Source: Health Products and Food Branch (CA) Revision Year: 2020
OCTAPLASMA is indicated for:
The efficacy of in patients with Thrombotic Thrombocytopenic Purpura has not been studied sufficiently, therefore, the clinical experience in these patients is limited. OCTAPLASMA should be administered under the supervision of a qualified health professional who is experienced in the use of anticoagulation agents and in the management of coagulation disorders. Appropriate management of therapy and complications is only possible when adequate diagnostic and treatment facilities are readily available.
Geriatrics (>65 years of age):
No data are available.
Pediatrics (<16 years of age):
OCTAPLASMA was evaluated in 50 pediatric patients (age range 0-16 years) in a postmarketing study. (See CLINICAL TRIALS, Table 6). The product should only be administered to these individuals if the likely benefits clearly outweigh potential risks.
The dosage depends upon the clinical situation and underlying disorder. The volume and frequency of plasma exchanges vary depending on the individual patient, the clinical situation, and the preferred regimen of treatment. In the event of major haemorrhage or surgery, the expert advice of a haematologist should be sought.
The volume and frequency of plasma exchanges vary depending on the individual patient, the clinical situation, and the preferred regimen of treatment. The volume of the plasma exchange in most therapeutic procedures is usually equivalent to the plasma volume of the patient. A part of the exchanged plasma volume should be replaced with OCTAPLASMA in order to prevent haemostatic disorders associated with a decreased level of coagulation factors (especially in patients with impaired liver function).
The dosage depends upon the clinical situation and underlying disorder, but 12-15 mL OCTAPLASMA/kg body weight is a generally accepted starting dose (this should increase the patient’s plasma coagulation factor levels by approximately 25%). It is important to monitor the response, both clinically and with measurement of prothrombin time (PT), partial thromboplastin time (PTT) and/or specific coagulation factor assays.
An adequate haemostatic effect in minor and moderate haemorrhages or surgery is normally achieved after the infusion of 5-20 mL OCTAPLASMA/kg body weight (this should increase the patient’s plasma coagulation factor levels by approximately 10-33%). In the event of major haemorrhage or surgery the expert advice of a haematologist should be sought.
High dosages or infusion rates may induce hypervolaemia, pulmonary oedema and/or cardiac failure. High infusion rates may cause cardiovascular effects as a result of citrate toxicity (fall in ionised calcium), especially in patients with liver function disorders. Due to the risk of citrate toxicity, the infusion rate should not exceed 0.020-0.025 mmol citrate/kg body weight/min, which equals to 1 mL OCTAPLASMA/kg body weight/min. Toxic effects of citrate can be minimised by giving calcium gluconate i.v. into another vein. Patients should be observed for at least 20 minutes after the administration.
Not applicable because OCTAPLASMA is administered in a hospital setting by health care professionals.
Administration of OCTAPLASMA must be based on ABO-blood group specificity. In emergency cases, OCTAPLASMA blood group AB can be regarded as universal plasma since it can be given to all patients. OCTAPLASMA must be administered by intravenous infusion after thawing using an infusion set with a filter. Aseptic technique must be used throughout the infusion.
There are several options for thawing frozen OCTAPLASMA:
Other thawing systems for frozen OCTAPLASMA can be used on the condition that the methods are validated for that purpose.
Allow the content of the bag to warm to approximately +37°C before infusion. The temperature of OCTAPLASMA must not exceed +37°C. Remove the outer wrapper and examine the bag for cracks or leaks.
Avoid shaking.
Do not use solutions that are cloudy or have deposits.
Interactions with other drugs are unknown. OCTAPLASMA must not be mixed with other drugs as inactivation and precipitation may occur. To avoid the possibility of clot formation, solutions containing calcium must not be administered by the same intravenous line as OCTAPLASMA.
Due to the risk of activation/inactivation of OCTAPLASMA, the concomitant administration of other blood products should be avoided as much as possible, except for emergency situations. However, the product can be mixed with red blood cells and platelets.
Protect from light.
Thawed OCTAPLASMA must not be refrozen. Unused product must be discarded.
Overdose may lead to hypervolaemia and thereby pulmonary oedema and/or cardiac failure. In such cases, OCTAPLASMA transfusion should be stopped immediately. General measures such as the administration of furosemide can be considered, if clinically appropriate
For management of a suspected drug overdose, contact your regional Poison Control Centre.
The shelf life of OCTAPLASMA is 48 months when stored at ≤ -18 °C.
Protect from exposure to light.
After thawing OCTAPLASMA can be stored for up to 24 hours at +2-8 °C or for up to 8 hours at room temperature (+20 – 25°C) before use 19. Do not use solutions that are cloudy or have deposits.
Thawed OCTAPLASMA must not be refrozen. Unused product must be discarded.
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