CEFAZOLIN injection, powder, for solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Nopērc to tagad

Lejuplādēt Produkta apraksts (SPC)
13-12-2022

Aktīvā sastāvdaļa:

CEFAZOLIN SODIUM (UNII: P380M0454Z) (CEFAZOLIN - UNII:IHS69L0Y4T)

Pieejams no:

General Injectables & Vaccines, Inc.

Ievadīšanas:

INTRAMUSCULAR

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection, USP and other antibacterial drugs, Cefazolin for Injection, USP 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. Cefazolin for Injection, USP is indicated for the treatment of the following serious infections due to susceptible organisms. 1.1 Respiratory Tract Infections Respiratory tract infections due to S. pneumoniae, Klebsiella species, H. influenzae , S. aureus (penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci. Injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of strep

Produktu pārskats:

Cefazolin for Injection, USP is supplied as a sterile white or off-white powder or crystalline powder. Each vial contains cefazolin sodium equivalent to 1 gram of cefazolin. As with other cephalosporins, cefazolin tends to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected. Before reconstitution protect from light and store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

                                CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
GENERAL INJECTABLES & VACCINES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFAZOLIN FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CEFAZOLIN FOR
INJECTION.
CEFAZOLIN FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1973
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
CEFAZOLIN FOR INJECTION AND OTHER ANTIBACTERIAL DRUGS, CEFAZOLIN FOR
INJECTION SHOULD BE USED
ONLY TO TREAT OR PREVENT INFECTIONS THAT ARE PROVEN OR STRONGLY
SUSPECTED TO BE CAUSED BY
BACTERIA.
INDICATIONS AND USAGE
Cefazolin for Injection, USP is a cephalosporin antibacterial
indicated in the treatment of the following
infections caused by susceptible isolates of the designated
microorganisms: (1)
Respiratory tract infections. (1.1)
Urinary tract infections. (1.2)
Skin and skin structure infections. (1.3)
Biliary tract infections. (1.4)
Bone and joint infections. (1.5)
Genital infections. (1.6)
Septicemia. (1.7)
Endocarditis. (1.8)
Perioperative prophylaxis. (1.9)
DOSAGE AND ADMINISTRATION
For intravenous or intramuscular use. (2) (2)
*In rare instances, doses of up to 12 grams of cefazolin per day have
been used.
Recommended Dosing Schedule in Adult Patients with CrCl Greater Than
or Equal to 55 mL/min. (2.1)
Type of Infection
Dose
Frequency
Moderate to severe infections
500 mg to 1 gram
every 6 to 8 hours
Mild infections caused by susceptible gram-
positive cocci
250 mg to 500 mg
every 8 hours
Acute, uncomplicated urinary tract infections
1 gram
every 12 hours
Pneumococcal pneumonia
500 mg
every 12 hours
Severe, life-threatening infections (e.g.,
endocarditis, septicemia)*
1 gram to 1.5 grams
every 6 hours
(2)
DOSAGE FORMS AND STRENGTHS
1 g per vial.(3)
CONTRAINDICATIONS
Cefazolin for injection is contraindicated in patients with known
allergy to the cephalosporin group of
antibiotics.
WARNINGS AND PRECAUTI
                                
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