Hospira Inc.
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

A3207-22 Portex Amniocentesis 22G Quincke

A3207-22 Portex Amniocentesis 22G Quincke

A3207-22 Portex Amniocentesis 22G Quincke记起

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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:

利多卡因盐酸注射图1

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。

A3207-22 Portex Amniocentesis 22G Quincke制造商


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    A3207-22 Portex Amniocentesis 22G Quincke()套件[Smiths Medical Asd,Inc。]

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