podacima o lijeku.
English: Following reconstitution the product should be administered separately and not mixed with infusion solutions nor be given in a drip.
Croatian: Nakon rekonstitucije, lijek treba primijeniti zasebno i ne smije se miješati s infuzijskim otopinama niti davati u dripu.
English: The Marketing Authorisation Holder (MAH) shall ensure that, at launch, a letter is sent to all expected and actual prescribers of NovoThirteen with an Educational Pack containing the following: Physician brochure Patient brochure
Croatian: Nositelj odobrenja mora osigurati da se kod stavljanja lijeka na tržište svim trenutnim i budućim propisivačima lijeka NovoThirteen pošalje pismo s edukacijskim materijalima koji sadrže sljedeće: Brošuru za liječnika Brošuru za bolesnika
English: This is in agreement with the elimination pharmacokinetics estimated from a clinical pharmacology trial in healthy subjects, which determined the half-life to be 11.8 days.
Croatian: To je u skladu s eliminacijskom farmakokinetikom procijenjenom iz kliničkog farmakološkog ispitivanja u zdravih ispitanika kod kojeg je utvrđeni poluvijek bio 11,8 dana.
English: Both documents are to be used as part of an educational plan aiming to minimise risks of medication errors, risk of thromboembolic events due to increased levels of non-proteolytically activated rFXIII in connection with incorrect storage, and risk of off-label use for treatment of breakthrough bleeding.
Croatian: Oba dokumenta treba koristiti kao dio edukacijskog plana izrađenog kako bi se smanjio rizik od medikacijske pogreške, rizik od tromboembolijskih događaja zbog povećane razine neproteolitički aktiviranog rFXIII zbog nepravilnog čuvanja te zbog rizika vezanog za primjenu lijeka u neodobrenoj indikaciji za liječenje probojnog krvarenja.
English: Follow the injection procedure as instructed by your doctor.
Croatian: Pratite upute za injiciranje koje ste dobili od svog liječnika.
English: If you forget an injection of NovoThirteen, talk to your doctor.
Croatian: Ako zaboravite injekciju lijeka NovoThirteen, obratite se svom liječniku.
English: The side effects observed in children are the same as also observed in adults but the side effects may be more common in children than in adults.
Croatian: Nuspojave u djece iste su kao i nuspojave zabilježene u odraslih, ali se u djece mogu javiti češće nego u odraslih.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with NovoThirteen should be made taking into account the benefit of breast-feeding to the child and the benefit of NovoThirteen therapy to the mother.
Croatian: Potrebno je odlučiti da li nastaviti/prekinuti dojenje, odnosno da li nastaviti/prekinuti terapiju lijekom NovoThirteen uzimajući u obzir korist dojenja za dijete i korist liječenja lijekom NovoThirteen za majku.
English: There are no clinical data available on interaction between NovoThirteen and other medicinal products.
Croatian: Nema dostupnih kliničkih podataka o interakciji između lijeka NovoThirteen i drugih lijekova.
English: NovoThirteen replaces the missing factor XIII and helps to stabilise the initial blood clot by producing a mesh around the clot.
Croatian: NovoThirteen zamjenjuje faktor XIII koji nedostaje i tako pomaže u stabilizaciji inicijalnog krvnog ugruška stvaranjem mreže oko ugruška.
English: Analyses of data from paediatric patients included in clinical trials have not identified differences in treatment response according to age.
Croatian: Analize podataka iz kliničkih ispitivanja koja su uključivala pedijatrijske bolesnike nisu pokazale razlike u terapijskom odgovoru s obzirom na godine.
English: In patients below 6 years, no anti-rFXIII antibodies, no thromboembolic adverse events or other safety issues were reported.
Croatian: U bolesnika mlađih od 6 godina nije bio prijavljen razvoj protutijela na rFXIII, niti tromboemolijski štetni događaji ili drugi sigurnosni događaji.
English: Treatment should be initiated under the supervision of a doctor experienced in the treatment of rare bleeding disorders.
Croatian: Liječenje je potrebno započeti pod nadzorom liječnika s iskustvom u liječenju rijetkih poremećaja krvarenja.
English: What NovoThirteen is and what it is used for What you need to know before you use NovoThirteen How to use NovoThirteen
Croatian: Što je NovoThirteen i za što se koristi Što morate znati prije nego počnete primjenjivati NovoThirteen Kako primjenjivati NovoThirteen Moguće nuspojave
English: In all cases, the non-neutralising antibodies were found to be of no clinical significance.
Croatian: U svim slučajevima, ne-neutralizirajuća protutijela nisu bila klinički značajna.
English: Antibodies were transient in all patients.
Croatian: Pojava protutijela je u svih bolesnika bila prolazna.
English: Sodium chloride
Croatian: Natrijev klorid Saharoza
English: 3 patients (14%) aged between 6 and 18 years experienced serious adverse reactions in comparison to 0 patients over 18 years that experienced serious adverse reactions.
Croatian: U 3 bolesnika (14%) u dobi od 6 do 18 godina javile su se ozbiljne nuspojave u usporedbi sa 0 bolesnika starijih od 18 godina u kojih su se javile ozbiljne nuspojave.