FrancophonIA/ELRC3.0 huggingface dataset:
English: Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC.
Croatian: Kad se ovaj lijek primjenjuje u bolesnika s bolešću jetre, bolesnika nakon operacije, novorođenčadi ili u bolesnika s rizikom od razvoja trombotskih pojava ili DIK-a, zbog potencijalnog rizika od trombotskih komplikacija potrebno je uvesti kliničko praćenje ranih znakova trombotske i potrošne koagulopatije uz odgovarajuće biološko testiranje.
English: Pfizer Luxembourg SARL filiāle Latvijā Pfizer Limited Tel: +371 670 35 775
Croatian: Пфайзер Люксембург САРЛ, Клон България Тел.: +359 2 970 4333
English: Sími: + 354 540 8000
Croatian: Icepharma hf. Sími: + 354 540 8000
English: 1 pre-filled syringe with 5 ml solvent 1 sterile vial adapter reconstitution device 1 sterile infusion set
Croatian: 1 napunjena štrcaljka s 5 ml otapala 1 sterilni nastavak za bočicu za pripremu otopine
English: Amount of BeneFIX per Vial
Croatian: Količina BeneFIX-a po bočici
English: BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection Nonacog alfa (recombinant coagulation factor IX)
Croatian: BeneFIX 250 IU prašak i otapalo za otopinu za injekciju BeneFIX 500 IU prašak i otapalo za otopinu za injekciju BeneFIX 1000 IU prašak i otapalo za otopinu za injekciju BeneFIX 1500 IU prašak i otapalo za otopinu za injekciju BeneFIX 2000 IU prašak i otapalo za otopinu za injekciju BeneFIX 3000 IU prašak i otapalo za otopinu za injekciju nonakog alfa (rekombinantni koagulacijski faktor IX)
English: Preliminary information suggests a relationship may exist between the presence of major deletion mutations in a patient's factor IX gene and an increased risk of inhibitor formation and of acute hypersensitivity reactions.
Croatian: Potrebno je naglasiti da bolesnici s inhibitorima faktora IX mogu biti pod povećanim rizikom od anafilaksije kod kasnijeg izlaganja faktoru IX. Preliminarne informacije ukazuju na mogući odnos između prisutnosti velikih delecijskih mutacija u genu bolesnika za faktor IX, i povećanog rizika od stvaranja inhibitora i akutnih reakcija preosjetljivosti.
English: BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection
Croatian: BeneFIX 250 IU prašak i otapalo za otopinu za injekciju BeneFIX 500 IU prašak i otapalo za otopinu za injekciju BeneFIX 1000 IU prašak i otapalo za otopinu za injekciju BeneFIX 1500 IU prašak i otapalo za otopinu za injekciju BeneFIX 2000 IU prašak i otapalo za otopinu za injekciju BeneFIX 3000 IU prašak i otapalo za otopinu za injekciju
English: Haemorrhage Early haemarthrosis, muscle bleeding or oral bleeding
Croatian: Rana hemartroza, krvarenje u mišiće ili iz usne šupljine
English: Break off the tamper-resistant plastic tip cap from the solvent syringe by snapping the perforation of the cap.
Croatian: Otkinite plastični poklopac za zaštitu od nepažljivog rukovanja s vrška štrcaljke s otapalom tako što ćete ga prelomiti duž perforacije na poklopcu.
English: Powder Sucrose Glycine L-Histidine Polysorbate 80
Croatian: L-histidin polisorbat 80
English: Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX.
Croatian: Bolesnici s hemofilijom B mogu razviti neutralizirajuća protutijela (inhibitore) na faktor IX. Ako nastanu takvi inhibitori, stanje se može očitovati kao nedovoljan klinički odgovor.
English: BeneFIX 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog alfa (recombinant coagulation factor IX).
Croatian: BeneFIX 2000 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 2000 IU nonakoga alfa (rekombinantnog koagulacijskog faktora IX).
English: BeneFIX 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU nonacog alfa (recombinant coagulation factor IX).
Croatian: BeneFIX 250 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 250 IU nonakoga alfa (rekombinantnog koagulacijskog faktora IX).
English: BeneFIX 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU nonacog alfa (recombinant coagulation factor IX).
Croatian: BeneFIX 3000 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 3000 IU nonakoga alfa (rekombinantnog koagulacijskog faktora IX).
