natgillin/translations-raw huggingface dataset:
Olaratumab recognises and attaches specifically to a protein known as platelet-derived growth factor receptor-α (PDGFR-α).
Olaratumab prepozna in se specifično veže na beljakovino, znano kot receptor-α za trombocitni rastni dejavnik (PDGFR-α, platelet-derived growth factor receptor-α).
For serious Grade ≥ 3 non-haematologic toxicity deemed related to olaratumab, the dose of olaratumab should be withheld until toxicity is ≤ Grade 1 or has returned to pretreatment baseline.
Pri resni nehematološki toksičnosti stopnje ≥ 3, povezani z olaratumabom, je treba naslednji odmerek olaratumaba odložiti, dokler se toksičnost ne vrne na stopnjo ≤ 1 ali na vrednost pred zdravljenjem.
Absorption Olaratumab is administered as an intravenous infusion only.
Absorpcija Olaratumab se daje samo v obliki intravenske infuzije.
Polysorbate 20 (E432)
L-histidin polisorbat 20 (E432) voda za injekcije
For patients who experience Grade 1 or 2 IRR, the infusion should be interrupted and paracetamol, H1 antagonist and dexamethasone (or equivalent medicinal products) administered as needed.
Pri bolnikih, pri katerih pride do pojava IRR stopnje 1 ali 2, je treba infuzijo prekiniti in po potrebi aplicirati paracetamol, antagonist H1 in deksametazon (ali ekvivalentna zdravila).
The infusion solution should be prepared using aseptic technique to ensure the sterility of the prepared solution.
Pri pripravljanju infuzijske raztopine je treba uporabljati aseptične tehnike, da se zagotovi sterilnost pripravljene raztopine.
Neutrophil count should be monitored during the treatment with olaratumab and doxorubicin and supportive care should be administered such as antibiotics or G-CSF as per local guidelines.
Med zdravljenjem z olaratumabom in doksorubicinom je potrebno spremljati število nevtrofilcev in v skladu z lokalnimi smernicami zagotoviti podporno oskrbo, kot so antibiotiki ali G-CSF.
If you have an infusion-related reaction during treatment, your doctor or nurse may slow down or stop your Lartruvo infusion.
Če bi se med zdravljenjem pojavila reakcija, povezana z infuzijo, bosta zdravnik ali sestra infuzijo zdravila Latruvo upočasnila ali ustavila.
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1143/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1143/001
Taking into account the PRAC Assessment Report on the PSUR(s) for olaratumab, the scientific conclusions of CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za olaratumab je odbor CHMP sprejel naslednje znanstvene zaključke:
- The other ingredients are mannitol, glycine, L-histidine monohydrochloride monohydrate, L-histidine, sodium chloride (see section 2 “Lartruvo contains sodium”), polysorbate 20 and water for injections.
− Druge sestavine zdravila so manitol, glicin, L-histidinijev klorid monohidrat, L-histidin, natrijev klorid (glejte poglavje 2 »Zdravilo Lartruvo vsebuje natrij«), polisorbat 20 in voda za injekcije.
The rates of discontinuation were comparable between treatment arms across all age groups.
Delež ukinitve zdravljenja je bil pri obeh zdravljenih skupinah in pri vseh starostnih skupinah podoben.
Lartruvo contains sodium
Zdravilo Lartruvo vsebuje natrij
Other medicines and Lartruvo Tell your doctor if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Each 19mL vial contains approximately 22 mg (1 mmol) sodium.
Ena 19-ml viala vsebuje približno 22 mg (1 mmol) natrija.
Lartruvo is used in combination with another anti-cancer medicine called doxorubicin for the treatment of adults with advanced soft tissue sarcoma who have not been previously treated with doxorubicin.
Zdravilo Lartruvo se v kombinaciji s še enim zdravilom proti raku, imenovanim doksorubicin, uporablja za zdravljenje odraslih z napredovalo obliko sarkoma mehkih tkiv, ki z doksorubicinom predhodno še niso bili zdravljeni.
If you have a severe infusion-related reaction, your doctor may recommend reducing the dose of Lartruvo or stop your treatment with Lartruvo.
Pri hudi reakciji, povezani z infuzijo, bo zdravnik morda predlagal zmanjšanje odmerka zdravila Lartruvo ali prekinitev zdravljenja z njim.
