Australia - English - 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.

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

bayer healthcare llc - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 1000 [iu] in 2.5 ml - kogenate® fs is a recombinant antihemophilic factor indicated for: kogenate fs is not indicated for the treatment of von willebrand disease. kogenate fs is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product (sucrose, glycine, histidine, sodium, calcium chloride, polysorbate 80, imidazole, tri-n-butyl phosphate, and copper). there are no data with kogenate fs use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted with kogenate fs. it is also not known whether kogenate fs can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. 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 is no information regarding the presence of kogenate fs in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kogenate fs and any potential adverse effects on the breastfed child from kogenate fs or from the underlying maternal condition. safety and efficacy studies have been performed in previously untreated and minimally treated pediatric patients. children, in comparison to adults, present higher factor viii clearance values and, thus, lower half-life and recovery of factor viii. this may be due to differences in body composition.13 account for this difference in clearance when dosing or following factor viii levels in the pediatric population [see clinical pharmacology (12.3)] . routine prophylactic treatment in children ages 0–2.5 years with no pre-existing joint damage has been shown to reduce spontaneous joint bleeding and the risk of joint damage. this data can be extrapolated to ages >2.5–16 years for children who have no existing joint damage [see clinical studies (14)] . clinical studies with kogenate fs did not include patients aged 65 and over. dose selection for an elderly patient should be individualized.

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

takeda pharmaceuticals america, inc. - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 125 [iu] in 1 ml - advate [antihemophilic factor (recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia a (congenital factor viii deficiency) for: - control and prevention of bleeding episodes. - perioperative management. - routine prophylaxis to prevent or reduce the frequency of bleeding episodes. advate is not indicated for the treatment of von willebrand disease. advate is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product (mannitol, trehalose, sodium chloride, histidine, tris, calcium chloride, polysorbate 80, and/or glutathione). risk summary there are no data with advate use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with advate. it is not known whether advate can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity. in the u.s. general popu

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

takeda pharmaceuticals amercia, inc. - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 2 ml - adynovate, antihemophilic factor (recombinant), pegylated, is a human antihemophilic factor indicated in children and adults with hemophilia a (congenital factor viii deficiency) for: - on-demand treatment and control of bleeding episodes - perioperative management - routine prophylaxis to reduce the frequency of bleeding episodes limitation of use adynovate is not indicated for the treatment of von willebrand disease. adynovate is contraindicated in patients who have had prior anaphylactic reaction to adynovate, to the parent molecule (advate), mouse or hamster protein, or excipients of adynovate (e.g. tris, mannitol, trehalose, glutathione, and/or polysorbate 80). risk summary there are no data with adynovate use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with adynovate. it is unknown whether adynovate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no information regarding the presence of adynovate in human milk, the effect on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for adynovate and any potential adverse effects on the breastfed infant from adynovate or from the underlying maternal condition. safety and efficacy studies have been performed in 91 previously treated, pediatric patients age 1 year to <18 years who received at least one dose of adynovate as part of routine prophylaxis, on-demand treatment of bleeding episodes, or perioperative management. adolescent subjects age 12 to <18 (n=25) were enrolled in the adult and adolescent safety and efficacy trial, and subjects <12 years of age (n=66) were enrolled in a pediatric trial. the safety and efficacy of adynovate in routine prophylaxis and the treatment of bleeding episodes were comparable between children and adults. [see clinical studies (14) ] pharmacokinetic studies in children (<12 years) have demonstrated higher clearance, a shorter half-life and lower incremental recovery of factor viii compared to adults. because clearance (based on per kg body weight) has been demonstrated to be higher in children (<12 years), dose adjustment or more frequent dosing based on per kg body weight may be needed in this population. [see clinical pharmacology (12.3) ] clinical studies of adynovate did not include subjects aged 65 and over. adynovate [antihemophilic factor (recombinant), pegylated] (for intravenous use only) do not attempt to do an infusion to yourself unless you have been taught how by your healthcare provider or hemophilia center. step-by-step instructions for reconstituting adynovate are found at the end of this leaflet. always follow the specific instructions given by your healthcare provider. the steps listed below are general guidelines for using adynovate. if you are unsure of the procedures, please call your healthcare provider before using. call your healthcare provider right away if bleeding is not controlled after using adynovate. your healthcare provider will prescribe the dose that you should take. reconstituted product (after mixing dry product with wet diluent) must be used within 3 hours and cannot be stored or refrigerated. your healthcare provider may need to take blood tests from time to time. talk to your healthcare provider before traveling. plan to bring enough adynovate for your treatment during this time. dispose of all materials, including any leftover reconstituted adynovate product, in an appropriate container. - prepare a clean flat surface and gather all the materials you will need for the infusion. check the expiration date, and let the adynovate warm up to room temperature. wash your hands and put on clean exam gloves. if infusing yourself at home, the use of gloves is optional. - check the expiration date, and let the adynovate warm up to room temperature. - wash your hands and put on clean exam gloves. if infusing yourself at home, the use of gloves is optional. - open the adynovate package by peeling away the lid. remove the adynovate from the package and visually inspect the contents of the product and diluent vial. the adynovate powder should be white to off-white in color and the diluent should not contain particles. do not use if discoloration or particles are seen. - place on a flat surface with the diluent vial on top. the diluent vial has a blue stripe. - with one hand holding the adynovate housing, press down firmly on the diluent vial with the other hand until the system is fully collapsed and the diluent flows down into the adynovate vial. both vials will move into the housing when pressed. if you don't see the diluent transfer to the product vial, press the vials again to assure they are completely inserted. do not remove the blue cap until instructed in a later step. - swirl the adynovate gently and continuously until the adynovate is completely dissolved. do not shake . do not refrigerate after reconstitution . inspect the adynovate solution for particulate matter and discoloration prior to administration. the solution should be clear and colorless in appearance. if not, do not use the solution and notify your healthcare provider immediately. - take off the blue cap from the housing and connect the syringe. be careful to not inject air into the adynovate. - turn over the adynovate so that the vial containing the adynovate solution is on top. draw the adynovate solution into the syringe by pulling back the plunger slowly. if the solution does not draw into the syringe, be sure that both vials are pressed firmly together. the contents of more than one vial may be drawn into a single, appropriately sized syringe if you are using more than one vial of adynovate. - disconnect the syringe from the system. attach the infusion needle to the syringe using a winged (butterfly) infusion set, if available. point the needle up and remove any air bubbles by gently tapping the syringe with your finger and slowly and carefully pushing air out of the syringe and needle. - apply a tourniquet and get the injection site ready by wiping the skin well with an alcohol swab (or other suitable solution suggested by your healthcare provider or hemophilia center). - insert the needle into the vein and remove the tourniquet. slowly infuse the adynovate. do not infuse any faster than 10 ml per minute. - take the needle out of the vein and use sterile gauze to put pressure on the infusion site for several minutes. - remove the peel-off label from blister lid and place it in your logbook. clean any spilled blood with a freshly prepared mixture of 1 part bleach and 9 parts water, soap and water, or any household disinfecting solution. - do not recap the needle. place needle, syringe and adynovate system in a hard-walled sharps container for proper disposal. do not dispose of these supplies in ordinary household trash. important: contact your healthcare provider or local hemophilia treatment center if you experience any problems. takeda pharmaceuticals u.s.a., inc. lexington, ma 02421 u.s. license no. 1898 adynovate® , advate® and baxject® are registered trademarks of baxalta incorporated. adynovate® is a registered trademark of baxalta incorporated. takeda® and the takeda logo® are registered trademarks of takeda pharmaceutical company limited. patented: see www.takeda.com/en-us/patents revised: 3/2023

