natgillin/translations-raw huggingface dataset:
A multi-center, randomized double-blind study comparing cabozantinib (N = 219) with placebo (N = 111) was conducted in patients with unresectable locally advanced or metastatic MTC and documented radiographic disease progression within 14 months prior to study entry.
Pri bolnikih z neizrezljivim, lokalno napredovalim ali metastatskim medularnim karcinomom ščitnice in z radiografsko dokumentiranim napredovanjem bolezni v roku 14 mesecev pred vstopom v študijo so opravili multicentrično, randomizirano, dvojno slepo študijo, v kateri so primerjali kabozantinib (N = 219) s placebom (N = 111).
Not applicable.
če je mogoče.
• Blister, pain of the hands or soles of the feet, rash or redness of the skin, dry skin
• mehurji, bolečine v dlaneh ali podplatih, izpuščaj ali rdečina kože, suha koža
For invasive dental procedures, cabozantinib treatment should be held at least 28 days prior to scheduled surgery, if possible.
Zdravljenje s kabozantinibom je treba ustaviti vsaj 28 dni pred načrtovanim invazivnim zobozdravstvenim posegom, če je mogoče.
• Abnormal connection of the tissue in your trachea (airway), oesophagus, or lungs
• nenormalne povezave tkiva v sapniku (dihalih), požiralniku ali pljučih
Skin and subcutaneous tissue disorders palmar-plantar erythrodysaesthesia syndrome, hair colour changes, rash, dry skin, alopecia, erythema hyperkeratosis, acne, blister, hair growth abnormal, skin exfolation, skin hypopigmentation skin ulcer, telangiectasia
Bolezni kože in podkožja sindrom palmarnoplantarne eritrodisestezije, spremenjena barva las, izpuščaj, suha koža, alopecija, eritem hiperkeratoza, akne, mehurji, nenormalna rast las, luščenje kože, hipopigmentacija kože kožne razjede, telangiektazija
• Inflammation of the oesophagus; symptoms can include heartburn, chest pain, feeling sick, altered taste, bloating, belching and indigestion
• vnetje požiralnika; simptomi lahko vključujejo zgago, bolečine v prsnem košu, siljenje na bruhanje, spremenjeno okušanje, napenjanje, spahovanje in prebavne motnje
Reproductive system and breast disorders amenorrhoea, vaginal haemorrhage
Motnje reprodukcije in dojk amenoreja, vaginalna krvavitev
Concurrent administration of cabozantinib with the strong CYP3A4 inhibitor ketoconazole resulted in an increase in cabozantinib plasma exposure.
Sočasna uporaba kabozantiniba z močnim zaviralcem CYP3A4, ketokonazolom, je povzročila povečanje izpostavljenosti kabozantinibu v plazmi.
Peel paper backing
Odluščite papirno hrbtno plast
Palmar-plantar erythrodysaesthesia syndrome (PPES) has been observed with cabozantinib.
Pri uporabi kabozantiniba so opazili sindrom palmarno-plantarne eritrodisestezije (PPES, Palmarplantar erythrodysaesthesia syndrome).
Concurrent administration of cabozantinib with the strong CYP3A4 inducer rifampicin resulted in a decrease in cabozantinib plasma exposure.
Sočasna uporaba kabozantiniba z močnim induktorjem CYP3A4, rifampicinom, je povzročila zmanjšanje izpostavljenosti kabozantinibu v plazmi.
Events of venous thromboembolism and events of arterial thromboembolism have been observed with cabozantinib.
Pri uporabi kabozantiniba so opazili dogodke venske trombembolije in dogodke arterijske trombembolije.
SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM
• Redness, swelling or pain in the mouth or throat, difficulty in speaking, hoarseness
• rdečina, oteklina ali bolečina v ustih ali žrelu, težave z govorjenjem, hripavost
Uncommon side effects (may affect 1 in 100 people)
Občasni neželeni učinki (pojavijo se lahko pri 1 od 100 bolnikov)
• Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth
• bolečine v ustih, zobeh in/ali čeljustih, oteklost ali razjede v ustih, omrtvelost ali občutek teže v čeljustih ali zrahljanje zoba
• Generalised pain, chest or muscle pain, ear pain, ringing in ears
• bolečine po vsem telesu, bolečine v prsnem košu ali mišicah, bolečine v ušesih, zvonjenje v ušesih
Dispensing instructions
Navodila za dajanje
Investigations weight decreased, serum ALT, AST, and ALP increased, blood LDH increased, blood TSH increased, lymphopenia, neutropenia, thrombocytopenia blood creatinine phosphokinase increased activated partial thromboplastin time shortened, eosinophil count increased, platelet count increased
Preiskave zmanjšanje telesne mase, zvišanje vrednosti ALT, AST in ALP v serumu, zvišanje vrednosti LDH v krvi, zvišanje vrednosti TSH v krvi, limfopenija, nevtropenija, trombocitopenija zvišanje vrednosti kreatinin-fosfokinaze v krvi skrajšani aktivirani delni tromboplastinski čas, zvišanje števila eozinofilcev, zvišanje števila trombocitov
21 x 20 mg capsules (60 mg/day dose for a 7-day supply) 28 day pack containing:
21 x 20 mg kapsul (odmerek 60 mg/dan, zaloga za 7 dni) 28-dnevno pakiranje, ki vsebuje:
100 mg Dose
100 mg odmerek
140 mg Dose
140 mg odmerek
Vascular disorders hypertension hypotension, venous thrombosis, pallor, peripheral coldness arterial thrombosis Aneurysms and artery dissections
Žilne bolezni hipertenzija hipotenzija, venska tromboza, bledica, periferni hlad arterijska tromboza anevrizme in disekcije arterij
Musculoskeletal and connective tissue disorders arthralgia, muscle spasms, pain in extremity musculoskeletal chest pain, osteonecrosis of jaw rhabdomyolysis
Bolezni mišičnoskeletnega sistema in vezivnega tkiva artralgija, mišični spazmi, bolečine v okončinah mišično-skeletne bolečine v prsnem košu, osteonekroza čeljusti rabdomioliza
Cabozantinib should be discontinued in patients who experience a GI perforation or a GI or non-GI fistula.
Uporabo kabozantiniba je treba pri bolnikih, pri katerih se pojavi gastrointestinalna perforacija ali gastrointestinalna oz. ne-gastrointestinalna fistula, prekiniti.
Tell your doctor if any of these affect you.
Če vas kar koli od tega zadeva, to povejte zdravniku.
• Stomach upset, including diarrhoea, nausea, vomiting, constipation, indigestion, and abdominal pain
• razdražen želodec, vključno z drisko, slabostjo, bruhanjem, zaprtostjo, prebavnimi motnjami in bolečinami v trebuhu
Capsule content Microcrystalline cellulose Croscarmellose sodium Sodium starch glycolate Silica colloidal anhydrous Stearic acid
Vsebina kapsule mikrokristalna celuloza premreženi natrijev karmelozat natrijev karboksimetilškrob brezvodni koloidni silicijev dioksid stearinska kislina
Nervous system disorders dysgeusia, headache, dizziness cerebrovascular accident, peripheral neuropathy, paraesthesia, ageusia, tremor ataxia, disturbance in attention, hepatic encephalopathy, loss of consciousness, speech disorder, posterior reversible encephalopathy syndrome
Bolezni živčevja disgevzija, glavobol, omotica možganska kap, periferna nevropatija, parestezija, agevzija, tremor ataksija, motnje pozornosti, jetrna encefalopatija, izguba zavesti, motnje govora, sindrom posteriorne reverzibilne levkoencefalopatije
• Symptoms including pain in the abdomen, nausea, vomiting, constipation, or fever.
• Simptomi, ki vključujejo bolečine v trebuhu, slabost, bruhanje, zaprtost ali zvišano telesno temperaturo.
