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Logo BIOPLASMA FDP lyophilised powder for IV infusion
P1883 01/2002

REGISTRATION NUMBER
28/30.3/405

PROPRIETARY NAME
(and dosage form):

BIOPLASMA FDP lyophilised powder for IV infusion

DESCRIPTIVE NAME OF MEDICINE
Fresh Human Plasma

PHARMACOLOGICAL CLASSIFICATION
A 30.3 Biologicals (Blood fractions)

SCHEDULING STATUS
S4

COMPOSITION
Bioplasma FDP is produced from pooled fresh human plasma of volunteer, non-remunerated blood donors. Each unit of plasma has been individually tested and found non-reactive for hepatitis B surface antigen, antibodies to the hepatitis C virus and antibodies to the human immunodeficiency viruses, HIV-1 and HIV-2, using approved methods. Bioplasma FDP is prepared using a solvent-detergent treatment process, which inactivates lipoprotein-coated viruses including HIV, hepatitis B and hepatitis C.
After reconstitution with Water for Injection each 100 mL Bioplasma FDP contains 4 g-6 g plasma proteins with a normal distribution of human plasma components including albumin, immunoglobulins, coagulation and complement factors and their inhibitors. Bioplasma FDP contains a minimum of 0,4 IU/mL of each coagulation factor.
Bioplasma FDP contains no antimicrobial agent or preservative.

IDENTIFICATION
Lyophilised powder: light-yellow to yellow powder or solid friable mass.
Reconstituted solution: slightly opalescent solution.

PHARMACOLOGICAL ACTION OF THE MEDICINE
Plasma and coagulation factor replacement.

INDICATIONS
Bioplasma FDP can be used where plasma and/or coagulation factors are required.

CONTRA-INDICATIONS
Known hypersensitivity to plasma proteins, including patients with IgA deficiency. The risk of hypersensitive reactions should be weighed against that of the condition.
Bioplasma FDP must not be used for volume replacement where no coagulation disorder is present.
The safety of Bioplasma FDP in pregnancy has not been established in controlled clinical trials.

DOSAGE AND DIRECTIONS FOR USE
Dosage:
Dosage and infusion rate are based on the clinical picture and the results of coagulation tests. Coagulation factor levels should be maintained above 30% of normal values. A starting dose of 12-15 mL/kg is generally adequate. A sufficient volume should be administered to stop bleeding and maintain haemostasis.
In massive transfusion, infusion of one plasma unit after every three units of packed cells is advised. It is important to monitor the response, both clinically and with measurement of prothrombin time (PT), partial thromboplastin time (PTT) or specific factor assays. The volume and frequency of plasma exchange vary depending on the individual patient, the clinical situation and the preferred regimen of treatment. The volume of the plasma exchanged in most therapeutic procedures is usually equivalent to the plasma volume of the patient. As a guideline, a course of 4-5 plasma exchange procedures within 7-10 days is generally followed.
Reconstitution procedure:
Read all instructions before commencing the reconstitution procedure. Please note that there are separate reconstitution procedures for Bioplasma FDP 200 mL and Bioplasma FDP 50 mL presentations. See point 3a and 3b for further details.
1. Remove the aluminium closures from theBioplasma FDP and diluent (Water for Injection). Swab the exposed rubber stoppers with a suitable antibacterial agent.
2. Insert the airvent needle into the small circular port (labelled B) of the diluent bottle.
  (See accompanying diagram of the rubber stopper)
3a Bioplasma FDP 200 mL:
  Clamp the transfer set and then insert the transfer set needle into the largest circular port (labelled A) of the diluent bottle. Insert the opposite end of the transfer setneedle into either of the two ports of the Bioplasma FDP bottle. Raise the diluent bottle above the Bioplasma FDP bottle and release the clamp of the transfer set. The vacuum will draw the diluent into the bottle. Once the transfer is complete, remove the transfer set and the diluent bottle as a unit and discard.
3b Bioplasma FDP 50 mL:
  Connect the needle to the syringe and insert the needle into the largest port (labeled A) of the diluent bottle. Draw up 50 mL of Water for Injection. Insert the needle into either of the ports of the Bioplasma FDP bottle. The vacuum will draw the diluent into the bottle. Discard the needle, syringe and the remaining diluent.
NB: Lyophilised powders are packed under vacuum. If this vacuum is lost, it may be difficult to reconstitute this product as the diluent flow into the bottle will decrease and eventually stop. Should this occur, insert an airvent needle through the rubber stopper of the Bioplasma FDP bottle and draw the diluent into the bottle by gravity.
4. Gently swirl the bottle. Do not shake and avoid foaming. Allow the product to stand until completely dissolved, swirling occasionally. This may take up to 20 minutes.

