Target species
Cattle (lactating cow)
Indications for use
Treatment of clinical mastitis caused by penicillin susceptible streptococci or staphylococci occurring during the lactation phase.
Contra-indications
Do not use in cases of hypersensitivity to the active substances, to substances of the β-lactam group or to any of the excipients.
Do not use in cases of infections with β-lactamase-forming pathogens.
Special warnings for each target species
If the product is used in treatment of mastitis caused by Staphylococcus aureus, an appropriate parenteral antimicrobial may be required.
Special precautions for use in animals
Use of the product should be based on identification and 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, national and regional antimicrobial policies should be taken into account when the product is used. In some geographical areas or in some individual herds resistance to penicillin in S. aureus is widespread.
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 lactam antimicrobials (penicillins and cephalosporins) due to the potential for cross-resistance.
The feeding of waste milk containing residues of antimicrobials to calves should be avoided up to the end of the milk withdrawal period (except during the colostral phase), because it could select for antimicrobial-resistant bacteria within the intestinal microbiota of the calf and increase the faecal shedding of these bacteria.
The cleaning towel should not be used in presence of teat injuries.
Care must be taken when applying the product in case of severe udder quarter swelling, milk duct swelling and/or congestion of detritus in the milk duct.
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 in case of hypersensitivity to penicillins or cephalosporins or if you have been advised not to work with such preparations.
∙ Handle this product with great care to avoid exposure taking all recommended precautions.
∙ Persons handling or administering the veterinary medicinal product should wear appropriate disposable gloves. Avoid contact with the eyes. Wash exposed skin after use. In case of eye contact, wash the eyes thoroughly with copious amounts of clean running water.
∙ If you develop symptoms following exposure such as a skin rash, you should seek medical advice immediately and show the package leaflet or the label to the physician. Swelling of the face, lips or eyes or difficulty with breathing, are more serious symptoms and require urgent medical attention.
The cleaning towels provided contain isopropyl alcohol, which may be irritating to skin and eyes. It is recommended that disposable gloves are also worn when using the cleaning towels. Wash hands after use.
Adverse reactions
Hypersensitive reactions to penicillin or procaine have been reported very rarely on post marketing safety experience and may include symptoms like oedema, dermatological changes such as urticaria, angio-oedema or erythema and anaphylactic shock.
In case adverse reactions occur, the current treatment should be withdrawn and symptomatic treatment should be initiated.
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
Can be used during pregnancy, but not during the dry period.
Interactions
Do not combine with bacteriostatic agents. Tetracyclines, macrolides, sulphonamides, lincomycin or tiamulin may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action.
Amounts to be administered and administration route
Intramammary use.
Infuse the contents of one intramammary syringe (equivalent to 600 mg benzylpenicillin procaine monohydrate) per affected udder quarter once daily after milking. The treatment is continued for 3-5 days.
Parenteral therapy may also be required depending upon the clinical presentation.
Clean and disinfect the end of the teat and teat orifice thoroughly before applying the product. Remove the cover of the tip and infuse the product gently into the teat. The intramammary syringe has a double tip. It is recommended to remove only the outer cover, revealing a tip about 5 mm long. Using the shorter tip reduces the mechanical irritation of the teat canal when the veterinary medicinal product is applied (partial insertion). If the inner cover is removed as well, a tip of about 20 mm is revealed. This can be used only exceptionally to facilitate infusion, for instance to a teat with pronounced oedema (full insertion). The partial insertion technique is preferred, whenever achievable. After infusion, the quarter is massaged so that the drug is evenly distributed.
Overdose
Not applicable.
Withdrawal periods
Milk: 6 days.
Meat and offal: 3 days.