natgillin/translations-raw huggingface dataset:
Additional effects, observed in other studies included QTc interval prolongation, LVEF reduction, pituitary hypertrophy, and testicular tubular atrophy, increased mesangial cells in kidney, haemorrhage in GI tract and oral mucosa, and hypertrophy of anterior pituitary cells.
Med dodatnimi učinki, opaženimi v drugih študijah, so bili podaljšanje intervala QTc, zmanjšanje LVEF, hipertrofija hipofize in atrofija tubulov v modih, zvečanje mezangijskega matriksa v ledvicah, krvavitve iz prebavil in ustne sluznice ter hipertrofija celic v sprednjem delu hipofize.
Changes in the uterus (endometrial atrophy) and bone growth plate (physeal thickening or dysplasia of cartilage) are thought to be related to the pharmacological action of sunitinib.
Spremembe na maternici (atrofija endometrija) in kostni rastni ploščici (zadebelitev fize ali displazija hrustanca) so domnevno
In rats, embryo-foetal mortality was evident as significant reductions in the number of live foetuses, increased numbers of resorptions increased postimplantation loss, and total litter loss in 8 of 28 pregnant
Pri podganah se je embrio- fetalna umrljivost kazala s pomembno manjšim številom živih plodov, večjim številom resorpcij, večjimi poimplantacijskimi izgubami ter popolno izgubo legla pri 8 od 28 brejih samic, in sicer pri plazemski izpostavljenosti, ki je bila 5, 5- krat večja kot med klinično uporabo.
Orange Capsule Shell Gelatin Red Iron Oxide (E172) Titanium dioxide (E171)
Ovojnica kapsule oranžne barve želatina rdeči železov oksid (E172) titanov dioksid (E171)
Caramel Capsule Shell Gelatin Titanium dioxide (E171) Yellow Iron Oxide (E172) Red Iron Oxide (E172) Black Iron Oxide (E172)
36 titanov dioksid (E171) rumeni železov oksid (E172) rdeči železov oksid (E172) črni železov oksid (E172)
Printing ink Shellac Propylene glycol Sodium hydroxide Povidone Titanium dioxide (E171)
Črnilo šelak propilenglikol natrijev hidroksid povidon titanov dioksid (E171)
Each capsule contains sunitinib malate equivalent to 50 mg of sunitinib Excipient(s):
Pomožne snovi:
79,326 mg of mannitol.
79, 326 mg manitola.
Hard Capsules Gelatin capsule with caramel cap and caramel body, printed with white ink “ Pfizer” on the cap and “ STN 50 mg” on the body and containing yellow to orange granules.
Na zgornjem delu je z belim črnilom natisnjeno "Pfizer", na spodnjem delu pa "STN 50 mg".
Paediatric use:
38 Uporaba pri otrocih:
37 SUTENT should not be used in paediatric population until further data become available.
V pediatrični populaciji SUTENTA ne smemo uporabljati, dokler ne bo na voljo dodatnih podatkov.
In clinical trials treatment-related tumour haemorrhage occurred in approximately 2% of patients with GIST.
V kliničnih preskušanjih so se z zdravljenjem povezana krvavitev tumorja se je pojavila pri približno 2% bolnikov z GIST.
In patients receiving SUTENT for treatment-naïve MRCC, 28% had bleeding events compared to 7% of patients receiving IFN-α.
Med bolniki, ki so dobivali SUTENT za še nezdravljen MRCC, je imelo pojave
Seven (1.9%) patients on sunitinib malate versus 0% of patients on IFN-α experienced Grade 3 or greater treatment-related bleeding events.
39 krvavitev 28%, med bolniki, ki so dobivali IFN- α, pa 7%.
38 refractory MRCC, 26% experienced bleeding.
Krvavitve so se pojavile pri 26% bolnikov, ki so sunitinibijev malat dobivali za zdravljenje metastatskega karcinoma ledvičnih celic, odpornega proti citokinom.