English: BeneFIX 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU nonacog alfa (recombinant coagulation factor IX).
Croatian: BeneFIX 1500 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 1500 IU nonakoga alfa (rekombinantnog koagulacijskog faktora IX).
English: BeneFIX 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog alfa (recombinant coagulation factor IX).
Croatian: BeneFIX 1000 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 1000 IU nonakoga alfa (rekombinantnog koagulacijskog faktora IX).
English: infusion-site reaction n; infusion-site pain m
Croatian: Opći poremećaji i reakcije na mjestu primjene pireksija nelagoda u prsima o; reakcija na mjestu infuzije n; bol na mjestu infuzije neodgovarajući terapijski odgovor*
English: BeneFIX 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog alfa (recombinant coagulation factor IX).
Croatian: BeneFIX 500 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 500 IU nonakoga alfa (rekombinantnog koagulacijskog faktora IX).
English: BeneFIX 250
Croatian: Otapalo za BeneFIX
English: Reporting of side effects
Croatian: Zapisivanje primjene
English: - A kidney disorder (nephrotic syndrome) has been reported following high doses of plasma-derived factor IX in haemophilia B patients with factor IX inhibitors and a history of allergic reactions.
Croatian: - Kod bolesnika koji imaju hemofiliju B s inhibitorima faktora IX i alergijskim reakcijama u povijesti bolesti prijavljen je poremećaj bubrega (nefrotski sindrom) nakon visokih doza faktora IX dobivenog iz plazme.
English: Visual impairment e
Croatian: Poremećaji oka oštećenje vida
English: Vss (mL/kg)
Croatian: Klirens (ml/h/kg) Vss (ml/kg) Poluvijek eliminacije (h)
English: Nervous system disorders
Croatian: Poremećaji bubrega i mokraćnog sustava infarkt bubrega
English: OTHER SPECIAL WARNING(S), IF NECESSARY Use only the pre-filled syringe of solvent provided in the box for reconstitution.
Croatian: Za pripremu otopine upotrijebite samo napunjenu štrcaljku priloženu u kutiji.
English: However, as with all factor IX products you should be carefully monitored for the development of factor IX inhibitors while being treated with BeneFIX.
Croatian: - Protutijela koja neutraliziraju aktivnost (inhibitori) manje su česta pojava u bolesnika prethodno liječenih lijekovima koji sadrže faktor IX. Međutim, kao i s drugim lijekovima koji sadrže faktor IX, dok se liječite BeneFIX-om trebate biti pažljivo praćeni zbog mogućeg razvoja inhibitora faktora IX.
English: Elimination half-life (h) Recovery (IU/dL per IU/kg)
Croatian: Povrat (IU/dl po IU/kg)
English: Potentially life-threatening anaphylactic reactions (severe allergic reactions) have occurred with factor IX products, including BeneFIX.
Croatian: nastale su anafilaktičke reakcije (teške alergijske reakcije) potencijalno opasne po život.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 100 IU nonacog alfa.
Croatian: Nakon rekonstitucije s 5 ml (0,234%) priložene otopine natrijevog klorida za injekciju, jedan ml otopine sadrži približno 100 IU nonakoga alfa.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 50 IU nonacog alfa.
Croatian: Nakon rekonstitucije s 5 ml (0,234%) priložene otopine natrijevog klorida za injekciju, jedan ml otopine sadrži približno 50 IU nonakoga alfa.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 600 IU nonacog alfa.
Croatian: Nakon rekonstitucije s 5 ml (0,234%) priložene otopine natrijevog klorida za injekciju, jedan ml otopine sadrži približno 600 IU nonakoga alfa.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 400 IU nonacog alfa.
Croatian: Nakon rekonstitucije s 5 ml (0,234%) priložene otopine natrijevog klorida za injekciju, jedan ml otopine sadrži približno 400 IU nonakoga alfa.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 300 IU nonacog alfa.
Croatian: Nakon rekonstitucije s 5 ml (0,234%) priložene otopine natrijevog klorida za injekciju, jedan ml otopine sadrži približno 300 IU nonakoga alfa.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 200 IU nonacog alfa.
Croatian: Nakon rekonstitucije s 5 ml (0,234%) priložene otopine natrijevog klorida za injekciju, jedan ml otopine sadrži približno 200 IU nonakoga alfa.
