Presentation
Liquid. Single vials of 50mlL (2.5g), 100mL (5g), or 200mL (10g).
Each contains 50mg/ml solution.
Indications for Use
Can be used for replacement therapy and immunomudulatory effect. In accordance to the National Blood Authority (NBA) standing offer Octagam will be used at times of shortage or part of a planned roll out from the national reserve according to stages of self-sufficiency for intravenous immunoglobulin. (Please refer to Intravenous Immunoglobulin: A Clinician’s Guide).
Contraindications
Individuals with:
- IgA deficiency – unless they have no circulating anti IgA antibodies
- A true anaphylactic reaction to a human immunoglobulin
Precautions
For intravenous administration only.
Occasional reports of renal dysfunction, acute renal failure and osmotic nephrosis. Increased risk with patients >65years of age, pre-existing renal insufficiency, diabetes mellitus, volume depleted, sepsis, overweight or taking concomitant nephrotoxic medication.
Patients judged to be at risk should have a maximum infusion rate of less than 4mL/kg/hour.
Availability
Requests to ARCBS. Issued on an individual patient basis following approval by an ARCBS Medical Officer or available by Jurisdictional Direct Order.
Dosage and Administration
Dosage varies and is dependent on the clinical indication.
Infusions should be commenced slowly and rate increased only if tolerated to a maximum rate of 480mL/hr. Commence at 1mL/kg/hr for 30minutes. If well tolerated, the rate may be gradually increased to a maximum of 5ml/kg/hr. Recommended maximum rate of 480 mL/hour regardless of weight.
Bring product to room temperature prior to administration.
Contains no antimicrobial infuse immediately after opening.
Administer separately from other intravenous infusions or medications.
Refer to the current product information sheet for further information.
Patient Monitoring
Vital signs and general status should be monitored regularly throughout the infusion in line with your hospital's policy.
First infusion
Monitor patient prior to infusion, five minutes after start and five minutes after every increase in rate, then hourly until infusion complete and then post administration.
Subsequent infusions
Monitor patient prior to infusion, at 15 minutes, 45 minutes, 75 minutes and then hourly until infusion is complete and then post administration.
Adverse reactions
Adverse reactions occur occasionally and these may include chills, headache, dizziness, allergic reaction, nausea, joint pain, chest pain, fever, vomiting and moderate back pain. Rare reactions such as hypotension, rash, shortness of breath and wheezing can occur.
If an adverse reaction occurs, stop transfusion and seek medical assistance.
Adverse events should be reported to treating medical staff, hospital transfusion service/transfusion provider, ARCBS and Octapharma on 1800 780 169 or online at www.octapharma.com/Australia
Refer to the current porduct information sheet for further information.