FrancophonIA/ELRC3.0 huggingface dataset:
English: The overall assessment of tolerability was good to very good in more than 98 % of the children for both, the physician's and the patient/parent's assessment (see also section 4.8).
Croatian: I od strane liječnika i od strane bolesnika/roditelja ukupna ocjena podnošljivosti bila je dobra ili vrlo dobra u više od 98 % djece (vidi i dio 4.8.).
English: The text below should be inserted by replacing the existing text of this section:
Croatian: U ovom dijelu treba umetnuti tekst u nastavku, kojim se zamjenjuje postojeći tekst:
English: The E. coli bacteria are excreted via the faeces.
Croatian: Bakterija E. coli izlučuje se u stolici.
English: If signs of gastrointestinal symptoms like flatulence, diarrhoea, abdominal pain or abdominal discomfort worsen or occur more frequently at the beginning of treatment, Symbioflor E. coli should be taken diluted in water, or the dose should be reduced or the number of drops should be increased more slowly.
Croatian: Ako se znakovi gastrointestinalnih simptoma, kao što su flatulencija, proljev, bolovi u trbuhu ili nelagoda u trbuhu, pogoršaju ili se češće pojavljuju na početku liječenja, potrebno je uzeti lijek Symbioflor E. coli razrjeđen u vodi, ili smanjiti dozu ili sporije povećavati broj kapi.
English: Section 3 How to take Symbioflor E. coli
Croatian: Kako uzimati Symbioflor E. coli
English: Overall, Symbioflor E. coli was well tolerated in the clinical trial with no significant differences in the tolerability compared to placebo regarding vital functions, body weight and all laboratory parameters tested.
Croatian: Nije bilo značajnih razlika u podnošljivosti u pogledu vitalnih funkcija, tjelesne težine i svih laboratorijski ispitanih parametara kada se taj lijek usporedi s placebom.
English: E. coli.
Croatian: Prilog III.
English: E. coli bacteria are not absorbed but act locally at the intestinal immune system.
Croatian: U ovom dijelu treba umetnuti tekst u nastavku, kojim se zamjenjuje postojeći tekst: Bakterija E. coli se ne apsorbira, već djeluje lokalno u crijevnom imunološkom sustavu.
English: Do not take Symbioflor E. coli: - if you are allergic to Escherichia coli bacteria or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Symbioflor E. coli: - ako ste alergični na bakteriju Escherichia coli ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako imate teške organske bolesti probavnog sustava, kao što su akutna upala žučnog mjehura ili gušterače ili crijevna opstrukcija (začepljenje) - ako imate vrlo veliki, abnormalni gubitak težine ili krajnje veliki gubitak težine zbog neuhranjenosti (kaheksija, marazam).
English: The following undesirable effects may occur: Common (may affect up to 1 in 10 patients): - Abdominal pain (including upper abdominal pain and abdominal discomfort) - Hives These reactions usually occur within the first 4 weeks of treatment and disappear within a few days even if treatment is continued.
Croatian: Te se nuspojave pojavljuju obično tijekom prva 4 tjedna terapije i nestaju u roku od nekoliko dana čak i ako se terapija nastavi.
English: The text below should be inserted by replacing the existing text of this section: Posology
Croatian: U ovom dijelu treba umetnuti tekst u nastavku, kojim se zamjenjuje postojeći tekst: Doziranje
English: If you stop taking Symbioflor E. coli
Croatian: Ako prestanete uzimati Symbioflor E. coli Nisu potrebne posebne mjere.
English: Only non-serious adverse events were recorded with a slightly higher frequency for Symbioflor
Croatian: Za lijek Symbioflor E. coli prijavljena je nešto veća učestalost samo onih štetnih događaja koji nisu ozbiljni.
English: Children under 1 year
Croatian: Djeca mlađa od 1 godine
English: Time (Week)
Croatian: Vrijeme (tjedan)
English: • sweating.
Croatian: • znojenje.
English: July 2019
Croatian: srpanj 2019.
