FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/012
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/693/012
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Actavis 6 mg capsules rivastigmine
Croatian: NAZIV LIJEKA Rivastigmin Actavis 6 mg kapsule rivastigmin
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Actavis 3 mg capsules rivastigmine
Croatian: NAZIV LIJEKA Rivastigmin Actavis 3 mg kapsule rivastigmin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/008
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/693/008
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/693/004
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 6 mg rivastigmine (as hydrogen tartrate).
Croatian: TVARI 1 kapsula sadrži 6 mg rivastigmina (u obliku rivastagminhidrogentartarata).
English: Rivastigmine Actavis 3 mg hard capsules EU/1/11/693/005
Croatian: Rivastigmine Actavis 3 mg tvrde kapsule EU/1/11/693/005
English: Rivastigmine Actavis 4.5 mg hard capsules EU/1/11/693/009
Croatian: Rivastigmine Actavis 4,5 mg tvrde kapsule EU/1/11/693/009
English: Off-white to slightly yellow powder in a hard capsule with red cap and orange body, with red imprint “RIV 6mg” on body.
Croatian: Bjelkasti do blago žuti prašak u tvrdoj kapsuli s crvenom kapicom i narančastim tijelom, s crvenom oznakom „RIV 6mg“ na tijelu kapsule.
English: Dementia associated with ADAS-Cog ADAS-Cog ADCS- CGIC ADCS-CGIC Parkinson's Disease
Croatian: ADCS-CGIC Placebo
English: Rivastigmine Actavis 1.5 mg hard capsules EU/1/11/693/001
Croatian: Rivastigmine Actavis 1,5 mg tvrde kapsule EU/1/11/693/001
English: Off-white to slightly yellow powder in a hard capsule with orange cap and orange body, with red imprint “RIV 3mg” on body.
Croatian: Bjelkasti do blago žuti prašak u tvrdoj kapsuli s narančastim kapicom i narančastim tijelom, s crvenom oznakom „RIV 3mg“ na tijelu kapsule.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 3 mg rivastigmine (as hydrogen tartrate).
Croatian: TVARI 1 kapsula sadrži 3 mg rivastigmina (u obliku rivastagminhidrogentartarata).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/013[ 28 blister]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/693/013 [28 blister]
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 1.5 mg rivastigmine (as hydrogen tartrate).
Croatian: TVARI 1 kapsula sadrži 1,5 mg rivastigmina (u obliku rivastagminhidrogentartarata).
English: Dementia associated with ADAS-Cog ADAS-Cog ADAS-Cog ADAS-Cog Parkinson's Disease
Croatian: One uključuju ADAS-Cog ljestvicu (eng.
English: • Chest pain
Croatian: • Bol u prsima
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/005[ 28 blister]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/693/005 [28 blister]
English: A mild eye/mucosal irritation potential of rivastigmine was identified in a rabbit study.
Croatian: Ispitivanje rivastigmina na zečevima ukazalo je na blagi potncijal iritacije oka/sluznice.
English: Tel: +48 22 345 93 00
Croatian: Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 22 345 93 00
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/009[ 28 blister]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/693/009 [28 blister]
English: Rivastigmine Actavis 3 mg, 4.5 mg and 6 mg hard capsules Red iron oxide (E172)
Croatian: Rivastigmine Actavis 3 mg, 4,5 mg i 6 mg tvrde kapsule željezov oksid, crveni (E172) titanijev dioksid (E171) željezov oksid, žuti (E172) želatina
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/001[ 28 blister]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/693/001 [28 blister]
English: • if you have, or have ever had, difficulties in passing urine.
Croatian: • ako imate ili ste imali otežano mokrenje.
English: ITT - LOCF population (n=287)
Croatian: Populacija ITT - LOCF
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Actavis 1.5 mg capsules rivastigmine
Croatian: Rivastigmin Actavis 1,5 mg kapsule rivastigmin
English: 1 pre-filled pen + 7 NovoFine needles
Croatian: 1 napunjena brizgalica + 7 NovoFine igala
English: 5 pre-filled pens
Croatian: 5 napunjenih brizgalica
English: 1 pre-filled pen + 7 NovoTwist needles
Croatian: NovoTwist igala
English: What is Scandonest?
Croatian: Što je Scandonest?
English: Scandonest is given by injection.
Croatian: Scandonest se daje injekcijom.
English: What is the outcome of the review?
