Normoglobin IV Infusion Injection - (500mg/10ml)

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Ashik Medical
Bolaspur Mymensingh
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Introduction
Normoglobin IV Infusion is used to strengthen the body's natural immune system to lower the risk of infection in persons with weakened immune system. This is made from healthy human blood that has a high level of certain defensive substances (antibodies), which help fight infections. Normoglobin IV Infusion has been shown to be effective in bone marrow transplant patients > 20 years of age in the first 100 days post - transplant for the prevention of systemic and local infections. It is indicated in the treatment of primary immunodeficiency states in which severe impairment of antibody forming capacity is there. This puts you at greater risk for infections. It gives you antibodies that your body is not making on its own so you can fight infections. Both children and adults can have this therapy. It is administered intravenously. Your doctor will monitor you for some time after administration of Human Normal Immunoglobulin to check for any side effects. Normoglobin IV Infusion may sometimes cause side effects like back pain, chills, flushing (sense of warmth in the face, ears, neck and trunk), dizziness, headache, nausea, decreased blood pressure, and muscle pain. If you get any of these, or other side effects, or just feel unwell, you should tell your doctor. There may be ways of preventing or reducing these effects. Before using it, you should tell your doctor if you have any problems with blood clotting and if you have recently had, or plan to have, a vaccination. It is not known whether this medicine is completely safe during pregnancy or breastfeeding so please take advice from your doctor.
Uses of Normoglobin IV Infusion
  • Immunoglobulins deficiency
Side effects of Normoglobin IV Infusion
Common
  • Back pain
  • Chills
  • Flushing (sense of warmth in the face, ears, neck and trunk)
  • Dizziness
  • Headache
  • Nausea
  • Decreased blood pressure
  • Muscle pain
  • Slow heart rate
  • Wheezing
How to use Normoglobin IV Infusion
Your doctor or nurse will give you this medicine. Kindly do not self-administer.
How Normoglobin IV Infusion works
Immune globulin belongs to class of agents called immunostimulants. It works by producing antibodies against foreign substances thereby fighting against infection.
What if you forget to take Normoglobin IV Infusion?
If you miss a dose of Normoglobin IV Infusion, please consult your doctor.
Quick Tips
  • Normoglobin IV Infusion is used for the treatment of certain diseases that are caused due to lack of antibodies in your blood.
  • It may be injected under the skin or given into a muscle.
  • Your doctor will monitor you for some time after administration of Normoglobin IV Infusion to check for any side effects.
  • Do not drive or do anything requiring concentration unless you know how Normoglobin IV Infusion affects you.
  • Inform your doctor if you have received any live vaccine (e.g. oral polio, MMR) in the last three months.
Brief Description
Indication
Treatment of primary immunodeficiency, For combined therapy with antibiotics in severe bacterial or viral infections, A-/Hypogammaglobulinemia, Idiopathic Thrombocytopenic Purpura, Guillain-Barre Syndrome, Kawasaki Syndrome.
Administration
Method of administration: The human normal immunoglobulin is for intravenous use only. The product should be warmed to room or body temperature before use. The human normal immunoglobulin should be infused intravenously at the following rates: 0.01~0.02ml/kg/min for first 30 minutes and then infusion rate can be gradually increased maximum 0.06ml/kg/min, if no abnormal sign appears from patients.This infusion can be recalculated by hourly basis; it is 0.6~1.2ml/kg/hr and 3.6ml/kg/hr (maximum).
Adult Dose
Intravenous Adults: 1) For combined therapy with antibiotics in severe bacterial or viral infections and A-/Hypogammaglobulinemia: The usual dosage for adults and children is 2500-5000 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. 2) For Idiopathic Thrombocytopenic Purpura: The usual dose is 200-400 mg/kg daily given for 5 consecutive days. The additional doses are discontinued if an adequate response does not occur. 3) For Guillain-Barre Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days. 4) For Kawasaki Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days (approximately) or 2000 mg daily by intravenous drip infusion. It is recommended that the administration start within 7 days from the onset of Kawasaki Syndrome.
Child Dose
Neonates and infants: 5 ml (250 mg)/kg body weight daily on 3 consecutive days. Further infusion may be required depending on the clinical course. Children: 1) For combined therapy with antibiotics in severe bacterial or viral infections and A-/Hypogammaglobulinemia: The usual dosage for adults and children is 2500-5000 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. 2) For Idiopathic Thrombocytopenic Purpura: The usual dose is 200-400 mg/kg daily given for 5 consecutive days. The additional doses are discontinued if an adequate response does not occur. 3) For Guillain-Barre Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days. 4) For Kawasaki Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days (approximately) or 2000 mg daily by intravenous drip infusion. It is recommended that the administration start within 7 days from the onset of Kawasaki Syndrome.
Contraindication
Hypersensitivity to human Ig, circulating Abs to IgA.
Mode of Action
Human normal immunoglobulin is derived from donations of pooled human plasma. It contains antibodies, mainly immunoglobulin G (IgG), to various bacteria and viruses present in the general population such as hepatitis A, measles, mumps, rubella and varicella. It has a distribution of IgG subclasses that is very close to that of the normal human plasma. It is therefore, used to provide passive immunisation against such diseases.
Precaution
For IV use only. Lactation: Use of this product has not been evaluated in nursing mothers.
Side Effect
Symptoms of shock may occur. Liver function disorders or jaundice accompanying and increase in ALT or AST may occur. Decrease in platelets may occur. Occasionally, chills, headache, fever, allergic reactions, nausea, arthralgia & mild back pain. In particular cases & esp after high IV doses, reversible aseptic meningitis & impaired renal function (dose-dependent) may occur. Rarely, fall in BP. In isolated cases, anaphylactic shock.
Pregnancy Category Note
Pregnancy: Safety for a pregnant woman has not been established. The possibility of parvovirus B-19 infection cannot be excluded from the administration of human normal immunoglobulin. In case of parvovirus B-19 infection, fetal disturbances (Abortion, Hydrops fetalis, fetal death) may occur. Human normal immunoglobulin should be given to a pregnant woman only if the expected benefit justifies the possible risk.
Interaction
May interfere with the immune response to live measles vaccine, live mumps vaccine, live rubella vaccine and live varicella vaccine, therefore these vaccines should be given at least 3 wk before or 3 mth after the admin of the immunoglobulins.

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