Renal and urinary disorders proteinuria, dysuria, haematuria renal failure acute
Bolezni sečil proteinurija, dizurija, hematurija akutna ledvična odpoved
NAME OF THE MEDICINAL PRODUCT COMETRIQ 20 mg hard capsules
IME ZDRAVILA COMETRIQ 20 mg trde kapsule
Each 100 mg daily dose contains a combination of one grey 20 mg capsule and one orange 80 mg capsule.
En 100 mg dnevni odmerek vsebuje kombinacijo ene sive 20 mg kapsule in ene oranžne 80 mg kapsule.
EU/1/13/890/002 7 x 20 mg and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply) EU/1/13/890/003 21 x 20 mg and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply) EU/1/13/890/005 56 capsules (4 blister cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for 28 day supply)
EU/1/13/890/002 7 x 20 mg in 7 x 80 mg kapsul (odmerek 100 mg/dan, zaloga za 7 dni) EU/1/13/890/003 21 x 20 mg in 7 x 80 mg kapsul (odmerek 140 mg/dan, zaloga za 7 dni) EU/1/13/890/005 56 kapsul (4 pretisne zgibanke z: 7 x 20 mg in 7 x 80 mg) (odmerek
• Haemorrhoids
• zamegljen vid
Effective methods of contraception should be used by male and female patients and their partners during therapy, and for at least 4 months after completing therapy.
Med zdravljenjem in še vsaj 4 mesece po končanju terapije morajo tako bolniki in bolnice kot tudi njihovi partnerji uporabljati zanesljiv način kontracepcije.
Each daily dose is given in one row and contains three 20 mg capsules:
Vsak dnevni odmerek je v eni vrsti in vsebuje tri 20 mg kapsule:
• Infection and inflammation in the lung, collapse of lung
• okužbe in vnetje pljuč, sesedanje pljuč
Two non-conjugated metabolites (XL184-N-oxide and XL184
Dva nekonjugirana presnovka (XL184-N-oksid in produkt cepitve XL184 amida), ki imata zaviralno učinkovitost na kinazo, ki je
Pack for the 140 mg daily dose
Pakiranje s 140 mg dnevnim odmerkom
No dose adjustment is indicated when gastric pH modifying agents (i.e., PPIs, H2 receptor antagonists, and antacids) are co-administered with cabozantinib.
Pri sočasni uporabi zdravil, ki spreminjajo vrednost pH v želodcu (tj. zaviralci protonske črpalke, antagonisti receptorjev H2 in antacidi) odmerka kabozantiniba ni treba prilagajati.
Pack for the 100 mg daily dose
Pakiranje s 100 mg dnevnim odmerkom
Non-GI fistula should be ruled out as appropriate in cases of onset of mucositis after start of therapy.
V primeru pojava mukozitisa po uvedbi terapije je treba ustrezno izključiti ne-gastrointestinalne fistule.
Each 140 mg daily dose contains a combination of three grey 20 mg capsules and one orange 80 mg capsule.
En 140 mg dnevni odmerek vsebuje kombinacijo treh sivih 20 mg kapsul in ene oranžne 80 mg kapsule.
• Impaired hearing
• nenormalna rast las
Titanium dioxide (E171)
Ovojnica kapsule želatina črni železov oksid (E172) titanov dioksid (E171)
What COMETRIQ contains
Kaj vsebuje zdravilo COMETRIQ
Table 1: Adverse reactions reported with cabozantinib
Preglednica 1: Neželeni učinki, o katerih so poročali pri kabozantinibu Organski sistem po
How to take COMETRIQ
Kako jemati zdravilo COMETRIQ
PHARMACEUTICAL FORM AND CONTENTS 60 mg Dose 28 day pack: 84 capsules (4 blister cards of 21 x 20 mg capsules) for the 60 mg daily dose for a 28 day supply.
FARMACEVTSKA OBLIKA IN VSEBINA odmerek 60 mg 28-dnevno pakiranje: 84 kapsul (4 pretisne zgibanke z: 21 x 20 mg kapsulami) za odmerek 60 mg na dan, zaloga za 28 dni.
Caution should be used in patients receiving agents associated with ONJ, such as bisphosphonates.
