FrancophonIA/ELRC3.0 huggingface dataset:
English: Vandetanib is not recommended for use in adult and paediatric patients with hepatic impairment (serum bilirubin greater than 1.5 times upper limit of reference range (ULRR), this criterion does not apply to patients with Gilbert's Disease and alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) greater than 2.5 times ULRR, or greater than 5.0 times ULRR if judged by the physician to be related to liver metastases), since there is limited data in patients with hepatic impairment, and safety and efficacy have not been established (see section 4.4).
Slovenian: Vandetaniba ni priporočljivo uporabljati pri odraslih in pediatričnih bolnikih z okvaro jeter (vrednost bilirubina v serumu več kot 1,5-kratna zgornja meja referenčnega območja (ZMRO); to merilo ne velja za bolnike z Gilbertovo boleznijo in alanin-aminotransferazo (ALT), aspartat-aminotransferazo (AST) ali alkalno fosfatazo (ALP) nad 2,5-kratno ZMRO oziroma več kot 5,0-kratno ZMRO, če zdravnik presodi, da je to povezano z metastazami v jetrih), ker je podatkov o bolnikih z okvaro jeter malo in varnost in učinkovitost nista ugotovljeni (glejte poglavje 4.4).
English: In healthy subjects with wild type for OCT2, the AUC(0-t) and Cmax for metformin (OCT2 substrate) were increased by 74% and 50%, respectively and CLR of metformin was decreased by 52% when given together with vandetanib.
Slovenian: Pri zdravih preiskovancih z divjim tipom OCT2 se je AUC(0-t) metformina (ki je substrat OCT2) povečala za 74 % in njegova Cmax za 50 %, očistek (CLR) metformina pa se je zmanjšal za 52 %, če je bil uporabljen skupaj z vandetanibom.
English: Therefore, the concomitant use of vandetanib with medicinal products known to also prolong the QTc interval and/or induce Torsades de pointes is either contraindicated or not recommended depending on existing alternative therapies.
Slovenian: Zato je sočasna uporaba vandetaniba z zdravili, ki podaljšajo interval QTc in/ali sprožijo Torsades de pointes ali kontraindicirana ali pa ni priporočljiva (odvisno od tega ali so na voljo alternativna zdravljenja).
English: In Study 58, RET mutation testing was performed by using the polymerase chain reaction (PCR) based Amplification Refractory Mutation System (ARMS) assay for the M918T mutation, and direct sequencing of DNA for mutations in exons 10, 11, 13, 14, 15 and 16 (site of M918T mutation) on all sporadic patients where DNA was available (297/298).
Slovenian: V Študiji 58 so pri vseh sporadičnih bolnikih, katerih DNA je bila na voljo (297/298), izvajali preskušanje za mutacijo RET, in sicer z uporabo verižne reakcije s polimerazo (polymerase chain reaction, PCR), ki je temeljila na metodi pomnoževanja in refrakcije (amplification refractory mutation system, ARMS) za določitev mutacije M918T ter z neposrednim določanjem zaporedja DNA za mutacije v eksonih 10, 11, 13, 14, 15 in 16 (mesto mutacije M918T).
English: There is no experience in paediatric patients with hereditary MTC below 9 years of age (see section 5.1).
Slovenian: Kliničnih izkušenj pri otrocih z dednim medularnim rakom ščitnice (MTC), mlajših od 9 let, ni (glejte poglavje 5.1).
English: The half-life of vandetanib (19 days) renders this prolongation in QTc interval particularly problematic (see section 4.8).
Slovenian: Še zlasti je problematičen razpolovni čas vandetaniba (19 dni), ki daje povod za podaljšanje intervala QTc (glejte poglavje 4.8).
English: • What are the side effects associated with CAPRELSA and which monitoring is requested;
Slovenian: • Katert neželeni učinki so povezani z uporabo zdravila Caprelsa in kakšno spremljanje je potrebno;
English: • Vandetanib is not recommended in paediatric patients with severe renal impairment
Slovenian: • se uporaba vandetaniba ne priporoča pri pediatričnih bolnikih s hudo okvaro ledvic.
English: • Abnormalities in your liver or pancreas (shown in blood tests).
