Component Portfolio 2009-07-15New

澳門特區政府衛生局

捐血中心 MACAO BLOOD TRANSFUSION SERVICE

血液成分簡介

COMPONENT PORTFOLIO

第三版 3rd edition

( 2009 )

編輯：許萍、何啓桂、蔡少灼、帥敬鑣校對：楊秀紅出版日期：2009年 7月 Editors: P.HUI, C.HOO, S.C.SHOI, K.P.SOI Reviewer: S.H.YEUNG Date: July 2009

澳門捐血中心 Macao Blood Transfusion Service Page 2/40

目錄 CONTENT

1. 簡介 INTRODUCTION............................................................................................................................... 3

2. 血液成分的品質保證 QUALITY ASSURANCE OF BLOOD COMPONENTS ..................................... 3

3. 輸血的風險 TRANSFUSION HAZARDS ................................................................................................ 3

4. 血液成分的標籤 BLOOD PRODUCTS LABELS.................................................................................... 3 4.1 電腦印製標籤 COMPUTER PRINTED LABELS ISBT 128 ........................................................... 3 4.2 手工血型標籤 MANUAL BLOOD GROUP LABELS ............................................................................ 4 (當電腦系統發生故障，而又必須緊急發放血液，捐血中心使用手工血型標籤來代替上述的電腦標籤，圖樣如下) ............................................................................................................................................ 4 (WHEN THE COMPUTER SYSTEM IS NOT FUNCTIONING AND BLOOD IS NEEDED, MANUAL BLOOD GROUP LABEL WILL BE USED AS BELOW.) ................................................................................................................ 4

5. 血液成分 BLOOD COMPONENT........................................................................................................... 5 5.1 捐血中心現有血液成分的清單 (1) PRODUCT LIST(1) ....................................................... 5 捐血中心現有血液產品的清單(3) PRODUCT LIST(3) ............................................................... 5 捐血中心現有血液產品的清單(4) PRODUCT LIST(4) ............................................................... 6 5.2 血液產品 BLOOD PRODUCTS ................................................................................................ 7 Ø 濃縮紅血球 RED BLOOD CELLS ..................................................................................... 7 Ø 濃縮紅血球 RED BLOOD CELLS ..................................................................................... 8 Ø 有添加劑濃縮紅血球 RED BLOOD CELLS in Additive Solution................................... 9 Ø 有添加劑少白細胞濃縮紅血球 RED CELLS in Additive Solution, Buffy Coat Removed 10 Ø 濾去白細胞之濃縮紅血球 RED BLOOD CELLS, Leucocyte Depleted....................... 11 Ø 濾去白細胞濃縮紅血球 RED BLOOD CELLS, Leucocyte Depleted........................... 12 Ø 濾去白細胞有添加劑之濃縮紅血球 RBC in Additive Solution, Leucocyte Depleted. ... 13 Ø 全血液 WHOLE BLOOD ( 1 ) ................... 14 Ø 全血液 WHOLE BLOOD ( 2 ) ................... 15 Ø 濾去白細胞之全血 WHOLE BLOOD, Leucocyte Depleted ..................................... 16 Ø 濾去白細胞之輻照濃縮紅血球 (新生兒⁄幼兒用) ( 1 ) .................... 17 Ø 濾去白細胞之輻照濃縮紅血球 (新生兒⁄幼兒用) ( 2 ) .................... 18 Ø 濾去白細胞之濃縮紅血球 (小兒或成人-小量紅細胞) .......................................................... 19 Ø 濾去白細胞之輻照濃縮紅血球 (新生兒換血用) ............................................................ 20 Ø 洗滌紅血球 Washed Red Blood Cells ...................................................................... 21

5.3冰凍產品 FROZEN PRODUCTS ................................................................................................. 22 Ø 去甘油紅血球 DEGLYCEROLIZED RED BLOOD CELLS................................................. 22 Ø 新鮮冰凍血漿 FRESH FROZEN PLASMA (1).................... 23 Ø 新鮮冰凍血漿 FRESH FROZEN PLASMA (2).................... 24 Ø 新鮮冰凍血漿 FRESH FROZEN PLASMA (3).................... 25 Ø 單採新鮮冰凍血漿 FRESH FROZEN PLASMA Apheresis (4) .................... 26 Ø 冰凍血漿之低溫沉澱物 CRYOPRECIPITATE.................................................................... 27 Ø 除去低溫沉澱物之血漿 PLASMA, CRYOPRECIPITATE REDUCED ................................. 28

5.4 血小板 PLATELETS ........................................................................................................................ 29 Ø 濃縮血小板 PLATELETS CONCENTRATE .................................................................... 29 Ø 單採血小板 PLATELETS Apheresis .............................................................................. 30 Ø 交叉配型吻合的血小板 Crossmatched compatible platelets .......................................... 31

5.5 Γ- 射線輻照之血液成分 BLOOD COMPONENT TREATED WITH Γ-RAY IRRADIATION ............................ 32 Ø γ- 射線輻照之有添加劑濃縮紅血球 RBC In Additive Solutionγ-ray irradiated .... 33 Ø γ- 射線輻照之全血液WHOLE BLOODγ-ray irradiated................................................... 34 Ø γ射線輻照之濃縮血小板 PLATELETS CONCENTRATE (γ-ray irradiated)................... 35 Ø γ射線輻照之單採血小板 Apheresis PLATELETS (γ-ray irradiated)............................. 36

6. 血漿製品 PLASMA FRACTIONATION PRODUCTS ....................................................................... 37 6.1 靜脈注射免疫球蛋白 INTRAVENOUS GLOBULIN............................................................................. 37 6.2 人類白蛋白 NORMAL SERUM ALBUMIN, HUMAN............................................................................. 38 6.3 第八因子 FACTOR VIII .................................................................................................................... 38 6.4 第九因子 FACTOR IX ...................................................................................................................... 39


1. 簡介 Introduction

本手冊是捐血中心根據現有的血液 /血液成分及血漿制品編寫的，目的是為臨床

用家提供清晰的產品介紹和說明。

The purpose of this handbook is to provide for the clinicians a list of the blood components currently available in MBTC.

2. 血液成分的品質保證 Quality Assurance of Blood Components

在本手冊列出的血液成分，是捐血中心根據歐洲聯盟委員會出版的成分輸血指

南(現行版)的標準而製備的。

捐血中心所提供的血液 /血液成分，是以所引入的質量保證管理系統，以及上述

指引來檢驗和制備，以確保血液及血液成分的質量和可持續性。

All components described in this handbook are prepared according to the specifications defined in the “Guide to the preparation, use and quality assurance of blood components” published by the Council of Europe. The quality of components is assured by the implementation of Quality management system and by testing, as specified in the above Guidelines.

3. 輸血的風險 Transfusion Hazards

所有發放予醫院的的血液 /血液成分，皆已通過了乙型肝炎病毒表面抗原和乙型

肝炎病毒核酸、愛滋病病毒抗體和病毒核酸、丙型肝炎病毒抗體和病毒核酸、人類

T 淋巴細胞病毒和梅毒抗體的篩驗。

另者，捐血中心實行嚴格的皮膚消毒程序和監控，以及使用“先取血樣本”的

血液收集袋，將細菌污染的風險減至最低。

但是，由於空窗期和血液儲存期有限等問題的存在，所有血液 /血液成分的輸

用，皆可能傳染細菌、病毒和其它不明的病原菌。

All components are tested for hepatitis B surface antigen, anti-HIV1+2, anti-HCV, HIV RNA, HCV RNA, HBV DNA, anti-HTLVI/II and antibodies to T. pallidum. Skin disinfection monitoring and usage of pre-sampling blood collection set ensure that the risk of bacterial contamination is minimal. However, all transfusions of blood and components carry the possibility of infection with bacteria, viruses and unknown pathogens.

