natgillin/translations-raw huggingface dataset:
• Calculate the required volume of the reconstituted solution needed to obtain the appropriate dose according to patient body surface area.
• Izračunajte potreben volumen rekonstituirane raztopine, da dobite ustrezen odmerek glede na bolnikovo telesno površino.
Warnings and precautions When you first receive this medicine and during the course of treatment, tell your doctor or nurse if you:
Opozorila in previdnostni ukrepi Ko zdravilo prejmete prvič in med zdravljenjem, obvestite zdravnika ali medicinsko sestro, če:
• Your doctor may lower your dose based on your response to treatment.
• Zdravnik lahko zmanjša odmerek glede na vaš odziv na zdravljenje.
MYLOTARG must not to be used in children and adolescents under 15 years of age because limited data are available in this population.
Zdravila MYLOTARG ne smemo uporabljati pri otrocih in mladostnikih, mlajših od 15 let, saj so podatki za to populacijo omejeni.
Immediately contact your doctor if you experience any of the following serious side effects (see also section 2 “What you need to know before you are given MYLOTARG”):
Nemudoma obvestite zdravnika, če se vam pojavi kateri od naslednjih resnih neželenih učinkov (glejte tudi poglavje 2 "Kaj morate vedeti, preden boste prejeli zdravilo MYLOTARG"):
• are allergic to gemtuzumab ozogamicin or any of the other ingredients of this medicine (listed in section 6).
• ste alergični na gemtuzumab ozogamicin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
The relevance of these animal findings to humans is uncertain.
Pomen teh ugotovitev pri živalih za ljudi je negotov.
Increased embryolethality was also observed in the presence of maternal toxicity.
Zvečano smrtnost zarodkov so opazili tudi ob prisotnosti toksičnosti za mater.
Limitations of this analysis include the small sample size of some studies, heterogeneity of the studies, and the lack of control data in this setting.
Omejitve te analize vključujejo majhno velikost vzorca v nekaterih študijah, raznolikost študij in pomanjkanje kontrolnih podatkov v zadevnih okoliščinah.
*Including fatal outcome.
Vključno s primeri s smrtnim izidom.
The primary endpoint was event-free survival (EFS).
Primarni opazovani dogodek je bilo preživetje brez dogodkov (EFS - Event-Free Survival).
Five (3.8%) of these VOD reactions occurred within 28 days of any dose of gemtuzumab ozogamicin.
Pet (3,8 %) od teh reakcij VOD se je pojavilo v 28 dneh po kateremkoli odmerku gemtuzumab ozogamicina.
Treatment of MYLOTARG overdose should consist of general supportive measures.
Zdravljenje prevelikega odmerjanja zdravila MYLOTARG mora obsegati splošne podporne ukrepe.
Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki viale in škatli poleg oznake ''EXP''.
Definitive conclusions cannot be drawn between the presence of antibodies and potential impact on efficacy and safety due to the limited number of patients with positive ADAs.
Dokončni zaključki glede prisotnosti protiteles in možnem vplivu na učinkovitost in varnost zaradi omejenega števila bolnikov s pozitivnim izvidom na ADA niso mogoči.
For these reasons, comparison of incidence of antibodies to gemtuzumab ozogamicin with the incidence of antibodies to other products may be misleading.
Zato je primerjava pojavnosti protiteles proti gemtuzumab ozogamicinu s pojavnostjo protiteles proti drugim zdravilom lahko zavajajoča.
Determination of PK parameters for unconjugated calicheamicin was limited due to the low systemic concentration levels.
Določanje farmakokinetičnih parametrov za nekonjugirani kaliheamicin je bilo zaradi nizkih sistemskih koncentracij omejeno.
This includes the time required for reconstitution, dilution, and administration.
To vključuje čas, potreben za rekonstitucijo, redčenje in uporabo.
The overall minimum and maximum ages range from 0 years to 22.3 years, with an overall median age of 8.7 years at the time of treatment.
Celokupni razpon najnižje in najvišje starosti je bil od 0 let do 22,3 leta, celokupna mediana starost v času zdravljenja pa je bila 8,7 leta.
The mITT population included all patients who were randomised, unless withdrawal of consent prior to start of treatment and were analysed according to initial randomisation arm.
