WARNING - FDA records indicate that this drug has been recalled.
产品描述: | 1%利多卡因HCL注射,USP,无防腐剂,10 mg/ml,30毫升单剂量小瓶,包装在25座纸箱中,仅RX,Hospira,Inc。,Inc。,Forest,IL 60045,美国,NDC 0409-4279-02。 |
---|---|
地位: | Ongoing |
City: | 湖森林 |
State: | il |
国家: | 我们 |
自愿/要求: | Voluntary: Firm Initiated |
Initial Firm Notification: | 新闻稿 |
Distribution Pattern: | 全国。 |
Classification: | Class I |
产品数量: | 120,900 vials |
召回的原因: | 颗粒物的存在:确认的客户抱怨,发现嵌入在玻璃小瓶中并漂浮在溶液中的橙色和黑色颗粒物被鉴定为氧化铁。 |
召回开始日期: | 20140418 |
报告日期: | 20150211 |
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Questions & Answers
Side Effects & Adverse Reactions
警告
LIDOCAINE HYDROCHLORIDE INJECTION, FOR INFILTRATION AND NERVE BLOCK, SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES THAT MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED AND THEN ONLY AFTER ENSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY EQUIPMENT, AND THE PERSONNEL NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES (See also ADVERSE REACTIONS and PRECAUTIONS). DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH.
关节镜和其他外科手术后的局部麻醉剂的关节内输注是未经批准的用途,并且在接受此类输注的患者的软骨溶解后出现了销售后的报道。大多数报道的软骨溶解病例都涉及肩关节。关节内麻醉剂和不含肾上腺素的局部麻醉剂在48至72小时内,在小儿和成年患者中已经描述了Gleno-Humeral软骨溶解病例。没有足够的信息来确定较短的输注周期是否与这些发现无关。症状的发作时间,例如关节疼痛,僵硬和运动丧失可能是可变的,但可能早在手术后第二个月就开始了。目前,没有有效的软骨溶解治疗。经历了软骨溶解的患者需要额外的诊断和治疗方法,并需要一些需要的关节置换术或肩部置换。
To avoid intravascular injection, aspiration should be performed before the local anesthetic solution is injected. The needle must be repositioned until no return of blood can be elicited by aspiration. Note, however, that the absence of blood in the syringe does not guarantee that intravascular injection has been avoided.
Local anesthetic solutions containing antimicrobial preservatives (e.g., methylparaben) should not be used for epidural or spinal anesthesia because the safety of these agents has not been established with regard to intrathecal injection, either intentional or accidental.
法律问题
目前尚无该药物可用的法律信息。
FDA安全警报
目前,该药物没有FDA安全警报。
制造商警告
目前尚无该药物可用的制造商警告信息。
FDA标记更改
目前no FDA labeling changes available for this drug.
Uses
INDICATIONS AND USAGE
Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.
历史
目前,该药物没有药物史。
其他信息
利多卡因盐酸注射液,溶液
[Hospira, Inc.]
AQUEOUS SOLUTIONS FOR INFILTRATION
AND NERVE BLOCK
Ampul
塑料多剂量Fliptop小瓶
玻璃抽搐小瓶
仅Rx
描述
Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows:
浓度 |
0.5% |
1% |
1.5% |
2% |
毫克/毫升盐酸利多卡因(anhyd)。 |
5 |
10 |
15 |
20 |
mg/ml氯化钠 |
8 |
7 |
6.5 |
6 |
Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). See HOW SUPPLIED section for various sizes and strengths.
Lidocaine is a local anesthetic of the amide type.
Lidocaine Hydrochloride, USP is chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular weight is 288.82. It has the following structural formula:
用于塑料小瓶的半刚性小瓶是由特殊配方的聚烯烃制成的。它是乙烯和丙烯的共聚物。根据USP生物学标准对塑料容器的测试证实了塑料的安全性。容器不需要蒸气屏障来维持适当的药物浓度。
来源
A3207-22 Portex Amniocentesis 22G Quincke制造商
-
史密斯医疗ASD,Inc。
A3207-22 Portex amniocentesis 22g Quincke |史密斯医疗ASD,Inc。
剂量和给药
表1(推荐剂量)总结了盐酸利多卡因注射的推荐体积和浓度,用于各种麻醉程序的USP。该表中建议的剂量是针对正常健康的成年人,并指使用无肾上腺素溶液。当需要较大的体积时,仅应使用含有肾上腺素的溶液,除非在可能禁忌使用血管加压药物的情况下。
在关节镜和其他外科手术后,接受了局部麻醉剂关节内输注的患者软骨解的不利事件报道。利多卡因未获得此用途的批准(请参阅警告,剂量和管理)。
这些建议的剂量仅作为大多数常规程序所需的麻醉量的指南。beplay体验实际的体积和浓度取决于许多因素,例如手术程序的类型和程度,麻醉深度和所需的肌肉松弛程度,所需的麻醉持续时间以及患者的身体状况。在所有情况下,应给出最低浓度和最小剂量,将产生所需的结果。对于儿童,老年人和衰弱的患者以及心脏和/或肝病患者,应降低剂量。
The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Thus, an increase in volume and concentration of Lidocaine Hydrochloride Injection will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of Lidocaine Hydrochloride Injection may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected.
对于静脉注射区域麻醉,只有50毫升含有0.5%利多卡因盐酸盐的单剂量小瓶,应使用USP。
硬膜外麻醉
对于硬膜外麻醉,仅建议通过霍斯佩拉注射利多卡因盐酸盐的以下特定产品:
1%。。。。。。。。。。 . . . . . . . . . . 30 mL single-dose teartop vials
1.5%。。。。。。。。。。 . . . . . . . . . . . . . 20 mL single-dose ampuls
2%。。。。。。。。。。 . . . . . . . . . . . . . . . 10 mL single-dose ampuls
Although these solutions are intended specifically for epidural anesthesia, they may also be used for infiltration and peripheral nerve block provided they are employed as single dose units. These solutions contain no bacteriostatic agent. In epidural anesthesia, the dosage varies with the number of dermatomes to be anesthetized (generally 2−3 mL of the indicated concentration per dermatome).
