FrancophonIA/ELRC3.0 huggingface dataset:
English: Contact your doctor immediately if you: - have difficulty breathing, a swollen face, lips or tongue, or a severe skin rash as these symptoms may indicate that you are having a severe allergic reaction - have signs of overheating - high body temperature but little or no sweating, rapid heartbeat and breathing, muscle cramps, and confusion - have thoughts of harming or killing yourself.
Croatian: Odmah se obratite liječniku ako Vam se pojavi: - otežano disanje, oticanje lica, usana ili jezika ili teški osip na koži jer ti simptomi mogu značiti da imate tešku alergijsku reakciju - znakovi pregrijanosti - visoka tjelesna temperatura ali uz malo znojenja ili bez znojenja, brzi otkucaji srca i brzo disanje, grčevi u mišićima i smetenost - pomišljate da se ozlijedite ili na samoubojstvo; mali broj osoba liječenih antiepileptičnim lijekovima kao što je Zonisamide Mylan pomišljali su na to da se ozlijede ili na samoubojstvo - bol u mišićima ili osjećaj slabosti, jer to može biti znak nenormalne razgradnje mišića što može dovesti do tegoba s bubrezima - iznenada Vas zaboli u leđima ili trbuhu, boli vas pri mokrenju ili opazite krv u mokraći, jer to može biti znak bubrežnih kamenaca - tegobe s vidom kao što je bol u oku ili zamagljen vid dok uzimate zonisamid.
English: INFORMATION IN BRAILLE Zonisamide Mylan 25 mg
Croatian: Zonisamide Mylan 25 mg
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja poremećaj disanja
English: Secondary Tonic-Clonic Generalized Tonic-Clonic
Croatian: Podvrsta napadaja (bez napadaja 6 mjeseci - PP populacija) svi parcijalni jednostavni parcijalni kompleksni parcijalni svi generalizirani toničko-klonički sekundarni toničko-klonički generalizirani toničko-klonički
English: 500 mg/day (once a day)
Croatian: 300 do 500 mg na dan (jedanput na dan)
English: Investigations Decreased bicarbonate
Croatian: Napadaji povezani s ukidanjem lijeka
English: Zonisamide Mylan 25 mg and 100 mg hard capsules
Croatian: 6.1 Popis pomoćnih tvari Zonisamide Mylan 25 mg i 100 mg tvrde kapsule
English: Contents of the pack and other information
Croatian: Kako čuvati Zonisamide Mylan Sadržaj pakiranja i druge informacije
English: This summary was last updated in March 2017.
Croatian: Sažetak je posljednji put ažuriran u ožujku 2017.
English: The vaccine starts to be effective 2 weeks after vaccination and protection lasts for 17 weeks.
Croatian: Cjepivo postaje djelotvorno 2 tjedna nakon cijepljenja, a zaštita traje 17 tjedana.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Croatian: Cjepiva djeluju tako da „nauče” imunosni sustav (prirodna obrana tijela) kako se obraniti od bolesti.
English: The full EPAR for Ingelvac CircoFLEX can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Ingelvac CircoFLEX nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: These studies were performed under laboratory as well as under typical European farming conditions.
Croatian: Ta su ispitivanja provedena u laboratorijskim uvjetima te u uvjetima uzgoja tipičnim za Europu.
English: response will help to protect the pig against the disease caused by this virus.
Croatian: Takav aktivni imunosni odgovor pomoći će u zaštiti svinje od bolesti prouzročene ovim virusom.
English: The most common side effect with Ingelvac CircoFLEX (which may affect more than 1 in 10 animals) is a mild and short lived increase in body temperature on the day of vaccination.
Croatian: Najčešća nuspojava VMP-a Ingelvac CircoFLEX (može se javiti u više od 1 na 10 životinja) jest blago i kratkotrajno povećanje tjelesne temperature na dan cijepljenja.
English: When a pig is given the vaccine, the pig's immune system recognises the protein as ‘foreign' and reacts by building up an active immune response.
