I.V.-Globulin SN

1 mL contains: Human Immunoglobulin-G (active ingredient) 50 mg, Maltose (stabilizer) 100 mg, Water for Injection (solvent) q.s.
This product 'IV-Globulin SN Inj. (Human Normal Immunoglobulin in maltose, pH 4.25)', as a biological product, is manufactured with plasma which was collected for the purpose of manufacture of plasma derivatives from individual donors. All plasma processes thawing, cold ethanol fractionation and virus inactivation processes such as S/D treatment and nano-filtration. Fraction II which comes from plasma fractionation is purified with chromatography. and takes S/D treatment for virus inactivation. Another purification process with chromatography is taken and dia-filtration is conducted. Nano-filtration process follows in order to remove viruses and bulk product is produced. Final bulk is manufactured by adding maltose (as stabilizer) to bulk product and passing through sterile filter, after this final bulk is filled into vials.

A-/Hypogammaglobulinemia.
Combined therapy with antibiotics in severe bacterial or viral infections.
Idiopathic Thrombocytopenic Purpura (In the case where other medicinal products are not effective of patients show apparent hemorrhage of patients need temporary control of hemostasis such as surgeon treatments or childbirth etc.).
Guillain-Barre Syndrome (Subacute febrile polyneuritis).
Kawasaki Syndrome (To prevent the disease of coronary artery complication).

For Combined therapy with antibiotics in severe bacterial or viral infections and A-/Hypogammaglobulinemia. The usual dosage for adults and children is 2,500~5,000 mg and 50~150 mg/kg respectively (as a single dose) by intravenous drip infusion or direct intravenous infusion. In case of intravenous injection, it should be injected very slowly.
Idiopathic Thrombocytopenic Purpura: The usual dosage for the treatment of acute or chronic ITP is 200-400 mg/kg daily given for 5 consecutive days. The additional doses are discontinued if an adequate response does not occur.
Guillain-Barre Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days.
Kawasaki Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days (approximately), or 2,000 mg daily by intravenous drip infusion. It is recommended that the administration of I.V.-Globulin SN inj. start within 7 days from the onset of Kawasaki Syndrome.

Patients with history of anaphylaxis to ingredients of I.V.-Globulin SN inj.
Patients with history of shock to ingredients of I.V.-Globulin SN inj.

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.

Safety for a pregnant woman has not been established. The possibility of parvovirus B-19 infection cannot be excluded from the administration of I.V.-Globulin SN inj. In case of parvovirus B19 infection, fetal disturbances (Abortion, Hydrops fetalis, Fetal death) may occur. I.V.-Globulin SN inj. should be given to a pregnant woman only if the expected benefit justifies the possible risk.

Shock: Symptoms of shock may occur. If dyspnea, wheeze, chest pain, hypotension or weak pulse are watched, administration should be discontinued, and 0.1~0.5 mL epinephrine (1:1,000) or the administration of cortisone should be considered.
Circulatory: Rapid administration can cause hypotension. (Caution should be taken to patients with A-/Hypogammaglobulinemia.)
Liver: Liver function disorders or jaundice accompanying and increase in ALT or AST may occur. Caution should be taken, and proper treatment should be followed if needed.
Kidney: It has been reported in the literature that acute renal failure may occur with the use of immune globulin (human) products. If dehydration, hypouresis, increase of creatinine or increase of BUN, etc. are observed, administration should be discontinued, and proper treatment should be taken.
The administration dosage and rate should be lowered (as low as possible) for patients at high risk of acute renal failure.
Central Nervous System: Aseptic meningitis from a large volume of I.V.-Globulin SN inj. administration (Nuchal rigidity, fever, headache, nausea, vomiting, mental fog, etc.) may occur. In these cases, administration should be discontinued and proper treatment taken.
Blood: Because a decrease in platelets may occur with the administration of I.V.-Globulin SN inj., caution should be taken. If this symptom occurs, proper treatment should be taken.
Other possible undesirable effects: Drowsiness, chill, chest pain, abdominal pain, gluteal pain and anxiety etc.

There is a possibility that live vaccines (Measles, Mumps, Rubella and Varicella vaccine etc.) do not work for the patients who were treated with I.V.-Globulin SN inj.. Therefore, vaccination should be delayed for 3 months after administration.
If I.V.-Globulin SN inj. is administered within 14 days after vaccination, re-vaccination should be taken after more than 3 months post I.V.-Globulin SN inj. administration.
After a large bolus (more than 200 mg/kg) administration for the ITP and Kawasaki disease, use of live vaccines should be delayed more than 6 months (In case of low risk of measles infection, measles vaccination can be delayed more than 11 months).

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Special precautions for disposal and other handling: Precautions for administration: Avoid mixing with other medicinal products except for fluids which is close to neutral such as 5%-Glucose, normal saline or electrolyte solution, etc.
Rapid administration may cause hypotension. Drip infusion intravenous injection is recommendable. If direct intravenous injection is needed, it should be administered very slowly. (Caution should be taken with A-/Hypogammaglobulinemia patients.)
If particulate matter is observed, or color is not clear, the product should be discarded.
I.V.-Globulin SN inj. should be used within 1 hour after the container is opened. Do not use the remaining solution due to the possibility of microbial contamination. (I.V.-Globulin SN inj. is protein and does not contain preservatives.)
Do not use if I.V.-Globulin SN inj. was ever frozen.
Precautions for handling: When a needle is inserted through the rubber stopper, the needle should be inserted vertically and slowly. If a needle is inserted in a tilted or twisted direction, rubber fragments may be mixed with medicinal product. If there are any rubber fragments, discard the product.

Store at 2~8°C in hermetic container.
Store in a dark place.
Shelf-life: 2 years from the date of manufacture.

Vaccines, Antisera & Immunologicals

J06BA02 - immunoglobulins, normal human, for intravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.

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