Rilexine DC 375 mg Intramammary Suspension for Dry Cows

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 reaction to these
substances may occasionally be serious.
People with known hypersensitivity to penicillins or cephalosporins, or who have
been advised not to work with penicillin or cephalosporin preparations, should avoid
contact with the veterinary medicinal product.
Handle this veterinary medicinal product with great care to avoid exposure. Wear
gloves during administration of the veterinary medicinal product and wash hands
after use.
In case of accidental contact with skin or eyes, wash immediately with clean water.
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If you develop symptoms following exposure, such as a skin rash, 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.
Those developing a reaction after contact with the veterinary medicinal product
should avoid handling the product (and other cephalosporin and penicillin
containing products) in future.
The cleaning towels supplied with the veterinary medicinal product contain
isopropyl alcohol, which may cause skin or eye irritation in some people. The
wearing of gloves is recommended during the administration of the veterinary
medicinal product and when handling the cleaning towels.
Special precautions for the protection of the environment:
Not applicable.
3.6
Adverse events
Cattle (dry cows):
Rare
(1 to 10 animals /
10,000 animals
treated):
Allergic reaction
(Agitation, Trembling,
Mammary gland oedema, Swollen eyelid,
Swollen lip)
Immediate, can lead to death in certain animals.
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.
3.7
Use during pregnancy, lactation or lay
Pregnancy:
The veterinary medicinal product is intended for use during pregnancy. The safety
of the veterinary medicinal product has not been established during pregnancy in
specific target animal safety studies.
However, no adverse effects on the foetus were observed in the clinical trial.
Moreover, as the quantities of cephalexin absorbed by the intramammary route
are low, the use of this medication during pregnancy does not present any
particular problem.
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Lactation:
Do not use during lactation of lactating dairy cows.
3.8
Interaction with other medicinal products and other forms of interaction
The safety of concomitant use of the veterinary medicinal product and other
intramammary products has not been established, simultaneous use is
discouraged.
Do not use simultaneously with bacteriostatic antibiotics.
3.9
Administration routes and dosage
Intramammary use.
375 mg of cefalexin (equivalent to 500 mg of cefalexin benzathine) i.e. the content of
one syringe should be infused one into each quarter via the teat canal immediately
after the last milking of the lactation.
Milk out thoroughly before starting administration. Before administering the veterinary
medicinal product, the teats should be thoroughly cleaned and disinfected using the
provided cleaning towel, and care should be taken to avoid contamination of the
syringe nozzle. Administer the full content of a syringe in each quarter. Massage
after administration. After administration it is recommended to immerse the teat in
an approved disinfectant bath. Do not milk after treatment.
3.10
Symptoms of overdose (and where applicable, emergency procedures
and antidotes)
See section 3.