Who can administer
May be administered by registered competent doctor or nurse/midwife
Important information
- Should be prepared by an experienced member of staff (very expensive)
- Contraindicated in individuals with selective IgA deficiency who are known to have antibodies against IgA, as allergic reactions to the point of anaphylactic shock may occur in such cases
- Blood product- record batch number and expiry date in patient's notes
Available preparations
Prolastin 1g powder and solvent for Solution for Infusion
Reconstitution
Water for injection
- Bring vials to room temperature before reconstitution. Add 40ml per 1g vial (solvent supplied)
- Use a Mix2Vial device supplied with the product to reconstitute the vial
- Push the blue end of the Mix2Vial device into the solvent bottle first
- Place the vial containing the drug on to a flat surface and invert the solvent bottle with the Mix2Vial device still attached
- While holding the Prolastin Vial securely, push the clear end of the Mix2Vial straight down until the spike penetrates the stopper. The solvent will flow down into the Prolastin vial
- Note: If the Mix2Vial is connected at an angle, the vacuum may be released from the product vial and the solvent will not transfer- in which case, a needle and syringe will be needed to make the transfer
- Gently swirl the concentrate bottle until powder is completely dissolved
- Do not shake- to avoid foaming
- Visually inspect for particulate matter and discolouration
Infusion fluids
Not applicable
Methods of intravenous administration
- The reconstituted solution is added to an empty infusion bag
- Use a 16Gauge needle (ref BD 300637) to draw up the drug solution
- Add the total dose to the empty infusion bag
Intermittent intravenous infusion (administer using an electronically controlled infusion device)
- Use a 500ml empty bag for doses up to 12g and a 1000ml empty bag for doses greater than this
- Administer at a rate of 4.8ml/kg/hour
Dose in adults
Usual dose
- Give 60mg/kg every week
- The dose can be rounded down to the nearest gram
Further information
- Vaccination against Hepatitis A and B is recommended before starting treatment
- Because it is a blood derived product, interruptions to supply can occur
- Consultant signed protocol for Prolastin on file in Pharmacy, MPH, as required by nursing intravenous policy
- Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses. There is also the possibility that unknown infectious agents many be present in such products. Any suspicion of such infection should be reported to the manufacturers
- May cause a transient increase in blood volume - use with caution in patients with severe heart failure and in patients at risk of circulatory overload
Order code numbers for empty bags are:
500ml bag (Baxter E3MC-3802),
1000ml bag (Baxter E3MC-3803)
Items required:
BD 16g needles ref 300637- available from surgical stores
Extended intervals
- No longer recommended (ref 1)
- A consultant may choose to use a different dosage interval, on an individual patient basis
Storage
- Store below 250C, do not freeze
- Prepare infusion immediately before administration
- Administration must be complete within 3 hours of reconstitution and do not refrigerate after reconstitution
References
SPC November 2022
1: Alpha-1 Foundation in Beaumont (01 8093871) - contacted 8th May 2023
Therapeutic classification
Proteinase inhibitor
