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Logo BIOPLASMA FDP

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form):

BIOPLASMA FDP
(lyophilised powder for IV infusion)

COMPOSITION
Descriptive name
: Fresh
Human Plasma
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 (HBsAg), antibodies to the hepatitis C virus (HCV) and antibodies to the human immunodeficiency viruses, HIV-1 and HIV-2, using approved methods.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
Bioplasma FDP is prepared using a solvent/detergent treatment process, which inactivates lipoprotein-coated viruses including HIV, hepatitis B and hepatitis C. This process may be of limited value against non-enveloped viruses such as hepatitis A (HAV) and parvovirus B19. To further reduce the risk of viral transmission, only plasma pools tested and found negative for anti-HIV-1 & -2, HBsAg and anti-HCV by serological testing; and for HIV, HBV, HCV and HAV by Nucleic Acid Amplification Techniques (NAT), are used in the manufacture of Bioplasma FDP. In addition, only pools containing <10U/mL parvovirus B19 are used.
After reconstitution with Water for Injection each 100 ml Bioplasma FDP contains 4 - 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.QuickMarkQuickMark
Bioplasma FDP contains no antimicrobial agent or preservative.

PHARMACOLOGICAL CLASSIFICATION
A 30.3 Biologicals (Blood fractions)

PHARMACOLOGICAL ACTION
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.
Severe Protein S deficiency.

WARNINGS
High infusion rates may cause cardiovascular effects as a result of citrate toxicity (fall in calcium) especially in patients with liver function disorders.

INTERACTIONS
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.

PREGNANCY AND LACTATION
The safety of Bioplasma FDP in pregnancy and lactation has not been established in controlled clinical trials. However, Bioplasma FDP is a normal constituent of human blood, and therefore may be used if clearly needed during pregnancy after careful risk-benefit analysis. (Refer to “Special Precautions.”)

DOSAGE AND DIRECTIONS FOR USE
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 varies 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 3.(a) and 3.(b) for further details.
1. Remove the aluminium closures from the Bioplasma 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) [OMITTED Ed. Please refer to original Package Insert]
3. (a) Bioplasma FDP 200 mL:
Clamp the transfer set and then insert the transfer set needle into the larger circular port (labelled A) of the diluent bottle. Insert the opposite end of the transfer setneedle into the port 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.
3. (b) Bioplasma FDP 50 mL:
Connect the needle to the syringe and insert the needle into the largest port (labelled A) of the diluent bottle. Draw up 50 mL of Water for Injection. Insert the needle into the port 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.
Insert the airvent set approximately 2 mm from the port of the rubber stopper to break the vacuum. Infuse the solution through an appropriate giving-set with an in-line filter, inserted into the port of the rubber stopper, with the airvent in place to vent the infusion.
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
Side effects
The following side effects may occur with Bioplasma FDP:
Skin and Appendages: Less frequent: Cutaneous manifestations (urticaria, pruritis, increased sweating)
CNS and PNS Disorders: Less frequent: Dysphonia
Psychiatric Disorders: Less frequent: Agitation
Gastro-Intestinal System: Less frequent: Vomiting, abdominal pain, nausea, diarrhoea
Cardiovascular disorders, general: Less frequent: Hypotension, cardio-respiratory collapse due to hypersensitivity to infused proteins or anti-IgA.
Heart rate and Rhythm Disorders: Less frequent: Tachycardia
Metabolic And Nutritional: Less frequent: Citrate toxicity (Hypocalcaemia)
Vascular (Extracardiac): Less frequent: Flushing of the skin, vasodilation
Respiratory System: Less frequent: Pulmonary manifestation, bronchospasms, dyspnoea.
Body As A Whole –General: Less frequent: Chills with/without fever, back pain, substernal pain, allergic and anaphylactic reactions (due to hypersensitivity to infused proteins and IgA.)
Special precautions
Adrenaline, corticosteroids and full resuscitation equipment should be on hand when administering this product. Less severe allergic reactions may be controlled with antihistamines.
Bioplasma FDP should be given with caution to a patient with diminished cardiac reserve because of circulatory overload and pulmonary oedema.
Bioplasma FDP should not be used as a volume expander where no coagulation deficiency has been documented or in coagulation factor deficiencies where the required specific factor concentrate is available for use.
The risk of parvovirus B19 infection following administration of Bioplasma FDP cannot be totally excluded. Parvovirus B19 infection may be serious for pregnant woman (foetal infection), individuals with immunodeficiency or increased erythropoeisis (e.g. haemolytic anaemia), therefore Bioplasma FDP should only be administered to these patients after careful risk-benefit analysis (Refer “Composition”).
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 on a routine basis
.
It is strongly recommended that every time that Bioplasma FDP is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Hypervolaemia, pulmonary oedema and cardiac failure may occur in cases of high dosages, or infusion rates which may lead to citrate toxicity.
Treatment is symptomatic and supportive.

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

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.

STORAGE INSTRUCTIONS
Store below 25ºC.
Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER
28/30.3/405

NAME AND BUSINESS ADDRESS OF THE APPLICANT
NATIONAL BIOPRODUCTS INSTITUTE
Company Reg. No. 1994/002044/08
NPO Reg. No. 020-898-NPO
PRIVATE BAG X9043         10 EDEN ROAD
PINETOWN         PINETOWN
3600         3610
Telephone:        086 016 2472
Telefax:        (031) 708 5614

DATE OF PUBLICATION OF THIS PACKAGE INSERT
2012/05/30

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

NAMIBIAN         S2
Reg. No.:         04/30.3/1043
2011/02P47

Updated on this site: August 2014
Source: Pharmaceutical Industry

Disclaimer:
Please note that the National 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 (031) 714 6700 or +27 082 870 3705 or +27 082 320 3306
.
Email: info@nbisa.org.za

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