39 SUTENT arm experienced fatal cardiac events.
V študiji 3. faze pri še nezdravljenih bolnikih z MRCC pa so se smrtni srčni dogodki pojavili pri 0, 6% bolnikov v kraku z IFN- α ter pri nobenem bolniku v kraku s SUTENTOM.
QT Interval prolongation Data from non-clinical (in vitro and in vivo) studies, at doses higher than the recommended human dose, indicate that sunitinib has the potential toinhibit the cardiac action potential repolarization process (e. g. prolongation of QT interval).
Podaljšanje intervala QT Podatki iz nekliničnih študij (in vitro in in vivo) z odmerki, večjimi od priporočenega odmerka za človeka, kažejo, da lahko sunitinib zavre repolarizacijsko fazo srčnega akcijskega potenciala (npr. podaljšanje intervala QT).
Using comprehensive serial ECG assessments at times corresponding to either therapeutic or greater than therapeutic exposures, none, of the patients in the evaluable or ITT populations were observed to develop QTc prolongation considered as “ severe” (i. e. equal to or greater than Grade 3 by CTCAE version 3.0).
Med tem ovrednotenjem pri nobenem bolniku v ocenljivi populaciji ali populaciji z- namenom- zdravljenja niso opazili podaljšanja QTc, ki bi veljalo za "hudo" (tj. enako ali večje stopnji 3 po CTCAE, verzija 3. 0).
No subjects experienced an effect on the QTc inteval greater than Grade 2 (CTCAE version 3.0).
41 nobenem preiskovancu niso ugotovili učinka na interval QTc, ki bi bil večji od stopnje 2 (CTCAE verzija 3. 0).
40 Seven patients (3%) on SUTENT and none on placebo in a phase 3 GIST study experienced venous thromboembolic events; five of the seven were Grade 3 deep venous thrombosis (DVT), and two were Grade 1 or 2.
2. stopnje.
Cases with fatal out- come had been observed in post-marketing setting (see respiratory events and section 4.8).
Smrtne izide so zabeležili v v postmarketinškem obdobju (glejte Dogodki na dihalih in poglavje 4. 8).
Pulmonary Events Patients who presented with pulmonary embolism within the previous 12 months were excluded from SUTENT clinical studies.
Dogodki na dihalih V klinične študije zdravila SUTENT niso bili vključeni bolniki, ki so imeli pljučno embolijo v zadnjih 12 mesecih.
In patients who received Sutent in Phase 3 registrational studies, treatment-related pulmonary events (i. e. dyspnoea, pleural effusion, pulmonary embolism or pulmonary oedema) were reported in approximately 5% of patients with GIST and in approximately 14% of patients with MRCC.
Pri bolnikih, ki so dobivali SUTENT v registracijskih študijah 3. faze, so z zdravljenjem povezane plučne dogodke (tj. dispnejo, plevralni izliv, pljučno embolijo ali pljučni edem) zabeležili pri približno 5% bolnikov z GIST in približno 14% bolnikov z MRCC.
Rare cases of hyperthyroidism, some followed by hypothyroidism, have been reported in clinical trials and through post-marketing experience.
42 Med kliničnimi preskušanji in pomarketinškim obdobjem so bili opisani redki primeri hipertiroidizma, ki mu je včasih sledil hipotiroidizem.
If symptoms of pancreatitis or hepatic failure are present, patients should have SUTENT discontinued and be provided with appropriate supportive care.
Opisani so bili primeri resnih pankreatičnih pojavov, včasih s smrtnim izidom Če se pri bolnikih pojavijo simptomi pankreatitisa ali odpovedi jeter, je treba zdravljenje s SUTENTOM prekiniti in jim nuditi ustrezno podporno oskrbo.
Cases of hepatobiliary events, some with fatal outcome, have been reported.
Delovanje jeter Pri bolnikih s čvrstimi tumorji so se pojavili resni hepatobiliarni učinki, povezani s SUTENTOM; odpoved jeter so zabeležili pri < 1% teh bolnikov. Opisani so bili primeri hepatobiliranih pojavov, včasihc s smrtnim izidom.