Croatian: Kada svinja primi cjepivo, imunosni sustav svinje prepozna bjelančevinu kao „strano tijelo” i reagira razvojem aktivnog imunosnog odgovora.
English: PCV2 infections can produce clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty breathing, pale skin and jaundice (yellowing of the skin).
Croatian: Infekcije virusom PCV2 mogu dovesti do kliničkih znakova kao što su gubitak tjelesne težine ili prestanak rasta, povećani limfni čvorovi, otežano disanje, blijeda koža i žutica (žuta boja kože).
English: The European Commission granted a marketing authorisation valid throughout the EU for Ingelvac CircoFLEX on 13 February 2008.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Ingelvac CircoFLEX na snazi u Europskoj uniji od 13. veljače 2008.
English: The withdrawal period for meat from pigs treated with Ingelvac CircoFLEX is ‘zero days', which means there is no mandatory waiting time.
Croatian: Razdoblje karencije za meso svinja liječenih VMP-om Ingelvac CircoFLEX iznosi „nula dana”, drugim riječima, nema obveznog razdoblja čekanja.
English: Other information about Ingelvac CircoFLEX:
Croatian: Ostale informacije o VMP-u Ingelvac CircoFLEX:
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Ingelvac CircoFLEX's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Ingelvac CircoFLEX nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: It also reduced the levels of PCV2 in the blood, clinical signs of PCV2 infection, the number of runts and death rates.
Croatian: Također su se smanjile razine virusa PCV2 u krvi, klinički znakovi infekcije virusom PCV2, broj svinja zaostalih u razvoju i stope smrtnosti.
English: Ingelvac CircoFLEX is available as a suspension for injection and can only be obtained with a prescription.
Croatian: Ingelvac CircoFLEX dostupan je kao suspenzija za injekciju i izdaje se samo na veterinarski recept.
English: In the future, the immune system will be able to react against the virus more quickly when it is exposed to the virus.
Croatian: izložen virusu, moći će protiv njega brže reagirati.
English: The trials showed that vaccination of pigs with Ingelvac CircoFLEX reduced weight loss in the piglets.
Croatian: Ispitivanja su pokazala da se cijepljenjem svinja cjepivom Ingelvac CircoFLEX smanjio gubitak težine u praščića.
English: It is not intended to provide practical advice on how to use Ingelvac CircoFLEX.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju VMP-a Ingelvac CircoFLEX.
English: porcine circovirus type 2 vaccine
Croatian: cjepivo protiv cirkovirusa svinja tipa 2
English: Why is Ingelvac CircoFLEX approved?
Croatian: Zašto je Ingelvac CircoFLEX odobren?
English: This is a summary of the European public assessment report (EPAR) for Ingelvac CircoFLEX.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR)veterinarsko-medicinskog proizvoda Ingelvac CircoFLEX.
English: Ingelvac CircoFLEX is a vaccine used to protect pigs from the two weeks of age against porcine circovirus type 2 (PCV2).
Croatian: Ingelvac CircoFLEX je cjepivo koje se primjenjuje za zaštitu svinja starijih od dva tjedna od cirkovirusa svinja tipa 2 (PCV2).
English: For the full list of restrictions and all side effects reported with Ingelvac CircoFLEX, see the package leaflet.
Croatian: Potpuni popis ograničenja i svih nuspojava zabilježenih pri primjeni VMP-a Ingelvac CircoFLEX potražite u uputi o VMP-u.
English: What is Ingelvac CircoFLEX and what is it used for?
Croatian: Što je Ingelvac CircoFLEX i za što se koristi?
English: For more information about treatment with Ingelvac CircoFLEX, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Ingelvac CircoFLEX vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Ingelvac CircoFLEX contains small amounts of a protein from PCV2.
Croatian: Ingelvac CircoFLEX sadrži male količine bjelančevine iz virusa PCV2.
English: What are the risks associated with Ingelvac CircoFLEX?
Croatian: Koji su rizici povezani s VMP-om Ingelvac CircoFLEX?