V populacijo mITT so vključili vse randomizirane bolnike, razen če so bolniki pred začetkom zdravljenja preklicali privolitev, analizirali pa so jih v skladu z začetno randomizirano skupino.
***Frequency is based on laboratory values (Grade per NCI CTCAE v4.03).
Pogostnost temelji na laboratorijskih vrednostih (stopnja po NCI CTCAE v4.03).
Few patients (13.7%) had low CD33 expression (less than 30% of blasts).
Pri nekaj bolnikih (13,7 %) je bilo izražanje CD33 nizko (manj kot 30 % blastov).
Most studies were in the compassionate use setting (70.6%).
Večino študij so izvajali v sklopu sočutne uporabe zdravila (70,6 %).
Use appropriate aseptic technique for the reconstitution and dilution procedures.
Za postopke rekonstitucije in redčenja uporabite ustrezno aseptično tehniko.
Patients who experienced remission were also eligible for allogeneic transplantation.
Bolniki, pri katerih je prišlo do remisije, so bili primerni tudi za alogensko presaditev.
Response rate (by Investigator)
Stopnja odziva (po oceni raziskovalca)
• Decreased appetite
• pomanjkanje apetita
Single doses higher than 9 mg/m2 in adults were not tested.
Enkratnih odmerkov, večjih od 9 mg/m2, pri odraslih niso preskušali.
Based on the primary definition of EFS: event dates (induction failure, relapse, or death) determined by investigator assessment.
Na podlagi primarne definicije EFS: datumi dogodkov (neuspešna indukcija, ponovitev bolezni ali smrt) po oceni raziskovalca.
MYLOTARG has moderate influence on the ability to drive and use machines.
Zdravilo MYLOTARG ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Protect from light and do not freeze.
Zaščitite pred svetlobo in ne zamrzujte.
The infusion line does not need to be protected from light.
Infuzijske cevke ni treba zaščititi pred svetlobo.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden prejmete to zdravilo.
The median time from the last gemtuzumab ozogamicin dose to onset of VOD was 9 days (range: 2-298 days).
Mediani čas od zadnjega odmerka gemtuzumab ozogamicina do pojava VOD je bil 9 dni (razpon: 2298 dni).
MYLOTARG must not be used during pregnancy unless the potential benefit to the mother outweighs the potential risks to the foetus.
Zdravila MYLOTARG se ne sme uporabljati med nosečnostjo, razen če morebitna korist za mater odtehta morebitna tveganja za plod.
Patients should be monitored for signs and symptoms of TLS and treated according to standard medical practice.
Bolnike je treba spremljati glede znakov in simptomov TLS in jih zdraviti v skladu z običajno medicinsko prakso.
• Infections (signs of a low number of white blood cells known as neutrophils) Some infections may be serious and can be due to viruses, bacteria, or other causes that may be life-threatening.
• Okužbe (znaki majhnega števila belih krvnih celic, imenovanih nevtrofilci) Nekatere okužbe so lahko resne in so lahko posledica virusov, bakterij ali drugih vzrokov, ki so lahko življenjsko ogrožajoči.
c: Rates across studies were estimated using inverse variance weighting with fixed effects.
c: Deleže v študijah so ocenjevali z obtežitvijo študij s fiksnimi učinki z inverzno varianco.
There is no information regarding the presence of gemtuzumab ozogamicin or its metabolites in human milk, the effects on the breast-fed child, or the effects on milk production.
Ni podatkov o prisotnosti gemtuzumab ozogamicina ali njegovih presnovkov v materinem mleku, učinkih na dojenega otroka ali učinkih na nastajanje mleka.
Overall, the incidence rate of ADA development after MYLOTARG treatment was < 1% across the 4 clinical studies with ADA data.
Na splošno je bila stopnja pojavnosti ADA po zdravljenju z zdravilom MYLOTARG < 1 % v vseh 4 kliničnih študijah s podatki o ADA.
• Reduced number of white blood cells which may result in general weakness and a tendency to develop infections
• zmanjšanje števila belih krvnih celic, kar lahko povzroči splošno oslabelost in nagnjenost k razvoju okužb
No dose adjustment is required in elderly patients (≥ 65 years) (see section 5.2).
