natgillin/translations-raw huggingface dataset:
Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, haemoptysis, arm or leg swelling or pain.
Bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če se jim pojavijo simptomi, kot so kratka sapa, bolečina v prsih, hemoptiza, otekanje roke ali noge ali bolečina.
If the diagnosis of TTP/HUS is excluded, Kyprolis can be restarted.
Če je diagnoza TTP/HUS izključena, se lahko zdravilo Kyprolis začne znova uporabljati.
Based on the number of relevant cases reported cumulatively, including 16 events with a fatal outcome during the reporting period, the existing warning on cardiac disorders should be updated to recommend that patients should be evaluated for cardiovascular risk factors before treatment with carfilzomib, that a comprehensive cardiological assessment should be considered for patients at high-risk for cardiovascular disease and that hypertension should be controlled during treatment, as a history of hypertension was frequently reported in patients presenting with cardiac disorders.
Glede na število skupnih poročanih relevantnih primerov, vključno s 16 dogodki s smrtnim izidom v obdobju poročanja, je treba obstoječe opozorilo o srčnih boleznih posodobiti s priporočilom, da je treba za bolnike pred zdravljenjem s karfilzomibom opraviti oceno dejavnikov tveganja za srce in ožilje, da je treba pri bolnikih z visoko stopnjo tveganja za bolezni srca in ožilja razmisliti o celoviti kardiološki oceni in da je treba med zdravljenjem nadzorovati hipertenzijo, ker so pri bolnikih z visoko stopnjo tveganja za srčne bolezni pogosto poročali o anamnezi hipertenzije.
Study PX-171-011 was an open-label randomised phase 3 study (N = 315; exposure to ≥ 3 prior therapies required).
Študija PX-171-011 je bila odprta randomizirana študija 3. faze (n = 315, zahtevana je bila izpostavljenost ≥ 3 predhodnim zdravljenjem).
Store refrigerated (2°C to 8°C).
Shranjujte v hladilniku (2 °C do 8 °C).
On the basis of the scientific conclusions for carfilzomib the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing carfilzomib is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za karfilzomib odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) karfilzomib, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Progressive Multifocal Leukoencephalopathy
Progresivna multifokalna levkoencefalopatija
An evaluation of possible effects of carfilzomib on cardiac function was performed by analysing, via central blind reading, triplicate ECG in 154 subjects with advanced malignancies, including multiple myeloma.
Oceno možnih učinkov karfilzomiba na srčno funkcijo so naredili z analiziranjem preko centralno slepega odčitavanja trojnih EKG pri 154 bolnikih z napredovanimi malignomi, vključno z diseaminiranim plazmocitomom.
The median OS improved by 7.9 months in patients in the KRd arm compared with those in the Rd arm (see Table 6 and Figure 2).
Mediana OS se je pri bolnikih v skupini s KRd izboljšala za 7,9 meseca v primerjavi z bolniki v skupini z Rd (glejte tabelo 6 in sliko 2).
The reconstituted solution contains carfilzomib at a concentration of 2 mg/mL.
Rekonstituirana raztopina vsebuje karfilzomib v koncentraciji 2 mg/ml.
In vitro, carfilzomib inhibits OATP1B1 with an IC50 = 2.01 µM whereas it is unknown whether carfilzomib may or not inhibit other transporters OATP1B3, OAT1, OAT3, OCT2 and BSEP, at the systemic level.
Karfilzomib in vitro zavira OATP1B1 z IC50 = 2,01 µM, medtem ko pa ni znano ali karfilzomib na sistemskem nivoju lahko ali ne more zavirati drugih prenašalcev OATP1B3, OAT1, OAT3, OCT2 in BSEP.
The systemic clearance ranged from 151 to 263 L/hour, and exceeded hepatic blood flow, suggesting that carfilzomib was largely cleared extrahepatically.
Sistemski očistek je bil od 151 do 263 l/uro in je presegal jetrni pretok krvi, kar kaže, da glavni del izločanja karfilzomiba poteka zunaj jeter.
• Absolute neutrophil count < 0.5 x 109/L and an oral temperature > 38.5°C or two consecutive readings of > 38.0°C for 2 hours
• Absolutno število nevtrofilcev < 0,5 x109/l in v ustih izmerjena temperatura > 38,5 °C ali dve zaporedni meritvi > 38,0 °C v 2 urah
Hepatitis B Virus (HBV) Reactivation
Ponovna aktivacija virusa hepatitisa B (HBV)
PML is known safety issue of bortezomib, which belongs to the same class as carfilzomib.
