FrancophonIA/ELRC3.0 huggingface dataset:
English: Progression free survival, months* Median (95 % CI) Hazard ratio (95 % CI) p-value Overall survival, months Median (95 % CI) Hazard ratio (95 % CI) p-value Abbreviations: CI = confidence interval * By investigator assessment **Met phase 2 protocol defined significance level of 0.19
Slovenian: Preživetje brez napredovanja bolezni, v mesecih* mediana (95-% IZ) razmerje tveganja (95-% IZ) p-vrednost Celokupno preživetje, v mesecih mediana (95-% IZ) razmerje tveganja (95-% IZ) p-vrednost Kratice: IZ= interval zaupanja * Po oceni raziskovalca **Dosežena je bila stopnja značilnosti 0,19, opredeljena s protokolom faze 2
English: In order to accommodate larger infusion volumes that may be needed for patients requiring higher doses, the duration of infusion should be increased such that the maximum infusion rate of 25 mg/minute is not exceeded.
Slovenian: Za večjo prostornino infuzije pri bolnikih, ki potrebujejo večje odmerke, naj se trajanje infuzije podaljša tako, da največja hitrost infuzije ne bo presegla 25 mg/min.
English: As monoclonal antibodies are not metabolised by cytochrome P450 (CYP) enzymes or other drug metabolising enzymes, inhibition or induction of these enzymes by co-administered medicinal products is not anticipated to affect the pharmacokinetics of olaratumab.
Slovenian: Ker se monoklonska protitelesa ne presnavljajo z encimi iz skupine citokromov P450 (CYP) ali drugimi encimi, ki presnavljajo zdravila, se ne pričakuje, da bi zaviranje ali indukcija teh encimov s sočasno danimi zdravili lahko vplivala na farmakokinetiko olaratumaba.
English: There is no experience with Lartruvo overdose in human clinical trials.
Slovenian: Izkušenj s prevelikim odmerjanjem zdravila Lartruvo v kliničnih preskušanjih pri človeku ni.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with olaratumab in one or more subsets of the paediatric population in soft tissue sarcoma (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z olaratumabom za eno ali več podskupin pediatrične populacije s sarkomom mehkih tkiv (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Table 1 - Management recommendations for infusion-related reactions (IRRs)
Slovenian: Preglednica 1 - Priporočila za ukrepanje ob pojavu reakcij, povezanih z infuzijo (IRR)
English: Infusion-related reactions (IRRs)
Slovenian: Reakcije, povezane z infuzijo (IRR)
English: EU/1/16/1143/003 - 2 vials of 19 mL.
Slovenian: EU/1/16/1143/003 - 2 viali z 19 ml
English: As doxorubicin is rapidly metabolised and predominantly eliminated by the biliary system, the toxicity of doxorubicin is enhanced in patients with hepatic impairment.
Slovenian: Ker se doksorubicin hitro presnavlja in izloča predvsem skozi žolčni sistem, je toksičnost doksorubicina povečana pri bolnikih z okvaro jeter.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not shake.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
English: What Lartruvo is and what it is used for
Slovenian: Kaj je zdravilo Lartruvo in za kaj ga uporabljamo
English: Olaratumab-treated patients from Phase 2 study
Slovenian: Z olaratumabom zdravljeni bolniki iz študije 2. faze:
English: L-Histidine monohydrochloride monohydrate L-Histidine
Slovenian: L-histidinijev klorid monohidrat
English: Parenteral medicines should be inspected visually for particulate matter prior to administration.
Slovenian: Parenteralna zdravila je treba pred uporabo vizualno pregledati.
English: What you need to know before you are given Lartruvo 3.
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Lartruvo 3.
English: Infusion reactions Lartruvo has been associated with infusion reactions (see section 2 “Warnings and precautions”).
Slovenian: Zdravilo Lartruvo je povezano z infuzijskimi reakcijami (glejte poglavje 2 »Opozorila in previdnostni ukrepi«).
English: It is not known whether olaratumab gets into breast milk and if the breast-fed infant is at risk of harm.
