FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Symbioflor E. coli during a treatment with antibiotics or within 5 days after the end of such a treatment (see also section 4.5).
Slovenian: Zdravila Symbioflor E. coli ne jemljite med zdravljenjem z antibiotiki ali v petih dneh po zaključku zdravljenja z antibiotiki (glejte tudi poglavje 4.5).
English: The text below should be inserted by replacing the existing text of this section: Prior to a diagnosis of ‚irritable bowel syndrome‘, organic causes of the gastrointestinal disorders must be excluded.
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Besedilo v nadaljevanju je treba vstaviti namesto obstoječega besedila v tem poglavju: Pred diagnozo „sindroma razdražljivega črevesja“ je treba izključiti organske vzroke za bolezni prebavil.
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.
Slovenian: Bistvenih razlik v prenašanju zdravila v primerjavi s placebom glede življenjskih funkcij, telesne mase in vseh testiranih laboratorijskih parametrov niso opazili.
English: If gastrointestinal symptoms (like abdominal pain, flatulence or diarrhoea) worsen or occur more frequently at the beginning of the treatment, please refer to section 4.2 for measures to be taken to reduce or avoid these symptoms.
Slovenian: Če se simptomi bolezni prebavil (kot so bolečine v trebuhu, flatulenca ali diareja) na začetku zdravljenja poslabšajo ali pojavljajo pogosteje, glejte poglavje 4.2, v katerem so navedeni ukrepi za omejevanje ali preprečevanje teh simptomov.
English: If you take more Symbioflor E. coli than you should
Slovenian: Če ste vzeli večji odmerek zdravila Symbioflor E. coli, kot bi smeli Protiukrepi niso potrebni.
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.
Slovenian: Če se simptomi bolezni prebavil, kot so flatulenca, diareja, bolečine v trebuhu ali neprijeten občutek v trebuhu, na začetku zdravljenja poslabšajo ali pojavljajo pogosteje, je treba zdravilo Symbioflor E. coli jemati razredčeno v vodi, zmanjšati odmerek ali počasneje povečevati število kapljic.
English: The E. coli bacteria are excreted via the faeces.
Slovenian: Bakterija E. coli se izloči z blatom.
English: The text below should be inserted by replacing the existing text of this section: Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Slovenian: Poglavje 3 Kako jemati zdravilo Symbioflor E. coli Besedilo v nadaljevanju je treba vstaviti namesto obstoječega besedila v tem poglavju: Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta.
English: The evaluation of undesirable effects is based on the following frequencies: Very common (≥1/10)
Slovenian: Neželeni učinki so navedeni v skupinah po pogostnosti:
English: Talk to your doctor or pharmacist before taking Symbioflor E. coli.
Slovenian: Pred začetkom jemanja zdravila Symbioflor E. coli se posvetujte z zdravnikom ali farmacevtom.
English: If you stop taking Symbioflor E. coli
Slovenian: Če ste prenehali jemati zdravilo Symbioflor E. coli Ni posebnih ukrepov.
English: The text below should be inserted by replacing the existing text of this section: Posology
Slovenian: Besedilo v nadaljevanju je treba vstaviti namesto obstoječega besedila v tem poglavju: Odmerjanje
English: Package leaflet
Slovenian: Bolezni prebavil
English: Gastrointestinal disorders
Slovenian: Bolezni imunskega sistema
English: Method of administration
Slovenian: Navodilo za uporabo
English: May 2020
Slovenian: maj 2020
English: July 2019
Slovenian: julij 2019
English: It is used in children of 1 year and older, and adolescents who are still growing.
Slovenian: Uporablja se pri otrocih, ki so stari 1 leto ali več, in pri mladostnikih, ki še rastejo.
English: • sweating.
Slovenian: • znojenje.
English: • Reactions where the injection was given, which may include:
Slovenian: • reakcije na mestu, kjer so vam dali injekcijo, ki lahko vključujejo:
English: Side effects (very common - may affect more than 1 in 10 children)
Slovenian: Neželeni učinki (zelo pogosti - lahko se pojavijo pri več kot 1 od 10 otrok)
English: This is a type of medicine called a human monoclonal antibody.
Slovenian: To je vrsta zdravila, ki se imenuje človeško monoklonsko protitelo.
