I.V.-Globulin SN inj.
Including high purity IgG immune function improved formulation
- Description &
Human normal immunoglobulin G & Colorless transparent liquid formulation
· I.V.-Globulin SN inj. is a biological product manufactured from plasma derivatives of individual donors.
· I.V.-Globulin SN inj. (Human normal immunoglobulin in maltose, pH 4.25) is a biological product manufactured from plasma of individual donors. Manufacturing processes include thawing, cold ethanol fractionation, and virus inactivation, such as S/D treatment and nano-filtration. For the finished product, the following manufacturing processes are applied. Firstly, fraction II, which comes from fractionated plasma, is purified with chromatography, and S/D treatment is applied for virus inactivation. Additional purification processes include dia-filtration.
Each 1 mL contains· Human immunoglobulin-G(active ingredient) ------------------------ 50 mg
· Maltose (stabilizer) ---------------------- 100 mg
· Water for injection (solvent) ---------- q.s.
· Combined therapy with antibiotics for severe bacterial or viral infections
· Idiopathic thrombocytopenic purpura (where other medicinal products are not effective or patients show apparent hemorrhage or need temporary hemostasis during surgery or childbirth, etc.)
· Guillain-Barre syndrome (Subacute febrile polyneuritis)
· Kawasaki syndrome (prevents coronary artery complications)
· For combined therapy with antibiotics for 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. Administration by intravenous injection should be performed very slowly.
· Idiopathic thrombocytopenic purpura (ITP): The usual dosage for treatment of acute or chronic ITP is 200-400 mg/kg daily, given for 5 consecutive days. Additional doses are discontinued if no adequate response occurs.
· 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 after 7 days from the onset of Kawasaki syndrome.
- Quantity per pack
· SHELF-LIFE: 30 months from date of manufacture
· STORAGE: Store at 2~8 °C in hermetic container. Store in a dark place.
- Precaution for use
· For administration precautions, please click the Download Manual button.
1. Precautions for Administration
· Avoid mixing with other medicinal products except for 5%-Glucose. (Do not mix with normal saline)
· Rapid administration may cause hypotension. Drip infusion intravenous injection is recommended. 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 solution is not clear, discard the product.
· 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 a protein and does not contain preservatives.)
· Do not use I.V.-Globulin SN inj. that has ever been frozen.
2. Precautions for Handling
· Inserting a needle through the rubber stopper should be done vertically and slowly. If a needle is tilted or twisted during insertion, rubber fragments may contaminate the medicinal product. If this occurs, discard the product.
Last update 29 Mar 2017