natgillin/translations-raw huggingface dataset:
Clinical data from MTC
Klinični podatki za MTC
If vandetanib is used during pregnancy or if the patient becomes pregnant while receiving vandetanib, she should be apprised of the potential for foetal abnormalities or loss of the pregnancy.
Če se vandetanib uporablja med nosečnostjo ali če bolnica med zdravljenjem s tem zdravilom zanosi, jo je treba opozoriti na možne nepravilnosti ploda oziroma prekinitev nosečnosti.
If you get side effects
Če se vam pojavijo neželeni učinki
• A type of rash that affects the hands and feet (hand foot syndrome).
• posebna vrsta izpuščaja, ki prizadene dlani in podplate (sindrom dlani in podplatov)
• Malnutrition.
• podhranjenost;
Your doctor or nurse should perform tests to check the levels of your blood potassium, calcium, magnesium, and thyroid-stimulating hormone (TSH) as well as the electrical activity of your heart with a test called an electrocardiogram (ECG).
Zdravnik ali medicinska sestra morata opraviti preiskave za kontrolo koncentracije kalija, kalcija, magnezija in tiroideo-stimulirajočega hormona (TSH) v krvi in za kontrolo električne aktivnosti srca s preiskavo, ki jo imenujemo elektrokardiogram (EKG).
Five out of 6 patients (83%) with moderate renal failure who were treated with vandetanib had a dose reduction to 200 mg for adverse reaction; 1 patient required a further reduction to 100 mg.
Petim bolnikom z zmerno okvaro ledvic izmed 6 (83 %), zdravljenih z vandetanibom, so zaradi neželenega učinka zmanjšali odmerek na 200 mg; 1 bolniku je nadalje bilo potrebno zmanjšati odmerek na 100 mg.
• The dosing and monitoring guide for paediatric patients and patient's caregivers;
• Vodnik za odmerjanje in spremljanje za pediatrične bolnike in njihove skrbnike;
Therefore, the concomitant use of ondansetron with vandetanib is not recommended.
Zato sočasna uporaba ondansetrona z vandetanibom ni priporočljiva.
There is limited data with 300 mg in patients with moderate renal impairment: the dose needed to be lowered to 200 mg in 5 out of 6 patients.
Podatkov o uporabi 300 mg pri bolnikih z zmerno okvaro ledvic je malo: pri 5 bolnikih od 6 je bilo potrebno odmerek zmanjšati na 200 mg.
There were no statistically significant differences observed for the exploratory endpoint of diarrhoea (reported as stool frequency).
Statistično značilnih razlik glede driske kot opazovanega dogodka ni bilo (poročano kot pogostnost odvajanja blata).
MARKETING AUTHORISATION HOLDER Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
IMETNIK DOVOLJENJA ZA PROMET Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam,
Patients treated with Caprelsa must be given the patient alert card and be informed about the risks of Caprelsa (see also package leaflet).
Bolniki, zdravljeni z zdravilom Caprelsa, morajo dobiti opozorilno izkaznico in treba jih je seznaniti s tveganji za zdravilo Caprelsa (glejte tudi navodilo za uporabo).
Paediatric clinical trial data with vandetanib in MTC (see section 5.1) obtained during drug development is limited to 16 patients aged 9 years to 17 years with hereditary medullary thyroid carcinoma (Study IRUSZACT0098).
Podatki kliničnih preskušanj vandetaniba pri pediatričnih bolnikih z medularnim rakom ščitnice (glejte poglavje 5.1), pridobljeni med razvojem zdravila, so omejeni na 16 bolnikov, starih od 9 do 17 let, z dednim medularnim rakom ščitnice (študija IRUSZACT0098).
• The educational material, including: o Information about the risks associated with CAPRELSA: - QTc prolongation and Torsades de pointes - Posterior reversible encephalopathy syndrome (PRES); - Teeth and bone development abnormalities in pediatric patients - Medication errors in the pediatric population o The Physicians' dosing and monitoring guide for paediatric patients;
• Izobraževalno gradivo za zdravstvene delavce, ki vsebuje - Informacije o tveganjih, povezanih z zdravilom CAPRELSA o podaljšanje QTc intervala in Torsade de pointes o sindrom posteriorne reverzibilne encefalopatije (PRES) o razvojne nepravilnosti kosti in zob pri pediatričnih bolnikih o napake pri uporabi zdravila v pediatrični populaciji - Zdravnikov vodnik za odmerjanje in spremljanje pri pediatričnih bolnikih;
• Urgent desire to urinate.
