干扰能
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241页（28598字）
【中文释文】：
注射剂(商品名：干扰素α-2b)
供静脉注射、皮下注射或病灶内注射。
〔说明〕
干扰能是由重组DNA技术生产的无菌、稳定、真空冻干形成的高度纯化的干扰素α-2b，是一种分子量约为19300道尔顿的水溶性蛋白。它来源于一种含有遗传工程质粒的大肠杆菌克隆，而该质粒与人白细胞的干扰素α-2基因进行了杂交。真空冻干的干扰能，注射剂是一种介于白色和乳色之间的粉剂。
干扰能注射剂的活性以国际单位(U)表示，10×106U相当于0．06mg干扰素α-2b蛋白。国际单位是通过比较干扰素α-2b的活性与世界卫生组织规定的人白细胞干扰素国际参照制剂的活性而决定的。
每瓶干扰能注射剂含有1×106U、3×106U、5×106U、10×106U或30×106U干扰素α-2b。此外，含有缓冲剂氨基乙酸、磷酸氢二钠，磷酸氢钠和稳定剂人白蛋白。
〔作用〕
干扰素α-2b无论在细胞培养系统还是在动物的人肿瘤异种移植的临床前研究中均表现出抗增殖作用，体外试验亦证明有明显的免疫调节作用。干扰素α-2b还能在体外或体内抑制病毒的复制。
干扰素是靠连接到细胞膜表面上的特异性受体而发挥他们的细胞活性作用的。一些研究的结果表明：一旦连接到细胞膜上，干扰素就起动了包括诱导某些酶在内的一系列复杂的细胞内过程。据认为，这一过程至少从一定程度上负起了细胞对干扰素治疗的各类应答作用，如在病毒感染的细胞中抑制病毒的复制，细胞增殖的抑制以及诸如提高巨噬细胞的吞噬活性和增强淋巴细胞对靶细胞的特异性细胞毒作用等这类免疫调节活动。所有这些活性均可归结到干扰素的治疗作用。
〔适应证和用途〕
干扰能注射剂适用于治疗多发性骨髓瘤，艾滋病病人的卡波济肉瘤，恶性黑色素瘤，毛细胞白血病，喉乳头状瘤，慢性髓细胞性白血病，尖锐湿疣，慢性乙型肝炎，慢性非甲非乙型肝炎和慢性丁型肝炎。
〔剂量和用法〕
1．多发性骨髓瘤 干扰能注射剂起始剂量为2×106U／m2，每周3次(隔日1次)皮下给药。根据耐受情况应每周逐渐加量直到最大耐受量5～10×106U／m2，每周3次。如果没有疾病迅速发展或未出现严重不可耐受情况，皮下注射应继续进行，按照医生的意见，病人也可自行给药。
如果发生不良反应，应该调整剂量或暂停治疗直到不良反应减轻。若在进行适当的剂量调整后，不能耐受的情况仍持续或反复发生，或疾病有所发展，就应中止干扰能的注射。
2．卡波济肉瘤 干扰能注射剂的推荐剂量为50×106U／m2，每日给药连续5d，每次30min静脉输注。然后，至少间隔9d再进行下一个5d的治疗期。此方案可持续下去，除非疾病迅速发展或出现不可耐受的情况。如果不良反应发生，应该调整剂量或暂停治疗直到情况好转。适当的调整剂量后，不能耐受的情况若仍持续或反复出现或疾病进展，就应中止干扰能的治疗。
3．恶性黑色素瘤 干扰能注射剂的推荐剂量为10×106U／m2，皮下给药，每周3次(隔日1次)，剂量可根据病人对治疗的耐受性而调整。出现疗效的中位时间约为2个月。若无疾病迅速发展或发生严重的不能耐受的情况该方案应持续使用。
如果不良反应发生，应调整剂量或中断治疗。经适当的剂量调整后，不能耐受的情况若仍持续或反复出现或疾病发展，就应中止干扰能的治疗。按照医生的意见，病人也可自行给药。
4．毛细胞白血病 干扰能注射剂的推荐剂量为2×106U／m2，皮下给药，每周3次(隔日1次)，剂量可根据病人对治疗的耐受情况而调整。出现疗效的中位时间约为1～2个月。若无疾病迅速发展或严重的不能耐受的情况发生，该方案应继续使用。
如果不良反应发生，应调整剂量或暂时中断治疗直到不良反应减轻。经剂量调整后，不能耐受的情况若仍持续或反复出现或疾病发展，就应中止干扰能的治疗。按照医生的意见，病人也可自行给药。
5．喉乳头状瘤病 干扰能注射剂的推荐剂量为3×106U／m2，皮下给药，每周3次(隔日1次)，在手术(激光)切除肿瘤组织后即可开始，剂量可根据病人对治疗的耐受性而调整。疗效的出现有可能需要6个月以上的治疗。若无疾病迅速发展或发生严重的不能耐受的情况，治疗应持续进行。
如果不良反应发生，应调整剂量或暂时中断治疗直到不良反应减轻。经适当剂量调整后，不能耐受的情况若仍持续或反复出现或疾病发展，就应中止干扰能的治疗。按照医生的意见，病人也可自行给药。
6．慢性髓细胞性白血病 干扰能注射剂的推荐剂量为4×106～5×106U／m2·d，皮下给药。当白细胞计数控制后，可减至每周3次(隔日1次)给药，剂量可根据病人对治疗的耐受性而调整。若无疾病迅速发展或严重的不能耐受的情况发生，治疗应持续进行。
如果不良反应发生，应调整剂量或暂时中断治疗直到不良反应减轻。经适当剂量调整后，不能耐受的情况若仍持续或反复出现或疾病发展，就应中止干扰能的治疗。按照医生的意见，病人也可自行给药。
7．尖锐湿疣 干扰能注射剂是以粉剂形式供应的，使用时须用无菌注射用水溶解，病灶或需注射的病灶首先需用无菌酒精纱布消毒，病灶内注射应采用细针头(30号口径)从病灶的基底部进行。将0．1ml含有1×106U干扰能注射剂的无菌溶液注入病灶，每周3次(隔日1次)连续3周。一次可处理多达5个病灶，但每周的最大总剂量不宜超过15×106U。
大的病灶可多点注射(干扰能的总剂量可达5×106U／d)或相继注射病灶的不同部位。
通常，病情改善发生在第一疗程开始后的4～8周，如果此时结果并不令人满意，只要临床症状和体征，或实验室参数的改变等不影响再次治疗，就可考虑以同样剂量程序进行第二程治疗。
8．慢性乙型肝炎 干扰能注射剂可以初始剂量每周35×106U做皮下注射，以5×106U／d或隔日10×106U给药均可。
干扰能注射剂还可以在一个逐渐减量的口服强的松的方案后给予。用法为：60mg／d每日1次连续2周，接着40mg／d，每日1次连续2周，20mg／d每日1次连续2周，紧跟着一个2周的无皮质类固醇间歇期后再开始干扰能注射剂的治疗，5×106U／d皮下注射。二种给药方案均可根据病人的耐受性而调整。若无严重的不能耐受的情况发生，所选的方案应持续4个月。按照医生的意见病人也可自行给药。
9．慢性非甲非乙型肝炎 干扰能注射剂可以初始剂量1～5×106U／d皮下注射，虽然可进行较长时间的治疗，但至少应治疗4个月。
剂量可根据病人的疗效和耐受性而调整。按照医生的意见，病人也可自行给药。
10．慢性丁型肝炎 干扰能注射剂初始剂量5×106U／m2，每周3次皮下注射，至少用3～4个月，虽然可行较长时间的治疗。
剂量可根据病人对治疗的耐受性而调整。按照医生的意见，病人也可自行给药。
配制真空冻干的干扰能注射剂：干扰能注射剂以粉剂形式提供，必须将其溶于1ml无菌注射用水中以形成等渗溶液供注射用。
用消毒的针管注入1ml无菌注射用水到干扰能注射剂的小瓶中，轻轻摇动以加速粉剂的完全溶解，抽出适当的剂量进行皮下注射或加入静脉输液中(见静脉输注液制备项下)。
稳定性：用1ml无菌注射用水配制后，溶液在2～30℃之下24h仍稳定。配制后的溶液是无色到浅黄色的透明溶液。
