Revised: December 2018
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
Seclaris DC 250 mg Intramammary Suspension for dry cows [UK AT BG HR CY CZ
EE FR DE EL HU IE IT LV LT PL PT RO SK SI]
Seclaris Secado 250 mg Intramammary Suspension for dry cows [ES]
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each intramammary syringe of 3 g contains:
Cefalonium (as cefalonium dihydrate)
For the full list of excipients see section 6.1.
Shiny off-white to yellowish ointment.
Cattle (dry cow).
Indications for use, specifying the target species
For the treatment of subclinical mastitis at drying-off and the prevention of new
bacterial infections of the udder during the non-lactating period of cows caused by
Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae,
Streptococcus uberis, Trueperella pyogenes, Escherichia coli and Klebsiella spp
susceptible to cefalonium.
Do not use in animals with known hypersensitivity to cefalosporins, other ß-lactam
antibiotics or to any of the excipients.
Special warnings for each target species
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Revised: December 2018
Special precautions for use
Special precautions for use in animals
Use of the product should be based on susceptibility testing of bacteria isolated from
milk samples obtained from the udder quarter(s) of each cow to be dried off. If this is
not possible, therapy should be based on local (regional, farm level) risk based
epidemiological information about the expected pathogen challenge, and
susceptibility of target bacteria. Use of the product deviating from the instructions
given in the SPC may contribute to the development of bacterial resistance to
cefalonium which may also decrease the effectiveness of treatment with other beta
lactams. Dry cow therapy protocols should take local and national policies on
antimicrobial use into consideration, and undergo regular veterinary review.
The feeding to calves of milk containing residues of cefalonium that could select for
antimicrobial-resistant bacteria (e.g. ESBL) should be avoided up to the end of the
milk withdrawal period, except during the colostral phase.
The efficacy of the product is only established against the pathogens mentioned in
Section 4.2 “Indications for use”. Consequently, serious acute mastitis (potentially
fatal) due to other pathogen species, particularly Pseudomonas aeruginosa, can
occur after drying off. Good hygienic practices should be thoroughly respected in
order to reduce this risk.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Wash hands after use.
Penicillin and cefalosporins may cause sensitisation (allergy) following injection,
inhalation, ingestion or skin contact. Sensitivity to penicillin may lead to cross-
sensitivity to cefalosporin 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
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 breathing are more serious symptoms and require urgent medical attention.
The cleaning towels supplied with this product contain isopropyl alcohol, which may
cause skin or eye irritation in some people. It is recommended to wear protective
gloves when administering the product and handling the cleaning towels.
In very rare cases immediate hypersensitivity reactions were observed in some
animals (restlessness, tremors, swelling of mammary gland, eyelids and lips). These
reactions may lead to death.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals )
- rare (more than 1 but less than 10 animals in 10,000 animals)
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Revised: December 2018
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy, and lactation or lay
Intended for use during the last trimester of pregnancy once the lactating cow has
been dried off. There is no adverse treatment effect on the foetus.
Do not use in cows that are lactating.
Interaction with other medicinal products and other forms of interaction
Cefalosporins should not be administered concurrently with bacteriostatic
antimicrobials. Concomitant use of cefalosporins and nephrotoxic drugs may
increase renal toxicity.
Amounts to be administered and administration route
For intramammary use.
The contents of one syringe should be infused into the teat canal of each quarter
immediately after the last milking of the lactation. After milking is complete,
thoroughly clean and disinfect the end of the teat with the cleaning towel provided.
There are two options for administration of the product:
Option 1: For short nozzle intramammary administration
Hold the barrel of the syringe and the base of the cap in one hand and twist off the
small upper part of the cap above the indent mark (the base portion of the cap
remains on the syringe) Take care not to contaminate the nozzle.
Option 2: For full nozzle intramammary administration
Remove the cap fully by holding the barrel of the syringe firmly in one hand and with
the thumb push up and along the length of the cap until the cap clicks off. Take care
not to contaminate the nozzle.
Insert the nozzle into the teat canal and apply steady pressure on the syringe plunger
until the full dose has been delivered. Holding the end of the teat with one hand,
gently massage upwards with the other to aid dispersion of the antibiotic into the
quarter. After infusion it is advisable to dip the teats in an antiseptic preparation
specifically designed for this purpose.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Repeated doses in cattle on three consecutive days did not demonstrate or produce
any adverse effects.
4.11 Withdrawal period
Meat and offal: 21 days
Milk: 96 hours after calving if the dry period is longer than 54 days
58 days following the treatment if the dry period is less than or equal to 54 days
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Revised: December 2018
Pharmacotherapeutic group: other beta-lactam antibacterials for intramammary use,
first-generation cefalosporins.ATCvet Code: QJ51DB90
Cefalonium is an antibacterial drug of the first generation cefalosporin group which
acts by inhibition of cell wall synthesis (bactericidal mode of action).
Three mechanisms of resistance to cefalosporin are known: reduced permeability of
the cell wall, enzymatic inactivation and absence of specific penicillin binding sites. In
Gram-positive bacteria and particularly staphylococci, the main cefalosporin
resistance mechanism is through alteration of penicillin binding proteins. In Gram-
negative bacteria resistance may consist in the production of (broad- or extended-
Cefalonium is active against Staphylococcus aureus, Streptococcus agalactiae,
Streptococcus dysgalactiae, Streptococcus uberis, Trueperella pyogenes,
Escherichia coli and Klebsiella spp susceptible to cefalonium.
Cefalonium is extensively but slowly absorbed from the udder and excreted primarily
in the urine. Between 7 and 13% of the active substance is eliminated in urine on
each of the first three days post dosing whilst daily excretion in faeces is < 1% over
the same period.
Mean blood concentration remains fairly constant during approximately 10 days after
dosing which is consistent with slow but prolonged absorption of cefalonium from the
The long term persistence of cefalonium in the dry udder was examined over a time
span of 10 weeks after infusion. Effective levels of cefalonium in udder secreta
remained up to 10 weeks after infusion.
List of excipients
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
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Revised: December 2018
Special precautions for storage
Do not store above 25°C.
Nature and composition of immediate packaging
White polyethylene syringes with red polyethylene caps.
Cleaning towels (70% viscose/30% polyester, alcohol impregnated) in paper
aluminium copolymer laminate sachets.
20 intramammary syringes and 20 cleaning towels
72 intramammary syringes and 72 cleaning towels
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal products should be disposed of in accordance with local
MARKETING AUTHORISATION HOLDER
Ceva Animal Health Ltd
Unit 3, Anglo Office Park
White Lion Road
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION
13 December 2017
DATE OF REVISION OF THE TEXT
Approved: 05 December 2018
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