natgillin/translations-raw huggingface dataset:
Gemtuzumab is a humanised immunoglobulin class G subtype 4 (IgG4) antibody which specifically recognises human CD33.
Gemtuzumab je humanizirano protitelo, imunoglobulin razreda G podtipa 4 (IgG4), ki specifično prepoznava humani CD33.
The activity (cytotoxicity) of the resultant metabolites is expected to be significantly attenuated.
Aktivnost (citotoksičnost) nastalih presnovkov je pričakovano znatno oslabljena.
The overall safety profile of MYLOTARG is based on data from patients with acute myeloid leukaemia from the combination therapy study ALFA-0701, monotherapy studies, and from post-marketing experience.
Celoten varnostni profil zdravila MYLOTARG temelji na podatkih bolnikov z akutno mieloično levkemijo iz študije kombiniranega zdravljenja ALFA-0701, študijah monoterapije in izkušnjah v obdobju trženja zdravila.
• Following dilution with sodium chloride 9 mg/mL (0.9%) solution for injection, MYLOTARG solution should be infused immediately.
• Po redčenju z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje je treba raztopino zdravila MYLOTARG infundirati takoj.
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC05
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC05
4 studies; N per study (range) 12-84; 42.2%
4 študije; n na študijo (razpon) 12-84; 42,2 %
Do not mix MYLOTARG with, or administer as an infusion with, other medicinal products.
Zdravila MYLOTARG ne smete mešati ali ga dajati kot infuzijo z drugimi zdravili.
• Interstitial pneumonia (inflammation of the lungs causing coughing and difficulty breathing)
• intersticijska pljučnica (vnetje pljuč, ki povzroča kašelj in težko dihanje)
Effect of other medicinal products on gemtuzumab ozogamicin
Učinek drugih zdravil na gemtuzumab ozogamicin
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; SOS=sinusoidal obstruction syndrome; ULN=upper limit of normal; VOD=venoocclusive disease.
Okrajšave: ALT = alanin-aminotransferaza; AST = aspartat-aminotransferaza; SOS = sindrom obstrukcije sinusoidov; ZMN = zgornja meja normale; VOD = venookluzivna bolezen.
Probability (%) calculated by the product-limit method; CI calculated from the log log transformation of survival probability using a normal approximation and the Greenwood formula.
Verjetnost (%), izračunana po Kaplan-Meierjevi metodi; IZ, izračunan iz transformacije log-log verjetnosti preživetja z uporabo normalne aproksimacije in Greenwoodove formule.
Your doctor may do blood tests and find abnormalities in liver blood tests, which might be signs of a potentially life-threatening condition called venoocclusive liver disease.
Zdravnik bo morda opravil krvne preiskave, ki lahko pokažejo nenormalno delovanje jeter, kar so lahko znaki potencialno življenjsko ogrožajoče bolezni, ki se imenuje venookluzivna bolezen jeter.
5 studies; N per study (range) 12-30; 28.4%
5 študij; n na študijo (razpon) 12-30; 28,4 %
• Reduced number of blood platelets (cells that help blood to clot)
• zmanjšanje števila krvnih ploščic (celic, ki pomagajo pri strjevanju krvi)
In patients who experience VOD/SOS, MYLOTARG should be discontinued and patients treated according to standard medical practice.
Pri bolnikih, pri katerih pride do VOD/SOS, je treba zdravljenje z zdravilom MYLOTARG prekiniti in te bolnike zdraviti v skladu z običajno medicinsko prakso.
• The active substance is gemtuzumab ozogamicin.
• Učinkovina je gemtuzumab ozogamicin.
Additional findings included effects on the testes, epididymides and mammary gland as well as fertility.
Dodatno so ugotovili učinke na testise, epididimis in mlečno žlezo ter plodnost.
• Infusion reactions
• Reakcije na infuzijo
Tumour lysis syndrome (TLS)
Sindrom tumorske lize (TLS - Tumour Lysis Syndrome)
Other medicines and MYLOTARG
Druga zdravila in zdravilo MYLOTARG
• High blood sugar
• visoka raven sladkorja v krvi
Persistent thrombocytopenia (Platelets < 100,000/mm3 at the planned start date of the consolidation course)
Prilagoditve odmerkov perzistentna trombocitopenija (število trombocitov < 100.000/mm na načrtovani datum začetka konsolidacijskega cikla)
Given that the hP67.6 portion renders target selectivity on the intact molecule, and that gemtuzumab ozogamicin dosages are reported in terms of milligrams of protein (hP67.6), the hP67.6 concentration results are reported as the primary PK measures.
