United States - English - NLM (National Library of Medicine)

merck sharp & dohme llc - bezlotoxumab (unii: 4h5ymk1h2e) (bezlotoxumab - unii:4h5ymk1h2e) - bezlotoxumab 25 mg in 1 ml - zinplava™ is indicated to reduce recurrence of clostridioides difficile infection (cdi) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for cdi and are at a high risk for cdi recurrence. limitation of use: zinplava is not indicated for the treatment of cdi. zinplava is not an antibacterial drug. zinplava should only be used in conjunction with antibacterial drug treatment of cdi. [see dosage and administration (2.1).] none. risk summary adequate and well controlled studies with zinplava have not been conducted in pregnant women. no animal reproductive and developmental studies have been conducted with bezlotoxumab. the background risk of major birth defects and miscarriage for the indicated population is 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. risk summary there is no information regarding the presence of bezlotoxumab in human m

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - bezlotoxumab -

Israel - English - Ministry of Health

merck sharp & dohme israel ltd - bezlotoxumab - concentrate for solution for infusion - bezlotoxumab 25 mg / 1 ml - bezlotoxumab - zinplava is indicated for the prevention of recurrence of clostridium difficile infection (cdi) in adults who are receiving antibacterial drug treatment of cdi and are at high risk for recurrence of cdi

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - bezlotoxumab - enterocolitis, pseudomembranous - immune sera and immunoglobulins, - zinplava is indicated for the prevention of recurrence of clostridium difficile infection (cdi) in adults at high risk for recurrence of cdi.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - bezlotoxumab - solution for infusion - 25mg/1ml

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

msd k.k. - bezlotoxumab (genetical recombination) - injection

Australia - English - Department of Health (Therapeutic Goods Administration)

bristol-myers squibb australia pty ltd - elotuzumab, quantity: 440 mg - injection, powder for - excipient ingredients: sodium citrate dihydrate; citric acid monohydrate; sucrose; polysorbate 80; water for injections - empliciti (elotuzumab) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

bristol-myers squibb australia pty ltd - elotuzumab, quantity: 340 mg - injection, powder for - excipient ingredients: sodium citrate dihydrate; citric acid monohydrate; sucrose; polysorbate 80; water for injections - empliciti (elotuzumab) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

United States - English - NLM (National Library of Medicine)

e.r. squibb & sons, l.l.c. - elotuzumab (unii: 1351pe5ugs) (elotuzumab - unii:1351pe5ugs) - elotuzumab 300 mg - none. there are no available data on empliciti use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. animal reproduction studies have not been conducted with elotuzumab. empliciti is administered in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone. lenalidomide and pomalidomide can cause embryo-fetal harm and are contraindicated for use in pregnancy. refer to the lenalidomide, pomalidomide and dexamethasone prescribing information for additional information. lenalidomide and pomalidomide are only available through a rems program. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. there are no data on the presence of empliciti in hum