4. 血液成分的標籤 Blood Products Labels 4.1 電腦印製標籤 COMPUTER PRINTED LABELS ISBT 128

捐血中心血液成分標籤在一般情况下，是通過電腦系統 ISBT128 系統形成和打

印的。

ISBT 128 系統是國際輸血組織 (ISBT)標籤系統，是應用於組織移植和輸血範疇的資

訊轉換的國際標準。此系統提供了全球性的唯一捐贈編碼系統，編寫時的血液成分定義是國

際化的標準，同時，其條碼和電子化數據轉換的數據結構，也是標準化的。

The labels of blood and blood components are based on ISBT 128 and are computer printed. ISBT 128 system is an international standard for the transfer of information associated with tissue transplantation and blood transfusion. It provides for a globally unique donation


numbering system, internationally standardized product definitions, and standard data structures for bar coding and electronic data interchange.

電腦印製標籤樣本 Example of Computer Printed Label (AB+MIS Computerized Auto Blood Bank Management):

- 抗凝劑或添加劑種類 Type of Anticoagulant / Additive solution - 血液成分類型 Type of blood product - 血液成分容積 Volume of blood product

4.2 手工血型標籤 Manual Blood Group Labels (當電腦系統發生故障，而又必須緊急發放血液，捐血中心使用手工血型標籤來代替上述的電腦標籤，圖樣如下)

(When the computer system is not functioning and blood is needed, manual blood group label will be used as below.)

血型 Blood Group

有效期 Expiry Date

捐血編號

Donation Number

血液成分名稱

Type of Blood Components

紅細胞表型 Red Cells Phenotype

容量

Volume

血液收集日期和

時間

Blood collection Date & time


5. 血液成分 BLOOD COMPONENT

5.1 捐血中心現有血液成分的清單 (1) PRODUCT LIST(1)

紅血球成分 RED BLOOD CELLS COMPONENTS 可用性 Availability

1. 濃縮紅血球 Red Cells

2. 有添加劑濃縮紅血球 Red Cells in Additive Solution

3. 濾去白細胞濃縮紅血球 Red Cells, leucocyte depleted

4. 濾去白細胞有添加劑濃縮紅血球 Red Cells in additive solution, leucocyte depleted

5. 有添加劑的少白細胞濃縮紅血球 Red Cells in Additive Solution Buffy Coat Removed

標準存貨品種 Standard Stock item

6. 全血 Whole Blood

7. 已鑑定紅細胞表型的濃縮紅血球 Red Cells antigen phenotyped

8. 去甘油紅血球 Deglycerolized Red Blood Cells

9. 洗滌紅細胞 Washed Red Cells

特別申請 On request

捐血中心現有血液成分的清單(2) PRODUCT LIST(2)

冰凍產品 FROZEN PRODUCTS 可用性 Availability

1. 新鮮冰凍血漿 Fresh Frozen Plasma

2. 低溫沉澱物 Cryoprecipitate

3. 除去低溫沉澱物之血漿 Plasma – Cryo reduced (P：CR)

標準存貨品種 Standard stock item

捐血中心現有血液產品的清單(3) PRODUCT LIST(3)

血小板 PLATELETS 可用性 Availability

1. 濃縮血小板 Platelets Concentrate 標準存貨品種 Standard stock item

2. 單採血小板 Platelets – Apheresis 特別申請 On request

3. 交叉配型吻合的血小板特別申請 On request


捐血中心現有血液產品的清單(4) PRODUCT LIST(4)

γ- 射線輻照之血液成分 BLOOD COMPONENT TREATED WITH γ-RAY IRRADIATION

可用性 Availability

1. γ- 射線輻照之濃縮紅血球

RED BLOOD CELLS (γ-ray irradiated) 特別申請

On request

2. γ- 射線輻照之全血液

WHOLE BLOOD (γ-ray irradiated) 特別申請

On request

3. γ射線輻照之濃縮血小板

PLATELETS CONCENTRATE (γ-ray irradiated) 特別申請

On request

4. γ射線輻照之單採血小板

Apheresis PLATELETS (γ-ray irradiated) 特別申請

On request

5. 濾去白細胞之輻照濃縮紅血球(新生兒/幼兒用)

Red Cells, Leucocyte Depleted, Irradiated, For Neonatal /Infant Use 特別申請

On request

6. 濾去白細胞之輻照濃縮紅細胞 (新生兒換血用)

Red Cells, Leucodeplete, Irradiated for Exchange Transfusion 特別申請

On request


5.2 血液產品 BLOOD PRODUCTS

濃縮紅血球 RED BLOOD CELLS

描述 DESCRIPTION

於全血中移去大部分血漿的血液。 A component prepared by removing most of the plasma from whole blood.

用途 USAGE

貧血及外科或創傷性失血等。 For anemia and surgical or traumatic blood loss.

來源於 450ml 的全血容積：260 ± 50 ml 紅細胞壓積：0.65 – 0.75

From 450ml whole blood ： Volume : 260 ± 50 ml Hematocrit：0.65 – 0.75

說明 SPECIFICATION

抗凝劑：CPDA1 血色素：最少 45g/unit 儲存期末溶血： < 0.8% 紅細胞總量

Anticoagulant : CPDA1 Hemoglobin：minimum 45g/unit Haemolysis at the end of storage： < 0.8% of red cells mass

可用性 AVAILABILITY

標準存貨品種

Standard stock item

保存期，儲存溫度 SHELF LIFE, STORAGE 35 days at 4 ± 2o C

標籤樣本 Example of Computer Printed Label

手工標籤樣本 Example of Manual Label




描述 DESCRIPTION

於全血中移去大部分血漿的血液。 A component prepared by removing most of the plasma from whole blood.

用途 USAGE


來源於 350ml 的全血：容積：210 ± 45 ml 紅細胞壓積： 0.65 – 0.75

From 350ml whole blood： Volume：210 ± 45 ml Hematocrit：0.65 – 0.75


抗凝劑：CPDA1 血色素：最少 35g/unit 儲存期末溶血： < 0.8% 紅細胞總量

Anticoagulant : CPDA1 Hemoglobin：minimum 35g/unit Haemolysis at the end of storage： < 0.8% of red cells mass








有添加劑濃縮紅血球 RED BLOOD CELLS in Additive Solution

描述 DESCRIPTION

由全血分離出 90%的血漿後，再在紅血球中加入添加劑。 A component prepared by removing > 90% of the plasma from the whole blood. The red cells are re-suspended in an additive solution.

用途 USAGE

貧血及外科或創傷性失血，不適用於新生兒換血或大量輸血。 For anemia and surgical or traumatic blood loss. NOT RECOMMENDED FOR EXCHANGE OR MASSIVE TRANSFUSION IN NEONATES


容積：350 ± 70 ml 紅細胞壓積：0.50 – 0.70 血色素：最少 45g/unit 儲存期末溶血： < 0.8% 紅細胞總量

Volume : 350 ± 70 ml Hematocrit : 0.50 – 0.70 Hemoglobin：minimum 45g/unit Haemolysis at the end of storage：< 0.8%of red cells mass


標準存貨品種。有紅細胞添加劑的濃縮紅血球及有紅細胞添加劑並除去白膜的濃縮紅血球

可交換使用。 Standard stock item. Interchangeable with Red Cells in Additive Solution and Red Cells in Additive Solution Buffy Coat Removed


電腦標籤樣本 Example of Computer Printed Label


有添加劑濃縮紅血球 RED BLOOD CELLS

in ADDITIVE SOLUTION

紅細胞添加劑

Red Cell additive

solution


有添加劑少白細胞濃縮紅血球 RED CELLS in Additive Solution, Buffy Coat Removed

描述 DESCRIPTION

全血分離出血漿並除去白細胞層，再加入添加劑而成。 A component prepared by removing most of the plasma, leucocytes and platelets from the whole blood. The red cells are suspended in an additive solution.

