European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.    - recombinant modified vaccinia ankara bavarian nordic virus encoding the: ebola virus zaire (zebov) mayinga strain glycoprotein (gp); ebola virus sudan gulu strain gp; ebola virus taï forest strain nucleoprotein and the marburg virus musoke strain gp - hemorrhagic fever, ebola - vaccines - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.,

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.    - recombinant adenovirus type 26 (ad26) encoding the glycoprotein (gp) of the ebola virus zaire (zebov) mayinga strain - hemorrhagic fever, ebola - vaccines - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.,

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein - hemorrhagic fever, ebola - vaccines - ervebo is indicated for active immunization of individuals 1 year of age or older to protect against ebola virus disease (evd) caused by zaire ebola virus.the use of ervebo should be in accordance with official recommendations.

Canada - English - Health Canada

merck canada inc - ebola zaÏre vaccine (rvsv [delta] g-zebov-gp, live) - solution - 72000000pfu - ebola zaÏre vaccine (rvsv [delta] g-zebov-gp, live) 72000000pfu

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

ridgeback biotherapeutics, lp - ansuvimab (unii: tg8iq19ng2) (ansuvimab - unii:tg8iq19ng2) - ebanga is indicated for the treatment of infection caused by zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is rt-pcr positive for zaire ebolavirus infection [see dosage and administration (2.2) and clinical studies (14)] . limitations of use: the efficacy of ebanga has not been established for other species of the ebolavirus and marburgvirus genera. zaire ebolavirus can change over time, and factors such as emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. consider available information on drug susceptibility patterns for circulating zaire ebolavirus strains when deciding whether to use ebanga. none . risk summary zaire ebolavirus infection is life-threatening for both the mother and fetus and treatment should not be withheld due to pregnancy (

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

recombinant) solution for injection 0.5ml pre-filled syringes (imported (united states) - recombinant haemagglutinin proteins - solution for injection

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

wyeth biopharma division of wyeth pharmaceuticals llc - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 1000 [iu] in 5 ml - benefix® , coagulation factor ix (recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia b (congenital factor ix deficiency or christmas disease) for: limitation of use benefix is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3)] . benefix is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein. risk summary there are no data with benefix use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with benefix. it is not known whether benefix can affect reproductive capacity or cause fetal harm when given to pregnant women. 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 informa

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

novo nordisk - coagulation factor viia recombinant human (unii: ac71r787ov) (coagulation factor viia recombinant human - unii:ac71r787ov) - coagulation factor viia recombinant human 1 mg in 1 ml - novoseven rt, coagulation factor viia (recombinant), is indicated for: none known. risk summary there are no adequate and well-controlled studies using novoseven rt in pregnant women to determine whether there is a drug-associated risk. treatment of rats and rabbits with novoseven in reproduction studies has been associated with mortality at doses up to 6 mg per kg body weight and 5 mg per kg body weight respectively. at 6 mg per kg body weight in rats, the abortion rate was 0 out of 25 litters; in rabbits at 5 mg per kg body weight, the abortion rate was 2 out of 25 litters. twenty-three out of 25 female rats given 6 mg per kg body weight of novoseven gave birth successfully, however, two of the 23 litters died during the early period of lactation. no evidence of teratogenicity was observed after dosing with novoseven. 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

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

antares pharma, inc. - hyaluronidase (human recombinant) (unii: 743quy4vd8) (hyaluronidase (human recombinant) - unii:743quy4vd8) - hyaluronidase (human recombinant) 150 [usp'u] in 1 ml - hylenex recombinant is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. hylenex recombinant is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs. hylenex recombinant is indicated as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. hylenex recombinant is contraindicated in patients with known hypersensitivity to hyaluronidase or any of the excipients in hylenex recombinant. discontinue hylenex recombinant if sensitization occurs. risk summary there are no adequate and well-controlled studies of hylenex recombinant administration in pregnant women to inform a drug-associated risk. subcutaneous administration of hylenex recombinant to pregnant mice throughout organogenesis did not produce teratogenic effects at clinically relevant doses. administration of hylenex recombinant to mice in a pre-/postnatal study did not produce adverse effects on offspring at clinically relevant doses. human data limited available data with hylenex recombinant in pregnant women have not identified any potential risks. animal data in an embryofetal development study, subcutaneous administration of hyaluronidase to pregnant mice throughout organogenesis produced reduced fetal weight and increased numbers of fetal resorptions at daily doses greater or equal to 3 mg/kg (approximately 360,000 usp units/kg). no malformations were produced at any dose up to approximately 18 mg/kg (approximately 2,200,000 usp units/kg). these doses are several orders of magnitude greater than the maximum recommended human dose (5 usp units/kg). in a pre- and postnatal development study, mice were dosed daily by subcutaneous injection with hyaluronidase at dose levels up to 9 mg/kg (approximately 1,100,000 usp units/kg). the study found no adverse effects on sexual maturation, learning and memory of offspring, or their ability to produce another generation of offspring. risk summary there is no information regarding the presence of hylenex recombinant in human milk, the effects on the breastfed infants, or the effects on milk production to inform risk of hylenex recombinant to an infant during lactation. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for hylenex recombinant. clinical hydration requirements for children can be achieved through administration of subcutaneous fluids facilitated with hylenex recombinant. the dosage of subcutaneous fluids administered is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. the potential for chemical or physical incompatibilities should be kept in mind [see drug interactions (7)]. the rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion. for premature infants or during the neonatal period, the daily dosage should not exceed 25 ml/kg of body weight, and the rate of administration should not be greater than 2 ml per minute. during subcutaneous fluid administration, special care must be taken in pediatric patients to avoid over hydration by controlling the rate and total volume of the infusion [see dosage and administration (2.1)]. no overall differences in safety or effectiveness have been observed between elderly and younger adult patients.

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

merck sharp & dohme (australia) pty ltd - hepatitis b surface antigen recombinant, quantity: 10 microgram/ml - injection, suspension - excipient ingredients: aluminium; borax; sodium chloride; water for injections - h-b-vax ii is indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. adolescent vaccination is not necessary for children who have received a primary course of hepatitis b vaccine. vaccination is recommended in adults who ar at substantial risk of hepatitis b virus infection and have demonstrated or judged to be susceptible. vaccination of individuals who have antibodies against hepatitis b virus from a previous infection is not necessary.