41 Renal function The safety of continued SUTENT treatment in patients with moderate to severe proteinuria has not been systematically evaluated.
Delovanje ledvic Varnost nadaljnjega zdravljenja z zdravilom SUTENT pri bolnikih z zmerno do hudo proteinurijo ni bila sistematično ocenjena.
In addition, there have been rare (< 1%) reports of subjects presenting with seizures and radiological evidence of reversible posterior leukoencephalopathy syndrome (RPLS).
Poleg tega je bilo nekaj redkih (< 1%) poročil o preiskovancih s konvulzijami in radiološkimi znaki reverzibilnega posteriornega levkoencefalopatskega sindroma (RPLS).
Administration of SUTENT with potent inducers of the CYP3A4 family (e. g., dexamethasone, phenytoin, carbamazepine, rifampin, phenobarbital or Hypericum perforatum known also as St.
Uporaba SUTENTA z močnimi induktorji družine CYP3A4 (npr. deksametazonom, fenitoinom, karbamazepinom, rifampinom, fenobarbitalom ali Hypericum perforatum, znano tudi kot šentjanževka) lahko zniža koncentracijo sunitiniba.
John’ s Wort) may decrease sunitinib concentrations.
Kombinacijam z induktorji se je torej treba
Combination with inducers should therefore be avoided, or selection of an alternate concomitant medication with no, or minimal potential to induce CYP3A4 should be considered.
43 izogniti ali pa je treba izbrati drugo sočasno zdravilo z minimalnim potencialom za indukcijo CYP3A4 ali brez takšnega potenciala.
42 Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with SUTENT.
Ženskam v rodni dobi moramo povedati, naj med zdravljenjem s SUTENTOM ne zanosijo.
Fatal events other than those listed in section 4.4 above or section 4.8 below which were considered possibly related to SUTENT included multi-system organ failure, disseminated intravascular coagulation, peritoneal haemorrhage, rhabdomyolysis, cerebrovascular accident, dehydration, adrenal insufficiency, renal failure, respiratory failure, pleural effusion, pneumothorax, shock, and sudden death.
Med dogodki s smrtnim izidom (razen naštetih v poglavju 4. 4 zgoraj ali poglavju 4. 8 spodaj), ki so jih ocenili kot morda povezane s SUTENTOM so bili: odpoved več organov, diseminirana intravaskularna koagulacija, peritonealna krvavitev, rabdomioliza, cerebrovaskularni inzult, dehidracija, adrenalna insuficienca, odpoved ledvic, respiratorna insuficienca, plevralni izliv, pnevmotoraks, šok in nenadna smrt.
Treatment-related adverse reactions that were reported in > 2% of solid tumour patients are listed below, by system organ class, frequency and grade of severity.
44 Z zdravljenjem povezani neželeni učinki, opisani pri > 2% bolnikov s čvrstimi tumorji, so našteti spodaj, po organskih sistemih, pogostnosti in stopnji izraženosti.