English: The dose is based on your body weight.
Croatian: Doza se temelji na tjelesnoj težini.
English: There was no evidence of teratogenic effects.
Croatian: Nisu nađeni dokazi teratogenih učinaka.
English: • medicines that work in the same way as calcium in the body (“calcimimetics”).
Croatian: • lijekove koji djeluju na jednaki način kao kalcij u tijelu (“kalcimimetici”).
English: This is because it is not known if CRYSVITA will affect the baby.
Croatian: To je zbog toga što nije poznato hoće li CRYSVITA utjecati na dijete.
English: The safety and efficacy of burosumab in children aged less than one year have not been established.
Croatian: Sigurnost i djelotvornost burosumaba u djece mlađe od jedne godine nisu ustanovljene.
English: Store in a refrigerator (2°C to 8°C).
Croatian: Čuvati u hladnjaku (od 2°C do 8°C).
English: CRYSVITA is not recommended in pregnancy.
Croatian: CRYSVITA se ne preporučuje u trudnoći.
English: The events were mild or moderate in severity.
Croatian: Događaji su bili blage ili umjerene težine.
English: Side effects (very common - may affect more than 1 in 10 children)
Croatian: Nuspojave (vrlo česte - mogu se pojaviti u više od 1 na 10 djece)
English: • Pain in muscles (myalgia) and hands and feet
Croatian: • bol u mišićima (mialgija) te rukama i nogama
English: (positive indicates healing)
Croatian: (pozitivna vrijednost pokazuje stupanj izlječenja)
English: This is a type of medicine called a human monoclonal antibody.
Croatian: To je vrsta lijeka koji se naziva ljudsko monoklonsko protutijelo.
English: • you are allergic to burosumab or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ako ste alergični na burosumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Your doctor will perform checks to make sure that you are getting the right dose, and may change your dose if needed.
Croatian: Liječnik će Vam provesti testove kako bi provjerio primate li odgovarajuću dozu, a možda će i promijeniti dozu ako je potrebno.
English: May 2020
Croatian: svibanj 2020.
English: If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist 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 ili ljekarniku za savjet prije nego primite ovaj lijek.
English: • Reactions where the injection was given, which may include:
Croatian: • reakcije na mjestu primjene injekcije koje mogu uključivati:
English: You should discuss this with your doctor.
Croatian: O tome morate porazgovarati s liječnikom.
English: In the paediatric studies, approximately 57% of the patients had an injection site reaction.
Croatian: U pedijatrijskim ispitivanjima reakciju na mjestu injekcije imalo je približno 57% bolesnika.
English: 370-0013 Gunma JAPAN
Croatian: 370-0013 Gunma
English: It is used in children of 1 year and older, and adolescents who are still growing.
Croatian: Primjenjuje se u djece u dobi od 1 i više godina te adolescenata koji još rastu.
English: Do not shake before use.
Croatian: Nemojte tresti prije upotrebe.
English: Stop taking CRYSVITA and tell your doctor straight away if you have any of the following side effects, as they could be signs of an allergic reaction:
Croatian: Prestanite s primjenom lijeka CRYSVITA i odmah se obratite liječniku ako imate bilo koju od sljedećih nuspojava jer one mogu biti znakovi alergijske reakcije:
English: If you have been given more CRYSVITA than you should If you think that you have been given too much CRYSVITA, tell your doctor straight away.
Croatian: Ako ste primili više lijeka CRYSVITA nego što ste trebali Mislite li da ste primili previše lijeka CRYSVITA, odmah kažite liječniku.
English: Date of first authorisation: 19 February 2018 Date of latest renewal: 21 February 2019
Croatian: Datum prvog odobrenja: 19 veljača 2018
English: The maximum volume of medicinal product per injection site is 1.5 ml.
Croatian: Najveći volumen lijeka po mjestu injiciranja iznosi 1,5 mL.
