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

santarus, inc. - conestat alfa (unii: 5qs67n4551) (conestat alfa - unii:5qs67n4551) - conestat alfa 2100 u - ruconest is a c1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (hae). limitation of use:  effectiveness was not established in hae patients with laryngeal attacks. pregnancy category b. studies performed in rats and rabbits at doses up to 12.5 times the human dose of 50 u/kg could not exclude an effect on embryofetal development. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, ruconest should only be used during pregnancy if clearly needed. the safety and efficacy of ruconest administration prior to or during labor and delivery have not been established. use only if clearly needed. it is not known if ruconest is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when ruconest is administered to a nursing woman. the safety and efficacy of ruconest were evaluated

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

pharming healthcare inc. - conestat alfa (unii: 5qs67n4551) (conestat alfa - unii:5qs67n4551) - conestat alfa 2100 u - ruconest is a c1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (hae). limitation of use: effectiveness was not established in hae patients with laryngeal attacks. - ruconest is contraindicated in patients with a history of allergy to rabbits or rabbit-derived products. - ruconest is contraindicated in patients with a history of life-threatening immediate hypersensitivity reactions to c1 esterase inhibitor preparations, including anaphylaxis. risk summary there are no adequate and well-controlled studies of ruconest in pregnant women. in the u.s. general population, regardless of drug exposure, available data suggest that major birth defects occur in 2 to 4% of the general population and miscarriage occurs in 15 to 20% of clinically recognized pregnancies. data human data limited available postmarketing safety data with ruconest use in pregnant women do not indicate any adverse effects in this population. in a retrospec

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

bioconnection b.v. - conestat alfa (unii: 5qs67n4551) (conestat alfa - unii:5qs67n4551) - ruconest is a c1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (hae). limitation of use: effectiveness was not established in hae patients with laryngeal attacks. - ruconest is contraindicated in patients with a history of allergy to rabbits or rabbit-derived products. - ruconest is contraindicated in patients with a history of life-threatening immediate hypersensitivity reactions to c1 esterase inhibitor preparations, including anaphylaxis. pregnancy category b. studies performed in rats and rabbits at doses up to 12.5 times the human dose of 50 u/kg could not exclude an effect on embryofetal development. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, ruconest should only be used during pregnancy if clearly needed. the safety and efficacy of ruconest administration prior to or during labor and delivery have

Israel - English - Ministry of Health

kamada ltd, israel - conestat alfa - powder for solution for injection - conestat alfa 2100 u/vial - conestat alfa - ruconest is indicated for treatment of acute angioedema attacks in adults and adolescents aged 12 years and above with hereditary angioedema (hae) due to c1 esterase inhibitor deficiency.

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

takeda pharmaceuticals australia pty ltd - lanadelumab, quantity: 300 mg - injection, solution - excipient ingredients: citric acid monohydrate; water for injections; dibasic sodium phosphate dihydrate; polysorbate 80; histidine; sodium chloride - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (c1-esterase-inhibitor deficiency or dysfunction) in patients aged 12 years and older.

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

oxbridge pharma ltd - c1-esterase inhibitor human - powder and solvent for solution for injection - 500unit

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

csl behring uk ltd - c1-esterase inhibitor human - powder and solvent for solution for injection - 2000unit

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

csl behring uk ltd - c1-esterase inhibitor human - powder and solvent for solution for injection - 3000unit

New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - factor viii inhibitor bypassing fraction 1000 u;  ;   - powder for injection with diluent - 1000 u - active: factor viii inhibitor bypassing fraction 1000 u     excipient: sodium chloride sodium citrate dihydrate water for injection - feiba nf is indicated for treatment of haemorrhage and to cover surgical interventions in: · haemophilia a patients with factor viii inhibitors · haemophilia b patients with factor ix inhibitors. feiba nf is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia a subjects with inhibitors experiencing >/= 12 bleeding episodes per year. prophylaxis with feiba nf is recommended for patients with high titer (>5bu) inhibitor or low titer (<5 bu) inhibitor, refractory to increased dosing with fviii or fix.

New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - factor viii inhibitor bypassing fraction 2500 u;  ;   - powder for injection with diluent - 2500 u - active: factor viii inhibitor bypassing fraction 2500 u     excipient: sodium chloride sodium citrate dihydrate water for injection - feiba nf is indicated for treatment of haemorrhage and to cover surgical interventions in: · haemophilia a patients with factor viii inhibitors · haemophilia b patients with factor ix inhibitors. feiba nf is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia a subjects with inhibitors experiencing >/= 12 bleeding episodes per year. prophylaxis with feiba nf is recommended for patients with high titer (>5bu) inhibitor or low titer (<5 bu) inhibitor, refractory to increased dosing with fviii or fix.