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Names of Products: Ceftioful Sodium for Injection
Publication date: 2015-12-22
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English Names: Ceftioful Sodium for Injection
Components: Ceftioful Sodium

 QUALITATIVE AND QUANTITATIVE COMPOSITION

              Powder vial contains:

              Active Substance

           Ceftiofur (as ceftiofur sodium)   4g

              Or

              Ceftiofur (as ceftiofur sodium)   10g

PHARMACEUTICAL FORM

              Powder and solvent for solution for injection

Target species

Cattle and pigs.

Indications for use, specifying the target species

Cattle

Treatment of cattle with acute bacterial respiratory disease in which Mannheimia haemolytica, Pasteurella multocida or Histophilus somni sensitive to ceftiofur are involved.

Treatment of cattle with acute interdigital necrobacillosis (foul in the foot) in which Fusobacterium necrophorum and Bacteroides melaninogenicus are involved. 

Pigs

Treatment of pigs with bacterial respiratory disease in which Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida and/or Streptococcus suis sensitive to ceftiofur are involved.

Amounts to be administered and administration route

This product is for intramuscular use only.  See section 4.5(i).  Normal aseptic injection technique should be practiced.

Reconstitution

1 g vial:  reconstitute by adding 20 ml of water for injection.

4 g vial:  reconstitute by adding 80 ml of water for injection.

Directions for Reconstitution:

1. Remove stopper overseal from diluent and sterile powder vials.

2. Remove exactly 20ml (80ml) Water for Injections using a sterile 18G needle and syringe.

3. Inject the exact volume of diluent into sterile powder vial.

4. Shake solution until complete reconstitution of powder occurs.

Rapid addition of diluent maintained at room temperature will give best results. Normally accepted aseptic technique should be followed during reconstitution to avoid microbial contamination.

The resulting solution contains 50 mg of ceftiofur per ml.

Dosage in cattle and pigs.

Target Species

Dosage

Dosage of reconstituted product

Indication

Frequency of administration

Cattle

1   mg/kg

1ml/50kg

Respiratory   disease

Once   daily at 24 hour intervals for 3-5 days in total

Foul   in the foot

Once   daily at 24 hour intervals for 3 days in total

Pigs

3   mg/kg

1ml/16kg

Respiratory   disease

Once   daily at 24 hour intervals for 3 days in total

In pigs, an appropriately-graduated syringe must be used to allow accurate administration of the required dose volume.  This is particularly important when injecting piglets weighing less than 16 kg. 

Do not administer more than 10 ml per injection site. 

Do not exceed 20 broachings per vial.  If more than 20 broachings are required, the use of a draw-off needle is recommended.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale (powder):  3 years.

Shelf-life of the veterinary medicinal product after reconstitution:  24 hours.

Shelf-life of diluent:  3 years.

Special precautions for storage

Store unreconstituted product (powder and diluent) in a refrigerator (2°C to 8°C). 

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

After reconstitution, store in a refrigerator (2°C to 8°C). 

Any reconstituted product remaining after the stated periods should be discarded.