More than 25 different soft tissue sarcoma subtypes were represented in this trial, the most frequent being leiomyosarcoma (38.4 %), undifferentiated pleomorphic sarcoma (18.1 %) and liposarcoma (17.3 %).
V klinično preskušanje je bilo vključenih več kot 25 podvrst sarkoma mehkih tkiv, od tega so bili najpogostejši leiomiosarkom (38,4 %), neopredeljeni pleomorfni sarkom (18,1 %) in liposarkom (17,3 %).
Based on a PopPK analysis, no clinically meaningful differences in the clearance of olaratumab were observed in patients with mild (total bilirubin within upper limit of normal [ULN] and AST>ULN, or total bilirubin > 1.0-1.5 times ULN and any AST level, n = 16), or moderate (total bilirubin > 1.5-3.0 times ULN, n = 1) hepatic impairment compared to patients with normal hepatic function (total bilirubin and AST ≤ ULN, n = 126).
Analiza PopPK ni pokazala klinično pomembnih razlik med bolniki z blago (skupni bilirubin pod zgornjo mejo normale [ULN] in AST > ULN ali skupni bilirubin > 1,0-1,5-krat ULN in katera koli raven AST, n = 16) ali zmerno (skupni bilirubin > 1,5-3,0-krat ULN, n = 1) okvaro jeter in bolniki z normalnim delovanjem jeter (skupni bilirubin in AST ≤ ULN, n = 126).
Infusion-related reactions (IRRs) Recommendations for the management of olaratumab IRRs are provided in table 1.
Reakcije, povezane z infuzijo (IRR, infusion-related reactions) Priporočila za ukrepanje ob pojavu z olaratumabom povezanih IRR so navedena v preglednici 1.
The primary efficacy outcome measure was progression free survival (PFS) by investigator assessment.
Osnovno merilo učinkovitosti je bilo preživetje brez napredovanja bolezni (PFS,
Premedication with an H1 antagonist (e.g., diphenhydramine) and dexamethasone (or equivalent medicinal products) should be given, intravenously, 30-60 minutes prior to the olaratumab doses on days 1 and 8 of cycle 1 in all patients.
Potrebna je intravenska premedikacija z antagonistom H1 (npr. difenhidraminom) in deksametazonom (ali ekvivalentnimi zdravili) od 30 do 60 minut pred odmerkom olaratumaba, 1. in 8. dan prvega cikla pri vseh bolnikih.
Known toxicities reported for doxorubicin, observed in the combination of olaratumab and doxorubicin include fatigue, anaemia, thrombocytopenia and alopecia.
Znani toksični učinki doksorubicina, o katerih so poročali pri uporabi kombinacije olaratumaba in doksorubicina, vključujejo utrujenost, anemijo, trombocitopenijo in alopecijo.
If you experience significant bleeding, symptoms may include extreme tiredness, weakness, dizziness or changes in the colour of your stools.
Simptomi, ki bi se lahko pojavili, če bi močno krvaveli, so skrajna utrujenost, oslabelost, omotica ali sprememba barve blata.
No other formal DDI studies with olaratumab and medicinal products commonly used in cancer patients, including those with STS (e.g. antiemetics, analgesics, anti-diarrheal drugs, oral contraceptives, etc.), have been performed.
Druge formalne študije medsebojnega delovanja olaratumaba in zdravil, ki se pogosto uporabljajo pri bolnikih z rakom, vključno s sarkomom mehkih tkiv (npr. antiemetiki, analgetiki, antidiaroiki, peroralni kontraceptivi idr.
This medicine is for single use only.
Zdravilo je namenjeno za enkratno uporabo.
Marketing Authorisation Holder Eli Lilly Nederland B.V.
Imetnik dovoljenja za promet z zdravilom Eli Lilly Nederland B.V.
There are very limited data regarding olaratumab administration in patients with moderate hepatic impairment.
Podatki o uporabi olaratumaba pri bolnikih z zmerno jetrno okvaro so zelo omejeni.
A low white blood cell count may increase your risk for infection.
Njihovo nizko število lahko poveča tveganje za okužbe.
Patients should be monitored during the infusion for signs and symptoms of infusion-related reactions (IRRs) in a setting with available resuscitation equipment (see section 4.4).