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

bayer healthcare llc - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 2.5 ml - kovaltry is not indicated for the treatment of von willebrand disease. kovaltry is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins [see description (11)]. there are no data with kovaltry use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted using kovaltry. it is not known whether kovaltry can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 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 is no information regarding the presence of kovaltry in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kovaltry and any potential adverse effects on the breastfed infant from kovaltry or from the underlying maternal condition. safety and efficacy studies with kovaltry have been performed in 51 pediatric ptps ≤12 years of age and 43 pediatric pups/mtps <6 years of age [see clinical studies (14)]. body weight adjusted clearance of factor viii in children ≤12 years of age is higher than in adults and adolescents. consider higher or more frequent dosing in children to account for this difference in clearance [see clinical pharmacology (12.3)] . clinical studies with kovaltry did not include patients aged 65 and over to determine whether or not they respond differently from younger patients. however, clinical experience with other factor viii products has not identified differences between the elderly and younger patients. as with any patient receiving recombinant factor viii, dose selection for an elderly patient should be individualized.

Malta - English - Medicines Authority

octapharma (ip) limited - human von willebrand factor; human coagulation factor viii - powder and solvent for solution for injection - human von willebrand factor 500 iu; human coagulation factor viii 500 iu - antihemorrhagics

Malta - English - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - human von, willebrand factor, human coagulation, factor xiii - powder and solvent for solution for injection - human von willebrand factor 1000 iu human coagulation factor viii 1000 iu - antihemorrhagics

Israel - English - Ministry of Health

dover medical & scientific equipment ltd, israel - factor viii (human); von willebrand factor - powder and solvent for solution for injection - von willebrand factor 1000 iu/vial; factor viii (human) 1000 iu/vial - coagulation factor viii - von willebrand disease (vwd) :prevention and treatment of haemorrhage or surgical bleeding in von willebrand disease (vwd), when desmopressin (ddavp) treatment alone is ineffective or contra-indicated.haemophilia a :treatment and prophylaxis of bleeding in patients with haemophilia a (congenital fviii deficiency).

Israel - English - Ministry of Health

dover medical & scientific equipment ltd, israel - factor viii (human); von willebrand factor - powder and solvent for solution for injection - von willebrand factor 500 iu/vial; factor viii (human) 500 iu/vial - coagulation factor viii - von willebrand disease (vwd) :prevention and treatment of haemorrhage or surgical bleeding in von willebrand disease (vwd), when desmopressin (ddavp) treatment alone is ineffective or contra-indicated.haemophilia a :treatment and prophylaxis of bleeding in patients with haemophilia a (congenital fviii deficiency).

Israel - English - Ministry of Health

bayer israel ltd - recombinant human coagulation factor viii - powder and solvent for solution for injection - recombinant human coagulation factor viii 1000 iu - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). kovaltry can be used for all age groups.