WARNING - FDA records indicate that this drug has been recalled.
Product Description: | ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medicines, Inc., Irvine, CA. NDC 073-3019-11 (individual vial), NDC 0703-3019-12 (carton of five). |
---|---|
Status: | Ongoing |
City: | 霍舍姆 |
State: | PA |
Country: | US |
Voluntary/Mandated: | Voluntary: Firm Initiated |
最初公司Notification: | 信 |
Distribution Pattern: | Nationwide. |
Classification: | 课上我 |
Product Quantity: | 6001 vials |
召回原因: | 颗粒物质的存在:发现漂浮在溶液中的硅酮橡胶和氟尿嘧啶晶体 |
召回启动日期: | 20150724 |
Report Date: | 20150902 |
Are you a medical professional?
Trending Topics
Adrucil Recall
Get an alert发出召回时。
Questions & Answers
副作用和不良反应
(see boxed WARNING)
THE DAILY DOSE OF ADRUCIL INJECTION IS NOT TO EXCEED 800 MG. IT IS RECOMMENDED THAT PATIENTS BE HOSPITALIZED DURING THEIR FIRST COURSE OF TREATMENT.
ADRUCIL should be used with extreme caution in poor risk patients with a history of high-dose pelvic irradiation or previous use of alkylating agents, those who have a widespread involvement of bone marrow by metastatic tumors or those with impaired hepatic or renal function.
Rarely, unexpected, severe toxicity (e.g., stomatitis, diarrhea, neutropenia and neurotoxicity) associated with 5-fluorouracil has been attributed to deficiency of dipyrimidine dehydrogenase activity. A few patients have been rechallenged with 5-fluorouracil and despite 5-fluorouracil dose lowering, toxicity recurred and progressed with worse morbidity. Absence of this catabolic enzyme appears to result in prolonged clearance of 5-fluorouracil.
Fluorouracil may cause fetal harm when administered to a pregnant woman. Fluorouracil has been shown to be teratogenic in laboratory animals. Fluorouracil exhibited maximum teratogenicity when given to mice as single intraperitoneal injections of 10 to 40 mg/kg on day 10 or 12 of gestation. Similarly, intraperitoneal doses of 12 to 37 mg/kg given to rats between days 9 and 12 of gestation and intramuscular doses of 3 to 9 mg given to hamsters between days 8 and 11 of gestation were teratogenic. Malformations included cleft palates, skeletal defects and deformed appendages, paws and tails. The dosages which were teratogenic in animals are 1 to 3 times the maximum recommended human therapeutic dose. In monkeys, divided doses of 40 mg/kg given between days 20 and 24 of gestation were not teratogenic.
There are no adequate and well-controlled studies with fluorouracil in pregnant women. While there is no evidence of teratogenicity in humans due to fluorouracil, it should be kept in mind that other drugs which inhibit DNA synthesis (例如据报道,甲氨蝶呤和氨基酮蛋白在人类中是致畸的。应该建议育儿潜力的妇女,以避免怀孕。如果在妊娠期间使用药物,或者如果患者在服用药物的同时怀孕,则应讲述患者对胎儿的潜在危害。氟尿嘧啶只有在潜在利益对胎儿的潜在风险证明妊娠期时才会使用。
Any form of therapy which adds to the stress of the patient, interferes with nutrition or depresses bone marrow function will increase the toxicity of fluorouracil.
法律问题
There is currently no legal information available for this drug.
FDA安全警报
目前没有用于此药物的FDA安全警报。
制造商警告
目前还没有生产informa的警告tion available for this drug.
FDA标记更改
There are currently no FDA labeling changes available for this drug.
Uses
ADRUCIL Injection is effective in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas.
History
目前没有这种药物没有毒品历史。
Other Information
Adrucil®(氟尿嘧啶注射,USP)抗肿瘤抗体粘土,是静脉内施用的无菌,非膨动式可注射溶液。每10毫升含有500mg氟尿嘧啶;用氢氧化钠将pH调节至约9.2。
Chemically, fluorouracil, a fluorinated pyrimidine, is 5-fluoro-2,4 (1H,3H)-pyrimidinedione. It is a white to practically white crystalline powder which is sparingly soluble in water. The molecular weight of fluorouracil is 130.08 and the structural formula is:
分子式:C.4H3FN2O2
来源
Adrucil Manufacturers
-
Teva肠外药品,Inc。
adrucil |Teva肠外药品,Inc。
General Instructions亚霉素注射应仅静脉内施用,使用护理避免外渗。不需要稀释。
所有剂量都基于患者的实际体重。然而,如果患者是肥胖的,或者如果由于水肿,腹水或其他形式的异常流体保持术,则使用估计的贫体质量(干重)。
It is recommended that prior to treatment each patient be carefully evaluated in order to estimate as accurately as possible the optimum initial dosage of ADRUCIL.
