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Ig VENA 50gm IV Injection (Mfg. by: Kedrion S.p.A, Italy)
IndicationsIg VENA (IgG) is indicated in: • 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* রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'DescriptionThis is a ready to use, sterile, clear or slightly opalescent and colorless to pale yellow, liquid preparation of purified immunoglobulin-G (IgG) obtained from human plasma pools. The purification processes include thawing, cold ethanol fractionation, chromatography, virus inactivation with S/D fractionation and nano-filtration and dia-filtration. The final bulk is manufactured by adding maltose (as stabilizer) to bulk product and passing through sterile filter, after this the final bulk is filled into vials.DosageNeonates 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 and adults: • 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. • 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.For Guillain-Barre Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days.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.* রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'AdministrationThe human normal immunoglobulin is for intravenous use only. For intravenous injection, it should be injected very slowly. The product should be warmed to room or body temperature before use. The human normal immunoglobulin should be infused intravenously at the following rates:0.01~0.02 ml/kg/min for first 30 minutes and then infusion rate can be gradually increased maximum 0.06 ml/kg/min, if no abnormal sign appears from patients. This infusion can be recalculated by hourly basis; it is 0.6~1.2 ml/kg/hr and 3.6 ml/kg/hr (maximum).General cautions: • The human normal immunoglobulin is for intravenous use only. • 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. • The vial should be inspected for visible particulate matter and color prior to administration. Do not use the vial if particles are detected. Do not use if turbid. • Several vials may be pooled into an empty sterile solution container by using aseptic technique, if large doses are to be administered. • The human normal immunoglobulin cannot be diluted with intravenous fluids. Other medications cannot be injected into the intravenous tubing being used for the human normal immunoglobulin. In case of idiopathic Thrombocytopenic Purpura for children, spontaneous remission should be considered. • Additional administration to patients with Kawasaki Syndrome should be conducted when the effectiveness of immunoglobulin is insufficient (e.g. symptomatic remission) or additional administration is clearly necessary.(Safety and efficacy for additional administration has not been established) • Patients should be aware of the risk and discuss with their healthcare professionals and contact them if any signs or symptoms of thrombosis during or after receiving this product develop. • Healthcare professionals should be aware of the risk for thrombosis with human normal immunoglobulin products and discuss with their patients the risk of thrombosis associated with this product.There is a possibility that live vaccines (measles, mumps, rubella and varicella vaccine etc.) do not work for the patients who were treated with human normal immunoglobulin. Therefore vaccination should be delayed for 3 months after administration. If human normal immunoglobulin is administered within 14 days after vaccination, re-vaccination should be taken after more than 3 months post 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.* রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Ig VENA 50gm IV Injection (Mfg. by: Kedrion S.p.A, Italy)
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Indications
Ig VENA (IgG) is indicated in:
• 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
* রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Description
This is a ready to use, sterile, clear or slightly opalescent and colorless to pale yellow, liquid preparation of purified immunoglobulin-G (IgG) obtained from human plasma pools. The purification processes include thawing, cold ethanol fractionation, chromatography, virus inactivation with S/D fractionation and nano-filtration and dia-filtration. The final bulk is manufactured by adding maltose (as stabilizer) to bulk product and passing through sterile filter, after this the final bulk is filled into vials.
Dosage
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 and adults:
• 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.
• 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.
For Guillain-Barre Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days.
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.
* রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Administration
The human normal immunoglobulin is for intravenous use only. For intravenous injection, it should be injected very slowly. The product should be warmed to room or body temperature before use. The human normal immunoglobulin should be infused intravenously at the following rates:
0.01~0.02 ml/kg/min for first 30 minutes and then infusion rate can be gradually increased maximum 0.06 ml/kg/min, if no abnormal sign appears from patients. This infusion can be recalculated by hourly basis; it is 0.6~1.2 ml/kg/hr and 3.6 ml/kg/hr (maximum).
