| TURKEY |
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| Last
update |
2009-11 |
2007-05 |
2007-05 |
2010-02 |
|
| Company |
Baxter |
Kedrion |
LFB |
Octapharma |
|
| Name of
product |
KIOVIG |
IG
VENA |
TEGELINE |
Octagam
5% |
|
| Available
for Hospital therapy |
Yes |
Yes |
Yes |
Yes |
|
| Available
for Home therapy |
May vary in
different countries due to different licensing situations. |
None |
Yes |
Depends on
legal situation, may be used at home
in general |
|
| IVIG,
SCIG or IMIG |
IVIG |
IVIG |
IVIG |
IVIG |
|
| Patient´s
age |
All ages |
Adults &
Children |
None |
Children and
adults |
|
| Présentation |
Liquid |
Liquid |
Lyoph. |
Liquid |
|
| Concentration
% |
10% |
5% |
5% |
5% |
|
| Content
of IgG |
≥ 98% |
95% |
> 97% |
≥ 95% |
|
| IgG1 |
56.9% |
24,3 -
37,2 mg |
58.80% |
62,2% ± 2,2 |
|
| IgG2 |
26.6% |
12,4 -
22,1 mg |
34.10% |
31,1% ± 2,3 |
|
| IgG3 |
3.4% |
0,9 -
1,5 mg |
5.40% |
6,1% ± 1,6 |
|
| IgG4 |
1.7% |
0,1 -
0,5 mg |
1.70% |
1,2 % ± 0,2 |
|
| Content
of IgA |
≤ 0.14
mg/ml |
< 0,05 mg/ml |
17 mg/ g of
proteins |
≤ 0.2
mg/mL |
|
| Glucose,
Maltose,… |
Glycine |
Maltose |
Saccharose
: 2 g/g of proteins |
Maltose 10% |
|
| Average
dosage for PID |
The dosage
regimen should achieve a trough level of 4-6 g/l. The dose and dosage regimen
may need to be individualised depending on pharmacokinetic and clinical
response (Also see European core SPC). |
0,4 - 0,8 g/kg |
0.4
to 0.8 g/kg |
0.4 g/kg b.w. |
|
| Max.
Speed of infusion |
Human normal
immunoglobulin should be infused at an initial rate of 0.5 ml/kg BW/hr for 30
minutes. If well tolerated, the rate of administration may be gradually
increased to a maximum of 6 ml/kg BW/hr. Clinical data obtained from a
limited number of patients also indicate that adult PID patients may tolerate
an infusion rate of up to 8 ml/kg BW/hr. |
40 drops/minute |
4 mL / kg / h |
3 ml/kg/hour |
|
| Intervals
of infusion for PID |
See European
core SPC |
21-28 days |
Every 2 to 4
weeks |
every 3 to 4
weeks |
|
| Preserving |
• Store in a
refrigerator (2°C - 8°C) • KIOVIG may be stored at room temperature
(not more than 25°C) for up to 9 months.
Once stored at room temperature KIOVIG must not be returned to the
refrigerator and must be discarded, if not used by the end of the 9-month
period. • Do not store above 25°C • Do
not freeze • Keep the container in the outer carton in
order to protect from light |
+2C°<
T <+8C° |
< 25 ° C |
Below 25°C |
|
| Time for
reconstitution |
N/A |
Ready for use |
< 30 min. |
none |
|
| Packaging* |
Pack
sizes of 1 vial of 1 g/10 ml, 2.5 g/25 ml, 5 g/50 ml, 10 g/100 ml and 20
g/200 ml |
1g/
20 ml ; 2,5 g/ 50 ml ; 5 g/ 100 ml ;
10 g/ 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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