Presentation
Liquid. Available in 50mL (3g) or 200mL (12g) vials.
Indications for Use
To ensure demand can be met from the limited supply of intravenous immunoglobulin (IVIg), Intragam P is issued in accordance with the Criteria for the clinical use of Intravenous Immunoglobulin in Australia (2008) which have been developed to assist clinicians and transfusion medicine professionals to identify the conditions and circumstances for which the use of IVIg is appropriate and funded under the National Blood Arrangements.
A list of the criteria can be found here or you can view the full criteria at www.nba.gov.au. Hard copies, as well as a quick reference guide can be ordered via the National Blood Authority (NBA) website.
Contraindications
In patients with a true anaphylactic reaction to human immunoglobulin preparation.
Precautions
Administer intravenously only.
Contains traces of IgA which may provoke anaphylaxis in patients with IgA deficiency or IgA antibodies.
- Aseptic meningitis syndrome (AMS): occurs infrequently with intravenous immunoglobulin treatment; occurring within several hours to 2 days following treatment.
- Occasional reports of renal dysfunction and acute renal failure, mainly with sucrose containing preparations. This product does not contain sucrose. Increased risk with patients >65years of age, pre-existing renal insufficiency, diabetes mellitus, volume depleted or taking concomitant nephrotoxic medication.
Availability
Requests to ARCBS. Issued on an individual patient basis following approval based on the Criteria for the clinical use of intravenous immunoglobulin in Australia by an ARCBS Medical Officer.
Dosage and Administration
Dosage varies and is dependent on the clinical indication. Intragam P may be administered through any standard intravenous giving set.
Bring product to room temperature prior to administration.
Contains no antimicrobial infuse immediately after opening.
Administer separately from other intravenous infusions or medications.
Infusions should be commenced slowly and rate increased only if tolerated to a maximum date of 240mL/hr. Initially commencing at 1 mL/min for 15 mins (60 mL/hr) then increased to 2 mL/min for 15 mins (120 mL/hr) to a maximum of 4 mL/min until infusion complete.
Refer to the current product information sheet for further information.
Patient Monitoring
Vital signs should be monitored regularly throughout the infusion, in line with your hospital's policy. It is recommended that blood pressure, pulse, respiratory rate and temperature monitored prior to the infusion, every 15 minutes of the first hour, twice in the next hour and then hourly for the duration of the infusion.
Adverse Reactions
Reactions to intravenous immunoglobulin occur infrequently, however they may include malaise, abdominal pain, headache, chest tightness, facial flushing, erythema, dyspnoea, rash, nausea and change in blood pressure. Rarely, transient haemolytic anaemia, neutropenia, acute renal failure, aseptic meningitis, hypersensitivity and thrombotic events have been reported.
If an adverse event occurs, stop the transfusion immediately and consult medical staff. in cases of minor reactions the infusion can often be restarted cautiously at a slower rate with medical consultation.
Please report adverse events to the treating medical staff, hospital transfusion service/transfusion provider, ARCBS and CSL Bioplasma's Medical/Technical Inquiries service, phone 1800 067 140.
Refer to the current product sheet for further information.