Intravenous human immunoglobulin
Description
Extracting from Iranian plasma containing 50-gram plasma protein per 1 milliliter (IgG more than 96%) under commercial name of “interatect” by biotest company from Germany and “privigen” by CSL Behring company from Switzerland.
Medical Group
- Blood coagulation factor
- Anti – hemophilia and anti – homology
Medicine types
- 250 injection units
- 500 injection units
Vial compounds
- Effective component: coagulation factor VIII extracted from human plasma (500IU/vial)
- Excipients: Glycine, sodium chloride, sodium citrate, calcium chloride, water for injections
Medical uses
- Prevention and treatment of bleeding in hemophilia A (congenital factor 8 deficiency)
- Prevention and treatment of bleeding in Factor 8 acquired deficiency
- For treatment of patients with Factor VIII inhibitors
Prohibited usage
In cases of hypersensitivity to coagulation factor 8 or any of the excipients in the formulation
Indications and dosage
- Factor 8 solution must administrate through intravenous injection
- Factor 8 dosage must determine individually base on type of surgery, severity of factor VII lack and The amount of bleeding.
Warnings
-
- There might be relations between severed side effects of this drug and the injection speed, so we suggest that injection instructions (in prescription method) Carefully observe. Since the potential side effects have direct relation with injection speed, the patient, through and after injection, must be under careful monitoring to prevent any undesirable side effect. In these cases the possibility of side effects increase:
- Fast injection
- In patients with a deficiency or absence of gamma globulin with or without IgA deficiency
- These side effects are rare in patients who take natural immunoglobulin for the first time or used other human gamma globulin products (products from two different company) before or in case of prolonged interval between the first and second injection.
- The following methods can potentially prevent complications:
- In patients who are not sensitive to human natural immunoglobulin, the first transfusion should be done slowly. [024 (ml/kg/min)]
- Patients, specially Patients who take human natural immunoglobulin for the first time, patients who used IVIg alternative Products or in cases that long time past from last administration needs careful monitoring during the administration and for few hours after first injection. Other patients must examine carefully for at least 20 minutes after injection.
- These considerations are vital for prescription IVIg in all patients:
- Enough hydration is necessary before IVIg injections begins.
- control of urine output
- examine and control of serum Creatinine level
- Avoid concomitant use of diuretics drugs affecting Henle’s loop
other drugs shall not mix or add to this product, because any changes in electrolyte concentration or pH cause protein Sedimentation or denaturation
- There might be relations between severed side effects of this drug and the injection speed, so we suggest that injection instructions (in prescription method) Carefully observe. Since the potential side effects have direct relation with injection speed, the patient, through and after injection, must be under careful monitoring to prevent any undesirable side effect. In these cases the possibility of side effects increase:
Storage and shelf-life
- Solution must store in temperature below 25°F, be protected against light and prevented from freezing.