Croatian: Kakav je rezultat procjene?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2 August 2018
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2. kolovoza 2018.
English: Scandonest has been authorised in the EU via national procedures.
Croatian: Scandonest je odobren u EU-u u okviru nacionalnih postupaka.
English: In children, the recommended dose is 0.75 mg/kg.
Croatian: U djece preporučena doza iznosi 0,75 mg/kg.
English: Scandonest is also available in the EU under the trade names Biocaine and Scandicaine.
Croatian: Scandonest je dostupan u EU-u i pod trgovačkim nazivima Biocaine i Scandicaine.
English: In adults, the maximum recommended dose is 4.4 mg per kg body weight, up to a maximum total dose of 300 mg.
Croatian: U odraslih, maksimalna preporučena doza iznosi 4,4 mg po kg tjelesne težine, do maksimalne ukupne doze od 300 mg.
English: Why was Scandonest reviewed?
Croatian: Zašto je Scandonest ponovno ocjenjivan?
English: In addition, it must not be used in children below 4 years of age, in patients with severe problems affecting the heart's electrical activity which are not resolved by a pace-maker, and in epileptic patients whose disease is not adequately controlled.
Croatian: Osim toga, ne smije se primjenjivati u djece mlađe od 4 godine, u bolesnika s teškim problemima koji utječu na električnu aktivnost srca i nisu regulirani elektrostimulatorom srca, te u bolesnika s epilepsijom u kojih bolest nije odgovarajuće kontrolirana.
English: The recommended dose of Scandonest depends on the patient's age and body weight.
Croatian: Preporučena doza lijeka Scandonest ovisi o dobi i tjelesnoj težini bolesnika.
English: Other harmonised sections of the SmPC include sections 4.4 (special warnings and precautions for use) 4.5 (interactions), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use machines), and 4.8 (side effects).
Croatian: Drugi harmonizirani dijelovi sažetka opisa svojstava lijeka uključuju dijelove 4.4. (Posebna upozorenja i mjere opreza pri uporabi), 4.5. (Interakcije s drugim lijekovima), 4.6. (Plodnost, trudnoća i dojenje), 4.7. (Utjecaj na sposobnost upravljanja vozilima i strojevima) i 4.8. (Nuspojave).
English: After review of the available data, a number of other contraindications which were only valid in some countries were considered not to be supported by sufficient data, or to be redundant and already included in the current list above.
Croatian: Nakon pregleda dostupnih podataka zaključeno je da i neke druge kontraindikacije, koje su vrijedile samo za neke zemlje, nisu potkrijepljene s dovoljno podataka ili su redundantne i već uključene u prethodno navedene kontraindikacije.
English: Scandonest is now authorised for use as local anaesthetic in dental surgery in adults, adolescents and children above 4 years of age (weighing around 20 kg).
Croatian: Scandonest je trenutno odobren za primjenu kao lokalni anestetik u zubnoj kirurgiji u odraslih, adolescenata i djece starije od 4 godine (težine otprilike 20 kg).
English: The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.
Croatian: Ocjenu je proveo EMA-in Odbor za lijekove za humanu uporabu (CHMP), nadležan za pitanja koja se odnose na lijekove za primjenu u ljudi.
English: Use of Scandonest and associated names (mepivacaine) to be harmonised EMA/533239/2018
Croatian: Primjena lijeka Scandonest i pridruženih imena (mepivakain) koju treba uskladiti EMA/533239/2018
English: Where justified by data, some of the previous contraindications have been included in section 4.4 Special warnings and precautions for use.
Croatian: Tamo gdje je to prema navedenim podatcima bilo opravdano, neke od prethodnih kontraindikacija bile su uključene u dio 4.4 „Posebna upozorenja i mjere opreza pri uporabi”.
English: It contains the active substance mepivacaine.
Croatian: Sadrži djelatnu tvar mepivakain.
English: This has led to inconsistency across Member States in the way the medicine is produced and can be used, as seen in the differences in the prescribing information [summary of product characteristics (SmPC), labelling and package leaflet] in the countries where the medicine is marketed.
Croatian: To je dovelo do neujednačenosti među državama članicama u pogledu načina proizvodnje i primjene lijeka, što se odražava u razlikama između informacija za propisivanje [sažetak opisa svojstava lijeka, označivanje i uputa o lijeku] u zemljama u kojima je lijek stavljen u promet.