43 System Organ Class
Bolezni živčevja
Dyspnoea
hipertenzija epistaksa dispneja
Renal and urinary disorders
101 (23, 0%) 28 (6, 4%) 16 (3, 6%)
0 (0.0%)
43 (9, 8%) 1 (0, 2%) 2 (0, 5%)
Skin and subcutaneous
45 Organski sistem
Very common
Pogostnost
Yellow skin/ Skin discolouration
Neželeni učinek
146 (33.2%)
Vse stopnje n (%)
0 (0.0%)
3. stopnja n (%)
0 (0.0%)
4. stopnja n (%)
Palmar-plantar erythrodysaesthesia syndrome
porumenela koža/ obarvanje kože
Adverse Reactions
sindrom palmarno- plantarne eritrodizestezije
All Grades n (%)
106 (24, 1%)
Grade 3 n (%)
27 (6, 1%)
Skin hyperpigmentation
spremembe barve las
15 (3.4%)
67 (15, 2%)
39 (8.9%) 29 (6.6%) 21(4.8%) 11 (2.5%) 10 (2.3%)
54 (12, 3%) 39 (8, 9%) 29 (6, 6%) 21 (4, 8%) 11 (2, 5%) 10 (2, 3%)
70 (15.9%)
59 (13, 4%)
Oedema** Pyrexia
pireksija
Haemoglobin decrease
znižanje ravni hemoglobina
Amylase increased Aspartate aminotransferase increased
zvišanje amilaze
45 Treatment-Related Adverse Reactions reported in cytokine-refractory and treatment-naïve MRCC studies
Z zdravljenjem povezani neželeni učinki, o katerih so poročali v študijah MRCC, odpornega proti citokinom, ter še nezdravljenega MRCC
Neutropoenia Thrombocytopoenia
nevtropenija trombocitopenija
89 (16.4%) 86 (15.8%)
89 (16, 4%) 86 (15, 8%)
46 (8.5%) 37 (6.8%)
46 (8, 5%) 37 (6, 8%)
5 (0.9%) 5 (0.9%)
5 (0, 9%) 5 (0, 9%)
Very common Common Common
zelo pogosti pogosti pogosti
Anaemia Leukopoenia Lymphopenia
anemija levkopenija limfopenija
67 (12.3%) 45 (8.3%) 21 (3.9%)
67 (12, 3%) 45 (8, 3%) 21 (3, 9%)
20 (3.7%) 16 (2.9%) 12 (2.2%)
20 (3, 7%) 16 (2, 9%) 12 (2, 2%)
3 (0.6%) 0 (0%) 1 (0.2%)
3 (0, 6%) 0 (0%) 1 (0, 2%)
Eye disorders
Očesne bolezni Presnovne in
Lacrimation increased
močnejše solzenje edem vek
39 (7.2%)
39 (7, 2%) 12 (2, 2%)
Eyelid oedema
zmanjšanje teka a
33 (6.1%) 250 (46.0%)
33 (6, 1%)
7 (1.3%) 1 (0.2%)
(1, 3%)
Very common Common Common Common
Bolezni živčevja
Headache Dizziness Paraesthesia Neuropathy peripheral
zelo pogosti
82 (15.1%) 38 (7.0%) 36 (5.9%) 33 (6.1%)
250 (46, 0%)
3 (0.6%) 2 (0.4%) 0 (0%) 1 (0.2%)
1
0 (0%) 0 (0%) 0 (0%) 0 (0%)
(0, 2%)
Common Common
zelo pogosti pogosti pogosti pogosti pogosti pogosti
Hypoaesthesia Hyperaesthesia
glavobol omotica parestezije periferna nevropatija hipestezija hiperestezija
20 (3.7%) 17 (3.1%)
82 (15, 1%) 38 (7, 0%) 36 (5, 9%) 33 (6, 1%) 20 (3, 7%) 17 (3, 1%)
0 (0%) 0 (0%)
3 2 0 1 0 0
0 (0%) 0 (0%)
(0, 6%) (0, 4%) (0%) (0, 2%) (0%) (0%)
Vascular disorders
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Flushing Hot flush
zardevanje valovi vročine
Common Common Common Common Common Common
pogosti pogosti pogosti pogosti
Cough Dysphonia Nasal dryness Dyspnoea exertional Nasal congestion Pleural effusion
kašelj disfonija suhost nosu dispneja med naporom
Diarrhoea
zamašenost nosu plevralen izliv
326 (59.9%)
12 (2, 2%) 12 (2, 2%)
38 (7.0%)
0 (0%) 3 (0, 6%)
Adverse Reactions
bruhanje bolečina v trebuhu c
Abdominal pain c / distension
/ napihnjenost
Very common Very common Very common Very common Very common Common
zelo pogosti zelo pogosti pogosti pogosti pogosti pogosti
Common Common Common Common Common Common Common Common