Intravenous administration:
Please note: The reconstituted solution is slightly opalescent and may exhibit slight foaming.
  Do not use if preparation contains particles or is turbid.
  Administer only once all the powder has completely dissolved.
  Infuse immediately after reconstitution.
  Bioplasma FDP must not be mixed or used concomitantly with other medications as inactivation or precipitation may occur.
  Solutions containing calcium should not be administered through the same intravenous line because of possible clot formation.
Insert the airvent set into a port of the rubber stopper and infuse the solution through an appropriate giving-set with an in-line filter, inserted into a port of the rubber stopper.
Infusion rate:
Due to the risk of citrate toxicity, the infusion rate should never exceed 0,02-0,025 mmol citrate/kg body mass/min equal to <1 mL Bioplasma FDP/kg body mass/min.
Discard any unused portion.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The following adverse reactions have been reported with Bioplasma FDP: Cutaneous manifestations, chills with/without fever, nausea, vomiting, pulmonary manifestation, hypocalcaemia, anaphylactoid reaction.
The following adverse reactions may occur with Bioplasma FDP:
* Acute, mild allergic reaction eg. urticaria, chills, fever, nausea, vomiting, abdominal or back pain due to hypersensitivity of infused proteins.
* Acute, severe allergic reactions (anaphylactic or anaphylactoid) characterised by eg. flushing of the skin, hypotension, substernal pain, bronchospasms, dyspnoea, cardio-respiratory collapse due to hypersensitity to infused proteins or anti-IgA.
Adrenaline, corticosteroids and full resuscitation equipment should therefore be on hand when administering this product. Less severe reactions may be controlled with antihistamines.
* High infusion rates may cause cardiovascular effects as a result of citrate toxicity (fall in calcium) especially in patients with liver function disorders.
Bioplasma FDP should be given with caution to a patient with diminished cardiac reserve because of circulatory overload and pulmonary oedema.
Infectious diseases due to transmission of infective agents, cannot be totally excluded. Consideration should be given to appropriate vaccination of patients receiving human blood or plasma derived medicinal products.

PRESENTATION
Pack sizes available:
200 mL: Lyophilised powder vacuum packed in a 250 mL clear glass bottle sealed with a rubber stopper and an aluminium closure. 200 mL Water for Injection and reconstitution set are also included.
50 mL: Lyophilised powder vacuum packed in a 100 mL clear glass bottle sealed with a rubber stopper and an aluminium closure. 200 mL Water for Injection and reconstitution set are also included.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT
Hypervolaemia, pulmonary oedema and cardiac failure may occur in cases of high dosages or infusion rates. High infusion rates may cause cardiovascular effects as a result of citrate toxicity, especially in patients with liver function disorders.
See side effects and special precautions. Treatment is symptomatic and supportive.

STORAGE DIRECTIONS
Store below 25°C.
Protect from light.
Keep out of reach of children

NAME AND BUSINESS ADDRESS OF THE APPLICANT
NATAL BIOPRODUCTS INSTITUTE
Company Reg. No. 1994/002044/08
PRIVATE BAG X9043 10 EDEN ROAD
PINETOWN PINETOWN
3600 3610
Telephone No. 031 7196789 Fax No. 031 7085614

Under licence from Octapharma Pharmazeutika, Produktionsgesellschaft MBH, Doerenkampgasse 4, A-1100 Vienna, Austria.

DATE OF PUBLICATION OF PACKAGE INSERT
7/94

P1883 01/2002

Please note that the Natal Bioproducts Institute cannot be held responsible for the accuracy of the text. The package insert on the screen may not be the latest version. We therefore recommend that an alternative source of information be consulted, particularly when confirmation of dosages and indications are required. Please refer to the printed package inserts inside the packs, recognised reference books or alternatively, you may contact the NBI Information Centre at (+27)(+31) 719 6789 or 082 870 3705 or 082 895 0056.

Updated on this site: March 2003
Source: Pharmaceutical Industry

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