USA - engelska - NLM (National Library of Medicine)

kedrion biopharma, inc. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 10 g in 100 ml - gammaked is an immune globulin injection (human) 10% liquid that is indicated for the treatment of: gammaked is indicated for treatment of primary humoral immunodeficiency in patients 2 years of age and older. this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies.(1-4) gammaked is indicated for the treatment of adults and children with idiopathic thrombocytopenic purpura to raise platelet counts to prevent bleeding or to allow a patient with itp to undergo surgery.(5,6) gammaked is indicated for the treatment of cidp in adults to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse. gammaked is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. gammaked is contraindicated in iga deficient patients with antibodies against iga and history of hyperse

USA - engelska - NLM (National Library of Medicine)

grifols usa, llc - human rabies virus immune globulin (unii: 95f619atq2) (human rabies virus immune globulin - unii:95f619atq2) - human rabies virus immune globulin 150 [iu] in 1 ml - rabies vaccine and hyperrab s/d should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. hyperrab s/d should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given. recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the u.s. public health service advisory committee on immunization practices (acip). [19] every exposure to possible rabies infection must be individually evaluated. the following factors should be considered before specific antirabies treatment is initiated: carnivorous wild animals (especially skunks, foxes, coyotes, raccoons, and bobcats) and bats are the animals most commonly infected with rabies and have caused most of the indigenous cases of human rabies

USA - engelska - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 100 mg in 1 ml - gammagard liquid is indicated as replacement therapy for primary humoral immunodeficiency (pi) in adult and pediatric patients two years of age or older. this includes, but is not limited to, common variable immunodeficiency (cvid), x-linked agammaglobulinemia, congenital agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies.1,2 gammagard liquid is indicated as a maintenance therapy to improve muscle strength and disability in adult patients with multifocal motor neuropathy (mmn). gammagard liquid is indicated as a therapy to improve neuromuscular disability and impairment in adult patients with chronic inflammatory demyelinating polyneuropathy (cidp). limitation of use gammagard liquid has not been studied in immunoglobulin-naive patients with cidp. gammagard liquid maintenance therapy in cidp has not been studied for periods longer than 6 months. after responding during an initial treatment period, not all patients require indefinite maintenance therapy with gammagard liquid in order to remain free of cidp symptoms. individualize the duration of any treatment beyond 6 months based upon the patient’s response and demonstrated need for continued therapy. gammagard liquid is contraindicated in patients who have a history of anaphylactic or severe systemic hypersensitivity reactions to administration of human immune globulin. gammagard liquid is contraindicated in iga-deficient patients with antibodies to iga and a history of hypersensitivity. anaphylaxis has been reported with intravenous use of gammagard liquid and is theoretically possible following subcutaneous administration [see warnings and precautions (5.1)] . risk summary animal reproduction studies have not been conducted with gammagard liquid. it is not known whether gammagard liquid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. gammagard liquid should be given to a pregnant woman only if clearly indicated. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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. risk summary there is no information regarding the presence of gammagard liquid in human milk, its effects on the breastfed infant or its effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for gammagard liquid and any potential adverse effects on the breastfed infant from gammagard liquid or from the underlying maternal condition. treatment of primary immunodeficiency (pi) gammagard liquid administered intravenously was evaluated in 15 pediatric subjects with pi (7 subjects aged 2 to <12 years and 8 subjects aged 12 to <16 years) in a multicenter clinical study. gammagard liquid administered subcutaneously was evaluated in 18 pediatric subjects with pi (14 subjects aged 2 to <12 years and 4 subject aged 12 to <16 years) in another multicenter clinical study. the safety and efficacy profiles were similar to adult subjects. no pediatric-specific dose requirements were necessary to achieve the desired serum igg levels. safety and efficacy of gammagard liquid in pediatric patients below the age of 2 have not been established. treatment of multifocal motor neuropathy (mmn) and chronic inflammatory demyelinating polyneuropathy (cidp) safety and effectiveness in pediatric patients with mmn and cidp have not been established. treatment of primary immunodeficiency (pi) limited information is available for the geriatric use of gammagard liquid. gammagard liquid administered intravenously and subcutaneously was evaluated in two pi studies with a total of 8 subjects over the age of 65 years. no differences in safety or efficacy were observed for this group. monitor patients who are at an increased risk for developing renal failure or thrombotic events. do not exceed the recommended dose. infuse at the minimum intravenous infusion rate practicable [see boxed warning, warnings and precautions (5.2, 5.4) and dosage and administration (2.5)] . treatment of multifocal motor neuropathy (mmn) gammagard liquid was administered intravenously for treatment of mmn in 5 subjects aged 65 years and above. there was an insufficient number of subjects aged 65 years and above to determine whether they respond differently from younger subjects [see boxed warning, warnings and precautions (5.2, 5.4) and dosage and administration (2.5)] . treatment of chronic inflammatory demyelinating polyneuropathy (cidp) gammagard liquid was administered intravenously for the treatment of cidp in 5 subjects aged 65 years and above and 15 subjects aged below 65 years. there was an insufficient number of subjects aged 65 years and above to determine whether they respond differently from younger subjects. [see boxed warning, warnings and precautions (5.2, 5.4) and dosage and administration (2.5)] .