pogosti pogosti pogosti pogosti pogosti pogosti pogosti pogosti
Dysphagia Cheilitis Gingival bleeding Haemorrhoids Proctalgia Mouth ulceration Stomach discomfort Rectal haemorrhage
disfagija heilitis krvavitev iz dlesni hemoroidi proktalgija razjede v ustih nelagodje v želodcu rektalna krvavitev
20 (3.7%) 19 (3.5%) 18 (3.3%) 18 (3.3%) 17 (3.1%) 16 (2.9%) 15 (2.8%) 13 (2.4%)
20 (3, 7%) 19 (3, 5%) 18 (3, 3%) 18 (3, 3%) 17 (3, 1%) 16 (2, 9%) 15 (2, 8%) 13 (2, 4%)
Very common Common Common Common Common Common Common Common
zelo pogosti pogosti pogosti pogosti pogosti pogosti
Alopecia Erythema Skin exfoliation Pruritus Periorbital oedema Dermatitis Skin lesion Nail disorder/ discolouration
alopecija eritem eksfoliacija kože srbenje periorbitalni edem dermatitis
64 (11.8%) 51 (9.4%) 47 (8.6%) 40 (7.4%) 31 (5.7%) 27 (5.0%) 26 (4.8%) 25 (4.6%)
64 (11, 8%) 51 (9, 4%) 47 (8, 6%) 40 (7, 4%) 31 (5, 7%) 27 (5, 0%)
0 (0%) 2 (0.4%) 4 (0.7%) 1 (0.2%) 1 (0.2%) 4 (0.7%) 1 (0.2%) 0 (0%)
0 (0%) 2 (0, 4%) 4 (0, 7%) 1 (0, 2%) 1 (0, 2%) 4 (0, 7%)
Very Common Common Common Common Common
zelo pogosti pogosti pogosti pogosti pogosti
Common Common Common Common
pogosti pogosti zelo pogosti
Pyrexia Chills Pain Chest pain
nespečnost depresija zmanjšanje iztisnega deleža
37 (6.8%) 35 (6.4%) 20 (3.7%) 13 (2.4%)
22 (4, 0%) 15 (2, 8%) 84 (15, 4%)
3 (0.6%) 2 (0.4%) 0 (0%) 2 (0.4%)
0 (0%) 1 (0, 2%) 16 (2, 9%)
The following terms have been combined: a Anorexia and decreased appetite b Dysgeusia, ageusia and taste disturbance c Abdominal pain and abdominal pain upper d Oedema, oedema peripheral and oedema face e White blood cell count decreased, neutrophil count decreased, and leukocyte count decreased
Združeni so naslednji izrazi: a anoreksije in zmanjšanje teka b Dizgevzija, asgevzija in motnje okušanja 49 c Bolečine v trebuhu in bolečine v zgornjem delu trebuha d Edemi, periferni edemi in edem obraza e Zmanjšanje števila belih krvnih celic, zmanjšanje števila nevtrofilcev in zmanjšanje števila levkocitov
48 Uncommon:
Občasni:
Infections and Infestations Not known:
Infekcijske in parazitske bolezni:
Infections(with or without neutropoenia) connective tissue disorders Myopathy and/ or Rhabdomyolysis
Bolezni pljuč
There is no specific antidote for overdosage with SUTENT and treatment of overdose should consist of general supportive measures.
Zdravljenje prevelikega odmerjanja mora obsegati splošne podporne
49 CLINICAL STUDIES The clinical safety and efficacy of SUTENT has been studied in the treatment of patients with malignant gastrointestinal stromal tumour (GIST) who were resistant to imatinib (i. e. those who experienced disease progression during or following treatment with imatinib) or intolerant to imatinib (i. e. those who experienced significant toxicity during treatment with imatinib that precluded further treatment) and the treatment of patients with metastatic renal cell carcinoma (MRCC) Efficacy is based on time to tumour progression and an increase in survival in GIST and on progression free survival and objective response rates for treatment-naïve and cytokine-refractory MRCC respectively.