English: The adverse reactions are presented by system organ class and frequency categories, defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave su prikazane prema klasifikaciji organskih sustava i učestalosti, definirano na temelju sljedećeg dogovora: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • rash and itching all over the body
Croatian: • osip i svrbež po cijelom tijelu
English: Crysvita should not be given to children under 1 year of age because the safety and effects of the medicine have not been studied in this age group.
Croatian: Lijek Crysvita ne smiju primiti djeca mlađa od 1 godine jer sigurnost i učinci lijeka nisu ispitivani u toj dobnoj skupini.
English: In case of overdose, it is recommended to stop burosumab and to monitor biochemical response.
Croatian: U slučaju predoziranja preporučuje se prekinuti primjenu burosumaba i pratiti biokemijski odgovor.
English: Do not take CRYSVITA if any of the above apply to you.
Croatian: Nemojte primijeniti lijek CRYSVITA ako se bilo što od prethodno navedenog odnosi na Vas.
English: Results are summarised in Table 2.
Croatian: Rezultati su sažeti u tablici 2.
English: Ectopic mineralisation
Croatian: Ektopična mineralizacija
English: • severe swelling of eyelids, mouth or lips (angio-oedema)
Croatian: • teško oticanje vjeđa, usta ili usana (angioedem)
English: • Tooth abscess (infection)
Croatian: • apsces zuba (infekcija)
English: Co-administration of these medicinal products has not been studied in clinical trials and could potentially exacerbate hypocalcaemia.
Croatian: Istodobna primjena tih lijekova nije ispitana u kliničkim ispitivanjima i mogla bi pogoršati hipokalcijemiju.
English: • Low vitamin D in your blood
Croatian: • niska razina vitamina D u krvi
English: If you think you are affected, do not ride a bike, use any tools or machines or drive, and tell your doctor.
Croatian: Ako mislite da lijek utječe na Vas, nemojte voziti bicikl, ne rukujte alatima ili strojevima i ne vozite, a o tome obavijestite liječnika.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from CRYSVITA therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom CRYSVITA uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: (reduced RSS score indicates improvement in rickets severity)
Croatian: (smanjeni RSS rezultat pokazuje poboljšanje težine rahitisa)
English: These injection site reactions are usually mild and occur within a day after the injection and usually get better in around 1 to 3 days.
Croatian: Te reakcije na mjestu primjene injekcije obično su blage, pojave se unutar jednog dana poslije injekcije i najčešće se poboljšaju nakon otprilike 1 do 3 dana.
English: Due to its molecular size, burosumab is not expected to be directly excreted.
Croatian: Zbog veličine molekula burosumaba, ne očekuje se njegovo izravno izlučivanje.
English: • The low level of phosphate may lead to bones that cannot grow and harden properly.
Croatian: • Niska razina fosfata može dovesti do toga da kosti ne mogu rasti i postajati čvršće koliko je potrebno.
English: Caution should be exercised when combining burosumab with calcimimetic medicinal products (i.e. agents that mimic the effect of calcium on tissues by activating the calcium receptor).
Croatian: Potreban je oprez kada se burosumab kombinira s kalcimimeticima (tj. lijekovima koji oponašaju učinak kalcija na tkiva aktivacijom receptora za kalcij).
English: Do not take CRYSVITA and tell your doctor if you are taking: • phosphates or vitamin D supplements.
Croatian: Nemojte primiti lijek CRYSVITA i kažite liječniku ako uzimate: • nadomjeske fosfata ili vitamina D.
English: Burosumab should not be adjusted more frequently than every 4 weeks.
Croatian: Doza burosumaba ne smije se prilagođavati češće od svaka 4 tjedna.
English: The maximum dose you will be given is 90 mg.
Croatian: Najviša doza koju ćete primiti iznosi 90 mg.
English: Table 1 gives the adverse reactions observed from clinical trials.
Croatian: U tablici 1 navedene su nuspojave opažene u kliničkim ispitivanjima.
English: Treatment should be initiated by a physician experienced in the management of patients with metabolic bone diseases.
Croatian: Liječenje treba započeti liječnik s iskustvom u liječenju bolesnika s metaboličkim bolestima kostiju.
