Cefazolin Sodium for Injection 1g/10ml Finished Medicine with GMP

CEFAZOLIN SODIUM FOR INJECTION 1G/10ML

Indications:

Cefazolin 1g Powder for solution for injection/infusion is indicated for the treatment of the following infections caused by cefazolin-susceptible micro-organisms:

- skin and soft tissue infections

- bone and joint infections.

Perioperative prophylaxis. For surgical operations with increased risk of infections with anaerobic pathogens, e.g. colorectal surgery, a combination with an appropriate drug with activity against anaerobes is recommended.

The use of cefazolin should be limited to cases where parenteral treatment is needed.

Susceptibility of causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available.

Dosage and Administration:

The dosage as well as the method of administration are dependent on the location and severity of the infection and on the clinical and bacteriological progress. Local therapeutic guidance should be taken into consideration.

Contraindications

Hypersensitivity to cefazolin sodium.

Patients with known hypersensitivity to cephalosporin antibiotics.

History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).

Precautions:

In case of a renal insufficiency with a glomerular filtration rate under 55 mL / min, an accumulation of cefazolin must be taken into consideration. Therefore, the dosage has to be reduced accordingly or the dosage interval has to be prolonged

In patients with renal impairment the use of cefazolin may be associated with seizures.

Prolonged prothrombin time may occur in patients with renal or hepatic impairment or poor nutritional state, as well as in patients receiving a protracted course of antimicrobial therapy, and patients previously stabilised on anticoagulant therapy. In these patients the prolongation of prothrombin time has to be monitored under treatment with cefazolin since it can very rarely cause plasmatic blood coagulation diseases.

Long-term and repeated administration can lead to overgrowth of resistant organisms.

If superinfection occurs during therapy, appropriate measures should be taken.

Drug interactions:

Anticoagulants

Vitamin K1

Probenecid

Nephrotoxic substances

When co-administered with cefazolin, kidney function tests must be carefully monitored.

Storage instructions:

Store below 30°C.

Keep the vials in the outer carton in order to protect from light.

Cefazolin Sodium for Injection   Other Specifications: