HUMAN NORMAL IMMUNOGLOBULIN:
Indications: Replacement therapy in: Primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia. common variable immunodeficiency. severe combined immunodeficiency. Wiskott Aldrich syndrome. Myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. Children with congenital AIDS and recurrent infections. Immunomodulation. Idiopathic thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count. Guillain Barré syndrome. Kawasaki disease Allogeneic bone marrow transplantation.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to homologous immunoglobulins, especially in the very rare cases of IgA deficiency when the patient has antibodies against IgA.
Dose and Administration: The dose and dosage regimen is dependent on the indication. In replacement therapy the dosage may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. The dosage regimen should achieve a trough level of IgG (measured before the next infusion) of at least 4 – 6 g/l. Three to six months are required after the initiation of therapy for equilibration to occur. The recommended starting dose is 0.4 – 0.8 g/kg, followed by at least 0.2 g/kg every three weeks. The dose required to achieve a trough level of 6 g/l is of the order of 0.2 – 0.8 g/kg/month. The dosage interval when steady state has been reached, varies from 2 to 4 weeks. Trough levels should be measured in order to adjust the dose and dosage interval. Guillain Barré syndrome: 0.4 g/kg/day for 3 to 7 days.
HEPATITIS B IMMUNOGLOBULIN:
Indications: indicated for post-exposure prophylaxis following either parenteral exposure (e.g. accidental “needle-stick”), direct mucous membrane contact, or oral ingestion of HBsAg-positive materials, such as blood, plasma or serum. Also indicated for the temporary protection of infants born to HBsAg-positive mothers (especially those who are HBeAg-positive), since these infants are at risk of acquiring hepatitis B infection. Infants born to HBsAg-positive mothers should receive hepatitis B immunoglobulin and the first dose of hepatitis B vaccine at the same time.
Contraindications: Intramuscular injections are not advocated for patients with bleeding disorders. The risk-benefit ratio in patients with a history of immunoglobulin A (IgA) deficiency or severe anaphylactic reactions to plasma
products should be considered. Is not appropriate for the treatment of any type of hepatitis B infection.
Dose and Administration: By intramuscular injection (as soon as possible after exposure; ideally within 12 hours, but no later than 7 days after exposure), adult and child over 10 years 500 units; child under 5 years 200 units, 5–9 years 300 units; neonate 200 units as soon as possible after birth
ANTI-D (RH0) IMMUNOGLOBULIN:
Indications: Rh (D) incompatibility.
Contraindications: Thrombocytopenia, coagulation disorders preventing intramuscular injection.
Dose and Administration: By intramuscular injection, to rhesus-negative woman for prevention of Rh0 (D) sensitisation: Following birth of rhesus-positive infant, 1000–1650 units immediately or within 72 hours; for large transplacental blood loss, 50–125 units per mL of fetal red cells. Antenatal prophylaxis, 1000– 1650 units given at weeks 28 and 34 of pregnancy; if infant rhesus-positive, further dose is needed immediately or within 72 hours of delivery.
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