United States - English - 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

United States - English - 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

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

protein sciences corporation - influenza a virus a/california/7/2009 (h1n1) recombinant hemagglutinin antigen (unii: 1se9z7d2qr) (influenza a virus a/california/7/2009 (h1n1) recombinant hemagglutinin antigen - unii:1se9z7d2qr), influenza a virus a/victoria/361/2011 (h3n2) recombinant hemagglutinin antigen (unii: k5313h4vgs) (influenza a virus a/victoria/361/2011 (h3n2) recombinant hemagglutinin antigen - unii:k5313h4vgs), influenza b virus b/wisconsin/1/2010 recombinant hemagglutinin antigen (unii: n9c76986u2) (influenza b virus b/wisco - influenza a virus a/california/7/2009 (h1n1) recombinant hemagglutinin antigen 45 ug in 0.5 ml - flublok is a vaccine indicated for active immunization against disease caused by influenza virus subtypes a and type b contained in the vaccine. flublok is approved for use in persons 18 through 49 years of age. flublok is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis), to any component of the vaccine (see description [11]).  reproduction studies have been performed in rats at a dose approximately 300 times the human dose (on a mg/kg basis) and have revealed no evidence of impaired fertility or harm to the fetus due to flublok. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this vaccine should be used during pregnancy only if clearly needed. the effect of flublok on embryo-fetal and pre-weaning development was evaluated in pregnant rats. animals were administered flublok by intramuscular injection twice prior to gestation and once during the period of organ

Singapore - English - HSA (Health Sciences Authority)

pharmeng technology pte. ltd. - sars-cov-2 recombinant spike protein (omicron xbb.1.5) - injection, suspension - sars-cov-2 recombinant spike protein (omicron xbb.1.5) 5 µg/dose

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - recombinant cholera toxin b subunit 1mg; vibrio cholerae inaba 48 classical biotype 31250 million organisms (heat inactivated); vibrio cholerae inaba 6973 el tor biotype 31250 million organisms (formalin inactivated); vibrio cholerae ogawa 50 classical biotype 62500 million organisms (equal parts heat inactivated and formalin inactivated) - oral suspension - active: recombinant cholera toxin b subunit 1mg vibrio cholerae inaba 48 classical biotype 31250 million organisms (heat inactivated) vibrio cholerae inaba 6973 el tor biotype 31250 million organisms (formalin inactivated) vibrio cholerae ogawa 50 classical biotype 62500 million organisms (equal parts heat inactivated and formalin inactivated) excipient: dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate sodium chloride water for injection citric acid raspberry flavour 52383 ap0551 saccharin sodium sodium bicarbonate sodium carbonate sodium citrate dihydrate citric acid raspberry flavour 52383 ap0551 saccharin sodium sodium bicarbonate sodium carbonate sodium citrate - active immunisation of adults and children from two years of age, who will be visiting areas with an ongoing or anticipated epidemic or who will be spending an extended period of time in areas in which cholera infection is a risk. the vaccine should be considered for foreign aid workers and others intending to visit or spend an extended period of time in areas endemic or epidemic for cholera.

Israel - English - Ministry of Health

j-c health care ltd - recombinant human erythropoietin - solution for injection - recombinant human erythropoietin 1000 iu / 0.5 ml - erythropoietin - erythropoietin - treatment of severe anemia associated with chronic renal failure, anemia in zidovudine treated hiv infected patients, anemia in cancer patients on chemotherapy.to increase the yield of autologous blood from patients in a predonation programme initiated to avoid the use of homologous blood. treatment is indicated in patients with moderate anemia (packed cell volume (pcv) approximately 33 to 39% , no iron deficiency) if blood conserving procedures are not available or insufficient either: a: when the scheduled major elective surgery requires a large volume of blood ( 4 or more units of blood for females or 5 or more units for males) or b: when the period necessary to obtain the required volume of autologous blood is too short. perisurgery: reduction of allogeneic blood transfusion in surgery patients : eprex is indicated for the treatment of anemic patients (hemoglobin 9-11 g/dl) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions. eprex is indicated for patients at high risk for periopertive transfusions with significant, anticipated blood loss. eprex is not indicated for anemic patients who are willing to donate autologous blood. the safety of the perioperative use of eprex has been studied only in patients who are receiving anticoagulant prophylaxis. eprex is indicated before surgerios known be associated with excessive blood loss (at least 2 units ).