用途 USAGE

需要長期、定期輸血的病人適用。可減少病人多次輸血後的非溶血性發熱

反應。 For patients who needed regular transfusion. Reduces the risk on non-haemolytic febrile transfusion reaction in multitransfused patients.


容積：300 ± 60 ml 紅細胞壓積：0.50 – 0.70 殘留白細胞 / 單位：<1.2x109 血色素：最少 43g/unit 保存期末溶血： < 0.8% 紅細胞總量

Volume：300 ± 60 ml Hematocrit：0.50 – 0.70 Leucocyte count /unit：<1.2x109 Hemoglobin：minimum 43g/unit Haemolysis at the end of storage： < 0.8% of red cells mass




其他 OTHERS

* ResLeu:<1.2 x 109 ( Residual Leucocytes <1.2 x 109 /unit )



少白細胞之濃縮紅血球

RED BLOOD CELLS in Additive Solution, Buffy Coat Removed

白細胞殘留量

Residual Leucocytes 280


濾去白細胞之濃縮紅血球 RED BLOOD CELLS, Leucocyte Depleted

描述 DESCRIPTION

紅血球成分經過濾白細胞後，含有白細胞數目少於 1X106/ unit。 A red blood cell component containing less than 1 x 106 leucocytes by filtration.

用途 USAGE

需要經常接受輸血的兒科和血液腫瘤科病人。

可有效防止發熱輸血反應，減少產生 HLA抗體。

可當作 CMV陰性的紅血球使用。

Pediatric patients and Hemato-oncologic patients who are going to have regular blood transfusion. Effective in prevention of febrile transfusion reactions. Can help to reduce the development of alloantibodies to HLA antigens. Is considered as a safe alternative to CMV seronegative red cells.


容積：250 ± 50 ml 殘留白細胞：< 1x106 / unit 血色素：最少 40g/unit 儲存期末溶血： < 0.8% 紅細胞總量

Volume：250 ± 50 ml Residual Leucocyte：< 1x106 Hemoglobin：minimum 40g/unit Haemolysis at the end of storage： < 0.8% of red cells mass



保存期，儲存溫度 SHELF LIFE, STORAGE 35 days, at 4 ± 2o C

其他 OTHERS

來源於 450ml 的全血。 From 450ml whole blood.



濾去白細胞之濃縮紅血球 RED BLOOD CELLS

LEUCOCYTE DEPLETED

白細胞殘留量

Residual Leucocytes


濾去白細胞濃縮紅血球 RED BLOOD CELLS, Leucocyte Depleted

描述 DESCRIPTION

紅血球成分經過濾白細胞後，含有白細胞數目少於 1X106/ unit。 A red blood cell component containing less than 1 x 106 leucocytes by filtration.

用途 USAGE

需要經常接受輸血的兒科和血液腫瘤科病人。

可有效防止發熱輸血反應，減少產生 HLA抗體。

可當作 CMV陰性的紅血球使用。

Pediatric patients and Hemato-oncologic patients who are going to have regular blood transfusion. Effective in prevention of febrile transfusion reactions. Can help to reduce the development of alloantibodies to HLA antigens. Is considered as a safe alternative to CMV seronegative red cells.


容積：200 ± 50 ml 殘留白細胞：< 1x106 / unit 血色素：最少 30g/unit 儲存期末溶血： < 0.8% 紅細胞總量

Volume：200 ± 50 ml Residual Leucocyte：< 1x106 Hemoglobin：minimum 30g/unit Haemolysis at the end of storage： < 0.8% of red cells mass




其他 OTHERS

來源於 350ml 的全血。 From 350ml whole blood.



濾去白細胞之濃縮紅血球 RED BLOOD CELLS

LEUCOCYTE DEPLETED

白細胞殘留量

Residual Leucocytes


濾去白細胞有添加劑之濃縮紅血球 RBC in Additive Solution, Leucocyte Depleted.

描述 DESCRIPTION

紅血球經過濾後含有白細胞數目少於 1X106且加入添加劑。

A red cell component containing less than 1 x 106 leucocytes by filtration and suspended in an additive solution

用途 USAGE

需要經常接受輸血的兒科病人和血液腫瘤科病人。

不適用於新生兒換血或大量輸血。

防止發熱輸血反應，減少產生 HLA抗體，可當作 CMV陰性紅血球。

Pediatric patients and Hemato-oncologic patients who are going to have regular blood transfusion. NOT RECOMMENDED FOR EXCHANGE OR MASSIVE TRANSFUSION IN NEONATES. Effective in prevention of febrile transfusion reactions. Can help to reduce the development of alloantibodies to HLA antigens. Pre-storage leucodepletion is now considered as a safe alternative to CMV seronegative red cells.


容積：300 ± 60 ml 血色素最少：30 g/unit 殘留白細胞：<1x106/unit 儲存期末溶血： < 0.8% 紅細胞總量

Volume：300 ± 60 ml Hemoglobin minimum：30 g/unit Leucocyte count：<1x106/unit Haemolysis at the end of storage： < 0.8% red cells mass




其他 OTHERS

來源於 450ml或 350ml的全血。

From 450ml or 350ml whole blood. 電腦標籤樣本 Example of Computer Printed Label


濾去白細胞有添加劑濃縮紅血球 RED BLOOD CELLS in ADDITIVE

SOLUTION, LEUCOCYTE DEPLETED

白細胞殘留量

Residual Leucocytes


全血液 WHOLE BLOOD ( 1 )

描述 DESCRIPTION

全血液，不製備其它成分。

Whole blood, not processed into components.

用途 USAGE

主要治療於短期內失血量大於 25%血容量的病人。

Primarily used to treat patients who are actively bleeding with loss > 25% of blood volume.

來源於 450ml 的全血

容積：510 ± 45ml 紅細胞壓積：> 0.35

From 450ml whole blood Volume：510 ± 45 ml Hematocrit：> 0.35

說明 SPECIFICATION 抗凝劑：CPDA1 或 CPD

血色素：最少 45g/unit 儲存期末溶血： < 0.8% 紅細胞總量

Anticoagulant : CPDA1 or CPD Hemoglobin：minimum 45g/unit Haemolysis at the end of storage： < 0.8% of red cells mass



保存期，儲存溫度 SHELF LIFE, STORAGE 35 days at 4 ± 2o C or 28 days at 4 ± 2o C



全血液

WHOLE BLOOD


全血液 WHOLE BLOOD ( 2 )

描述 DESCRIPTION

全血液，不製備其它成分。

Whole blood, not processed into components.

用途 USAGE

主要治療於短期內失血量大於 25% 血容量的病人。

Primarily used to treat patients who are actively bleeding with loss > 25% of blood volume.

來源於 350ml 的全血

容積：400 ± 35ml 紅細胞壓積：> 0.35

From 350ml whole blood Volume：400 ± 35 ml Hematocrit：> 0.35

說明 SPECIFICATION 抗凝劑：CPDA1或 CPD

血色素：最少 40g/unit 儲存期末溶血： < 0.8% 紅細胞總量

Anticoagulant : CPDA1 or CPD Hemoglobin：minimum 40g/unit Haemolysis at the end of storage： < 0.8% of red cells mass






全血液

WHOLE BLOOD


濾去白細胞之全血 WHOLE BLOOD, Leucocyte Depleted

描述 DESCRIPTION

全血液經過濾白細胞後，含有白細胞數目少於 1X106/ unit。 Whole blood containing less than 1 x 106 leucocytes by filtration.