Zaradi možnosti pojava znakov in simptomov reakcij, povezanih z infuzijo, je treba bolnike med infuzijo spremljati v prostorih, kjer je na voljo oprema za oživljanje (glejte poglavje 4.4).
Each 50 mL vial contains approximately 57 mg (2.5 mmol) sodium.
Ena 50-ml viala vsebuje približno 57 mg (2,5 mmol) natrija.
Excipients: mannitol, glycine, sodium chloride, L-histidine monohydrochloride monohydrate, L-histidine, polysorbate 20 and water for injections.
Pomožne snovi: manitol, glicin, natrijev klorid, L-histidinijev klorid monohidrat, L-histidin, polisorbat 20 in voda za injekcije.
Fertility There are no data on the effect of olaratumab on human fertility.
Podatkov o vplivu olaratumaba na plodnost pri človeku ni.
Lartruvo is indicated in combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin (see section 5.1).
Zdravilo Lartruvo je indicirano v kombinaciji z doksorubicinom pri odraslih bolnikih z napredovalim sarkomom mehkih tkiv, ki jih ni mogoče učinkovito zdraviti z operacijo ali radioterapijo in ki z doksorubicinom še niso bili zdravljeni (glejte poglavje 5.1).
Patients receiving olaratumab and doxorubicin are at risk of neutropenia (see section 4.8).
Bolnike, ki prejemajo olaratumab in doksorubicin, ogroža nevtropenija (glejte poglavje 4.8).
This medicine contains 22 mg sodium in each 19 mL vial and 57 mg sodium in each 50 mL vial.
To zdravilo vsebuje 22 mg natrija na eno 19-ml vialo in 57 mg natrija na eno 50-ml vialo.
Lartruvo has been administered in a Phase 1 study up to 20 mg/kg on days 1 and 8 of a 21 day cycle without reaching a maximum tolerated dose.
V študiji faze 1 je bilo zdravilo Lartruvo v 21-dnevnem ciklu aplicirano 1. in 8. dan v odmerku do 20 mg/kg, ne da bi bil dosežen največji tolerirani odmerek.
The efficacy and safety of olaratumab was assessed in a Phase 1b/2, multi-centre study in anthracycline naïve patients with histologically or cytologically confirmed, advanced soft tissue sarcoma not amenable to receive surgery or radiotherapy with curative intent.
Klinična učinkovitost in varnost Učinkovitost in varnost olaratumaba sta bili ocenjeni v multicentričnem kliničnem preskušanju faze 1b/2 z bolniki, ki še niso prejemali antraciklinov, pri katerih je bil histološko ali citološko dokazan napredovali sarkom mehkih tkiv, ki ga ni bilo mogoče zdraviti z operacijo ali obsevanjem.
If particulate matter or discolouration is identified, the vial must be discarded.
Če so opazni vidni delci ali obarvanje, je treba vialo zavreči.
What Lartruvo looks like and contents of the pack Lartruvo concentrate for solution for infusion (sterile concentrate) is a clear to slightly opalescent and colourless to slightly yellow liquid supplied in a glass vial with an elastomeric stopper.
Izgled zdravila Lartruvo in vsebina pakiranja Zdravilo Lartruvo - koncentrat za raztopino za infundiranje (sterilen koncentrat) - je prozorna do rahlo opalescentna in brezbarvna do nekoliko rumenkasta raztopina brez vidnih delcev v viali z elastomernimzamaškom.
Patients should be monitored during the infusion for signs and symptoms of IRRs in a setting with available resuscitation equipment.
Zaradi možnosti pojava znakov in simptomov IRR je treba bolnike med infuzijo nadzorovati v prostorih, kjer je na voljo oprema za oživljanje.
Very Common Common a Refer to NCI CTCAE Criteria (Version 4.03) for each Grade of toxicity b Musculoskeletal pain includes arthralgia, back pain, bone pain, flank pain, groin pain,
Splošne težave in spremembe na mestu aplikacije zelo pogosti pogosti a Glejte merila NCI CTCAE (različica 4.03) za vsako stopnjo toksičnosti b Mišično-skeletna bolečina vključuje artralgijo, bolečine v hrbtu, kosteh, bokih, dimljah, mišično skeletno bolečino v prsnem košu, mišično-skeletno bolečino, mialgijo, mišične krče, bolečino v vratu in bolečino v okončini.
