Fresh Human Plasma

Registered South African indications:

• Plasma and coagulation factor replacement

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Immunoglobulin A deficiency
• Severe protein S deficiency

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• High infusion rates
• Diminished cardiac reserve
• Immunodeficiency
• Increased erythropoeisis

Forms avail. in SA and covered in this monograph: inj

Replacement of plasma and coagulation factors

• IV: 12-15ml/kg as an infusion; Max infusion rate: <1ml/kg/min

Total dose and infusion rate should be based on clinical assessment and coagulation test results

Coagulation factor levels should be maintained >30% of normal values

A sufficient volume should be administered to stop bleeding and maintain haemostasis

In massive transfusion, infusion of 1 plasma unit after every 3 units of packed cells is advised

See additional prescribing points for reconstitution directions

Do not mix or use concomitantly with other agents administered in the same intravenous line

No information available

Pregnancy

• FDA Pregnancy Category Not Rated (NR)

Breastfeeding

• Caution; no information available

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; dose adjustment recommended 

Elderly

• Caution; no information available

Drugs in Sport

• Permitted - No warning

Central Nervous System Disorders

• Dysphonia
• Agitation

Cardiovascular Disorders

• Hypotension
• Tachycardia
• Flushing
• Vasodilation
• Hypervolaemia
• Pulmonary oedema
• Cardiac failure

Respiratory Disorders

• Bronchospasm
• Dyspnoea

Gastrointestinal Disorders

• Nausea and vomiting
• Abdominal pain
• Diarrhoea

Endocrine and Metabolic Disorders

• Hypocalcaemia (citrate toxicity)

Musculoskeletal Disorders

• Back pain

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Pruritus
• Increased sweating

Immune, Blood and Lymphatic System Disorders

• Cardio-respiratory collapse due to hypersensitivity to infused proteins or anti-IgA
• Fever
• Allergic and anaphylactic reactions

Others

• Chills

Calcium containing solutions 

• Prothrombin time
• Partial thromboplastin time
• Specific factor assays

Reconstitution procedure

- Bioplasma FDP 200ml

• Insert airvent set needle into one side of the central port (A) of the diluent bottle to release the vacuum (Figure 1)
• Clamp the transfer set and insert it into the other side of the central port of the diluent (B)
• Insert the opposite end of the transfer set into the port of the Bioplasma FDP bottle (Figure 2)
• Holding the airvent set tubing against the diluent bottle, raise the diluent bottle above the Bioplasma FDP bottle and release the clamp of the transfer set (Figure 3). The vacuum in the Bioplasma FDP will draw the diluent into the bottle
• Once the transfer is complete, remove the transfer set and the diluent bottle from the Bioplasma FDP bottle and discard

- Bioplasma FDP 50ml

• Insert the airvent set needle into one side of the central port (A) of the diluent bottle to release the vacuum (Figure 1)
• Connect the needle to the syringe and insert into the other side of the central port of the diluent bottle (B)
• Draw up 50ml of water for injection into the syringe. Insert this into the central port of the Bioplasma FDP bottle. The vacuum in the Bioplasma FDP will draw the diluent into the bottle. Discard the needle, syringe and the remaining diluent in the bottle

Infusion procedure

• After transfer of the diluent, gently swirl the bottle
• Do not shake and avoid foaming
• Allow product to stand still until completely dissolved (up to 20 minutes)
• Do not use if preparation contains particles or is turbid
• Infuse immediately after reconstitution
• Insert the airvent set approximately 2mm from the port of the rubber stopper to break the vacuum
• Infuse the solution through an appropriate administration set with an in-line filter, inserted into the port of the rubber stopper, with the airvent in place to vent the infusion
• Discard any unused portion

Fresh human plasma consists of individually tested and pooled blood donations. The reconstituted plasma contains 4-6g of plasma proteins with a normal distribution of human plasma constituents (such as albumin, immunoglobulins, coagulation and complement factors).

Injection (per ml) 0.4iu

• Bioplasma FDP (NBI)