I.V.-Globulin SN Special Precautions

Special warnings: I.V.-Globulin inj., manufactured from human plasma, has the potential to transmit hepatitis viruses or other viruses which can cause infection. The risk of virus infection cannot be entirely eliminated. Accordingly, patients with hemophilia or immunodeficiency are recommended to be appropriately vaccinated (Hepatitis A vaccine, etc.), and the attending physician should monitor patients regularly to check any signs of virus infection. Since I.V.-Globulin SN inj. has potential risks as previously mentioned, the product must be carefully used. If the product is prescribed, only the necessary amount should be administered.
Special precautions: Patients with IgA deficiency (I.V. Globulin SN inj. may cause anaphylaxis to patients who have anti-IgA).
Patients with renal disorder (Renal function may deteriorate.).
Patients with hemolytic anemia or anemia from blood loss (Human parvovirus B19 infection may occur. In case of B19 infection, acute systemic symptoms with fever and severe anemia may occur.).
Patients with immunological incompetence or immunodeficiency (Human parvovirus B19 infection may occur. In case of infection, continuous anemia may occur.).
Patients with cerebrovascular and cardiovascular disorders or case history thereof example, (Elderly patients with ischemic disease, cardiovascular disorder, cerebrovascular disorder; or patients with cerebrovascular and cardiovascular disorders or case history thereof: a large bolus administration can cause thrombus or embolism such as cerebral infarction, a myocardial infarction, etc., due to blood viscosity increase.).
Patients with high risk of thrombus or embolism (Thrombus or embolism may occur due to an increase of blood viscosity due to large bolus administration.).
Patients with low heart function (A large bolus administration may cause heart failure or deterioration of heart condition.).
General cautions: In case of successive or interval administration, shock or severe abnormal reactions may occur. Accordingly, administration should be done with caution, and catamnesis also should be carefully observed. Especially for children, special caution should be taken for the rate of administration and catamnesis.
Administration of I.V.-Globulin SN inj. for the treatment of Idiopathic Thrombocytopenic Purpura is for symptomatic therapy, not causal treatment.
In case of Idiopathic Thrombocytopenic Purpura for children, spontaneous remission should be considered.
In present plasma fractionation process, it is difficult to inactivate or remove human parvovirus B19 etc. completely. Accordingly, possibilities of infection cannot be disregarded, and special caution should be taken for catamnesis.
Even though a safety plan for the prevention of the spread of infection is prepared, the risk of infection cannot be entirely disregarded since I.V.-Globulin SN inj. originates from human blood. The risk should be explained to patients.
Since I.V.-Globulin SN inj. contains anti-A and anti-B, hemolytic anemia may occur when a large bolus is administered to patients with blood type A, B or AB.
Additional administration to patients with Kawasaki Syndrome should be conducted when the effectiveness of I.V. Globulin SN inj. is insufficient (e.g. symptomatic remission) or additional administration is clearly necessary. (Safety and efficacy for additional administration has not been established.)
In the case of combined therapy with antibiotics in severe infections, I.V.-Globulin SN inj. should be used for patients who show insufficient response to proper antimicrobial chemotherapy.
There have been published reports that immune globulin intravenous injection is related to disorders of renal function, osmotic renal diseases, including death etc.
Influences to clinical examination results: I.V.-Globulin SN inj. contains pathogens or antibodies against the pathogens. Therefore, antibodies can be occasionally detected in blood after administration. Clinical diagnosis should be taken with special cautions and confirmed.
Effects on ability to drive and use machines: Some of the effects mentioned under "Adverse Reactions" may affect the ability to drive or use machines.
Use in Children: Safety for low birth weight infants and neonates has not been established.
Use in the Elderly: Since elderly patient generally have low physiological function, I.V. Globulin SN inj. should be administered with special care.