Based on cases of anaphylactic reaction and anaphylactic shock reported in the post-marketing setting, these adverse drug reactions should be specifically be mentioned under the category of infusion-related reactions in section 4.8 of the SmPC.
Na podlagi primerov anafilaktične reakcije in anafilaktičnega šoka, o katerih so poročali po pridobitvi dovoljenja za promet z zdravilom, je treba ti dve neželeni reakciji posebej navesti v kategoriji reakcij,
Lartruvo is given in combination with the medicine doxorubicin for up to 8 cycles and then it is given on its own.
Zdravilo Lartruvo se največ 8 ciklov daje v kombinaciji z doksorubicinom, nato pa samostojno.
Coagulation parameters should be monitored in patients with conditions predisposing to bleeding, such as anticoagulant use.
Pri bolnikih s stanji, ki povečujejo tveganje krvavitev, kot je npr. uporaba antikoagulantov, je treba spremljati koagulacijske parametre.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti pogosti
It is not known if Lartruvo will affect your ability to drive.
Vpliv zdravila Lartruvo na sposobnost vožnje ni znan.
Three Grade ≥3 events, including one fatal, have been reported across the clinical development programme of olaratumab (see section 4.4).
V času programa kliničnega razvoja olaratumaba so poročali o treh dogodkih stopnje ≥ 3 (glejte poglavje 4.4).
Symptoms may include back pain, chest pain and/or tightness, chills, fever, flushing, difficulty in breathing and wheezing.
Simptomi so lahko bolečina v hrbtu, bolečina in/ali tiščanje v prsnem košu, mrzlica,
In a dedicated DDI study, no pharmacokinetic interactions were observed in patients between olaratumab and doxorubicin.
V usmerjeni študiji medsebojnega delovanja zdravil farmakokinetične interakcije olaratumaba in doksorubicina pri bolnikih niso bile opažene.
- If you get any side effects, talk to your doctor.
− Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
In the phase 2 trial the incidence of Musculoskeletal pain was 64.1 % (all Grades) and 7.8 % (Grade 3) in the olaratumab plus doxorubicin arm and 24.6 % (all Grades) and 1.5 % (Grade 3) in the doxorubicin alone arm.
Pri preskušanju faze 2 je bila pogostnost mišično-skeletne bolečine 64,1 % (vse stopnje) in 7,8 % (stopnja 3) v skupini, zdravljeni z olaratumabom in doksorubicinom, ter 24,6 % (vse stopnje) in 1,5 % (stopnja 3) v skupini, zdravljeni samo z doksorubicinom.
After dilution in sodium chloride 9 mg/mL (0.9 %) solution for injection, olaratumab is administered as an intravenous infusion over approximately 60 minutes.
Po redčenju v 9 mg/ml (0,9 %) raztopini natrijevega klorida za injiciranje se olaratumab aplicira v obliki približno 60 minut trajajoče intravenske infuzije.
In the phase 2 trial, the incidence of neutropenia was 59.4 % (all Grades) and 54.7 % (Grade 3) in the olaratumab plus doxorubicin arm and 38.5 % (all Grades) and 33.8 % (Grade 3) in the doxorubicin alone arm.
Pri preskušanju faze 2 je bila incidenca nevtropenije 59,4 % (vse stopnje) in 54,7 % (stopnja 3) v skupini, zdravljeni s kombinacijo olaratumaba in doksorubicina, in 38,5 % (vse stopnje) in 33,8 % (stopnja 3) v skupini, zdravljeni samo z doksorubicinom.
During Cycles 5 to 8 on both arms, dexrazoxane (dosed at a ratio of 10:1 to the administered dose of doxorubicin) could be administered on Day 1 of each cycle at the investigator's discretion to reduce potential doxorubicin-related cardiotoxicity.
Pri obeh skupinah je med 5. in 8. ciklom preiskovalec lahko 1. dan vsakega izmed ciklov apliciral deksrazoksan (v razmerju 10 : 1 glede na aplicirani odmerek doksorubicina), da bi se zmanjšala možnost kardiotoksičnosti, povezane z doksorubicinom.
