Cefradine for Injection

Sterile powder for injection IM/IV

[Indications]

Cefradine is indicated for use primarily in the treatment of infections of the respiratory tract, genitourinary tract, soft tissue and skin, blood stream, and bones, caused by susceptible organisms as listed above. Cefradine is also effective in cases of peritonitis. Cefradine is prophylaxis-effective to avoid infections due to susceptible organisms in patients about to undergo cesarean section or vaginal hysterectomy.
Cefradine is primarily indicated for those patients unable to tolerate oral medication. It is also indicated for intravenous use either by direct intravenous injection or by intravenous infusion for the treatment of serious and life threatening infections.

[Method of use]

For intramuscular use: Aseptically add 4.0ml sterile water for injection, bacteriostatic water, or 0.9% sodium chloride injection. Shake to effect solution and withdraw the entire contents. Intramuscular solutions should be used within 2 hours at room temperature. If stored in a refrigerator at 5 °C solutions retain full potency for 12 hours, reconstituted solutions may vary in colour from light to straw yellow, however, this does not affect the potency.
If local anaesthetic is considered desirable for intramuscular use, only 0.5% lidocaine hydrochloride solution is recommended as the solvent in place of the above mentioned volumes of water for injection. Other diluents also suitable for I.M. use are lidocaine HCl 1% or procaine HCl 1% or 2% solutions.
For intravenous use: Cefradine may also be administered by direct intravenous injection or by intravenous infusion. A 3µg/ml serum concentration can be maintained for each mg of cefradine per kg body mass per hour of infusion.
Suitable IV infusions are 5% dextrose solutions, isotonic solutions of sodium chloride or M/6 sodium lactate solution.
For Direct Intravenous Injection: Suitable intravenous injection solutions are sterile water for injection, 5% dextrose injection, or 0.9% sodium chloride injection. Aseptically add 10 ml to the 1 g vial. Shake to effect solution and withdraw the entire contents. The solution may be slowly injected directly into a vein over a three to five minute period or may be given through the I.V. tubing. The solutions should be used within 2 hours when kept at room temperature; if stored at 5 °C solutions retain full potency for 12 hours.
For Continuous or Intermittent IV infusion: Suitable intravenous infusion solutions are sterile water for injection (50 mg/ml cefradine solutions are approximately isotonic); 5% or 10% dextrose injection, 0.9% sodium chloride injection, sodium lactate injection (M/6 sodium lactate); dextrose and sodium chloride injection (5%:0.9%) or (5%:0.45%); 10% invert sugar in water for injection; lactated Ringer’s injection; Ringer’s injection; 5% dextrose in lactated Ringer’s injection; 5% dextrose in Ringer’s injection.
Aseptically add 10 ml of sterile water for injection to the vial and shake to affect solution. Aseptically transfer the entire contents to the IV diluent.
Intravenous infusions prepared with the above infusion solutions remain potent for 24 hours at room temperature or 1 week at 5 °C at concentrations up to 10 mg of cefradine activity per ml (1%), and for 10 hours at room temperature or 48 hours at 5 °C at concentrations up to 50 mg of cefradine activity per ml (5%). For prolonged infusions, replace 5% infusions every 10 hours and 1% infusions every 24 hours with freshly prepared solutions.
Protect solutions of cefradine from concentrated light or direct sunlight.