配制后的物质，就像所有非肠道给药的产品一样，在使用前都应用肉眼检查有无颗粒状物质或变色的情况发生。
干扰能注射剂的静脉输注液制备：如果可能，输注液应在制备之后立即使用。将1ml无菌注射用水加到小瓶中以溶化干扰能的冻干粉剂，然后抽取所计算的适当量的干扰素加到50ml无菌生理盐水中。
每次干扰能注射剂给药前，病人都应有21号蝶形针插入静脉或其他准备好的静脉通路。
在给药前应先进行的10min的无菌生理盐水输注，速率200ml／h，一旦干扰能注射剂开始使用，生理盐水输注就应停止。
准备好的50ml无菌生理盐水药液应该输注30min以上。
药液输注完后，应以200ml／h的原速率再进行10min的生理盐水输注。
不能与干扰能注射剂一起同时输注其他药物!
与其他静脉液体的相容性：除了静脉用生理盐水外，干扰能注射剂在终浓度为5×104～1×106U／ml时是稳定的并可与下列混合物在冰箱或室温下的玻璃瓶中相容24h：
林格注射液(Ringers Injection)；
乳酸林格注射液(Lactated Ringers Injection)；
氨基酸注射液；
5%碳酸氢钠注射液。
以上混合物在通过输液器输注时6h仍能保持稳定。
对干扰能注射剂在生理盐水中最低浓度1×105U／ml时的相容性做了调查，在不同的静脉输液器中的结果总结如下：
经鉴定相容性的各类静脉输液器：
输液装置 厂家
可接受的
2C001 Travenol
VI400 McGaw
Venoset 78 Abbott
Ultipor血液输注滤过及给药器 Pall
Intrafix Air B．Braun
STK注射器Type L76 Asca
Perfu Pal Dubernarid Vitrum
Vacoset V34 Baxter
Vacoset V2400 Pharmaseal
Hiplex-Venosteril ——
Venoset Abbott
Vacoset V-736 McGaw
Vacoset V-7 1 7U McGaw
不可接受的
VersasetV1 3 Rivero
Addit IV V1444 McGaw
Continue-Flow Travenol
配合治疗：常发生于干扰能治疗中的发热和头痛等症状用扑热息痛来缓解是很有效的。扑热息痛的推荐剂量为每次500～1000mg，在干扰能注射剂给药前30min给予。扑热息痛的最大剂量为1g，1日4次。
实验室检查：所有用干扰能注射剂治疗的病人都应在治疗前和治疗中定期进行如下项目的实验检查。
标准的血液学检查，包括全血细胞计数，分类和血小板计数。
血液化学，包括电解质、血钙、肝酶检查和血清肌酐。
由于多发性骨髓瘤损伤肾功能，因此在多发性骨髓瘤病人的治疗中应定期进行肾功能的检查。
〔不良反应〕
1．所报道的最常见的不良反应 发热和疲倦。这些反应与剂量相关并在中断或停止治疗后的72h内可逆转。常见的不良反应还有：厌食、腹泻、恶心、肌痛、头痛、血小板和粒细胞减少。
2．不太常见的不良反应 高血压、低血压、呕吐、关节痛、知觉损害、精神错乱、眩晕、运动失调、感觉异常、焦虑、抑郁、神经过敏、嗜睡、瘙痒、脱发及一过性皮疹。
3．较少报道的不良反应 大腿痉挛、便秘、失眠、疱疹性发疹，唇疱疹(非疱疹性)、皮疹、荨麻疹、潮热、心动过速、鼻衄、口炎、麻痹性肠绞痛、凝血性疾病(凝血酶原时间和部分凝血酶致活酶时间的延长)，激动不安、咳嗽、疖肿和视觉异常。
4．罕见的不良反应 体位性低血压、皮肤红斑、消化不良、紫癜、呼吸困难、打喷嚏，注射部位反应和发炎，眼球运动麻痹、鼻充血、胃肠胀气，唾液增多，高血糖和溃疡性口炎。
5．最常见的实验室检查异常，尤其在剂量超过10×106U／d时 肝功能(SGOT，SGPT)增高，粒细胞和血小板计数减少。当停止或减少干扰能注射剂治疗时，这些异常现象可迅速逆转。其他报道的异常实验室发现还有白细胞减少和血清肌酐、乳酸脱氢酶和碱性磷酸酶的升高。
心血管不良反应，特别是心律不齐似乎与以前存在的心血管病或进行过对心脏毒性治疗有关。
〔禁忌证〕
对于干扰素α-2b或任何其他干扰能注射剂成分有过敏史者均禁用。
〔预防措施〕
虽然对干扰能注射剂的严重急性过敏反应尚未见到，但如果发生应立即终止治疗。
一旦中等程度到严重的不良反应发生就可能需要调整病人的剂量或在某些病例中需终止干扰能的治疗。
低血压可发生在干扰能注射剂的治疗期间或治疗后的第2d，因而可能需要支持治疗。
病人在干扰能注射剂治疗时，应维持适当补液，因在病人中发现过由于液体丢失而造成的低血压，补液可能是必要的。
晚期代偿失调的肝硬化，食管静脉曲张出血，腹水，血小板计数等于或低于100000／mm3，总胆红素增高，凝血酶原时间延长或血清白蛋白水平降低等病人，在干扰能注射剂治疗前不应口服强的松，并且治疗应在谨慎和密切监督的情况下进行。
对于有心肌梗塞病史的病人或以前和现在有心律不齐病症者，若需干扰能注射剂治疗，也应在密切监督下进行。对于那些以前存在心脏异常或癌症晚期阶段的病人，在治疗前和治疗中都应进行心电图的检查。心律不齐者(主要为室上性)通常对常规剂量治疗有效，但也可能需要调整剂量或中断干扰能的治疗。
虽然中枢神经系统效应，如抑郁、精神错乱和其他精神状态改变一般来说是可逆的，但少数病例也可能要长达3周才能完全消失。一旦中枢神经系统效应发生，中断干扰能的治疗可能是必要的。癫痫样发作非常罕见于高剂量干扰能注射剂治疗。在干扰能注射剂治疗时若同时给予麻醉剂、催眠剂或镇静剂，应特别谨镇。
干扰能注射剂的局部用药均能被很好地耐受，组织坏死的情况未见报道。
〔儿科使用〕
对18岁以下的病人，用药经验有限，因此对这些病例应仔细权衡利弊。
〔妊娠和哺乳妇女的使用〕
由于尚不知干扰能给妊娠妇女使用时是否能伤害胎儿或影响生殖能力，因此，只有在可能给母亲带来的好处明确超过可能给胎儿造成的危害时方可给孕妇使用。
尚不清楚该药的成分是否进人乳排出，但由于许多药物均于人乳中排出而且干扰能注射剂也可能给乳期婴儿带来不良反应，因此充分考虑该药对母亲的重要性后，应做出是否终止哺乳或终止给药的决定。
〔包装〕
瓶装，每瓶含1×106U，2×106U，3×106U，10×106U或30×106U。
干扰能注射剂于2～8℃贮藏。
〔生产厂家〕
美国新泽西Kenilworth，先灵葆雅公司生产
【外文释文】：
Brand of interferon alfa-2b
For intravenous，subcutaneous or intralesional administration
Descrition
Intron A Injection is a sterile，stable，lyophilized formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques．Interferon alfa-2b is a water soluble protein with a molecular weight of approximately 19，300 daltons．It is obtained from a clone of E．coli，which has a genetically engineered plasmid hybridized with an interferon alfa-2 gene from human leukocytes．Lyophilized intron A Injection is a white to cream colored powder．