English: 1 vial: 1500 IU nonacog alfa (approx. 300 IU/ml after reconstitution).
Croatian: 1 bočica: 1500 IU nonakoga alfa (pribl.
English: Discard the vial with the adapter attached.
Croatian: Bacite bočicu zajedno sa spojenim nastavkom.
English: Vomiting; nausea
Croatian: Poremećaji probavnog sustava povraćanje; mučnina
English: Headache d
Croatian: D.
English: However, the relevance for clinical protection is unknown.
Croatian: Međutim, važnost za kliničku zaštitu nije poznata.
English: This means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product.
Croatian: To znači da zbog znanstvenih razloga nije bilo moguće doći do potpunih informacija o ovom lijeku.
English: - Reporting to be monthly for the first 6 months.
Croatian: - Mjesečno izvještavanje prvih 6 mjeseci.
English: It is best to see how Foclivia affects you before you try these activities.
Croatian: Najbolje je najprije vidjeti kako Foclivia utječe na vas prije nego pokušate ove aktivnosti.
English: Foclivia has been authorised under “Exceptional Circumstances”.
Croatian: Foclivia je odobrena pod "iznimnim okolnostima".
English: This leaflet was last revised in {MM/YYYY}.
Croatian: Ova je uputa zadnji puta revidirana u {MM/GGGG}.
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego što primite ovo cjepivo jer sadrži vama važne podatke.
English: The following age groups will be used: < 2 years, 2-8 years, > 9 years.
Croatian: Koristit će se sljedeće dobne skupine: < 2 godine, 2-8 godina,
English: 1 Based on the assumption that product name will not be provided in a significant proportion of cases.
Croatian: 1 Na temelju pretpostavke da naziv lijeka neće biti naveden u značajnom udjelu slučajeva.
English: • Format of the simplified PSUR:
Croatian: • Format pojednostavljenog PSUR-a:
English: Packs of 1 and 10 with or without needle.
Croatian: Pakiranja od 1 i 10, sa ili bez igle.
English: Tell your doctor if you have any known allergies.
Croatian: Recite svome liječniku ako imate poznate alergije.
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Croatian: Sukladno članku 114 Direktive 2001/83/EC službeno puštanje serije lijeka u promet preuzet će državni laboratoriji ili laboratorij određen za tu svrhu.
English: When a person is given the vaccine, the body's natural defence system (immune system) produces its own protection (antibodies) against the disease.
Croatian: Kada osoba primi cjepivo, prirodni obrambeni sustav tijela (imunološki sustav) stvara vlastitu zaštitu (protutijela) protiv bolesti.
English: narrow SMQ “Demyelination” (as GBS is also included in this SMQ, there will be an overlap in the number of cases for these two categories).
Croatian: suženi SMQ “Demijelinizacija” (budući da je GBS također uključen u ovaj SMQ, doći će do preklapanja broja slučajeva u ove dvije kategorije).
English: The safety and efficacy of Foclivia in subjects under 18 years of age have not yet been established.
Croatian: Sigurnost i djelotvornost cjepiva Foclivia u ispitanika mlađih od 18 godina nisu još ustanovljene.
English: The signs of pandemic flu are similar to those of ordinary flu but may be more serious.
Croatian: Simptomi pandemijske gripe slični su onima obične gripe, no mogu biti teži.
English: Moreover, a 6-monthly cycle may be too long to allow assessment of the safety of a vaccine for which high levels of exposure are expected within a short period of time.
Croatian: Štoviše, 6-mjesečni ciklus može biti predug za procjenu sigurnosti cjepiva, zbog čega se visoke razine izlaganja očekuju u kratkom roku.
English: Not applicable.
Croatian: nije primjenjivo.
English: Packs of 10.
Croatian: Pakiranje od 10.
English: - A line listing of fatal cases will be provided in an Annex.
Croatian: - Linearni popis smrtnih slučajeva bit će naveden u Dodatku.
English: Tell your doctor or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koji drugi lijek, uključujući lijekove dobivene bez recepta.
English: Adults and elderly: 0.5 ml at an elected date.
Croatian: Odrasli i starije osobe: 0,5 ml na odabrani datum.
English: The doctor should inform you about the posibility to experience convulsion, in particular if you have had previous history of epilepsy.
Croatian: Liječnik vas treba obavijestiti o mogućnosti pojave konvulzija, naročito ako ste ranije imali epilepsiju.