English: For practical information about using Ingelvac CircoFLEX, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Ingelvac CircoFLEX vlasnici ili uzgajivači životinja trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Ingelvac CircoFLEX contains the active substance porcine circovirus type 2 ORF2 protein.
Croatian: Ingelvac CircoFLEX sadrži djelatnu tvar cirkovirus svinja tipa 2, bjelančevinu ORF2.
English: Ingelvac CircoFLEX has been studied in a number of trials involving pigs of various breeds.
Croatian: Proveden je niz ispitivanja VMP-a Ingelvac CircoFLEX koja su uključivala svinje raznih pasmina.
English: How is Ingelvac CircoFLEX used?
Croatian: Kako se Ingelvac CircoFLEX koristi?
English: Ingelvac CircoFLEX is a vaccine.
Croatian: Ingelvac CircoFLEX je cjepivo.
English: What benefits of Ingelvac CircoFLEX have been shown in studies?
Croatian: Koje su koristi VMP-a Ingelvac CircoFLEX utvrđene u ispitivanjima?
English: How does Ingelvac CircoFLEX work?
Croatian: Kako djeluje Ingelvac CircoFLEX?
English: This active immune
Croatian: Ubuduće, kada se dogodi da je imunosni sustav
English: Examples of such circumstances are:
Croatian: Primjeri takvih okolnosti su:
English: Read this section carefully.
Croatian: Pažljivo pročitajte ovaj dio.
English: What kind of monitoring is required during the infusion?
Croatian: Koja vrsta nadzora je potrebna tijekom infuzije?
English: In certain circumstances, special precautions may be necessary.
Croatian: određenim okolnostima mogu biti potrebne posebne mjere opreza.
English: This is an extremely rare disorder.
Croatian: To je iznimno rijedak poremećaj.
English: Somnolence, tremor
Croatian: Somnolencija, tremor
English: There are two alternative treatment schedules:
Croatian: Postoje dva rasporeda liječenja:
English: If you receive more Privigen than you should
Croatian: Ako primite više Privigena nego što ste trebali
English: • proteinuria,
Croatian: • proteinurija,
English: This leaflet was last revised in.
Croatian: Ova uputa je zadnji puta revidirana u
English: Risk Management Plan (RMP)
Croatian: LIJEKA Plan upravljanja rizikom (RMP)
English: For instruction, see section 6.6.
Croatian: Za upute vidjeti dio 6.6.
English: Only a few families with this disease are known worldwide.
Croatian: U svijetu je poznato samo nekoliko obitelji koje pate od ovog poremećaja.
English: However, true allergic reactions are rare.
Croatian: Međutim, prave su alergijske reakcije rijetke.
English: Always pierce the stopper at its centre, within the marked area.
Croatian: Uvijek probušiti čep na sredini, unutar označenog područja.
English: This is an acute disease that primarily affects young children.
Croatian: To je akutna bolest koja uglavnom zahvaća mlađu djecu.
English: t½ (days)
Croatian: t½ (dana)
English: • you are receiving Privigen for the first time or after a long break in treatment (e.g. several months).
Croatian: • primate Privigen prvi put ili nakon duljeg prekida u liječenju (primjerice, nakon nekoliko mjeseci)
English: Of these, 72 completed the 12 months of treatment.
Croatian: Od njih, 72 su dovršili 12-mjesečno liječenje.
English: The approximate percentage of IgG subclasses is as follows:
Croatian: Približan postotak podrazreda IgG je sljedeći:
English: If this happens, you should not drive or use machines until these effects have disappeared.
Croatian: U tom slučaju ne smijete upravljati vozilima i raditi sa strojevima sve dok ti učinci ne nestanu.
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/EZ, službeno puštanje serije lijeka u promet preuzet će državni laboratoriji ili laboratorij određen za tu svrhu.
English: Interference with serological testing
Croatian: Interferencije sa serološkim testiranjem
English: Do NOT take Privigen
Croatian: NEMOJTE uzimati Privigen
English: The half-life may vary from patient to patient.