用途 USAGE


Effective in prevention of febrile transfusion reactions. Can help to reduce the development of alloantibodies to HLA antigens. Pre-storage leucodepletion is now considered as a safe alternative to CMV seronegative red cells.

來源於 450ml 的全血容積：500 ± 45 ml 紅細胞壓積：> 0.35 抗凝劑：CPDA1 or CPD 血色素：最少 45g/unit 儲存期末溶血： < 0.8% 紅細胞總量

From 450ml whole blood Volume：500 ± 45 ml Hematocrit：> 0.35 Anticoagulant：CPDA1 or CPD Hemoglobin：minimum 45g/unit Haemolysis at the end of storage：< 0.8% of red cells mass 說明

SPECIFICATION 來源於 350ml 的全血容積：400 ± 35 ml 紅細胞壓積：> 0.35

抗凝劑：CPDA1 or CPD 血色素：最少 40g/unit 儲存期末溶血： < 0.8% 紅細胞總量

From 350ml whole blood Volume：400 ± 35 ml Hematocrit：> 0.35 Anticoagulant：CPDA1 or CPD Hemoglobin：minimum 40g/unit Haemolysis at the end of storage：< 0.8% of red cells mass






濾去白細胞之全血液 WHOLE BLOOD

LEUCOCYTE DEPLETED

白細胞殘留量

Residual Leucocytes


濾去白細胞之輻照濃縮紅血球 (新生兒⁄幼兒用) ( 1 ) Red Cells, Leucocyte Depleted, Irradiated, For Neonatal /Infant Use (3splits)

描述 DESCRIPTION

紅血球經過濾後含有白細胞數目少於 1X106 。

A red cell component containing less than 1 x 106 leucocytes by filtration and suspended in an additive solution.

用途 USAGE

需要接受輸血的新生兒⁄幼兒病人。

預防發熱輸血反應，減少產生 HLA 抗體的機率，並可視為 CMV 陰性的紅血

球使用。

Pediatric patients who are going to have blood transfusion. Effective in prevention of febrile transfusion reactions. Can help to reduce the development of alloantibodies to HLA antigens. Pre-storage leucodepletion is now considered as a safe alternative to CMV seronegative red cells.


容積：70 --130 ml 紅細胞壓積：50%--75% 殘留白細胞：<1x106/unit 儲存期末溶血： < 0.8% 紅細胞總量

Volume：70 -- 130 ml Hct：50%--75% Leucocyte count：<1x106/unit Haemolysis at the end of storage： <0.8% red cells mass



保存期，儲存溫度 SHELF LIFE,STORAGE 14 days, at 4 ± 2o C

其他 OTHERS 來源於 450ml 的全血。 From 450ml whole blood.



濾去白細胞之輻照濃縮紅血球 (新生兒⁄幼兒用)

Red Cells, Leucocyte Depleted, Irradiated, For Neonatal ⁄Paediatric Use (3 splits)

已輻照⁄白細胞殘留量

Irradiated⁄Residual Leucocytes

110


濾去白細胞之輻照濃縮紅血球 (新生兒⁄幼兒用) ( 2 ) Red Cells, Leucocyte Depleted, Irradiated, For Neonatal ⁄Infant Use (3 splits)

描述 DESCRIPTION

紅血球經過濾後含有白細胞數目少於 1X106 。

A red cell component containing less than 1 x 106 leucocytes by filtration and suspended in an additive solution. Small volume aliquots are provided as the standard product. They are in unit splits of 3.

用途 USAGE

適用於幼兒⁄新生兒，可有效防止發熱輸血反應，減少產生 HLA 抗體的機

率，並可視為 CMV陰性紅血球使用。

Pediatric patients. Effective in prevention of febrile transfusion reactions. Can help to reduce the development of alloantibodies to HLA antigens. Can be considered as a safe alternative to CMV seronegative red cells.


容積：50 --130 ml 紅細胞壓積：50%--75% 殘留白細胞：<1x106/unit 儲存期末溶血： < 0.8% 紅細胞總量

Volume：50--130 ml Hct：50%--75% Leucocyte count：<1x106/unit Haemolysis at the end of storage： <0.8% red cells mass







濾去白細胞之輻照濃縮紅血球 (新生兒⁄幼兒用)

Red Cells, Leucocyte Depleted, Irradiated, for Neonatal ⁄Paediatric Use (3 splits)

已輻照/白細胞殘留量

Irradiated/Residual Leucocytes


濾去白細胞之濃縮紅血球 (小兒或成人-小量紅細胞) Red Cells, Leucocyte Depleted For Paediatric patient or Adults Use (3splits)

描述 DESCRIPTION

紅血球經過濾後含有白細胞數目少於 1X106 /unit。

A red cell component containing less than 1 x 106 leucocytes by filtration and suspended in an additive solution.

用途 USAGE

需要接受輸血的(小兒)病人，或心功能不全的成人。


Pediatric patients / cardiac insufficient adults who are going to have blood transfusion. Effective in prevention of febrile transfusion reactions. Can help to reduce the development of alloantibodies to HLA antigens. Pre-storage leucodepletion is now considered as a safe alternative to CMV seronegative red cells.


容積：90—130ml (3小包) 紅細胞壓積：50%--75% 殘留白細胞：<1x106/unit 儲存期末溶血： < 0.8% 紅細胞總量

Volume：90—130ml (3 splits) Hct：50%--75% Leucocyte count：<1x106/unit Haemolysis at the end of storage： < 0.8% red cells mass







濾去白細胞之濃縮紅血球

RED CELL, LEUCOCYTE DEPLETED

白細胞殘留量

Residual Leucocytes

100


濾去白細胞之輻照濃縮紅血球 (新生兒換血用) Red Cells, Leucodeplete, Irradiated for Neonatal Exchange Transfusion

描述 DESCRIPTION

收集後 7天內的 O型紅細胞加入 AB型血漿，紅血球壓積 0.5至 0.6，經濾

過白細胞和γ射線輻照。

Group O red cells and AB plasma, Fresh (<= 7 days), Known Hct (0.5 to 0.6), Leucocyte reduced, Irradiated at time of blood issue. Negative for red cell antigens to which the mother has antibodies. 治療劑量 Theraputic Dosage：80 – 200ml / Kg.

用途 USAGE

防止發熱輸血反應，減少產生 HLA抗體，可作為 CMV陰性紅血球使用。

Effective in prevention of febrile transfusion reactions. Can help to reduce the development of alloantibodies to HLA antigens. Pre-storage leucodepletion is now considered as a safe alternative to CMV seronegative red cells.


容積：200 至 400ml 血色素：35-60g/unit Haematocrit (L/L)：0.5 --0.6 殘留白細胞：<1x106/unit

Volume：200 to 400ml Hemoglobin：35-60 g/unit Haematocrit (L/L)：0.5 to 0.6 Leucocyte count：<1x106/unit



保存期，儲存溫度 SHELF LIFE, STORAGE 24 hours, at 4 ± 2o C

其他 OTHERS 紅細胞保存劑 preservative solution for RBC：CPD OR CPDA-1



濾去白細胞之輻照濃縮紅血球 (新生兒換血用)

Red Cells, Leucodeplete, Irradiated for Exchange Transfusion

已輻照⁄白細胞殘留量

Irradiated/Residual Leucocytes


洗滌紅血球 Washed Red Blood Cells

描述 DESCRIPTION

紅血球經過生理鹽水洗滌後，移除大部分的血漿蛋白、抗體和電解質。洗

滌後的紅細胞再懸浮於添加液中。 Red Cells are washed with 0.9% sterile isotonic saline by a manual method to remove the majority of plasma proteins, antibodies and electrolytes. The washed red cells are then resuspended in additive solution.

