natgillin/translations-raw huggingface dataset:
Effects noted in other studies included inhibition of human ether-à-go-go related gene (hERG) current and prolongation of QTc interval in dogs.
Med učinki, ugotovljenimi v drugih študijah, sta bila zavrtje toka hERG (humanega ether-a-go-go povezanega gena) in podaljšanje intervala QTc pri psih.
An ECG, and levels of serum potassium, calcium and magnesium and thyroid stimulating hormone (TSH) should be obtained at baseline, at 1, 3, 6 and 12 weeks after starting treatment and every 3 months for at least a year thereafter.
Snemanje EKG in meritve serumskih ravni kalija, kalcija in magnezija ter tiroideo-stimulirajočega hormona (TSH) je treba opraviti izhodiščno, nato 1, 3, 6 in 12 tednov po začetku zdravljenja ter vsake 3 mesece vsaj eno leto potem.
Reduction in dose may be necessary (see section 4.8).
Morda bo potrebno zmanjšanje odmerka (glejte poglavje 4.8).
Intent-to-treat (ITT) analysis includes patients who received open-label vandetanib before progression according to the central read.
Analiza »znamenom-zdravljenja« (ITT - "Intent to treat")) vključuje bolnike, ki so odprto ("open-label") prejemali vandetanib pred napredovanjem v skladu s centralnim odčitkom.
Serum potassium, serum magnesium and serum calcium should be kept within normal range to reduce the risk of ECG QTc prolongation.
Vrednosti kalija, magnezija in kalcija v serumu je treba vzdrževati v normalnem območju, da bi zmanjšali tveganje za podaljšanje intervala QTc.
Vandetanib is not a substrate of multidrug resistance protein 2 (MRP2), p-glycoprotein (P-gp) or breast cancer resistance protein (BCRP).
Vandetanib ni substrat beljakovine MRP2 (multidrug resistance protein 2), P-glikoproteina (P-gp) ali BCRP (breast cancer resistance protein).
For a further supply, a new prescription is required.
Za nadaljno izdajo zdravila je zahtevan nov zdravniški recept.
• Lack of urine.
• pomanjkanje urina;
As regards other P-gp substrates such as dabigatran, a clinical monitoring is recommended in case of combination with vandetanib.
Kar zadeva druge substrate P-gp kot je dabigatran, je priporočljivo klinično spremljanje v primeru uporabe skupaj z vandetanibom.
Keep in mind Caprelsa may make you feel tired, weak, or cause blurred vision.
Zavedajte se, da lahko zdravilo Caprelsa povzroči utrujenost, šibkost ali zamegljen vid.
These may be common (affecting less than 1 in 10 people) or uncommon (affects less than 1 in 100 people) depending on the type of skin reaction.
Lahko so pogoste (pojavijo se pri manj kot 1 od 10 bolnikov) ali občasne (pojavijo se pri manj kot 1 od 100 bolnikov), odvisno od vrste kožne reakcije.
At 12 months, the proportion of patients alive and progression-free was 192 (83%) for patients randomised to vandetanib and 63 (63%) for patients randomised to placebo.
Po 12 mesecih je bil delež bolnikov, ki so bili živi in brez napredovanja, 192 (83 %) med bolniki, randomiziranimi na vandetanib, in 63 (63 %) med bolniki, randomiziranimi na placebo.
QTc and serum electrolytes should be monitored more frequently.
Treba je bolj pogosto spremljati interval QTc in elektrolite v serumu.
Effect of other medicinal products on vandetanib
Vpliv drugih zdravil na vandetanib
Other medicines and Caprelsa
Druga zdravila in zdravilo Caprelsa
Treatment should be initiated and supervised by a physician experienced in treatment of MTC and in the use of anticancer medicinal products and experienced in the assessment of electrocardiogram (ECG).
Zdravljenje mora uvesti in nadzirati zdravnik, ki ima izkušnje z zdravljenjem MTC in z uporabo zdravil za zdravljenje rakavih bolezni ter izkušnje glede ocene elektrokardiograma (EKG).
• Loss of body fluid (dehydration).
