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Advate（人基因重组抗血友病（FVIII）因子）

2011-11-21 23:02:39 作者：新特药房来源：中国新特药网天津分站浏览次数：791 文字大小：【大】【中】【小】

简介： Baxter(Baxter International Inc)公司近日称，欧盟已经批准该公司新药——通过非血浆/白蛋白方法制备的重组基因人凝血因子Ⅷ(rAHF-PFM)上市销售，商品名为Advate，用于控制A型血友病患者的出血症状。 ...

关键字：Advate（人基因重组抗血友病（FVIII）因子）

Baxter(Baxter International Inc)公司近日称，欧盟已经批准该公司新药——通过非血浆/白蛋白方法制备的重组基因人凝血因子Ⅷ(rAHF-PFM)上市销售，商品名为Advate，用于控制A型血友病患者的出血症状。

本品单剂量包装有4种：250、500、1000IU/瓶和超高效能1500/瓶。其包装包括1个10mL的注射器、蝶绷带、酒精药签和1个包装垫。

本品是一种细胞重组基因人凝血因子Ⅷ，在细胞培养过程、净化和最后的配方中均未加入任何人类或兽类血浆蛋白和清蛋白，因此减少了这些蛋白的携带病菌所引起的感染风险。

本品引起的不良反应较轻，主要包括：味觉障碍、注射部位瘙痒、头晕、头疼、与输液管相关的感染、潮热、腹泻、下肢浮肿、发汗、恶心、腹上部或胸下部疼痛、红细胞数量减少、关节肿大和呼吸短促等。

【主要成分】第八凝血因子
【适应症】控制和预防A型血友病患者(先天性第八凝血因子缺乏)之出血事件。
【简介】ADVATE系利用基因重组工程从中国仓鼠卵巢(CHO) 细胞合成第八凝血因子，经由一系列之色层分析管柱纯化自培养液所得。用于制造ADVATE的细胞培养与纯化过程都没有添加任何人类或动物来源的添加物，生产过程包含了一道专门病毒去活化溶剂清洁剂处理步骤。本产品之生物活性与结构皆与人类抗血友病因子相似。
本剂是一灭菌、去热原、白色至黄白色粉末之静脉注射配方制剂，单一剂量瓶装，每瓶分别含有250、500、1000国际单位(IU)包装。当与适量溶剂配制时，产品含有下列稳定剂不超过：38 mg/mL乳糖、10 mg/mL trehalose、108 mEq/L sodium、12毫莫耳(mM) histidine、12毫莫耳(mM)Tris 、19 mM calcium钙离子、0.15 mg/mL polysorbate-80以及0.10 mg/mL glutathione。 Von Willebrand Factor (vWF) 在细胞培养时与第八因子一同表现，以帮助稳定培养中的第八因子，最终成品含量每IU rAHF不超过2 ng vWF，对于von Willebrand's疾病病人并无临床上的疗效。
本剂不含防腐剂。本剂每瓶均以IU标示其rAHF活性，其生物活性是采用参照世界卫生组织（WHO）Factor VIII: C浓缩液国际标准品，以体外实验测定，其特异活性为每毫克蛋白4000至10000 IU 。
【禁忌症】对鼠、仓鼠蛋白或本剂使用之任何成分过敏者。
【用法用量】本药限由医师使用。
依患者出血严重程度、欲提升血中第八因子活性百分比、治疗疗程不同，静脉给予本剂每8至24小时每公斤体重10~50 IU不等。

生产厂家：美国百特生命科学公司

Evolution of Factor VIII
WELCOME TO THE FUTURE:
The evolution of factor VIII therapy
When you and your doctor choose ADVATE, you select the most advance full-length recombinant factor VIII therapy available today. Here's what makes ADVATE the clear choice:
"One of the reasons we switched my grandson to ADVATE is because it is the only therapy that's processed without the addition of blood components." - TOM
Efficacy
ADVATE works hard so you can play to your fullest
ADVATE has been shown to stop bleeds in everyday situations. You can count on ADVATE to work when you need it. In clinical trials most bleeds were managed with just 1 infusion of ADVATE.1 Whether it's for simple injuries or complicated surgeries, ADVATE works so you can get back to what's important — your life.1,2
"Without my factor VIII therapy, I wouldn't be living the active lifestyle I am today."
– SETH____
Inhibitor Information
Inhibitor safety with ADVATE
There is a chance of developing antibodies, called inhibitors, to factor VIII when you introduce factor into your body. This is a risk with all factor therapies, including ADVATE. However, studies of previously treated patients (PTPs) have shown a low rate of inhibitors with ADVATE.1,2
"Times are different now, and new therapies, such as ADVATE, have made great improvements." – DAWN ____
How to Use ADVATE
ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] (For Intravenous Use only)
IMPORTANT: Contact your doctor or local hemophilia Treatment Center if you experience any problems with this procedure. These instructions are intended only as a visual aid for those patients who have been instructed by their doctor or hemophilia center on the proper way to self-infuse the product.
Do not attempt to self-infuse unless you have been taught how by your doctor or hemophilia center.
Click here for a printer friendly version of this page.
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1. In a quiet place, prepare a clean flat surface and gather all the materials you will need for the infusion. Check the expiration date, and let the vial with the ADVATE concentrate and the Sterile Water for Injection, USP (diluent) warm up to room temperature. Wash your hands and put on clean exam gloves. If infusing yourself at home, the use of gloves is optional.