PML je znana varnostna pomanjkljivost bortezomiba, ki izhaja iz iste skupine kot karfilzomib.
The risk of cardiac failure is increased in elderly patients (≥ 75 years).
Tveganje za srčno popuščanje je večje pri starejših bolnikih (≥ 75 let).
The effect of carfilzomib on cardiac repolarisation using the QT interval with Fridericia's correction (QTcF interval) and the analysis of concentration-QTc relationships show no clear signal of any dose-related effect.
Učinek karfilzomiba na srčno repolarizacijo z uporabo intervala QT s korekcijo Fridericia (interval QTcF) in analizo ocen koncentracije-QTc ne kaže jasnega signala kakršnega koli učinka, odvisnega od odmerka.
• Changes to blood tests (decreased blood levels of potassium, increased blood levels of sugar and/or creatinine)
• spremembe preiskave krvi (znižanje koncentracij kalija v krvi, zvišanje koncentracij sladkorja in/ali kreatinina v krvi),
The pharmacokinetics of carfilzomib was studied in two dedicated renal impairment studies.
Farmakokinetiko karfilzomiba so raziskali v dveh namenskih študijah okvare ledvic.
Discard any unused portion left in the vial.
Morebitni neporabljeni ostanek v viali zavrzite.
No fertility studies have been performed in animals (see section 5.3).
Študij plodnosti na živalih niso izvedli (glejte poglavje 5.3).
If the diagnosis is suspected, stop Kyprolis and evaluate patients for possible TTP/HUS.
Če obstaja sum na to diagnozo, je treba uporabo zdravila Kyprolis prekiniti in bolnike ovrednotiti glede možnega TTP/HUS.
The metabolites have no known biologic activity.
Presnovki nimajo znane biološke aktivnosti.
There is biological plausibility for carfilzomib induced PML (lymphopenia and opportunistic infections are expected ADRs).
Obstaja biološka verjetnost, da karfilzomib inducira PML (limfopenija in oportunistične okužbe so pričakovani neželeni učinki zdravila).
While you are being treated with Kyprolis you may experience fatigue, dizziness, fainting, and/or a drop in blood pressure.
Medtem, ko se zdravite z zdravilom Kyprolis, se vam lahko pojavi utrujenost, omotica, omedlevica in/ali padec krvnega tlaka.
• Inflammation of the colon caused by a bacteria called Clostridium difficile
• vnetje debelega črevesa, ki ga povzroči bakterija Clostridium difficile,
OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksično
Carfilzomib does not inhibit CYP1A2, 2B6, 2C8, 2C9, 2C19 and 2D6 in vitro and is therefore not expected to influence exposure of medicinal products that are substrates of these enzymes as a result of inhibition.
Karfilzomib in vitro ne zavira CYP1A2, 2B6, 2C8, 2C9, 2C19 in 2D6, zato ni pričakovati, da bi preko njihovega zavrtja vplival na izpostavljenost zdravilom, ki so substrati teh encimov.
In line with the labelling and risk minimisation activities proposed by Segec et al, inclusion of a warning on PML in section 4.4 of the SmPC is warranted.
V skladu z dejavnostmi za označevanje in zmanjševanje tveganja, ki jih predlaga Segec in drugi, je treba zagotoviti vključitev opozorila glede PML v poglavje 4.4 povzetka glavnih značilnosti zdravila.
• Heart failure and heart problems including rapid, strong or irregular heartbeat
• srčno popuščanje in težave s srcem, vključno s hitrim, močnim ali nerednim bitjem srca,
In addition, due to an increased risk of venous thromboembolic events associated with carfilzomib, females should avoid the use of hormonal contraceptives that are associated with a risk of thrombosis during treatment with carfilzomib (see sections 4.4 and 4.8).
Poleg tega ženske zaradi večjega tveganja za venske tromboembolične dogodke, ki so povezani z uporabo karfilzomiba, med zdravljenjem s karfilzomibom ne smejo uporabljati hormonskih kontraceptivov, ki so povezani z večjim tveganjem za trombozo (glejte poglavji 4.4 in 4.8).
