Presentation:
Vials containing a powder for solution for injection. Vials contain either 1g or 4g ceftiofur as the sterile, freeze-dried sodium salt. Ceftiofur sodium is an off white to brown coloured powder requiring reconstitution with Water for Injection. Each ml of reconstituted solution contains ceftiofur sodium equivalent to 50mg ceftiofur.
Uses:
Cattle: Treatment of cattle with acute bacterial respiratory disease in which Mannheimia haemolytica, Pasteurella multocida orHistophilus 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.
Horses: Treatment of horses with bacterial respiratory disease in which Streptococcus spp including Streptococcus zooepidermicus and Streptococcus equi, Staphylococcus spp and/or Pasteurella spp are involved.
Dosage & Administration:
This product is for intramuscular use only. Normal aseptic injection technique should be practiced.
Reconstitution:
1g vial Reconstitute by adding 20ml of Water for Injection.
4g vial Reconstitute by adding 80ml of Water for Injection.
Dosage in cattle, pigs and horses:
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
Horses 2 mg/kg 2ml/50kg Respiratory disease Once daily at 24 hour intervals for up to 10 days in total
(or 48 hours after clinical signs have disappeared)
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.
Withdrawal Period:
Cattle Meat and offal: 2 days.
Milk: Zero hours.
Pigs Meat and offal: 2 days.
Not to be used in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under national horsepassport legislation.
Contraindictions, Warnings etc:
Do not use in animals previously found to be hypersensitive to ceftiofur and other ?-lactam antibiotics. Do not use in cases of known resistance to the active substance.
Special precautions for use in animals: Ceftiofur should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to more narrow spectrum antimicrobials.
Official and national antimicrobial policies should be taken into account when the product is used.
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Use of the product deviating from the instructions given in the data sheet may increase the prevalence of bacteria resistant to ceftiofur and may decrease the effectiveness of treatment with other cephalosporins, due to the potential for cross resistance.
In the pig, particular care must be taken to avoid injection into the fat tissue.
In horses, ceftiofur is active against the following microorganisms, found in respiratory-tract infections: Streptococcus spp (including Streptococcus zooepidermicus and Streptococcus equi), Staphylococcus spp, Pasteurella spp.
Avoid repeated injection at the same site.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.
Do not handle this product if you are sensitised or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure, taking all recommended precautions.
If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. Wash hands after use.
Adverse reactions (frequency and seriousness): Use of this product may cause transient local discomfort at the site of the injection.
Hypersensitivity reactions can occasionally occur. In the case of an allergic reaction, treatment should be stopped. In pigs, local irritation at the injection site may occur and can persist for 5 days or more.
Use during pregnancy, lactation or lay: Laboratory studies in the rat have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
The safety of the veterinary medicinal product has not been assessed during pregnancy and lactation in cattle or pigs. Use only according to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction: None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary: In cattle, no evidence of systemic toxicity was observed following administration of an overdose. In pigs, no evidence of systemic toxicity was observed following the administration of doses of up to 8 times the recommended dose, administered daily by intramuscular injection for 15 days.
Pharmaceutical Precautions:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Shelf-life of the veterinary medicinal product after reconstitution: 24 hours.
Shelf-life of diluent: 2 years.
Store unreconstituted product in the 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.
Diluent: Store in the refrigerator (2°C to 8°C).
Any unused product or waste material should be disposed of in accordance with national requirements.
Further Information
Pharmacodynamic properties:
After intramuscular administration ceftiofur is quickly metabolised to desfuroylceftiofur which reaches maximum plasma concentration within 1 hour. The plasma half-life for desfuroylceftiofur is on average over 9 hours in cattle and 13 hours in pigs. No accumulation has been shown after several administrations.
Pharmacodynamic properties:
The active ingredient, ceftiofur sodium, is a third-generation cephalosporin (beta-lactam antibiotic) which acts against both gram-positive and gram-negative bacteria, including beta-lactamase producing bacteria. Also its main metabolite, desfuroylceftiofur, shows some antibacterial activity. Ceftiofur is a bactericidal antibiotic in vitro which acts by interfering with bacte