États-Unis - anglais - NLM (National Library of Medicine)

physicians total care, inc. - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro 100 [iu] in 1 ml - humalog is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. humalog is contraindicated: - during episodes of hypoglycemia - in patients who are hypersensitive to humalog or to any of its excipients. pregnancy category b. all pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. this background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. it is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. in patients with diabetes or gestational diabetes insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. careful monitoring of glucose control is essential in these patients. therefore, female patients should be advised to tell their physicians

États-Unis - anglais - NLM (National Library of Medicine)

remedyrepack inc. - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro injection is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. insulin lispro injection is contraindicated: - during episodes of hypoglycemia - in patients who are hypersensitive to insulin lispro injection or to any of its excipients. risk summary the limited available data with insulin lispro injection in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of 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) . pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis. no adverse effects on embryo/fetal

États-Unis - anglais - NLM (National Library of Medicine)

remedyrepack inc. - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro injection is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. insulin lispro injection is contraindicated: - during episodes of hypoglycemia - in patients who are hypersensitive to insulin lispro injection or to any of its excipients. risk summary the limited available data with insulin lispro injection in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of 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) . pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis

Israël - anglais - Ministry of Health

kamada ltd, israel - human hepatitis b immunoglobulin - solution for infusion - human hepatitis b immunoglobulin 50 mg / 1 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - prophylaxis against hepatitis b in adults and children over 2 years of age who have not been vaccinated against hepatitis b (including persons whose vaccination is incomplete or missing) who are at risk of infection with hepatitis b by accidental contact with hepatitis b virus containing material following: - percutaneous exposure (e.g. accidental needle stick). - direct mucous membrane contact. when the administration of an intramuscular hepatitis b immunoglobulin is not possible. the immunoglobulin should be administered in association with hepatitis b vaccine. prophylaxis against re-infection of a transplanted liver in patients who carry the surface antigen of the hepatitis b virus. immunoprophylaxis of hepatitis b in the newborn of a hepatitis b virus carrier mother.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

octapharma australia pty ltd - human immunoglobulin g, quantity: 100 mg/ml - injection - excipient ingredients: octoxinol 10; maltose; tributyl phosphate; water for injections; human immunoglobulin a - replacement therapy in: primary immunodeficiency syndromes: congenital agammaglobulinaemia and hypogammaglobulinaemia; common variable immunodeficiency; severe combined immunodeficiencies; wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. children with congenital acquired immune deficiency syndrome (aids) who have repeated bacterial infections; immunomodulation: idiopathic thrombocytopenic purpura, in adults or children with a high risk of bleeding or prior to surgery to correct platelet count. guillain barre syndrome. kawasaki disease. allogeneic bone marrow transplantation.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

octapharma australia pty ltd - human immunoglobulin g, quantity: 100 mg/ml - injection - excipient ingredients: maltose; octoxinol 10; tributyl phosphate; water for injections; human immunoglobulin a - replacement therapy in: primary immunodeficiency syndromes: congenital agammaglobulinaemia and hypogammaglobulinaemia; common variable immunodeficiency; severe combined immunodeficiencies; wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. children with congenital acquired immune deficiency syndrome (aids) who have repeated bacterial infections; immunomodulation: idiopathic thrombocytopenic purpura, in adults or children with a high risk of bleeding or prior to surgery to correct platelet count. guillain barre syndrome. kawasaki disease. allogeneic bone marrow transplantation.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

octapharma australia pty ltd - human immunoglobulin g, quantity: 100 mg/ml - injection - excipient ingredients: tributyl phosphate; maltose; octoxinol 10; water for injections; human immunoglobulin a - replacement therapy in: primary immunodeficiency syndromes: congenital agammaglobulinaemia and hypogammaglobulinaemia; common variable immunodeficiency; severe combined immunodeficiencies; wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. children with congenital acquired immune deficiency syndrome (aids) who have repeated bacterial infections; immunomodulation: idiopathic thrombocytopenic purpura, in adults or children with a high risk of bleeding or prior to surgery to correct platelet count. guillain barre syndrome. kawasaki disease. allogeneic bone marrow transplantation.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

octapharma australia pty ltd - human immunoglobulin g, quantity: 100 mg/ml - injection - excipient ingredients: octoxinol 10; maltose; tributyl phosphate; water for injections; human immunoglobulin a - replacement therapy in: primary immunodeficiency syndromes: congenital agammaglobulinaemia and hypogammaglobulinaemia; common variable immunodeficiency; severe combined immunodeficiencies; wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. children with congenital acquired immune deficiency syndrome (aids) who have repeated bacterial infections; immunomodulation: idiopathic thrombocytopenic purpura, in adults or children with a high risk of bleeding or prior to surgery to correct platelet count. guillain barre syndrome. kawasaki disease. allogeneic bone marrow transplantation.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

octapharma australia pty ltd - human immunoglobulin g, quantity: 50 mg/ml - injection - excipient ingredients: octoxinol 10; water for injections; tributyl phosphate; maltose; human immunoglobulin a - replacement therapy: primary immunodeficiency syndromes: congenital agammaglobulinaemia and hypogammaglobulinaemia; common variable immunodeficiency; severe combined immunodeficiencies; wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. children with congenital acquired immune deficiency syndrome (aids) who have repeated bacterial infections; immunomodulatory effect: idiopathic thrombocytopenic purpura, in adults or children with a high risk of bleeding or prior to surgery to correct platelet count. guillain barre syndrome. kawasaki disease. allogeneic bone marrow transplantation.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

octapharma australia pty ltd - human immunoglobulin g, quantity: 50 mg/ml - injection - excipient ingredients: maltose; human immunoglobulin a; octoxinol 10; water for injections; tributyl phosphate - replacement therapy: primary immunodeficiency syndromes: congenital agammaglobulinaemia and hypogammaglobulinaemia; common variable immunodeficiency; severe combined immunodeficiencies; wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. children with congenital acquired immune deficiency syndrome (aids) who have repeated bacterial infections; immunomodulatory effect: idiopathic thrombocytopenic purpura, in adults or children with a high risk of bleeding or prior to surgery to correct platelet count. guillain barre syndrome. kawasaki disease. allogeneic bone marrow transplantation.