AMPIDEXALONE, suspension for injection for cattle, horses and pigs

AMPIDEXALONE 100 ML

AMPIDEXALONE, suspension for injection for cattle, horses and pigs.

DECLARATION OF ACTIVE SUBSTANCES AND OTHER SUBSTANCES:
Each ml of product contains:
Active substances:
Ampicillin (as trihydrate) …… 87.0 mg
Colistin (as sulfate) …… 250,000 IU
Dexamethasone…… 0.25 mg
Excipients:
Methyl parahydroxybenzoate (E218) ……. 1.25 mg
Propyl parahydroxybenzoate (E216) …… 0.25 mg
Oily, slightly yellowish suspension.

TARGET SPECIES:
Cattle, horses, pigs.

INDICATION(S):
Cattle, horses, pigs:
– in the treatment of infections caused by microorganisms sensitive to ampicillin and colistin (gastrointestinal infections, respiratory and urinary tract infections).
– in preventive treatment in groups of animals where the disease has been diagnosed.

CONTRAINDICATIONS:
Do not use in the second half of gestation.
Do not use for rabbits and rodents.
Do not use in case of known hypersensitivity to the active substances or to any of the excipients.
It is not administered intravenously.

SIDE EFFECTS
Penicillins and cephalosporins may cause hypersensitivity reactions (anaphylaxis) after administration.
Allergic reactions to these substances can occasionally be serious.
The use of corticosteroids in lactating cattle may induce a temporary decrease in milk production.

DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION:
It is administered to cattle, pigs and horses intramuscularly, subcutaneously and intraperitoneally.

1 ml of product per 10 kg of body weight, every 12 hours, for 3 consecutive days.
Shake the bottle vigorously before use.
To ensure the appropriate dose, the body weight of the animals should be calculated as accurately as possible to avoid underdosing of the product.

RECOMMENDATIONS ON CORRECT ADMINISTRATION:
In intramuscular injection, the amounts administered at a single point should be moderate so as not to injure or damage the histological and anatomical structures. Shake the bottle vigorously before use.

WAITING TIME:
Meat and offal: 21 days.
Milk: 9 milkers (4.5 days).

SPECIAL WARNING(S), AS APPLICABLE:
Special Warnings:
In intramuscular injection, the amounts administered at a single point should be moderate so as not to injure or damage the histological and anatomical structures.
Special precautions for safe use in target species:

The use of the product must be based on the result of susceptibility tests of bacteria isolated from the field. If this is not possible, treatment should be carried out on the basis of local epidemiological information (region, farm) regarding the susceptibility of the target bacteria. Official and local antimicrobial policies should be taken into account when using the product. Use of the product outside the instructions in the SmPC may increase the prevalence of resistance to active substances and may decrease the effectiveness of treatments as a result of cross–resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
People with known hypersensitivity to active substances should avoid contact with the veterinary medicinal product. Measures will be taken to avoid accidental self–injection. In case of accidental self-injection, seek the advice of your veterinarian immediately and present the label and package leaflet. Wash your hands thoroughly after treatment.
Gestation:
Do not use in the second half of gestation.
Interaction with other medicinal products and other forms of interaction:
The bactericidal effect of ampicillin is neutralized when molecules with bacteriostatic effect are used concomitantly (macrolides, sulfonamides and tetracyclines). Corticosteroids can reduce the immune response to vaccination, do not use concomitantly with vaccines.
Incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products.

SPECIAL STORAGE CONDITIONS:
Keep out of sight and reach of children.

Do not store at a temperature higher than 25 DEGREES.
Store the bottle in the outer carton to protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and bottle.
The expiration date refers to the last day of that month.
Shelf life after the first opening of the bottle: 28 days.

DIMENSION:
Bottle x 100 ml.