• izguba telesnih tekočin (dehidracija);
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (gleje Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
The result of the primary analysis of PFS showed a statistically significant improvement in PFS for patients randomised to vandetanib compared to placebo (Hazard Ratio (HR) = 0.46; 95% Confidence Interval (CI) = 0.31-0.69; p=0.0001).
Rezultat primarne analize PFS je pokazal statistično značilno izboljšanje PFS pri bolnikih, randomiziranih na vandetanib, v primerjavi s placebom (razmerje ogroženosti (HR - hazard ratio)) = 0,46, 95 % interval zaupanja (IZ) = 0,31-0,69, p = 0,0001).
• Abnormal sensation of the skin.
• nenormalen občutek kože;
Results should be interpreted with caution due to the high percentage of patients in the placebo arm switching to openlabel vandetanib (79.0% [79/100] of patients).
Rezultate je treba tolmačiti previdno, ker je velik delež bolnikov v skupini s placebom prešel na odprto uporabo vandetaniba (79,0 % [79/100] bolnikov).
What you need to know before you take Caprelsa
Kaj morate vedeti, preden boste vzeli zdravilo Caprelsa
If you are not sure, talk to your doctor.
Če ste negotovi, se posvetujte z zdravnikom.
• Toxins in the blood as a complication of infection.
• strupene snovi v krvi kot zaplet okužbe;
• As instructed by your doctor or pharmacist
• Po navodilu zdravnika ali farmacevta.
• Blurred vision, including mild changes in the eye which can lead to blurred vision (corneal opacity).
• zamegljen vid, vključno z blagimi očesnimi spremembami, ki lahko povzročijo zamegljen vid
Recommended dosing regimens and dose modifications are presented in Table 1.
Priporočene odmerne sheme in prilagoditve odmerka prikazuje preglednica 1.
The starting dose could be reduced to 200 mg in patients with moderate renal impairment; safety and efficacy have however not been established with 200 mg (see section 4.4).
Bolnikom z zmerno okvaro ledvic je možno zmanjšati začetni odmerek na 200 mg, vendar varnost in učinkovitost nista bili dokazani z uporabo 200 mg (glejte poglavje 4.4).
Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.
Zdravilo Caprelsa je indicirano za zdravljenje agresivnega in simptomatskega medularnega raka ščitnice (medullary thyroid cancer, MTC) pri bolnikih z neresektabilno lokalno napredovalo ali metastatsko boleznijo.
Characteristics of the patients at study entry were the following: mean age 14.2 years (range 9-17 years), 50% female, 50% male, 93.8% White, 26.7% Hispanic and 6.3% were Black.
14,2 leta (razpon: od 9 do 17 let), 50 % deklet, 50 % fantov, 93,8 % belcev, 26,7 % hispanov in 6,3 % črncev.
• carbamazepine and phenobarbital (used to control seizures)
• karbamazepin in fenobarbital (uporabljata se za obvladovanje napadov krčev)
Effect of vandetanib on other medicinal products
Vpliv vandetaniba na druga zdravila
However, long term safety data in paediatric patients are not available.
Vendar pa dolgoročnih podatkov o varnosti pri pediatričnih bolnikih ni.
Upon objective disease progression based on the investigator's assessment, patients were discontinued from blinded study treatment and given the option to receive open-label vandetanib.
Po objektivnem napredovanju bolezni, na podlagi raziskovalčeve ocene, so bolniki končali slepljeno zdravljenje v študiji in ponudili so jim možnost, da odprto prejemajo vandetanib.
Either symptomatic disease or progressive disease alone is not enough to prompt the need of treatment with vandetanib.
Prisotnost zgolj simptomatske bolezni ali zgolj progresivne bolezni ni zadosten razlog za takojšnje zdravljenje z vandetanibom.
Vandetanib also inhibits both wild type and the majority of mutated, activated forms of RET, and significantly inhibits the proliferation of MTC cell lines in vitro.
Vandetanib zavira tudi divji tip in večino mutiranih, aktiviranih oblik RET ter pomembno zavre proliferacijo celičnih linij MTC in vitro.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCA, ODGOVORNA ZA SPROŠČANJE SERIJ
Not reached (predicted 30.5 months)
ni dosežena (predvidena
Fourteen of the 28 patients (50%) who stopped vandetanib for an adverse event discontinued without a dose reduction.