English: NA***
Croatian: NP***
English: - “Cumulatively” means since the use of the vaccine; events not reported during the period of interest should not be presented in the tables.
Croatian: - “Skupno” znači od uporabe cjepiva; događaji koji nisu prijavljeni tijekom razdoblja od interesa ne unose se u tablice.
English: If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
Croatian: Ako to pandemijska situacija dopušta, imunizaciju je potrebno odgoditi u pacijenata s teškom febrilnom bolesti ili akutnom infekcijom.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this vaccine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili medicinskoj sestri za savjet prije nego primite ovo cjepivo.
English: To put the safety report into context, a summary of vaccine distribution should be included and should provide details of the number of doses of vaccine distributed in i) EU member states for the reporting period by batch number, ii) EU member states cumulatively and iii) the rest of the world.
Croatian: Radi pružanja konteksta za izvješće o sigurnosti, potrebno je uključiti sažetak distribucije cjepiva koje pruža pojedinosti o broju doza cjepiva distribuiranih u i) državama članicama EU za izvještajno razdoblje po serijskom broju, ii) državama članicama EU skupno i iii) ostatku svijeta.
English: Your doctor or nurse administers the vaccine in accordance with official recommendations.
Croatian: Vaš liječnik ili medicinska sestra daje cjepivo u skladu sa službenim preporukama.
English: The majority of these reactions usually disappear within 1-2 days without treatment.
Croatian: Većina ovih reakcija uglavnom nestaje u roku od 1 do 2 dana bez liječenja.
English: Date of first authorisation: 19 October 2009 Date of latest renewal: 19 October 2014
Croatian: Datum posljednje obnove odobrenja: 19. listopada 2014.
English: A short summary should be provided in which validated signals and areas of concern are highlighted, taking into account information arising from the prospective cohort study described in 4.5.
Croatian: Potrebno je uključiti kratki sažetak u kojemu su naglašeni potvrđeni signali i područja od posebne važnosti, uzimajući u obzir informacije koje proizlaze iz prospektivnog kohortnog ispitivanja opisanog u dijelu 4.5.
English: These reactions usually disappear within 1-2 days without treatment.
Croatian: Ove reakcije uglavnom nestaju u roku od 1 do 2 dana bez liječenja.
English: Foclivia should be used in accordance with Official Guidance.
Croatian: Foclivia se treba koristiti u skladu sa Službenim općim smjernicama.
English: Very rare (<1/10,000):
Croatian: Vrlo rijetko (<1/10 000):
English: • Supportive data in adult and elderly populations
Croatian: • Popratni podaci u populaciji odraslih i starijih osoba
English: In the event of multiple signals, signal work-up may be prioritised and appropriate timelines for submission of a full signal evaluation report should be provided.
Croatian: U slučaju pojave više signala, obrada signala može dobiti prioritet te je potrebno osigurati odgovarajuće vremenske planove za predaju potpunih izvješća o procjeni signala.
English: Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with a specific review of AESI and possible adverse events related to adjuvants.
Croatian: Izvan razdoblja pandemije bit će zadržana uobičajena periodičnost i format PSUR-a, uz specifičan pregled AESI-a i mogućih štetnih događaja povezanih s adjuvansima.
English: Foclivia contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose.
Croatian: Foclivia sadrži manje od 1 mmol natrija (23 mg) i manje od 1 mmol kalija (39 mg) po dozi.
English: Other medicines and Foclivia
Croatian: Drugi lijekovi i FOCLIVIA
English: The report should include the following Tables of aggregate data (using the pre-defined templates attached in Annex 2).
Croatian: To izvješće treba sadržavati sljedeće tablice skupnih podataka (korištenjem gotovih predložaka priloženih u Dodatku 2).
English: What Foclivia is and what it is used for
Croatian: Što je FOCLIVIA i za što se koristi
English: Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Croatian: Liječnici su svjesni te mogućnosti, zbog čega imaju spremno hitno liječenje za takve slučajeve.
English: During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan
Croatian: Tijekom pandemije podnositelj će provesti prospektivno kohortno ispitivanje navedeno u Farmakovigilancijskom planu
English: NA*** N=36
Croatian: NP*** N=36
English: NA*** N=69
Croatian: NP*** N=69
English: Immunogenicity was assessed in a subset (n=197) of the study population.
