“國血製劑益康”人類免疫球蛋白靜脈注射劑

Land: Taiwan

Språk: kinesiska

Källa: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Aktiva substanser:

Human Immunoglobulin G

Tillgänglig från:

醫療財團法人台灣血液基金會 台北市中正區南海路３號３樓 (01010553)

ATC-kod:

J06BA02

Läkemedelsform:

注射劑

Sammansättning:

Human Immunoglobulin G (8004000650) MG

Enheter i paketet:

瓶裝

Klass:

菌　疫

Receptbelagda typ:

限由醫師使用

Tillverkad av:

CSL BEHRING (AUSTRALIA) PTY LTD 189-209 CAMP ROAD BROADMEADOWS VICTORIA 3047 AUSTRALIA AU

Terapiområde:

immunoglobulins, normal human, for intravascular adm.

Terapeutiska indikationer:

IgG的替代治療用藥，適應症包括：1.原發性免疫不全症（primary immune deficiency）。2.由潛在疾病或治療所引發之次發性症狀性低伽瑪球蛋白血症。用於改善免疫調節機能，適應症包括：3.原發性血小板缺乏性紫斑症【idiopathic thrombocytopenic purpura（ITP）】，高危險出血的成人或小孩ITP患者；或者，手術前用以修正血小板數目。4.異體骨髓移植（allogeneic bone marrow transplantation）。5.川崎氏症（Kawasaki Disease）。6. Guillain-Barré 症候群(Guillain-Barré Syndrome (GBS))。

Produktsammanfattning:

有效日期: 2027/07/12; 英文品名: "TBSF" Human Immunoglobulin for Intravenous Use

Tillstånd datum:

2007-07-12

Bipacksedel

“
”
"TBSF" Human Immunoglobulin for Intravenous Use 000841
1human immune globulin
2
3
4human
immune globulin
5
6
“
”
100 ml6 g10 gpH4.25
98%
G90%
IgG
(preclinical batches)(clinical batches)
“
”
IgG
61% IgG
1
,
36% IgG
2
, 3% IgG
3
1% IgG
4
“
”
IgA
(Immunoglobulin A)(< 0.025 mg/mL)
“
”
“
”
IgG
IgGIgG
“
”
(60
°
C10
)pH
“
”
Intragam
®
P
Intragam
®
PCSL Limited
(IVIg)
“
”
IgG
• (primary immune deficiency (PID))
•
“
”
• (Idiopathic Thrombocytopenic Purpura (ITP))
ITP
• (allogeneic bone marrow transplantation)
• (Kawasaki Disease)
• Guillain-Barré (Guillain-Barré Syndrome (GBS))
IVIgITP
1, 2
(Replacement therapy)
“
”
IgG5 g/L
0.2-0.6 g IgG/kg
(0.4-0.6 g IgG/kg)
IgG
(Immunomodulatory therapy)
(Idiopathic Thrombocytopenic Purpura (ITP))
“
”
2
52 g IgG/kg
(Kawasaki disease)
“
”
2
51.6-2.0 g IgG/kg
2 g IgG/kg
(Allogeneic bone marrow transplantation)
“
”
(conditioning
regime)
“
”
0.5 g
IgG/kg
Guillain Barré(Guillain Barré Syndrome (GBS))
“
”
0.4g IgG/kg
“
”
“
”
“
”
1 mL (60 mL)
15
15 3-4 mL (180-240 mL)
“
”
IVIgIVIg
(
“
-
”
)
“
”
“
”
0.9%5%
“
”
1.
2.
3.
4.
5.
6.
7. (
(cannula))
8.
“
”
9.
“
”
•
• IgAIgA
•
“
”
IVIg
•
• IgA(agammaglobulinemia)
(hypogammamaglobulinemia)
•
“
”
IgA
IgA
IgA(IgA deficiency)
(anaphylactoid reaction)
IVIg
65
(volume depletion)(sepsis)(monoclonal
gammopathy)(nephrotoxic)
(
)
IVIgIVIg
“
”
IVIg
IVIg
IVIg
IgG
(
/
)
/
IVIg
(IVIg)(Aseptic Meningitis
Syndrome (AMS))IVIg
(photophobia)
(cerebrospinal
fluid, CSF)
(pleocytosis)(granulocytic series)
AMSIVIg (2 g/kg)
IVIgAMS
(
A
B
D
)
(direct antiglobulin test)(haemolysis)
(crossmatching)
IVIg (
40.4 g/ kg)O
IVIg(
0.4 g/kg)ABO
IVIg/
IVIg
(0.4 g/kg)
(6
)
(thrombophlebitis)
(Creutzfeldt-Jakob Disease, CJD)
HIV ()
BC
A
parvovirus B19
parvovirus B19
“
”
65
“
”
(
A
B
D)
(Coombs)
“
”
“
”
/
“
”
“
”
“
”
“
”
()
/
,
“
”
“
”
“
”
“
”
“
”
“
”
“
INTRAGAM
® P
”
(Primary