• nujna potreba po uriniranju;
In healthy subjects, no clinically significant interaction was shown between vandetanib (a single dose of 300mg) and the potent CYP3A4 inhibitor, itraconazole (repeated doses of 200mg once daily).
Pri zdravih preiskovancih niso ugotovili klinično pomembnih medsebojnih delovanj med vandetanibom (enkratni odmerek 300 mg) in itrakonazolom (ponavljajoči se odmerki 200 mg enkrat na dan), ki je močan zaviralec CYP3A4.
The pharmacokinetics of vandetanib at the 300 mg dose in MTC patients are characterised by a volume of distribution of approximately 7450 l.
Za farmakokinetiko vandetaniba v odmerku 300 mg pri bolnikih z MTC je značilen volumen porazdelitve, ki je približno 7.450 l.
Dosing at 100mg/m2/day of the indicated posology (function of BSA) in paediatrics delivers similar exposure to that achieved in adults at 300 mg daily.
Odmerki 100 mg/m2/dan v okviru indiciranega odmerjanja (funkcija telesne površine) pri pediatričnih bolnikih dosežejo podobno izpostavljenost kot jo pri odraslih doseže odmerjanje 300 mg na dan.
If ondansetron is administered with vandetanib, closer monitoring of serum electrolytes and ECGs and aggressive management of any abnormalities is required.
Če se ondansetron daje z vandetanibom, je zahtevano skrbno spremljanje serumskih elektrolitov in EKG ter vztrajna obravnava kakršnih koli nenormalnosti.
Individual patient management will be required by the physician, especially in paediatric patients with low BSA.
Zdravnik mora voditi vsakega bolnika posamezno; to še zlasti velja za pediatrične bolnike z majhno telesno površino.
If you get side effects, your doctor may tell you to take Caprelsa at a lower dose.
Če se vam pojavijo neželeni učinki, vam bo zdravnik morda naročil, da jemljite manjši odmerek zdravila Caprelsa.
Figure 1: Kaplan Meier plot of PFS
Kaplan-Meierjev prikaz PFS
• Patients who develop a single value of corrected ECG QTc interval of at least 500 msec should stop taking CAPRELSA.
• Bolniki, ki se jim na EKG pojavi ena sama vrednost korigiranega intervala QTc v vrednosti vsaj 500 ms, morajo prenehati z jemanjem zdravila CAPRELSA.
What Caprelsa is and what it is used for What you need to know before you take Caprelsa How to take Caprelsa
Kaj je zdravilo Caprelsa in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Caprelsa Kako jemati zdravilo Caprelsa Možni neželeni učinki
Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk, CB9 8PU, United Kingdom Or
Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk, CB9 8PU, Velika Britanija ali
PRES has also been observed in patients receiving vandetanib as monotherapy.
PRES so opažali tudi pri bolnikih, ki so prejemali vandetanib kot monoterapijo.
Based on height measurements at all visits, all children and adolescents in a paediatric study demonstrated linear growth while receiving vandetanib.
Meritve telesne višine na vseh obiskih so pokazale, da je bila v pediatrični študiji pri vseh otrocih in mladostnikih, ki so prejemali vandetanib, rast linearna.
• Sore mouth (stomatitis).
• vnetje ust (stomatitis);
At a dose of 300 mg per day in MTC, ECG QTc prolongation to above 500 msec was observed in a phase III study in 11% of patients.
V študiji III. faze so, pri odmerku 300 mg na dan za MTC, opazili podaljšanje QTc večje od 500 ms pri 11 % bolnikov.
The concomitant use of vandetanib with ondansetron is not recommended (see section 4.5)
Sočasna uporaba vandetaniba z ondansetronom ni priporočljiva (glejte poglavje 4.5).
• The posology regimens according to patient's body surface area (BSA), including a visual representation of the two-week posology regimen per BSA;
• Sheme odmerjanja glede na bolnikovo telesno površino, vključno z vizualnim prikazom dvotedenske sheme odmerjanja glede na telesno površino.
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).
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).
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.
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.
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.
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).
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).
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).
There is no experience in paediatric patients with hereditary MTC below 9 years of age (see section 5.1).
Kliničnih izkušenj pri otrocih z dednim medularnim rakom ščitnice (MTC), mlajših od 9 let, ni (glejte poglavje 5.1).
The half-life of vandetanib (19 days) renders this prolongation in QTc interval particularly problematic (see section 4.8).
Še zlasti je problematičen razpolovni čas vandetaniba (19 dni), ki daje povod za podaljšanje intervala QTc (glejte poglavje 4.8).