Učinkovitost temelji na času do napredovanja tumorja in podaljšanju preživetja pri GIST, na preživetju brez napredovanja bolezni pri še nezdravljenem MRCC ter na objektivnem odzivu na zdravljenje pri MRCC, odpornemu proti citokinom.
50 The primary efficacy endpoint of this study was Objective Response Rate (ORR).
Primarni opazovani dogodek kot merilo učinkovitosti v tej študiji je bil objektivni odziv na zdravljenje (ORR).
Concurrent administration of SUTENT with the potent CYP3A4 inducer, rifampin, resulted approximately in 56% and 78% reduction in sunitinib Cmax and AUC0-∞, values respectively, after a single dose of SUTENT in healthy volunteers.
52 Sočasna uporaba SUTENTA z močnim induktorjem CYP3A4 rifampinom je pri zdravih prostovoljcih po posamičnem odmerku SUTENTA zmanjšala Cmax sunitiniba za 56% in AUC0– ∞ sunitiniba za 78%.
51 Plasma Pharmacokinetics Following oral administration in healthy volunteers, the elimination half-lives of sunitinib and its primary active desethyl metabolite are approximately 40 - 60 hours, and 80 - 110 hours, respectively.
Plazemska farmakokinetika Razpolovni čas izločanja sunitiniba po peroralni uporabi pri zdravih prostovoljcih je približno 40– 60 ur, njegovega primarnega aktivnega dezetil- presnovka pa približno 80– 110 ur.
In rat and monkey repeated-dose toxicity studies up to 9-months duration, the primary target organ effects were identified in the gastrointestinal tract (emesis and diarrhoea in monkeys), adrenal gland (cortical congestion and/ or haemorrhage in rats and monkeys, with necrosis followed by fibrosis in rats), haemolymphopoietic system (bone morrow hypocelularity, and lymphoid depletion of thymus, spleen, and lymph node), exocrine pancreas (acinar cell degranulation with single cell necrosis), salivary gland (acinar hypertrophy), bone joint (growth plate thickening), uterus (atrophy) and ovaries (decreased follicular development).
Vsi izsledki so se
All findings occurred at clinically relevant sunitinib plasma exposure levels.
53 pojavili pri izpostavljenosti klinično pomembnim količinam sunitiniba v plazmi.
Capsule content Mannitol Croscarmellose Sodium Povidone (K-25) Magnesium Stearate
Vsebina kapsule manitol premreženi natrijev karmelozat povidon magnezijev stearat
Capsule Shell Gelatin Titanium dioxide (E171) Yellow Iron Oxide (E172) Red Iron Oxide (E172) Black Iron Oxide (E172)
54 titanov dioksid (E171) rumeni železov oksid (E172) rdeči železov oksid (E172) črni železov oksid (E172)
53 6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
PFIZER Italia S. r. l Via del Commercio Zona Industriale IT-63046 Marino del Tronto (Ascoli Piceno) Italy
Via del Commercio Zona Industriale IT- 63046 Marino del Tronto (Ascoli Piceno) Italija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.1 (dated 8 November 2007) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti sistem farmakovigilance (opisan v različici 1. 1, predstavljen v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet, z datumom 8. november 2007), ki mora biti vzpostavljen in mora delovati preden da zdravilo v promet, in med časom, ko je v prometu.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt o obvladovanju tveganja Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo opravil študije in dodatne farmakovigilančne dejavnosti, podrobno navedene v načrtu farmakovigilance, kot je dogovorjeno v skladu z različico 3. 0 Načrta o obvladovanju tveganja (RMP), predstavljenega v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom, ter vsemi morebitnimi poznejšimi posodobitvami RMP, dogovorjenimi z Odborom za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernicami CHMP o sistemih obvladovanja tveganja za zdravila za uporabo v humani medicini je treba posodobljeni RMP vložiti hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.
