【药品名称】 复方氟尿嘧啶注射液(Compound Fluorouracil Injection)

【成 份】 本品为复方制剂，其组分为每10ml内含氟尿嘧啶40mg,人参多糖40mg。辅料为油酸、胆固醇、维生素E、大豆磷脂、聚山梨酯80、聚维酮K30、磷酸二氢钠、磷酸氢二钠。

【性 状】 本品为乳白色或淡黄色混悬液体，放置若分层，经振摇后仍应呈均匀的混悬液。

【适 应 症】 用于消化道癌症(结肠癌、直肠癌、胃癌)、乳腺癌、原发性肝癌等癌症的治疗。

【规 格】 10ml:40mg (氟尿嘧啶)，10ml/支，10支/盒

【用法用量】 静脉滴注。

起始量80mg/日，随后逐渐增大剂量，最大量一般不超过160mg/日，加入生理盐水500ml中静脉滴注，滴速每分钟不超过60滴，每日一次，一个疗程总量按氟尿嘧啶计算为3-4g，一个疗程结束后休息1-2周，继续第二疗程。

手术病人：术后2周开始维持给药，120-160mg/次，每周2次。

[禁忌]

1、当伴发水痘或带状疱疹时禁用。

2、妇女妊娠初期3个月内禁用。

【注意事项】

1.本品在动物实验中有致畸和致癌性，但在人类，其致突变、致畸和致癌性均明显低于氮芥类或其他细胞毒性药物，长期应用本品导致第二个原发恶性肿瘤的危险性比氮芥等烷化剂为小。

2、除单用本品较小剂量作放射增敏剂外，一般不宜和放射治疗同用。

3、开始治疗前及疗程中应定期检查周围血象。

4、有下列情况者慎用：

(1)肝功能明显异常

(2)周围血白细胞计数低于3500/MM3、血小板低于5万/ MM3者。

(3)感染、出血(包括皮下和胃肠道)或发热超过38℃者。

(4)明显胃肠道梗阻。

(5)脱水或(和)酸碱、电解质平衡失调者。

5、老年患者慎用氟尿嘧啶，年龄在70岁以上及女性患者，曾报道对氟尿嘧啶为基础的化疗有个别的严重毒性危险因素，密切监测和保护脏器功能是必要的。

6、服用本药时不宜饮酒或同用阿司匹林类药物，以减少消化道出血的可能。

7、本品不可直接静脉注射。

[贮藏] 遮光、密闭，在凉暗处(避光并不超过20℃)保存。

[有效期] 24个月

【批准文号】 国药准字H32025827

[生产企业]

企业名称：江苏振国药业有限公司

生产地址：江苏省如皋市跃进西路139号

功效与特点：

本品属于代谢类抗肿瘤药，是新型的脂质体制剂，是“靶向给药”与“扶正祛邪”相结合的典范。副作用小，放疗增敏，杀伤肿瘤作用强。

1、抗肿瘤作用 具有对肿瘤组织的靶向作用，可集中药力杀死癌细胞。同时具有较高的淋巴亲和性，防止肿瘤通过淋巴道的转移与复发，该药与同等剂量的氟尿嘧啶注射液相比，在癌周淋巴组织中药物浓度提高17倍。另外具有长效作用，药物在体内作用时间长达24小时。

2、免疫调节作用 该药处方中含有人参多糖，具有强效提升机体白细胞，增强患者自身免疫能力的作用。

3、增效作用 该药中含有的大豆磷脂、油酸、胆固醇等成分，能改善体内环境，起协同增效作用。

Compound Fluorouracil Injection

【Name of Drug】Compound Fluorouracil Injection

【Ingredients】 This product is compound preparation and 10ml product contains fluorouracil 40mg and ginseng carbohy 40mg. Excipients: oletic acid, cholesterol, vitamin E, soya lecithin powder, polysorbate 80, povidone K30, sodium dihydrogen phosphate and disodium hydrogen phosphate dodecahydrate

【Characteristics】 The product is milky white or light yellow suspension. It will be divided into two layers if remaining. An even suspension is formed after vibration and shaking.

【Indications】 It is applied to the treatment of carcinoma of digestive tract (colon carcinoma, rectum carcinoma and gastric carcinoma), breast carcinoma, primary hepatic carcinoma, etc

【Specification】 10ml:40mg (fluorouracil), 10ml×10pcs/box

【Usage and Dosage】 Intravenous drop .

Initial volume is 80mg/d and dose is increased gradually afterwards, but the maximal volume should not be over160mg/d generally. Physiological saline 500ml is added for intravenous drop, less than 60 drops/min. The treatment is given once a day. The total dose of fluoruracil in one session treatment is 3 to 4g. There are 1 to 2 weeks of interval between two sessions.

Patient for operation: Maintenance medication starts in 2 weeks after operation, 120-160mg/time, twice a week.

[Prohibition]

3、 Prohibition if associated with blisters or herpes zoster

4、 Prohibition for women within first 3 month pregnancy

【Precautions】

1.Animal experiment discovers teratogenicity and carcinogensis of the product. But in human being, mutagenesis, teratogenicity and carcinogenesis of the product are lower apparently comparing with those of nitromins or other cellular toxic drugs. The risk of second primary malignant tumor induced by the product is less than that induced by alkylating agent, such as nitromin.

2. Except that the single product of small dose is taken as radiosensitizer, the product is not suitable to be applied together with radiotherapy generally.

3. Peripheral hemogram should be examined regularly before and during treatment.

4. The product is applied cautiously in following situation:

1) Apparent abnormality of liver function

2) Peripheral WBC <3500/MM3 and platelet count <50,000/ MM3

3) Infection, hemorrhage (including subcutaneous and gastrointestinal bleeding) or fever>38℃

4) Apparent gastrointestinal obstruction

5) Dehydration or (and) disturbance of acid-base, and electrolyte balances

5. Aged patient should use fluoruracil cautiously. It has been reported that severe toxic risk happens in the treatment on the basis of fluoruracil specially for the patient aged over 70 years old and female patient. Hence, it is necessary to monitor closely and protect organ function.

6. During the application of the drug, in order to reduce the probability of digestive hemorrhage, alcohol or aspirins should not be applied.

7. Direct intravenous injection of the product is not available.

【Storage】 Avoid light, store in cool place (≤20ºC)

【Validity】 24 months

【Approval Number】 National Pharmaceutical Approval Number H32025827

【Manufacturing Enterprise】 Jiangsu Zhenguo Pharmaceutical Limited Company

【Address】 No. 139, Yuan Ji Xi Lu, Rugao, Jiangsu Province

Zip code：226502 Tel:0513-87533938

Website：http://www.wzg.cn E-mail:th@wzg.cn

Efficacy and Characteristics：

The product is antitumor drug in metabolic category. It is new liposome preparation and is the example of the coordination between “target medication” and “strengthening body resistance and eliminating pathogen”. It has less side effect and strong actions on sensibilization of radiotherapy and killing tumor.

1. Antitumor. It has targeting function to tumor tissue and can focus on killing cancer cell. Additionally, it has quite strong lymphatic affinity, prevents from metastasis and recurrence of tumor through lymphatic channel. Comparing with Fluoruracil Injection of equal dose, the drug concentration of this one in lymphoid tissue around tumor is increased by 17 times and this product has long-term efficacy of 24hr in the body.

2. Immune adjustment. The prescription of this drug contains ginseng polysaccharide that has strong efficacy on improving leucocytes and enhancing self-immunity.

3. Improvement of efficacy. This drug contains soya lecithin, oleic acid and cholesterol, which can improve internal environment and efficacy of treatment coordinately.