用途 USAGE

洗滌紅細胞適用於 IgA缺乏且已產生了抗 IgA抗體的患者。也可能有助於

降低長期輸血患者發生嚴重反复發生的發熱、蕁麻疹和嚴重的過敏性反應

的比率。

Indicated for patients who have IgA deficiency with antibodies against IgA. May reduce the incidence of severe recurrent febrile, urticarial and possible anaphylactic transfusion reactions in multitransfused patients.


容積：>180ml 血色素：≥37g/ unit 紅細胞壓積：0.50 – 0.70 儲存期末溶血：<0.8% 殘餘白細胞數：<1 x 106/unit 洗涤後浮游蛋白：<0.5g/units

Volume：> 180mL

Hb： > 37g/unit Hct : 0.50 – 0.70 Haemolysis (at expiry) : < 0.8%; Leucocyte count : < 1 x 106/unit Last wash supernatant : total protein < 0.5g/unit



保存期，儲存溫度 SHELF LIFE, STORAGE 14 days , at 4 ± 2o C

其他 OTHERS Residual Leucocytes <5 x 106 /unit



洗滌紅血球

WASHED RED BLOOD CELLS


5.3冰凍產品 FROZEN PRODUCTS 去甘油紅血球 DEGLYCEROLIZED RED BLOOD CELLS

描述 DESCRIPTION

用甘油冰凍保存的紅細胞，經解凍去甘油，再在紅細胞中加入一定量之添

加劑而成。 Thawed, deglycerolized, frozen red cells of rare blood type. The red cells are resuspended in an additive solution.

用途 USAGE



容積：>180 ml 紅細胞壓積：0.65 至 0.75 血色素：>36g/unit 滲透壓：< 400mOsm/l 白細胞：<0.1x109 /unit

Volume：>180 ml Hematocrit：0.65 to 0.75 Hemoglobin：> 36g/unit Osmolarity：< 400mOsm/l Leucocyte：<0.1x109 /unit



保存期，儲存溫度 SHELF LIFE, STORAGE

去甘油後 3日，保存於 4± 2o C。 3 days after deglycerolization at 4 ± 2o C.

其他 OTHERS

每單位血液解凍全過程需 90分鐘。 The deglycerolization process takes about 90 minutes.



去甘油紅血球

DEGLYCEROLIZED RED BLOOD CELLS


新鮮冰凍血漿 FRESH FROZEN PLASMA (1) 描述 DESCRIPTION

從全血中分離出來，並於收集後 8小時內冰凍至攝氏零下 30oC。

Plasma that has been obtained from whole blood, frozen to – 30oC within 8 hours of collection.

用途 USAGE

- 可用於凝血功能障礙，尤其是有多種凝血因子缺陷的病人。 - 可用於血栓性血小板減少性紫癜。 - May be used in coagulation disorders, particularly in those clinical

situations in which a multiple coagulation deficit exists. - May be used in the treatment of thrombotic thrombocytopenic purpura

(TTP).


容積：> 150 ml 殘留細胞： -紅細胞：< 6.0 x 109/L -白細胞：< 0.1 x 109/L -血小板：< 50 x 109/L 第八因子：> 0.7 IU/ml

Volume：> 150 ml Residual cells: -Red cells：< 6.0 x 109/L -Leucocytes：< 0.1 x 109/L -Platelets：< 50 x 109/L Factor VIIIc：> 0.7 IU/ml

可用性 AVAILIBILITY



攝氏零下 30oC或以下保存 24個月 24 months at – 30oC or below

特定捐血者 SPECIFIC DONOR SELECTION

來自多次捐血的捐血者 Not from 1st time donors

其他 OTHERS

37oC的條件下解凍後，應置於室溫，並在 4小時內輸用。不可以再冰凍。

Once thawed, fresh frozen plasma should be stored at ambient temperature, must not be refrozen and must be used within 4 hours.



新鮮冰凍血漿

FRESH FROZEN PLASMA



從全血中分離出來，並於收集後 8小時內冰凍至攝氏零下 30oC。


用途 USAGE



(TTP).



Volume：> 150 ml Residual cells： - Red cells：< 6.0 x 109/L - Leucocytes：< 0.1 x 109/L - Platelets：< 50 x 109/L Factor VIIIc: > 0.7 IU/ml







其他 OTHERS

370Ｃ的條件下解凍後，應置於室溫，並在 4小時內輸用。不可以再冰凍。 Once thawed, fresh frozen plasma should be stored at ambient temperature, must not be refrozen and must be used within 4 hours


人手標籤樣本 Example of Manual Label

新鮮冰凍血漿

FRESH FROZEN PLASMA



從全血中分離出來，並於收集後 8小時內冰凍至攝氏零下 30oC 。


用途 USAGE



(TTP).



Volume：> 150 ml Residual cells： - Red cells：< 6.0 x 109/L - Leucocytes：< 0.1 x 109/L - Platelets：< 50 x 109/L Factor VIIIc: > 0.7 IU/ml




攝氏零下 30oC 或以下保存 24個月 24 months at – 30oC or below



其他 OTHERS

370Ｃ的條件下解凍後，應置於室溫，並在 4小時內輸用。不可以再冰凍。

Once thawed, fresh frozen plasma should be stored at ambient temperature, must not be refrozen and must be used within 4 hours



Blood Bag 350ml

新鮮冰凍血漿

FRESH FROZEN PLASMA


單採新鮮冰凍血漿 FRESH FROZEN PLASMA Apheresis (4) 描述 DESCRIPTION

從單採術分離出來，並於收集後 3小時內冰凍至攝氏零下 30oC。

Plasma that has been obtained by apheresis, frozen to – 30oC within 3 hours of collection.

用途 USAGE

- 可用於凝血功能障礙，尤其是有多種凝血因子缺陷的病人。

- 可用於血栓性血小板減少性紫癜。

- May be used in coagulation disorders, particularly in those clinical situations in which a multiple coagulation deficit exists.

- May be used in the treatment of thrombotic thrombocytopenic purpura (TTP).


容積：500 ml – 600ml 殘留細胞： - 紅細胞：< 6.0 x 109/L - 白細胞：< 0.1 x 109/L - 血小板：< 50 x 109/L 第八因子：> 0.7 IU/ml

Volume : 500 ml – 600ml Residual cells： - Red cells：< 6.0 x 109/L - Leucocytes：< 0.1 x 109/L - Platelets：< 50 x 109/L Factor VIIIc：> 0.7 IU/ml







其他 OTHERS

370Ｃ的條件下解凍後，應置於室溫，並在 4小時內輸用。不可以再冰凍。

Once thawed, fresh frozen plasma should be stored at ambient temperature, must not be refrozen and must be used within 4 hours



單採新鮮冰凍血漿 APHERESIS FRESH FROZEN

PLASMA


冰凍血漿之低溫沉澱物 CRYOPRECIPITATE

描述 DESCRIPTION

由多於 150ml的新鮮冰凍血漿制作而來。含大量第八因子和纖維蛋白原。

The component contains most of the Factor VIII and Fibrinogen from >150 ml of fresh frozen plasma.

用途 USAGE

- 第八因子缺乏(無法獲得合適的病毒滅活血制品的血友病患者、維勒布

蘭德氏病患者)。

- 彌漫性血管內凝血。

- 纖維蛋白原缺乏。

- Factor VIII deficiency states (haemophilia A, Von Willebrand disease where a suitable virus inactivated product is not available).

- DIC. - Fibrinogen defects.


容積：30 to 40ml 第八因子：> 70 IU/unit 纖蛋白原：> 140 mg / unit

Volume：30 to 40m Factor VIIIc：> 70 IU/unit Fibrinogen：> 140 mg / unit




攝氏零下 30oC 以下保存 24個月 24 months at – 30oC or below



其他 OTHERS

在 370Ｃ解凍後，置於室溫，並在四小時內輸用，不可以再冰凍。

Once thawed, the product should be stored at ambient temperature, Must not be refrozen and must be used within 4 hours.