Prilagajanje odmerka pri starejših bolnikih (≥ 65 let) ni potrebno (glejte poglavje 5.2).
• Calculate the dose (mg) of MYLOTARG required.
• Izračunajte odmerek (mg) zdravila MYLOTARG, ki ga potrebujete.
Other severe or life-threatening non-haematologic toxicities
Druge hude ali življenjsko ogrožajoče nehematološke toksičnosti
Some of the side effects could be serious and may occur during or after treatment with MYLOTARG.
Nekateri neželeni učinki so lahko resni in se lahko pojavijo med zdravljenjem z zdravilom MYLOTARG ali po njem.
MYLOTARG should be administered under the supervision of a physician experienced in the use of anticancer medicinal products and in an environment where full resuscitation facilities are immediately available.
Zdravilo MYLOTARG je treba uporabljati pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil za zdravljenje rakavih obolenj, in v okolju, kjer je takoj na voljo vsa oprema za reanimacijo.
Previously untreated AML
Predhodno nezdravljena AML
The ALFA-0701 trial was not designed to prospectively evaluate the benefit of MYLOTARG in subgroups; analysis are presented for descriptive purposes only.
Namen preskušanja ALFA-0701 ni bil prospektivno oceniti koristi zdravila MYLOTARG v podskupinah; analize so predstavljene samo za namen predstavitve.
EFS and OS analysed by cytogenetic risk classification and cytogenetic/molecular risk classification are presented in Table 9 and Table 10 below.
EFS in OS, ki so jih analizirali v skladu s klasifikacijo citogenetskega tveganja in klasifikacijo citogenetskega/molekularnega tveganja, so predstavljeni v preglednici 9 in preglednici 10 spodaj.
Effects on male rat reproductive organs were partially reversible or not reversible (see section 4.6).
Vplivi na reprodukcijske organe pri samcih podgan so bili delno reverzibilni ali niso bili reverzibilni (glejte poglavje 4.6).
c. 2-sided p-value from the log-rank test.
2-stranska vrednost p po testu log-rank.
ALFA-0701 study of previously untreated patients with de novo AML
Študija ALFA-0701 predhodno nezdravljenih bolnikov z AML de novo
Signs and symptoms of infusion related reactions may include fever and chills, and less frequently hypotension, tachycardia, and respiratory symptoms that may occur during the first 24 hours after administration.
Znaki in simptomi z infuzijo povezanih reakcij lahko vključujejo vročino in mrzlico, manj pogosto pa hipotenzijo, tahikardijo in respiratorne simptome, ki se lahko pojavijo v prvih 24 urah po uporabi zdravila.
For patients who develop abnormal liver tests, more frequent monitoring of liver tests and clinical signs and symptoms of hepatotoxicity is recommended.
Pri bolnikih, pri katerih pride do nenormalnih vrednosti jetrnih testov, je priporočljivo pogostejše spremljanje jetrnih testov in kliničnih znakov ter simptomov hepatotoksičnosti.
• During the infusion, the intravenous bag or syringes needs to be protected from light using a light (including ultraviolet light) blocking cover.
• Med infundiranjem je treba intravensko vrečo ali brizge zaščititi pred svetlobo s pregrinjalom, ki ne prepušča svetlobe (vključno z ultravijolično svetlobo).
Total bilirubin > 2 × ULN and AST and/or ALT > 2.5 × ULN
celokupni bilirubin > 2 × ZMN in AST in/ali ALT > 2,5 × ZMN
• MYLOTARG contains no bacteriostatic preservatives.
• Zdravilo MYLOTARG ne vsebuje bakteriostatičnih konzervansov.
The adverse reactions are presented by system organ class (SOC) and frequency categories, defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Neželeni učinki so predstavljeni po organskih sistemih in pogostnosti pojavljanja skladno z naslednjim dogovorom: zelo pogosti ( 1/10); pogosti ( 1/100 do < 1/10); občasni ( 1/1.000 do < 1/100); redki ( 1/10.000 do < 1/1.000), zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Withdraw this amount from the vial using a syringe.
Z brizgo izvlecite to količino iz viale.
