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英文药名: Fragmin(Dalteparin Injection Solution) 中文药名: 法安明（达肝素注射液） 生产厂家: Pfizer 药品名称 英文药名: Fragmin (Dalteparin Injection) Pfizer 辉瑞 本药是一种抗血栓形成剂，含有达肝素钠（低分子量肝素钠）以及非活性成分如氯化钠或注射用水。 达肝素钠是从猪肠粘膜制备的肝素钠通过可控亚硝酸解聚作用而生产的。其平均相对分子质量为5000。达肝素钠的抗血栓形成作用通过抗凝血酶而加强抑制凝血因子Xa和凝血酶。达肝素钠加强抑制凝血因子Xa的能力，相对大于延长凝血时间的能力。达肝素钠对血小板功能和血小板粘附性的影响比肝素小，因而对初级阶段止血只有很小的作用。尽管如此，达肝素钠的某些抗血栓形成的特性被认为是通过对血管壁或纤维蛋白溶解系统的作用而形成的。 静脉注射后的半衰期为2小时，皮下注射后为3-4小时。皮下注射后的生物利用率约为90% ；药物动力学基本上是非剂量依赖性的。 急性深静脉血栓的治疗。急性肾功能衰竭或慢性肾功能不全者进行血液透析和血液过滤期间防止体外循环系统中发生凝血。不稳定型冠心病，如不稳定型心绞痛和非Q-波型心肌梗塞。预防与手术有关的血栓形成。 急性深静脉血栓的治疗 特别在大剂量时，可能引起出血，常见报道的副作用是注射部位皮下血静肿。罕见血小板减少症、皮肤坏死、过敏反应和出血。曾观察到肝转氨酶（AST、ALT）一过性轻度至中等度升高。少见于过敏样反应。 对本药过敏。急性胃十二指肠溃疡和脑出血。严重凝血疾患。脓毒性心内膜炎。中枢神经系统、眼及耳受伤或手术。用达肝素钠时体外血小板聚集试验结果阳性的血小板减少症病人。治疗急性深静脉血栓形成时伴用局部麻醉。 各种低分子质量肝素的特性不同，推荐的剂量也不同，因此需要特别小心，并必须遵守各种特定产品的使用方法。不可经肌肉内途径给药。 对于血小板减少症和血小板缺陷、严重肝及肾功能不全、未控制的高血压、高血压性或糖尿病性视网膜病以及已知对肝素及/或低分子质量肝素过敏者，建议慎用此药。对新近手术的病人应用大剂量本药治疗时，也应小心。达肝素钠对于凝血时间，例如APTT（部分凝血酶原时间）或凝血酶时间。只有轻微的延长作用。建议用抗Xa方法作为实验室监测。延长APTT而增加剂量，可能引起用药过量和出血。应用本药进行慢性血液透析的病人通常只需要少数几次剂量调整，所以只需要少数几次检查抗Xa浓度即可。进行急性血液透析的病人的治疗间歇较短，应接受抗Xa浓度的全面监测。 曾在孕妇中测定过本药，没有见到对妊娠过程以及对胎儿和新生儿健康的有害影响。但在妊娠期间不应该使用含防腐剂的注射液，因为它含有苯甲醇，后者可能通过胎盘。必须记住，如在分娩或剖腹产前给予苯甲醇，这对早产儿有潜在的毒性。尚无资料证明达肝素钠是否进入母乳。 同时应用对止血有影响的药物，例如乙酰水杨酸、非类固醇抗炎药、维生素K拮抗剂及葡聚糖，可能加强本药的抗凝作用。 鱼精蛋白可抑制达肝素钠引起的抗凝作用。所引起的凝血时间的延长可被完全抵消，但抗Xa活性只抵消约25-50%，每1 mg鱼精蛋白可抑制100 IU抗Xa的达肝素钠的作用。鱼精蛋白本身对初级阶段止血有抑制作用，所以只能在紧急情况下应用。 本药可加于玻璃输液瓶或塑料容器装的等渗氯化钠或等渗葡萄糖输注液，该溶液应在12小时内使用。本药和其它产品的相容性尚未调查。 可在最高30°C的室温下存放。小瓶装的含防腐剂的法安明溶液应在第一次打开小瓶后14天内使用，过期不可再用。
10000iu 10(支) x 1ml
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Drug name: Fragmin
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Active Ingredients:
- dalteparin sodium
Therapeutic actions: Dalteparin is an anticoagulant (blood thinner). Dalteparin prevents the formation of blood clots.