For dosage adjustments related to neutropenia, refer to section 4.2.
Za prilagajanje odmerka v zvezi z nevtropenijo glejte poglavje 4.2.
In the olaratumab plus doxorubicin arm, the most serious (Grade ≥3) adverse drug reactions (ADRs) observed were neutropenia (54.7 %) and musculoskeletal pain (7.8 %).
V skupini, zdravljeni s kombinacijo olaratumaba in doksorubicina, sta bila najresnejša neželena učinka (stopnja ≥ 3) pri bolnikih, zdravljenih z olaratumabom, nevtropenija (54,7 %) in mišično-skeletna bolečina (7,8 %).
Olaratumab should be immediately and permanently discontinued in patients who experience Grade 3 or 4 IRR (see sections 4.2 and 4.8).
Pri bolnikih, pri katerih pride do pojava IRR stopnje 3 ali 4, je treba dajanje olaratumaba takoj in trajno ukiniti (glejte poglavji 4.2 in 4.8).
Talk to your doctor or nurse immediately if the following applies to you (or you are not sure):
Če za vas velja (ali bi lahko veljalo) naslednje, se nemudoma pogovorite z zdravnikom ali medicinsko sestro: - Reakcije, povezane z infuzijo
There is no known antidote to Lartruvo overdose.
Znanega antidota ni.
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1143/002 - 1 vial of 19 mL.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1143/002 - 1 viala z 19 ml
To be taken into consideration by patients on a controlled sodium diet.
To je treba upoštevati pri bolnikih, ki imajo dieto z omejenim vnosom natrija.
Inspect the contents of the vials for particulate matter and discolouration.
Pred uporabo vsebino viale vizualno preglejte glede prisotnosti delcev in obarvanja.
For subsequent cycles, premedication with an H1 antagonist (e.g., diphenhydramine) should be given intravenously 30-60 minutes prior to each dose of olaratumab.
Pri vseh nadaljnjih ciklih je potrebna ponovna intravenska premedikacija z antagonistom H1 (npr. difenhidraminom) od 30 do 60 minut pred vsakim odmerkom olaratumaba.
The Phase 2 portion of the study was a randomised, open label study of olaratumab plus doxorubicin versus doxorubicin alone.
Faza 2 je bilo primerjalno randomizirano, odprto preskušanje za primerjavo kombinacije olaratumaba in doksorubicina ter doksorubicina samega.
For intravenous use after dilution.
Za intravensko uporabo po redčenju.
Sodium restricted diet
Dieta z omejitvijo vnosa natrija
E. 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 IN DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
Infusion-related reactions may occur during treatment with Lartruvo.
Med zdravljenjem z zdravilom Lartruvo lahko pride do reakcij, povezanih z infuzijo.
No clinically meaningful difference in doxorubicin-related cardiotoxicity was observed between the two treatment arms of the study.
Med obema zdravljenima skupinama študije ni bila opažena nobena klinično pomembna razlika v povezavi s kardiotoksičnostjo, povezano z doksorubicinom.
Lartruvo is administered in combination with doxorubicin for up to 8 cycles of treatment, followed by Lartruvo monotherapy in patients whose disease has not progressed.
Zdravilo Lartruvo se v kombinaciji z doksorubicinom uporablja v največ osmih ciklih zdravljenja, nato pa ga v monoterapiji uporabljajo le bolniki, pri katerih ni prišlo do napredovanja bolezni.
How to store Lartruvo
Shranjevanje zdravila Lartruvo
The concentrate is clear to slightly opalescent and colourless to slightly yellow solution without visible particles.
Koncentrat je prozorna do rahlo opalescentna, brezbarvna do nekoliko rumenkasta raztopina brez vidnih delcev.
In patients who have experienced a previous Grade 1 or 2 IRR, premedication with diphenhydramine hydrochloride (intravenously), paracetamol, and dexamethasone is recommended.
Pri bolnikih, pri katerih se je v preteklosti pojavila IRR stopnje 1 ali 2, se priporoča premedikacija z difenhidraminijevim kloridom (intravensko), paracetamolom in deksametazonom.
There are no data for the combination of olaratumab and doxorubicin in anthracycline pre-treated patients, including pre-treatment with doxorubicin (see section 4.1).