English: Children under 1 year
Slovenian: Otroci do 1 leta starosti
English: Time (Week)
Slovenian: čas (tedni)
English: If these reactions are severe, tell your doctor.
Slovenian: Če so te reakcije hude, povejte zdravniku.
English: There was no evidence of teratogenic effects.
Slovenian: Znakov teratogenih učinkov ni bilo.
English: Results are summarised in table 2.
Slovenian: Rezultati so povzeti v preglednici 2.
English: (See “CRYSVITA contains sorbitol” in section 2 for more information).
Slovenian: (Glejte “Zdravilo CRYSVITA vsebuje sorbitol” v poglavju 2 za več informacij.)
English: • medicines that work in the same way as calcium in the body (“calcimimetics”).
Slovenian: • zdravila, ki v telesu delujejo na enak način kot kalcij (“kalcimimetiki”).
English: In the paediatric studies, approximately 57% of the patients had an injection site reaction.
Slovenian: V pediatričnih študijah je imelo reakcijo na mestu injiciranja približno 57 % bolnikov.
English: The events were mild or moderate in severity.
Slovenian: Po izraženosti so bili dogodki blagi ali zmerni.
English: Burosumab should not be adjusted more frequently than every 4 weeks.
Slovenian: Burosumaba ne prilagajajte pogosteje kot vsake 4 tedne.
English: Your doctor will work out the right dose for you.
Slovenian: Zdravnik bo izračunal pravilni odmerek za vas.
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.
Slovenian: Zdravilo Crysvita se ne sme dajati otrokom, mlajšim od 1 leta, ker varnosti in učinkov zdravila v tej starostni skupini niso proučili.
English: The safety and efficacy of burosumab in children aged less than one year have not been established.
Slovenian: Varnost in učinkovitost burosumaba pri otrocih, mlajših od enega leta, nista bili dokazani.
English: • you are allergic to burosumab or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • če ste alergični na burosumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: Znotraj vsake pogostnostne skupine so neželeni učinki navedeni po padajoči resnosti.
English: Do not take CRYSVITA if any of the above apply to you.
Slovenian: Ne uporabite zdravila CRYSVITA, če karkoli od zgoraj navedenega velja za vas.
English: Due to its molecular size, burosumab is not expected to be directly excreted.
Slovenian: Zaradi velikosti molekule se ne pričakuje, da bi se burosumab izločal neposredno.
English: This is because it is not known if CRYSVITA will affect the baby.
Slovenian: Razlog za to je, da ni znano, ali bo zdravilo CRYSVITA vplivalo na otroka.
English: Date of first authorisation: 19 February 2018 Date of latest renewal: 21 February 2019
Slovenian: Datum zadnjega podaljšanja: 21. februar 2019
English: Do not use CRYSVITA if it contains visible particles.
Slovenian: Ne uporabljajte zdravila CRYSVITA, če vsebuje vidne delce.
English: The dose is based on your body weight.
Slovenian: Odmerek bo temeljil na vaši telesni masi.
English: • Pain in muscles (myalgia) and hands and feet
Slovenian: • bolečine v mišicah (mialgija), dlaneh in stopalih
English: In case of overdose, it is recommended to stop burosumab and to monitor biochemical response.
Slovenian: V primeru prevelikega odmerjanja je priporočljivo ukiniti burosumab in spremljati biokemični odziv.
English: No adverse effects on female reproductive organs were observed in these studies.
Slovenian: V teh študijah niso opazili nobenih neželenih učinkov na ženske reproduktivne organe.
English: Your doctor will perform checks to make sure that you are getting the right dose, and may change your dose if needed.
Slovenian: Zdravnik bo opravil kontrolne preglede, zato da se prepriča, da boste dobili pravilni odmerek, ki ga lahko po potrebi tudi spremeni.
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:
Slovenian: Prenehajte jemati zdravilo CRYSVITA in nemudoma povejte zdravniku, če imate katerega od naslednjih neželenih učinkov, ker bi bili lahko znak alergijske reakcije:
English: 370-0013 Gunma JAPAN
Slovenian: 370-0013 Gunma
English: The maximum dose you will be given is 90 mg.
Slovenian: Največji odmerek, ki ga boste prejeli, je 90 mg.
English: If you could get pregnant, you must use an effective method of contraception (birth control) while using CRYSVITA.