Štirinajst od 28 bolnikov (50 %), ki so nehali prejemati vandetanib zaradi neželenega dogodka, je zdravljenje prekinilo brez zmanjšanja odmerka.
100 every other day
100 vsak drugi dan
Effects on reproduction in paediatric patients treated with vandetanib are not known.
Vplivi na reprodukcijo pri pediatričnih bolnikih, zdravljenih z vandetanibom, niso znani.
The amount of Caprelsa given will depend on your child's body weight and height.
Uporabljena količina zdravila Caprelsa bo odvisna od bolnikove telesne mase in telesne višine.
All prescribers of Caprelsa must be familiar with the Physician Information and Management Guidelines.
Vsi zdravniki, ki predpisujejo zdravilo Caprelsa, morajo biti seznanjeni z Informacijami za zdravnika in Smernicami za vodenje.
• itraconazole, ketoconazole, ritonavir, clarithromycin, rifampicin and moxifloxacin (medicines used to treat infections)
• itrakonazol, ketokonazol, ritonavir, klaritromicin, rifampicin in moksifloksacin (zdravila, ki se uporabljajo za zdravljenje okužb)
The concomitant use of vandetanib with strong CYP3A4 inducers (such as rifampicin, St John's Wort, carbamazepine, phenobarbital) should be avoided (see section 4.5).
Sočasni uporabi vandetaniba z močnimi induktorji CYP3A4 (kot so rifampicin, šentjanževka, karbamazepin, fenobarbital) se je treba izogibati (glejte poglavje 4.5).
At various exposure durations, median haemoglobin levels in patients treated with vandetanib were increased by 0.5-1.5 g/dl compared to baseline.
Pri različnih obdobjih izpostavljenosti so bile mediane vrednosti hemoglobina pri bolnikih, zdravljenih z vandetanibom, povečane za 0,5-1,5 g/dl v primerjavi z izhodiščem.
Results of a pharmacodynamic and pharmacokinetic interaction study indicated that co-administration with ondansetron in healthy patients appeared to have little effect on the pharmacokinetics of vandetanib, but had a small additive effect on the prolongation of the QTc interval of approximately 10 ms.
Rezultati študij farmakodinamičnih in farmakokinetičnih medsebojnih delovanj kažejo, da sočasno dajanje z ondansetronom zdravim osebam, po vsem sodeč, le malo vpliva na farmakokinetiko vandetaniba, ima pa majhen aditiven učinek na podaljšanje intervala QTc za približno 10 ms.
Administration of vandetanib with potent CYP3A4 inducers should be avoided.
Uporabi vandetaniba z močnimi induktorji CYP3A4 se je treba izogibati.
• Not to stop taking CAPRELSA, or change the dose, without consulting the prescriber;
• Opozorilo, naj bolnik ne neha jemati zdravila CAPRELSA in naj ne spremeni njegovega odmerka, ne da bi se posvetoval z zdravnikom, ki je predpisal zdravilo.
• The active substance is vandetanib.
• Učinkovina je vandetanib.
Excretion of the dose was slow and further excretion beyond 21 days would be expected based on the plasma half-life.
Izločanje odmerka je bilo počasno in glede na razpolovni čas v plazmi je pričakovati nadaljnje izločanje še po preteku 21 dni.
The liquid can also be administered through nasogastric or gastrostomy tubes.
Tekočino je mogoče dati tudi po nazogastrični ali gastrostomijski sondi.
In the vandetanib arm, a total of 73 (32%) patients progressed: 64 (28%) by response evaluation criteria in solid tumours (RECIST) progression and 9 (4%) by death in the absence of progression.
V kraku z vandetanibom se je napredovanje pojavilo pri skupaj 73 (32 %) bolnikov; pri 64 (28 %) so ugotovili napredovanje po RECIST (response evaluation criteria in solid tumours - merila za ocenjevanje odziva parenhimskih tumorjev) in 9 (4 %) bolnikov je umrlo, ne da bi se pojavilo napredovanje.
These usually go away when Caprelsa is stopped.
Ponavadi minejo po prenehanju uporabe zdravila Caprelsa.