English: Injections sites should be rotated and carefully monitored for signs of potential reactions (see section 4.4).
Croatian: Mjesta primjene injekcije treba izmjenjivati i pažljivo pratiti zbog znakova mogućih reakcija (vidjeti dio 4.4).
English: Talk to your doctor before taking CRYSVITA if you are taking:
Croatian: Obratite se liječniku prije nego što primite lijek CRYSVITA ako uzimate:
English: If you are not sure, talk to your doctor before using CRYSVITA.
Croatian: Ako niste sigurni, obratite se liječniku prije nego što primijenite lijek CRYSVITA.
English: Do not use CRYSVITA if it contains visible particles.
Croatian: Lijek CRYSVITA ne smije se upotrijebiti ako sadrži vidljive čestice.
English: Changes in serum phosphate concentration over time are shown in Figure 1.
Croatian: Promjene koncentracije fosfata u serumu tijekom vremena prikazane su na slici 1.
English: Pharmacotherapeutic group: Drugs for the treatment of bone diseases, other drugs affecting bone structure and mineralisation, ATC code: M05BX05.
Croatian: Farmakoterapijska skupina: lijekovi za liječenje bolesti kostiju, drugi lijekovi koji utječu na građu i mineralizaciju kostiju, ATK oznaka: M05BX05.
English: 2132NP Hoofddorp The Netherlands medinfo@kyowakirin.com
Croatian: 2132NP Hoofddorp Nizozemska medinfo@kyowakirin.com
English: Its metabolism and elimination are expected to follow the immunoglobulin clearance pathways, resulting in degradation to small peptides and individual amino acids.
Croatian: Očekuje se da će metabolizam i eliminacija slijediti puteve klirensa imunoglobulina, što rezultira razgradnjom na male peptide i pojedinačne aminokiseline.
English: If a dose is missed, talk to your doctor straight away.
Croatian: Ako ste propustili dozu, odmah se obratite liječniku.
English: Dose interruption and/or dose reduction may be required (see section 4.2).
Croatian: Može biti potrebno privremeno prekinuti primjenu i/ili smanjiti dozu (vidjeti dio 4.2).
English: For handling of burosumab before administration, see section 6.6.
Croatian: Za upute o rukovanju burosumabom prije primjene vidjeti dio 6.6.
English: • FGF23 lowers the amount of phosphate in the blood.
Croatian: • FGF23 snižava količinu fosfata u krvi.
English: It is not known if CRYSVITA passes into breast milk, and a risk to newborns or infants cannot be ruled out.
Croatian: Nije poznato prelazi li CRYSVITA u majčino mlijeko i ne može se isključiti rizik za novorođenčad ili dojenčad.
English: Your doctor will work out the right dose for you.
Croatian: Liječnik će odrediti koja je doza odgovarajuća za Vas.
English: Scores range from -3 (indicating severe worsening of rickets) to +3 (indicating complete healing of rickets).
Croatian: Rezultati se kreću u rasponu od -3 (što pokazuje teško pogoršanje rahitisa) do +3 (pokazuje potpuno izlječenje rahitisa).
English: If you could get pregnant, you must use an effective method of contraception (birth control) while using CRYSVITA.
Croatian: Ako biste mogli zatrudnjeti, dok primate lijek CRYSVITA morate upotrebljavati učinkovitu metodu kontracepcije (zaštita od trudnoće).
English: If a patient misses a dose, burosumab should be resumed as soon as possible at previously prescribed dose.
Croatian: Ako bolesnik propusti dozu, primjenu burosumaba treba nastaviti što prije u prethodno propisanoj dozi.
English: The missed dose should be given as soon as possible and your doctor will re-arrange future doses accordingly.
Croatian: Propuštenu dozu morate primiti što prije, a liječnik će Vam prema tome rasporediti sljedeće doze.
English: These changes were a consequence of higher than normal serum phosphate levels, which accelerated bone turnover and also led to periosteal hyperostosis and a decrease in bone strength in adult animals, but not in juvenile animals at the doses tested.