2. Remove caps from the ADVATE concentrate and diluent vials to expose the centers of the rubber stoppers.
3. Disinfect the stoppers with an alcohol swab (or other suitable solution suggested by your doctor or hemophilia center) by rubbing the stoppers firmly for several seconds, and allow to dry prior to use. Place the vials on a flat surface.
4. Open the BAXJECT II device package by peeling away the lid, without touching the inside of the package. Do not remove the BAXJECT II device from the package.
5. Turn the package with the BAXJECT II device upside down, and place it over the top of the diluent vial. Fully insert the clear plastic spike of the device into the center of the diluent vial’s stopper by pushing straight down. Grip the package at its edge and lift it off the device. Be careful not to touch the white plastic spike. Do not remove the blue cap from the BAXJECT II device.

The diluent vial now has the BAXJECT II device connected to it and is ready to be connected to the ADVATE vial.

6. To connect the diluent vial to the ADVATE vial, turn the diluent vial over and place it on top of the vial containing ADVATE concentrate. Fully insert the white plastic spike into the ADVATE vial’s stopper by pushing straight down. Diluent will flow into the ADVATE vial. This should be done right away to keep the liquid free of germs.
7. Swirl the connected vials gently and continuously until the ADVATE is completely dissolved. Do not shake. The ADVATE solution should look clear and colorless. If not, do not use it and notify Baxter immediately.
8. Take off the blue cap from the BAXJECT II device and connect the syringe.
BE CAREFUL TO NOT INJECT AIR.
9. Turn over the connected vials so that the ADVATE vial is on top. Draw the ADVATE solution into the syringe by pulling back the plunger slowly. Disconnect the syringe from the vials. Attach the infusion needle to the syringe using a winged (butterfly) infusion set, if available. Point the needle up and remove any air bubbles by gently tapping the syringe with your finger and slowly and carefully pushing air out of
the syringe and needle.
If you are using more than one vial of ADVATE, the contents of more than one vial may be drawn into the same syringe. However, you will need a separate diluent and BAXJECT II device to mix each additional vial of ADVATE.

10. Apply a tourniquet, and get the injection site ready by wiping the skin well with an alcohol swab (or other suitable solution suggested by your doctor or hemophilia center).
11. Insert the needle into the vein, and remove the tourniquet. Slowly infuse the ADVATE. Do not infuse any faster than 10 mL per minute.

12. Take the needle out of the vein and use sterile gauze to put pressure on the infusion site for several minutes.

Do not recap the needle.Place it with the used syringe in a hard-walled
Sharps container for proper disposal.

13. Remove the peel-off label from the ADVATE vial and place it in your logbook. Clean any spilled blood with a freshly prepared mixture of 1 part bleach and 9 parts water, soap and water, or any household disinfecting solution.
14. Dispose of the used vials and BAXJECT II system in your hard-walled Sharps container, without taking them apart. Do not dispose of these supplies in ordinary household trash.
BAXJECT II Needle-less Transfer Device
Good things come in ADVATE packages…
Now every package of ADVATE contains BAXJECT II for even
greater ease of use

Baxject II has been completely redesigned to make mixing as easy as 1-2-3.

1 BAXJECT II is EASIER* than ever!
No valves to turn, no air to inject Color coding makes connecting easy

2 BAXJECT II is FASTER* than ever!

Mix in less than a minute1
With fewer steps, you'll spend less time mixing

3 BAXJECT II is SAFER* than ever!
Built-in filters maintain product purity Reduced risk of injury: needle-less designand no glass parts or syringes

* Compared to the original BAXJECT and needles

Rx Only. For safe and proper use of this device, please refer to the instructions for use.

The BAXJECT II device is intended for use with a single vial of product and is for single use only. Therefore, reconstitution and withdrawing a second vial into the syringe requires a second BAXJECT II device.

Indications

ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] is indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes and for perioperative management of patients with hemophilia A.

ADVATE is not indicated for the treatment of von Willebrand’s disease.
Important Safety Information:

Let your doctor know if you have had any previous allergic reactions to other factor VIII products or mouse or hamster proteins.

The most common related adverse reactions observed during the ADVATE clinical studies include: strange taste in mouth, headache, dizziness, and redness in the face.

There is a possibility that you can have an allergic reaction to ADVATE. Symptoms of an allergic reaction may include rash, hives, itching, tightness in throat or chest, difficulty breathing, feeling dizzy or light-headed, or a weak pulse. If you experience any of these symptoms, stop the infusion immediately and promptly contact your doctor.

Contact your doctor if you are not able to prevent or control bleeding episodes with your regular doses of factor VIII therapy.