The Patient Alert Card should include the following key elements:
Opozorilna izkaznica za bolnika mora vsebovati naslednje ključne elemente:
• Instructions on how to use the dosing and monitoring guide and the daily tracker for paediatric patients and caregivers.
• Navodila za uporabo vodnika za odmerjanje in spremljanje ter dnevnega sledilnika za pediatrične bolnike in njihove skrbnike.
A single dose pharmacokinetic study in volunteers indicated that hepatic impairment did not affect exposure to vandetanib.
Farmakokinetična študija enkratnega odmerka pri prostovoljcih kaže, da okvara jeter ne vpliva na izpostavljenost vandetanibu.
The benefit of vandetanib in patients with CTN less than 500 pg/ml has not been determined, therefore use in patients with CTN < 500 pg/ml should be carefully considered because of the treatment related risks of vandetanib.
Korist vandetaniba pri bolnikih s CTN, manjšim od 500 pg/ml, ni bila ugotovljena, zato je treba uporabo vandetaniba pri bolnikih s CTN < 500 pg/ml natančno pretehtati zaradi možnih, z zdravljenjem povezanih, tveganj uporabe vandetaniba.
Fourteen patients treated with vandetanib, and 3 with placebo had unresectable locally advanced disease only.
Štirinajst bolnikov, zdravljenih z vandetanibom, in 3 bolniki, zdravljeni s placebom, so imeli zgolj lokalno napredovalo neresektabilno bolezen.
If there is no appropriate alternative therapy, not recommended combinations with vandetanib may be made with additional ECG monitoring of the QTc interval, evaluation of electrolytes and further control at onset or worsening of diarrhoea.
Če ni drugega ustreznega alternativnega zdravljenja, je mogoče z vandetanibom uporabiti kombinacije, ki niso priporočljive ter ob tem dodatno spremljati interval QTc, določati elektrolite in nadalje nadzirati pojav ali poslabšanje driske.
Calcium hydrogen phosphate dihydrate Microcrystalline cellulose Crospovidone (type A) Povidone (K 29-32) Magnesium stearate
Jedro tablete kalcijev hidrogenfosfat dihidrat mikrokristalna celuloza krospovidon (vrsta A) povidon (K 29-32) magnezijev stearat
In consideration of the high intra-individual variability of the response to anticoagulation, and the possibility of interaction between vitamin K antagonists and chemotherapy, an increased frequency of the INR (International Normalised Ratio) monitoring is recommended, if it is decided to treat the patient with vitamin K antagonists.
Zaradi velike intraindividualne variabilnosti odziva na antikoagulantno zdravljenje in možnosti medsebojnih delovanj med antagonisti vitamina K in kemoterapijo, so v primeru zdravljenja z antagonisti vitamina K priporočljive pogostejše kontrole INR (internacionalnega normaliziranega razmerja).
For patients in whom Rearranged during Transfection (RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision (see important information in sections 4.4 and 5.1).
Pri bolnikih, za katere status mutacije RET ni znan ali pa je negativen (rearranged during transfection - prerazporejen med transfekcijo), je pred vsako posamezno odločitvijo glede zdravljenja treba upoštevati morebitno manjšo korist zdravljenja (glejte pomembne informacije v poglavjih 4.4 in 5.1).
• Changes in taste of foods (dysgeusia).
• spremenjen okus hrane (dizgevzija).
• Loss of hair from the head or body (alopecia).
• izguba las ali dlak (alopecija);
Pharmacokinetics in paediatric population
Farmakokinetika v pediatrični populaciji
• Dehydration.
• dehidracija;
Very common (affects more than 1 in 10 people):
Zelo pogosti (pojavijo se pri več kot 1 od 10 bolnikov):
• Frequent urination.
• pogosto uriniranje;
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Paediatric patients treated with Caprelsa and patients' caregivers must be given the dosing guide and be informed on the correct dose to be taken with the initial prescription and each subsequent dose adjustment.
Pediatričnim bolnikom, ki prejemajo zdravilo Caprelsa in osebam, ki zanje skrbijo, je treba izročiti vodnik za odmerjanje ter jih seznaniti s pravilnim odmerkom, ki ga je treba uporabljati, ko je zdravilo predpisano in ob vsaki nadaljnji prilagoditvi odmerka.
• Involuntary muscle contraction (convulsions).
