B. Braun Medical Inc
产品描述: Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Use Only, Single Use, Sterile, Rx Only, B Braun Medical Inc, Irvine CA 92614-5895, NDC 0264-3123-11
地位: Ongoing
City: Irvine
state: CA
国家: US
自愿/要求: Voluntary: Firm Initiated
Initial Firm Notification: Letter
Distribution Pattern: nationwide, Puerto Rico and Spain
Classification: Class I
产品数量: 22,584 units
reason For Recall: Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
记起Initiation Date: 20131121
报告日期: 20140507

Cefoxitin And Dextrose

Cefoxitin And Dextrose

Cefoxitin And Dextrose Recall

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Questions & Answers

side Effects & Adverse Reactions

BEFORE THERAPY WITH CEFOXITIN FOR INJECTION AND DEXTROSE INJECTION IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFOXITIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN WITH CAUTION TO PENICILLIN-SENSITIVE PATIENTS. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. IF AN ALLERGIC REACTION TO CEFOXITIN FOR INJECTION AND DEXTROSE INJECTION OCCURS, DISCONTINUE THE DRUG. SERIOUS HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES.

艰难梭菌据报道,相关的腹泻(CDAD)使用了几乎所有抗菌剂,包括用于注射和右旋糖的头孢辛蛋白,并且可能范围从轻度腹泻到致命结肠炎。用抗菌剂的治疗改变了结肠的正常菌群,导致过度生长艰难梭菌

艰难梭菌produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of艰难梭菌导致发病率和死亡率提高,因为这些感染可能是对抗菌治疗的难治性,并且可能需要结肠切除术。在使用抗生素后,所有患有腹泻的患者必须考虑CDAD。由于据报道CDAD发生在抗菌剂后的两个月内,因此需要仔细的病史。

如果怀疑或确认了CDAD,则不针对持续的抗生素使用艰难梭菌may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of艰难梭菌, and surgical evaluation should be instituted as clinically indicated.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

目前尚无该药物可用的制造商警告信息。

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefoxitin for Injection and Dextrose Injection and other antibacterial drugs, Cefoxitin for Injection and Dextrose Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Treatment

用于注射和右旋糖注射的头孢辛素用于治疗以下疾病中指定的微生物易感性菌株引起的严重感染。

(1) Lower respiratory tract infections,including pneumonia and lung abscess, caused bystreptococcus pneumoniae, other streptococci (excluding enterococci, e.g.,Enterococcus faecalis[formerlystreptococcus faecalis]),,staphylococcus aureus(including penicillinase-producing strains),Escherichia coli, Klebsiellaspecies,嗜血杆菌流感, andBacteroidesspecies.

(2)尿路感染Escherichia coli, Klebsiellaspecies,Proteus mirabilis,Morganella Morganii,Proteus dulgarisandProvidencia物种(包括P. rettgeri).

(3) Intra-abdominal infections,including peritonitis and intra-abdominal abscess, caused byEscherichia coli, Klebsiellaspecies,Bacteroides包括细菌性脆弱, and梭状芽胞杆菌species.

(4) Gynecological infections,包括子宫内膜炎,骨盆蜂窝织炎和骨盆炎性疾病Escherichia coli, Neisseria gonorrhoeae(including penicillinase-producing strains),Bacteroides包括B. Fragilis,梭状芽胞杆菌species,Peptococcus niger, Peptostreptococcusspecies, and链球菌agalactiae。Cefoxitin, like cephalosporins, has no activity against衣原体沙眼。Therefore, when cefoxitin is used in the treatment of patients with pelvic inflammatory disease andC.气管is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added.

(5) Septicemiastreptococcus pneumoniae, Staphylococcus aureus(including penicillinase-producing strains),Escherichia coli, Klebsiellaspecies, andBacteroides包括B. fragilis

(6) Bone and joint infectionsstaphylococcus aureus(including penicillinase-producing strains).

(7) Skin and skin structure infectionsstaphylococcus aureus(including penicillinase-producing strains),staphylococcus epidermidis, Streptococcus pyogenesand other streptococci (excluding enterococci, e.g.,Enterococcus faecalis[formerlystreptococcus faecalis]),大肠杆菌,Proteus mirabilis,Klebsiellaspecies,Bacteroides包括B. Fragilis,梭状芽胞杆菌species,Peptococcus niger, andPeptostreptococcusspecies.

Appropriate culture and susceptibility studies should be performed to determine the susceptibility of the causative organisms to cefoxitin. Therapy may be started while awaiting the results of these studies.

在随机比较研究中,头孢辛蛋白和头孢霉素在由革兰氏阳性球菌和革兰氏阴性杆上引起的感染的治疗中相当安全且有效。在存在细菌β-内酰胺酶(青霉素酶和头孢菌素酶)的情况下,头孢辛蛋白具有高度的稳定性。

Many infections caused by aerobic and anaerobic Gram-negative bacteria resistant to some cephalosporins respond to cefoxitin. Similarly, many infections caused by aerobic and anaerobic bacteria resistant to some penicillin antibiotics (ampicillin, carbenicillin, penicillin G) respond to treatment with cefoxitin. Many infections caused by mixtures of susceptible aerobic and anaerobic bacteria respond to treatment with cefoxitin.

Prevention

Cefoxitin is indicated for the prophylaxis of infection in patients undergoing uncontaminated gastrointestinal surgery, vaginal hysterectomy, abdominal hysterectomy, or cesarean section.

If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate treatment may be instituted.

历史

There is currently no drug history available for this drug.

Other Information

The drug chamber is filled with cefoxitin sodium USP, a semi-synthetic, broad-spectrum cepha antibiotic sealed under nitrogen for intravenous administration. It is derived from cephamycin C, which is produced by链霉菌。Its chemical name is sodium (6r,7s)-3-(羟甲基)-7-甲氧基-8-OXO-7- [2-(2-硫烯基)乙酰胺] -5- thia-1-1- azabicyclo [4.2.0] oct-2-2-end-2-ene-2-烯键羧酸盐氨基甲酸酯(酯)。经验公式是C16H16n3naO7s2,分子量449.44。方法,al formula is:

Cefoxitin sodium

Cefoxitin sodium contains approximately 53.8 mg (2.3 mEq) of sodium per gram of cefoxitin activity.

Cefoxitin for Injection and Dextrose Injection is supplied as a sterile, nonpyrogenic, single use packaged combination of cefoxitin (filled using Cefoxitin Sodium USP) and Dextrose Injection (diluent). After reconstitution, each 50 mL contains cefoxitin sodium equivalent to either 1 gram or 2 grams cefoxitin. The diluent chamber contains Dextrose Injection. The concentration of Dextrose Hydrous USP in Water for Injection USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose Hydrous USP has been added to adjust the osmolality to approximately 290 mOsmol/kg (approximately 2 g (4% w/v) and 1.1 g (2.2% w/v) to the 1 g and 2 g doses, respectively). Dextrose Injection is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents.

葡萄糖液压USP具有以下结构(分子)公式:

Dextrous hydrous

The molecular weight of Dextrose Hydrous USP is 198.17.

After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted according to instructions in the product labeling, the approximate osmolality of the reconstituted solution of Cefoxitin for Injection and Dextrose Injection is approximately 290 mOsmol/kg. After reconstitution, the pH is approximately 6.5. Solutions of Cefoxitin for Injection and Dextrose Injection range from colorless to light amber.

not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP).

The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.

Cefoxitin And Dextrose Manufacturers


  • B. Braun Medical Inc.
    Cefoxitin And Dextrose (Cefoxitin Sodium) Injection, Solution [B. Braun Medical Inc.]

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