ABD - İngilizce - 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

ABD - İngilizce - 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

Singapur - İngilizce - 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

Birleşik Krallık - İngilizce - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - peginterferon alfa-2b - powder and solvent for solution for injection - 50microgram

Birleşik Krallık - İngilizce - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - peginterferon alfa-2b - powder and solvent for solution for injection - 80microgram

Birleşik Krallık - İngilizce - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - peginterferon alfa-2b - powder and solvent for solution for injection - 120microgram

Birleşik Krallık - İngilizce - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - peginterferon alfa-2b - powder and solvent for solution for injection - 150microgram

Birleşik Krallık - İngilizce - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - peginterferon alfa-2b - powder and solvent for solution for injection - 100microgram

Yeni Zelanda - İngilizce - 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.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

unigene uk ltd. - recombinant salmon calcitonin - hypercalcemia; osteitis deformans; bone resorption - calcium homeostasis - calcitonin is indicated for:prevention of acute bone loss due to sudden immobilisation such as in patients with recentosteoporotic fracturespaget's diseasehypercalcaemia of malignancy