Contraindications
Not to be administered to animals which are known to be hypersensitive to cephalosporin antibiotics or other ß-lactam antibiotics.
Not to be administered to cows with clinical mastitis.
Withdrawal periods
Meat and offal: 2 days
Milk: 1 day after calving when the dry period is more than 5 weeks. 36 days after treatment where the dry period is 5 weeks or less.
Special precautions for use
Special precautions for safe use in the target species:
Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal. If it is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Do not use the cleaning towel on teats with lesions.
In case of erroneous use during lactation the milk should be discarded for 35 days.
The efficacy of the veterinary medicinal product is only established against the pathogens mentioned in section "Uses”. Consequently, serious acute mastitis (potentially fatal) due to other pathogen species, mainly Pseudomonas aeruginosa, can occur after the drying off. Good hygienic practices should be thoroughly respected in order to reduce that risk; cows should be housed in a hygienic paddock far from the milking parlour and regularly checked several days after drying off.
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 sensitivity to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious.
Do not handle this veterinary medicinal product if you know you are sensitised to penicillins or cephalosporins, or if you have been advised not to work with such preparations.
Handle this veterinary medicinal product with great care to avoid exposure. Personal protective equipment consisting of impervious gloves should be worn when handling the veterinary medicinal product. Wash exposed skin after use.
If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the package leaflet or the label to the physician. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention. Persons developing a reaction after contact with the veterinary medicinal product should avoid handling the product (and other cephalosporin and penicillin containing products) in future.
Wash hands after using the towels and wear protective gloves if skin irritation due to isopropyl alcohol is known or suspected. Avoid contact with eyes because isopropyl alcohol can cause eye irritation.
Adverse Reactions
Cattle (dry cows):
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Hypersensitivity reaction |
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 the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy:
There is no evidence of reproductive toxicity (incl. teratogenicity) in cattle. Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
The veterinary medicinal product is intended for use during pregnancy. In the clinical trials, no adverse effects on the foetus were observed.
Lactation:
Do not use during lactation.
Interactions
See Further Information with regard to cross-resistance in the cephalosporin group.
The neutralising effect of bacteriostatic acting pharmaceuticals (macrolides, sulfonamides and tetracyclines) on bactericidal effect of cefquinome has not been evaluated yet. Therefore there is no information about the safety and efficacy of this kind of association.