EVOMELA- melphalan injection, powder, lyophilized, for solution САЩ - английски - NLM (National Library of Medicine)

evomela- melphalan injection, powder, lyophilized, for solution

acrotech biopharma inc - melphalan hydrochloride (unii: 1vxp4v453t) (melphalan - unii:q41or9510p) - evomela is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. history of serious allergic reaction to melphalan. risk summary based on its mechanism of action, evomela can cause fetal harm when administered to a pregnant woman, including teratogenicity and/or embryo-fetal lethality [see clinical pharmacology (12.1)] . melphalan is a genotoxic drug and can cause chromatid or chromosome damage in humans [see nonclinical toxicology (13.1)] . in animal studies, melphalan was embryolethal and teratogenic in rats at doses below the recommended clinical doses [see data] . advise a pregnant woman of the potential risk to a fetus.. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background risk in the u.s. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. data   animal data adequate ani

EVOMELA- melphalan injection, powder, lyophilized, for solution САЩ - английски - NLM (National Library of Medicine)

evomela- melphalan injection, powder, lyophilized, for solution

cenexi - bla - melphalan hydrochloride (unii: 1vxp4v453t) (melphalan - unii:q41or9510p) - evomela is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. history of serious allergic reaction to melphalan. risk summary based on its mechanism of action, evomela can cause fetal harm when administered to a pregnant woman, including teratogenicity and/or embryo-fetal lethality [see clinical pharmacology ( 12.1)] . melphalan is a genotoxic drug and can cause chromatid or chromosome damage in humans [see nonclinical toxicology ( 13.1)] . in animal studies, melphalan was embryolethal and teratogenic in rats at doses below the recommended clinical doses [see data] . advise a pregnant woman of the potential risk to a fetus.. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background risk in the u.s. general population of major birth def

Melphalan Tillomed 50 mg inj./inf. sol. (pwdr. + solv.) i.arter./i.v. vial Белгия - английски - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

melphalan tillomed 50 mg inj./inf. sol. (pwdr. + solv.) i.arter./i.v. vial

tillomed pharma gmbh - melperone hydrochloride 55,973 mg - eq. melphalan 50 mg - powder and solvent for solution for injection/infusion - 50 mg - melperone hydrochloride 55.973 mg - melphalan

Alkeran Нова Зеландия - английски - Medsafe (Medicines Safety Authority)

alkeran

pharmacy retailing (nz) ltd t/a healthcare logistics - melphalan 50mg - solution for injection - 50 mg - active: melphalan 50mg excipient: hydrochloric acid povidone ethanol propylene glycol sodium citrate dihydrate

Alkeran 50mg, Powder and Solvent for Solution for Infusion Ирландия - английски - HPRA (Health Products Regulatory Authority)

alkeran 50mg, powder and solvent for solution for infusion

aspen pharma trading limited - melphalan - powder and solvent for solution for infusion - 50 milligram(s) - nitrogen mustard analogues; melphalan

Alkeran 2 mg Film-coated Tablets Ирландия - английски - HPRA (Health Products Regulatory Authority)

alkeran 2 mg film-coated tablets

aspen pharma trading limited - melphalan - film-coated tablet - 2 milligram(s) - nitrogen mustard analogues; melphalan