冰凍血漿之低溫沉澱物

CRYOPRECIPITATE


除去低溫沉澱物之血漿 PLASMA, CRYOPRECIPITATE REDUCED

描述 DESCRIPTION

在製備低溫沉澱物時取出的上層血漿。 Supernatant plasma removed during the preparation of cryoprecipitate.

用途 USAGE

僅適用於血栓性血小板減少性紫癜。 Is indicated in TTP only.


容積：>150 ml/unit Volume：>150 ml/unit







其他 OTHERS

在 370Ｃ解凍後，應置於室溫，並在四小時內輸用，不可以再冰凍。

Once thawed, the product should be stored at ambient temperature, Must not be refrozen and must be used within 4 hours.



除去低溫沉澱物之血漿

PLASMA, CRYOPRECIPITATE REDUCED


5.4 血小板 PLATELETS

濃縮血小板 PLATELETS CONCENTRATE

描述 DESCRIPTION

由新鮮全血中提取。 A component derived from fresh whole blood which contains the majority of the original platelet content in a therapeutical effective form.

用途 USAGE

不應只根據血小板的數目來決定血小板的輸用。主要適應症：嚴重血小板減少並伴有因血小板功能缺陷而致臨床上有明顯

出血的病人。 The decision to transfuse platelets should not be based on low platelet count alone. Mandatory indication: the presence of severe thrombocytopenia with clinically significant haemorrhage attributable to the platelet deficit.


容積：50-60 ml 血小板計數：> 60 x 109 / unit 殘留白細胞：< 0.2 x 109/ unit 保存期末酸鹼值：6.8 - 7.4

Volume：50-60 ml Platelet count：> 60 x109 / unit Residual leucocytes：< 0.2 x 109/ unit pH at the end of shelf life：6.8 - 7.4



保存期，儲存溫度 SHELF LIFE, STORAGE 5 days at 22 ± 2oC



其他 OTHERS

4個單位可作為 1個成年人治療劑量

4 units are 1 therapeutic dose.



濃縮血小板

PLATELETS CONCENTRATE


單採血小板 PLATELETS Apheresis

描述 DESCRIPTION

不應只根據血小板的數目來決定血小板的輸用。應用單採機器從血液中獲得血小板及小量血漿，其餘成分回輸給捐血者。 This product is prepared by a suitable apheresis machine with retention of the platelets and a portion of the plasma. The remaining elements are returned to the donor.

用途 USAGE

主要適應症：嚴重血小板減少並伴有因血小板功能缺陷而致臨床上有明顯

出血的病人。

The decision to transfuse platelets should not be based on low platelet count alone. Mandatory indication: the presence of severe thrombocytopenia with clinically significant haemorrhage attributable to the platelet deficit.


容積：190 -- 265ml 血小板計數：> 200×109/unit 殘留白細胞：<1.0x109/unit 保存期末酸鹼值：6.8-7.4

Volume：190 -- 265ml Platelet count：> 200×109/unit Residual leucocytes：<1.0x109/unit pH at the end of shelf life：6.8-7.4




其他 OTHERS

一個單位可當作一個治療劑量 1 unit is 1 therapeutic dose.

抗凝劑 Anticoagulant

Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A solution：(g/L)，1：11比率與全血混合 Sodium citrate：0.4734 - 0.6417 (g/L)；Citric acid：0.0016 - 0.0021 (g/L)；Dextrose：0.5281 - 0.7159 (g/L)



單採濃縮血小板

PLATELETS, APHERESIS

單採血小板 Apheresis Platelets


交叉配型吻合的血小板 Crossmatched compatible platelets

描述 DESCRIPTION

病人血清與捐血者血小板以微板法作交叉配合試驗，結果陰性者為交叉配

型吻合血小板。 Donor platelets that give a negative crossmatch test result against patient’s serum.

用途 USAGE

血小板反覆輸注無效 (即輸注血小板 2 次或以上)，即時或 24 小時血小板增

加少於 10×109/L。

Poor responses to random platelets on 2 or more occasions (immediate or 24 hour increment of <10×109/L).


容積：50-60 ml 血小板計數：> 60 x 109 / unit 殘留白細胞： < 0.2 x 109/ single unit equivalent 保存期末酸鹼值：6.8 - 7.4

Volume：50-60 ml Platelet count：> 60 x 109 / unit Residual leucocytes： < 0.2 x 109/ single unit equivalent pH at the end of shelf life：6.8 - 7.4




其他 OTHERS

4個單位可作為 1個成年人治療劑量 4 units are 1 therapeutic dose



濃縮血小板

PLATELETS


5.5 γ- 射線輻照之血液成分 Blood Component Treated with γ-ray irradiation

γ- 射線輻照之濃縮紅血球 RED BLOOD CELLS γ-ray irradiated

描述 DESCRIPTION

γ- 射照射後，滅活血液中的 T淋巴細胞。 γ- ray irradiated, T-Lymphocytes are inactivated.

用途 USAGE

預防輸血相關性移植物抗宿主疾病。

宮內輸血。宮內/新生兒置換輸血。

先天性免疫缺陷、急性血癌、幹細胞移植、淋巴細胞癌、近親輸血。

Prevent TA-GVHD (Transfusion Associated - Graft vs Host Disease. Intrauterine transfusion. Intrauterine/neonate exchange transfusions. Congenital immunodeficiencies infant/children; Acute leukaemia and transplantation; Lymphoma; Transfusion between family members. 來源於 450ml 的全血容積：250 ± 50 ml 紅細胞壓積：0.65 – 0.75 抗凝劑：CPDA1 血色素：最少 45g/unit 儲存期末溶血： < 0.8% 紅細胞總量

From 450ml whole blood Volume：250 ± 50 ml Hematocrit：0.65 – 0.75 Anticoagulant：CPDA1 Hemoglobin：minimum 45g/unit Haemolysis at the end of storage： < 0.8% of red cells mass 說明

SPECIFICATION 來源於 350ml 的全血容積：200 ± 50 ml 紅細胞壓積：0.50 – 0.70 抗凝劑：CPDA1 血色素：最少 35g/unit 儲存期末溶血： < 0.8% 紅細胞總量

From 350ml whole blood Volume：200 ± 50 ml Hematocrit：0.50 – 0.70 Anticoagulant：CPDA1 Hemoglobin：minimum 35g/unit Haemolysis at the end of storage： < 0.8% of red cells mass



保存期，儲存溫度 SHELF LIFE, STORAGE 照射後 14日內保存於 4 ± 2o C 14 days at 4 ± 2o C after irradiation



濾去白細胞之輻照濃縮紅細胞

Red Cells, Leucodeplete, Irradiated


γ- 射線輻照之有添加劑濃縮紅血球 RBC In Additive Solutionγ-ray irradiated

描述 DESCRIPTION

γ- 射照射後，滅活血液中的 T淋巴細胞。

γ- ray irradiated, T-Lymphocytes are inactivated.

用途 USAGE

預防輸血相關性移植物抗宿主疾病。 Prevent TA-GVHD (Transfusion Associated - Graft vs Host Disease.


來源於 450ml 的全血容積：300 ± 60 ml 紅細胞壓積：0.50 – 0.70 添加劑：SAGM或其它血色素：最少 45g/unit 保存期末溶血： < 0.8% 紅細胞總量

From 450ml whole blood Volume：300 ± 60 ml Hematocrit：0.50 – 0.70 AdditiveSlutions：SAGM or Other Hemoglobin：minimum 45g/unit Haemolysis at the end of storage：< 0.8%of red cells mass


先天性免疫缺陷、急性血癌、幹細胞移植、淋巴細胞癌、近親輸血。 Acute leukaemia and transplantation; Lymphoma; Transfusion between family members.


