| SLOVAK
REPUBLIC |
|
|
|
|
|
|
| Last
update |
2010-02 |
2010-02 |
2008-04 |
2010-02 |
2008-04 |
|
| Company |
CSL-Behring |
CSL-Behring |
Grifols |
Octapharma |
Octapharma |
|
| Name
of product |
Privigen |
Vivaglobin |
Flebogamma |
Octagam
5% |
Gammanorm |
|
| Available
for Hospital therapy |
Registered |
Registered |
Yes |
Yes |
Yes |
|
| Available
for Home therapy |
No |
Yes |
|
Depends on
legal situation, may be used at home
in general |
Yes |
|
| IVIG,
SCIG or IMIG |
IVIG |
SCIG |
IVIG |
IVIG |
SCIG |
|
| Patient´s
age |
Adults and
children |
Adults and
children |
|
Children and
adults |
Children and
adults |
|
| Présentation |
Liquid |
Liquid |
Liquid |
Liquid |
Liquid |
|
| Concentration
% |
10% |
16% |
5% |
5% |
16.5 % |
|
| Content
of IgG |
≥ 98% |
IgG
monomers & dimers 97-97% • IgG polymers 3-5% |
≥ 99% |
≥ 95% |
≥ 95% |
|
| IgG1 |
67.8% |
61% |
70.3% |
62,2% ± 2,2 |
59% |
|
| IgG2 |
28.7% |
28% |
24.7% |
31,1% ± 2,3 |
36% |
|
| IgG3 |
2.3% |
5% |
3.1% |
6,1% ± 1,6 |
4.5% |
|
| IgG4 |
1.2% |
6% |
2% |
1,2 % ± 0,2 |
0.5% |
|
| Content
of IgA |
≤ 0,025
mg/ml |
0.39-1.17 g/l |
<0,05 mg/ml |
≤ 0.2
mg/mL |
max. 0,0825
mg/ml |
|
| Glucose,
Maltose,… |
L-proline (natural amino acid) - Contains no
sugar |
Glycine |
|
Maltose 10% |
Glycine |
|
| Average
dosage for PID |
0.2-0.8g/kg
bodyweight |
0.2-0.8g/kg
bodyweight |
|
0.4 g/kg b.w. |
0.1 g/kg |
|
| Max.
Speed of infusion |
4.8
ml/kg bw/hr - If well tolerated Up to 7.2 ml/kg bw/hr. |
About 22ml/hour |
|
5 ml/kg/hour |
40 ml/hour
using two pumps simultaneously |
|
| Intervals
of infusion for PID |
Usually every
2-4 weeks |
usually weekly |
|
every 3 to 4
weeks |
weekly
(flexible) |
|
| Preserving |
•
2 years • Do not store above 25 °C. • Do not freeze. • Keep the vial in
the outer carton in order to protect from light. |
3 years |
Between +2ºC
and +25ºC. Do not freeze. Discard after expiration date. |
Between 2- 25°C |
2
years between 2 and 8 °C - 1 month under 25°C |
|
| Time
for reconstitution |
none |
none |
none |
none |
none |
|
| Packaging* |
2g, 5g, 10g,
20g |
3g, 10g, 20g |
|
1g, 2.5g, 5g,
10g |
10 ml (packs of 1, 10 or 20) |
|
| * May be different from country to country |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|