Croatian: Poluvijek može varirati od bolesnika do bolesnika.
English: Thus, also your baby can receive the protective antibodies.
Croatian: Na taj način će i Vaše dijete primiti zaštitna protutijela.
English: Which circumstances increase the risk of having side effects?
Croatian: Koje okolnosti povećavaju rizik od nuspojava?
English: The dose calculation for children and young patients is not different from that for adults.
Croatian: Izračun doze za djecu i mlađe bolesnike ne razlikuje se od onog za odrasle.
English: For the non dominant hand similar results were observed in both PRIMA and PATH trials.
Croatian: Za ne-dominantnu ruku slični rezultati su primijećeni i u ispitivanjima PRIMA i PATH.
English: In case of shock, standard medical treatment for shock should be implemented.
Croatian: U slučaju šoka, potrebno je provesti standardno liječenje šoka.
English: L-proline is a physiological, nonessential amino acid.
Croatian: L-prolin je fiziološka, neesencijalna amino kiselina.
English: The treatment can be repeated if relapse occurs.
Croatian: Liječenje se može ponoviti u slučaju relapsa bolesti.
English: If you tolerate this well, your doctor can gradually increase the infusion rate.
Croatian: Ako dobro podnosite ovu dozu, Vaš liječnik može postupno povećavati brzinu infuzije.
English: IgG and IgG complexes are broken down in the cells of the reticuloendothelial system.
Croatian: IgG i IgG kompleksi se razgrađuju u stanicama retikuloendotelnog sustava.
English: Overall, 91 % of subjects (188 patients) showed improvement in at least one of the criteria above by week 13.
Croatian: Sveukupno, 91% ispitanika (188 bolesnika) pokazalo je poboljšanje u barem jednom od gore navedenih kriterija do 13. tjedna.
English: For spontaneous post-marketing ADRs, the reporting frequency is categorized as unknown.
Croatian: Za spontane postmarketinške nuspojave, učestalost izvještavanja je kategorizirana kao nepoznata.
English: Anyone experiencing such symptoms should immediately be transported to a hospital emergency room for evaluation and treatment.
Croatian: Svaku osobu koja ima te simptome treba odmah prebaciti u bolnicu na odjel za hitne slučajeve radi obrade i liječenja.
English: Please also refer to section 2 “What you need to know before you are given Privigen” for additional details on circumstances which increase the risk of side effects.
Croatian: Molimo pročitajte dio 2 “Što morate znati prije nego primite Privigen” za dodatne pojedinosti o okolnostima koje povećavaju rizik od nuspojava.
English: Non-clinical data reveal no special risk for humans based on safety pharmacology and toxicity studies.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju sigurnosne farmakologije i toksikoloških ispitivanja.
English: You must not take it if you suffer from hyperprolinaemia (see also section 2 “What you need to know before you are given Privigen”).
Croatian: Ne smijte uzimati ovaj lijeka ako patite od hiperprolinemije (pogledajte također dio 2, "Što morate znati prije nego primite Privigen").
English: Privigen does not contain sucrose, maltose or glucose.
Croatian: Privigen ne sadrži saharozu, maltozu ili glukozu.
English: It is characterised by inflammation of blood vessels throughout the body.
Croatian: Karakterizirana je upalom krvnih žila u cijelom tijelu.
English: Stability after first opening:
Croatian: 3 godine Stabilnost nakon prvog otvaranja:
English: 12.3 (10.4-18.8) (3-week schedule) 9.4 (7.3-13.2) (4-week schedule)
Croatian: 12,3 (10,4-18,8) (3-tjedni raspored) 9,4 (7,3-13,2) (4-tjedni raspored)
English: As this event was commonly reported in non-O blood group patients receiving high doses for non-PID indications, increased vigilance is recommended.
Croatian: Budući da je ovaj događaj često prijavljivan u skupini bolesnika koji nisu krvna grupa 0, koji primaju visoke doze za ne-PID indikacije, preporučuje se pojačan nadzor.