Pri bolnikih, ki prejemajo učinkovine, povezane z osteonekrozo čeljusti, kot so difosfonati, je potrebna previdnost.
Concomitant medicinal products
Sočasna uporaba z drugimi zdravili
Cabozantinib treatment should be discontinued in patients with RPLS.
Pri bolnikih z RPLS je treba z zdravljenje s kabozantinibom prenehati.
• Fungal infection that can be in the skin, mouth, or genitals
• glivične okužbe kože, ust ali spolovil
COMETRIQ 20 mg hard capsules COMETRIQ 80 mg hard capsules
COMETRIQ 20 mg trde kapsule COMETRIQ 80 mg trde kapsule
Respiratory, thoracic, and mediastinal disorders dysphonia, oropharyngeal pain non-gastrointestinal fistula (including tracheal, pneumomediastinu m, tracheooesophageal), pulmonary embolism, respiratory tract haemorrhage (including pulmonary, bronchial, tracheal), pneumonia aspiration atelectasis, pharyngeal oedema, pneumonitis
Bolezni dihal, prsnega koša in mediastinalneg a prostora disfonija, orofaringealne bolečine ne-gastrointestinalna fistula (vključno s trahealno, pnevmomediastinumo m, traheoezofagealno), pljučna embolija, krvavitev v dihalih (vključno s pljuči, sapnicami, sapnikom), aspiracijska pljučnica atelektazija, faringealni edem, pnevmonitis
Gastrointestinal disorders diarrhoea, nausea, stomatitis, constipation, vomiting, abdominal pain, dyspepsia, dysphagia, glossodynia gastrointestinal perforation, gastrointestinal haemorrhage, pancreatitis, haemorrhoids, anal fissure, anal inflammation, cheilitis gastrointestinal fistula, oesophagitis
Bolezni prebavil driska, navzea, stomatitis, konstipacija, bruhanje, bolečine v trebuhu, dispepsija, disfagija, glosodinija gastrointestinalna perforacija, gastrointestinalna krvavitev, pankreatitis, hemoroidi, analna fisura, analno vnetje, heilitis gastrointestinaln a fistula, ezofagitis
Caution is required when administering cabozantinib with agents that are strong CYP3A4 inhibitors.
Pri uporabi kabozantiniba z učinkovinami, ki so močni zaviralci CYP3A4, je potrebna previdnost.
Pack for the 60 mg daily dose Each 60 mg daily dose contains three grey 20 mg capsules.
Pakiranje s 60 mg dnevnim odmerkom En 60 mg dnevni odmerek vsebuje tri sive 20 mg kapsule.
EU/1/13/890/001 21 x 20 mg capsules (60 mg/day dose for a 7-day supply) EU/1/13/890/004 84 capsules (4 blister cards of 21 x 20 mg) (60 mg/day dose for a 28 day supply)
EU/1/13/890/001 21 x 20 mg kapsule (odmerek 60 mg/dan, zaloga za 7 dni) EU/1/13/890/004 84 kapsul (4 pretisne zgibanke z 21 x 20 mg) (odmerek 60 mg/dan, zaloga za
Each daily dose is provided in one row and contains one 80 mg capsule and one 20 mg capsule:
Vsak dnevni odmerek je v eni vrsti in vsebuje eno 80 mg kapsulo in eno 20 mg kapsulo:
Respiratory, thoracic, and mediastinal disorders dysphonia, oropharyngeal pain non-gastrointestinal fistula (including tracheal, pneumomediastinum, tracheo-oesophageal), pulmonary embolism, respiratory tract haemorrhage (including pulmonary, bronchial, tracheal), pneumonia aspiration atelectasis, pharyngeal oedema, pneumonitis
Bolezni dihal, prsnega koša in mediastinalnega prostora disfonija, orofaringealne bolečine ne-gastrointestinalna fistula (vključno s trahealno, pnevmomediastinumom, traheo-ezofagealno), pljučna embolija, krvavitev v dihalih (vključno s pljuči, sapnicami, sapnikom), aspiracijska pljučnica atelektazija, faringealni edem, pnevmonitis
Pack for the 60 mg daily dose 21 x 20 mg capsules (60 mg/day dose for a 7-day supply) Each 60 mg daily dose contains three grey 20 mg capsules.