The activity of intron A Injection is expressed in terms of International Units(U)，with 10 million U corresponding to 0．06 mg of interferon alfa-2b protein．International Units are determined by comparison of the activity of the interferon alfa-2b wi th the activity of the international reference preparation of human leukocyte interferon established by the World Health Organization．Each vial of intron A Injection contains either 1 million，3 million，5 million，10 million or 30 million U of interferon alfa 2b；also，aminoacetic acid，sodium phosphate dibasic and sodium phosphate monobasic as buffering agents；human albumin as a stabilizer．
Actions
Interferon alfa-2b has exbibited antiprolifer ative effects in preclinical studies employing both cell culture systems and human tumour xenografts in animals，and has demonstrated significant immunomodulatory activity in vitro．Interferon alfa-2b also inhibits viral replication in vitro and in vivo．
Interfeons exert their cellular activities by binding to specific membrane receptors on the cell surface．The results of several studies suggest that，once bound to the cell membrane，interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes．It is thought that this process，at least in part，is responsible for the various cellular responses to interferon，including inhibition of virus replication in virus-infected cells，suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells．All of these activities possibly contribute to interferon’s therapeutic effects．
Indications and usage
Intron A Injection is indicated for the treatment of multiple myeloma，Kaposi’s sarcoma in patients with acquired immune deficiency syndrome，malignant melanoma，hairy cell leukemia，laryngeal papillomatosis，chronic myelogenous leukemia，condylomata acuminata，chronic type B hepatitis，chronic non-A，non-B hepatitis，and chronic delta hepatitis．
Dosage and administration
Multiple myeloma-intron A Injection should be administered subcutaneously three times a week(every other day)beginning at a dose of 2 million U／m2．Depending upon tolerance，the dosage should be progressively increased weekly to the maximum tolerated dose(5-10 million U／m2)and administered three times a week．Subcutaneous administration should be continued unless the disease progresses rapidly or severe intolerance is manifested．At the discretion of the physician，the patient may self-administer the dose．
If adverse reactions develop，the dosage should be modified or therapy should be discontinued temporarily until the adverse reactions abate．If persistent or recurrent intolerance develops following adequate dosage adjustment，or disease progresses，treatment with intron A Injection should be discontinued．
