| COLOMBIA |
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| Last
update |
2007-05 |
2007-05 |
2010-02 |
2007-05 |
2007-05 |
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| Company |
Bio-Products
Laboratory |
Biotest Pharma
GmbH |
CSL-Behring |
Grifols |
Kedrion |
|
| Name of
product |
Vigam |
Intraglobin®
F |
Sandoglobulin
(lyo) |
Flebogamma |
IG
VENA |
|
| Available
for Hospital therapy |
Yes |
Yes |
Registered |
Yes |
Yes |
|
| Available
for Home therapy |
- |
not available
for home therapy |
- |
|
None |
|
| IVIG,
SCIG or IMIG |
IVIG |
IVIG |
IVIG |
IVIG |
IVIG |
|
| Patient´s
age |
Adults and
pediatrics |
unlimited |
Adults and
children |
|
Adults &
Children |
|
| Présentation |
Liquid |
ready-to-use
solution |
Lyophilisat |
Liquid |
Liquid |
|
| Concentration
% |
5% |
5% solution |
3%, 6%, 9%, 12% |
5% |
5% |
|
| Content
of IgG |
95% |
≥ 95% |
≥ 96% |
≥ 99% |
95% |
|
| IgG1 |
65 |
62% |
60.7% |
70.3% |
24,3 -
37,2 mg |
|
| IgG2 |
29 |
34% |
31.9% |
24.7% |
12,4 -
22,1 mg |
|
| IgG3 |
6 |
0.5% |
3.8% |
3.1% |
0,9 -
1,5 mg |
|
| IgG4 |
1 |
3.5% |
3.6% |
2% |
0,1 -
0,5 mg |
|
| Content
of IgA |
< 0.02% w/w |
≤ 2.5
mg/ml |
1.2g/L (typical
value) |
<0,05 mg/ml |
< 0,05 mg/ml |
|
| Glucose,
Maltose,… |
Sucrose |
glucose 25 mg |
Sucrose |
|
Maltose |
|
| Average
dosage for PID |
Dependant on
age and weight of patient |
initial 0.4 -
0.8 g/kg, followed by 0.2 -0.8 g/kg |
0.2-0.8g/kg
bodyweight |
|
0,4 - 0,8 g/kg |
|
| Max.
Speed of infusion |
3 ml/minute |
2.2 mg/ml per
hour |
About
2.5ml/min |
|
40 drops/minute |
|
| Intervals
of infusion for PID |
Every 2-4 weeks
to obtain IgG trough level of at least 4-6 g/L |
dependent on
the individual serum IgG level between 2 and 4 weeks |
Usually every
2-4 weeks |
|
21-28 days |
|
| Preserving |
Vigam® Liquid should be stored
in the dark in its carton, between 2° and 8°C. DO NOT FREEZE. A short period up to 3 months at 25°C is
possible within the shelf-life period. |
storage in
refrigerator (+2 to +8 0C) - shelf-life: 2 years |
3 years
≤25°C |
Between +2ºC
and +25ºC. Do not freeze. Discard after expiration date. |
+2C°<
T <+8C° |
|
| Time for
reconstitution |
N/A |
|
A few minutes |
none |
Ready for use |
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| Packaging* |
|
containers
with 20, 50, 100 or 200 ml |
1g, 3g, 6g, 12g |
|
1g/
20 ml ; 2,5 g/ 50 ml ; 5 g/ 100 ml ;
10 g/ 200 ml |
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| * May be different from country to country |
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