Slovenian: Ni znano, ali olaratumab prehaja v materino mleko in ali bi lahko škodovalo dojenemu otroku.
English: Severe IRRs such as anaphylactic reactions can occur despite the use of premedication.
Slovenian: Do hudih IRR, kot so anafilaktične reakcije, lahko pride kljub premedikaciji.
English: How you are given Lartruvo 4.
Slovenian: Kako boste prejemali zdravilo Lartruvo 4.
English: All severe IRRs occurred during or immediately after the first administration of olaratumab.
Slovenian: Vse hude IRR so se pojavile med prvim dajanjem olaratumaba ali takoj po njem.
English: Posology adjustments for olaratumab
Slovenian: Prilagajanje odmerjanja olaratumaba
English: Manufacturer Lilly S.A.
Slovenian: Izdelovalec Lilly S.A.
English: No data were available from patients with severe renal impairment (CLcr 15-29 mL/min).
Slovenian: Podatki o bolnikih s hudo okvaro ledvic (CLcr 15-29 ml/min) niso bili na voljo.
English: Forest plot for subgroup analysis of overall survival (ITT population)
Slovenian: Drevesni graf analize celokupnega preživetja po podskupinah (populacija z-namenomzdravljenja)
English: Within each frequency grouping, ADRs are presented in order of decreasing seriousness.
Slovenian: V vsaki skupini pogostnosti so neželeni učinki razvrščeni po padajoči resnosti.
English: • Shortness of breath
Slovenian: • pomanjkanje sape.
English: Each vial is intended for single use only.
Slovenian: Vsaka viala je namenjena le enkratni uporabi.
English: In some patients there was a recurrence of pain .The pain did not worsen with time or during recurrence.
Slovenian: Bolečina se s časom ali ob ponovitvi ni poslabšala.
English: If not used immediately, the dosing solution should be stored under refrigeration for up to 24 hours at 2 °C to 8 °C and up to an additional 8 hours at room temperature (up to 25 °C) assuming dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če se ne uporabi nemudoma, jo je treba hraniti v hladilniku do največ 24 ur pri temperaturi od 2 do 8 °C in nato še največ osem ur pri sobni temperaturi (do 25 °C), če je bilo redčenje opravljeno v nadzorovanih in validiranih aseptičnih pogojih.
English: Olaratumab is not recommended during pregnancy and in women of childbearing potential not using contraception, unless the potential benefit justifies the potential risk to the foetus.
Slovenian: Olaratumab se med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcijskih sredstev, odsvetuje, razen kadar potencialne koristi uporabe odtehtajo potencialna tveganja za plod.
English: - Reduction in the number of white blood cells Lartruvo and doxorubicin may decrease the number of white blood cells (including neutrophils).
Slovenian: Zdravilo Lartruvo in doksorubicin lahko zmanjšata število belih krvnih celic (vključno z nevtrofilci).
English: Olaratumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology.
Slovenian: Olaratumab je humano monoklonsko protitelo IgG1, pridobljeno iz mišjih celic (NS0) s pomočjo rekombinantne DNK tehnologije.
English: It is available in packs of: - 1 vial of 19 mL - 2 vials of 19 mL - 1 vial of 50 mL
Slovenian: Na voljo je v pakiranju z: - 1 vialo z 19 ml - 2 vialama z 19 ml - 1 vialo s 50 ml
English: In order to further confirm the efficacy and safety of olaratumab in the treatment of patients with advanced soft tissue sarcoma, the MAH should submit the clinical study report of the phase III study JGDJ comparing doxorubicin plus olaratumab versus doxorubicin in patients with advanced or metastatic STS (including exploratory biomarker data).
Slovenian: Za nadaljnjo potrditev učinkovitosti in varnosti olaratumaba pri zdravljenju bolnikov z napredovalim sarkomom mehkih tkiv mora imetnik dovoljenja za promet z zdravilom predložiti poročilo o klinični študiji za fazo III študije JGDJ o primerjavi kombinacije doksorubicina in olaratumaba z doksorubicinom pri bolnikih z napredovalim ali metastatskim sarkomom mehkih tkiv (vključno z raziskovalnimi podatki o biomarkerjih).