One VOD event occurred more than 28 days of last dose of gemtuzumab ozogamicin; with 1 of these events occurring a few days after having started an HSCT conditioning regimen.
En primer VOD se je pojavil več kot 28 dni po zadnjem odmerku gemtuzumab ozogamicina; 1 od teh dogodkov se je pojavil nekaj dni po začetku pripravljalnega režima za PKMC.
This is consistent with the known induction of DNA breaks by calicheamicin and other enediyne antitumour antibiotics.
To je skladno z znano indukcijo pretrganja DNK s kaliheamicinom in drugimi endiinskimi protitumorskimi antibiotiki.
Effect on UGT substrates
Učinek na substrate UGT
When male rats were mated again after a 9-week non-dosing period, effects on sperm and fertility were worse but there was partial recovery of the lower spermatogonia and spermatocytes in the testes.
Ko so se podgane po 9-tedenskem obdobju brez odmerjanja ponovno parile, so bili učinki na spermo in plodnost slabši, vendar pa je prišlo do delnega izboljšanja zmanjšanega števila spermatogonijev in spermatocitov v testisih.
• infection: have or think you have, an infection, develop chills or shivering, or feel warm, or have fever.
• okužba: imate ali mislite, da imate okužbo, občutite mrzlico ali drgetanje, vam je toplo ali imate vročino.
A monoclonal antibody is a protein which recognises certain cancer cells.
Monoklonsko protitelo je beljakovina, ki prepozna določene rakave celice.
Relapsed or refractory AML
Recidivna ali refraktarna AML
In patients, the total volume of distribution of hP67.6 antibody (sum of V1 [10 L] and V2 [15 L]) was found to be approximately 25 L.
Pri bolnikih so ugotovili, da je celokupni volumen porazdelitve protitelesa hP67.6 (seštevek vrednosti V1 [10 l] in V2 [15 l]) približno 25 l.
Consolidation Course 2a,b
2. konsolidacijski cikel a,b
What you need to know before you are given MYLOTARG
Kaj morate vedeti, preden boste prejeli zdravilo MYLOTARG
Ask your doctor how to throw away medicines you no longer use.
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte z zdravnikom.
• Changes in the levels of different enzymes in the blood (may show in your blood tests)
• spremembe ravni raznih encimov v krvi (se lahko pokaže pri krvnih preiskavah)
• Your doctor will do blood tests during the treatment to check for side effects and for response to treatment.
• Zdravnik bo med zdravljenjem opravljal preiskave krvi in vas tako preverjal glede pojava neželenih učinkov in vašega odziva na zdravljenje.
Patients should be monitored until signs and symptoms completely resolve.
Bolnike je treba spremljati, dokler znaki in simptomi ne izzvenijo popolnoma.
In clinical studies, TLS was reported (see section 4.8).
V kliničnih študijah so poročali o TLS (glejte poglavje 4.8).
Infections and bleeding/haemorrhagic reactions were reported, some of which were life-threatening or fatal.
Poročali so o okužbah in krvavitvah/hemoragičnih reakcijah; nekateri od teh primerov so bili življenjsko ogrožajoči ali smrtni.
Tables 3 and 4 show the dose modification guidelines for haematological and non-haematological toxicities, respectively.
Preglednici 3 in 4 prikazujeta smernice za prilagajanje odmerkov za hematološko oziroma nehematološko toksičnost.
The number of patients with persistent thrombocytopenia remained similar across treatment courses (8 [7.4%] patients at the induction phase and 8 [8.5%] patients at the consolidation 1 phase and 10 [13.2%] patients at the consolidation 2 phase).
Tekom zdravljenja je število bolnikov s perzistentno trombocitopenijo ostalo podobno (8 bolnikov [7,4 %] v indukcijski fazi, 8 bolnikov [8,5 %] v 1. konsolidacijski fazi in 10 bolnikov [13,2 %] v 2. konsolidacijski fazi).
Interrupt the infusion and institute appropriate medical management based on the severity of symptoms.
Z infuzijo povezane reakcije Infundiranje prekinite in zagotovite ustrezno medicinsko obravnavo glede na resnost simptomov.
The safety and efficacy of MYLOTARG in patients less than 15 years of age has not been established.