Slovenian: • nepravilnosti jeter ali trebušne slinavke (pokažejo se pri preiskavah krvi).
English: • Painful urination.
Slovenian: • boleče uriniranje;
English: This suggests that vandetanib slows but does not prevent wound healing.
Slovenian: To kaže, da vandetanib upočasni celjenje ran, ga pa ne prepreči.
English: • Blistering of skin (bullous dermatitis).
Slovenian: • mehurji na koži (bulozni dermatitis).
English: Vandetanib binds to human serum albumin and alpha-1-acid-glycoprotein with in vitro protein binding being approximately 90%.
Slovenian: Vandetanib se veže na človeški serumski albumin in alfa-1-kisli glikoprotein; njegova vezava in vitro je približno 90 %.
English: Vandetanib was excreted into milk in rat and found in plasma of pups following dosing to lactating rats.
Slovenian: Vandetanib se je izločal v mleku podgan in po uporabi pri doječih podganah, so ga ugotovili v plazmi mladičev.
English: If you take more Caprelsa than you have been prescribed, talk to a doctor or go to a hospital straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Caprelsa, kot bi smeli Če vzamete več zdravila Caprelsa, kot vam je predpisal zdravnik, se takoj posvetujte z zdravnikom ali pojdite v bolnišnico.
English: Vandetanib is not recommended for use in adult and paediatric patients with moderate or severe renal impairment since there is limited data, and safety and efficacy have not been established (see sections 4.2, 5.1, and 5.2).
Slovenian: Uporaba vandetaniba pri odraslih in pediatričnih bolnikih z zmerno ali hudo okvaro ledvic ni priporočljiva, saj je na voljo le malo podatkov in učinkovitost ter varnost nista bili dokazani (glejte poglavja 4.2, 5.1 in 5.2).
English: Vandetanib is an inhibitor of the organic cation 2 (OCT2) transporter.
Slovenian: Vandetanib je zaviralec prenašalca, imenovanega organski kationski prenašalec 2 (OCT2 - organic cation transporter 2).
English: Following oral administration of vandetanib absorption is slow with peak plasma concentrations typically achieved at a median of 6 hours, range 4-10 hours, after dosing.
Slovenian: Po peroralni uporabi vandetaniba je absorpcija počasna in največja koncentracija v plazmi se praviloma pojavi mediano 6 ur (razpon: od 4 do 10 ur) po odmerjanju.
English: In addition, the possibility of QTc prolongation and Torsades de pointes should be considered.
Slovenian: Poleg tega je treba upoštevati možnost podaljšanja intervala QTc in Torsades de pointes.
English: The administration of vandetanib with substances known to prolong the ECG QTc interval is contraindicated or not recommended (see section 4.3 and 4.5).
Slovenian: Dajanje vandetaniba skupaj z zdravili, ki podaljšajo interval QTc je kontraindicirano ali pa ni priporočljivo (glejte poglavji 4.3 in 4.5).
English: Posterior reversible encephalopathy syndrome (PRES) also known as reversible posterior leukoencephalopathy syndrome (RPLS)
Slovenian: Sindrom posteriorne reverzibilne encefalopatije (PRES), znan tudi kot sindrom reverzibilne posteriorne levkoencefalopatije (RPLS)
English: Due to the 19-day half-life, adverse reactions including a prolonged QTc interval may not resolve quickly (see section 4.4).
Slovenian: Zaradi 19-dnevnega razpolovnega časa lahko neželeni učinki, vključno s podaljšanjem intervala QTc, ne izginejo hitro (glejte poglavje 4.4).
English: The signs may include redness, pain, ulcers, blisters and shedding of the skin.
Slovenian: Med znaki so lahko pordelost, bolečine, razjede, mehurji in lupljenje kože.
English: • Combinations not recommended: Methadone, haloperidol, amisulpride, chlorpromazine, sulpiride, zuclopenthixol, halofantrine, pentamidine and lumefantrine.
Slovenian: • Kombinacije, ki niso priporočljive: metadon, haloperidol, amisulprid, klorpromazin, sulpirid, zuklopentiksol, halofantrin, pentamidin in lumefantrin.
English: In healthy subjects, the exposure for midazolam (CYP3A4 substrate) was not affected when given together with a single dose of vandetanib at 800 mg.