Kaposi’s sarcoma-The recommended dosage of intron A Injection is 50 million U／m2 administered daily as a 30 minute intravenous infusion for 5 consecutive days followed by a minimum interval of 9 days until beginning the next 5 day treatment period．This regimen should be maintained indefinitely unless the disease progresses rapidly or severe intolerance is manifested．If adverse reactions develop，the dosage should be modified or therapy should be discontinued temporarily until the adverse reactions abate．If persistent or recurrent intolerance develops followint adequate dosage adjustment，or disease progresses，treatment with intron A Injection should be discontinued．
Malignant melanoma-The recommended dosage of intron A Injection is 10 million U／m2 administered subcutaneously three times a week(every other day)．The dosage may be adjusted according to patient’s tolerance to medication．The median time to response is approximately two months．This regimen shuld be maintained unless the disease progresses rapidly，or severe intolerance is manifested．
If adverse reavtions develop，the dosage should be modifed，or therapy should be discontinued．If persistent or recurrent intolerance develops following adeqdate dosage adjustment，or disease progresses，treatment with intron A Injection should be discontinued．At the discretion of the physician，the patient may self-administer the dose．
Hairy cell leukemia-The recommended dosage of intron A Injection is 2 million U／m2 administered subcutaneously three times a week(every other day)．The dosage may be adjusted according to the patient’s tolerance to the medication．The madian time to response is approximately one to two months．This regimen should be maintained unless the disease progresses rapidly，or severe intolerance is manifested．
Laryngeal papillomatosis--The recommended dosage of intron A Injection is 3 million U／m2 administered subcutaneously three times a week(every other day)，beginning after surgical(laser)removal of tumor tissue．The dosage may be adjusted according to the patient’s tolerance to medication．Response to treatment may require is manifested．
If adverse reactions develop，the dosage should be modified，or therapy should be temporarily discontinued until the adverse reactions abate．If persistent or recurrent intolerance develops following adequate dosage adjustment，or disease progresses，treatment with intron A Injection should be discontinued．At the discretion of the physician，the patient may selfadminister the dose．
Chronic myelogenous leukemia--The recommended dosage of intron A Injection is 4-5 million U／m2 administered daily subcutaneously．When the white blood count is controlled，the dosage may be administered three times a week(every other day)．The dosage may be adjusted to the patient’s tolerance to the medication．This should be maintained unless the disease progresses rapidly or severe intolerance is manifested．
If adverse reactions develop，the dosage should be modified or therapy should be discontinued temporarily until the adverse reactions abate．If persistent or recurrent intolerance develops following adequate dosage adjustment or disease progresses，the treatment with intron A Injection should be discontinued．At the discretion of the physician，the patient may selfadminister the dose．
