Depomycin, benzylpenicillin procain 200 mg/ml and dihydrostreptomycin 200 mg/ml

DEPOMYCIN

Depomycin, injectable suspension for cattle, pigs, sheep, horses, dogs and cats.

COMPOSITION:
Active substances:
Procaine benzylpenicillin 200 mg/ml
(corresponding to 200,000 IU procaine benzylpenicillin)
Dihydrostreptomycin 200 mg/ml
(corresponding to 278.9 mg/ml dihydrostreptomycin sulfate/ml)
Excipients:
Sodium formaldehyde sulfoxylate
Methyl parahydroxybenzoate (E2l8)

INDICATIONS:
It is indicated for the treatment of infections caused by the following pathogenic germs: Staphylococcus aureus, Streptococcus dysgalactiae, Streptococcus uberis and Escherichia coli (such as penicillin-sensitive staphylococci, streptococci, Pasteurella spp., Clostridium spp., Salmonella spp., Haemophilus paragallinarum and E.coli) and against penicillin-sensitive Actinobacillus pleuropneumoniae, Arcanobacterium pyogenes, Bordetella bronchiseptica, Erysipelothrix rhusiopathiae, Streptococci suis, Staphylococci, Streptococci, Pasteurella spp., Salmonella spp. and E.coli.
It is used for the treatment of infections caused by these germs in the respiratory, gastrointestinal, genital tract, in meningitis, arthritis, skin infections, caused by/or associated with bacteria sensitive to penicillin and/or dihydrostreptomycin, in cattle, pigs, sheep, horses, dogs and cats.

CONTRAINDICATIONS:
Do not use in animals known to be allergic to penicillin or dihydrostreptomycin. Do not use if β-lactamase producing microorganisms are known to be present.

ADVERSE REACTIONS:
Allergic reactions have occasionally been observed. Ototoxicity has been described. In pigs, administration of products containing procaine benzylpenicillin may occasionally cause transient pyrexia, vomiting, tremors, apathy and incoordination. In pregnant sows and gilts, in a small number of cases, vulvar discharge has been reported which may be associated with abortions.

If you notice any serious reactions or other effects not mentioned in this leaflet, please inform your veterinarian.

TARGET SPECIES:
cattle, pigs, sheep, horses, dogs and cats.

ADMINISTRATION METHOD:
Cattle and horses: 1 ml Depomycin/25 kg b.w., intramuscularly.
Pigs and sheep: 1 ml Depomycin/20 kg b.w., intramuscularly.
Dogs and cats: 1 ml Depomycin/10 kg b.w., intramuscularly or subcutaneously.
Injections may be repeated at 24-hour intervals, up to 3 consecutive days, depending on the clinical situation.

RECOMMENDATIONS ON CORRECT ADMINISTRATION:
Repeated injections should be performed at different sites. The usual aseptic precautions should be observed when administering the product. Shake vigorously before use.

WITHDRAWAL TIME:
Meat: 14 days. Organs: 21 days (cattle, pigs); 35 days (sheep).
Cow’s milk: 3 days (6 milkings).
Do not administer to horses intended for human consumption. Do not administer to lactating sheep producing milk for human consumption.

SPECIAL STORAGE PRECAUTIONS:
Keep out of the sight and reach of children. Store in a refrigerator at 20C – 80C. Do not use after the expiry date stated on the carton or bottle label.
Shelf life after first opening the immediate packaging: 28 days.

SPECIAL WARNINGS:
Special warnings for each target species:
Use with caution in animals with known kidney disease or renal dysfunction. Do not exceed the recommended dose and treatment period.
Special precautions for use in animals:

Due to the variability (temporal, geographical) in bacterial susceptibility when using the product, it is recommended to collect bacteriological samples and perform susceptibility testing on microorganisms isolated from diseased animals. If this is not possible, treatment should be based on local epidemiological information (region, farm) regarding the susceptibility of the target bacteria. Use of the product deviating from the instructions in the SPC may increase the prevalence of resistance to the active substance and may decrease the effectiveness of the treatment due to the potential for cross-resistance. Official and local antimicrobial policies should be taken into account when using the product.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label. People with known hypersensitivity to antibiotics/β-lactams should avoid contact with the veterinary medicinal product.
Use during pregnancy and lactation:
Can be used during lactation.

Interactions with other medicinal products or other forms of interaction:
Antagonism may occur between Depomycin and bacteriostatic products. Bacterial resistance may re-emerge with cross-resistance to other antibiotics/β-lactams. Synergism with other bactericidal products has been shown.
Overdose:
Double the recommended dose of Depomycin was well tolerated systemically.
Incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY:
Medicinal products should not be disposed of via wastewater or household waste. Ask your veterinarian or pharmacist for information on how to dispose of medicines no longer required. These measures will help to protect the environment.

SIZE:
100 ml and 250 ml bottle