Slovenian: Pri zdravih preiskovancih se izpostavljenost midazolamu (ki je substrat CYP3A4) ni spremenila, če je bil uporabljen skupaj z enkratnim odmerkom 800 mg vandetaniba.
English: Furthermore, the bradycardiac effect of digoxin may increase the risk of vandetanib QTc interval prolongation and Torsade de Pointes.
Slovenian: Prav tako lahko vpliv digoksina na bradikardijo poveča tveganje za, z vandetanibom povzročeno, podaljšanje intervala QTc in Torsade de Pointes.
English: • Flu.
Slovenian: • gripa;
English: - if you are taking any of the following medicines: arsenic, cisapride (used to treat heartburn), erythromycin intravenous and moxifloxacin (used to treat infection), toremifene (used to treat breast cancer), mizolastine (used to treat allergies), Class IA and III antiarrhythmics (used to control heart rhythm).
Slovenian: če jemljete katero od naslednjih zdravil: arzen, cisaprid (uporablja se za zdravljenje zgage), eritromicin intravensko ali moksifloksacin (uporabljata se za zdravljenje okužb), toremifen (uporablja se za zdravljenje raka dojke), mizolastin (uporablja se za zdravljenje alergij), antiaritmike skupin IA in III (uporabljajo se za obvladovanje motenj srčnega ritma).
English: • CAPRELSA prolongs the QTc interval and can cause Torsades de pointes and sudden death
Slovenian: • Zdravilo CAPRELSA podaljša interval QTc in lahko sproži Torsades de pointes in nenadno smrt.
English: These may be signs of a condition called RPLS (Reversible Posterior Leukoencephalopathy Syndrome).
Slovenian: To so lahko znaki bolezni, imenovane RPLS (sindrom reverzibilne posteriorne levkoencefalopatije).
English: Caprelsa has uncommonly been associated with life-threatening changes in heart rhythm.
Slovenian: Zdravilo Caprelsa je bilo občasno povezan s smrtno nevarnimi motnjami srčnega ritma.
English: • 12 weeks after starting Caprelsa
Slovenian: • 12 tednov po začetku zdravljenja z zdravilom Caprelsa,
English: • If it is less than 12 hours until your next dose: Skip the missed dose.
Slovenian: • Če je do naslednjega odmerka manj kot 12 ur: Izpustite pozabljeni odmerek.
English: This medicinal product has been authorized under a so-called “conditional approval” scheme.
Slovenian: Zdravilo je pridobilo tako imenovano “pogojno dovoljenje za promet”.
English: • Information about the risks of QTc prolongation and Torsades de pointes, and Posterior reversible encephalopathy syndrome (PRES);
Slovenian: • Informacije o tveganju za podaljšanje intervala QTc in za torsades de pointes ter o tveganju za posteriorno reverzibilno encefalopatijo (PRES).
English: Teeth and bone development abnormalities in pediatric patients
Slovenian: Razvojne nepravilnosti zob in kosti pri pediatričnih bolnikih
English: Caprelsa comes in blister packs of 30 tablets.
Slovenian: Zdravilo Caprelsa je na voljo v pretisnih omotih s 30 tabletami.
English: • Patients who are on the starting dose (a in Table 1), should be recommenced at the reduced dose (c in Table 1).
Slovenian: • Bolniki, ki prejemajo začetni odmerek (a v preglednici 1), morajo zdravljenje znova začeti z manjšim odmerkom (c v preglednici 1).
English: • Gallstones (cholelithiasis).
Slovenian: • žolčni kamni (holelitiaza);
English: In rats, embryofoetal toxicity was evident as foetal loss, delayed foetal development, heart vessel abnormalities and precocious ossification of some skull bones.
Slovenian: Pri podganah so se embriofetalni toksični učinki kazali kot izguba ploda, upočasnjen razvoj ploda, nenormalnosti srčnih žil in prezgodnja osifikacija nekaterih lobanjskih kosti.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Genzyme Europe B.V.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Genzyme Europe B.V.
English: Mechanism of action and pharmacodynamic effects Vandetanib is a potent inhibitor of vascular endothelial growth factor receptor-2 (VEGFR-2 also known as kinase insert domain containing receptor [KDR]), epidermal growth factor receptor (EGFR) and RET tyrosine kinases.