Ob upoštevanju, da del protitelesa hP67.6 povzroči tarčno selektivnost na intaktni molekuli in da o odmerkih gemtuzumab ozogamicina poročajo v miligramih beljakovine (hP67.6), so rezultati koncentracije hP67.6 navedeni kot primarno farmakokinetično merilo.
• Reduced number of red blood cells (anaemia) which may result in fatigue and shortness of breath
• zmanjšanje števila rdečih krvnih celic (slabokrvnost), kar lahko povzroči utrujenost in kratko sapo
CD33 expression on AML blasts by flow cytometry harmonised from local laboratory results was determined in 194/271 (71.6%) patients overall.
Izražanje CD33 na blastih AML so ugotavljali s pretočno citometrijo, usklajeno z rezultati lokalnega laboratorija, pri skupno 194/271 bolnikov (71,6 %).
Reconstituted and diluted solution: Following reconstitution and dilution, the solution should be protected from light and should be used immediately.
Rekonstituirana in razredčena raztopina: Po rekonstituciji in redčenju je treba raztopino zaščititi pred svetlobo in jo uporabiti takoj.
Gemtuzumab ozogamicin is a CD33-targeted ADC.
Gemtuzumab ozogamicin je ADC, usmerjen proti CD33.
MYLOTARG should be used only in patients eligible to receive intensive induction chemotherapy.
Zdravilo MYLOTARG se sme uporabljati samo pri bolnikih, ki so primerni za intenzivno indukcijsko kemoterapijo.
• Toxic waste disposal procedures prescribed for anticancer medicinal products must be used.
• Ravnati je treba skladno s postopki za odstranjevanje strupenih odpadkov, ki so predpisani za zdravila za zdravljenje rakavih obolenj.
• Infuse the diluted solution for 2 hours.
• Razredčeno raztopino infundirajte 2 uri.
Nervous system alterations were identified in rats with other antibody-calicheamicin conjugates.
Spremembe živčevja so ugotovili pri podganah s konjugati drugih protiteles in kaliheamicina.
daunorubicin + cytarabine (N=137)
daunorubicin + citarabin (n = 137)
Discontinue MYLOTARG (see section 4.4).
Prekinite zdravljenje z zdravilom MYLOTARG (glejte poglavje 4.4).
MYLOTARG was given as induction treatment in most studies (82.4%).
MYLOTARG so v večini študij (82,4 %) dajali kot indukcijsko zdravljenje.
chills or fever, back pain during or after MYLOTARG infusion
mrzlica ali vročina, bolečina v hrbtu med infundiranjem zdravila MYLOTARG ali po njem
The trial met its primary objective of demonstrating that MYLOTARG added in fractionated doses (3 mg/m2 × 3) to standard induction chemotherapy for patients with previously untreated de novo AML resulted in a statistically significant and clinically meaningful improvement in EFS.
Preskušanje je doseglo svoj primarni cilj dokazati, da dodajanje zdravila MYLOTARG v frakcioniranih odmerkih (3 mg/m2 × 3) standardni indukcijski kemoterapiji pri bolnikih s predhodno nezdravljeno AML de novo povzroči statistično in klinično pomembno izboljšanje EFS.
Consolidation Course 1a,b
1. konsolidacijski cikel a,b
• It is recommended that the infusion container be made of polyvinyl chloride (PVC) with DEHP, or polyolefin (polypropylene and/or polyethylene).
• Priporočljivo je, da so infuzijski vsebniki izdelani iz polivinilklorida (PVC), ki vsebuje DEHP, ali poliolefina (polipropilena in/ali polietilena).
The secondary endpoints included CR and CRp rates, relapse-free survival (RFS), overall survival (OS), and safety of the combination DA with or without MYLOTARG.
Sekundarni opazovani dogodki so vključevali stopnje CR in CRp, preživetje brez ponovitve bolezni (RFS - Relapse-Free Survival), celokupno preživetje (OS - Overall Survival) in varnost kombinacije DA z zdravilom MYLOTARG ali brez njega.
However, it was also found that increased toxicity (post-remission toxic mortality) was observed in patients with low-risk AML which was attributed to the prolonged neutropenia that occurred after receiving gemtuzumab ozogamicin during intensification Course 2 (see sections 4.2 and 4.8).