English: All patients receiving more than 4 cycles of doxorubicin received dexrazoxane.
Slovenian: Vsi bolniki, ki so prejeli več kot 4 cikle doksorubicina, so prejeli deksrazoksan.
English: Olaratumab is a targeted, recombinant, fully human immunoglobulin G subclass 1 (IgG1) monoclonal antibody that specifically binds PDGFR-α, blocking PDGF AA, -BB, and -CC binding and receptor activation.
Slovenian: Olaratumab je tarčno, rekombinantno, popolnoma humano monoklonsko protitelo, imunoglobulin G podrazreda 1 (IgG1), ki se specifično veže na PDGFR-α in s tem blokira vezavo PDGF AA, -BB, in -CC in aktivacijo receptorja.
English: The foetal effects in mice administered the surrogate antibody occurred at exposures less than the AUC exposure at the maximum recommended human dose of 15 mg/kg olaratumab.
Slovenian: Vpliv na plod pri miših, ki so prejele nadomestno protitelo, je bil opažen pri izpostavljenosti, ki je bila manjša kot izpostavljenost (AUC) ob največjem priporočenem odmerku za človeka, ki znaša 15 mg/kg olaratumaba.
English: Very Common Common
Slovenian: Skupna pogostnost
English: The median age was 58 years with 42 patients ≥ 65 years of age.
Slovenian: Mediana starost je znašala 58 let, od tega je bilo 42 bolnikov starih 65 let ali več, 86,4 % bolnikov je bilo belcev.
English: Administer via an infusion pump.
Slovenian: Aplicirajte z infuzijsko črpalko.
English: A total of 133 patients were randomised, of whom 129 received at least one dose of study treatment (64 in the olaratumab plus doxorubicin arm and 65 in the doxorubicin arm).
Slovenian: Randomiziranih je bilo 133 bolnikov, od tega jih je 129 prejelo vsaj en odmerek preiskovanega zdravljenja (64 v skupini, zdravljeni s kombinacijo olaratumaba in doksorubicina, in 65 v skupini, zdravljeni samo z doksorubicinom).
English: The median cumulative dose of doxorubicin was 487.6 mg/m2 in the olaratumab plus doxorubicin arm and 299.6 mg/m2 in the doxorubicin alone arm.
Slovenian: Mediani kumulativni odmerek doksorubicina je znašal 487,6 mg/m2 pri skupini, zdravljeni s kombinacijo olaratumaba in doksorubicina, in 299,6 mg/m2 v skupini, ki je bila zdravljena le z doksorubicinom.
English: During each infusion, your doctor or nurse will check for side effects.
Slovenian: Med vsako infuzijo bosta zdravnik ali medicinska sestra spremljala prisotnost neželenih učinkov.
English: The medicinal product should not be administered or mixed with dextrose containing solutions.
Slovenian: Zdravila ne smemo dajati ali mešati z raztopinami, ki vsebujejo dekstrozo.
English: There are no or limited amount of data from the use of olaratumab in pregnant women.
Slovenian: O uporabi olaratumaba pri nosečnicah podatkov ni ali jih je malo.
English: Difference in objective response rate [complete response (CR) + partial response (PR)] according to investigator assessment was not statistically significant (18.2 % vs 11.9 % in patients randomised to olaratumab plus doxorubicin compared to patients randomized to doxorubicin respectively).
Slovenian: Razlika v objektivni stopnji odziva [popoln odziv (CR, complete response) + delni odziv (PR, partial response)] po oceni preiskovalca ni bila statistično značilna (18,2 % pri bolnikih, randomiziranih na olaratumab in doksorubicin, in 11,9 % pri bolnikih, randomiziranih na doksorubicin).
English: In the event that intravenous administration of an H1 antagonist is not possible, equivalent alternative premedication should be given (e.g. oral diphenhydramine hydrochloride at least 90 minutes prior to the infusion).
Slovenian: Če intravenske aplikacije antagonista H1 ni mogoče izvesti, je treba aplicirati ekvivalentno drugo premedikacijo (npr. difenhidraminijev klorid peroralno vsaj 90 minut pred infuzijo).