Varnost in učinkovitost zdravila MYLOTARG pri bolnikih, mlajših od 15 let, nista bili dokazani.
• Signs of an enlarged liver (hepatomegaly), such as an enlarged belly
• znaki zvečanih jeter (hepatomegalija), kot je povečan trebuh
Patients in the Phase 2 trials did not develop antidrug antibodies (ADAs) and only 2 patients in a Phase 1 trial developed antibodies against the calicheamicin-linker complex, 1 of whom had reduced hP67.6 plasma concentrations.
V preskušanjih 2. faze bolniki niso razvili protiteles proti zdravilu (ADA - Antidrug Antibody), v preskušanju 1. faze pa sta le 2 bolnika razvila protitelesa proti kompleksu kaliheamicin-povezovalec, pri čemer je 1 od njiju imel znižane koncentracije hP67.6 v plazmi.
See section 5.2 for available data from in vitro studies.
Za razpoložljive podatke iz študij in vitro glejte poglavje 5.2.
Hepatotoxicity, including hepatic VOD/SOS
Hepatotoksičnost, vključno z VOD jeter/SOS
Total dosing of MYLOTARG ranged from 1.8 mg/m2 to 9 mg/m2.
Skupni odmerek zdravila MYLOTARG je bil v razponu od 1,8 mg/m2 do 9 mg/m2.
f. Overall response difference; CI based on Santner and Snell method.
Razlika v celokupnem odzivu; IZ na podlagi Santner-Snellove metode.
Safety results from a systematic literature review in paediatric patients with relapsed or refractory AML who received MYLOTARG
Rezultati varnosti iz sistematičnega pregleda literature pri pediatričnih bolnikih z recidivno ali refraktarno AML, ki so prejemali zdravilo MYLOTARG
Safety results observed in a systematic literature review of studies evaluating MYLOTARG in paediatric patients (see section 5.1), are presented in Table 7.
Rezultati varnosti, ki so jih opazili pri sistematičnem pregledu literature o študijah, v katerih so ocenjevali zdravilo MYLOTARG pri pediatričnih bolnikih (glejte poglavje 5.1), so predstavljeni v preglednici 7.
Hepatotoxicity, including hepatic venoocclusive disease/sinusoidal obstruction syndrome (VOD/SOS)
Hepatotoksičnost, vključno z venookluzivno boleznijo jeter/sindromom obstrukcije sinusoidov (VOD/SOS)
Proportions were transformed using Freeman-Tukey double arcsine transformation prior to combining studies, and the estimated combined rate was back-transformed using the harmonic mean of study sample sizes.
Deleže so pretvorili s Freeman-Tukeyevo arkus sinus korensko transformacijo pred združevanjem študij, ocenjeni združeni delež pa so pretvorili nazaj s harmonizirano srednjo vrednostjo velikosti vzorca v študijah.
b. For patients experiencing a complete remission (CR) following induction.
Pri bolnikih, pri katerih je po indukciji prišlo do popolne remisije (CR).
What MYLOTARG is and what it is used for
Kaj je zdravilo MYLOTARG in za kaj ga uporabljamo
Overall, the median age of patients was 62 years (range 50 to 70 years) and most patients (87.8%) had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 at baseline.
Skupno je bila mediana starost bolnikov 62 let (razpon od 50 do 70 let), večina bolnikov (87,8 %) pa je imela izhodiščno stanje zmogljivosti (PS - Performance Status), ocenjeno po lestvici ECOG (Eastern Cooperative Oncology Group), od 0 do 1.
• Excessive accumulation of fluid in the abdomen/stomach
• čezmerno kopičenje tekočine v trebuhu/želodcu
Both men and women should seek advice on fertility preservation before treatment.
Moški in ženske se morajo pred zdravljenjem posvetovati glede ohranjanja plodnosti.
MYLOTARG was given as monotherapy in 47.1%, part of a combination in 23.5%, and in both settings in 29.4% of the studies.
Zdravilo MYLOTARG so dajali kot monoterapijo v 47,1 %, kot del kombiniranega zdravljenja v 23,5 % in v obeh oblikah v 29,4 % študij.
MYLOTARG is intended for the treatment of AML for patients age 15 years and above who have not tried other treatments.