Israel - English - Ministry of Health

j-c health care ltd - recombinant human erythropoietin - solution for injection - recombinant human erythropoietin 2000 iu / 0.5 ml - erythropoietin - erythropoietin - treatment of severe anemia associated with chronic renal failure, anemia in zidovudine treated hiv infected patients, anemia in cancer patients on chemotherapy.to increase the yield of autologous blood from patients in a predonation programme initiated to avoid the use of homologous blood. treatment is indicated in patients with moderate anemia (packed cell volume (pcv) approximately 33 to 39% , no iron deficiency) if blood conserving procedures are not available or insufficient either: a: when the scheduled major elective surgery requires a large volume of blood ( 4 or more units of blood for females or 5 or more units for males) or b: when the period necessary to obtain the required volume of autologous blood is too short. perisurgery: reduction of allogeneic blood transfusion in surgery patients : eprex is indicated for the treatment of anemic patients (hemoglobin 9-11 g/dl) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions. eprex is indicated for patients at high risk for periopertive transfusions with significant, anticipated blood loss. eprex is not indicated for anemic patients who are willing to donate autologous blood. the safety of the perioperative use of eprex has been studied only in patients who are receiving anticoagulant prophylaxis. eprex is indicated before surgerios known be associated with excessive blood loss (at least 2 units ).

Israel - English - Ministry of Health

j-c health care ltd - recombinant human erythropoietin - solution for injection - recombinant human erythropoietin 4000 iu / 0.4 ml - erythropoietin - erythropoietin - treatment of severe anemia associated with chronic renal failure, anemia in zidovudine treated hiv infected patients, anemia in cancer patients on chemotherapy.to increase the yield of autologous blood from patients in a predonation programme initiated to avoid the use of homologous blood. treatment is indicated in patients with moderate anemia (packed cell volume (pcv) approximately 33 to 39% , no iron deficiency) if blood conserving procedures are not available or insufficient either: a: when the scheduled major elective surgery requires a large volume of blood ( 4 or more units of blood for females or 5 or more units for males) or b: when the period necessary to obtain the required volume of autologous blood is too short. perisurgery: reduction of allogeneic blood transfusion in surgery patients : eprex is indicated for the treatment of anemic patients (hemoglobin 9-11 g/dl) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions. eprex is indicated for patients at high risk for periopertive transfusions with significant, anticipated blood loss. eprex is not indicated for anemic patients who are willing to donate autologous blood. the safety of the perioperative use of eprex has been studied only in patients who are receiving anticoagulant prophylaxis. eprex is indicated before surgerios known be associated with excessive blood loss (at least 2 units ).

Israel - English - Ministry of Health

j-c health care ltd - recombinant human erythropoietin - solution for injection - recombinant human erythropoietin 10000 iu/ml - erythropoietin - erythropoietin - treatment of severe anemia associated with chronic renal failure, anemia in zidovudine treated hiv infected patients, anemia in cancer patients on chemotherapy.to increase the yield of autologous blood from patients in a predonation programme initiated to avoid the use of homologous blood. treatment is indicated in patients with moderate anemia (packed cell volume (pcv) approximately 33 to 39% , no iron deficiency) if blood conserving procedures are not available or insufficient either: a: when the scheduled major elective surgery requires a large volume of blood ( 4 or more units of blood for females or 5 or more units for males) or b: when the period necessary to obtain the required volume of autologous blood is too short. perisurgery: reduction of allogeneic blood transfusion in surgery patients : eprex is indicated for the treatment of anemic patients (hemoglobin 9-11 g/dl) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions. eprex is indicated for patients at high risk for periopertive transfusions with significant, anticipated blood loss. eprex is not indicated for anemic patients who are willing to donate autologous blood. the safety of the perioperative use of eprex has been studied only in patients who are receiving anticoagulant prophylaxis. eprex is indicated before surgerios known be associated with excessive blood loss (at least 2 units ).

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - recombinant human deoxyribonuclease - solution for inhalation - recombinant human deoxyribonuclease 1 mg/ml - dornase alfa (desoxyribonuclease) - dornase alfa (desoxyribonuclease) - management of cystic fibrosis not for patients under 5 years of age or with fvc<40% .