72.立止血

出处:按学科分类—医药、卫生 军事医学科学出版社《临床常用进口药物手册》第412页(4689字)

【中文释文】:

(巴曲酶)

立止血是用Von Klobusitzky教授首创的专利方法,由予头(Bothrops atrox)的毒液制备得到的。立止血是经过分离和提纯的血凝酶,绝对不含神经毒素及其它毒素。每一批产品都经过严格仔细的生物学检验,并通过动物试验进行毒理检查以确认不存在毒素。

〔成分〕

每安瓿含一个克氏单位(KU)的凝血酶冻干型。一个克氏单位是指在体外37℃下,使标准人血浆在60±20s内凝固的凝血酶的量。

〔立止血对人体的影响〕

注射1KU立止血后20min,健康正常成年人的出血时间测定会缩短1/2或1/3。这种已增高的止血能力可保持2~3d,立止血仅具有止血功效,血液的凝血酶原数量并不因此而增高,因此,注射立止血决无血栓形成的危险。

〔适应证〕

立止血可用于需减少流血或止血的各种医疗情况下,如:外科、内科、妇产科、眼科、耳鼻喉科、口腔科等临床科室的出血及出血性疾病。

预防:手术前用药,可减少出血倾向,避免手术部位及手术后出血。

〔用法及剂量〕

静脉注射,肌肉注射,也可局部使用。

成人:1.0~2.0KU

儿童:0.3~1.0KU

应防止用药过量,否则功效会下降。

紧急情况下,立即静脉注射1KU,同时肌肉注射1Ku。各类外科手术:手术前1h,肌肉注射1KU,或手术前15min,静脉注射1KU。

手术后每日肌肉注射1KU,连用3d。在用药期间,应注意观察病人的出、凝血时间。

〔副作用〕

不良反应发生率极低。偶见过敏样反应。如出现以上情况,可按一般抗过敏处理方法,给予抗组胺药或(和)糖皮质激素及对症治疗。

〔禁忌〕

虽无关于血栓的报道,为安全计,有血栓病史者禁用。

〔注意事项〕

立止血尚无关于怀孕期之研究,故除非紧急情况,一般不予使用。孕期未超过3个月的妇女也不宜使用。

〔包装〕

每盒5安瓿,每安瓿含1KU立止血的冻干粉剂,各配1支溶媒。

本品为处方用药,仅限由医师使用。

〔生产厂家〕

瑞士巴塞尔素高大药厂

(附本品别名:立血止,凝血酶素,Botropase,Defidrase,Ophidiase)

【外文释文】:

Reptilase is prepared by the patented process,designed by prof.von Klobusitzky,from the venom of the Brazilian snake Bothrops atrox.Reptilase is the isolated purified enzyme heamocoagulase and is completely free of neurotoxins and other toxic substances.Each batch is carefully controlled biologically.The absence of toxins in checked in animal tests.

Composition

Each vial contains 1 Klobusitzky Unit(KU)of haemocoagulase in lyophilized form.One KU is the quantity of the enzyme haemocoagulase which coagulates standard human plasma incubated at 37℃ in vitro within 60±20 seconds.

Effects of Reptilase in Man

Twenty minutes after the pareniteral adminstration of 1 KU of Reptilase,the normal bleeding time in healthy adults sinks to half or third.This tendency towards elevated coagulability is maintained for two to three days.The haemostatic effect of Reptilase is not associated with any increase in the prothrombin level in the blood and therefore constitutes no danger of thrombosis.

Indications

Reptilase is used in all medical situations where the loss of blood has to be limited or stopped,e.g.bleeding in surgery,obstetrics,internal medicine,ophthalmology,otorhinolaryngology,dentistry,etc.Prophylactically can be used before surgical interventions to decrease the tendency to bleed,to avoid spilling or blood in the operation field as well as postoperative blood losses.

Dosage

Adults:1-2KU

Children:0.3-0.5-1.0KU

The administration can be intravenous or intramuscular.Topical use of the product is also possible.An overdose should be avoided as it weakens the action of Reptilase.

In urgent cases:1KU immediately,intravenously;if necessary a second 1KU intramuscularly.

Surgery of all kinds:1KU intramuscularly 1 hour before surgery or 1KU intravenously 15 minutes before the operation.

After treatment:1KU intramuscularly daily for three days.

The bleeding time should be continuously monitored during parenteral use of Reptilase.

Adverse Effects

Exceptionally,anaphylactic or anaphylactoid reactions have been observed in isolated cases after intravenous administration of Reptilase.

Therefore,appropriate drugs for intravenous administration(antihistamines,corticosteroids)should be kept at hand to counter severe reactions.

Contraindications

Although Reptilase has not been associated with thrombosis,for reasons of safety its use should be avoided in patients with a known history of thrombotic disorders.

Caution

The use of Reptilase during pregnancy has not been investigated.It is recommended to use it solely when the benefits to be gained outweigh the potential risks.Its use is not recommended if the patient’s gestational period is less than three months.

Packing

Boxes of 1 and 5 vials of 1 Klobusitzky Unit of haemocoagulase in lyophilized form with solvent.

On medical prescription.

Manufacturer

Solco Basle,Ltd,.Birstelden-Basle(Switzerland)

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