General cautions:
• The human normal immunoglobulin is for intravenous use only.
• 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.
• The vial should be inspected for visible particulate matter and color prior to administration. Do not use the vial if particles are detected. Do not use if turbid.
• Several vials may be pooled into an empty sterile solution container by using aseptic technique, if large doses are to be administered.
• The human normal immunoglobulin cannot be diluted with intravenous fluids. Other medications cannot be injected into the intravenous tubing being used for the human normal immunoglobulin. In case of idiopathic Thrombocytopenic Purpura for children, spontaneous remission should be considered.
• Additional administration to patients with Kawasaki Syndrome should be conducted when the effectiveness of immunoglobulin is insufficient (e.g. symptomatic remission) or additional administration is clearly necessary.(Safety and efficacy for additional administration has not been established)
• Patients should be aware of the risk and discuss with their healthcare professionals and contact them if any signs or symptoms of thrombosis during or after receiving this product develop.
• Healthcare professionals should be aware of the risk for thrombosis with human normal immunoglobulin products and discuss with their patients the risk of thrombosis associated with this product.
There is a possibility that live vaccines (measles, mumps, rubella and varicella vaccine etc.) do not work for the patients who were treated with human normal immunoglobulin. Therefore vaccination should be delayed for 3 months after administration. If human normal immunoglobulin is administered within 14 days after vaccination, re-vaccination should be taken after more than 3 months post 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.
* রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Ig VENA (IgG) is indicated in:
• 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
* রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Description
This is a ready to use, sterile, clear or slightly opalescent and colorless to pale yellow, liquid preparation of purified immunoglobulin-G (IgG) obtained from human plasma pools. The purification processes include thawing, cold ethanol fractionation, chromatography, virus inactivation with S/D fractionation and nano-filtration and dia-filtration. The final bulk is manufactured by adding maltose (as stabilizer) to bulk product and passing through sterile filter, after this the final bulk is filled into vials.
Dosage
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 and adults:
• 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.
• 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.
For Guillain-Barre Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days.
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.
* রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Administration
The human normal immunoglobulin is for intravenous use only. For intravenous injection, it should be injected very slowly. The product should be warmed to room or body temperature before use. The human normal immunoglobulin should be infused intravenously at the following rates:
0.01~0.02 ml/kg/min for first 30 minutes and then infusion rate can be gradually increased maximum 0.06 ml/kg/min, if no abnormal sign appears from patients. This infusion can be recalculated by hourly basis; it is 0.6~1.2 ml/kg/hr and 3.6 ml/kg/hr (maximum).
General cautions:
• The human normal immunoglobulin is for intravenous use only.
• 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.
• The vial should be inspected for visible particulate matter and color prior to administration. Do not use the vial if particles are detected. Do not use if turbid.
• Several vials may be pooled into an empty sterile solution container by using aseptic technique, if large doses are to be administered.
• The human normal immunoglobulin cannot be diluted with intravenous fluids. Other medications cannot be injected into the intravenous tubing being used for the human normal immunoglobulin. In case of idiopathic Thrombocytopenic Purpura for children, spontaneous remission should be considered.
• Additional administration to patients with Kawasaki Syndrome should be conducted when the effectiveness of immunoglobulin is insufficient (e.g. symptomatic remission) or additional administration is clearly necessary.(Safety and efficacy for additional administration has not been established)
• Patients should be aware of the risk and discuss with their healthcare professionals and contact them if any signs or symptoms of thrombosis during or after receiving this product develop.
• Healthcare professionals should be aware of the risk for thrombosis with human normal immunoglobulin products and discuss with their patients the risk of thrombosis associated with this product.
There is a possibility that live vaccines (measles, mumps, rubella and varicella vaccine etc.) do not work for the patients who were treated with human normal immunoglobulin. Therefore vaccination should be delayed for 3 months after administration. If human normal immunoglobulin is administered within 14 days after vaccination, re-vaccination should be taken after more than 3 months post 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.
* রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'