• nehotni mišični krči (konvulzije);
If a patient presents with respiratory symptoms such as dyspnoea, cough and fever, vandetanib treatment should be interrupted and prompt investigation initiated.
Če ima bolnik dihalne simptome, npr. dispnejo, kašelj in vročino, je treba zdravljenje z vandetanibom prekiniti in bolnika takoj pregledati.
Temporary or permanent discontinuation of therapy may be necessary in patients with heart failure.
Pri bolnikih s srčnim popuščanjem bo morebiti potrebna začasna ali dokončna prekinitev zdravljenja.
There is a limited amount of data on the use of vandetanib during pregnancy.
Podatkov o uporabi vandetaniba med nosečnostjo je malo.
• Rapidly alternating muscular contraction and relaxation (clonus).
• hitro in izmenično krčenje ter sprostitev mišic (klonus);
Statistically significant advantages were seen for vandetanib for the secondary endpoints of response rate, disease control rate, and biochemical response.
Statistično značilne prednosti so bile za vandetanib opazne pri sekundarnih opazovanih dogodkih deleža odziva, deleža obvladanja bolezni in biokemičnega odziva.
• Heart rhythm changes (shown in an ECG).
• motnje srčnega ritma (pokažejo se na EKG).
If ILD is confirmed, vandetanib should be permanently discontinued and the patient treated appropriately.
Če je IBP potrjena, je treba zdravljenje z vandetanibom trajno prekiniti in bolnika ustrezno zdraviti.
- if you have a heart problem that you were born with called ‘congenital long QTc syndrome'.
če imate prirojeno srčno motnjo, imenovano "prirojeni sindrom dolgega QTc".
• Details of medicinal products where the co-administration of CAPRELSA is either contraindicated or not recommended;
• Podrobnosti glede zdravil s katerimi je sočasno dajanje zdravila CAPRELSA ali kontraindicirano ali pa ni priporočljivo.
In healthy male subjects, the exposure to vandetanib was reduced by 40% when given together with the potent CYP3A4 inducer, rifampicin.
Pri zdravih moških preiskovancih se je izpostavljenost vandetanibu zmanjšala za 40 %, če je bil uporabljen skupaj z močnim induktorjem CYP3A4 rifampicinom.
Summary of the safety profileThe most commonly reported adverse drug reactions have been diarrhoea, rash, nausea, hypertension, and headache.
Povzetek varnostnega profila Najpogosteje poročani neželeni učinki so bili driska, izpuščaj, navzea, hipertenzija in glavobol.
In the blinded comparison of vandetanib vs. placebo, only 2 patients known to be RET negative at all 6 exons received vandetanib and none demonstrated responses.
V slepljeni primerjavi vandetaniba s placebom sta zgolj 2 bolnika z negativnim RET v vseh 6 eksonih, prejela vandetanib in nobeden ni pokazal odziva.
It is important that you keep this dosing guide and show it to your caregiver.
Pomembno je, da ta vodnik za odmerjanje shranite in ga pokažete osebi, ki skrbi za vas.
Vandetanib had no effect on fertility in male rats.
Vandetanib ni vplival na plodnost podganjih samcev.
• Patients with a QTc interval over 480 msec.
• Bolniki z intervalom QTc, daljšim od 480 ms.
Pharmacotherapeutic Group: antineoplastic agent, protein kinase inhibitor, ATC Code: L01XE12
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinkinaze; oznaka ATC: L01XE12
Your doctor may need to prescribe or change your thyroid hormone treatment.
Zdravnik vam bo morda moral predpisati zdravljenje s ščitničnim hormonom ali vam takšno zdravljenje spremenil;
Of the patients enrolled in the study 10 patients on vandetanib and 4 on placebo (4% of all patients) had a World Health Organization performance status (WHO PS) score of ≥ 2 and 28 (12.1%) patients on vandetanib and 10 (10.1%) on placebo had cardiac impairment.
Med bolniki, vključenimi v študijo, je imelo 10 prejemnikov vandetaniba in 4 prejemniki placeba (4 % vseh bolnikov) oceno zmogljivostnega stanja po Svetovni zdravstveni organizaciji (WHO PS) ≥ 2; 28 (12,1 %) prejemnikov vandetaniba in 10 (10,1 %) prejemnikov placeba je imelo okvaro srca.