The pharmacokinetics of Kyprolis has not been evaluated in patients with severe hepatic impairment.
Farmakokinetike zdravila Kyprolis niso ocenili pri bolnikih s hudo okvaro jeter.
Kyprolis has minor influence on the ability to drive and use machines.
Zdravilo Kyprolis ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
If a patient is currently using oral contraceptives or a hormonal method of contraception that is associated with a risk of thrombosis, the patient should switch to an alternative method of effective contraception.
Če bolnica trenutno uporablja peroralne kontraceptive ali kakšno hormonsko kontracepcijo, povezano z večjim tveganjem za trombozo, mora preiti na nek drug učinkovit način kontracepcije.
The safety and efficacy of Kyprolis in paediatric patients have not been established.
Varnost in učinkovitost zdravila Kyprolis pri pediatričnih bolnikih še nista bili dokazani.
If foaming occurs, allow the solution to settle in the vial until foaming subsides (approximately 5 minutes) and the solution is clear.
Če se pojavi penjenje, pustite raztopino, da se v viali umiri, dokler penjenje ne izgine (približno 5 minut) in je raztopina bistra.
There are limited efficacy and safety data on patients with baseline creatinine clearance < 30 mL/min.
Podatki o učinkovitosti in varnosti pri bolnikih z izhodiščnim očistkom kreatinina < 30 ml/min so omejeni.
There have been cases of QT interval prolongation reported in clinical studies.
V kliničnih študijah so poročali o primerih podaljšanja intervala QT.
Kyprolis can cause elevations of serum transaminases (see section 4.8).
Zdravilo Kyprolis lahko povzroči zvišanje serumskih transaminaz (glejte poglavje 4.8).
Multiple myeloma is a cancer of plasma cells (a type of white blood cell).
Diseminirani plazmocitom je rak celic plazmatk (plazmatke so vrsta belih krvnih celic).
Carfilzomib is a P-glycoprotein (P-gp) but not a BCRP substrate.
Karfilzomib je substrat P-glikoproteina (P-gp), ne pa tudi substrat BCRP.
• Febrile neutropenia
• Febrilna nevtropenija
Patients enrolled to study PX-171-011 were more heavily pre-treated with lower organ and marrow function as compared to those enrolled in study PX-171-009.
Bolniki v študiji PX-171-011 so bili predhodno intenzivneje zdravljeni in so imeli slabše delovanje organov in kostnega mozga kot bolniki v študiji PX-171-009.
Lenalidomide is structurally related to thalidomide.
Lenalidomid je strukturno podoben talidomidu.
Therefore, resumption of therapy should be discussed with experts in managing HBV.
Zato se je treba o nadaljevanju zdravljenja posvetovati s strokovnjaki za obvladovanje HBV.
Subjects had received 1 to 3 prior lines of therapy (median of 2), including prior treatment with bortezomib (66%), thalidomide (44%) and lenalidomide (20%).
Preiskovanci so predhodno dobivali od 1 do 3 linije zdravljenja (mediano 2), vključno s predhodnim zdravljenjem z bortezomibom (66 %), talidomidom (44 %) in lenalidomidom
Kyprolis should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus.
Zdravila Kyprolis se med nosečnostjo ne sme uporabljati, razen če možna korist odtehta možno tveganje za plod.
• All other grade 3 or 4 non-haematologic toxicities (see section 4.4)
• Vsi drugi nehematološki toksični učinki 3. ali 4. stopnje (glejte poglavje 4.4)
In the second study, the exposures for M14 were greater (approximately 4-fold) in subjects with ESRD than in subjects with normal renal function.
V drugi študiji so bile izpostavljenosti za M14 večje (približno 4-krat) pri osebah s končno ledvično odpovedjo ledvic, kot pri osebah z normalnim delovanjem ledvic.
Patients receiving carfilzomib should be monitored for any new or worsening neurologic, cognitive or behavioural signs and symptoms that may be suggestive of PML as part of the differential diagnosis of CNS disorders.
Pri bolnikih, ki prejemajo karfilzomib, je treba spremljati novonastale nevrološke, kognitivne ali vedenjske znake in simptome ali njihovo poslabšanje, kar bi lahko nakazovalo, da je PML del diferencialne diagnoze bolezni osrednjega živčnega sistema.
