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Clinical particulars
Target species
Cattle (lactating cows).
Indications for use
Treatment of clinical and subclinical mastitis in lactating cows caused by staphylococci and streptococci, susceptible to penicillin.
Do not use in cases of known hypersensitivity to the active substance, or to any of the excipients.
Do not administer by intravenous injection.
Special warnings for each target species
Cross-resistance has been shown between benzylpenicillin and penicillins and beta-lactam antimicrobials in staphylococci and streptococci. Use of benzylpenicillin should be carefully considered when susceptibility testing has shown resistance to penicillins or beta-lactam antimicrobials because its effectiveness may be reduced.
Special precautions for use in animals
Use of the product should be based on identification and susceptibility testing of the target pathogens. If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level.
Use of the product should be in accordance with official, national and regional antimicrobial policies.
The feeding of waste milk containing residues of penicillin 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 (e.g. ESBL) 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
This veterinary medicinal product can cause sensitisation and contact dermatitis.
Hypersensitivity to penicillins may lead to cross reactions to cephalosporins, and vice versa.
Allergic reactions to these substances may occasionally be serious.
Handle this product with great care to avoid direct skin contact or self-injection.
People with known hypersensitivity to penicillin should avoid contact with the veterinary medicinal product.
Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product.
Wash hands after use.
In case of accidental contact with the skin, wash immediately with plenty of water. If symptoms following exposure such as skin develop or in case of accidental self-injection, 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.
Adverse reactions
Cattle (lactating cows):
Very rare (<1 animal / 10,000 animals treated, including isolated reports):
Urticaria, Anaphylactic shocka , deatha . Sensitisation against penicillins.
Undetermined frequency (cannot be estimated from the available data):
Skin reactions (mild), such as dermatitis
aAnaphylactic shock can be fatal, very rarely.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.
Use during pregnancy and lactation
Can be used during pregnancy or lactation.
The veterinary medicinal product should not be administered concurrently with bacteriostatic antibiotics.
Amounts to be administered and administration route
Shake well before use.
For intramuscular administration only, preferably in the neck.
Administer alternately on the left and the right side.
Administer 10-15 mg penethamate hydriodide per kg body weight per day, once daily for 3 consecutive days, corresponding to 2.5-3.75 ml of the veterinary medicinal product per 100 kg body weight per day, once daily for 3 consecutive days.
Avoid underdosing. To ensure a correct dosage, body weight should be determined as accurately as possible.
In case of overdose, no adverse effects other than those mentioned in Adverse reactions are to be expected.
Withdrawal periods
Milk: 4 days.
Meat and offal: 10 days.