Dermipred 5 mg Tablets for Dogs

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 veterinary medicinal 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 veterinary medicinal product contain isopropyl
alcohol, which may cause skin or eye irritation in some people.
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The wearing of gloves is recommended during administration of the veterinary
medicinal 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 veterinary medicinal product if you know you are sensitised, or if
you have been advised not to work with such preparations.
Handle this veterinary medicinal 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 doctor this warning.
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 veterinary medicinal
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
Cattle (lactating 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 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.
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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 veterinary medicinal 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.
Combined therapy for the treatment of bovine mastitis. In the situation where
systemic treatment as well as intramammary treatment is necessary, especially in
cases of serious clinical mastitis Combiclav Injection can be administered in
combination with this product.
For combined therapy the following minimum treatment regime should be followed:
Potentiated Penicillin InjectionPotentiated Penicillin Intramammary
Suspension for Lactating Cows
Intramuscular injection at a dose rate of
8.75 mg/kg bodyweight (7,0 amoxicillin
and 1,75 mg clavulanic acid) which
corresponds to 1 mL of veterinary
medicinal product/20 kg bodyweight
daily for 3 days as follows:
8.75 mg/kg bodyweight (7.0 mg
amoxicillin, 1.75 mg clavulanic acid) i.e.
1 mL/20 kg bodyweight
24 hours
8.75 mg/kg bodyweight (7.0 mg
amoxicillin, 1.75 mg clavulanic acid) i.e.
1 mL/20 kg bodyweight
24 hours
8.75 mg/kg bodyweight (7.0 mg
amoxicillin, 1.75 mg clavulanic acid) i.e.
1 mL/20 kg bodyweight
Where necessary Potentiated Penicillin
Injection may be administered for an
additional two days for a total of 5 daily
injections
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 as
follows:
One syringe gently infused into the teat
of the infected quarter
12 hours
One syringe gently infused into the teat
of the infected quarter
12 hours
One syringe gently infused into the teat
of the infected quarter
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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.
Combined Therapy:
When using this product and Combiclav Injection in combination:
Meat and offal: 42 days
Milk: 84 hours
From the last treatment of Combiclav Injection, following the minimum posology
regime.