“國血製劑益康”高純度第八凝血因子/溫韋伯氏因子注射劑

国家: 台湾

语言: 中文

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

有效成分:

FACTOR VIII;;VWF: Rco

可用日期:

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代码:

B02BD02

药物剂型:

凍晶乾燥注射劑

组成:

VWF: Rco (2012102600) I.U.; FACTOR VIII (8004003300) I.U.

每包单位数:

瓶裝;;瓶裝

类:

菌　疫

处方类型:

限由醫師使用

厂商:

CSL BEHRING GMBH EMIL-VON-BEHRING STRASSE 76,35041 MARBURG GERMANY DE

治疗领域:

coagulation factor VIII

疗效迹象:

1.當von Willebrand disease病人使用desmopressin (DDAVP)治療無效時或為其禁忌時，預防和治療病人非手術與手術造成的出血。2.預防和治療因A 型血友病而引起缺乏第八凝血因子相關之非手術與手術造成的出血。

產品總結:

有效日期: 2027/10/11; 英文品名: "TBSF" High Purity Factor VIII/Von Willebrand Factor Concentrate

授权日期:

2007-10-11

资料单张

upright, attach a plastic disposable syringe to the Mix2Vial™
(transparent plastic
part). Invert the system and draw the reconstituted product into the
syringe by
pulling the plunger back slowly. One large syringe may be used to pool
several
vials of reconstituted product.
2. Once the “TBSF” High Purity Factor VIII / Von Willebrand Factor
Concentrate has
been transferred into the syringe, firmly hold the barrel of the
syringe (keeping
the syringe plunger facing down) and detach the Mix2Vial™ from the
syringe.
Discard the Mix2Vial™ (transparent plastic part) and empty product
vial in an
appropriate waste container. Fit the syringe to a suitable injection
needle to
administer the reconstituted product. Do not use the Mix2Vial™ for
injection.
3. Give the dose slowly by the intravenous route (usually within 5 to
6 minutes,
or as tolerated by the patient). The injection/infusion rate should
not exceed 6 mL
per minute and the patient should be observed carefully during
administration. If
there is any reaction that might be related to the administration of
“TBSF” High
Purity Factor VIII / Von Willebrand Factor Concentrate, the rate of
injection should
be decreased or if needed, the application should be stopped (see
section 4.4:
Special warnings and precautions for use).
4. When the contents of more than one vial are to be given, it will be
convenient to
pool the total amount prior to administration (e.g. in a large syringe
or sterile
bag). This must be done aseptically.
5. To reduce microbiological hazard, use as soon as practicable after
reconstitution/
preparation. For use in surgery, the conditions described under
Continuous
infusion can apply. This product is for single use only and any unused
portion
remaining in the vial must be discarded appropriately.
6. The solution must not be added or mixed with any other fluids to be
given, including
whole blood.
Medical personnel, family carers and patients should be adequately
trained in the
techniques for the preparation and the administration of “TBSF