Tsjekkia - tsjekkisk - SUKL (Státní ústav pro kontrolu léčiv)

baxalta innovations gmbh, vídeň array - 5167 normÁlnÍ lidskÝ imunoglobulin pro intravenÓznÍ podÁnÍ - prášek a rozpouštědlo pro infuzní roztok - 50mg/ml - imunoglobuliny, normÁlnÍ lidskÉ, pro intravaskulÁrnÍ aplikaci

USA - engelsk - 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)] .

USA - engelsk - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 50 mg in 1 ml - primary immunodeficiency (pi) gammagard s/d is indicated for the treatment of primary immunodeficiency (pi) associated with defects in humoral immunity, in adults and children two years and older. this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, wiskott-aldrich syndrome, and severe combined immunodeficiencies.1,2,3 b-cell chronic lymphocytic leukemia (cll) gammagard s/d is indicated for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with b-cell chronic lymphocytic leukemia (cll).4 idiopathic thrombocytopenic purpura (itp) gammagard s/d is indicated for the treatment of adult chronic idiopathic thrombocytopenic purpura to increase platelet count and to prevent and/or to control bleeding. kawasaki syndrome gammagard s/d is indicated for the prevention of coronary artery aneurysms associated with kawasaki syndrome in pediatric patients.5 gammagard s/d is contraindicated in patients wh

USA - engelsk - NLM (National Library of Medicine)

baxalta us inc. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 50 mg in 1 ml - primary immunodeficiency (pi) gammagard s/d is indicated for the treatment of primary immunodeficiency (pi) associated with defects in humoral immunity, in adults and children two years and older. this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, wiskott-aldrich syndrome, and severe combined immunodeficiencies.1,2,3 b-cell chronic lymphocytic leukemia (cll) gammagard s/d is indicated for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with b-cell chronic lymphocytic leukemia (cll).4 idiopathic thrombocytopenic purpura (itp) gammagard s/d is indicated for the treatment of adult chronic idiopathic thrombocytopenic purpura to increase platelet count and to prevent and/or to control bleeding. kawasaki syndrome gammagard s/d is indicated for the prevention of coronary artery aneurysms associated with kawasaki syndrome in pediatric patients.5 - gammagard s/d is contraindicated in patients

Spania - spansk - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

baxalta innovations gmbh - inmunoglobulina humana normal - polvo y disolvente para soluciÓn para perfusiÓn - 5 g - inmunoglobulina humana normal 5 g - inmunoglobulinas humanas normales para adm. intravascular

Spania - spansk - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

baxalta innovations gmbh - inmunoglobulina humana normal - polvo y disolvente para soluciÓn para perfusiÓn - 10 g - inmunoglobulina humana normal 10 g - inmunoglobulinas humanas normales para adm. intravascular

Spania - spansk - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

baxter, s.l. - inmunoglobulina humana normal - excipientes: glucosa monohidrato,cloruro de sodio - inmunoglobulinas - inmunoglobulinas humanas normales - inmunoglobulinas humanas normales para adm. intravascular

Frankrike - fransk - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

baxalta innovations gmbh - immunoglobuline humaine normale (plasmatique) 50 mg - poudre - 50 mg - pour 1 ml de solution reconstituée > immunoglobuline humaine normale (plasmatique 50 mg solvant > pas de substance active. - antiserums et immunoglobulines (immunoglobulines humaines normales pour administration intravasculaire) - antiserums et immunoglobulines.gammagard appartient à la classe des médicaments dénommés immunoglobulines. ces médicaments contiennent des anticorps humains, également présents dans votre sang. les anticorps aident votre corps à combattre les infections. les médicaments comme gammagard sont utilisés chez les patients ne possédant pas suffisamment d’anticorps dans leur sang et sujets à de fréquentes infections. ils peuvent aussi être utilisés chez les patients ayant besoin d’anticorps supplémentaires lors du traitement de certains troubles inflammatoires (maladies auto-immunes).gammagard est une immunoglobuline humaine normale indiquée chez les patients avec déficits en immunoglobuline a (iga) et anticorps anti-iga :le traitement de patients ne possédant pas suffisamment d’anticorps (traitement substitutif). ces patients sont répartis en cinq groupes : patients présentant un défaut congénital de production d’anticorps (déficits immunitaires primitifs, dip) ; patients présentant un cancer du sang (leucémie lymphoïde chronique) entraînant un déficit de production d’anticorps et des infections récurrentes en cas d’échec du traitement préventif par antibiotiques ; patients présentant un cancer de la moelle osseuse (myélome multiple) et un déficit de production d’anticorps accompagnée d’infections récurrentes, qui ne répondent pas à un vaccin contre certaines bactéries (pneumocoques) ; patients ayant un déficit immunitaire suite à une infection par le vih depuis leur naissance et présentant des infections fréquentes ; patients présentant une faible production d’anticorps après une greffe de cellules de moelle osseuse provenant d’un donneur.le traitement des patients souffrant de certains troubles inflammatoires (traitements immunomodulateurs). ces patients sont répartis en trois groupes : patients n’ayant pas assez de plaquettes dans le sang (purpura thrombopénique immunitaire primaire/idiopathique) et présentant des risques élevés d’hémorragie ou devant subir une opération chirurgicale dans un futur proche ; patients atteints d’une maladie associée à une inflammation de plusieurs nerfs du corps (syndrome de guillain barré) ; patients présentant une maladie provoquant une inflammation de plusieurs organes du corps (maladie de kawasaki).

Nederland - nederlandsk - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

baxalta innovations gmbh industriestrasse 67 1221 vienna (oostenrijk) - humaan, normaal immunoglobuline voor intraveneus gebruik 10 g/flacon - poeder en oplosmiddel voor oplossing voor infusie - glucose 1-water ; glycine (e 640) ; humaan albumine ; natriumchloride ; water voor injectie, - immunoglobulins, normal human, for intravascular adm.

Nederland - nederlandsk - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

baxalta innovations gmbh industriestrasse 67 1221 vienna (oostenrijk) - humaan, normaal immunoglobuline voor intraveneus gebruik 5 g/flacon - poeder en oplosmiddel voor oplossing voor infusie - glucose 1-water ; glycine (e 640) ; humaan albumine ; natriumchloride ; water voor injectie, - immunoglobulins, normal human, for intravascular adm.