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<DOCUMENT author="perl program" datec=020199 title="leaflet" book="ABPI" edition="1996-97" section="company">

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Please read this leaflet carefully.
</EMPH>

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<DIV type=0>

<HEAD weight="bold" >
SANDOGLOBULIN 1g
</HEAD>


<BLOCK>
Freeze-dried, human normal immunoglobulin for preparation of a solution for intravenous infusion.
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<DIV type=1>

<HEAD weight="bold" >
Reconstitution
</HEAD>


<BLOCK>
Prepare solution immediately before use.
</BLOCK>


<BLOCK>
To prepare a 
<EMPH uline="plain">
3% solution
</EMPH>
 – dissolve the entire contents of the 
<EMPH weight="bold">
Sandoglobulin
</EMPH>
 bottle in 33 ml 0.9% w/v normal saline.
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<DIV type=2>

<HEAD weight="bold"  justified="center" >
Reconstitution    
</HEAD>


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<CB n=2>


<FIGURE></FIGURE>


<CB n=1>


<BLOCK>
1. Tear off the protective caps from the sterile saline for injection and 
<EMPH weight="bold">
Sandoglobulin
</EMPH>
 bottles. Disinfect both rubber stoppers.
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<CB n=2>
<FIGURE></FIGURE>
<CB n=1>

<BLOCK>
2. Remove the protective cover from one end of the transfer set and insert the spike through the rubber stopper of the bottle of 
<EMPH weight="bold">
saline
</EMPH>
.
</BLOCK>


<BLOCK>
3. Remove the protective cover from the other end of the transfer set. Lift both bottles, 
<EMPH weight="bold">
holding at a slight angle to the work surface
</EMPH>
, and insert spike into the 
<EMPH weight="bold">
Sandoglobulin
</EMPH>
 bottle.
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<CB n=2>
<FIGURE></FIGURE>
<CB n=1>

<BLOCK>
4. Invert the bottles so that the saline flows into the 
<EMPH weight="bold">
Sandoglobulin 
</EMPH>
bottle.
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<BLOCK>
Turn both bottles vertically so that the 
<EMPH weight="bold">
Sandoglobulin 
</EMPH>
is on the bottom and the saline is on top.
</BLOCK>


<BLOCK>
Hold both bottles firmly to prevent loss of vacuum while the saline is drawn into the 
<EMPH weight="bold">
Sandoglobulin 
</EMPH>
bottle. In this manner the vacuum in the 
<EMPH weight="bold">
Sandoglobulin 
</EMPH>
bottle, together with gravity, works to accelerate the rate of saline transfer.
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<CB n=2>
<FIGURE></FIGURE>
<CB n=1>

<BLOCK>
5. Once the saline is transferred, lift the saline bottle off the spike to release the vacuum. This will reduce foaming and facilitate dissolution.
</BLOCK>


<BLOCK>
Remove the spike.
</BLOCK>


<BLOCK>
The powder should dissolve within a few minutes to form an opalescent solution.
</BLOCK>


<BLOCK>
In exceptional cases, dissolution may take up to 20 minutes. It is important that all particles of 
<EMPH weight="bold">
Sandoglobulin 
</EMPH>
are completely dissolved and no clumps remain.
</BLOCK>


<BLOCK>
You can help this process by gently swirling the bottle but 
<EMPH weight="bold">
DO NOT SHAKE
</EMPH>
. Shaking can cause foaming and particle formation, both of which can impede the dissolving and administration process.
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</DIV>
<DIV type=2>

<HEAD weight="bold"  justified="center" >
Administration
</HEAD>

<DIV type=3>

<HEAD justified="center" >
Sandoglobulin is for intravenous use only
</HEAD>


<BLOCK>
Infusion Sets:
</BLOCK>


<BLOCK>
Any infusion set with the following features is suitable for use with 
<EMPH weight="bold">
Sandoglobulin
</EMPH>
:- a) An air vent.
</BLOCK>


<BLOCK>
b) A drop chamber to control infusion rate.
</BLOCK>


<BLOCK>
c) A 15&#109; <PB n=7> <CB n=1> <FIGURE></FIGURE> <CB n=2>
</BLOCK>


<BLOCK>
6.Remove the protective cover of the cannula of the infusion set and push the cannula through the rubber stopper of the 
<EMPH weight="bold">
Sandoglobulin
</EMPH>
 bottle with a sharp thrust.
</BLOCK>


<BLOCK>
7.Clamp off the infusion tube tightly.
</BLOCK>

<PB n=8>
<CB n=1>
<FIGURE></FIGURE>
<CB n=2>

<BLOCK>
8.Invert and suspend the 
<EMPH weight="bold">
Sandoglobulin 
</EMPH>
bottle. Squeeze the drip chamber lightly with thumb and index finger so that the solution flows into it.
</BLOCK>

<PB n=9>
<CB n=1>
<FIGURE></FIGURE>
<CB n=2>

<BLOCK>
9.Open the clamp slowly and allow the 
<EMPH weight="bold">
Sandoglobulin 
</EMPH>
to fill the infusion set expelling all the air. Close the clamp.
</BLOCK>


<BLOCK>
10.Connect the infusion set to the infusion needle. Open the clamp slowly and set the drop rate.
</BLOCK>


<BLOCK>
Proceed with the infusion only if the solution is free from particulate matter and at close to body temperature.
</BLOCK>

<CB n=1>

<BLOCK>
To minimise the risk of inflammatory side effects, resulting from a reaction between the antibodies administered and the recipients free antigen, 
<EMPH weight="bold">
Sandoglobulin
</EMPH>
 should be given as follows:
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</DIV>

</DIV>

</DIV>
<DIV type=1>

<HEAD weight="bold" >
1. FIRST INFUSION
</HEAD>


<BLOCK>
The very first infusion of 
<EMPH weight="bold">
Sandoglobulin
</EMPH>
 should be of a 3% solution. This should be infused at the following rate:
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<BLOCK>
a) 0 - 15 minutesat a rate not exceeding 10 to 20 drops per minute.
</BLOCK>


<BLOCK>
b) 15 - 30 minutesthe rate may be increased to 20 to 30 drops per minute, if necessary. 
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<BLOCK>
c) After 30 minutesthe rate may be increased to 40 to 50 drops per minute, if necessary. 
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</DIV>
<DIV type=1>

<HEAD weight="bold" >
2. SUBSEQUENT INFUSIONS
</HEAD>


<BLOCK>
Subsequent infusions of a 3% solution may be administered at a rate of 40 to 50 drops per minute.
</BLOCK>


<BLOCK>
For repeated administrations of high doses a 6% solution may be used.
</BLOCK>


<BLOCK>
Note: 20 drops = approximately 1 ml.
</BLOCK>


<BLOCK>
Discard any solution remaining after infusion.
</BLOCK>

<DIV type=2>

<HEAD justified="center" >
Further information, including product data sheet, is available from:-  
</HEAD>


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SANDOZ PHARMACEUTICALS <CB n=1> SANDOZ PRODUCTS (IRELAND) LTD <PB n=12> <CB n=2> Sandoglobulin is a registered Trade Mark <PB n=13> <CB n=1> <FIGURE></FIGURE>
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</DIV>

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