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FLEBOGAMMA  10% DIF Intravenous Immunoglobulin 

BloodSafe Guide to Administration, Public - I2 - A1 TP-L3-418  v1.1 5/11/2015 
Page 1 of 2 

 

 

FLEBOGAMMA  10% DIF is a human intravenous (IV) immunoglobulin (IVIg) solution for infusion. 
It is available in Australia as 5 g (50 mL), 10 g (100 mL) &amp; 20 g (200 mL) vials. 
Always read the Product Information (PI) in the box carefully before commencing. 
WARNING! DO NOT administer FLEBOGAMMA  10% DIF using infusion protocols for 
FLEBOGAMMA  5% DIF or ANY other brands of IVIg (including PRIVIGEN  10% &amp; INTRAGAM  P 6%). 

 

 

STORAGE 
? FLEBOGAMMA  10% DIF must be stored below 

30 C or refrigerated in a monitored blood fridge 
(in transfusion service where available). 

? It must not be stored in domestic/ward refrigerator. 
? Do not freeze. 
? Removal from storage must be documented in the 

register or electronic system for the purposes of 
tracking as per health service procedures / 
transfusion service provider requirements. 

? Do not use after the expiry date. 
? Store protected from light. 
? FLEBOGAMMA  10% contains no antimicrobial 

preservative. Use in 1 patient, on 1 occasion only. 
? Contact transfusion service provider/product 

provider for advice re handling/return of any unused 
bottles (unopened). 

? Used bottles MUST be discarded in medical waste &amp; 
are not suitable for recycling. 

VISUALLY INSPECT PRODUCT 
? FLEBOGAMMA  10% DIF should be a clear or 

slightly opalescent, colourless to pale yellow liquid. 
? Do not use solutions that are cloudy or have 

deposits (any sediment or particles) - contact the 
transfusion service provider. 

CONTRAINDICATIONS &amp; PRECAUTIONS 
? Always refer to the full PI. 
? Patients with rare total IgA deficiency should have 

the IVIg product with the lowest IgA content - 
INTRAGAM  P 6% is the preferred product. 

? Contraindicated in those with known hypersensitivity 
to this product. 

? Product contains 50 mg/mL of sorbitol as excipient. 
? WARNING! Contraindicated in patients with rare 

hereditary problems of fructose intolerance. 
? Babies and young children should NOT 

receive this product as hereditary fructose 
intolerance may not yet be diagnosed &amp; may be 
fatal. 

? SA Immunoglobulin Therapy Advisory Group 
has determined that this product will NOT be 
issued to children under 5 years old. 

? Interferences with determination of blood glucose 
levels are not expected. 

PRIOR TO ADMINISTRATION 
? Correct reversible risk factors for adverse reactions (such as 

dehydration) before infusion is given. 
? Ensure prescription is complete including the BRAND &amp; 

CONCENTRATION of IVIg prescribed. 
? Check informed consent is documented as per health 

service policy. 
? Explain procedure to patient including symptoms of possible 

reactions. 
? Ensure IV access patent. 
? Record baseline observations (TPR &amp; BP) &amp; general patient 

status including pre-existing rashes. 
? Ensure circumstances/situation appropriate to proceed. 
? Check resuscitation equipment, including oxygen &amp; 

adrenaline are available &amp; in working order. 
? Read the PI contained in the box. 
? Allow the product to reach room temperature 

ENSURE RIGHT PATIENT - RIGHT PRODUCT 
? WARNING! Verify correct patient, product (including brand 

&amp; concentration) &amp; prescription. 
? The patient s identify MUST always be confirmed prior to 

administration. 
? Check as per IV medication/health service policy. 

DOCUMENTATION OF BATCH NUMBER 
? All product batch numbers must be documented in the 

patient s medical record   the vials have a peel off label with 
the batch number. 

? The transfusion service provider may also attach peel off 
label(s). 

IV LINE/PUMPS 
? The use of a pump is recommended to ensure constant 

delivery of accurate rates. 
? A new standard IV line or blood administration set (170 - 200 

micron filter) may be used. 
? Administration from a glass bottle requires a vented system. 

MEDICATION/OTHER IV FLUIDS 
? CAUTION! Do not mix or piggy back this product with other 

medications or IV fluids. 
? Administered via a separate IV line. 
? Premedication may be prescribed (e.g. for a history of 

reaction as per treating doctor). 
? Consider clearing the line with 0.9% Sodium Chloride 

solution (Normal Saline) on completion of infusion. 
 