Croatian: Te promjene bile su posljedica razina serumskog fosfata viših od normalnih, što je ubrzalo pregradnju kosti, a također dovelo do periostalne hiperostoze te smanjenja čvrstoće kosti u odraslih, ali ne i mladih životinja pri testiranim dozama.
English: Ectopic mineralisation was not observed in foetuses or offspring and burosumab did not affect pre- and postnatal growth including survivability of the offspring.
Croatian: Ektopična mineralizacija nije bila opažena u fetusima ili mladunčadi i burosumab nije utjecao na prenatalni i postnatalni rast uključujući sposobnost preživljenja mladunčadi.
English: What CRYSVITA is and what it is used for
Croatian: Što je CRYSVITA i za što se koristi
English: Local reactions (e.g. injection site urticaria, erythema, rash, swelling, bruising, pain, pruritus, and haematoma) have occurred at the site of injection.
Croatian: Lokalne reakcije (npr. urtikarija, eritem, osip, oticanje, modrica, bol, pruritus i hematom na mjestu injekcije) pojavile su se na mjestu primjene injekcije.
English: If more than 1.5 ml is required on a given dosing day, the total volume of medicinal product should be split and should be administered at two different injection sites.
Croatian: Ako je na dan određen za doziranje potrebna doza viša od 1,5 mL, ukupni volumen lijeka treba podijeliti i primijeniti u dva različita mjesta na tijelu.
English: There are no clinical data available on the effect of burosumab on human fertility.
Croatian: Nema dostupnih kliničkih podataka o učinku burosumaba na plodnost u čovjeka.
English: What CRYSVITA is and what it is used for What you need to know before you use CRYSVITA How to use CRYSVITA
Croatian: Što je CRYSVITA i za što se koristi Što morate znati prije nego počnete primjenjivati lijek CRYSVITA
English: Burosumab clearance and volume of distribution are body weight dependent.
Croatian: Klirens burosumaba i volumen distribucije ovisni su o tjelesnoj težini.
English: Burosumab may have a minor influence on the ability to drive and use machines.
Croatian: Burosumab može malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: In paediatric patients, the most frequent potential hypersensitivity events were rash (22%), injection site rash (6%), and urticaria (4%).
Croatian: U pedijatrijskih bolesnika najčešći potencijalni događaji preosjetljivosti bili su osip (22%), osip na mjestu primjene injekcije (6%) i urtikarija (4%).
English: The active substance is burosumab.
Croatian: Djelatna tvar je burosumab.
English: No significant difference has been observed in paediatric patient pharmacokinetics or pharmacodynamics as compared with PK/PD in the adult population.
Croatian: U pedijatrijskih bolesnika nije opažena značajna razlika u farmakokinetici ili farmakodinamici bolesnika u usporedbi s onom u odrasle populacije.
English: This conventional therapy was discontinued 2-4 weeks prior to burosumab initiation.
Croatian: Ta konvencionalna terapija prekinuta je 2-4 tjedna prije početka primjene burosumaba.
English: Studies in animals have shown effects on male reproductive organs (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su učinke na reproduktivne organe u mužjaka (vidjeti dio 5.3).
English: Keep the vial in the outer carton in order to protect from light.
Croatian: Bočicu držite u vanjskoj kutiji radi zaštite od svjetlosti.
English: The injection site reactions were generally mild in severity, occurred within 1 day of medicinal product administration, lasted approximately 1 to 3 days, required no treatment, and resolved in almost all instances.
Croatian: Reakcije su bile uglavnom blage, pojavile su se unutar 1 dana od primjene lijeka, trajale su otprilike između 1 i 3 dana, nije bilo potrebno liječenje i povukle su se u gotovo svim slučajevima.
English: In repeat-dose toxicology studies of up to 40 weeks duration in cynomolgus monkeys, mineralisation of the rete testis/seminiferous tubules was observed in male monkeys; however, no changes were observed in semen analysis.