Pakiranje s 60 mg dnevnim odmerkom 21 x 20 mg kapsul (odmerek 60 mg/dan, zaloga za 7 dni) En 60 mg dnevni odmerek vsebuje tri sive 20 mg kapsule.
Each 60 mg daily dose contains a combination of three grey 20 mg capsules.
En 60 mg dnevni odmerek vsebuje tri sive 20 mg kapsule.
- have high blood pressure - have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
- imate visok krvni tlak, - imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile, - imate drisko, - ste pred nedavnim izkašljevali krvi ali imeli znatno krvavitev, - ste imeli v zadnjem mesecu kirurški poseg (ali ga načrtujete), vključno z zobozdravstvenimi posegi,
The COMETRIQ 80 mg capsules contain cabozantinib (S)-malate equivalent to 80 mg of cabozantinib.
Zdravilo COMETRIQ 80 mg kapsule vsebuje kabozantinib (S)-malat v količini, ki ustreza 80 mg kabozantiniba.
Hard capsules 20 mg
trda kapsula 20 mg odmerek 60 mg
One hard capsule contains cabozantinib (S)-malate equivalent to 20 mg or 80 mg cabozantinib.
Ena trda kapsula vsebuje kabozantinib (S)-malat v količini, ki ustreza 20 mg ali 80 mg kabozantiniba.
Each daily dose is provided in one row and contains one 80 mg capsule and three 20 mg capsules:
Vsak dnevni odmerek je v eni vrsti in vsebuje eno 80 mg kapsulo in tri 20 mg kapsule:
one orange 80 mg + three grey 20 mg
= 100 mg ena oranžna 80 mg + tri sive 20 mg
21 x 20 mg capsules and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply) Each 140 mg daily dose contains a combination of three grey 20 mg capsules and one orange 80 mg capsule.
Pakiranje s 140 mg dnevnim odmerkom21 x 20 mg in 7 x 80 mg kapsule (odmerek 140 mg/dan, zaloga za 7 dni) En 140 mg dnevni odmerek vsebuje kombinacijo treh sivih 20 mg kapsul in ene oranžne 80 mg kapsule.
The COMETRIQ 20 mg capsules contain cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
Zdravilo COMETRIQ 20 mg kapsule vsebuje kabozantinib (S)-malat v količini, ki ustreza 20 mg kabozantiniba.
Hypertension has been observed with cabozantinib.
Pri uporabi kabozantiniba so opazili hipertenzijo.
• Wounds that have difficulties healing
• rane, ki se slabo celijo
The 100 mg daily dose blister card contains seven 80 mg capsules and seven 20 mg capsules as 7 daily doses in total.
Pretisna zgibanka s 100 mg dnevnim odmerkom vsebuje sedem 80 mg kapsul in sedem 20 mg kapsul, kar je skupaj 7 dnevnih odmerkov.
COMETRIQ 20 mg COMETRIQ 80 mg 140 mg/day dose
COMETRIQ 20 mg COMETRIQ 80 mg odmerek 140 mg/dan
COMETRIQ 20 mg COMETRIQ 80 mg 100 mg/day dose
COMETRIQ 20 mg COMETRIQ 80 mg odmerek 100 mg/dan
BLISTER CARD, 60 mg dose
PRETISNA ZGIBANKA, odmerek 60 mg
84 capsules (4 blister cards of 21 x 20 mg) (60 mg/day dose) 56 capsules (4 blister cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose) 112 capsules (4 blister cards of 21 x 20 mg and 7 x 80 mg) (140 mg/day dose)
84 kapsul (4 pretisne zgibanke z: 21 x 20 mg) (odmerek 60 mg/dan) 56 kapsul (4 pretisne zgibanke z: 7 x 20 mg in 7 x 80 mg) (odmerek 100 mg/dan) 112 kapsul (4 pretisne zgibanke z: 21 x 20 mg in 7 x 80 mg) (odmerek 140 mg/dan)
COMETRIQ 20 mg hard capsules
COMETRIQ 20 mg trde kapsule
COMETRIQ 20 mg hard capsules Cabozantinib
COMETRIQ 20 mg trde kapsule kabozantinib
EU/1/13/890/006 112 capsules (4 blister cards of 21 x 20mg and 7 x 80 mg) (140 mg/day dose for 28
EU/1/13/890/006 112 kapsul (4 pretisne zgibanke z: 21 x 20 mg in 7 x 80 mg) (odmerek
A high-fat meal moderately increased Cmax and AUC values (41% and 57%, respectively) relative to fasted conditions in healthy volunteers administered a single 140 mg oral cabozantinib dose.
