Target species
Cattle (lactating cows)
Indications for use, specifying the target species
Treatment of mastitis in lactating cows caused by Streptococcus uberis, Streptococcus dysgalactiae, Streptococcus agalactiae and Staphylococcus aureus (beta-lactamase non-producing), sensitive to penicillin.
Contraindications
Do not use in cases of hypersensitivity to penicillins, cephalosporins, and/or any of the excipients.
Do not administer intravenously.
Do not administer to animals with renal disease including anuria or oliguria.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.’
Official and local antimicrobial policies should be taken into account when the product is used.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to benzylpenicillin and may decrease the effectiveness of treatment with other beta-lactams due to the potential for cross-resistance.
Using penethamate hydriodide for the treatment of mastitis must be accompanied by hygienic measures to prevent reinfection.
The feeding of waste milk containing penicillin residues to calves should be avoided up to the end of the milk withdrawal period (except during the colostral phase), because it could select antimicrobial-resistant bacteria within the intestinal microbiota of the calf and increase the faecal shedding of these bacteria.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.
Do not handle this product if you know you are sensitised to penicillins or any of the excipients, or if you have been advised not to work with such preparations.
Handle the product with great care to avoid exposure, taking all recommended precautions.
If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the Doctor this warning. Swelling of the face, lips or eyes or difficulty breathing are more serious symptoms and require urgent medical attention.
Care should be taken to avoid accidental self‐injection and contact with the skin. In case of accidental self‐injection, seek medical advice immediately.
Wash hands after use.
Adverse reactions (frequency and seriousness)
Animals may experience discomfort or pain upon administration of the product. Minimal swelling, which should resolve without treatment, may be observed at the injection site after administration of the product.
In very rare cases anaphylactic shock may occur, which can be fatal.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
Pregnancy:
Can be used during pregnancy.
Lactation:
Can be used during lactation.
Interaction with other medicinal products and other forms of interaction
Penicillins should not be administered concurrently with bacteriostatic antibiotics.
Amounts to be administered and administration route
For intramuscular use.
Reconstitution: Reconstitute the suspension by using a suitably scaled syringe to add exactly 15 ml solvent to the contents of the 5 g powder vial OR exactly 30 ml solvent to the contents of the 10 g powder vial, giving reconstituted volumes of 18 ml and 36 ml respectively. Once broached, the solvent vial with any residual solvent must be discarded.
Use only 5 g vial with 15 ml diluent and 10 g vial with 30 ml diluent to provide the correct dose.
Shake well after reconstitution and before each use.
Dosage:
The dose is 15 mg penethamate hydriodide per kg bodyweight.
This is equivalent to 5.4 ml of the reconstituted suspension per 100 kg bodyweight.
Shake well before administration.
The injection should be repeated with a time interval of 24 hours for 4 consecutive days in total.
The injection site volume should not exceed a maximum of 20 ml per injection site.
To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid under-dosing.
Overdose (symptoms, emergency procedures, antidotes), if necessary
None known.
Withdrawal period(s)
Meat and offal: 10 days
Milk: 96 hours