English: Patients were required to have histologically or cytologically confirmed, advanced soft tissue sarcoma and ECOG performance status of 0-2.
Slovenian: Bolniki so morali imeti histološko ali citološko dokazan napredovali sarkom mehkih tkiv in status zmogljivosti po lestvici ECOG od 0 do 2.
English: For dose adjustment recommendations related to doxorubicin, refer to the current doxorubicin prescribing information.
Slovenian: Za priporočila o prilagajanju odmerka v zvezi z doksorubicinom glejte trenutne informacije o predpisovanju doksorubicina.
English: Patients were randomised in a 1:1 ratio to either olaratumab (15 mg/kg) on Day 1 and Day 8 plus doxorubicin (75 mg/m²) on Day 1 of each 21-day cycle for up to 8 cycles or doxorubicin (75 mg/m2) alone on Day 1 of each 21-day cycle, also for up to 8 cycles.
Slovenian: Bolniki so bili v razmerju 1 : 1 randomizirani na olaratumab (15 mg/kg) 1. in 8. dan in doksorubicin (75 mg/m²) 1. dan vsakega 21-dnevnega cikla za največ 8 ciklov ali pa samo na doksorubicin 1. dan vsakega 21-dnevnega cikla, prav tako za največ 8 ciklov.
English: This should be taken into consideration if you are on a controlled sodium diet.
Slovenian: To je treba upoštevati, če imate dieto z omejenim vnosom natrija.
English: Symptoms of IRRs included flushing, shortness of breath, bronchospasm, or fever/chills, and in some cases manifested as severe hypotension, anaphylactic shock, or fatal cardiac arrest.
Slovenian: Simptomi IRR so vključevali rdečico, pomanjkanje sape, bronhospazem, vročino/mrzlico in v nekaterih primerih hudo hipotenzijo, anafilaktični šok ali smrtni srčni zastoj.
English: The risk of toxicity rises with increasing cumulative doses and is higher in individuals with a history of cardiomyopathy, mediastinal irradiation or pre-existing cardiac disease.
Slovenian: Tveganje za toksičnost se povečuje z rastjo kumulativnega odmerka in je večje pri osebah, ki imajo v anamnezi kardiomiopatijo, obsevanje mediastinuma ali obstoječo srčno bolezen.
English: For management and dose adjustments in patients who experience Grade 1 or 2 IRR during the infusion, see section 4.2.
Slovenian: Za vodenje bolnikov in prilagoditev odmerjanja pri bolnikih, pri katerih se ob dajanju pojavijo IRR stopnje 1 ali 2, glejte poglavje 4.2.
English: Concentrate for solution for infusion 190 mg/19 mL
Slovenian: koncentrat za raztopino za infundiranje 190 mg/19 ml
English: Your doctor will give you other medicines before you receive Lartruvo to reduce the risk of infusionrelated reactions.
Slovenian: Pred prejemanjem zdravila Lartruvo boste prejeli zdravila za zmanjšanje tveganja reakcije, povezane z infuzijo.
English: Reproductive and development toxicity study conducted with an anti-murine PDGFRα antibody in mice showed foetal malformations and skeletal alterations (see section 5.3).
Slovenian: Študija razmnoževalne in razvojne toksičnosti olaratumaba, ki je bila izvedena pri miših s protitelesom proti mišjemu PDGFR-α, je pokazala fetalne malformacije in spremembe skeleta (glejte poglavje 5.3).
English: Do not shake the vial.
Slovenian: Viale ne pretresajte.
English: Olaratumab and doxorubicin were administered by intravenous infusion.
Slovenian: Olaratumab in doksorubicin sta bila aplicirana z intravensko infuzijo.
English: In a study of olaratumab in combination with liposomal doxorubicin, there was one case of fatal intracranial haemorrhage in a patient who had experienced a fall while on treatment.
Slovenian: V študiji olaratumaba v kombinaciji z liposomskim doksorubicinom je v enem primeru prišlo do smrtne intrakranialne krvavitve pri bolniku, ki je med zdravljenjem padel.
