Cephaguard IV IM 4.5% powder and solvent for solution for injection

Presentation

Powder and solvent for solution for injection

1 vial with powder contains:

30 ml vial:          1.35 g cefquinome (as sulphate)

100 ml vial:        4.5 g cefquinome (as sulphate)

1 ml solvent contains:

Preservative: Benzyl alcohol 10 mg

Each ml of the reconstituted solution contains:

Active substance:

Cefquinome (as sulphate)           45 mg

Excipient:

Benzyl alcohol                           10 mg

Uses

For use in horses (adult and foal) for the treatment of:

-           Respiratory diseases in horses caused by Streptococcus equi  subsp. zooepidemicus.

-           Severe bacterial infections with a high risk of septicaemia in foals in which Escherichia coli  is involved.

Dosage and administration

Reconstitute the solution for injection by adding the whole content of the solvent vial. After reconstitution, shake the vial well before use. Do not use another solvent (e.g. water for injection).  Swab the rubber stopper before removing each dose. Use a dry sterile needle and syringe. An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. The rubber stopper may be punctured up to 20 times.

             * If no response is seen in 3-4 days, the diagnosis should be redetermined. 

All treatments should be given by intravenous or intramuscular injections. It is recommended to administer the product into different injection sites. In foals, it is recommended to start the treatment with intravenous injections for 3 days and to follow with intramuscular injections.

To ensure the correct dosage and to avoid possible underdosing, the bodyweight should be determined as accurately as possible.

Contra-indications, warnings, etc.

Do not use in animals which are known to be hypersensitive to cephalosporin antibiotics or other β-lactam antibiotics.

The safety of Cephaguard IV has not been determined in horses intended for breeding. There is no information on reproductive toxicity (incl. teratogenicity) in horses. Laboratory studies in rats and rabbits have not shown any teratogenic, foetotoxic or maternotoxic effects.  Use only according to the benefit/risk assessment by the responsible veterinarian.

Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.

Inappropriate use of the product may increase the prevalence of bacteria resistant to cefquinome and may decrease the effectiveness of treatment with cephalosporins, due to the potential for cross-resistance. Hypersensitivity reactions to cephalosporins occur rarely. Occasionally slight transient reactions may occur at the injection site.

Operator warnings:

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross- sensitivity to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

1. Do not handle this product if you know you are sensitised, or if you have been    advised not to work with such preparations.
   
2. Handle this product with great care to avoid exposure, taking all recommended precautions.
   
3. 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. 
   
   In case of accidental contact with eyes, rinse immediately with copious amounts              of water. Accidental spillage on the skin should be washed off immediately with          soap and water. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Withdrawal period:

Meat: 4 days

Not to be used in lactating mares producing milk for human consumption.

FOR ANIMAL TREATMENT ONLY.  KEEP OUT OF REACH AND SIGHT OF CHILDREN.

Pharmaceutical precautions

This veterinary medicinal product does not require any special storage conditions.

After dilution or reconstitution the product may be stored for 10 days when kept in a refrigerator (+2°C to + 8°C).   The date for discarding any unused product should be calculated and recorded on the space provided on the carton and vial label.   After this time, product remaining in the container should be discarded.

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

In the absence of compatibility studies, this veterinary medicinal product must not be mixed         with other veterinary medicinal products.

Legal category

POM-V                        To be supplied only on veterinary prescription.

Package quantities

Box of one 30 or 100 ml powder vial, packed with respectively one 30 or 100 ml solvent vial.    Packs of 5 or 10 units of either 30 or 100 ml powder and solvent vials.

Not all pack sizes may be marketed. 

Further information 

Nil.

Marketing Authorisation number

01708/4522                  UK authorised veterinary medicinal product.

Marketing Authorisation holder
Intervet UK Ltd.

Walton Manor

Walton

Milton Keynes

Bucks MK7 7AJ

Date of text preparation 

August 2006.

                                                                                                 75093^.August2006/MP/