English: Information for doctors and patients to be aligned across EU
Croatian: Informacije za liječnike i bolesnike koje treba uskladiti na prostoru EU-a
English: The European Commission issued an EU-wide legally binding decision to implement these changes on 2 August 2018.
Croatian: Europska komisija objavila je 2. kolovoza 2018. odluku o provedbi ovih promjena koja je zakonski obvezujuća na području cijelog EU-a.
English: In addition, Module 3 of the medicine dossier (which describes how the medicine is produced and its quality controlled) has also been harmonised.
Croatian: Nadalje, usklađen je i 3. modul dosjea o lijeku (koji opisuje kako se lijek proizvodi te kontrolira kakvoća).
English: Scandonest should no longer be used as local anaesthetic during chiropody procedures (treatment of corns, verrucae, etc.), because the data presented by the company were considered not sufficient to support this use.
Croatian: Scandonest se više ne smije primjenjivati kao lokalni anestetik tijekom postupaka pedikure (liječenje žuljeva, kurjih očiju itd.), jer se smatra da podatci koje je dostavila tvrtka nisu dostatni za podržavanje takve primjene.
English: Scandonest must not be used in patients who are allergic to the active substance mepivacaine or any of the other ingredients of the medicine.
Croatian: Scandonest se ne smije davati bolesnicima koji su alergični na djelatnu tvar mepivakain ili bilo koji drugi sastojak ovog lijeka.
English: Use of Scandonest and associated names (mepivacaine) to be harmonised
Croatian: Primjena lijeka Scandonest i pridruženih imena (mepivakain) koju treba uskladiti
English: Scandonest is a local anaesthetic, a medicine used to block sensation and pain in part of the body during medical procedures.
Croatian: Scandonest je lokalni anestetik, lijek koji se upotrebljava za blokiranje osjeta i boli u određenom dijelu tijela tijekom medicinskih postupaka.
English: On 31 May 2018, the European Medicines Agency (EMA) completed a review of Scandonest and associated names and recommended changes to the prescribing information in order to harmonise the way the medicine is used in the EU.
Croatian: Europska agencija za lijekove (EMA) završila je 31. svibnja 2018. procjenu lijeka Scandonest i pridruženih imena te preporučila izmjene informacija o propisivanju kako bi se uskladio način na koji se lijek primjenjuje u EU-u.
English: EMA/533239/2018 Rev. 1 EMEA/H/A-30/1455
Croatian: EMA/533239/2018 Rev.
English: After considering the available data on the use of Scandonest, the Agency concluded that the SmPC should be harmonised.
Croatian: Nakon razmatranja dostupnih podataka o primjeni lijeka Scandonest, Agencija je zaključila da je sažetak opisa svojstava lijeka potrebno uskladiti.
English: On 25 August 2017, Septodont, the company that markets Scandonest, referred the matter to EMA in order to harmonise the marketing authorisations for Scandonest in the EU.
Croatian: Taj je problem Septodont, tvrtka koja stavlja u promet lijek Scandonest, 25. kolovoza 2017. uputila EMA-i radi usklađivanja odobrenja za stavljanje lijeka Scandonest u promet u Europskoj uniji.
English: The review of Scandonest was initiated at the request of the marketing authorisation holder, Septodont, under Article 30 of Directive 2001/83/EC.
Croatian: Ocjena lijeka Scandonest započeta je na zahtjev nositelja odobrenja, tvrtke Septodont, u skladu s člankom 30.
English: The company that markets these medicines is Septodont.
Croatian: Te lijekove u promet stavlja tvrtka Septodont.
English: The package leaflet will be updated accordingly.
Croatian: U skladu s tim bit će ažurirana uputa o lijeku.
English: 4.1 Therapeutic indications
Croatian: Područja koja je potrebno uskladiti obuhvaćaju: 4.1 Terapijske indikacije
English: EU Number
Croatian: Page 1
English: The recommended dose is 35 international units (IU) per kilogram body weight once per month.
Croatian: Preporučena doza iznosi 35 internacionalne jedinice (IU) po kilogramu tjelesne mase jednom mjesečno.
English: This summary was last updated in 02-2014.
Croatian: Sažetak je posljednji put ažuriran: 02.2014.
English: The condition must be confirmed by suitable tests before starting treatment.
Croatian: Stanje se mora potvrditi primjerenim testovima prije početka terapije.
English: The European Commission granted a marketing authorisation valid throughout the European Union for NovoThirteen on 3 September 2012.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek NovoThirteen vrijedi na prostoru Europske unije od 3. rujna 2012.