Vendar pa so pri bolnikih z AML z nizkim tveganjem opazili tudi povečano toksičnost (umrljivost zaradi toksičnosti po remisiji), kar so pripisali podaljšani nevtropeniji, ki se je pri bolnikih pojavila po tem, ko so prejeli 2. intenzifikacijski cikel gemtuzumab ozogamicina (glejte poglavji 4.2 in 4.8).
In the combination therapy study, safety data consisting of selected treatment emergent adverse events (TEAEs) considered most important for understanding the safety profile of MYLOTARG consisted of all grades haemorrhages, all grades VOD, and severe infections.
V študiji kombiniranega zdravljenja so podatki o varnosti zdravila, ki obsegajo izbrane neželene učinke, ki so se pojavili med zdravljenjem in veljajo za najpomembnejše za razumevanje varnostnega profila zdravila MYLOTARG, obsegali krvavitve vseh stopenj, VOD vseh stopenj in hude okužbe.
Across all studies, near maximal peripheral CD33 saturation was observed post-MYLOTARG dose at all dose levels of 2 mg/m² and above, suggesting that a low dose of gemtuzumab ozogamicin is sufficient to bind all available CD33 sites.
V vseh študijah so opazili skoraj največjo periferno nasičenost CD33 po odmerku zdravila MYLOTARG pri vseh odmerkih 2 mg/m² in več, kar kaže na to, da za vezavo na vsa razpoložljiva mesta za CD33 zadostuje majhen odmerek gemtuzumab ozogamicina.
MYLOTARG should not be given if you:
Ne uporabljajte zdravila MYLOTARG, če:
Safety information on myelosuppression, infections, VOD overall and VOD post-HSCT, and death, which are known adverse events for MYLOTARG (see section 4.8 and Table 7), was obtained from literature.
Informacije o varnosti glede mielosupresije, okužb, celokupne VOD in VOD po PKMC ter smrti, ki so znani neželeni učinki zdravila MYLOTARG (glejte poglavje 4.8 in preglednico 7), so pridobili iz literature.
b. Estimated from Kaplan-Meier curve.
Ocena glede na Kaplan-Meierjevo krivuljo.
In patients, unconjugated calicheamicin plasma levels were typically low, with a predicted mean Cmax of 1.5 ng/mL following the third dose.
Pri bolnikih so bile koncentracije nekonjugiranega kaliheamicina v plazmi običajno nizke, predvidena srednja vrednost Cmax pa je bila 1,5 ng/ml po tretjem odmerku.
Store in a refrigerator (2°C-8°C).
Shranjujte v hladilniku (2 C - 8 °C).
Following reconstitution and dilution, the solution should be protected from light and should be used immediately.
Po rekonstituciji in redčenju je treba raztopino zaščititi pred svetlobo in jo uporabiti takoj.
Activation of N-acetyl gamma calicheamicin dimethyl hydrazide induces double-stranded DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.
Aktivacija N-acetil-gama-kaliheamicin dimetilhidrazida inducira pretrganja dvojno vijačne DNK, kar posledično inducira zaustavitev celičnega cikla in apoptotično celično smrt.
In the combination setting, the response rate was 49.0% with non-fractionated MYLOTARG (3 studies) and 38.8% with fractionated MYLOTARG (2 studies).
Pri kombiniranem zdravljenju je bila stopnja odziva 49,0 % pri nefrakcioniranem odmerjanju zdravila MYLOTARG (3 študije) in 38,8 % pri frakcioniranem odmerjanju zdravila MYLOTARG (2 študiji).
Tell your doctor right away if you have rapid weight gain, feel pain in the upper right side of your abdomen, have accumulation of fluid causing abdominal swelling.
Nemudoma obvestite zdravnika, če se vaša telesna masa hitro povečuje, občutite bolečino v zgornjem desnem delu trebuha ali se pojavi kopičenje tekočine, zaradi česar vam oteka trebuh.
In subgroup analyses in ALFA-0701, the addition of MYLOTARG to standard combination chemotherapy did not improve EFS in the subgroup of patients having adverse-risk cytogenetics (HR 1.11; 95% CI: 0.63, 1.95).
V analizah podskupin v študiji ALFA-0701 dodajanje zdravila MYLOTARG standardni kombinirani kemoterapiji ni izboljšalo EFS v podskupinah bolnikov, ki so imeli neugodno citogenetsko tveganje (HR 1,11; 95 % IZ: 0,63; 1,95).
A second course of induction therapy with DA but without MYLOTARG, regardless of the randomisation arm, was allowed.