Indications: Fragmin is primarily used in preventing the formation of blood clots in patients who will undergo hip replacement surgery or abdominal surgery. Fragmin is also used in treating certain types of angina and heart attacks. Fragmin is also used in preventing complications of blood clots in patients who are taking aspirin. Fragmin may also be used for purposes other than those indicated here.
Contraindications and cautions: Do not use dalteparin without first talking to your doctor if you
- have a very low level of platelets in your blood,
- have uncontrolled active bleeding,
- have an allergy to pork products, or
- cannot have accurate blood testing done prior to and during dosing.
Before using dalteparin, tell your doctor if you
- have bacterial endocarditis,
- have high blood pressure that is not being controlled,
- need to have surgery or another invasive procedure,
- have hemophilia or another blood disorder,
- have a stomach ulcer,
- have eye problems due to diabetes or high blood pressure,
- have liver disease, or
- have kidney disease.
You may not be able to use dalteparin, or you may require a dosage adjustment or special monitoring during therapy if you have any of the conditions listed above.
Dalteparin (Normiflo) is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not use dalteparin without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether dalteparin passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.
Do not take aspirin, ibuprofen (Motrin, Advil, Nuprin, and others), ketoprofen (Orudis KT, Orudis, Oruvail), naproxen (Aleve, Naprosyn, Anaprox, and others), indomethacin (Indocin), or any other nonsteroidal anti-inflammatory medication without first talking to your doctor. These medicines may lead to bleeding when taken with dalteparin. Ask your pharmacist or doctor before taking any prescription or over-the-counter medications, including vitamins, minerals, and herbal products.
Adverse effects: The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Fragmin may have any of the following serious side effects and allergic reactions:
- Difficulty in breathing
- Closing of the throat
- Swelling of the lips, tongue or face
- Hives
- Any prolonged or unexplained bleeding
- Pain, warmth, or redness in an arm or leg
- Ulceration at the injection site
If you experience any of these, discontinue use of Fragmin and inform your doctor.
Fragmin may also have less serious side effects that are more likely to occur. They include the following:
- Mild pain, redness or warmth at injection site
- Rash or itching
- Fever
If you experience any of these, continue using the product but inform your doctor immediately.
Other side effects may also occur when you take Fragmin. Inform your doctor if you experience anything unusual while or after taking Fragmin.
Interactions: There is a risk of bleeding in the spinal or epidural space, possibly resulting in paralysis, when dalteparin is used along with spinal or epidural anesthesia or spinal puncture. This risk may be increased by the use of indwelling epidural catheters or by the concomitant use of drugs that affect blood clotting.
Do not take dalteparin with any of the following medicines without first talking to your doctor:
- aspirin,
- ibuprofen (Motrin, Advil, Nuprin, and others), ketoprofen (Orudis KT, Orudis, Oruvail), naproxen (Aleve, Naprosyn, Anaprox, and others), indomethacin (Indocin), diclofenac (Cataflam, Voltaren), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), ketorolac (Toradol), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), tolmetin (Tolectin), or any other nonsteroidal anti-inflammatory medication;
- warfarin (Coumadin);
- aspirin and dipyridamole (Aggrenox);
- ticlopidine (Ticlid) or clopidogrel (Plavix); or
- dipyridamole (Persantine).
The drugs listed above may increase the effects of dalteparin, which could be dangerous. You may not be able to take dalteparin, or you may require a dosage adjustment or special monitoring during your treatment if you are taking any of the medicines listed above.
Drugs other than those listed here may also interact with dalteparin. Talk to your doctor and pharmacist before using any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
Additional Information: DO NOT SHARE THIS MEDICINE with others. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS PRODUCT, as well as syringes and needles, if needed during treatment, out of the reach of children. Do not reuse needles, syringes, or other materials.