English: There are no data in patients with severe hepatic impairment (see section 5.2).
Slovenian: O uporabi zdravila pri bolnikih s hudo jetrno okvaro ni podatkov (glejte poglavje 5.2).
English: It is not known whether olaratumab is excreted in human milk.
Slovenian: Ni znano, ali se olaratumab izloča v materino mleko.
English: Demographics and baseline characteristics were quite similar between treatment arms in the phase 2 portion of the clinical trial.
Slovenian: Izhodiščni in demografski podatki so bili v fazi 2 kliničnega preskušanja dokaj podobni v obeh skupinah.
English: The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsaj vsako leto ponovno pregledala nove podatke o tem zdravilu.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNE
English: Concentrate for solution for infusion 500 mg/50 mL
Slovenian: koncentrat za raztopino za infundiranje 500 mg/50 ml
English: PDGFR-α is found in large amounts on some cancer cells where it stimulates the cells to grow and divide.
Slovenian: PDGFR-α je v velikih količinah prisoten na nekaterih rakastih celicah in jih spodbuja k rasti in delitvi.
English: Key secondary efficacy outcome measures were overall survival (OS) and objective response rate (ORR) (see Table 3).
Slovenian: progression free survival) po oceni preiskovalca, ključni sekundarni merili učinkovitosti pa sta bila celokupno preživetje (OS, overall survival) in objektivna stopnja odziva (ORR, objective response rate) (glejte preglednico 3).
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: Olaratumab may have minor influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Olaratumab ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
English: In the phase 2 trial, patients in both treatment groups that received 5 or more cycles of doxorubicin received dexrazoxane prior to each dose of doxorubicin from cycle 5 onwards to minimize the risk of doxorubicin-related cardiotoxicity (see sections 4.8 and 5.1).
Slovenian: V preskušanju 2. faze so tisti bolniki iz obeh zdravljenih skupin, ki so prejeli 5 ali več ciklov doksorubicina, od petega cikla dalje pred vsakim odmerkom doksorubicina prejeli deksrazoksan za zmanjšanje tveganja kardiotoksičnih učinkov doksorubicina (glejte poglavji 4.8 in 5.1).
English: Before starting treatment you must tell your doctor if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Randomisation was stratified by PDGFR-α expression (positive versus negative), number of previous lines of treatment (0 versus 1 or more lines), histological tumour type (leiomyosarcoma, synovial sarcoma, and others) and ECOG performance status (0 or 1 versus 2).
Slovenian: Randomizacija je bila stratificirana glede na izražanje PDGFR-α (pozitivno ali negativno), število predhodnih linij zdravljenja (0 ali 1 in več linij), histološko vrsto tumorja (leiomiosarkom, sinovijski sarkom ali druge vrste) in status zmogljivosti po lestvici ECOG (0 ali 1 in 2).
English: In case of recurrence of a Grade 4 toxicity, treatment with olaratumab should be permanently discontinued.
Slovenian: Če se kljub zmanjšanju odmerka ponovno pojavi toksičnost stopnje 4, je treba zdravljenje z olaratumabom trajno ukiniti.
English: The dose and volume of olaratumab needed should be calculated to prepare the infusion solution.
Slovenian: Izračunati je treba odmerek in prostornino olaratumaba, ki ju potrebujete za pripravo raztopine za infuzijo.
English: The rate of treatment-emergent cardiac dysfunction was comparable between the two treatment arms (7.8 % in the Investigational Arm and 6.2 % in the Control Arm).
Slovenian: Pogostnost z zdravljenjem povezane srčne disfunkcije je bila primerljiva pri obeh zdravljenih skupinah (7,8 % pri preiskovani skupini in 6,2 % pri kontrolni skupini).
English: Soft tissue sarcoma is a cancer that starts in the soft tissues, such as the muscles, fat, cartilage and blood vessels.
Slovenian: Sarkom mehkih tkiv je rak, ki se začne v mehkih tkivih, kot so mišičje, maščevje, hrustanec in krvne žile.