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CTN Response
ODZIV CTN
• Depression.
• depresija;
Only one supply per prescription is allowed.
Dovoljena je le ena izdaja zdravila na posamezni zdravniški recept.
Cardiac impairment was defined as patients with previous cardiovascular abnormality.
Okvara srca je bila opredeljena kot stanje bolnikov, ki so predhodno imeli neko kardiovaskularno nepravilnost.
The European Medicines Agency will review new information on the medicine at least every year and this leaflet will be updated as necessary.
Evropska agencija za zdravila bo vsaj enkrat letno ponovno pregledala nove podatke o tem zdravilu.
Caprelsa works by slowing down the growth of new blood vessels in tumours (cancers).
Zdravilo Caprelsa deluje tako, da upočasni rast novih žil v tumorjih (raku).
• Inflammation of the main air passages to the lungs.
• vnetje glavnih dihalnih poti v pljučih;
This is uncommon (affects less than 1 in 100 people) but can be life-threatening.
Ta učinek je občasen (pojavi se pri manj kot 1 od 100 bolnikov), a je lahko smrtno nevaren.
If you get side effects always tell your doctor.
Če se vam pojavijo neželeni učinki, morate to vedno povedati zdravniku.
For patients whose RET mutation status could be negative, a possible lower benefit should be taken into account before individual treatment decisions and the use of vandetanib should be carefully considered because of the treatment related risks.
Pri bolnikih, katerih status mutacije RET bi lahko bil negativen, je pred vsako odločitvijo glede zdravljenja in uporabe vandetaniba treba skrbno upoštevati morebitno manjšo korist zaradi z zdravljenjem povezanih tveganj.
Vandetanib is also a sub-micromolar inhibitor of vascular endothelial receptor-3 tyrosine kinase.
Vandetanib je tudi submikromolaren zaviralec tirozin-kinaznega endotelijskega receptorja 3.
A glucuronide conjugate was seen as a minor metabolite in excreta only.
Glukuronidni konjugat so kot manj pomembni presnovek našli samo v izločkih.
In repeat-dose toxicity studies of up to 9 months duration, effects included emesis, body weight loss and diarrhoea in dogs and physeal dysplasia in young dogs and rats with open growth plates.
Med učinki, zabeleženimi v do 9-mesečnih študijah toksičnosti ponavljajočih se odmerkov, so bili bruhanje, zmanjšanje telesne mase in driska pri psih ter fizalna displazija pri mladih psih in podganah z odprtimi rastnimi ploščicami.
• Vandetanib has demonstrated adverse effect on growing tissue that relies on vascularization such as teeth and growth plates in non-clinical studies;
• Predklinične študije so pokazale neželen učinek vandetaniba na rastoča tkiva, odvisna od vaskularizacije, npr. na zobe in rastne ploščice.
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Vandetanib accumulates approximately 8-fold on multiple dosing with steady state achieved from approximately 2 months.
Vandetanib se med uporabo več odmerkov kopiči približno 8-kratno in stanje dinamičnega ravnovesja je doseženo po približno 2 mesecih.
• Patients who are on the increased dose (b in Table 1), should be recommenced at the starting dose (a in Table 1).
• Bolniki, ki prejemajo večji odmerek (b v preglednici 1), morajo zdravljenje znova začeti z začetnim odmerkom (a v preglednici 1).
• ondansetron (used to treat nausea and vomiting)
• ondansetron (uporablja se za zdravljenje občutka siljenja na bruhanje in bruhanja)
A post-hoc subgroup analysis of RET negative status based on absence of M918T mutation of the pivotal study 58 was performed.
V post-hoc podskupini je bila izvedena analiza negativnega statusa RET, ki je temeljila na odsotnosti mutacije M918T v ključni študiji 58.
In a repeat-dose toxicity study in rats, there was a decrease in the number of corpora lutea in the ovaries of rats given vandetanib for 1 month.
V študiji toksičnosti ponavljajočih se odmerkov pri podganah so ugotovili zmanjšanje števila rumenih telesc v jajčnikih podgan, ki so 1 mesec dobivale vandetanib.