English: The full EPAR for NovoThirteen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek NovoThirteen nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This dose is given in a single, slow injection into a vein.
Croatian: Ova se doza daje kao jedna injekcija polako u venu.
English: NovoThirteen catridecacog
Croatian: NovoThirteen katridekakog
English: This is an inherited blood clotting disorder characterised by bleeding episodes.
Croatian: Ovo je naslijeđeni poremećaj grušanja krvi koji karakteriziraju epizode krvarenja.
English: It is available as a powder and solvent to be made up into a solution for injection.
Croatian: Dostupan je kao prašak i otapalo za pripremu otopine za injekciju.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for NovoThirteen.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka NovoThirteen.
English: What measures are being taken to ensure the safe and effective use of NovoThirteen?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka NovoThirteen?
English: The CHMP concluded that the main study provided satisfactory results in terms of effectiveness, since no severe or life-threatening bleedings took place during treatment with NovoThirteen.
Croatian: CHMP je zaključio da je glavno ispitivanje osiguralo dovoljno zadovoljavajućih rezultata u smislu djelotvornosti, budući da tijekom liječenja lijekom NovoThirteen nije došlo do ozbiljnih ili po život opasnih krvarenja.
English: Additionally, the company that markets NovoThirteen will provide all doctors who are expected to prescribe it with an information pack for doctors and patients containing important information on the correct use of the medicine.
Croatian: Nadalje, tvrtka koja stavlja lijek NovoThirteen u promet dostavit će svim liječnicima od kojih se očekuje da će propisivati lijek informacijski paket za liječnike i bolesnike koji će sadržavati važne informacije o ispravnoj primjeni lijeka.
English: Factor XIII is a protein involved in the blood clotting process.
Croatian: Faktor XIII je protein koji sudjeluje u postupku grušanja krvi.
English: Other information about NovoThirteen
Croatian: Ostale informacije o lijeku NovoThirteen
English: The patients were given NovoThirteen for one year for preventative use.
Croatian: Bolesnici su primali NovoThirteen tijekom jedne godine u preventivne svrhe.
English: This is a summary of the European public assessment report (EPAR) for NovoThirteen.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek NovoThirteen.
English: Treatment with NovoThirteen should be started under the supervision of a doctor experienced in treating rare bleeding disorders.
Croatian: Liječenje lijekom NovoThirteen potrebno je započeti pod nadzorom liječnika s iskustvom u liječenju rijetkih poremećaja krvarenja.
English: A risk management plan has been developed to ensure that NovoThirteen is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka NovoThirteen.
English: For more information about treatment with NovoThirteen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom NovoThirteen pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: The factor XIII A-subunit in NovoThirteen is made by a method known as ‘recombinant DNA technology': it is produced by yeast cells that have received the gene (DNA) which makes the cells able to produce it.
Croatian: Faktor XIII podjedinica A u NovoThirteen proizvodi se metodom poznatom pod nazivom „tehnologija rekombinantne DNK”: proizvodi se iz stanica kvasca koji su primili gen (DNK) koji omogućuje stanicama da ga proizvode.
English: In certain situations the doctor may decide to adjust the dose required to prevent bleeding, based on the patient's factor XIII levels in the blood.
Croatian: U određenim situacijama, liječnik može odlučiti prilagoditi dozu potrebnu za sprječavanje krvarenja na temelju razine faktora XIII u krvi bolesnika.
English: The study was extended for a further year in 33 of the patients, to look at the long-term safety of treatment with NovoThirteen.
Croatian: Ispitivanje je produljeno za godinu dana među 33 bolesnika kako bi se istražila dugoročna sigurnost liječenja lijekom NovoThirteen.
English: The most common side effects with NovoThirteen (seen in between 1 and 10 patients in 100) are headache, leucopenia (low white blood cell counts), aggravated neutropenia (low levels of neutrophils, a type of white blood cell), pain in the extremities, injection site pain, and the presence in the blood of antibodies that attach to factor XIII and of small protein fragments called ‘fibrin D-dimer'.
Croatian: Najčešće nuspojave lijeka NovoThirteen (kod između 1 i 10 osoba) su glavobolja, leukopenija (mali broj bijelih krvnih stanica), pogoršana neutropenija (niska razina neutrofila, tipa bijelih krvnih stanica), bol u ekstremitetima, bol na mjestu injekcije i prisutnost protutijela koja se vežu na faktor XIII i malog broja fragmenata proteina u krvi naziva „fibrinski D-dimeri”.