Dosage每天一次静脉注射12毫克/千克,连续4天。每日剂量不应超过800毫克。如果没有观察到毒性,则在第6,8,第10天和第12天内给出6毫克/千克,除非发生毒性。在5,7,第9天或第11天没有提供治疗。治疗将在第12天结束时停用,即使没有毒性已经变得明显。(请参阅警告和注意事项部分。)
Poor risk patients or those who are not in an adequate nutritional state (see CONTRAINDICATIONS and WARNINGS sections) should receive 6 mg/kg/day for 3 days. If no toxicity is observed, 3 mg/kg may be given on the 5th, 7th and 9th days unless toxicity occurs. No therapy is given on the 4th, 6th or 8th days. The daily dose should not exceed 400 mg.
一系列时间表的一系列注射序列构成了“疗程”。
维护治疗在毒性尚未出现问题的情况下,建议使用以下任何一种时间表继续进行治疗:
Repeat dosage of first course every 30 days after the last day of the previous course of treatment. When toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dosage of 10 to 15 mg/kg/week as a single dose. Do not exceed 1 gm per week.The patient's reaction to the previous course of therapy should be taken into account in determining the amount of the drug to be used, and the dosage should be adjusted accordingly. Some patients have received from 9 to 45 courses of treatment during periods which ranged from 12 to 60 months.
Handling and DisposalProcedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1–7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Although the fluorouracil solution may discolor slightly during storage, the potency and safety are not adversely affected. If a precipitate occurs due to exposure to low temperatures, resolubilize by heating to 140°F and shaking vigorously; allow to cool to body temperature before using.
-
Teva肠外药品,Inc。
adrucil |Teva肠外药品,Inc。
General Instructions亚霉素注射应仅静脉内施用,使用护理避免外渗。不需要稀释。
所有剂量都基于患者的实际体重。然而,如果患者是肥胖的,或者如果由于水肿,腹水或其他形式的异常流体保持术,则使用估计的贫体质量(干重)。
It is recommended that prior to treatment each patient be carefully evaluated in order to estimate as accurately as possible the optimum initial dosage of ADRUCIL.
Dosage每天一次每天一次静脉内给出12个Mg / kg。每日剂量不应超过800毫克。如果没有观察到毒性,则在第6,8,第10天和第12天内给出6毫克/千克,除非发生毒性。在5,7,第9天或第11天没有提供治疗。治疗将在第12天结束时停用,即使没有毒性已经变得明显。(请参阅警告和注意事项部分。)
较差的风险患者或那些没有足够的营养状态(见禁忌症和警告部分)应获得6毫克/千克/天3天。如果没有观察到毒性,则在第5,7和第9天中可以给出3mg / kg,除非发生毒性。在第4,6或第8天没有给予治疗。每日剂量不应超过400毫克。
一系列时间表的一系列注射序列构成了“疗程”。
维护治疗在毒性尚未出现问题的情况下,建议使用以下任何一种时间表继续进行治疗:
Repeat dosage of first course every 30 days after the last day of the previous course of treatment. When toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dosage of 10 to 15 mg/kg/week as a single dose. Do not exceed 1 g per week.The patient's reaction to the previous course of therapy should be taken into account in determining the amount of the drug to be used, and the dosage should be adjusted accordingly. Some patients have received from 9 to 45 courses of treatment during periods which ranged from 12 to 60 months.
Handling and DisposalProcedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1–7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If a precipitate occurs due to exposure to low temperatures, resolubilize by heating to 140°F and shaking vigorously; allow to cool to body temperature before using.
Directions for proper use of pharmacy bulk package(Not for Direct Infusion)
50毫升和100毫升药房散装包仅用于药房掺合服务。它们应插入塑料悬挂装置中并作为层流罩中的单位悬挂在一起。仅在清除和密封完整和未损坏时使用。
使用该产品仅限于合适的工作区,例如层流罩。仅在清除和密封完整和未损坏时使用。在进入小瓶之前,用合适的防腐剂拆下翻盖密封并清洁橡胶闭合。容器封闭物可以仅穿透一次,利用合适的无菌转移装置或分配装置,该分配装置允许测量的内容物的分布。最初打开小瓶的日期和时间应记录在小瓶标签上提供的空间中。将个体剂量转移到适当的静脉内输注溶液中。不建议使用用针的注射器使用。多条目增加了微生物和颗粒污染的潜力。
The withdrawal of container contents should be accomplished without delay using aseptic technique.However, should this not be possible, a maximum time of 4 hours from initial closure entry is permitted to complete fluid transfer operations. It is recommended that the transferred fluids be used promptly.
Recommended Storage Conditions After OpeningKeep under laminar flow hood at room temperature.
Login To Your Free Account