尾尾和腰椎硬膜外阻滞:作为对蛛网膜下腔空间无意渗透后有时观察到的不良经历的预防措施,应在注射总体积之前至少5分钟,以施用2-3 mL的1.5%盐酸盐的测试剂量腰椎或尾性硬膜外块所需。如果患者以可能使导管移位的方式移动,则应重复测试剂量。如果在测试剂量中含有肾上腺素(建议使用10-15 mcg),则可能是对无意识性血管内注射的警告。如果注射到血管中,则这种肾上腺素可能会在45秒内产生短暂的“肾上腺素反应”,包括心率和收缩压的增加,周围的苍白球,pallor骨,pall骨,呼吸剂,呼吸症和未培养患者的紧张感。镇静的患者可以仅表现出每分钟的脉搏率增加20或更多15秒或更多秒。β受体阻滞剂的患者可能不会表现出心率的变化,但是血压监测可以检测到收缩压的复活升高。每次测试剂量给药后,应允许足够的时间进行麻醉。应避免通过导管快速注射大量的盐酸盐水注射,并且在可行的情况下应施用分数剂量。
如果已知大量注射大量局部麻醉溶液进入亚蛛网膜下腔空间,在适当的复苏后,如果有导管到位,请考虑尝试通过排出适量的脑脊液(例如10 mL)来尝试恢复药物)通过硬膜外导管。
最大推荐剂量
注意:此插件伴随的产品不含肾上腺素。
Adults: For normal healthy adults, the individual maximum recommended dose of lidocaine HCl with epinephrine should not exceed 7 mg/kg (3.5 mg/lb) of body weight and in general it is recommended that the maximum total dose not exceed 500 mg. When used without epinephrine, the maximum individual dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight and in general it is recommended that the maximum total dose does not exceed 300 mg. For continuous epidural or caudal anesthesia, the maximum recommended dosage should not be administered at intervals of less than 90 minutes. When continuous lumbar or caudal epidural anesthesia is used for non-obstetrical procedures, more drug may be administered if required to produce adequate anesthesia.
The maximum recommended dose per 90 minute period of lidocaine hydrochloride for paracervical block in obstetrical patients and non-obstetrical patients is 200 mg total. One-half of the total dose is usually administered to each side. Inject slowly five minutes between sides. (See also discussion of paracervical block in PRECAUTIONS).
For intravenous regional anesthesia, the dose administered should not exceed 4 mg/kg in adults.
儿童:很难为儿童提供最大剂量的任何药物,因为这会随着年龄和体重的作用而变化。对于3岁以上的儿童,体重正常,身体发育正常,最大剂量取决于儿童的年龄和体重。例如,在50磅的5岁儿童中,利多卡因HCl的剂量不得超过75-100 mg(1.5-2 mg/lb)。建议使用更多稀释溶液(即0.25-0.5%)和不超过3 mg/kg(1.4 mg/lb)的总剂量来诱导儿童静脉内麻醉。
为了防止全身毒性,应始终使用最低有效浓度和最低有效剂量。在某些情况下,有必要用0.9%氯化钠注射稀释可用浓度,以获得所需的终浓度。
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions that are discolored and/or contain particulate matter should not be used.
表格1
Recommended Dosages of Lidocaine Hydrochloride Injection, USP for Various Anesthetic
程序s in Normal Healthy Adults
盐酸利多卡因注射液,USP(没有Epinephrine)
程序
浓(%)
Vol. (mL)
总剂量(mg)
Infiltration
经皮
0.5或1.0
1−60
5−300
Intravenous Regional
0。5
10-60
50−300
Peripheral Nerve Blocks, e.g.
Brachial
1。5
15-20
225-300
牙科
2.0
1-5
20-100
肋间
1。0
3
30
副杂志
1。0
3−5
30−50
pudendal(每一侧)
1。0
10
100
帕科维克
产科镇痛
(each side)
1。0
10
100
交感神经阻滞,例如
Cervical (stellate ganglion)
1。0
5
50
Lumbar
1。0
5−10
50-100
中央神经障碍
硬膜外*
Thoracic
1。0
20−30
200−300
Lumbar
镇痛
1。0
25−30
250-300
麻醉
1。5
15-20
225-300
2.0
10-15
200−300
Caudal
产科镇痛
1。0
20−30
200−300
Surgical Anesthesia
1。5
15-20
225-300
*由麻醉的皮肤数(2至3 mL/皮肤病组)确定的剂量。
THE ABOVE SUGGESTED CONCENTRATIONS AND VOLUMES SERVE ONLY AS A GUIDE. OTHER VOLUMES AND CONCENTRATIONS MAY BE USED PROVIDED THE TOTAL MAXIMUM RECOMMENDED DOSE IS NOT EXCEEDED.
灭菌,储存和技术程序:含有重金属的消毒剂,导致各个离子(汞,锌,铜等)不应用于皮肤或粘膜消毒,因为它们与肿胀和水肿的发生率有关。当需要进行多剂量小瓶的化学消毒时,建议使用异丙醇(91%)或70%的乙醇。许多市售的摩擦酒精品牌以及非USP级的乙醇溶液中含有对橡胶有害的变性剂,因此不使用。建议通过在使用前用建议的棉花或纱布彻底擦拭棉花或纱布来完成化学消毒。
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