English: Secondary immunodeficiencies (as defined in 4.1)
Croatian: Sekundarne imunodeficijencije (kako su definirane u 4.1)
English: All other patients should be observed for at least 20 minutes after administration.
Croatian: Sve ostale bolesnike treba nadzirati barem 20 minuta nakon primjene.
English: The information given should be taken into consideration by you and your doctor before you are given Privigen.
Croatian: Navedene informacije trebate uzeti u obzir i Vi i Vaš liječnik prije primjene lijeka Privigen.
English: Solution for infusion (10%)
Croatian: Otopina za infuziju (10%)
English: • You receive this medicine in high doses either on 1 day or over several days and you have a blood group A, B or AB and/or you have an underlying inflammatory condition.
Croatian: • Primate ovaj lijek u visokim dozama bilo u jednom danu ili tijekom nekoliko dana i imate krvnu grupu A, B ili AB i/ili imate postojeću upalnu bolest.
English: You will usually be observed during the whole infusion and for at least 20 minutes thereafter.
Croatian: Obično će Vas nadzirati tijekom cijele infuzije i najmanje 20 minuta nakon toga.
English: Please refer to section 4.4 for details on risk factors and monitoring recommendations.
Croatian: Proučite dio 4.4 za pojedinosti o čimbenicima rizika i praćenju preporuka.
English: It is usually prepared from pooled plasma from not fewer than 1,000 donors.
Croatian: Obično je pripremljen iz sveukupno prikupljene plazme od najmanje 1000 davatelja.
English: Patients with hyperprolinaemia type I or II.
Croatian: Bolesnici s hiperprolinemijom tip I ili II.
English: If, in spite of this, you receive more Privigen than you should, your blood may become too thick (hyperviscous) which might increase the risk of developing blood clots.
Croatian: Ako ste, unatoč tome, dobili Privigena više nego što ste trebali, Vaša krv može postati pregusta (hiperviskozna) što može povisiti rizik od stvaranja krvnih ugrušaka.
English: Stability after dilution:
Croatian: Stabilnost nakon razrjeđivanja:
English: The results of this study show the median half-life of Privigen to be 31.1 days (see table below).
Croatian: Rezultati ovog ispitivanja pokazuju da je medijan poluvijeka Privigena 31,1 dan (vidjeti tablicu dolje).
English: *The dose is based on the dose used in the clinical studies conducted with Privigen.
Croatian: *Doza se temelji na dozi korištenoj u kliničkim ispitivanjima provedenim s lijekom Privigen.
English: B) to treat certain inflammatory disorders (immunomodulation).
Croatian: B) za liječenje određenih upalnih poremećaja (imunomodulacija).
English: Contents of the pack and other information What Privigen contains
Croatian: Sadržaj pakiranja i druge informacije Što Privigen sadrži
English: IgA ≤ 25 micrograms.
Croatian: IgA ≤ 25 mikrograma.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in the section below.
Croatian: Lijek se ne smije miješati s drugim lijekovima osim s onima navedenim u donjem odlomku.
English: In these rare cases allergic reactions such as a sudden fall in blood pressure or shock may occur (see also section 4 “Possible side effects”).
Croatian: U tim rijetkim slučajevima pojavile su se alergijske reakcije poput iznenadnog pada krvnog tlaka ili šoka (pogledajte također dio 4 "Moguće nuspojave").
English: If you receive Privigen while you are breast-feeding the antibodies in this medicine will also be found in the breast milk.
Croatian: Ako primate Privigen dok dojite, protutijela iz ovog lijeka također će se naći u majčinom mlijeku.
English: Contains 3 vials.
Croatian: Sadrži 3 bočice.
English: • you are receiving Privigen at a high infusion rate or
Croatian: • primate Privigen pri velikoj brzini infuzije ili
English: This medicine contains trace amounts of IgA (not more than 25 micrograms/ml).
