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

biomarin pharmaceutical inc. - galsulfase (unii: 59ua429e5g) (galsulfase - unii:59ua429e5g) - galsulfase 5 mg in 5 ml - naglazyme is indicated for patients with mucopolysaccharidosis vi (mps vi, maroteaux-lamy syndrome).  naglazyme has been shown to improve walking and stair-climbing capacity. none. risk summary available data from case reports and postmarketing experience with naglazyme use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, galsulfase administered intravenously to pregnant rats and rabbits during the period of organogenesis, showed no evidence of harm to the fetus at doses of about 0.5 and 0.97 times, respectively for rats and rabbits, the recommended human dose of 1 mg/kg based on body surface area (see data) .   the estimated background risk of major birth defects and miscarriage for the indicated population is unknown.  all pregnancies have a background risk of birth defects, loss, or other adverse outcomes.  in the u.s. general population, the estimated background risk of majo

Israel - English - Ministry of Health

medison pharma ltd - galsulfase - concentrate for solution for infusion - galsulfase 1 mg/ml - galsulfase - galsulfase - naglazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of mpsvi (n-acetylglactosamine 4 sulfatase deficiency maroteaux-lamy syndrome).

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

biomarin pharmaceutical australia pty ltd - galsulfase, quantity: 5 mg - injection, concentrated - excipient ingredients: monobasic sodium phosphate monohydrate; water for injections; dibasic sodium phosphate heptahydrate; polysorbate 80; sodium chloride - for the long-term enzyme replacement therapy in patients with mucopolysaccharidosis vi (mps vi - n acetylgalactosamine 4-sulfatase deficiency)

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

general injectables and vaccines, inc - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate 1 mg in 1 ml - neostigmine methylsulfate injection, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (nmba) after surgery.  neostigmine is contraindicated in patients with: - known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis).  - peritonitis or mechanical obstruction of the urinary or intestinal tracts. pregnancy risk summary there are no adequate or well-controlled studies of neostigmine methylsulfate injection in pregnant women.  it is not known whether neostigmine methylsulfate injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.  the incidence of malformations in human pregnancies has not been established for neostigmine as the data are limited.  all pregnancies, regardless of drug e

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

fresenius kabi usa, llc - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate 0.5 mg in 1 ml - neostigmine methylsulfate injection, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (nmba) after surgery.  neostigmine is contraindicated in patients with: - known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis).  - peritonitis or mechanical obstruction of the urinary or intestinal tracts. risk summary there are no adequate or well-controlled studies of neostigmine methylsulfate injection in pregnant women.  it is not known whether neostigmine methylsulfate injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.  the incidence of malformations in human pregnancies has not been established for neostigmine as the data are limited.  all pregnancies, regardless of drug exposure, h

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

avadel legacy pharmaceuticals, llc - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate 0.5 mg in 1 ml - bloxiverz is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. bloxiverz is contraindicated in patients with: - known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis). - peritonitis or mechanical obstruction of the intestinal or urinary tract. risk summary there are no adequate or well-controlled studies of bloxiverz in pregnant women. it is not known whether bloxiverz can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. the incidence of malformations in human pregnancies has not been established for neostigmine as the data are limited. all pregnancies, regardless of drug exposure, have a background risk of 2 to 4% for major birth defects, and 15 to 20% for pregnancy loss

Malta - English - Medicines Authority

mercury pharmaceuticals (ireland) limited 4045 kingswood road, city west business park, co, dublin, ireland - neostigmine metilsulfate - solution for injection - neostigmine metilsulfate 2.5 mg/ml - other nervous system drugs

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

juno pharmaceuticals pty ltd - neostigmine methylsulfate, quantity: 2.5 mg - injection, solution - excipient ingredients: water for injections; sodium chloride - neostigmine is indicated for:,? reversal of the effects of non-depolarising neuromuscular blocking agents.,? prophylaxis and treatment of post-operative intestinal atony and urinary retention.,? treatment of myasthenia gravis during acute exacerbations, when the condition is severe or in neonates.

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

special order - laurilsulfate - liquid - 100mg/1ml

New Zealand - English - Medsafe (Medicines Safety Authority)

max health limited - neostigmine metilsulfate 2.5 mg/ml - solution for injection - 2.5 mg/ml - active: neostigmine metilsulfate 2.5 mg/ml excipient: nitrogen sodium chloride water for injection - · propylaxis and treatment of post-operative intestinal atony and urinary retention.