USA - engelsk - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 250 [iu] in 5 ml - rixubis (coagulation factor ix [recombinant]) is an antihemophilic factor indicated in adults and children with hemophilia b for: - on-demand treatment and control of bleeding episodes - perioperative management of bleeding - routine prophylaxis to reduce the frequency of bleeding episodes. rixubis is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3)] . rixubis is contraindicated in patients who have: - known hypersensitivity to rixubis or its excipients including hamster protein - disseminated intravascular coagulation (dic) [see warnings and precautions (5.4)] - signs of fibrinolysis [see warnings and precautions (5.4)] risk summary there are no data with rixubis use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with rixubis. it is also not known whether rixubis can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. in the u.s. general population,

USA - engelsk - NLM (National Library of Medicine)

novo nordisk - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 62.5 [iu] in 1 ml - novoeight, antihemophilic factor (recombinant), is a human antihemophilic factor (human blood coagulation factor viii (fviii)) indicated for use in adults and children with hemophilia a for: novoeight is not indicated for the treatment of von willebrand disease. novoeight is contraindicated in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to novoeight or its components (including traces of hamster proteins). risk summary as hemophilia mainly affects males, there are no adequate and well-controlled studies using novoeight in pregnant women to determine whether there is a drug-associated risk. animal reproduction studies have not been conducted with novoeight. 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. there is no reliable data on the incidences specific to the hemophilia a population. risk summary there is no information regarding the prese

USA - engelsk - 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.

USA - engelsk - NLM (National Library of Medicine)

baxter healthcare corporation - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 25 [iu] in 1 ml - the use of recombinate [antihemophilic factor (recombinant)] is indicated in hemophilia a (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 recombinate is also indicated in the perioperative management of patients with hemophilia a (classical hemophilia). recombinate can be of therapeutic value in patients with acquired factor viii inhibitors not exceeding 10 bethesda units per ml.3   in clinical studies with recombinate, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 bethesda units per ml. however, in such uses, the dosage of recombinate should be controlled by frequent laboratory determinations of circulating factor viii levels as well as the clinical status of the patient. recombinate is not indicated in von willebrand’s disease. recombinate is contraindicated in patients w

USA - engelsk - 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 250 [iu] in 5 ml - the use of recombinate [antihemophilic factor (recombinant)] is indicated in hemophilia a (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 recombinate is also indicated in the perioperative management of patients with hemophilia a (classical hemophilia). recombinate can be of therapeutic value in patients with acquired factor viii inhibitors not exceeding 10 bethesda units per ml.3   in clinical studies with recombinate, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 bethesda units per ml. however, in such uses, the dosage of recombinate should be controlled by frequent laboratory determinations of circulating factor viii levels as well as the clinical status of the patient. recombinate is not indicated in von willebrand's disease. recombinate is contraindicated in patients w

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

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml - injection, suspension - excipient ingredients: monobasic sodium phosphate; water for injections; sodium chloride; dibasic sodium phosphate dihydrate; aluminium hydroxide hydrate - engerix-b is indicated for active immunisation against hepatitis b virus infection. the nh&mrc* recommend all infants, young children and unvaccinated adolescents receive a primary course of immunisation against hepatitis b. the nh&mrc also recommends immunisation for persons who are at substantial risk and have been demonstrated or judged to be susceptible to the hepatitis b virus. groups identified at increased risk of acquiring hbv infection include: infants born to carrier (hbsag-positive) mothers; individuals for whom post-exposure prophylaxis for hepatitis b is indicated; household contacts (other than sexual partners) of acute and chronic hepatitis b cases and carriers; susceptible sexual contacts. risk occurs in susceptible (anti-hbs negative) partners of hbv carriers and patients with acute hepatitis b; susceptible clients of std (sexually transmitted disease) clinics, and sexually active men who have sex with men are also at increased risk of infection; injecting drug users; haemodialysis patients, hiv-positive individuals and other immunosuppressed adults; patients receiving certain blood products especially patients with clotting disorders receiving blood product concentrates; individuals with chronic liver disease and / or hepatitis c; staff and residents of facilities for the intellectually disabled, including both residential and non-residential care of this group; liver transplant recipients. such individuals should be vaccinated prior to transplantation if seronegative for hepatitis b, as they may be at increased risk of infection from the transplanted organ; staff and inmates of long term correctional facilities; health care workers, dentists, embalmers, tattooists and body-piercers. all staff directly involved in patient care, embalming, or in the handling of human blood or tissue should be vaccinated; individuals adopting children from overseas. these children should be tested for hepatitis b, and if hbsag positive, members of the adoptive family should be vaccinated; others in whom vaccination may be justified include police, members of the armed forces and emergency services staff, depending on the risks of exposure associated with assigned duties. long term travellers to regions of high endemicity, and those residing for some time in such regions who may anticipate close personal contact with local residents, should be vaccinated. short-term tourists or business travellers are at very little risk of hepatitis b, provided they avoid exposure through sexual contact, injecting drug use, tattooing or body piercing. although the risk of hepatitis b infection in contact sports is low, immunisation of those involved should not be discouraged. as the risk in australian schools is very low, vaccination of classroom contacts is seldom indicated. nevertheless, vaccination of school children and adolescents should be encouraged; as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection, it can be expected that hepatitis d will also be prevented by vaccination with engerix-b. the vaccine will not protect against infection caused by hepatitis a, hepatitis c and hepatitis e viruses, and other pathogens known to infect the liver.