Croatian: Ovaj lijek sadrži tragove IgA (ne više od 25 mikrograma/ml).
English: If the product is diluted to lower concentrations (see section 6.6), immediate use after dilution is recommended.
Croatian: Ako je lijek razrijeđen na niže koncentracije (vidjeti dio 6.6), preporučuje se primjena neposredno nakon razrjeđivanja.
English: For safety with respect to transmissible agents and additional details on risk factors, see section 4.4.
Croatian: Za sigurnost s obzirom na prenosive agense i dodatne pojedinosti o čimbenicima rizika vidjeti dio 4.4.
English: Such vaccinations should be postponed for at least 3 months after the last infusion of Privigen.
Croatian: Takva cijepljenja treba odgoditi za najmanje 3 mjeseca nakon zadnje infuzije Privigena.
English: Tell your doctor if you are known to have medical problems.
Croatian: Obavijestite Vašeg liječnika ako imate medicinskih problema.
English: In these cases you will be closely observed during the whole infusion and for at least 1 hour afterwards.
Croatian: U tim slučajevima bit ćete pomno nadzirani tijekom cijele infuzije i barem 1 sat nakon toga.
English: In rare and isolated cases, the following side effects have been reported with immunoglobulin preparations:
Croatian: U rijetkim i izoliranim slučajevima zabilježene su sljedeće nuspojave s pripravcima imunoglobulina:
English: What Privigen looks like and contents of the pack
Croatian: Kako Privigen izgleda i sadržaj pakiranja
English: Although Privigen does not contain sugar, it may be diluted with a special sugar solution (5% glucose), which could affect your blood sugar level.
Croatian: Iako Privigen ne sadrži šećer, može se razrijediti s posebnom otopinom šećera (5%-tnom glukozom) što može utjecati na Vašu razinu šećera u krvi.
English: This medicinal product must not be mixed with other medicinal products, diluents, or solvents except those mentioned in section 6.6.
Croatian: Lijek se ne smije miješati s drugim lijekovima, sredstvima za razrjeđivanje ili otapalima osim onih navedenih u dijelu 6.6.
English: Privigen contains 100 mg/ml (10%) human protein of which at least 98% is IgG.
Croatian: Privigen sadrži 100 mg/ml (10%) ljudskih proteina od kojih je barem 98% IgG.
English: The dose and dose regimen is dependent on the indication.
Croatian: Doziranje Doza i režim doziranja ovise o indikaciji.
English: Privigen contains proline
Croatian: Privigen sadrži prolin
English: • if you suffer from hyperprolinaemia type I or II (a genetic disorder causing high levels of the amino acid proline in the blood).
Croatian: • ako patite od hiperprolinemije tip I ili II (genetskog poremećaja koji uzrokuju visoke razine aminokiseline prolina u krvi).
English: Privigen is intended solely for the infusion into a vein (intravenous infusion).
Croatian: Privigen je namijenjen isključivo za infuziju u venu (intravenska infuzija).
English: CSL Behring (Australia) Pty Ltd 189-209 Camp Road Broadmeadows, Vic 3047, Australia
Croatian: CSL Behring (Australia) Pty Ltd 189-209 Camp Road Broadmeadows, Vic 3047, Australija
English: It is usually administered by your doctor or healthcare professional.
Croatian: Obično će primijeniti Vaš liječnik ili zdravstveni radnik.
English: Proteinuria, increased blood creatinine
Croatian: Proteinurija, povišeni kreatinin u krvi
English: After receiving Privigen, the results of certain blood tests (serological tests) may be impaired for a certain time.
Croatian: Nakon primanja Privigena rezultati nekih krvnih pretraga (seroloških testova) mogu biti izmjenjeni kroz određeno vrijeme.
English: Although limited data is available, it is expected that the same warnings, precautions and risk factors apply to the paediatric population.
Croatian: Iako su dostupni ograničeni podaci, očekuje se da se ista upozorenja, mjere opreza i čimbenici rizika odnose na pedijatrijsku populaciju.