Dovolili so drugi cikel indukcijskega zdravljenja z DA, vendar brez zdravila MYLOTARG, ne glede na randomizirano skupino.
MYLOTARG is used to treat a certain type of cancer called acute myeloid leukaemia (AML) in which the bone marrow makes abnormal white blood cells.
Zdravilo MYLOTARG uporabljamo za zdravljenje določene vrste raka, ki se imenuje akutna mieloična levkemija (AML), pri kateri kostni mozeg tvori nenormalne bele krvne celice.
Patients with CR or CRp received consolidation therapy with 2 courses of treatment including DNR and AraC with or without MYLOTARG according to their initial randomisation.
Bolniki s CR ali CRp so prejeli konsolidacijsko zdravljenje z 2 cikloma zdravljenja, ki je vključevalo daunorubicin in citarabin z zdravilom MYLOTARG ali brez njega, odvisno od začetne randomizacije bolnika.
• Filtration of the diluted solution is required.
• Razredčeno raztopino je treba filtrirati.
When MYLOTARG was given in combination, a cytarabine based regimen was used in 8 of the 9 studies.
Kadar so zdravilo MYLOTARG dajali v kombinaciji z drugimi zdravili, so v 8 od 9 študij uporabljali režim na osnovi citarabina.
Increased embryolethality and foetal morphological anomalies included digital malformations, absence of the aortic arch, anomalies in the long bones in the forelimbs, misshapen scapula, absence of a vertebral centrum, and fused sternebrae.
Povečana smrtnost zarodkov in morfološke anomalije ploda so vključevale digitalne malformacije, odsotnost aortnega loka, anomalije dolgih kosti v sprednjih udih, deformirano lopatico, odsotnost osrednjega dela vretenca in fuzijo prsnice.
No clinical PK data have been collected using the fractionated regimen; however, the PK have been simulated using the population PK model.
Z režimom frakcioniranega odmerjanja niso zbrali nobenih kliničnih podatkov o farmakokinetiki, vendar pa so farmakokinetiko simulirali z uporabo populacijskega farmakokinetičnega modela.
No definitive relationship was found between VOD and time of HSCT relative to higher MYLOTARG monotherapy doses, however, the ALFA-0701 study recommended an interval of 2 months between the last dose of MYLOTARG and HSCT.
Dokončne povezave med VOD in časom PKMC v povezavi z večjimi odmerki zdravila MYLOTARG v monoterapiji niso ugotovili, vendar pa so v študiji ALFA-0701 priporočali interval 2 mesecev med zadnjim odmerkom zdravila MYLOTARG in PKMC.
• Budd-Chiari syndrome, which includes pain in the upper right part of the belly, an abnormally large liver, and/or accumulation of fluid in the belly associated with blood clots in the liver.
• Budd-Chiarijev sindrom, ki vključuje bolečino v zgornjem desnem delu trebuha, nenormalno zvečana jetra in/ali kopičenje tekočine v trebuhu, kar je povezano s krvnimi strdki v jetrih.
The safety and efficacy of MYLOTARG in paediatric patients with relapsed or refractory AML has not been established (see sections 4.1 and 4.2).
Varnost in učinkovitost zdravila MYLOTARG pri pediatričnih bolnikih z recidivno ali refraktarno AML nista bili dokazani (glejte poglavji 4.1 in 4.2).
Patients should be advised they may experience fatigue, dizziness and headache during treatment with MYLOTARG (see section 4.8).
Bolnike je treba opozoriti, da se jim lahko med zdravljenjem z zdravilom MYLOTARG pojavijo utrujenost, omotica in glavobol (glejte poglavje 4.8).
Mylotarg vials contain 5 mg of drug product with no overfill.
Viale z zdravilom MYLOTARG vsebujejo 5 mg zdravila brez presežka.
**Only selected safety data were collected in this study of newly diagnosed AML.
V tej študiji na novo diagnosticirane AML so zbrali le izbrane podatke o varnosti.
MYLOTARG does not undergo renal clearance, the pharmacokinetics in patients with severe renal impairment is unknown (see section 5.2).
Zdravilo MYLOTARG se ne izloča skozi ledvice, farmakokinetika pri bolnikih s hudo ledvično okvaro ni znana (glejte poglavje 5.2).
Patients with acute promyelocytic leukaemia (APL, AML3) and patients with AML arising from myelodysplastic syndrome (MDS) or secondary AML were excluded from the study.