Zdravilo MYLOTARG je namenjeno za zdravljenje AML pri bolnikih, starih 15 let in več, ki predhodno niso prejeli drugih zdravljenj.
Infusion related reactions (including anaphylaxis)
Reakcije, povezane z infuzijo (vključno z anafilaksijo)
• Yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice)
• rumenkasto obarvanje kože ali beločnic zaradi težav z jetri ali krvjo (zlatenica)
Symptoms may also include feeling sick (nausea) and/or vomiting.
Simptomi lahko vključujejo tudi slabost s siljenjem na bruhanje (navzea) in/ali bruhanje.
Overall, 59.0% and 65.3% of patients had documented favourable/intermediate-risk disease by the National Comprehensive Cancer Network (NCCN) and European LeukaemiaNet (ELN) 2010 risk classifications, respectively.
Skupno je imelo 59,0 % oziroma 65,3 % bolnikov dokumentirano bolezen z ugodnim tveganjem po klasifikaciji tveganj združenja NCCN (National Comprehensive Cancer Network) oziroma zmernim tveganjem po klasifikaciji tveganj združenja ELN (European LeukaemiaNet) iz leta 2010.
Both of these patients experienced VOD more than 28 days after the last dose of gemtuzumab ozogamicin.
Pri obeh bolnikih se je VOD pojavila več kot 28 dni po zadnjem odmerku gemtuzumab ozogamicina.
If you need treatment with MYLOTARG, you must stop breast-feeding during treatment and for at least 1 month after treatment.
Če potrebujete zdravljenje z zdravilom MYLOTARG, med zdravljenjem in še najmanj 1 mesec po zdravljenju ne smete dojiti.
The relevance of the irreversible animal findings to humans is uncertain.
Pomen ireverzibilnih ugotovitev pri živalih za ljudi je negotov.
Patients in either arm who did not receive the second course of induction therapy and did not achieve a CR after induction could receive a salvage course comprised of idarubicin, AraC, and granulocyte colonystimulating factor (G-CSF).
Bolniki v obeh skupinah, ki niso prejeli drugega cikla indukcijskega zdravljenja in po indukciji niso dosegli CR, so lahko prejeli cikel rešilnega zdravljenja, ki je obsegal idarubicin, citarabin in granulocitne kolonije stimulirajoči faktor (G-CSF - Granulocyte Colony-Stimulating Factor).
VOD was also reported in 2 patients who received MYLOTARG as a follow-up therapy following relapse of AML after chemotherapy treatment in the control arm of the combination therapy study.
O VOD so poročali tudi pri 2 bolnikih, ki sta zdravilo MYLOTARG prejemala kot nadaljnje zdravljenje po ponovitvi AML po zdravljenju s kemoterapijo v kontrolni skupini študije kombiniranega zdravljenja.
One of these patients experienced VOD 25 days after the subsequent HSCT.
Pri enem od teh bolnikov se je VOD pojavila 25 dni po kasnejši PKMC.
• Before you receive MYLOTARG, you will be given some medicines to help reduce symptoms such as fever and chills, known as infusion reactions, during or shortly after the MYLOTARG infusion.
• Preden boste prejeli zdravilo MYLOTARG, boste prejeli nekaj zdravil, ki pomagajo zmanjšati simptome z infuzijo povezane reakcije, kot sta vročina in mrzlica, ki se pojavijo med infundiranjem zdravila MYLOTARG ali kmalu po njem.
Do not use this medicine if you notice any particulate matter or discolouration prior to administration.
Tega zdravila ne uporabite, če pred uporabo opazite vidne delce ali obarvanost.
It is supplied as white to off-white cake or powder.
Na voljo je kot bela do belkasta pogača ali prašek.
Contact your doctor immediately if you or your partner becomes pregnant while taking this medicine.
Nemudoma obvestite zdravnika, če med zdravljenjem s tem zdravilom vi ali vaša partnerka zanosite.
MYLOTARG is for intravenous use and must be reconstituted and diluted before administration (see section 6.6).
Zdravilo MYLOTARG je za intravensko uporabo in ga je treba pred uporabo rekonstituirati in razredčiti (glejte poglavje 6.6).