• Pain, swelling, irritation or discomfort where you received the injection into your vein
• bolečina, otekanje, draženje ali neudobje na mestu, kjer ste dobili injekcijo v veno,
This means that Kyprolis will be given to you on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle.
To pomeni, da boste zdravilo Kyprolis dobili 1. in 2., 8. in 9. ter 15. in 16. dan vsakega 28-dnevnega ciklusa.
Pharmacotherapeutic group: Antineoplastic agents, ATC code: L01XX45 Mechanism of action
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XX45
95% CI of ORR 1-sided p-valueb
95 % IZ za ORR 1-stranska p-vrednostb
Recommended hydration includes both oral fluids (30 mL/kg/day for 48 hours before day 1 of cycle 1) and intravenous fluids (250 mL to 500 mL of appropriate intravenous fluid before each dose in cycle 1).
Priporočena hidracija obsega pitje tekočin (30 ml/kg/dan 48 ur pred 1. dnem 1. ciklusa) in intravensko dajanje tekočin (od 250 ml do 500 ml primerne intravenske tekočine pred vsakim odmerkom v 1. ciklusu).
• Stop dose and continue monitoring renal function (serum creatinine or creatinine clearance) Kyprolis should be resumed when renal function has recovered to within 25% of baseline; consider resuming at 1 dose level reductiona
• Prekinite odmerek in nadaljujte s spremljanjem delovanja ledvic (kreatinin v serumu ali očistek kreatinina) Z zdravilom Kyprolis je treba nadaljevati, ko se delovanje ledvic vrne na znotraj 25 % od izhodiščnega; razmislite o ponovni uporabi z zmanjšanjem odmerka za 1 ravena
Intravenous carfilzomib administration resulted in suppression of proteasome chymotrypsin-like (CT-L) activity when measured in blood 1 hour after the first dose.
Intravensko uporabljeni karfilzomib je zavrl proteasomsko himotripsinu podobno (CT-L) aktivnost, merjeno v krvi 1 uro po prvem odmerku.
• Low red blood cell count (anaemia) which may cause tiredness and fatigue
• nizko število rdečih krvnih celic (anemija), ki lahko povzroči utrujenost in izčrpanost,
Caution should be observed when carfilzomib is combined with substrates of P-gp (e.g. digoxin, colchicine).
Previdnost je potrebna, če je karfilzomib uporabljen skupaj s substrati P-gp (npr. z digoksinom, kolhicinom).
• Blood clots in the veins (deep vein thrombosis)
• krvni strdki v venah (globoka venska tromboza),
At doses between 20 and 56 mg/m2, there was a dose-dependent increase in exposure.
V odmerkih od 20 do 56 mg/m2 je izpostavljenost naraščala odvisno od odmerka.
Following repeated doses of Kyprolis at 15 and 20 mg/m2, systemic exposure (AUC) and half-life were similar on days 1 and 15 or 16 of cycle 1, suggesting there was no systemic carfilzomib accumulation.
Po večkratnih odmerkih zdravila Kyprolis 15 in 20 mg/m2 sta bili sistemska izpostavljenost (AUC) in razpolovni čas 1. in 15. ali 16. dan 1. ciklusa podobna; to kaže, da ni sistemskega kopičenja karfilzomiba.
Each vial contains 10 mg, 30 mg or 60 mg of carfilzomib.
Ena viala vsebuje 10 mg, 30 mg ali 60 mg karfilzomiba.
At any time during or after your treatment, tell your doctor or nurse immediately if you: experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion.
Kadar koli med zdravljenjem ali po njem morate takoj povedati zdravniku ali medicinski sestri, če se vam pojavijo zamegljen vid, izguba vida ali dvojni vid, težave pri govoru, šibkost v roki ali nogi, sprememba načina hoje ali težave z ravnotežjem, trdovratna omrtvičenost, zmanjšano zaznavanje ali izguba zaznavanja, izguba spomina ali zmedenost.
All patients should be routinely evaluated for hypertension while on Kyprolis and treated as needed.
Vse bolnike je treba med zdravljenjem z zdravilom Kyprolis redno ocenjevati glede hipertenzije in jih zdraviti, kot je potrebno.
In vitro, carfilzomib was found to have minimal neurotoxicity and minimal reaction to non-proteasomal proteases.
