| TUNISIA |
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| Last
update |
2007-05 |
2007-05 |
2010-02 |
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| Company |
Biotest Pharma
GmbH |
LFB |
Octapharma |
|
| Name of
product |
Intraglobin®
F |
TEGELINE |
Octagam
5% |
|
| Available
for Hospital therapy |
Yes |
Yes |
Yes |
|
| Available
for Home therapy |
not available
for home therapy |
Yes |
Depends on
legal situation, may be used at home
in general |
|
| IVIG,
SCIG or IMIG |
IVIG |
IVIG |
IVIG |
|
| Patient´s
age |
unlimited |
None |
Children and
adults |
|
| Présentation |
ready-to-use
solution |
Lyoph. |
Liquid |
|
| Concentration
% |
5% solution |
5% |
5% |
|
| Content
of IgG |
≥ 95% |
> 97% |
≥ 95% |
|
| IgG1 |
62% |
58.80% |
62,2% ± 2,2 |
|
| IgG2 |
34% |
34.10% |
31,1% ± 2,3 |
|
| IgG3 |
0.5% |
5.40% |
6,1% ± 1,6 |
|
| IgG4 |
3.5% |
1.70% |
1,2 % ± 0,2 |
|
| Content
of IgA |
≤ 2.5
mg/ml |
17 mg/ g of
proteins |
≤ 0.2
mg/mL |
|
| Glucose,
Maltose,… |
glucose 25 mg |
Saccharose
: 2 g/g of proteins |
Maltose 10% |
|
| Average
dosage for PID |
initial 0.4 -
0.8 g/kg, followed by 0.2 -0.8 g/kg |
0.4
to 0.8 g/kg |
0.4 g/kg b.w. |
|
| Max.
Speed of infusion |
2.2 mg/ml per
hour |
4 mL / kg / h |
5 ml/kg/hour |
|
| Intervals
of infusion for PID |
dependent on
the individual serum IgG level between 2 and 4 weeks |
Every 2 to 4
weeks |
every 3 to 4
weeks |
|
| Preserving |
storage in
refrigerator (+2 to +8 0C) - shelf-life: 2 years |
< 25 ° C |
Below 25°C |
|
| Time for
reconstitution |
|
< 30 min. |
none |
|
| Packaging* |
containers
with 20, 50, 100 or 200 ml |
0,5 g - 2,5 g -
5 g - 10 g |
1g, 2.5g, 5g,
10g |
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| * May be different from country to country |
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