Condylomata acuminata-intron A Injection is supplied as a powder and must be reconstituted with sterile Water for Injection．The lesion or lesions to be injectied should be cleaned first with a sterile alcohol pad．The intralesional injection should be made at the base of the lesion using a fine needle(30 gauge)．Inject 0．1 ml of sterile solution containing 1．0 million U intron A Injection into the lesion three times per week on alternate days，for three weeks．As many as five lesions can be treated at one time．The maximum total dose administered weekly should not exceed 1 5 million U．
large lesions may be treated by multiple injections(up to a total of 5．0 million IU of intron A per day)or by sequentially injecting different areas of the lesions．
Re-treatment：Improvement usually occurs four to eight weeks after initiation of the first treatment course．If results at this time are not satisfactory，a second course of treatment at the same dosage schedule may be instituted providing that clinical signs and symptoms or changes in laboratory parameters do not preclude re-treatment．
Chronic Type B Hepatitis-intron A Injection may be administered subcutaneously at initial doses of 35 million U per week，either as five million U every other day．
Intron A Injection may also be administered，five million U daily subcutaneously，after a tapered regimen of oral prednisone：60 mg once daily for two weeks，following by 40 mg once daily for two weeks and 20 mg once daily for two weeks，followed by a two week steroid-free interval prior to initiating therapy with intron A Injection．
The dosage of either regimen may be adj usted according to the patient’s tolerance to medication．The selected regimen should be maintained up to four moths，unless severe intolerance develops．At the discretion of the physician，the patient may self-administer the dose．
Chronic non-A，non-B hepatitis-intron A Injection may be administered subcutaneously at initial doses of one to five million U daily for at least four months，although a longer treatment period may be indicated．
Dosage may be adjusted to patients response and tolerance to medication．At the discretion of the physician，the patient may self-administer the dose．
Chronic delta hepatitis-intron A Injection may be administered subcutaneously at initial doses of five million U／m2three times per week for a least three to four months，although a longer treatment period may be indicated．
Dosage may be adjusted according to the patient’s tolerance to medication．At the discretion of the physician，the patient may self-administer the dose．
Reconstitution of lyophilized intron A Injection-intron A Injection is supplied as a powder and must be reconstituted with l ml of sterile Water for Injections to provide an isotoic solution for parenteral administeration．
