Примери за използване на Gemtuzumab на Английски и техните преводи на Български
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The active substance is gemtuzumab ozogamicin.
Gemtuzumab ozogamicin is a CD33-targeted ADC.
Each vial contains 5 mg of gemtuzumab ozogamicin.
Gemtuzumab ozogamicin was found to be clastogenic.
It contains the active substance gemtuzumab ozogamicin.
Effect of gemtuzumab ozogamicin on other medicinal products Effect on CYP substrates.
International non-proprietary name(INN): gemtuzumab ozogamicin.
The PK of gemtuzumab ozogamicin has not been studied in patients with severe renal impairment.
Effect of other medicinal products on gemtuzumab ozogamicin.
No formal PK studies of gemtuzumab ozogamicin have been conducted in patients with renal impairment.
After reconstitution each vial contains 1 mg/mL gemtuzumab ozogamicin.
The monoclonal antibody part(gemtuzumab) has been designed to attach to CD33.
Formal carcinogenicity studies have not been conducted with gemtuzumab ozogamicin.
Thus, the optimal dose of gemtuzumab ozogamicin for paediatric patients was not established(see section 4.2).
MYLOTARG 5 mg powder for concentrate for solution for infusion gemtuzumab ozogamicin.
Gemtuzumab is a humanised immunoglobulin class G subtype 4(IgG4) antibody which specifically recognises human CD33.
After reconstitution, each ml of the concentrated solution contains 1 mg gemtuzumab ozogamicin.
Abbreviations: C=cytarabine; D=daunorubicin;GO=gemtuzumab ozogamicin; mITT=modified intent-to-treat.
After reconstitution(see section 6.6),the concentrated solution contains 1 mg/mL gemtuzumab ozogamicin.
After gemtuzumab ozogamicin binds to the target it is internalised and N-acetyl calicheamicin is released by hydrolytic cleavage.
Both of these patients experienced VOD more than 28 days after the last dose of gemtuzumab ozogamicin.
The active substance in Mylotarg, gemtuzumab ozogamicin, is a cytotoxic(cell-killing) substance that is linked to a monoclonal antibody.
Five(3.8%) of these VOD reactions occurred within 28 days of any dose of gemtuzumab ozogamicin.
The active substance in Mylotarg, gemtuzumab ozogamicin, consists of two parts: a cytotoxic(cellkilling) substance and a monoclonal antibody(a type of protein).
Amber Type 1 glass vial, with butyl rubber stopper andcrimp seal with flip-off cap containing 5 mg gemtuzumab ozogamicin.
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.
Gemtuzumab ozogamicin is an antibody-drug conjugate(ADC) composed of CD33-directed monoclonal antibody(hP67.6) that is covalently linked to the cytotoxic agent N-acetyl-gamma calicheamicin.
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.
The pharmacokinetics(PK) of gemtuzumab ozogamicin is described by measuring PK characteristics of the antibody(hP67.6) as well as total and unconjugated calicheamicin derivatives.
Based on population pharmacokinetic(PK) analyses,the combination of gemtuzumab ozogamicin with DNR and AraC is not predicted to cause clinically meaningful changes in the PK of these agents.