In vitro je bil karfilzomib minimalno nevrotoksičen in je minimalno vplival na neproteasomske proteaze.
Patients randomised to the Vd arm could receive bortezomib either by the intravenous (n = 108) or subcutaneous (n = 357) route.
Bolniki, randomizirani v skupino Vd, so lahko dobivali bortezomib po intravenski (n = 108) ali subkutani (n = 357) poti.
Treatment with Kyprolis combined with lenalidomide and dexamethasone for longer than 18 cycles should be based on an individual benefit/risk assessment, as the data on the tolerability and toxicity of carfilzomib beyond 18 cycles are limited (see section 5.1).
Za več kot 18 ciklusov trajajoče zdravljenje z zdravilom Kyprolis v kombinaciji z lenalidomidom in deksametazonom se je treba odločiti na podlagi individualne ocene koristi in tveganj, ker so podatki o prenosljivosti in toksičnosti karfilzomiba po več kot 18 ciklusih omejeni (glejte poglavje 5.1).
However, it is unknown whether carfilzomib is an inducer of CYP1A2, 2C8, 2C9, 2C19 and 2B6 at therapeutic concentrations.
Ni pa znano, ali karfilzomib v terapevtski koncentraciji inducira CYP1A2, 2C8, 2C9, 2C19 in 2B6.
• Changes to blood tests (decreased blood levels of sodium, magnesium, protein, calcium or phosphate, increased blood levels of calcium, uric acid, potassium, bilirubin or c-reactive protein)
• spremembe preiskav krvi (znižanje koncentracij natrija, magnezija, beljakovin, kalcija ali fosfata v krvi, zvišanje koncentracij kalcija, sečne kisline, kalija, bilirubina ali C-reaktivnega proteina v krvi),
While taking Kyprolis and for 90 days after stopping treatment, you should use a condom even if your partner is pregnant.
Med zdravljenjem z zdravilom Kyprolis in še 90 dni po koncu zdravljenja morate uporabljati kondom, tudi če je vaša partnerka noseča.
Based on its mechanism of action and findings in animals, Kyprolis can cause foetal harm when administered to a pregnant woman.
Glede na mehanizem delovanja in izsledke pri živalih lahko zdravilo Kyprolis škoduje plodu, če je uporabljeno pri nosečnici.
While taking Kyprolis, and for 30 days after stopping treatment you should use a suitable method of contraception to ensure you do not become pregnant.
Med jemanjem zdravila Kyprolis in 30 dni po koncu zdravljenja z njim morate uporabljati ustrezno kontracepcijsko zaščito in tako poskrbeti, da ne zanosite.
This may impair your ability to drive or operate machines.
To lahko poslabša vašo sposobnost upravljanja vozil in strojev.
• Stop dose If recovered to ≥ 10 x 109/L and/or bleeding is controlled continue at same dose level
• Prekinite uporabo Če se število ponovno poveča na ≥ 10 x 109/l in/ali je krvavitev obvladana, nadaljujte z isto ravnjo odmerka
Kyprolis is used to treat adult patients with multiple myeloma who have had at least one previous treatment for this disease.
Zdravilo Kyprolis je namenjeno za zdravljenje odraslih bolnikov z diseminiranim plazmocitomom, ki so imeli vsaj eno predhodno zdravljenje te bolezni.
• Low white blood cell count, which may decrease your ability to fight infection and may be associated with fever
• nizko število belih krvnih celic, ki lahko zmanjša sposobnost za premagovanje okužb in ga lahko spremlja zvišana telesna temperatura,
The highest non-severely toxic dose of 0.5 mg/kg in monkeys resulted in interstitial inflammation in the kidney along with slight glomerulopathy and slight heart inflammation.
Največji odmerek, ki ni hudo toksičen, 0,5 mg/kg, je pri opicah povzročil intersticijsko vnetje v ledvici sočasno z rahlo glomerulopatijo in rahlim vnetjem v srcu.
In vitro studies indicated that carfilzomib did not induce human CYP3A4 in cultured human hepatocytes.
Študije in vitro kažejo, da karfilzomib v kulturah humanih hepatocitov ne inducira humanega CYP3A4.
• Absolute neutrophil count < 0.5 x 109/L (see section 4.4)
• Absolutno število nevtrofilcev < 0,5 x109/l (glejte poglavje 4.4)
It is not known if Kyprolis passes into breast milk in humans.