照射後 14日內保存於 4 ± 2o C 14 days at 4 ± 2o C after irradiation



已經 γ-射線照射 γ-ray irradiated


濾去白細胞有添加劑濃縮紅血球 RED BLOOD CELLS in Addit ive Solution, Leucocyte depleted


γ- 射線輻照之全血液WHOLE BLOODγ-ray irradiated

描述 DESCRIPTION

γ- 射照射後，滅活血液中的 T淋巴細胞。 γ- ray irradiated, T-Lymphocytes are inactivated.

用途 USAGE

預防輸血相關性移植物抗宿主疾病。

宮內輸血。宮內⁄新生兒置換輸血。

先天性免疫缺陷、急性血癌、斡細胞移植、淋巴細胞癌、近親輸血。

Prevent TA-GVHD (Transfusion Associated - Graft vs Host Disease. Intrauterine transfusion. Intrauterine/neonate exchange transfusions Congenital immunodeficiencies infant/children; Acute leukaemia and transplantation; Lymphoma; Transfusion between family members. 來源於 450ml 的全血容積：510 ± 45 ml 紅細胞壓積：> 0.35 抗凝劑：CPDA1 or CPD 血色素：最少 45g/unit 儲存期末溶血： < 0.8% 紅細胞總量

From 450ml whole blood Volume：510 ± 45 ml Hematocrit：> 0.35 Anticoagulant：CPDA1 or CPD Hemoglobin：minimum 45g/unit Haemolysis at the end of storage： < 0.8% of red cells mass 說明

SPECIFICATION 來源於 350ml 的全血 : 容積：400 ± 35 ml 紅細胞壓積：> 0.35 抗凝劑：CPDA1 血色素：最少 40g/unit 儲存期末溶血： < 0.8% 紅細胞總量

From 350ml whole blood Volume：400 ± 35 ml Hematocrit：> 0.35 Anticoagulant：CPDA1 Hemoglobin：minimum 40g/unit Haemolysis at the end of storage： < 0.8% of red cells mass




照射後 14日內保存於 4 ± 2o C 14 days at 4 ± 2o C after irradiation





全血液

WHOLE BLOOD


γ射線輻照之濃縮血小板 PLATELETS CONCENTRATE (γ-ray irradiated)

描述 DESCRIPTION

是由新鮮全血中提取的。γ- 射照射後，滅活血小板中的 T淋巴細胞。

A component derived from fresh whole blood which contains the majority of the original platelet content in a therapeutical effective form. γ- ray irradiated, T-Lymphocytes are inactivated.

用途 USAGE

不應只根據血小板的數目來決定血小板的輸用。


出血的病人。

The decision to transfuse platelets should not be based on low platelet count alone. Mandatory indication: the presence of severe thrombocytopenia with clinically significant hemorrhage attributable to the platelet deficit.


容積：50-60 ml 血小板計數：> 60 x 109 / unit 殘留白細胞：< 0.2 x 109/ unit 保存期末酸鹼值：6.8 - 7.4

Volume：50-60 ml Platelet count：> 60 x 109 / unit Residual leucocytes：< 0.2 x 109/ unit pH at the end of shelf life：6.8 - 7.4






其他 OTHERS

4個單位可作為 1個成年人治療劑量 4 units are 1 therapeutic dose



已經 γ-射線照射

濃縮血小板

PLATELETS CONCENTRATE 已經 γ-射線照射 γ-ray irradiated


γ射線輻照之單採血小板 Apheresis PLATELETS (γ-ray irradiated)

描述 DESCRIPTION

是由新鮮全血中提取的。γ- 射照射後，滅活血小板中的 T淋巴細胞。 A component derived from fresh whole blood which contains the majority of the original platelet content in a therapeutical effective form. γ- ray irradiated, T-Lymphocytes are inactivated.

用途 USAGE

不應只根據血小板的數目來決定血小板的輸用。


出血的病人。

The decision to transfuse platelets should not be based on low platelet count alone. Mandatory indication: the presence of severe thrombocytopenia with clinically significant hemorrhage attributable to the platelet deficit.


容積：>160 ml 血小板計數：> 200 x 109 / unit 殘留白細胞：< 1.0 x 106/ unit 保存期末酸鹼值：6.4 - 7.4

Volume：>160 ml Platelet count：> 200 x 109 / unit Residual leucocytes：< 1.0 x 106/ unit pH at the end of shelf life：6.4 - 7.4


特別申請

On request




其他 OTHERS

1單位可作為 1個成年人治療劑量 1 units is 1 therapeutic dose



* γ- 射線輻照的成分制品 –預防輸血相關性移植物抗宿主病。 * Blood products treated with γ-ray irradiation-- prevent TA-GVHD.

已經 γ-射線照射

單採濃縮血小板

PLATELETS, APHERESIS 已經 γ-射線照射 γ-ray irradiated


6. 血漿製品 Plasma Fractionation Products 澳門捐血中心和南韓綠十字公司提供的血漿製品是通過下述策略來保證血漿製品的安

全。 The plasma fractionation products prepared by MBTS and Green Cross (Korean) have good

safety and quality by implemented the following:

• 嚴格的捐血者篩選以排除有高危生活方式的人士捐血 Stringent selection of blood donors to exclude potential donors with lifestyle behaviours which may place them at an increased risk for a transfusion transmitted infection

• 於每一單位的血液檢測愛滋病、乙型和丙型肝炎、人類 T淋巴細胞白血病病毒和梅毒

Testing of all blood donations for infectious diseases including HIV 1/2, hepatitis B, hepatitis C, HTLV I/II and syphilis

• 在制備血漿製品的過程中引入病毒滅活和移除的程序 Inclusion of viral removal and inactivation steps in the final manufacturing process

6.1 靜脈注射免疫球蛋白 Intravenous Globulin

靜脈注射免疫球蛋白 Intravenous Globulin

標籖名稱 Label I.V.-Globulin S inj. (50ml)

描述 DESCRIPTION

澳門捐血中心從澳門捐血者中收集的血漿，送往南韓

GreenCross公司，滙集制作後提純為免疫球蛋白 G (IgG)。

Plasma, collected by the MBTS from Macao donors, is pooled and fractionated to produce an IgG concentrate by Green Cross company.

用途 USAGE

l 原發性血小板減少性紫癲 Idiopathic thrombocytopoenic purpura

l 輸血後血小板減少性紫癲 Post-transfusion purpura l 異體幹細胞或骨髓移植

Transplants - Alllogeneic stem cell or bone marrow l 兒科愛滋病患者 HIV/AIDS – Paediatric l 重症肌無力Myasthenia Gravis l 川畸病 Kawasaki 's disease l 格林巴利綜合症 Guillain Barre Syndrome l Wiskott-Aldrich Syndrome l 其它 Other

包裝 Packs 50ml/vial, IgG 含量 content：2500mg


保存於 2-8 oC，有效期兩年；當置於雪櫃外，室温要求應低於25 oC，並須於 3個月內使用。

Refrigerate 2 -8oC for up to 2 years. Once removed from refrigeration it should store below 25oC and use within 3 months.


6.2 人類白蛋白 Normal Serum Albumin, Human 人類白蛋白 Normal Serum Albumin, Human 標籖名稱 Label ALBUMIN -GCC 20%

描述 DESCRIPTION

由澳門自願無償捐血者的血漿，滙集制作後提純為人類白蛋白。 Plasma, collected by the MBTS from Macao voluntary donors, is pooled and fractionated to produce Normal Serum Albumin, Human by Green Cross company (Korean).