English: NovoThirteen is a medicine that contains the active substance catridecacog.
Croatian: NovoThirteen je lijek koji sadrži djelatnu tvar katridekakog.
English: This includes information on storage procedures, since incorrect storage after reconstitution can cause increased levels of activated NovoThirteen, thereby increasing the risk of thrombosis (formation of blood clots in the blood vessels), and information on administration procedures, since the factor XIII concentration in NovoThirteen is different from other factor XIIIcontaining medicines.
Croatian: To uključuje i informacije o postupku pohranjivanja, budući da nepravilno pohranjivanje nakon rekonstitucije može uzrokovati povišene razine aktiviranog lijeka NovoThirteen, te stoga povećati i rizik od tromboze (formiranja krvnih ugrušaka u krvnim žilama), i informacije o postupcima primjene, budući da se koncentracija faktora XIII u lijeku NovoThirteen razlikuje od drugih lijekova koji sadrže faktor XIII.
English: The safety and effectiveness of NovoThirteen in children below 6 years of age was supported by preliminary data from an ongoing long-term study during which the patients were given NovoThirteen to prevent bleeding episodes.
Croatian: Sigurnost i djelotvornost lijeka NovoThirteen u djece mlađe od 6 godina poduprto je preliminarnim podacima iz dugoročnog ispitivanja koje još uvijek traje tijekom kojeg su bolesnici primali lijek NovoThirteen kako bi se spriječile epizode krvarenja.
English: Moreover, no major side effects were seen with long term use of NovoThirteen.
Croatian: Nadalje, nisu uočene značajne nuspojave prilikom dugoročne primjene lijeka NovoThirteen.
English: This compared with around 2.9 episodes per year per patient treated on demand with another medicine containing factor XIII.
Croatian: Za usporedbu, otprilike 2,9 epizoda godišnje po bolesniku liječenom na zahtjev drugim lijekom koji je sadržavao faktor XIII.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for NovoThirteen, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za lijek NovoThirteen uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: NovoThirteen does not work in patients lacking the factor XIII B-subunit.
Croatian: NovoThirteen nije djelotvoran u bolesnika kojima nedostaje faktor XIII podjedinice B.
English: On average, there were approximately 0.15 bleeding episodes requiring factor XIII treatment per year per patient treated preventatively with NovoThirteen.
Croatian: Prosječno, bilo je otprilike 0,15 epizoda krvarenja godišnje koja su zahtijevala liječenje faktorom XIII po bolesniku koji je preventivno liječen lijekom NovoThirteen.
English: The study looked at the number of bleeding episodes requiring treatment with a factor XIII-containing medicine in these patients, compared with patients who had not received NovoThirteen, based on earlier data from 16 patients with congenital factor XIII A-subunit deficiency.
Croatian: Ispitivanje je istražilo broj epizoda krvarenja koja su zahtijevala liječenje lijekovima koji su sadržavali faktor XIII u ovih bolesnika, u usporedbi s bolesnicima koji nisu primili lijek NovoThirteen, na temelju prethodnih podataka prikupljenih u 16 bolesnika s prirođenim nedostatkom faktora XIII podjedinice A.
English: What is the risk associated with NovoThirteen?
Croatian: Koji su rizici povezani s lijekom NovoThirteen?
English: NovoThirteen is used for the long-term prevention of bleeding in patients with a condition called ‘congenital factor XIII A-subunit deficiency'.
Croatian: NovoThirteen se koristi za dugoročnu prevenciju krvarenja u bolesnika sa stanjem naziva „nedostatak faktora XIII podjedinice A”.
English: What is NovoThirteen?
Croatian: Što je NovoThirteen?
English: NovoThirteen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka NovoThirteen nadmašuju s njim povezane rizike te je preporučilo izdavanje odobrenja za stavljanje lijeka u promet.
English: The rate of bleeding episodes in patients receiving NovoThirteen preventatively was lower than the rate seen in the earlier data from patients treated on demand with another medicine containing factor XIII.
Croatian: Učestalost epizoda krvarenja u bolesnika koji su preventivno primali lijek NovoThirteen bila je manja od učestalosti uočene u ranijim podacima prikupljenima u bolesnika koji su liječeni na zahtjev drugim lijekovima koji su sadržavali faktor XIII.