AMOXICILLIN 100-COLISTIN 250/ DOPHARMA injectable suspension of amoxicillin-colistin for cattle, pigs
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
1 ml of suspension contains:
Active substances:
Amoxicillin (as trihydrate) 100 mg
Colistin sulfate 250.000 I.U.
Excipients:
Benzyl alcohol
Butylhydroxytoluene
Propyl glycol
INDICATIONS
It is indicated for infections caused by bacteria susceptible to the combination of amoxicillin-colistin, e.g. infections of the respiratory, gastrointestinal tract, urinary and genital system.
CONTRAINDICATIONS
Do not administer to animals with hypersensitivity to penicillins and polymyxins.
Do not administer to animals that are not referred to indications.
Do not administer to animals with severe renal dysfunction.
Do not administer to neonates.
Its use is contraindicated to dairy cows.
ADVERSE REACTIONS
After intramuscular administration in cattle and pigs local irritation of the injection site might be observed. Prolonged administration of doses higher than the recommended one may result in renal damages, which are due to colistin and reversible neurological disorders.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
TARGET SPECIES
Cattle, Pigs
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
It is administered only intramuscularly.
The general dose is 10 mg amoxicillin (as trihydrate) and 25.000 I.U. colistin sulfate per kg of body weight. This dose is equivelant to1 ml of suspension per 10 kg of body weight once daily. The doses can be repeated for 3 days.
ADVICE ON CORRECT ADMINISTRATION
Large quantities (over 20 ml) should be injected in two different injection sites. Shake well before use.
WITHDRAWAL PERIOD
Cattle: Meat and offal: 40 days
Pigs: Meat and offal: 8 days
Do not administer to cows producing milk for human consumption.
SPECIAL STORAGE PRECAUTIONS
Store below 25o C.
Do not refrigerate or freeze.
Shelf-life after first opening of the immediate packaging: 30 days
SPECIAL WARNINGS
Avoid concurrent administration with fast-acting bacteriostatic antimicrobials (e.g. tetracyclines). Likewise, avoid concurrent administration with aminoglycosides. Do not mix nor dilute the product with water or other diluents.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental injection/ self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
People with known hypersensitivity to penicillins or to other antibiotics susceptible to beta-lactam, as well as to colistin, should avoid contact with the veterinary medicinal product.
It is recommended to use gloves and masks while handling the product, especially in cases of known hypersensitivity to penicillins.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
OTHER INFORMATION
PACKAGE
Glass vial of 100 ml