O uporabi kombinacije olaratumaba in doksorubicina pri bolnikih, ki so bili predhodno zdravljeni z antraciklini, ni podatkov (glejte poglavje 4.1).
Summary of survival data - ITT population Lartruvo plus doxorubicin (n = 66)
Zdravilo Lartruvo v kombinaciji z doksorubicinom (n = 66)
No animal studies have been performed to test olaratumab for potential of carcinogenicity, genotoxicity, or fertility impairment.
Za preskus karcinogenosti, genotoksičnosti in zmanjšane plodnosti zaradi uporabe olaratumaba ni bila izvedena nobena študija na živalih.
Anthracycline pre-treated patients
Bolniki, ki so bili predhodno zdravljeni z antraciklini
Kaplan-Meier curves of overall survival for Lartruvo plus doxorubicin versus doxorubicin alone
Kaplan-Meierjevi krivulji celokupnega preživetja skupine, zdravljene s kombinacijo zdravila Lartruvo in doksorubicina, in skupine, zdravljene samo z doksorubicinom
Vaccination with a live vaccine should be avoided in patients receiving olaratumab in combination with doxorubicin.
Pri bolnikih, ki prejemajo olaratumab v kombinaciji z doksorubicinom, se je treba izogibati cepljenju z živim cepivom.
Name and address of the manufacturer(s) responsible for batch release Lilly S.A.
Ime in naslov izdelovalca, odgovornega za sproščanje serij
There are no data regarding olaratumab administration in patients with severe renal impairment (calculated creatinine clearance < 30 mL/min) (see section 5.2).
O uporabi zdravila pri bolnikih s hudo ledvično okvaro (izračunani očistek kreatinina < 30 ml/min) (glejte poglavje 5.2) ni podatkov.
For all subsequent infusions, premedication with the following (or equivalent medicinal products) diphenhydramine hydrochloride (intravenously), paracetamol, and dexamethasone, should be given.
Pri vseh nadaljnjih infuzijah je potrebna premedikacija z difenhidraminijevim kloridom (intravensko), paracetamolom in deksametazonom (ali ekvivalentnimi zdravili).
19 mL solution in a vial (Type I glass) with a chlorobutyl elastomeric stopper, an aluminium seal and a polypropylene cap.
19 ml raztopine v viali (steklo vrste I) z zamaškom iz klorobutilnega elastomera, aluminijasto zaporko in polipropilenskim pokrovom.
50 mL solution in a vial (Type I glass) with a chlorobutyl elastomeric stopper, an aluminium seal and a polypropylene cap.
50 ml raztopine v viali (steklo vrste I) z zamaškom iz klorobutilnega elastomera, aluminijasto zaporko in polipropilenskim pokrovom.
How you are given Lartruvo
Kako boste prejemali zdravilo Lartruvo
Very Common None reported
Bolezni živčevja zelo pogosti ni bilo poročil
When olaratumab attaches to PDGFR-α it may prevent cancer cell growth and survival.
PDGFR-α, lahko prepreči rast in preživetje rakastih celic.
PopPK data suggest that no dose adjustments are required in patients with mild or moderate renal impairment.
Podatki PopPK kažejo, da odmerka pri bolnikih z blago do zmerno ledvično okvaro ni treba prilagajati.
In the phase 2 trial, the frequency of haemorrhagic events considered related to any study drug was 3.1 % in either treatment arm. All of these events were Grade 1/2 and were confounded by multiple factors.
Hemoragični dogodki Pri preskušanju faze 2 je bila pogostnost hemoragičnih dogodkov v povezavi s katerim koli zdravilom v obeh skupinah zdravljenja 3,1 %.
A statistically significant improvement in OS was seen in the olaratumab plus doxorubicin arm in comparison to treatment with doxorubicin alone in the overall population.
V celotni populaciji je bilo v skupini, ki je prejemala kombinacijo olaratumaba in doksorubicina, opaženo statistično značilno izboljšanje OS v primerjavi s skupino, ki je prejemala le doksorubicin.
In case of overdose, use supportive therapy.
Pri prevelikem odmerjanju zdravila Lartruvo uporabite podporno zdravljenje.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost za učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Reakcije, povezane z infuzijo