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

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 10 microgram - injection, suspension - excipient ingredients: dibasic sodium phosphate dihydrate; aluminium hydroxide hydrate; sodium chloride; monobasic sodium phosphate; water for injections - engerix-b is indicated for active immunisation against hepatitis b virus infection. the nh&mrc* recommend all infants, young children and unvaccinated adolescents receive a primary course of immunisation against hepatitis b. the nh&mrc also recommends immunisation for persons who are at substantial risk and have been demonstrated or judged to be susceptible to the hepatitis b virus. groups identified at increased risk of acquiring hbv infection include: infants born to carrier (hbsag-positive) mothers; individuals for whom post-exposure prophylaxis for hepatitis b is indicated; household contacts (other than sexual partners) of acute and chronic hepatitis b cases and carriers; susceptible sexual contacts. risk occurs in susceptible (anti-hbs negative) partners of hbv carriers and patients with acute hepatitis b; susceptible clients of std (sexually transmitted disease) clinics, and sexually active men who have sex with men are also at increased risk of infection; injecting drug users; haemodialysis patients, hiv-positive individuals and other immunosuppressed adults; patients receiving certain blood products especially patients with clotting disorders receiving blood product concentrates; individuals with chronic liver disease and / or hepatitis c; staff and residents of facilities for the intellectually disabled, including both residential and non-residential care of this group; liver transplant recipients. such individuals should be vaccinated prior to transplantation if seronegative for hepatitis b, as they may be at increased risk of infection from the transplanted organ; staff and inmates of long term correctional facilities; health care workers, dentists, embalmers, tattooists and body-piercers. all staff directly involved in patient care, embalming, or in the handling of human blood or tissue should be vaccinated; individuals adopting children from overseas. these children should be tested for hepatitis b, and if hbsag positive, members of the adoptive family should be vaccinated; others in whom vaccination may be justified include police, members of the armed forces and emergency services staff, depending on the risks of exposure associated with assigned duties. long term travellers to regions of high endemicity, and those residing for some time in such regions who may anticipate close personal contact with local residents, should be vaccinated. short-term tourists or business travellers are at very little risk of hepatitis b, provided they avoid exposure through sexual contact, injecting drug use, tattooing or body piercing. although the risk of hepatitis b infection in contact sports is low, immunisation of those involved should not be discouraged. as the risk in australian schools is very low, vaccination of classroom contacts is seldom indicated. nevertheless, vaccination of school children and adolescents should be encouraged; as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection, it can be expected that hepatitis d will also be prevented by vaccination with engerix-b. the vaccine will not protect against infection caused by hepatitis a, hepatitis c and hepatitis e viruses, and other pathogens known to infect the liver.

USA - engelsk - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - recombinant varicella zoster virus glycoprotein e antigen (unii: cob9ff6i46) (recombinant varicella zoster virus glycoprotein e antigen - unii:cob9ff6i46) - ge: recombinant varicella zoster virus (vzv) glycoprotein e 50 ug in 0.5 ml - shingrix is a vaccine indicated for prevention of herpes zoster (hz) (shingles):     •    in adults aged 50 years and older.     •    in adults aged 18 years and older who are or will be at increased risk of hz due to immunodeficiency or immunosuppression caused by known disease or therapy. limitations of use : do not administer shingrix to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of shingrix [see description (11)] . risk summary all pregnancies have a 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% to 4% and 15% to 20%, respectively. the data are insufficient to establish if there is vaccine-associated risk with shingrix in pregnant women. a developmental toxicity study was performed in female rats administered shingrix or the as01b adjuvant alone prior to mating, during g

USA - engelsk - 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

USA - engelsk - NLM (National Library of Medicine)

novo nordisk - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 500 [iu] in 1 ml - rebinyn, coagulation factor ix (recombinant), glycopegylated, is a recombinant dna-derived coagulation factor ix concentrate indicated for use in adults and children with hemophilia b (congenital factor ix deficiency) for: limitations of use : rebinyn is not indicated for immune tolerance induction in patients with hemophilia b. rebinyn is contraindicated in patients who have known hypersensitivity to rebinyn or its components (including hamster proteins) [see warnings and precautions (5.1) and description (11) ] risk summary there are no data with rebinyn use in pregnant women to determine whether there is a drug-associated risk. animal reproduction studies have not been conducted with rebinyn. it is unknown whether rebinyn can cause fetal harm when administered to a pregnant woman or can affect fertility. 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 informati