CLAMOX RTU inj

COMPOSITION

Each mL of product contains 140 mg amoxicillin (as amoxicillin trihydrate) and 35 mg clavulanic acid (as potassium clavulanate).

TARGET SPECIES

Cattle, pigs, dogs and cats.

INDICATIONS

The product is indicated in cattle, pigs, dogs and cats for the treatment of infections caused by germs susceptible to the action of the active substances.

Cattle - Respiratory infections, soft tissue infections (abscesses, arthritis), metritis and mastitis.

Pigs - Respiratory infections. Colibacilosis.

Dogs and cats - Urinary tract infections, respiratory tract infections, skin and soft tissue infections (abscesses, pyoderma, perianal abscess, gingivitis).

CONTRAINDICATIONS

Do not use in cases of hypersensitivity to the active substance or to any of the excipients. The product should not be administered to rabbits, Guinea pigs or hamsters. Administer with caution to other small herbivores.

ADVERSE REACTIONS

Occasionally, the product may cause reactions at the injection site and/or local tissue reactions.

DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION

It can be administered subcutaneously or intramuscularly to dogs and cats and intramuscularly to cattle and pigs. The dose is 8.75 mg/kg body weight equivalent to 1 mL of product/20 kg body weight with 24-hour repeat, for 3 to 5 days.

The vial must be well shaken before use. After injection, the injection site will be massaged. Use a completely dry sterile syringe and needle. Combined therapy for the treatment of mastitis in cattle: If a general treatment is needed in addition to the intramammary treatment, Clamx RTU may be used in combination with Clamox LC.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

To ensure proper dosing and to avoid underdosing, animal body weight should be determined as accurately as possible.

WITHDRAWAL PERIOD(S)

Cattle (meat and offal) 28 days
Pigs (meat and offal) 19 days
Milk 48 hours

In the case of combined therapy, milk will be consumed 60 hours after the last treatment (after 5 milking times, if the cows are milked twice a day).

SHELF LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf-life after first opening the immediate packaging: 28 days.

SPECIAL PRECAUTIONS FOR STORAGE

Do not store above 25 °C. Keep away from light.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

The use of the product should be based on antimicrobial susceptibility testing of bacteria isolated from animals. If this is not possible, therapy should be based locally on epidemiological information on the target bacteria’s susceptibility. Using the product in violation of the instructions provided in the SmPC may increase the prevalence of resistant bacteria and may decrease treatment effectiveness due to their cross-resistance potential.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

Penicillins and cephalosporins may produce hypersensitivity (allergy) reactions after self-injection, inhalation, ingestion or skin contact. Penicillin hypersensitivity may be associated with cross-sensitivity to cephalosporins and vice versa. Occasionally, the allergic reactions to these substances can be serious. In the case of accidental injection, seek advice from a doctor, presenting the package leaflet or product label. In case of accidental contact with skin, wash with water and soap. Handle this product with great care to prevent exposure and take all precautions. Do not handle this product if you know you are a person exhibiting sensitivity to it or have been warned not to handle such preparations. Handle this product with great care to prevent exposure and take all precautions. If symptoms occur following exposure to this product, such as itchiness, you should immediately see a doctor and present this warning. Swelling of the face, lips or eyes or difficulty breathing are more serious symptoms and require immediate medical attention.

USE DURING PREGNANCY AND LACTATION

The product can be used in pregnant or lactating animals.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Do not administer concomitantly with incompatible bacteriostatic antibiotics.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Amoxicillin has low toxicity and is well tolerated in the case of parenteral administration. Except for occasional local reactions at the site of administration, which may even occur at the recommended dose, no other adverse effects have been observed even in case of accidental administration of an overdose.

INCOMPATIBILITIES

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

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Medicines should not be disposed of via waste water or household waste.

PRESENTATION/PACKAGE

50 mL, 100 mL, 250 mL and 500 mL high-density polypropylene vials sealed with bromobutyl rubber stopper and aluminium cap.