English: The recommended dose of olaratumab is 15 mg/kg administered by intravenous infusion on days 1 and 8 of each 3 week cycle until disease progression or unacceptable toxicity.
Slovenian: Priporočeni odmerek olaratumaba je 15 mg/kg z intravensko infuzijo 1. in 8. dan vsakega 3tedenskega cikla, dokler ne pride do napredovanja bolezni ali nesprejemljive toksičnosti.
English: If neutropenic fever/infection or Grade 4 neutropenia lasting longer than 1 week recurs despite dose reduction, the dose should be reduced further to 10 mg/kg.
Slovenian: Če se nevtropenična vročina/okužba ali nevtropenija stopnje 4, ki traja dlje kot 1 teden, ponovi kljub zmanjšanju odmerka, je treba odmerek dodatno zmanjšati na 10 mg/kg.
English: Conversely, olaratumab is not anticipated to affect the pharmacokinetics of co-administered medicinal products.
Slovenian: Obratno tudi ni pričakovati, da bi olaratumab vplival na farmakokinetiko sočasno danih zdravil.
English: 33 ImClone Drive
Slovenian: ImClone Systems LLC 33 ImClone Drive Branchburg
English: On the basis of the scientific conclusions for olaratumab the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing olaratumab is unchanged subject to the proposed changes to the product information.
Slovenian: Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov za olaratumab odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(a), ki vsebuje(jo) olaratumab, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: • Paracetamol, H1 antagonist and dexamethasone should be administered as needed (see premedication section)
Slovenian: • Po potrebi aplicirajte paracetamol, antagonist H1 in deksametazon (glejte poglavje o premedikaciji).
English: The number of patients receiving post-study systemic therapy was similar between arms.
Slovenian: Število bolnikov, zdravljenih tudi po opravljeni študiji, je bilo pri obeh skupinah podobno.
English: For subsequent infusions, the dose should be reduced to 12 mg/kg for serious Grade 3 toxicities and to 10 mg/kg for Grade 4 toxicities.
Slovenian: Pri nadaljnjih infuzijah je treba odmerek zmanjšati na 12 mg/kg pri resnih toksičnostih stopnje 3 in na
English: Your doctor or nurse will check for side effects during and after your infusion.
Slovenian: Zdravnik ali medicinska sestra bosta med infuzijo in po njej preverjala prisotnost neželenih učinkov.
English: Based on a PopPK analysis, no clinically meaningful differences in the clearance of olaratumab were observed in patients with mild (calculated creatinine clearance [CLcr] 60-89 mL/min, n = 43), or moderate (CLcr 30-59 mL/min, n = 15) renal impairment compared to patients with normal renal function (CLcr ≥90 mL/min, n = 85).
Slovenian: Analiza PopPK ni pokazala klinično pomembnih razlik med bolniki z blago (izračunani očistek kreatinina (CLcr 60-89 ml/min, n = 43) ali zmerno (CLcr 30-59 ml/min, n = 15) okvaro ledvic in bolniki z normalnim delovanjem ledvic (CLcr ≥ 90 ml/min, n = 85).
English: Administration of an anti-murine PDGFR- α surrogate antibody to pregnant mice during organogenesis at 50 and 150 mg/kg resulted in increased malformations (abnormal eyelid development) and skeletal alterations (frontal/parietal additional ossification site).
Slovenian: Aplikacija nadomestnega protitelesa proti mišjemu PDGFR-α brejim mišim v času organogeneze v odmerkih 50 in 150 mg/kg je povzročila povečanje števila malformacij (anomalen razvoj vek) in skeletnih sprememb (dodatno frontalno/parietalno mesto zakostenevanja).
English: The frequency of anaphylactic reactions/anaphylactic shock is already calculated as part of grade 3-4 infusion-related reactions in the table of Adverse Drug Reactions (ADRs) in the same section of the SmPC.
Slovenian: Pogostnost anafilaktičnih reakcij/anafilaktičnega šoka je že izračunana v okviru reakcij stopenj 3-4, povezanih z infuzijo, v preglednici neželenih reakcij v istem poglavju povzetka glavnih značilnosti zdravila.