• What are the side effects associated with CAPRELSA and which monitoring is requested;
• Katert neželeni učinki so povezani z uporabo zdravila Caprelsa in kakšno spremljanje je potrebno;
• Vandetanib is not recommended in paediatric patients with severe renal impairment
• se uporaba vandetaniba ne priporoča pri pediatričnih bolnikih s hudo okvaro ledvic.
• Abnormalities in your liver or pancreas (shown in blood tests).
• nepravilnosti jeter ali trebušne slinavke (pokažejo se pri preiskavah krvi).
• Painful urination.
• boleče uriniranje;
This suggests that vandetanib slows but does not prevent wound healing.
To kaže, da vandetanib upočasni celjenje ran, ga pa ne prepreči.
• Blistering of skin (bullous dermatitis).
• mehurji na koži (bulozni dermatitis).
Vandetanib binds to human serum albumin and alpha-1-acid-glycoprotein with in vitro protein binding being approximately 90%.
Vandetanib se veže na človeški serumski albumin in alfa-1-kisli glikoprotein; njegova vezava in vitro je približno 90 %.
Vandetanib was excreted into milk in rat and found in plasma of pups following dosing to lactating rats.
Vandetanib se je izločal v mleku podgan in po uporabi pri doječih podganah, so ga ugotovili v plazmi mladičev.
If you take more Caprelsa than you have been prescribed, talk to a doctor or go to a hospital straight away.
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.
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).
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).
Vandetanib is an inhibitor of the organic cation 2 (OCT2) transporter.
Vandetanib je zaviralec prenašalca, imenovanega organski kationski prenašalec 2 (OCT2 - organic cation transporter 2).
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.
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.
In addition, the possibility of QTc prolongation and Torsades de pointes should be considered.
Poleg tega je treba upoštevati možnost podaljšanja intervala QTc in Torsades de pointes.
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).
Dajanje vandetaniba skupaj z zdravili, ki podaljšajo interval QTc je kontraindicirano ali pa ni priporočljivo (glejte poglavji 4.3 in 4.5).
Posterior reversible encephalopathy syndrome (PRES) also known as reversible posterior leukoencephalopathy syndrome (RPLS)
Sindrom posteriorne reverzibilne encefalopatije (PRES), znan tudi kot sindrom reverzibilne posteriorne levkoencefalopatije (RPLS)
Due to the 19-day half-life, adverse reactions including a prolonged QTc interval may not resolve quickly (see section 4.4).
Zaradi 19-dnevnega razpolovnega časa lahko neželeni učinki, vključno s podaljšanjem intervala QTc, ne izginejo hitro (glejte poglavje 4.4).
The signs may include redness, pain, ulcers, blisters and shedding of the skin.
Med znaki so lahko pordelost, bolečine, razjede, mehurji in lupljenje kože.
• Combinations not recommended: Methadone, haloperidol, amisulpride, chlorpromazine, sulpiride, zuclopenthixol, halofantrine, pentamidine and lumefantrine.
• Kombinacije, ki niso priporočljive: metadon, haloperidol, amisulprid, klorpromazin, sulpirid, zuklopentiksol, halofantrin, pentamidin in lumefantrin.
In healthy subjects, the exposure for midazolam (CYP3A4 substrate) was not affected when given together with a single dose of vandetanib at 800 mg.
Pri zdravih preiskovancih se izpostavljenost midazolamu (ki je substrat CYP3A4) ni spremenila, če je bil uporabljen skupaj z enkratnim odmerkom 800 mg vandetaniba.
Furthermore, the bradycardiac effect of digoxin may increase the risk of vandetanib QTc interval prolongation and Torsade de Pointes.
Prav tako lahko vpliv digoksina na bradikardijo poveča tveganje za, z vandetanibom povzročeno, podaljšanje intervala QTc in Torsade de Pointes.
• Flu.
• gripa;
- 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).
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).
• CAPRELSA prolongs the QTc interval and can cause Torsades de pointes and sudden death
• Zdravilo CAPRELSA podaljša interval QTc in lahko sproži Torsades de pointes in nenadno smrt.
These may be signs of a condition called RPLS (Reversible Posterior Leukoencephalopathy Syndrome).
To so lahko znaki bolezni, imenovane RPLS (sindrom reverzibilne posteriorne levkoencefalopatije).
Caprelsa has uncommonly been associated with life-threatening changes in heart rhythm.
Zdravilo Caprelsa je bilo občasno povezan s smrtno nevarnimi motnjami srčnega ritma.