Singapore - engelska - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - human papillomavirus type 11 l1 protein; human papillomavirus type 16 l1 protein; human papillomavirus type 18 l1 protein; human papillomavirus type 6 l1 protein - solution, sterile - 40 mcg - human papillomavirus type 11 l1 protein 40 mcg; human papillomavirus type 16 l1 protein 40 mcg; human papillomavirus type 18 l1 protein 20 mcg; human papillomavirus type 6 l1 protein 20 mcg

Singapore - engelska - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - human papillomavirus type 11 l1 protein; human papillomavirus type 16 l1 protein; human papillomavirus type 18 l1 protein; human papillomavirus type 6 l1 protein - solution, sterile - 40 mcg - human papillomavirus type 11 l1 protein 40 mcg; human papillomavirus type 16 l1 protein 40 mcg; human papillomavirus type 18 l1 protein 20 mcg; human papillomavirus type 6 l1 protein 20 mcg

Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - human papillomavirus type 6 l1 protein; human papillomavirus type 31 l1 protein; human papillomavirus type 58 l1 protein; human papillomavirus type 52 l1 protein; human papillomavirus type 11 l1 protein; human papillomavirus type 16 l1 protein; human papillomavirus type 18 l1 protein; human papillomavirus type 33 l1 protein; human papillomavirus type 45 l1 protein - suspension for injection

USA - engelska - NLM (National Library of Medicine)

grifols usa, llc - human rho(d) immune globulin (unii: 48w7181flp) (human rho(d) immune globulin - unii:48w7181flp) - human rho(d) immune globulin 1500 [iu] - hyperrho s/d full dose is recommended for the prevention of rh hemolytic disease of the newborn by its administration to the rho (d) negative mother within 72 hours after birth of an rho (d) positive infant,(12) providing the following criteria are met: - the mother must be rho (d) negative and must not already be sensitized to the rho (d) factor. the mother must be rho (d) negative and must not already be sensitized to the rho (d) factor. - her child must be rho (d) positive, and should have a negative direct antiglobulin test (see precautions). her child must be rho (d) positive, and should have a negative direct antiglobulin test (see precautions). if hyperrho s/d full dose is administered antepartum, it is essential that the mother receive another dose of hyperrho s/d full dose after delivery of an rho (d) positive infant. if the father can be determined to be rho (d) negative, hyperrho s/d full dose need not be given. hyperrho s/d full dose should be administered within 72 hours to all nonimmuni

USA - engelska - NLM (National Library of Medicine)

novartis vaccines and diagnostics limited - influenza a virus a/christchurch/16/2010 nib-74 (h1n1) antigen (propiolactone inactivated) (unii: h41xp0e6g8) (influenza a virus a/christchurch/16/2010 nib-74 (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:w3d48fdo26) - influenza a virus a/christchurch/16/2010 nib-74 (h1n1) hemagglutinin antigen (propiolactone inactivated) 15 ug in 0.5 ml

USA - engelska - NLM (National Library of Medicine)

novo nordisk - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 100 [iu] in 1 ml - novolin r is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. novolin r is contraindicated: risk summary available data from published studies over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes (see data). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). animal reproduction studies were not performed. the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20-25% in women with a hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. 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. clinical considerations diseas

Australien - engelska - APVMA (Australian Pesticides and Veterinary Medicines Authority)

bioproperties pty. ltd. - newcastle disease strain v-4 virus - misc. vaccines or anti sera - newcastle disease strain v-4 virus vaccine-viral active 0.0 eid 50/d - immunotherapy - poultry broilers (meat for human consum) | chickens | chooks | meat birds - newcastle disease