Liv-Gamma SN

Liv-Gamma SN

human normal immunoglobulin

Manufacturer:

SK Plasma

Distributor:

Cosma Medical
Full Prescribing Info
Contents
Human immunoglobulin.
Description
Liv-Gamma injection is a solvent-detergent (S/D) treated sterile solution of highly purified immunoglobulin G derived from large pools of human plasma for intravenous infusion. S/D treatment inactivates the lipid-enveloped viruses such as HBV, HCV, HIV and make Liv-Gamma safe.
Each mL contains Immunoglobulin-G, Human 50 mg, maltose 100 mg and water for injection.
The percentage of IgG subclasses is approx.: 66.95% IgG1, 27.87% IgG2, 3.9% IgG3 and 1.21% IgG4.
Indications/Uses
Agammaglobulinemia, hypogammaglobulinemia, and combination therapy with antibiotics tor severe infections.
Idiopathic thrombocytopenic purpura (In case that distinguished hemorrhage tendency occur and transient hemostasis care is needed such as surgical treatment or delivery, when other drugs are not available).
Kawasaki disease (for the prevention of complication in coronary artery).
Guillian-Barre syndrome (Subacute demyelinating polyneuritis).
Dosage/Direction for Use
Agammaglobulinemia, hypogammaglobulinemia, and combination therapy with antibiotics for severe infections after reconstitution: The dosage is 2,500-5,000 mg (human immunoglobulin) as single dose for adult, 100-150 mg/kg as single dose for children by intravenous instillation or injection. In case of intravenous injection, administer very slowly.
Idiopathic thrombocytopenic purpura: The dosage is 200-400 mg/kg daily, If the improvement in symptom is not shown alter consecutive 5 days, administration should be discontinued.
Kawasaki disease (for the prevention of complication in coronary artery): The dosage is 400 mg/kg once a day for consecutive 5 days.
Guillian-Barresyndrome (subacute demyelinating polyneuritis): The dosage is 400 mg/kg once a day for consecutive 5 days.
Contraindications
This drug should be given with caution to the following patients: Patients with immunoglobulin A deficiency: (Hypersensitivity may be observed in patients with anti-IgA antibody).
Patients with renal disorder: (There is a risk that this drug may aggravate renal function).
Patients with hemolytic or hemorrhagic anemia: (There is a possibility of human parvovirus B19 infection. In case of infection, acute systemic response may occur along with fever and sudden and severe anemia.).
Patients with immunodeficiency or immunodepression: (There is a possibility of human parvovirus B19 infection. In case of infection, prolonged anemia may occur).
Special Precautions
General precautions: Since there is the possibility that serious adverse effect such as shock etc. may occur when the patient inject at interval or continuous administration, it should be given with caution to patients and the patients should be observed carefully.
Take a notice that the treatment of ITP with this drug is not causal therapy but symptomatic therapy.
In most of case, ITP of children remitted spontaneously.
Since it is difficult to delete or inactivate completely human parvovirus B19 etc. in the current manufacturing process of plasma fraction preparation, there is the possibility of infection. Therefore, the patients should be observed carefully after administration.
Do not administer this drug mixed with other solution except the solution which is near neutral pH such as saline, electrolyte solution containing sorbitol.
Intravenous instillation method is desirable. When administered intravenously by injection, administer very slowly. (Special attention should be needed for patient with agammaglobulinemia, hypogamma-globulinemia).
Do not use if any precipitation is shown.
Use immediately within one hour after opening, If once opened, the residue remainders should not be used since this drug dose not contain any preservatives.
Use In Pregnancy & Lactation
There is no evidence that the safety of this drug when administered to a pregnant woman. There is the possibility of parvovirus B19 infection due to administration of this drug. In case of infection, fetal disorder such as abortion, fetal hydrops, fetal death may occur. Therefore, it should be given a pregnant woman or a woman who may be pregnant only if clearly needed.
Adverse Reactions
Shock: Shock may rarely occur. If the symptoms such as dyspnea, wheezing, chest tightness, hypotension, or bradycardia may occur, this drug should be discontinued, and appropriate treatment should be taken.
If necessary, administer 0.1 mL-0.5 mL epinephrine (1:1000) and cortisone preparation for the improvement of symptom.
Hypersensitivity: Sometimes, headache, fever, nausea, vomiting, rash, pruritus, diarrhea, flush, or local edema may occur.
Circulatory: When administered rapidly, hypotension may rarely occur.
Liver: Sometimes, an increase in GOT or GPT may occur.
Renal: Acute renal failure has been reported. Therefore if the reduction of urinary volume, an increase of creatinine and BUN are confirmed under sufficient observation, this drug should be discontinued and proper treatment should be taken.
Storage
Store in a hermetic container in the darkness at 2-8°C. Protect from light. Do not freeze.
ATC Classification
J06BA02 - immunoglobulins, normal human, for intravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.
Presentation/Packing
Inj (vial) (clear or slightly opalescent and colourless to pale yellow liquid) 2.5 g x 1's. 5 g x 1's.
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