Noroclav Intramammary Suspension for Lactating Cows

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:
This product may cause skin and eye irritation. Avoid contact with the skin and eyes.
In the event of skin or eye contact rinse with plenty of clean water.
The cleaning towels supplied with the product contain isopropyl alcohol, which may
cause skin or eye irritation in some people.
The wearing of gloves is recommended during administration of the product and
when handling the cleaning towels.
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, 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.
If you develop symptoms following exposure such as a skin rash, you should seek
medical advice and show the label or leaflet to the doctor.
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Swelling of the face, lips or eyes or difficulty with breathing, are more serious
symptoms and require urgent medical attention.
Wash hands after use.
Special precautions for the protection of the environment:
Due to the endocrine-disrupting potential of prednisolone, the product may be
dangerous to fish and other aquatic organisms. Consequently, treated animals
should not have access to watercourses during the first 12 hours after treatment.
3.6 Adverse events
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.
3.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy and lactation.
3.8 Interaction with other medicinal products and other forms of interaction
None known.
3.9 Administration routes and dosage
Intramammary use.
The syringe must only be used once. Partly emptied syringes due to the
unsuccessful use should be discarded.
The content of one syringe should be infused gently into the teat of the infected
quarter every 12 hours after each of three consecutive milkings.
Milk out the infected quarters. After thoroughly cleaning and disinfecting the teat and
teat orifice with the cleaning towels provided, gently infuse the contents of one
syringe into each affected quarter. Disperse the product by gentle massage of the
teat and udder of the affected animal.
In cases of infections caused by Staphylococcus aureus, a longer course of
antibacterial therapy may be required. Therefore overall treatment length must be at
the veterinarian’s discretion but should be long enough to ensure complete resolution
of intramammary infection.
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3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
No adverse reactions are to be expected from an accidental overdose.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary
medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Meat and offal: 7 days
Milk: 84 hours.