Slovenian: Če je možno, da bi zanosili, morate uporabljati učinkovito metodo kontracepcije (preprečevanja zanositve), tačas ko uporabljate zdravilo CRYSVITA.
English: Dose interruption and/or dose reduction may be required (see section 4.2).
Slovenian: Mogoče bo potrebna prekinitev odmerjanja in/ali zmanjšanje odmerka (glejte poglavje 4.2).
English: • Low vitamin D in your blood
Slovenian: • znižan vitamin D v krvi
English: If you think you are affected, do not ride a bike, use any tools or machines or drive, and tell your doctor.
Slovenian: Če mislite, da zdravilo na tak način vpliva na vas, se ne vozite s kolesom, ne uporabljajte orodja ali strojev in ne vozite avta in obvestite zdravnika.
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.
Slovenian: Če so vam dali več zdravila CRYSVITA, kot bi smeli Če mislite, da so vam dali preveč zdravila CRYSVITA, nemudoma povejte zdravniku.
English: (reduced RSS score indicates improvement in rickets severity)
Slovenian: (zmanjšana ocena RSS kaže na izboljšanje izraženosti rahitisa)
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Slovenian: Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14(7) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:
English: The maximum volume of medicinal product per injection site is 1.5 ml.
Slovenian: Največji volumen zdravila na injekcijsko mesto je 1,5 ml.
English: If used together they may lower blood calcium.
Slovenian: Pri sočasni uporabi lahko znižujejo nivo kalcija v krvi.
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.
Slovenian: Te reakcije na mestu injiciranja so navadno blage in se pojavijo v enem dnevu po injekciji in se navadno izboljšajo v približno 1 do 3 dneh.
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.
Slovenian: Če je na dan, ko bolnik prejme zdravilo, treba injicirati več kot 1,5 ml, je treba celotni volumen zdravila razdeliti in ga injicirati v dve različni injekcijski mesti.
English: For handling of burosumab before administration, see section 6.6.
Slovenian: Za ravnanje z burosumabom pred uporabo glejte poglavje 6.6.
English: • rash and itching all over the body
Slovenian: • izpuščaj in srbenje po vsem telesu,
English: Scores range from -3 (indicating severe worsening of rickets) to +3 (indicating complete healing of rickets).
Slovenian: Ocene segajo od -3 (ki kaže hudo poslabšanje rahitisa) do +3 (ki kaže popolno ozdravitev rahitisa).
English: Monitoring of urine calcium and phosphate is suggested every 3 months.
Slovenian: Spremljanje kalcija in fosfatov v urinu je predlagano na vsake 3 mesece.
English: Genu varum inter-condylar distance and genu valgum inter-malleolar distance did not change from Baseline up to Week 64.
Slovenian: Interkondilarna razdalja pri genu varum in intermaleolarna razdalja pri genu valgum se od izhodišča do 64. tedna nista spremenili.
English: Pharmacotherapeutic group: Drugs for the treatment of bone diseases, other drugs affecting bone structure and mineralisation, ATC code: M05BX05.
Slovenian: Farmakoterapevtska skupina: Zdravila za bolezni kosti, druga zdravila z učinkom na strukturo in mineralizacijo kosti, oznaka ATC: M05BX05.
English: Treatment should be initiated by a physician experienced in the management of patients with metabolic bone diseases.
Slovenian: Zdravljenje mora uvesti zdravnik, ki je izkušen v obravnavanju bolnikov s presnovnimi boleznimi kosti.
English: All 13 patients were considered RGI-C responders as defined by RGI-C global score ≥ +2.0.
Slovenian: Vseh 13 bolnikov je veljalo za odzivne bolnike RGI-C, kot jih opredeljuje globalna ocena RGI-C ≥ +2,0.
English: CRYSVITA will be injected every two weeks.
Slovenian: Zdravilo CRYSVITA vam bodo injicirali vsaka dva tedna.
English: Ectopic mineralisation
Slovenian: Ektopična mineralizacija
English: The missed dose should be given as soon as possible and your doctor will re-arrange future doses accordingly.
Slovenian: Izpuščeni odmerek boste prejeli čimprej, zdravnik pa bo ustrezno prerazporedil prihodnje odmerke.
English: • The low level of phosphate may lead to bones that cannot grow and harden properly.
Slovenian: • Znižana raven fosfatov lahko vodi do neustrezne rasti in otrdelosti kosti.