用途 USAGE

ALBUMIN -GCC 20%主要的用途是保留血液中液體和攜帶中介物質。 The main functions of ALBUMIN -GCC 20% are to retain fluid in the blood stream and to carry intermediate products. l 極度低白蛋白 Extremely low albumin in critical ill l 燒傷 Burns l 肝硬化病人，腹水穿刺超過 6公升 Paracentesis of ascites in patients with cirrhosis or when the

volume exceeds l 血液析病人急需迅速移去過多血管外液體和保持灌注壓

Haemodialysis - may be used to assist rapid removal of excess extravascular fluid and to maintain perfusion pressure.

包裝 Packs 20% 50ml/vial 50ml/ vial ，含人類白蛋白 10克 contains human albumin 10g


室溫儲存(低於 30oC)。不可冰凍，需避光。 Room temperature (below 30oC). DO NOT FREEZE. Protect from light.

6.3 第八因子 Factor VIII 第八因子 Factor VIII 標籖名稱 Label Green-VIII 250 I.U

描述 DESCRIPTION

是由正常人血漿提純所得的干燥製品，含高純度凝血第八因子。 Green inj.250iu is a dried preparation containing human coagulation factor VIII.

用途 USAGE

主要用於甲型血友病患者，該類病人凝血第八因子减低，血液不能

自行凝固或凝血時間延長。

Is used for patients with haemophilia A, a bleeding disorder, in which there are reduced levels of factor VIII. Individuals with very low factor VIII levels have difficulty in forming blood clots, with these clots often taking longer to be made than normal.

劑量及使用 Dosage and administration

l After reconstitution, inject 250-2000I.U. intravenously or by drip-infusion靜脈注射或滴注 250-2000IU

l Infusion rate should not exceed 5ml/min 注射速度不能大於5ml/min

包裝 Package

每一劑量包含第 8凝血因子 250I.U，枸原酸鈉 29mg、醋酸 90mg、氯化鈣 1.8mg、氯化納 125mg 1 vial contains Factor VIII 250 I.U, sodium citrate 29mg, Calcium Chloride 1.8mg, aminoacetic acid 90mg, Sodium Chloride 125mg


保存於低於 10 oC ，由生產日期計 24個月內為有效期 Store below 10oC. Maximum validity：24months from the date of manufacture.


6.4 第九因子 Factor IX 第九因子 Factor IX

標籖名稱 Label Facnyne inj.250 I.U.

描述 DESCRIPTION

Facnyne 250 I.U是由正常人血漿提純所得的干燥製品，含高純度凝血因子第九因子。 Facnyne 250 I.U is a dried preparation of human factor IX, also known as blood clotting Factor IX.

用途 USAGE

Facnyne 250 I.U 含高純度凝血第九因子。第九因子是一重要的凝血因子，一般用於治療第九因子含量減低的乙型血友病患者。

Facnyne 250 I.U contains purified and concentrated factor IX, a protein which is essential for normal blood clotting. Facnyne 250 I.U is used in patients with haemophilia B or Christmas disease, a bleeding disorder, in which there are reduced levels of the clotting factor.

劑量及使用 Dosage and administration

以每公斤體重 10-20 I.U 的濃度靜脈注射或滴注 After reconstitution, inject 10-20 I.U/kg intravenously or by drip-infusion slowly.

包裝 Package

每一劑量含第 9凝血因子 250I.U，枸原酸鈉 29mg、Glycine 90mg和氯化納 128mg。 1 vial contains Factor IX complex, human 250 I.U, sodium citrate 29mg,Glycine 90 mg, Sodium Chloride 128mg


於 2至 8oC保存，由生產日起計 24個月為有效期 Maximum validity：24months from the date of manufacture.

7. 血袋內的抗凝劑和細胞添加劑

ANTICOAGULANTS and ADDITIVE SOLUTIONS 7.1 一般血袋：抗凝劑和

血袋類型Anticoagulant & Blood Bag

Type

抗凝劑 Anticoagulant

抗凝劑容量Volume of

Anticoagulant

100毫升抗凝劑內的組成成分 Constituents per 100 ml

anticoagulant

Citric Acid (hydrous) U.S.P 160 mg Sodium Citrate (hydrous) U.S.P 1.29 g Monobasic Sodium Phosphate (hydrous) U.S.P 109 mg

CPD 350 ml

Citrate Phosphate Dextrose Solution, U.S.P.

49 ml per unit (for collection of 350 ml of blood)

Dextrose (anhydrous) U.S.P 1.14 g

Citric Acid (hydrous) U.S.P. 206 mg

Sodium Citrate (hydrous) U.S.P 1.66 g

Monobasic Sodium Phosphate (hydrous) U.S.P 140 mg

Dextrose (anhydrous) U.S.P 1.83 g

CPDA1 450 ml

Citrate Phosphate Dextrose Adenine Solution


Adenine. 17.3 mg

CPD A1 350 ml

Citrate Phosphate Dextrose Adenine Solution


Citric Acid (anhydrous) Sodium Citrate (dihydrous) Monobasic Sodium Phosphate (monohydrous) Dextrose (anhydrous) U.S.P Adenine.

299 mg 2.63 g 222 mg 3.16g 27.5mg


Citrate Phosphate Dextrose


Citric Acid (anhydrous) Sodium Citrate ( ehydrate) Monobasic Sodium Phosphate (monohydrate) Dextrose monohydrate Aqua ad inject. Ad

299 mg 2.63 g 222 mg 2.55 g 100 ml CPD /

SAGM 450 ml

SAGM 100 ml per unit (to add to the red cells within 72 h after collection)

Sodium Chloride Dextros. Monohydrate Adenine Mannitol Aqua ad inject. Ad

877 mg 900 mg 16.9 mg 525 mg 100 ml

CPD

Citric Acid (anhydrous) U.S.P Sodium Citrate ( ehydrate) U.S.P Monobasic Sodium Phosphate (monohydrate) U.S.P Dextrose (monohydrate) U.S.P

188 mg 1.66 g 140mg 1.61 g

CPD/ OPTISOL (AS5) 450 ml OPTISOL

(AS5)

100 ml per unit (to add to the red cells within 72 h after collection) Sodium Chloride USP

Dextros. Monohydrate USP Adenine USP Mannitol USP

877 mg 900 mg 30 mg 525 mg

Aphersis Anticoagulant (Haemonetics MCS +)

Citrare Dextrose Solution USP (ACD) Formula A

500 to 600ml per unit

Dextrose(MonohydratE)USP Sodium Citrate(Dihydrate)USP Citric Acid (Anhydrous)USP

2.45g 2.2g 730mg

7.2 單採血袋：

7.2.1 單採血漿 Apheresis Plasma：使用 1：12比率與全血混合，一般收集量：500~619ml 22x1/12=1.83g/L

抗凝劑每升血內含抗凝劑量

(g/L) 單採血漿後袋內的抗凝劑量 (g/L)

sodium citrate 1.8300 0.9150 - 1.1328 citric acid 0.0061 0.0031 - 0.0038 dextrose 2.0417 1.0209 - 1.2638

7.2.2 單採血小板使用 1：11比率與全血混合，一般收集血小板量：194~263ml，及血漿量：200ml

抗凝劑每升血內含抗凝劑

量(g/L) 單採血小板後袋內

抗凝劑量 (g/L) 單採血漿後袋內抗

凝劑量 (g/L) sodium citrate 2.4400 0.4734 - 0.6417 0.4880

citric acid 0.0081 0.0016 - 0.0021 0.0016 dextrose 2.7222 0.5281 - 0.7159 0.5444

Reference • UK NBS Portfolio of Components and Guidance for their Clinical Use

• Australian Red Cross Blood Service

Documents

Component Portfolio 2009-07-15New