Croatian: U ispitivanjima toksičnosti ponovljenih doza u trajanju do 40 tjedana provedenim u makaki majmuna, u mužjaka je opažena mineralizacija rete testisa / sjemenskih kanalića; međutim, u analizi sjemena nisu opažene promjene.
English: Monitoring of plasma alkaline phosphatases, Calcium, PTH and creatinine is recommended every 6 months (every 3 months for children 1- 2 years) or as indicated.
Croatian: Preporučuje se pratiti alkalnu fosfatazu, kalcij, paratireoidni hormon (PTH) i kreatinin u plazmi svakih 6 mjeseci (svaka 3 mjeseca u djece u dobi od 1 do 2 godine) ili kako je indicirano.
English: Burosumab is composed solely of amino acids and carbohydrates as a native immunoglobulin and is unlikely to be eliminated via hepatic metabolic mechanisms.
Croatian: Kao nativni imunoglobulin, burosumab je sastavljen samo od aminokiselina i ugljikohidrata i nije vjerojatno da će se eliminirati putem hepatičkih metaboličkih mehanizama.
English: Burosumab did not promote abnormal bone development, as no changes in femur length or bone strength were noted in juvenile animals.
Croatian: Burosumab nije potaknuo abnormalni razvoj kostiju jer u mladunčadi nisu uočene promjene u duljini femoralne kosti ili čvrstoći kostiju.
English: Keep CRYSVITA out of the sight and reach of children.
Croatian: Lijek CRYSVITA čuvajte izvan pogleda i dohvata djece.
English: No adverse effects on female reproductive organs were observed in these studies.
Croatian: U tim ispitivanjima nisu ustanovljene nuspojave na reproduktivnim organima ženki.
English: This conventional therapy was discontinued 2-6 weeks prior burosumab initiation.
Croatian: Ta konvencionalna terapija prekinuta je 2-6 tjedana prije početka primjene burosumaba.
English: Serum burosumab and phosphate concentrations, as well as TmP/GFR, increased and decreased in parallel and reached maximum levels at approximately the same time point after each dose, supporting a direct PK-PD relationship.
Croatian: Serumske koncentracije burosumaba i fosfata, kao i TmP/GFR, paralelno su se povećavale i smanjivale, a maksimalne razine dosegnute su u približno istoj vremenskoj točki nakon svake doze, što potkrepljuje izravni farmakokinetičko-farmakodinamički odnos.
English: After initiation of treatment with burosumab, fasting serum phosphate should be measured every 2 weeks for the first month of treatment, every 4 weeks for the following 2 months and thereafter as appropriate.
Croatian: Nakon započete terapije burosumabom koncentraciju fosfata u serumu natašte treba mjeriti svaka 2 tjedna u prvom mjesecu liječenja, svaka 4 tjedna u sljedeća 2 mjeseca, a potom kako je odgovarajuće.
English: It is unknown whether burosumab/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se burosumab/metaboliti u majčino mlijeko.
English: Monitoring of urine calcium and phosphate is suggested every 3 months.
Croatian: Predlaže se praćenje kalcija i fosfata u mokraći svaka 3 mjeseca.
English: There is no experience with overdose of burosumab.
Croatian: Nema iskustva s predoziranjem burosumabom.
English: Clear glass vial with butyl rubber stopper, and aluminium seal.
Croatian: Bočica od prozirnog stakla s čepom od butilne gume i aluminijskim zatvaračem.
English: • you are taking any phosphate or vitamin D supplements
Croatian: • ako uzimate nadomjeske fosfata ili vitamina D
English: D-sorbitol E420
Croatian: D-sorbitol E420 polisorbat 80
English: Adverse reactions reported in paediatric patients with XLH (N=65)
Croatian: Tablica 1: Nuspojave zabilježene u pedijatrijskih bolesnika s XLH-om (N=65)
English: Each vial contains either 10, 20 or 30 mg of burosumab.
Croatian: Jedna bočica sadrži 10, 20 ili 30 mg burosumaba.