English: Injections sites should be rotated and carefully monitored for signs of potential reactions (see section 4.4).
Slovenian: Injekcijska mesta se morajo menjavati in skrbno spremljati glede znakov možnih reakcij (glejte poglavje 4.4).
English: Changes in serum phosphate concentration over time are shown in Figure 1.
Slovenian: Spremembe serumske koncentracije fosfatov v času kaže slika 1.
English: Do not use CRYSVITA after the expiry date which is stated on the carton and label.
Slovenian: Zdravila CRYSVITA ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in etiketi.
English: • Tooth abscess (infection)
Slovenian: • zobni ognojek (okužba)
English: Co-administration of these medicinal products has not been studied in clinical trials and could potentially exacerbate hypocalcaemia.
Slovenian: Sočasnega dajanja teh zdravil v kliničnih preskušanjih niso proučevali in bi lahko potencialno eksacerbirala hipokalcemijo.
English: Administration of burosumab may result in local injection site reactions.
Slovenian: Dajanje burosumaba lahko povzroči lokalne reakcije na mestu injiciranja.
English: Oral phosphate and vitamin D analogues should be discontinued 1 week prior to initiation of treatment.
Slovenian: Peroralne fosfate in analoge vitamina D je treba ukiniti 1 teden pred uvedbo zdravljenja.
English: Do not take CRYSVITA and tell your doctor if you are taking: • phosphates or vitamin D supplements.
Slovenian: Ne jemljite zdravila CRYSVITA in se posvetujte z zdravnikom, če jemljete: • fosfate ali prehranska dopolnila z vitaminom D.
English: 2132NP Hoofddorp The Netherlands medinfo@kyowakirin.com
Slovenian: 2132NP Hoofddorp Nizozemska medinfo@kyowakirin.com
English: How much CRYSVITA you will be given
Slovenian: Koliko zdravila CRYSVITA boste prejeli
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Table 1 gives the adverse reactions observed from clinical trials.
Slovenian: Preglednica 1 navaja neželene učinke, ki so jih ugotovili v kliničnih preskušanjih.
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.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom CRYSVITA, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: If a patient misses a dose, burosumab should be resumed as soon as possible at previously prescribed dose.
Slovenian: Če bolnik izpusti en odmerek, naj čimprej začne spet prejemati burosumab v odmerku, ki mu je bil predpisan prej.
English: Ectopic mineralisation was not observed in foetuses or offspring and burosumab did not affect pre- and postnatal growth including survivability of the offspring.
Slovenian: Ektopične mineralizacije niso ugotovili pri plodovih ali potomstvu in burosumab ni vplival na prenatalno in postnatalno rast, vključno s sposobnostjo potomstva za preživetje.
English: Keep the vial in the outer carton in order to protect from light.
Slovenian: Shranjujte vialo v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: • People with XLH have higher levels of a hormone called fibroblast growth factor 23 (FGF23).
Slovenian: • Osebe z XLH imajo višjo raven hormona, ki se imenuje fibroblastni rastni faktor 23 (FGF23).
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.
Slovenian: Po uvedbi zdravljenja z burosumabom je treba meriti serumske fosfate na tešče vsaka 2 tedna prvi mesec zdravljenja, vsake 4 tedne naslednja 2 meseca, po tistem pa, kot je primerno.
English: Patient's fasting serum phosphate level should be monitored due to the risk of hyperphosphatemia.
Slovenian: Bolnikovo koncentracijo serumskih fosfatov na tešče je treba spremljati zaradi tveganja hiperfosfatemije.
English: This conventional therapy was discontinued 2-4 weeks prior to burosumab initiation.
Slovenian: To konvencionalno zdravljenje so ukinili 2-4 tedne pred uvedbo burosumaba.
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.
Slovenian: Te spremembe so bile posledica serumskih koncentracij fosfatov, višjih od normalnih, ki so pospešile premeno kostnine in povzročile tudi periostno hiperostozo in zmanjšanje čvrstosti kosti pri odraslih živalih, ne pa pri mladostniških živalih pri testiranih odmerkih.
English: Local reactions (e.g. injection site urticaria, erythema, rash, swelling, bruising, pain, pruritus, and haematoma) have occurred at the site of injection.
