Stati Uniti - Ingliż - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - anti-inhibitor coagulant complex (unii: cs849dun3m) (anti-inhibitor coagulant complex - unii:cs849dun3m) - anti-inhibitor coagulant complex 500 [usp'u] in 20 ml - feiba is an anti-inhibitor coagulant complex indicated for use in hemophilia a and b patients with inhibitors for: - control and prevention of bleeding episodes - perioperative management - routine prophylaxis to prevent or reduce the frequency of bleeding episodes. feiba is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor viii or coagulation factor ix. - known anaphylactic or severe hypersensitivity reactions to feiba or any of its components, including factors of the kinin generating system. - disseminated intravascular coagulation (dic). - acute thrombosis or embolism (including myocardial infarction). risk summary there are no data with feiba use in pregnant women to inform a drug-associated risk. there are no adequate and well-controlled studies in pregnant women. animal reproduction studies have not been conducted with feiba. it is also not known whether feiba can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. in the u.s. general population, the estimated background risk for major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. there is no information available on the effect of feiba on labor and delivery. risk summary there is no information regarding the presence of feiba in human milk, the effect on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for feiba and any potential adverse effects on the breastfed child from feiba or from the underlying condition. safety and efficacy of feiba have been evaluated in nine pediatric subjects treated in the routine prophylaxis trial including 4 subjects ≥7 to <12 years of age and 5 subjects ≥12 to <16 years of age. the dosing for all pediatric subjects was based on body weight. a total of 576 infusions were given for the treatment of 223 bleeding episodes (504 infusions for joint bleeding episodes, 72 infusions for muscle and soft tissue bleeding episodes). in 223 (100%) of the episodes, hemostasis was achieved with one or more infusions. hemostatic efficacy was rated as excellent or good in a majority (96.9%) of the bleeding episodes in both regimens at 24 hours post infusion. the median annualized bleeding episode rate (abr) for children ≥7 to <12 years of age was 7.7 bleeds per patient per year, as compared to 39 for subjects treated with on-demand therapy [see clinical studies (14)] . the safety and efficacy of feiba has not been evaluated in neonates. the safety and efficacy of feiba has not been evaluated in subjects ≥65 years of age.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 1000 mg - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 1000 u - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 500 u - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

Ingilterra - Ingliż - MHRA (Medicines & Healthcare Products Regulatory Agency)

1,000unit) powder and 20ml solvent for solution for infusion vials (takeda uk ltd - factor viii inhibitor bypassing fraction - powder and solvent for solution for infusion - 1000unit

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

draeger australia pty ltd - 34142 - valve, maximum pressure control, single use - the hi-flow star valve kit is intended to connect into an adult breathing circuit for high-flow therapy to limit the maximum pressure in the breathing system. intended for single use only.

Awstralja - Ingliż - APVMA (Australian Pesticides and Veterinary Medicines Authority)

nutrien ag solutions limited - chlorpyrifos; liquid hydrocarbon - emulsifiable concentrate - chlorpyrifos organophosphorus active 500.0 g/l; liquid hydrocarbon solvent other 453.0 g/l - insecticide - annual pasture-improved | apple | asparagus | avocado | banana | barley | bean | beetroot | brassica spp. or cole crop | broad b - african black beetle | ant | argentine ant | argentine stem weevil | australian plague locust | avocado leafroller | banana flower thrips | banana scab moth | banana weevil borer | black beetle | blackheaded pasture cockchafer | blue oat or pea mite | bluegreen aphid | brown pasture looper | brown planthopper | cabbage aphid | cabbage cluster caterpillar | cabbage moth | cabbage white butterfly | california red scale | caterpillar | citrus leaf-eating weevil | citrus mealy bug | citrus rust thrip | cluster caterpillar | cockroach | cockroach infestation - heavy/residual | cockroach infestation - light | common armyworm - mythimna convecta | common cutworm - agrotis infusa | common mango scale | corn aphid | corn earworm | cotton aphid | cotton flea beetle | cricket | cutworm | cutworm - agrotis spp. | earwig | european earwig | false wireworm - celibe spp. | field cricket | flea | fruiteating weevil | fuller's rose weevil | funnel ant | grapevine moth | grapevine scale | green peach aphid | green tree ant | g