DENMARK

Last update

2009-11

2010-02

2009-11

2010-02

2009-11

Company

Baxter

CSL-Behring

Octapharma

Name of product

KIOVIG

SUBCUVIA

Privigen

Vivaglobin

Gammanorm

Octagam 5%

Octagam, infusionsvæske, opløsning 100 mg/ml

Available for Hospital therapy

Yes

Registered

Yes

Available for Home therapy

May vary in different countries due to different licensing situations.

Yes

Depends on legal situation, may be used at home in general

IVIG, SCIG or IMIG

IVIG

SCIG

IVIG

SCIG

IVIG

Patient´s age

All ages

Adults and juveniles at the age of ≥ 12 years

Adults and children

Children and adults

Présentation

Liquid

Concentration %

10%

16%

10%

16%

16.5 %

10%

Content of IgG

≥ 98%

≥ 90%

≥ 98%

IgG monomers & dimers 97-97% • IgG polymers 3-5%

≥ 95%

IgG1

56.9%

45-75%

67.8%

61%

59%

62,2% ± 2,2

ca. 60%

IgG2

26.6%

20-45%

28.7%

28%

36%

31,1% ± 2,3

ca. 32%

IgG3

3.4%

3-10%

2.3%

4.5%

6,1% ± 1,6

ca. 7%

IgG4

1.7%

2-8%

1.2%

0.5%

1,2 % ± 0,2

ca. 1%

Content of IgA

≤ 0.14 mg/ml

≤ 4.8 mg/ml

≤ 0,025 mg/ml

0.39-1.17 g/l

max. 0,0825 mg/ml

≤ 0.2 mg/mL

≤ 0.4mg/mL

Glucose, Maltose,…

Glycine

L-proline (natural amino acid) - Contains no sugar

Glycine

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).

The dosage should be adjusted to maintain an approximate level of at least 4-6 g/l of circulating IgG. • The dose and dosage regimen may need to be individualised depending on pharmacokinetic and clinical response

0.2-0.8g/kg bodyweight

0.1 g/kg

0.4 g/kg b.w.

0.4 - 0.8 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.

It is recommended to use an initial administration speed of 10 ml/h/pump. The infusion speed can be enhanced for 1 ml/h/pump every subsequent infusion. The recommended maximum speed is 20 ml/h/pump. More than 1 pump can be used simultaneously.

4.8 ml/kg bw/hr
If well tolerated Up to 7.2 ml/kg bw/hr.

About 22ml/hour

40 ml/hour using two pumps simultaneously

5 ml/kg/hour

7.2 mL/kg/hour

Intervals of infusion for PID

See European core SPC

After the loading dose, maintenance doses at repeated intervals to reach a cumulative monthly dose of 0.4-0.8 g/kg

Usually every 2-4 weeks

usually weekly

weekly (flexible)

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

• Store in a refrigerator (2°C - 8°C) • The packaged product may be kept at room temperature (up to 25°C) for up to 6 weeks. In this case, the product expires at the end of the 6 weeks period. • Do not freeze • Keep the vial in the carton to protect from light.

• 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

2 years between 2 and 8 °C - 1 month under 25°C

Between 2- 25°C

2 years between 2 and 8 °C - 3 months under 25°C

Time for reconstitution

N/A

None

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

Pack sizes of 1 x 5 ml, 20 x 5 ml, 1 x 10 ml, and 20 x 10 ml.

2g, 5g, 10g, 20g

3g, 10g, 20g

10 ml (packs of 1, 10 or 20) ; 20 ml (packs of 1, 10 or 20)

1g, 2.5g, 5g, 10g

20,50,100,200 ml

* May be different from country to country