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OCTAGAM 100 mg/ml solution for infusion 100 mg/ml Solution 200ml Vial
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SKU
10331014296
Octagam 100 mg/ml solution for infusion is a human normal immunoglobulin (IVIg) preparation for intravenous use. It provides passive immunity and is used to treat primary immunodeficiency, ITP, and certain neurological conditions like Guillain-Barré syndrome and CIDP. Administered by healthcare professionals, it helps modulate the immune system and protect against infections.
Product Overview
Octagam 100 mg/ml Solution for Infusion is a highly purified preparation of human normal immunoglobulin (IVIg) derived from pooled human plasma.
It is designed for intravenous administration to treat a range of conditions involving immune system deficiencies or dysregulation.
This 200ml vial provides a concentrated solution, ensuring effective delivery of antibodies to patients in need.
Octagam is manufactured by CSL Behring, a global leader in biotherapeutics, known for its commitment to quality and patient safety.
Benefits of Use
- Provides passive immunity in patients with primary immunodeficiency syndromes (PID), enhancing their ability to fight infections.
- Effective in treating immune thrombocytopenic purpura (ITP) by increasing platelet counts and reducing bleeding risk.
- Used in neurological disorders such as Guillain-Barré Syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), and multifocal motor neuropathy (MMN) to modulate immune responses.
- Indicated for Kawasaki disease, helping to reduce the incidence of coronary artery aneurysms.
- Helps to neutralize pathogenic antibodies and immune complexes, supporting the body's natural defense mechanisms.
How to Use
- Octagam must be administered intravenously by a healthcare professional.
- The dosage and infusion rate are determined by the treating physician based on the patient's weight, condition, and response to therapy.
- Prior to administration, inspect the solution visually for particulate matter and discoloration. Do not use if turbid or discolored.
- Ensure the solution is at room temperature before infusion.
- The infusion should start at a slow rate and be gradually increased if tolerated.
Caution & Warnings
- Hypersensitivity reactions: Patients may experience allergic or anaphylactic reactions. Ensure epinephrine and other emergency measures are readily available.
- Renal dysfunction: Risk of acute renal failure, especially in patients with pre-existing renal impairment, diabetes, or dehydration.
- Thromboembolic events: Risk of thrombosis (e.g., stroke, myocardial infarction, DVT, PE), particularly in elderly patients, those with cardiovascular risk factors, or prolonged immobilization.
- Aseptic Meningitis Syndrome (AMS): Symptoms include severe headache, nuchal rigidity, fever, photophobia, nausea, and vomiting.
- Hemolysis: May occur, especially in patients with blood groups A, B, or AB.
- Infusion-related reactions: Chills, fever, headache, nausea, vomiting, or dizziness may occur. Slowing the infusion rate or temporary interruption may alleviate symptoms.
- Patients with IgA deficiency may develop IgA antibodies and are at greater risk of severe hypersensitivity and anaphylactic reactions.
- Not for self-administration.
Ingredients
- Active ingredient: Human normal immunoglobulin (100 mg/ml).
- Excipients: Glucose, water for injections.
Product Details
- Product Name: OCTAGAM 100 mg/ml solution for infusion.
- Strength: 100 mg/ml.
- Volume: 200ml per vial.
- Form: Sterile solution for intravenous administration.
- Manufacturer: CSL Behring.
- Storage: Store in a refrigerator (2°C - 8°C). Do not freeze. Protect from light.
| Gtin | 2904210702 |
|---|---|
| Recommended Sale Price | 8965.6 |
| Is Wasfaty Product | No |
| Brand | Not Defined |
| Ingredient Name | NORMAL HUMAN IMMUNOGLOBULIN |
| SFDA Reg. No | 2904210702 |
| IBC | 2904210702 |
| Drug Type | Prescription |
| Scientific Name | Human Normal Immunoglobulin |
| Strength | 100 |
| Strength Unit | mg/ml |
| Form | Solution for infusion |
| Admin Route | Intravenous |
| Size | 200 |
| Size Unit | ml |
| Package Types | Vial |
| Package Size | 200ml |
| shelfLife | 3 years |
| Storage conditions | Store in a refrigerator (2°C - 8°C). Do not freeze. |
| Refrigerator Storage | Yes |
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