Croatian: Imunogenost je procijenjena u podskupini (n=197) ispitivane populacije.
English: Therefore, 6-monthly or annual PSURs falling within the pandemic period will be replaced by monthly “simplified PSURs” (S-PSUR) accompanied by a summary of vaccine distribution.
Croatian: Dakle, 6-mjesečni ili godišnji PSUR-ovi za vrijeme razdoblja pandemije bit će zamijenjeni mjesečnim “pojednostavljenim PSUR-ovima” koje prati sažetak distribucije cjepiva.
English: As with all vaccines, Foclivia may not fully protect all persons who are vaccinated.
Croatian: Kao i kod svih cjepiva, Foclivia možda neće u potpunosti zaštiti sve cijepljene osobe.
English: The vaccine contains an ‘adjuvant' (a compound containing squalene) to stimulate a better response.
Croatian: Cjepivo sadrži "adjuvans" (spoj koji sadrži skvalen) za poticanje boljeg odgovora.
English: Therefore, tell the doctor or nurse if you fainted with a previous injection.
Croatian: Stoga obavijestite liječnika ili medicinsku sestru ako ste se onesvijestili pri prijašnjim injekcijama.
English: There is limited experience of the booster dose in the elderly population.
Croatian: Postoji ograničeno iskustvo s booster dozom u starijoj populaciji.
English: Only spontaneously reported data should be included in the PSUR.
Croatian: U PSUR je potrebno uključiti samo spontano prijavljene podatke.
English: Booster dose
Croatian: Booster doza
English: Depending on and after implementation of vaccine when first pandemic will take place.
Croatian: Ovisno o početku i nakon uvođenja cjepiva prilikom prve pandemije.
English: Foclivia should not be given at the same time as other vaccines (if another vaccine is required at the same time, then the injection should be carried out on a different limb.
Croatian: Focliviju se ne smije davati istovremeno s drugim cjepivima (ako je istovremeno potrebno drugo cjepivo, injekciju treba dati u drugi ud.
English: These antigens can be considered as ‘novel' antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Croatian: Ti se antigeni mogu smatrati "novim" antigenima i simuliraju situaciju u kojoj je ciljna populacija za cijepljenje imunološki naivna.
English: A second dose of vaccine should be given after an interval of at least 3 weeks.
Croatian: Drugu dozu cjepiva treba primijeniti nakon intervala od najmanje 3 tjedna.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness: Nervous system disorders
Croatian: Unutar svake skupine učestalosti, nuspojave su navedene prema padajućoj ozbiljnosti: Poremećaji živčanog sustava
English: • Data in paediatric populations
Croatian: • Podaci u pedijatrijskoj populaciji
English: See section 4.2 for information on paediatric use.
Croatian: Vidjeti dio 4.2. za informacije o pedijatrijskoj primjeni).
English: The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Croatian: Imunološki odgovor može biti slabiji ako je pacijent podvrgnut imunosupresijskoj terapiji.
English: Children and adolescents aged 6 months to 17 years:
Croatian: Djeca i adolescenti u dobi od 6 mjeseci do 17 godina:
English: First dose
Croatian: Prva doza
English: It has to be used in adults (from 18 to 60 years old) and elderly (over 60 years) to prevent flu caused by the H5N1 type of the virus.
Croatian: Mora se koristiti u odraslih (u dobi od 18 do 60 godina) i starijih osoba (više od 60 godina) radi sprječavanja gripe uzrokovane virusom tipa H5N1.
English: Those which have not yet been entered should be reported in the following S-PSUR.
Croatian: Oni koji još nisu uneseni trebaju biti navedeni u sljedećem „pojednostavljenom PSUR-u“.
English: They are isolated from the surface of influenza virus particles, which are grown in fertilised hen's eggs from healthy chicken flocks and inactivated with formaldehyde.
Croatian: Izolirani su s površine čestica virusa influence, koje su umnožene u oplođenim kokošjim jajima iz jata zdravih kokoši i inaktivirane formaldehidom.
English: Immunogenicity results with Focetria H1N1v (Study V111_03):
Croatian: Rezultati imunogenosti s Focetria H1N1v (Studija V111_03):
English: The majority of febrile convulsions occurred in paediatric subjects.
Croatian: Do većine febrilnih konvulzija došlo je kod pedijatrijske populacije.