Obrok z visoko vsebnostjo maščob je pri zdravih prostovoljcih, ki so dobili en peroralni odmerek 140 mg kabozantiniba zmerno zvišal vrednosti Cmax in AUC (41 % oz. 57 %) v primerjavi s stanjem na tešče.
56 capsules (4 blister cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for a 28 day supply) 112 capsules (4 blister cards of 21 x 20mg and 7 x 80 mg) (140 mg/day dose for a 28 day supply)
56 kapsul (4 pretisne zgibanke s: 7 x 20 mg in 7 x 80 mg) (odmerek 100 mg/dan, zaloga za 28 dni) 112 kapsul (4 pretisne zgibanke z: 21 x 20 mg in 7 x 80 mg) (odmerek 140 mg/dan odmerek, zaloga za 28 dni)
BLISTER CARD OF 28 DAY PACK, 60 mg dose (WITHOUT BLUE BOX)
PRETISNA ZGIBANKA 28-DNEVNO PAKIRANJE, odmerek 60 mg (BREZ BLUE-BOXA)
The 140 mg daily dose blister card contains seven 80 mg capsules and twenty one 20 mg capsules as 7 doses in total.
Pretisna zgibanka s 140 mg dnevnim odmerkom vsebuje sedem 80 mg kapsul in enaindvajset 20 mg kapsul, kar je skupaj 7 dnevnih odmerkov.
7 x 20 mg capsules and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply).
7 x 20 mg in 7 x 80 mg kapsule (odmerek 100 mg/dan, zaloga za 7 dni).
21 x 20 mg capsules and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply).
21 x 20 mg in 7 x 80 mg kapsule (odmerek 140 mg/dan, zaloga za 7 dni).
Figure 1: Kaplan Meier curve of progression free survival
Slika 1: Krivulja preživetja brez napredovanja bolezni po lestvici Kaplan-Meier
Hemorrhage has been observed with cabozantinib.
Pri uporabi kabozantiniba so opazili krvavitve.
Cabozantinib should be discontinued in patients who develop nephrotic syndrome.
Pri bolnikih, pri katerih se razvije nefrotični sindrom, je treba z uporabo kabozantiniba prenehati.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/002
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/890/002
• A condition called posterior reversible encephalopathy syndrome (PRES) or reversible posterior leukoencephalopathy syndrome (RPLS), which has symptoms such as seizures, headaches,
Posterior Leukoencephalopathy Syndrome), znan tudi kot sindrom posteriorne reverzibilne encefalopatije (PRES, Posterior Reversible Encephalopathy Syndrome) s simptomi, kot so epileptični napadi, glavobol, zmedenost ali težave s koncentracijo
MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/890/001
You should also tell your dentist that you are taking COMETRIQ.
Če jemljete zdravilo COMETRIQ, to povejte svojemu zobozdravniku.
The 60 mg daily dose blister card contains twenty-one 20 mg capsules as 7 daily doses in total.
Pretisna zgibanka s 60 mg dnevnim odmerkom vsebuje enaindvajset 20 mg kapsul, kar je skupaj 7 dnevnih odmerkov.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/005 56 capsules (4 blisters cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for 28 day supply)
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/890/005 56 kapsul (4 pretisne zgibanke po 7 x 20 mg in 7 x 80 mg) (odmerek
21 x 20 mg capsules (60 mg/day dose for a 7-day supply).
