Mastiplan LC, 300 mg/20 mg (Cefapirin/Prednisolone), Intramammary Suspension for Lactating Cows

phase), because it could select antimicrobial-resistant bacteria within the intestinal
microbiota of the calf and increase the faecal shedding of these bacteria.
Use of the product deviating from the instructions given in the SPC may increase the
prevalence of bacteria resistant to the cefapirin and may decrease the effectiveness
of the treatment.
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.
People with known hypersensitivity to cephalosporins, penicillins or prednisolone should
avoid contact with the veterinary medicinal product.
Handle this product with care to avoid exposure, taking all recommended precautions.
If you develop symptoms following exposure, such as skin rash, you should seek
medical advice immediately and show the package leaflet or the label to the physician.
Swellings of the face, lips or eyes or difficulty breathing are more serious symptoms and
require urgent medical attention.
Wash hands after using the cleaning towels and wear protective gloves if skin irritation
due to isopropyl alcohol is known or suspected.
Special precautions for the protection of the environment:
Not applicable.
4.6 Adverse reactions (frequency and seriousness)
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

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either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See also ‘Contact details’ of
the package leaflet.
4.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
The veterinary medicinal product is intended for use during lactation.
Laboratory studies in mice, rats, rabbits, and hamster have not produced any
evidence of a teratogenic, foetotoxic, maternotoxic effects.
Because no specific studies have been performed in the target animal species, use
only according to the benefit/risk assessment by the responsible veterinarian during
pregnancy and in breeding animals.
4.8 Interaction with other medicinal products and other forms of interaction
The concurrent use with bacteriostatic antibiotics may cause antagonistic effects.
The concurrent use of parenteral aminoglycosides or other nephrotoxic drugs is not
recommended.
4.9 Amount(s) to be administered and administration route
For intramammary use:
The contents of one syringe should be infused into each affected quarter via the teat
canal, immediately after milking, at 12 hour intervals for four consecutive milkings.
Each syringe contains 300 mg cefapirin and 20 mg prednisolone. The syringe must
only be used once for one teat.
Before infusion, the udder should be milked out completely. The teat and its orifice
should be thoroughly cleaned and disinfected with the cleaning towel provided (A).
Care should be taken to avoid contamination of the syringe nozzle. Break the top of
cap and gently insert either about 5 mm (B) or remove whole cap and gently insert
the total length of the nozzle (C) into the teat canal. Infuse the total content of the
syringe into the quarter.
Disperse the product by gentle massage of the teat and the udder of the affected
cow.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
None known.
4.11 Withdrawal period(s)
Meat and offal: 4 days (96 hours)
Milk: 5.5 days (132 hours)

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5.