• 12 weeks after starting Caprelsa
• 12 tednov po začetku zdravljenja z zdravilom Caprelsa,
• If it is less than 12 hours until your next dose: Skip the missed dose.
• Če je do naslednjega odmerka manj kot 12 ur: Izpustite pozabljeni odmerek.
This medicinal product has been authorized under a so-called “conditional approval” scheme.
Zdravilo je pridobilo tako imenovano “pogojno dovoljenje za promet”.
• Information about the risks of QTc prolongation and Torsades de pointes, and Posterior reversible encephalopathy syndrome (PRES);
• Informacije o tveganju za podaljšanje intervala QTc in za torsades de pointes ter o tveganju za posteriorno reverzibilno encefalopatijo (PRES).
Teeth and bone development abnormalities in pediatric patients
Razvojne nepravilnosti zob in kosti pri pediatričnih bolnikih
Caprelsa comes in blister packs of 30 tablets.
Zdravilo Caprelsa je na voljo v pretisnih omotih s 30 tabletami.
• Patients who are on the starting dose (a in Table 1), should be recommenced at the reduced dose (c in Table 1).
• Bolniki, ki prejemajo začetni odmerek (a v preglednici 1), morajo zdravljenje znova začeti z manjšim odmerkom (c v preglednici 1).
• Gallstones (cholelithiasis).
• žolčni kamni (holelitiaza);
In rats, embryofoetal toxicity was evident as foetal loss, delayed foetal development, heart vessel abnormalities and precocious ossification of some skull bones.
Pri podganah so se embriofetalni toksični učinki kazali kot izguba ploda, upočasnjen razvoj ploda, nenormalnosti srčnih žil in prezgodnja osifikacija nekaterih lobanjskih kosti.
NAME OF THE MARKETING AUTHORISATION HOLDER Genzyme Europe B.V.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Genzyme Europe B.V.
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.
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.
• Increased levels of red cells in your blood.
• povečano število rdečih krvnih celic.
crospovidone (type A), povidone (K29-32), magnesium stearate, hypromellose, macrogol and titanium dioxide (E171).
(vrsta A), povidon (K29-32), magnezijev stearat, hipromeloza, makrogol in titanov dioksid
Following oral dosing of 14C- vandetanib, unchanged vandetanib and metabolites vandetanib N-oxide and N-desmethyl vandetanib were detected in plasma, urine and feces.
Po peroralni uporabi 14C-vandetaniba so v plazmi, urinu in blatu ugotovili nespremenjeni vandetanib ter presnovka vandetanib-N-oksid in N-desmetil-vandetanib.
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.
Kartica vsebuje pomembne informacije o varnosti s katerimi morate biti seznanjeni preden dobite zdravilo Caprelsa in med zdravljenjem s tem zdravilom.
Response rate ORb
Delež odziva ORb
In clinical studies, a small number of patients had surgery while receiving vandetanib and there were no reported wound healing complications.
V kliničnih študijah so imeli maloštevilni bolniki med zdravljenjem z vandetanibom operacijo; o zapletih celjenja ran niso poročali.
• Abdominal wall abscess.
• absces v trebušni steni;
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.
Previdnost je potrebna pri izpostavljenosti soncu zaradi možnosti fototoksičnih reakcij, povezanih z zdravljenjem z vandetanibom.
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.
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.
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.
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.
The safety findings in this study are consistent with the safety profile of vandetanib in adult patients with MTC.
Izsledki o varnosti v tej študiji se skladajo z varnostnimi značilnostmi vandetaniba, ugotovljenimi pri odraslih bolnikih z medularnim rakom ščitnice.
Dosing can be resumed at a reduced dose thereafter when fully recovered from adverse reactions
Uporabljati ga lahko znova začnejo v manjšem odmerku, potem ko si povsem opomorejo po neželenem učinku.
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).
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).
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.
V študiji plodnosti pri samicah je bil opazen trend k večji nerednosti estrusnega ciklusa, rahlemu zmanjšanju incidence brejosti in večjim implantacijskim izgubam.
Renal impairment in paediatric patients with MTC There is no experience with the use of vandetanib in paediatric patients with renal impairment.
Okvara ledvic pri pediatričnih bolnikih z MTC Izkušenj z uporabo vandetaniba pri pediatričnih bolnikih z okvaro ledvic ni.
- 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).
-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.
• Bacterial skin infection.
• bakterijska okužba kože;
• What CAPRELSA is, what it treats, how it is administered;
• Kaj je zdravilo Caprelsa, za kaj se uporablja, kako se daje;