21 x 20 mg kapsul (odmerek 60 mg/dan, zaloga za 7 dni).
7 x 20 mg and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply) 21 x 20 mg and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply)
7 x 20 mg in 7 x 80 mg kapsule (odmerek 100 mg/dan, zaloga za 7 dni) 21 x 20 mg in 7 x 80 mg kapsule (odmerek 140 mg/dan, zaloga za 7 dni) 28-dnevno pakiranje, ki vsebuje:
MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/003
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/890/003
Proteinuria has been observed with cabozantinib.
Pri uporabi kabozantiniba so opazili proteinurijo.
These may be signs of a condition called reversible posterior leukoencephalopathy syndrome (RPLS).
• Stanje, imenovano sindrom posteriorne reverzibilne levkoencefalopatije (RPLS, Reversible
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF 28 DAY PACK, 140 mg dose (INCLUDING BLUE BOX)
ZUNANJA OVOJNINA ENOTE PAKIRANJA ZA 28 DNI, odmerek 140 mg (VKLJUČNO Z BLUE BOXOM)
14.6 months
14,6 mesecev n/v
• Tear or hole or bleeding in your stomach or intestine, inflammation or tear of anus, , bleeding in lungs or trachea (airway)
• raztrganje, luknja ali krvavitev v želodcu ali prebavilih, vnetje ali raztrganje zadnjika,
General disorders and administration site conditions fatigue, mucosal inflammation, asthenia impaired wound healing, chills, face oedema cyst, facial pain, localised oedema
Splošne težave in spremembe na mestu aplikacije utrujenost, vnetje sluznice, astenija slabše celjenje ran, mrzlica, obrazni edem cista, bolečine obraza, lokaliziran edem
How to store COMETRIQ
Shranjevanje zdravila COMETRIQ
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF 28 DAY PACK, 100 mg dose (INCLUDING BLUE BOX)
ZUNANJA OVOJNINA ENOTE PAKIRANJA ZA 28 DNI, odmerek 100 mg (VKLJUČNO Z BLUE BOXOM)
Hepatobiliary disorders cholelithiasis
Bolezni jeter, žolčnika in žolčevodov holelitiaza
There is little experience with cabozantinib in non-White patients.
Rasa Pri nebelcih je le malo izkušenj s kabozantinibom.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/004 84 capsules (4 blisters cards of 21 x 20 mg) (60 mg/day dose for 28 day supply) 13.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/890/004 84 kapsul (4 pretisne zgibanke po 21 x 20 mg) (odmerek 60 mg/dan, zaloga za
MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/006 112 capsules (4 blisters cards of 21 x 20 mg and 7 x 80 mg) (140 mg/day dose for 28 day supply)
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/890/006 112 kapsul (4 pretisne zgibanje z 21 x 20 mg in 7 x 80 mg) (odmerek
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF 28 DAY PACK, 60 mg dose (INCLUDING BLUE BOX)
ZUNANJA OVOJNINA ENOTE PAKIRANJA ZA 28 DNI, odmerek 60 mg (VKLJUČNO Z BLUE BOXOM)
Cabozantinib should be used with caution in patients with mild or moderate renal impairment.
Pri bolnikih z blago ali zmerno ledvično okvaro je treba kabozantinib uporabljati previdno.
PHARMACEUTICAL FORM AND CONTENTS 100 mg Dose 28 day pack: 56 capsules (4 blister cards of 7 x 20 mg capsules and 7 x 80 mg capsules) for the 100 mg daily dose for a 28 day supply.
28-dnevno pakiranje: 56 kapsul (4 pretisne zgibanke s: 7 x 20 mg kapsulami in 7 x 80 mg kapsulami) za odmerek 100 mg na dan, zaloga za 28 dni.
Tel: +372 60 15 540 Ελλάδα, Κύπρος, Malta
Tel: +372 60 15 540