Slovenian: Vandetanib je močan zaviralec VEGFR-2 (vascular endothelial growth factor receptor-2 - receptor-2 žilnega endotelijskega rastnega dejavnika, znan tudi kot KDR [kinase insert domain containing receptor]), EGFR (epidermal growth factor receptor - receptor epidermalnega rastnega dejavnika) in RET tirozin-kinaze.
English: • Increased levels of red cells in your blood.
Slovenian: • povečano število rdečih krvnih celic.
English: crospovidone (type A), povidone (K29-32), magnesium stearate, hypromellose, macrogol and titanium dioxide (E171).
Slovenian: (vrsta A), povidon (K29-32), magnezijev stearat, hipromeloza, makrogol in titanov dioksid
English: Following oral dosing of 14C- vandetanib, unchanged vandetanib and metabolites vandetanib N-oxide and N-desmethyl vandetanib were detected in plasma, urine and feces.
Slovenian: Po peroralni uporabi 14C-vandetaniba so v plazmi, urinu in blatu ugotovili nespremenjeni vandetanib ter presnovka vandetanib-N-oksid in N-desmetil-vandetanib.
English: In addition to this leaflet you will be given the Patient Alert Card, which contains important safety information that you need to know before you are given Caprelsa and during treatment with Caprelsa.
Slovenian: Kartica vsebuje pomembne informacije o varnosti s katerimi morate biti seznanjeni preden dobite zdravilo Caprelsa in med zdravljenjem s tem zdravilom.
English: Response rate ORb
Slovenian: Delež odziva ORb
English: In clinical studies, a small number of patients had surgery while receiving vandetanib and there were no reported wound healing complications.
Slovenian: V kliničnih študijah so imeli maloštevilni bolniki med zdravljenjem z vandetanibom operacijo; o zapletih celjenja ran niso poročali.
English: • Abdominal wall abscess.
Slovenian: • absces v trebušni steni;
English: Care should be taken with sun exposure by wearing protective clothing and/or sunscreen due to the potential risk of phototoxicity reactions associated with vandetanib treatment.
Slovenian: Previdnost je potrebna pri izpostavljenosti soncu zaradi možnosti fototoksičnih reakcij, povezanih z zdravljenjem z vandetanibom.
English: Scheduled slit lamp examinations have revealed corneal opacities (vortex keratopathies) in treated patients; however, routine slit lamp examinations are not required for patients receiving vandetanib.
Slovenian: Načrtovani pregledi s špranjsko svetilko so pri zdravljenih bolnikih odkrili motnjave v roženici (vorteksne keratopatije), vendar redni pregledi s špranjsko svetilko med zdravljenjem z vandetanibom niso potrebni.
English: Vandetanib is not recommended for use in patients with severe renal impairment since there is limited data in patients with severe renal impairment, and safety and efficacy have not been established.
Slovenian: Vandetaniba ni priporočljivo uporabljati pri bolnikih s hudo okvaro ledvic, ker je podatkov o bolnikih s hudo okvaro ledvic malo in varnost ter učinkovitost nista bili dokazani.
English: The safety findings in this study are consistent with the safety profile of vandetanib in adult patients with MTC.
Slovenian: Izsledki o varnosti v tej študiji se skladajo z varnostnimi značilnostmi vandetaniba, ugotovljenimi pri odraslih bolnikih z medularnim rakom ščitnice.
English: Dosing can be resumed at a reduced dose thereafter when fully recovered from adverse reactions
Slovenian: Uporabljati ga lahko znova začnejo v manjšem odmerku, potem ko si povsem opomorejo po neželenem učinku.
English: A pharmacokinetic study in volunteers with mild, moderate and severe renal impairment shows that exposure to vandetanib after single dose is increased up to 1.5, 1.6 and 2-fold respectively in patients with mild, moderate (creatinine clearance ≥ 30 to < 50 ml/min) and severe (clearance below 30 ml/min) renal impairment at baseline (see section 5.2).
