科泛適注射劑 1000 IU

Negara: Taiwan

Bahasa: China

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

Bahan aktif:

ANTIHEMOPHILIC FACTOR

Tersedia dari:

台灣拜耳股份有限公司 台北市信義區信義路5段7號53樓 (23167184)

Kode ATC:

B02BD02

Bentuk farmasi:

凍晶注射劑

Komposisi:

ANTIHEMOPHILIC FACTOR (8004000100) Antihemophilic Factor (Recombinant) (rFVIII-PF)IU

Unit dalam paket:

盒裝

Kelas:

菌　疫

Jenis Resep:

限由醫師使用

Diproduksi oleh:

BAYER HEALTHCARE LLC 800 DWIGHT WAY, BERKELEY, CA 94710 USA US

Area terapi:

coagulation factor VIII

Indikasi Terapi:

控制及預防成人及兒童A 型血友病病人之出血事件；成人及兒童A 型血友病病人手術前中後之處置；作為例行預防，預防或降低成人及兒童A型血友病病人之出血事件發生率。本品不適用於治療vonWillebrand 疾病。

Ringkasan produk:

有效日期: 2027/05/10; 英文品名: Kovaltry injection 1000 IU

Tanggal Otorisasi:

2017-05-10

Selebaran informasi

KOVALTRY(inhibitor)
(1%)
(PTPs)
†
§
3() - 12
3 PART A (N=193)
12
324x539,75-000759

A

A

A
von Willebrand


20-40 IU KOVALTRY2
3

≤1225-50 IU KOVALTRY2
3
2
1

KOVALTRY

KOVALTRY3

KOVALTRY1
15


KOVALTRY(IU)
WHO ()
(IS)

KOVALTRY(chromogenic substrate assay)
41KOVALTRY
(one-stage clotting assay)
KOVALTRY

IU/dL
(
%)

(
)
KOVALTRY
1. 2050% [50 IU/dl]
KOVALTRY20 kg x 50 IU/dL x 0.5% (2 [IU/dL]/
[IU/kg]) = 500 IU
2. 502000 IU KOVALTRY
2000 IU / 50 kg() x 2 [IU/dL]/[IU/kg] = 80
IU/dL (80%)
IU/dL (
%)
KOVALTRY
≥



1KOVALTRY
1(
% IU/dL)
KOVALTRY
250
500
1000
2000 IU
KOVALTRYIU
(chromogenic substrate assay)
WHO
(≥3%)(PUPs)/
(MTPs)(
3)
193(PTPs)(51
<12)
KOVAL-
TRYKOVALTRY
≥12
(PTPs)372(EDs)159
<12(PTPs)182
2(
)
KOVALTRY
2
(%
IU/dL)
[(8.4)]
3.
(
B)
2. (
A)
1. KOVALTRY
(
37℃
99℉)
4. (
C)
5. (
D)
6.
(
E)
7.
(
F)
8. (
G)
9. (
H)
10.
()
(
I)
11.
(
J)
12.
(
K)
(EDs)
73
43
<6
(PUPs)/
(MTPs)KOVALTRY(MTP
(EDs)≤3
)43
239
(13
775
)(EDs)46
(1
55
(EDs))
KOVALTRY2
3(n=5)KOVALTRY
(n=6)
3(PTPs)
3 Part B(PUPs)/(MTPs)(N=43)
1
2
3 Part A[N=13
(30.2%)][N=23
(54.8%)]43
(PUPs)/42
(Immunogenicity)
KOVALTRY
modified
Bethesda
(
)
KOVALTRY(
13
)204A
(
<1%)≥50(EDs)
(PTP)
13(PTP)
550
(EDs)0.6
BU(anticardiolip-
in)IgGIU/kg 2.2 IU/dL(ABR)
(PUPs)/(MTPs)
4223(54.8%
95%39-70%)
(EDs)(
)
9(4-42)6
(14.3%)
(≤5.0 BU)
17(40.5%)(>5.0 BU)
13
11
(84.6%)
(
)
KOVALTRY
KOVALTRY
KOVALTRYKOVALTRY
2-4%
15-20%
KOVALTRY
KOVALTRY
KOVALTRY
51
≤12(PTPs)
43
<6
(PUPs)/
(MTPs)
KOVALTRY
*
†
(PUPs)/(MTPs)
(Immunogenicity)
‡
(Immunogenicity)
§
[(14)]
≤12
KOVALTRY65
KOVALTRY(
)
250 IU500 IU1000 IU2000 IU
(bromobutyl)
10 mLI
(sWFI)KOVALTRY
2.2% glycine1% sucrose30 mMsodium chloride2.5 mMcalcium chloride
20 mM histidine80 ppm polysorbate 80pH6.67.0
KOVALTRY
KOVALTRY
galactose-alpha-1,3-galac-
tose(alpha-Gal)N-glycolyl neuraminic acid (NGNA)
1%
KOVALTRY
70(HSP 70)(Baby Hamster Kidney, BHK)
HSP 70
KOVALTRY
Kogenate FS
KOVALTRY
KOVALTRY
(1)(detergent)
(2)
20 nm
[(12.3)]
(PTPs)A
(0
61
)KOVALTRY 50 IU/kg