STREPTOPEN

COMPOSITION

Each mL of product contains 200 mg of procaine benzylpenicillin and 250 mg of Dihydrostreptomycin sulfate

TARGET SPECIES

Cattle, horses, sheep, pigs  

INDICATIONS

For the treatment of systemic infections in cattle, horses, sheep, and pigs caused by or associated with microorganisms susceptible to penicillin and/or streptomycin, including: Arcanobacterium pyogenes, Erysipelothrix rhusiopathiae, Klebsiella pneumonia, Listeria spp, Pasteurella haemolytica, Pasteurella multocida, Staphylococcus spp (that do produce penicillinase), Streptococcus spp and Salmonella spp. and to combat bacterial secondary infections caused by microorganisms susceptible to this combination, associated to primary viral infections.

CONTRAINDICATIONS

Do not use in sheep whose milk is intended for human consumption. Do not use in horses whose meat is intended for human consumption. Do not use in case of hypersensitivity to the active substances or to any of the excipients.

ADVERSE REACTIONS

Sometimes, in piglets and gruntling, administration of this product may cause transient pyrexia, vomiting, trembling, restlessness, and lack of coordination. If signs of adverse reactions or other effects not mentioned in this leaflet are noted, please inform your vet.

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

Shake the vial before use. Administer by deep intramuscular injection. The recommended daily dose is 8 mg procaine benzylpenicillin and 10 mg dihidrostreptomycin sulfate/kg body weight, equivalent to 1 mL Streptopen/25 kg body weight. Treatment shall be administered for 3 consecutive days. 

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

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

The maximum volume administered in one place shall not exceed 15 mL for horses, 6 mL for cattle, 3 mL for sheep and 1.5 mL for pigs.

WITHDRAWAL PERIOD(S)

Cattle (meat and offal) 21 days

Cattle (milk) 48 hours

Sheep (meat and offal) 28 days

Sheep (milk) milk from treated animals shall not be used for human consumption.

Pigs (meat and offal) 18 days

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. Do not refrigerate. Do not use after the expiry date printed on the label. 

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

The use of the product should be based on the results of susceptibility testing of isolated bacteria 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. In pregnant sows and gilts, vulvar discharge has been observed which may be associated with abortion.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Do not administer concomitantly with tetracyclines or other aminoglycosides.

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. 

PRESENTATION/PACKAGE

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