Cepravin Dry Cow 250 mg Intramammary Suspension

The efficacy of the veterinary medicinal product has only been established against
pathogens sensitive to the active substance. Consequently, serious acute mastitis
(potentially fatal) due to other pathogen species, particularly Pseudomonas
aeruginosa, can occur after drying-off. Good hygiene practices should be thoroughly
respected in order to reduce this risk.
Do not bend the nozzle.
Do not contaminate the nozzle
If calving occurs before 54 days after treatment, the absence of antibiotic should be
confirmed by testing before the milk is used for human consumption. Milk for human
consumption may be taken after 54 days plus 96 hours after treatment.
In cows suffering from hypocalcaemia it may be necessary to discard milk for a longer
period.
If the veterinary medicinal product is used in heifers during their first pregnancy the
same precautions should be observed as in cows, i.e. infusions should be given not
less than 54 days before calving and milk discarded for the statutory four days after
calving.
Summer Mastitis - It is unlikely that antibiotic treatment alone will control Summer
Mastitis and therefore other measures should be implemented as part of routine
management. These measures include:
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with Summer Mastitis.
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infusions for the disease.
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avoid having animals at risk during the summer months.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Penicillins and cephalosporins may cause sensitisation (allergy) following injection,
inhalation, ingestion or skin contact. Hypersensitivity to penicillin 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 package leaflet or the label to the physician. Swelling of
the face, lips or eyes or difficulty breathing are more serious symptoms and require
urgent medical attention.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Cattle (dairy cows at drying-off):
None known.
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:
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.
Not to be used in cows that are lactating.
3.8 Interaction with other medicinal products and other forms of interaction
None known.
3.9 Administration routes and dosage
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. Before infusion, the teat should be
thoroughly cleaned and disinfected. Avoid contamination of the nozzle after removing
the cap. After infusion it is advisable to dip the teats in an antiseptic preparation
specifically designed for this purpose.
After milking is complete thoroughly clean and disinfect the end of the teat with the
cleaning towel provided.
Option 1: For short nozzle intramammary administration
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 short, exposed part of 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 and 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.
Finally immerse the teats in a teat dip.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
Repeated doses in cattle on three consecutive days did not demonstrate or produce
any adverse effects.
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: 21 days after last treatment.
Milk: Milk for human consumption may only be taken 96 hours after calving.
If calving occurs before 54 days after treatment, milk for human consumption may be
taken after 54 days plus 96 hours after treatment, ensuring that the milk from at least 7
complete milking is discarded.
The absence of antibiotic should be confirmed by testing before its milk is used for
human consumption. This is advisable because of variation in the milking cow’s ability
to excrete antibiotic from dry cow products. In cows suffering from hypocalcaemia, it
may be necessary to discard milk for a longer period.
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