Slovenian: Farmakokinetična študija pri prostovoljcih z blago, zmerno ali hudo okvaro ledvic kaže, da se izpostavljenost vandetanibu po enkratnem odmerku poveča do 1,5-, 1,6- in 2-krat pri bolnikih z blago, zmerno (kreatininski očistek ≥ 30 do < 50 ml/min) in hudo (kretininski očistek manj kot 30 ml/min) okvaro ledvic na začetku študije (glejte poglavje 5.2).
English: In a female fertility study, there was a trend towards increased oestrus cycle irregularity, a slight reduction in pregnancy incidence and increase in implantation loss.
Slovenian: V študiji plodnosti pri samicah je bil opazen trend k večji nerednosti estrusnega ciklusa, rahlemu zmanjšanju incidence brejosti in večjim implantacijskim izgubam.
English: Renal impairment in paediatric patients with MTC There is no experience with the use of vandetanib in paediatric patients with renal impairment.
Slovenian: Okvara ledvic pri pediatričnih bolnikih z MTC Izkušenj z uporabo vandetaniba pri pediatričnih bolnikih z okvaro ledvic ni.
English: - the clinical study report of study D4200C00104, an observational study including a retrospective arm to evaluate the Benefit/Risk of vandetanib (Caprelsa) 300 mg in RET mutation negative and RET mutation positive patients with symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic thyroid cancer (MTC).
Slovenian: -Poročilo o klinični študiji D4200C00058, opazovani študiji za oceno koristi in tveganj uporabe 300 mg vandetamiba (zdravila CAPRELSA) pri bolnikih, negativnih za mutacijo RET, in bolnikih, pozitivnih za mutacijo RET, ki so imeli simptomatskega, agresivnega, sporadičnega, inoperabilnega, lokalno napredovalega/metastatskega raka ščitnice.
English: • Bacterial skin infection.
Slovenian: • bakterijska okužba kože;
English: • What CAPRELSA is, what it treats, how it is administered;
Slovenian: • Kaj je zdravilo Caprelsa, za kaj se uporablja, kako se daje;
English: There is limited data in patients with hepatic impairment (serum bilirubin greater than 1.5 times upper limit of normal (see sections 4.2 and 4.4).
Slovenian: Podatkov o bolnikih z okvaro jeter (bilirubin v serumu večji od 1,5-kratnika zgornje normalne meje) je malo (glejte poglavji 4.2 in 4.4).
English: • How CAPRELSA dose for infants and adolescents is calculated;
Slovenian: • Kako izračunati odmerek zdravila CAPRELSA za otroke in mladostnike.
English: A patient was considered to have a RET mutation if either an M918T mutation by the ARMS assay, or a RET mutation in any exons sequenced was present in the tumour.
Slovenian: Za bolnika se je privzelo, da ima prisotno mutacijo, če je bila z metodo ARMS določena mutacija M918T ali mutacija RET v katerem koli določenem zaporedju eksonov v tumorju.
English: Vision blurred, corneal structural change (including corneal deposits and corneal opacity)
Slovenian: Očesne bolezni zamegljen vid, strukturne spremembe roženice (vključno z depoziti in motnostjo roženice)
English: Your doctor may recommend you take Caprelsa at a lower dose or stop taking Caprelsa.
Slovenian: Zdravnik vam bo morda svetoval, da jemljete manjši odmerek zdravila Caprelsa ali, da prenehate z jemanjem zdravila Caprelsa.
English: Your doctor may prescribe a medicine to treat this.
Slovenian: Zdravnik vam lahko za njegovo zdravljenje predpiše zdravilo.
English: • Swelling caused by excess fluid (oedema).
Slovenian: • otekanje zaradi čezmerne tekočine (edem);
English: Each tablet contains 100 or 300 mg of vandetanib.
Slovenian: Ena tableta vsebuje 100 ali 300 mg vandetaniba.
English: In an animal model of wound-healing, mice dosed with vandetanib had reduced skin-breaking strength compared with controls.
Slovenian: V živalskem modelu celjenja ran so imele miši, ki so prejemale vandetanib, zmanjšano moč za pretrganje kože kot kontrolne živali.
English: Vandetanib also inhibited the growth of MTC xenograft tumours in vivo.
Slovenian: Vandetanib je zavrl tudi rast ksenotransplantatov MTC in vivo.