Bolnikov z akutno promielocitno levkemijo (APL, AML3) in bolnikov z AML, ki nastane iz mielodisplastičnega sindroma (MDS), ali sekundarno AML, niso vključili v študijo.
• Oedema (excess fluid in body tissue, causing swelling of the hands and feet)
• edem (odvečna tekočina v telesnem tkivu, ki povzroča otekanje rok in stopal)
In the combination therapy study ALFA-0701, clinically relevant serious adverse reactions were hepatotoxicity, including VOD/SOS (3.8%), haemorrhage (9.9%), severe infection (41.2%), and tumour lysis syndrome (1.5%).
V študiji kombiniranega zdravljenja ALFA-0701 so bili klinično pomembni resni neželeni učinki hepatotoksičnost, vključno z VOD/SOS (3,8 %), krvavitvijo (9,9 %), hudo okužbo (41,2 %) in sindromom tumorske lize (1,5 %).
In vitro, the binding N-acetyl gamma calicheamicin dimethyl hydrazide to human plasma proteins is approximately 97%.
Delež vezave N-acetil-gama-kaliheamicin dimetilhidrazida na človeške plazemske beljakovine je in vitro približno 97 %.
An interval of at least 2 months between the last dose of MYLOTARG and transplantation was recommended.
Priporočeni interval od zadnjega odmerka zdravila MYLOTARG do presaditve je bil vsaj 2 meseca.
After reconstitution (see section 6.6), the concentrated solution contains 1 mg/mL gemtuzumab ozogamicin.
Po rekonstituciji (glejte poglavje 6.6) koncentrirana raztopina vsebuje 1 mg/ml gemtuzumab ozogamicina.
There are no or limited amount of data from the use of gemtuzumab ozogamicin in pregnant women.
Podatkov o uporabi gemtuzumab ozogamicina pri nosečnicah ni oziroma so omejeni.
The analysis included 405 patients in the following NCI ODWG impairment status categories: mild (B1, n=58 and B2, n=19), moderate (C, n=6), and normal hepatic function (n=322) (see section 4.2).
V analizo so vključili 405 bolnikov, ki so jih razvrstili v naslednje kategorije delovanja jeter po NCI ODWG: blaga okvara (B1, n = 58, in B2, n = 19), zmerna okvara (C, n = 6) ter normalno delovanje jeter (n = 322) (glejte poglavje 4.2).
The terminal plasma half-life (t½) for hP67.6 was predicted to be approximately 160 hours for a typical patient at the recommended dose level (3 mg/m2) of MYLOTARG.
Končni plazemski razpolovni čas (t½) za hP67.6 je bil predvidoma 160 ur pri tipičnem bolniku in priporočenem odmerku (3 mg/m2) zdravila
In clinical studies, neutropenia, thrombocytopenia, anaemia, leukopenia, febrile neutropenia, lymphopenia, and pancytopenia, some of which were life-threatening or fatal, were reported (see section 4.8).
V kliničnih študijah so poročali o nevtropeniji, trombocitopeniji, anemiji, levkopeniji, febrilni nevtropeniji, limfopeniji in pancitopeniji; nekateri od teh primerov so bili življenjsko ogrožajoči ali smrtni (glejte poglavje 4.8).
MYLOTARG should not be administered as an intravenous push or bolus (see section 6.6).
Zdravila MYLOTARG ne smete dajati kot hitro intravensko infuzijo ali bolus (glejte poglavje 6.6).
The main toxicities occurred in the liver, bone marrow and lymphoid organs, haematology parameters (decreased RBC mass and WBC counts, mainly lymphocytes), kidney, eye and male and female reproductive organs.
Glavne toksičnosti so se pojavile v jetrih, kostnem mozgu in limfatičnih organih, hematoloških parametrih (zmanjšana masa eritrocitov in zmanjšano število levkocitov, večinoma limfocitov), ledvicah, očeh ter moških in ženskih reprodukcijskih organih.
In the combination therapy study, VOD and hepatic laboratory abnormalities were collected.
V študiji kombiniranega zdravljenja so zbrali primere VOD in nenormalnih laboratorijskih vrednosti delovanja jeter.
Pregnant women, or patients becoming pregnant whilst receiving gemtuzumab ozogamicin, or treated male patients as partners of pregnant women, must be apprised of the potential hazard to the foetus.