Slovenian: Lokalne reakcije (npr. urtikarija, eritem, izpuščaj, oteklina, modrica, bolečina, pruritus in hematom na mestu injiciranja) se pojavljajo na mestu injiciranja.
English: No specific fertility studies in animals with burosumab were conducted.
Slovenian: Posebnih študij plodnosti na živalih z burosumabom niso opravili.
English: This conventional therapy was discontinued 2-6 weeks prior burosumab initiation.
Slovenian: To konvencionalno terapijo so ukinili 2-6 tednov pred uvedbo 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.
Slovenian: Serumske koncentracije burosumaba in fosfatov, pa tudi TmP/GFR, so se vzporedno višale in nižale in dosegle maksimalne ravni v približno isti časovni točki po vsakem odmerku, kar podpira neposredno razmerje FK-FD.
English: Studies in animals have shown effects on male reproductive organs (see section 5.3).
Slovenian: Študije na živalih so pokazale učinke na moške reproduktivne organe (glejte poglavje 5.3).
English: Talk to your doctor before taking CRYSVITA if you are taking:
Slovenian: Posvetujte se z zdravnikom, preden začnete jemati zdravilo CRYSVITA, če jemljete:
English: Paediatric PK/PD
Slovenian: Pediatrična FK/FD
English: Patients received burosumab at a dose of 0.8 mg/kg every two weeks.
Slovenian: Bolniki so prejemali burosumab v odmerku 0,8 mg/kg vsaka dva tedna.
English: There are no clinical data available on the effect of burosumab on human fertility.
Slovenian: Kliničnih podatkov o učinku burosumaba na plodnost pri ljudeh ni.
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.
Slovenian: Spremljanje plazemskih alkalnih fosfataz, kalcija, paratiroidnega hormona (PTH) in kreatinina je priporočljivo vsakih 6 mesecev (vsake 3 mesece za otroke, stare 1-2 leti) ali kot je indicirano.
English: Following subcutaneous administration, the time to reach maximum serum concentrations (Tmax) of burosumab is approximately 5-10 days.
Slovenian: Po subkutanem dajanju je čas za dosego najvišje serumske koncentracije (Tmax) burosumaba približno 5-10 dni.
English: No significant difference has been observed in paediatric patient pharmacokinetics or pharmacodynamics as compared with PK/PD in the adult population.
Slovenian: Pri farmakokinetiki in farmakodinamiki pediatričnih bolnikov niso opazili pomembnih razlik v primerjavi s FK/FD odrasle populacije.
English: Anti-drug antibodies (ADA) have been detected in a small percentage of patients receiving burosumab who had also tested positive for ADA prior to dosing; no adverse events or loss of efficacy was associated with these findings.
Slovenian: Protitelesa proti zdravilu (anti-drug antibodies - ADA) so odkrili pri majhnem odstotnem deležu bolnikov, ki so prejemali burosumab in pri katerih so bili rezultati preiskav ADA pred odmerjanjem pozitivni; s temi ugotovitvami neželeni učinki ali zmanjšanje učinkovitosti niso bili povezani.
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).
Slovenian: Pri kombiniranju burosumaba s kalcimimetičnimi zdravili (tj. sredstvi, ki posnemajo učinek kalcija na tkiva, tako da aktivirajo receptor za kalcij) je potrebna previdnost.
English: The most common adverse drug reaction (ADR) reported in paediatric patients up to 64 weeks was injection site reactions (57%), headache (54%), pain in extremity (42%), vitamin D decreased (28%), rash (23%), toothache (19%), tooth abscess (14%), myalgia (14%), and dizziness (11%) (See section 4.4 and ‘Description of selected adverse reactions' below).
Slovenian: Najpogostejši neželeni učinki (adverse drug reaction - ADR), o katerih so poročali pri pediatričnih bolnikih, starih do 64 tednov, so bili reakcije na mestu injiciranja (57 %), glavobol (54 %), bolečina v okončinah (42 %), znižan vitamin D (28 %), izpuščaj (23 %), zobobol (19 %), zobni absces (14 %), mialgija (14 %) in omotica (11 %) (glejte poglavje 4.4 in ‘Opis izbranih neželenih učinkov' v nadaljevanju).
English: • you are taking any phosphate or vitamin D supplements
Slovenian: • če jemljete prehranska dopolnila s fosfati ali vitaminom D;