English: RPLS is uncommon (affects less than 1 in 100 people).
Slovenian: RPLS je občasen neželeni učinek (pojavi se pri manj kot 1 od 100 bolnikov).
English: In a rat pre- and post-natal development study, at doses producing maternal toxicity during gestation and/or lactation, vandetanib increased pre-birth loss and reduced post-natal pup growth.
Slovenian: V študijah pre- in postnatalnega razvoja pri podganah je vandetanib v odmerkih, ki so povzročili toksične učinke pri samicah-materah med gestacijo in/ali dojenjem, povečal prenatalne izgube in zmanjšal postnatalno rast mladičev.
English: The pharmacokinetic parameters of vandetanib in paediatrics MTC patients aged 9-17 years were similar to those in adults.
Slovenian: Farmakokinetični parametri vandetaniba so bili pri pediatričnih bolnikih z medularnim rakom ščitnice, starih od 9 do 17 let, podobni kot pri odraslih.
English: • The role and use of the Patient Alert Card.
Slovenian: • Pomen in uporaba Opozorilne kartice za bolnika.
English: • Regularly during Caprelsa treatment
Slovenian: • redno med zdravljenjem z zdravilom Caprelsa:
English: Appropriate clinical and/or laboratory monitoring is recommended for patients receiving concomitant metformin and vandetanib, and such patients may require a lower dose of metformin.
Slovenian: Bolnike, ki sočasno prejemajo metformin in vandetanib, je priporočljivo ustrezno klinično in/ali laboratorijsko spremljati; takšni bolniki lahko potrebujejo nižji odmerek metformina.
English: Vandetanib treatment must not be started in patients whose ECG QTc interval is greater than 480 msec. Vandetanib should not be given to patients who have a history of Torsades de pointes.
Slovenian: Zdravljenja z vandetanibom se ne sme začeti pri bolnikih, ki imajo interval QTc daljši od 480 ms. Vandetaniba se ne sme dati bolnikom, ki imajo Torsades de pointes v anamnezi.
English: • cisapride (used to treat heart burn), pimozide (used to treat uncontrolled repeated movements of the body and verbal outbursts) and halofantrine and lumefantrine (used to treat malaria)
Slovenian: • cisaprid (uporablja se za zdravljenje zgage), pimozid (uporablja se za zdravljenje neobvladanih ponavljajočih se gibov telesa in besednih izbruhov), halofantrin in lumefantrin (uporabljata se za zdravljenje malarije)
English: • PRES should be considered in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function.
Slovenian: • PRES je treba upoštevati pri katerem koli bolniku, ki se mu pojavijo krči, glavobol, motnje vida, zmedenost ali duševne motnje.
English: Objective response rate (vandetanib arm)
Slovenian: Delež objektivnega odziva (krak z vandetanibom)
English: • If QTc increases markedly but stays below 500 msec, the advice of a cardiologist should be sought;
Slovenian: • Če se interval QTc znatno podaljša, vendar ostane krajši od 500 ms, je treba poiskati nasvet kardiologa.
English: The appropriate interval between discontinuation of vandetanib and subsequent elective surgery required to avoid the risks of impaired wound healing has not been determined.
Slovenian: Ni ugotovljeno, kolikšen je ustrezni interval med prenehanjem uporabe vandetaniba in poznejšo elektivno operacijo, da bi preprečili tveganje slabšega celjenja ran.
English: 116/231 81.6 months 0.99
Slovenian: 116/231 81,6 mesecev placebo
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in na škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: • Contact details of the CAPRELSA prescriber.
Slovenian: • Kontaktne podatke zdravnika, ki je predpisal zdravilo CAPRELSA.
English: • cyclosporine and tacrolimus (used to treat transplant rejection), digoxin (used to treat irregular heart rate), and metformin (used to control your blood sugar)
Slovenian: • ciklosporin in takrolimus (uporabljata se za zdravljenje zavrnitve presadkov), digoksin (uporablja se za zdravljenje nerednega srčnega utripa) in metformin (uporablja se za uravnavanje krvnega sladkorja)
English: Caprelsa should not be given to children below 5 years of age.
Slovenian: Zdravilo Caprelsa se ne sme dati otrokom mlajšim od 5 let.