Disclaimer: This is a guide only and the information contained herein is general in nature and does not correspond to or reflect any particular 
patient's circumstances or condition(s). It is not a substitute for expert opinion and/or clinical advice. Each of the parties involved in 
developing this document expressly disclaims and accepts no responsibility for any undesirable consequences arising from relying on the 
information, products, procedures or services referred to herein. 

 

Produced by SA BloodSafe Program, in conjunction with the SA Immunoglobulin Therapy Advisory Group, based on Australian Product 
information. 



FLEBOGAMMA  10% DIF Intravenous Immunoglobulin 

BloodSafe Guide to Administration, Public - I2 - A1 TP-L3-418  v1.1 5/11/2015 
Page 2 of 2 

 

 

 

FLEBOGAMMA  10% DIF INFUSION RATES 
? Infusion rates should be calculated &amp; prescribed by the 

treating doctor. Use ideal body weight to calculate 
infusion rates in obese patients. 

? Start slowly, increase rate gradually only if tolerated. 
? If the line is not primed with IVIg, consider this volume in 

the timing of rate increases. 
 

FLEBOGAMMA  10% DIF INFUSION RATES 
NOTE: INFUSION RATES# below are in mL/kg/hr: 

0.5 mL/kg/hr for 30 minutes 
1.0 mL/kg/hr for 30 minutes 
2.0 mL/kg/hr for 30 minutes 
3.0 mL/kg/hr with a max. rate of 400 mL/hr Routine 

use of higher rates is not recommended. 
#Lower max. rate of up to 2 mL/kg/hr (max. 200 mL/hr) 

is recommended in high risk patients e.g. 
&gt; 65 years; diabetics; obese; 
those with pre-existing or risk factors for: 
cardiac disease, renal failure or arterial or venous 
thromboembolism; 
those with hyperviscosity; paraprotein or dehydration 
(for more info see PI &amp; consult treating doctor). 

? In septic patients or those with multiple risk factors, 
discuss timing of IVIg administration with an expert. 

? During an infusion, subsequent vials may commence at 
same rate that the preceding vial finished. 

? Each bottle should be completed within 4 hours. 
? It is recommended that subsequent infusions are given 

according to the same protocol (consult treating doctor if 
there has been a change in health status or reaction to a 
previous infusion). 

REACTIONS 
? Tend to be related to the rate of the infusion &amp; are more 

common in certain patient groups - refer to PI. 
? Symptoms/signs may include: dyspnoea, wheezing, 

chest tightness, coughing, changes in blood pressure, 
tachycardia, flushing, fever, rigors, skin rash/urticaria, 
headache, vomiting, nausea &amp; abdominal &amp; back pain. 

 

REACTIONS (continued) 
? If a reaction does occur: 

? stop administration immediately 
? assess vital signs 
? notify the medical officer 
? provide emergency care as required. 

? For minor reactions (headache is most common) the 
infusion can often be restarted cautiously at a slower 
rate after patient has improved clinically. 

? Follow your institutional procedure for reporting 
adverse events to IVIg. Inform your transfusion 
service/product provider. 

OBSERVATIONS 
Refer to health service policies/procedures for IVIg 
infusions &amp; PI for any specific recommendations as well 
as considering individual patient factors &amp; consulting with 
the treating doctor. 
General recommendations: 
? Close observation is required &amp; patient s general 

status should be monitored regularly throughout the 
infusion. 

? A common approach is to take a TPR &amp; BP: 
  as a baseline prior to commencing 
  each rate increase 
  hourly once maximum rate is achieved 
  on completion 
  if the patient experiences new or increased 

symptoms. 

OBSERVATION POST INFUSION 
The following patients should be monitored for 1 hour after 
completion of the infusion: 
? those who have not had IVIg before 
? those who have switched from another product 
? where there has been a long interval since last 

infusion 
? where there has been a significant deterioration in 

health 
? those who have had a reaction to the current or 

previous infusion. 
Other patients should be observed for at least 20 minutes. 
See PI, health service procedure &amp; consult treating doctor. 

 

Disclaimer: This is a guide only and the information contained herein is general in nature and does not correspond to or reflect any particular 
patient's circumstances or condition(s). It is not a substitute for expert opinion and/or clinical advice. Each of the parties involved in 
developing this document expressly disclaims and accepts no responsibility for any undesirable consequences arising from relying on the 
information, products, procedures or services referred to herein. 

 

Produced by SA BloodSafe Program, in conjunction with the SA Immunoglobulin Therapy Advisory Group, based on Australian Product 
information. 

 

 

For updates see www.sahealth.sa.gov.au/bloodsafe 
 

 

 

  


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