Ni znano, ali zdravilo Kyprolis pri človeku prehaja v materino mleko.
However, Kyprolis treatment may also be stopped if you experience side effects that cannot be managed.
Zdravljenje z zdravilom Kyprolis pa je mogoče tudi končati, če se pojavijo neobvladljivi neželeni učinki.
The overall incidence of venous thromboembolic events was higher in the Kyprolis arms of two phase 3 studies.
Celotna incidenca venskih tromboemboličnih dogodkov je bila v dveh študijah 3. faze večja v skupinah z zdravilom Kyprolis.
Proteasome inhibition was maintained for ≥ 48 hours following the first dose of carfilzomib for each week of dosing.
Zavrtje proteasomov se je po prvem odmerku karfilzomiba vsak teden odmerjanja ohranilo za ≥ 48 ur.
In vitro, at concentrations (3 µM) lower than those expected at therapeutic doses, carfilzomib inhibits the efflux transport of digoxin, a P-gp substrate, by 25%.
In vitro karfilzomib v koncentraciji (3 µM), ki je nižja od pričakovane ob terapevtskih odmerkih, za 25 % zavre iztočni prenos digoksina, ki je substrat P-gp.
Lenalidomide and dexamethasone are other medicines used to treat multiple myeloma.
Lenalidomid in deksametazon sta dve drugi zdravili, ki se uporabljata za zdravljenje diseminiranega plazmocitoma.
• Liver problems, including a history of hepatitis, fatty liver, or if you have ever been told your liver is not working properly
• Težave z jetri - če ste kdaj imeli hepatitis, zamaščena jetra ali so vam kdaj rekli, da vam jetra ne delujejo pravilno.
Lenalidomide is expected to be harmful to the unborn child. As Kyprolis is given in combination with lenalidomide, you must follow the Pregnancy Prevention Programme (see package leaflet for lenalidomide for information on pregnancy prevention and discuss with your doctor, pharmacist or nurse).
Zdravilo Kyprolis se uporablja v kombinaciji z lenalidomidom, zato morate ravnati v skladu s programom za preprečevanje nosečnosti (glejte navodilo za uporabo lenalidomida za informacije o preprečevanju nosečnosti ter se pogovorite z zdravnikom, farmacevtom ali z medicinsko sestro).
Thrombocytopenia was reported in approximately 34% of subjects in clinical studies with Kyprolis and approximately 20% of subjects had grade ≥ 3 events.
O trombocitopeniji so poročali pri približno 34 % bolnikov v kliničnih študijah z zdravilom Kyprolis in približno 20 % bolnikov je imelo dogodke ≥ 3. stopnje.
From cycle 13, the day 8 and 9 doses of Kyprolis are omitted.
Od 13. ciklusa dalje se odmerka zdravila Kyprolis 8. in 9. dan ne uporabljata več.
Carfilzomib caused embryo-foetal toxicity in pregnant rabbits at doses that were lower than in patients receiving the recommended dose.
Karfilzomib je imel embrio-fetalne toksične učinke pri brejih samicah kuncev v odmerkih, manjših od priporočeni odmerkov, ki so jih prejemali bolniki.
As Kyprolis is administered in combination with other medicinal products, refer to their summaries of product characteristics for additional contraindications.
Ker je zdravilo Kyprolis uporabljeno v kombinaciji z drugimi zdravili, glejte njihove povzetke glavnih značilnosti zdravila za dodatne kontraindikacije.
Those findings were reported at 6 mg/m2 which are below the recommended dose in humans of 27 mg/m2.
O teh ugotovitvah so poročali pri odmerkih 6 mg/m2, ki so pod priporočenim odmerkom pri človeku 27 mg/m2.
Ensure that patients are well hydrated before administration of Kyprolis in cycle 1, and in subsequent cycles as needed (see section 4.2).
Poskrbite, da bo bolnik pred uporabo zdravila Kyprolis v 1. ciklusu in nadaljnjih ciklusih dobro hidriran, kot je potrebno (glejte poglavje 4.2).
• Numbness, tingling, or decreased sensation in hands and/or feet
• omrtvičenost, mravljinčenje ali zmanjšano zaznavanje v dlaneh in/ali stopalih,