Using a sterile syringe and needle，inject 1 ml sterile Water for Injection into the vial of intron A Injection，Agitate gently to hasten complete dissolution of the powder．The appropriate dose should then be withdrawn with a sterile and either injectied subcutaneously or added to an intravenous solution．(See Preparation of Intravenous Infusion)．
Stabiliy-After reconstitution with l ml of sterile Wate for Injections，the solution is stable for 24 hours at 2-30℃．The reconstituted solution is clear and colorless to light yellow in color．
The reconstituted material，as for all parenteral drug products，should be inspected visulally for particulate matter and discolouration prior to administration．
Preparation of intron A Injection for Intravenous Infusion-Where possible，the infusion should be prepared immediately prior to use．The lyophilized powder form of intron A Injection should be reconstituted by adding 1 ml of sterile Water for Injections to the vial．The calculated amount of interferon for the appropriate dose should then be withdrawn from the vial(s)and added to 50 ml of sterile normal saline．
Prior to administration of each dose of intron A Injection，the patient should have a 21-gauge butterfly inserted intravenously(or other intravenous access provided)．
An infusion of sterile normal saline(rate：200 ml／h)should be started approximately 10 minutes before drug administration is begun．This normal saline infusion should be stopped just before intron A Injection administration starts．
The previously prepared solution of the reconstituted drug preparation in 50 ml of sterile normal saline should be infused over a 30-minute period．
After drug administration has been completed，the normal saline infusion should be restarted for a 1 0-minute period at the original rate of 200 ml／hr．
No other drug can be infused concomitantly with intron a injection．
Compatibility with other intravenous fluids-In addition to intravenous normal saline solution，intron A Injection，at final concentrations of 50 thousand to one million IU per ml is stable and compatible in the following mixtures for up to 24 hours at refrigerated or at room temperature in glass bottles：
Ringers Injection
Lactated Ringers Injection
Amino Acid Injections
5% Sodium Bicarbonate Injection．
The admixtures remained stable for the six hour infusion period through an administration set．
The compatibility of intron A Injection at a minimum concentration of 1×105IU／ml in normal saline was evaluated in various IV administration sets．The results are summarized below．
I．V．ADMINISTRATION SETS EVALUATED FOR COMPArIBILITY
Administration Set Manufacturer Administration Set Manufacturer
Acceptable Acceptable
2C0001 Travenol Vacoset V34 Baxter
V1400 McGaw Vacoset V2 400 Pharmaseal
Venoset 78 Abbott Hiplex-Venosteril
Ultipor Blood Pall Venoset Abbott
Transfusion Filter Vacoset V-736 McGaw
and Administration Set Vacoset V-717U McGaw
Intrafix Air B．Braun NOT ACCEPTABLE
STK Injection Set Asca Versaset V13 Rivero
Type L76 Addit IV V1 444 McGaw