Če gemtuzumab ozogamicin prejemajo nosečnice, če bolnica med prejemanjem gemtuzumab ozogamicina zanosi ali če se z gemtuzumab ozogamicinom zdravijo bolniki, ki so partnerji nosečnic, jih je treba seznaniti z morebitno nevarnostjo za plod.
What MYLOTARG looks like and contents of the pack
Izgled zdravila MYLOTARG in vsebina pakiranja
The safety and efficacy of MYLOTARG in children and adolescents with previously untreated AML below the age of 15 years has not been established (see section 4.2).
Varnost in učinkovitost zdravila MYLOTARG pri otrocih in mladostnikih s predhodno nezdravljeno AML, mlajših od 15 let, nista bili dokazani (glejte poglavje 4.2).
Infusion of MYLOTARG should be performed under close clinical monitoring, including pulse, blood pressure, and temperature.
Zdravilo MYLOTARG je treba infundirati ob skrbnem kliničnem spremljanju, vključno s spremljanjem srčnega utripa, krvnega tlaka in telesne temperature.
Fatal severe infection was reported in 2 (1.53%) patients in the MYLOTARG arm and 4 (2.92%) patients in the control arm.
O hudi okužbi s smrtnim izidom so poročali pri 2 bolnikih (1,53 %) v skupini, ki je prejemala zdravilo MYLOTARG, in pri 4 bolnikih (2,92 %) v kontrolni skupini.
With MYLOTARG monotherapy, the response rate (CR/CRp/CRi; weighted average across studies) was 33.3% with fractionated dosing (1 study) and 24.3% with non-fractionated dosing (9 studies).
Pri monoterapiji z zdravilom MYLOTARG je bila stopnja odziva (CR/CRp/CRi; uteženo povprečje študij) 33,3 % pri frakcioniranem odmerjanju (1 študija) in 24,3 % pri nefrakcioniranem odmerjanju (9 študij).
In clinical studies of MYLOTARG in patients with relapsed or refractory AML, the immunogenicity of MYLOTARG was evaluated using 2 enzyme-linked immunosorbent assays (ELISAs).
V kliničnih študijah zdravila MYLOTARG pri bolnikih z recidivno ali refraktarno AML so imunogenost zdravila MYLOTARG ocenjevali z 2 encimskima imunskima testoma (ELISAEnzyme-Linked Immunosorbent Assay).
Premedication with a corticosteroid, antihistamine, and acetaminophen (or paracetamol) is recommended 1 hour prior to dosing to help ameliorate infusion-related symptoms (see section 4.4).
Premedikacija s kortikosteroidi, antihistaminiki in paracetamolom (oziroma acetaminofenom) je priporočljiva 1 uro pred odmerjanjem kot pomoč pri lajšanju z infuzijo povezanih simptomov (glejte poglavje 4.4).
For patients who proceed to HSCT, close monitoring of liver tests is recommended during the post-HSCT period, as appropriate.
Pri bolnikih, pri katerih bodo opravili PKMC, je v obdobju po PKMC priporočljivo, da po potrebi skrbno spremljate jetrne teste.
Patients should be monitored until signs and symptoms completely resolve and infusion may resume.
Bolnike je treba spremljati, dokler znaki in simptomi popolnoma ne izzvenijo in je mogoče nadaljevati z infundiranjem.
Based on Population PK analyses, the predicted clearance (CL) value of hP67.6 from plasma was 3 L/h immediately after the first dose and then 0.3 L/h.
Na podlagi populacijske farmakokinetične analize je predvideni očistek (CL - Clearance) protitelesa hP67.6 iz plazme 3 l/h takoj po prvem odmerku in nato 0,3 l/h.
The reconstituted solution may contain small white to off-white, opaque to translucent, and amorphous to fibre-like particles.
Rekonstituirana raztopina lahko vsebuje majhne neprozorne do prosojne, amorfne do vlaknaste delce bele do belkaste barve.
Supraventricular tachycardia#.
# in supraventrikularna tahikardija k.
When reconstituted to a 1 mg/mL concentration as directed, the extractable content of the vial is 4.5 mg (4.5 mL).
Ko zdravilo skladno z navodili rekonstituirate do koncentracije 1 mg/ml, je ekstraktibilna vsebina viale 4,5 mg (4,5 ml).
If you feel unusually tired, dizzy or have a headache (these are very common side effects of MYLOTARG) you should not drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Če se počutite neobičajno utrujeni, omotični ali imate glavobol (to so zelo pogosti neželeni učinki zdravila MYLOTARG), ne smete upravljati vozil ali strojev.