Poleg tega je treba posodobljeni RMP vložiti: • kadar so prejete nove informacije, ki bi lahko vplivale na veljavno specifikacijo varnosti, farmakovigilančni načrt ali dejavnosti za zmanjšanje tveganja, • v 60 dneh po tem, ko je bil dosežen pomemben mejnik (farmakovigilančni ali za zmanjšanje tveganja), • na zahtevo Evropske agencije za zdravila (EMEA).
58 PARTICULARS TO APPEAR ON THE OUTER PACKAGING< AND > < THE IMMEDIATE PACKAGING>
OZNAČEVANJE
{HDPE BOTTLE OUTER CARTON - 12.5 MG CAPSULES}
{ŠKATLA ZA PLASTENKO IZ HDPE - 12, 5 mg KAPSULE}
SUTENT 12.5 mg hard capsules Sunitinib
SUTENT 12, 5 mg trde kapsule sunitinib
Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib
Ena kapsula vsebuje 12, 5 mg sunitiniba v obliki sunitinibijevega malata.
Ingredients of the capsules include mannitol and propylene glycol
Med pomožnimi snovmi v kapsuli sta manitol in propilenglikol.
Use only as directed by a doctor
Uporabljajte natančno po zdravnikovem navodilu.
Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ Velika Britanija
60 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {HDPE BOTTLE – 12.5 MG CAPSULES}
{PLASTENKA IZ HDPE – 12, 5 mg KAPSULE}
SUTENT 12.5 mg hard capsules Sunitinib Oral use
SUTENT 12, 5 mg trde kapsule sunitinib Za peroralno uporabo
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING< AND > < THE IMMEDIATE PACKAGING>
62 PODATKI NA ZUNANJI OVOJNINI
{HDPE BOTTLE OUTER CARTON - 25 MG CAPSULES}
{ŠKATLA ZA PLASTENKO IZ HDPE – 25 mg KAPSULE}
SUTENT 25 mg hard capsules Sunitinib
SUTENT 25 mg trde kapsule sunitinib
Each capsule contains sunitinib malate, equivalent to 25.0 mg of sunitinib
Ena kapsula vsebuje 25 mg sunitiniba v obliki sunitinibijevega malata.
63 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {HDPE BOTTLE – 25 MG CAPSULES}
{PLASTENKA IZ HDPE – 25 mg KAPSULE}
SUTENT 25 mg hard capsules Sunitinib Oral use
SUTENT 25 mg trde kapsule sunitinib Za peroralno uporabo
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING< AND > < THE IMMEDIATE PACKAGING>
65 PODATKI NA ZUNANJI OVOJNINI
{HDPE BOTTLE OUTER CARTON - 50 MG CAPSULES}
{ŠKATLA ZA PLASTENKO IZ HDPE – 50 mg KAPSULE}
SUTENT 50 mg hard capsules Sunitinib
SUTENT 50 mg trde kapsule sunitinib
Each capsule contains sunitinib malate, equivalent to 50.0 mg of sunitinib
Ena kapsula vsebuje 50 mg sunitiniba v obliki sunitinibijevega malata.
66 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {HDPE BOTTLE – 50 MG CAPSULES}
{PLASTENKA IZ HDPE – 50 mg KAPSULE}
SUTENT 50 mg hard capsules Sunitinib Oral use
SUTENT 50 mg trde kapsule sunitinib Za peroralno uporabo
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING< AND > < THE IMMEDIATE PACKAGING>
68 PODATKI NA ZUNANJI OVOJNINI
{ACLAR/ PVC BLISTER OUTER CARTON - 12.5 MG CAPSULES}
{ŠKATLA S PRETISNIMI OMOTI IZ ACLAR/ PVC – 12, 5 mg KAPSULE}
69 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
70 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
{ACLAR/ PVC BLISTER – 12.5 MG CAPSULES}
{PRETISNI OMOTI IZ ACLAR/ PVC – 12, 5 mg KAPSULE}
SUTENT 12.5 mg hard capsules Sunitinib
SUTENT 12, 5 mg trde kapsule sunitinib Za peroralno uporabo.