Perfu Pal Dubernarid Vitrum Continue Flow Travenol
Concomitant therapy-acetaminophen(paracetamol)has been used successfully to alleviate the symptoms of fever and headache which can occur with intron A Injection therapy．The recommended acetaminophen dosage is 500 mg to 1 g given 30 minutes before administration of intron A Injection．The maximum dosage of acetaminophen to be given is 1 g four times daily．
Laboratory tests-The following laboratory tests should be conducted prior to and periodically during intron A Injection treatment for all patients：
·Standard hematologie tests-including complete blood counts and differential as well as platelet counts；
·Blood chemistries-including electrolytes，calcium，liver enzyme tests and serum creatinine．
Because multiple myeloma impairs renal function，patients being treated for multiple myeloma should have renal function tests performed periodically．
Adverse reactions
The most commonly reported reactions were fever and fatigue．These effects were reversible within 72 hours of interruption or cessation of treatment and were dose-related．
Common effects include anorexia，diarrhea，nausea，myalgia，headache，thrombocytopenia and granulocytopenia．
Less common adverse effects include hypertension，hypotension，vomiting，arthralgia，impaired consciousness，confusion，dizziness，ataxia．paresthesia，anxiety，depression，nervousness，somnolence，pruritis，alopecia and transient rash．Rarely reported adverse reactions include leg cramps，constipation，insomnia，herpetic eruptions，cold sores(non-herpetic)，rash，urticaria，hot flushes，tachycardia，epistaxis，stomatitiis，paralytic ileus，coagulation disorder(elevated prothrombin time and partial thromboplastin time)，agitaition，coughing，furunculosis and abnormal vision．
Very rarely occurring adverse effects include potural hypotension，erythema，dyspepsia，purpura，dyspnea，sneezing，injection site reaction and inflammation，oculomotor paralysis，nasal congestion，flatulence，increased saliva，hyperglycemia and ulcerative stomatitis．
Most frequently observed laboratory abnormalities，especially at doses greater than 10 million IU daily，include elevated liver function tests(SGOT，SGPT)and reduction in granulocytes and platelet counts．These abnormalities were rapidly reversible upon cessation or reduction of intron A Injection therapy．Other reported abnormal laboratory findings include decreases in WBC and increases in serum creatinine，LDH and alkaline phosphatase．
Increase in serum aminotransferase levels has been noted as an abnormality in some nonhepatitis subjects and also in some patients with chronic type B hepatitis coincident with clearance of viral DNAP．
Cardiovascular(CVS)adverse reactions，particularly arrhythmia appeared to be correlated with preexisting CVS disease and prior cardiotoxic therapy．
Contraindications
A history of hypersensitivity to interferon alfa-2b or any other of the components of intron A Injection contraindicates its use．
Precautions
Although serious，acute hypersensitivity reactions to intron A Injection have not beenobserved，if such a reaction develops，the drug should be discontinued immdiately．
Moderate to severe adverse experiences may require modification of the patient’s dosage regimen or in some cases，termination of intron A Injection therapy．
Hypotension may occur during intron A Injection therapy or up to two days post therapy and may require supportive treatment．Adequate hydration should be maintained in patients undergoing intron A Injection therapy since hypotension related to fluid depletion has been seen in patients．Fluid replacement may be necessary．
Patients with advanced decompensated cirrhosis，bleeding esophageal varices，ascites，platelet counts less than or equal to 100 000／m3，increased total bilirubin levels，prolonged prothrombin time or decreased serum albumin levels should not receive oral prednisone prior to intron A Injection and should be treated with intron A Ijection cautiously and monitored closely．Patients with a history of myocardial infarction and／or previous or current arrhythmic disorder，who require intron A Injection therapy，should be closely monitored．Those patients who have pre-existing cardiac abnormalities and／are in advanced stages of cancer，should have electrocardiograms taken prior to and during the course of treatment．Cardiac arrhythmias(primarily supreventricular)usually respond to conventional therapy but may require dose modification or discontinuation of intron A Injection therapy．
Although CNS effects，such as depession，confusion and other alterations of mental status，are generally reversible，in a few patients full resolution has taken up to three weeks．In case of CNS effects，discontinuation of intron A Injection therapy may be necessary．Very rarely seizures have occurred with high doses of intron A Injection．Narcotics，hypnotics or sedatives should be administered with caution concomitahtly with intron A Injection．
Local administration of intron A Injection has been well tolerated；tissue necrosis has not been reported．
Pediatric use
Experience in patients below 18 years of age has been limited and in such cases the expected benefits should be carefully weighed against potential hazards．
Usage during pregnancy and in nursing mothers
Because it is not known whether intron A Injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity，it should be given to a pregnant woman only if the potential benefits to the mother cearly outweigh the potential hazard to the fetus．
It is not known whether the components of this drug are excreted in human milk．Because many drugs are excreted in human milk and because of the potential for adverse reactions from intron A Injection in nursing infants，a decision should be made whether to discontinue nursing or to discontinue the drug，taking into account the importance of the drug to the mother．
How supplied
In vials of 1000000 U，3000000 U，10000000 U or30000000 U．
Store intron A Injection between 2-8℃．
Keep out of reach of children．
Manufacturer
New Jersey U．S．A．