MSD CEPRAVIN 20 syringes VET ONLY (S4)

PHARMACOLOGICAL ACTION

Cepravin® Dry Cow is a long acting intramammary cerate containing cephalonium, a semi-synthetic cephalosporin antibiotic. Cephalonium, a cephalosporin antibiotic, is active against the majority of gram-positive and gram-negative bacteria implicated in mastitis. It is a semi-synthetic cephalosporin with bactericidal activity and is active in the presence of milk. It is formulated to give persistent antibiotic levels in the dry udder. Effective levels of cephalonium are usually present in most quarters for up to 10 weeks after intra-mammary infusion at drying-off.

INDICATIONS

Cepravin® Dry Cow in recommended for routine dry cow therapy, to treat existing sub-clinical infections and to prevent new infections which occur during the dry period. Infusion at drying-off also reduces the risk of mastitis which commonly occurs at calving. Cephalonium is a broad spectrum cephalosporin antibiotic which has bactericidal activity against the majority of organisms associated with bovine mastitis. This antibacterial activity is not impaired in the presence of milk. Cephalonium is active against Staphylococcus aureus, including penicillin-resistant strains, Streptococcus agalactiae, Streptococcus dysgalactiae, Corynebacterium pyogenes and Corynebacterium ulcerans. Strains of Streptococcus uberis and E.coli isolated from post-calving mastitis cases were sensitive to cephalonium. The antibiotic was also active against environmental organisms recovered from the bovine udder, including Proteus spp., Klebsiella spp., Citrobacter spp., and Enterobacter strains. Effective levels of cephalonium are maintained in most quarters for up to 10 weeks after infusion of Cepravin® Dry Cow. Provided calving takes place 51 days or more after infusion, any antibiotic present at the end of the dry period is excreted within the first four days of lactation.

CONTRAINDICATIONS

Cepravin® Dry Cow must not be used in lactating cows.

WARNINGS

Cepravin® Dry Cow should not be used within 51 days of calving. Milk must be discarded for the statutory 4-day period after calving. In the event of a cow calving within 51 days of infusion, persistent antibiotic excretion may occur. The milk should therefore be discarded and tested at regular intervals until antibiotic can no longer be detected. In cows suffering from hypocalcaemia, it may be necessary to discard milk for a longer period.

Milk for human consumption may only be taken from 96 hours after calving.

Animals for human consumption should not be slaughtered until 21 days after last treatment.

DOSAGE AND DIRECTIONS FOR USE

The contents of 1 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. Care should be taken to avoid contamination of the syringe nozzle after the protective cap has been removed. After infusion it is advisable to dip the teats in an aseptic preparation specifically designed for this purpose.

SIDE EFFECTS AND SPECIAL PRECAUTIONS

There are no known side effects.

KNOWN SIGNS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

Not applicable.

IDENTIFICATION

A creamy white, sterile suspension packed in plastic, disposable, ready-to-use syringes.

PRESENTATION

Carton containing 20 syringes, 20 sachet wipes and an enclosed package insert.

STORAGE INSTRUCTIONS

Store at or below 25 °C in a cool dry place.

KEEP OUT OF REACH AND SIGHT OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.

REGISTRATION NUMBER

83/570 (Act 101/1965)

REGISTRATION HOLDER

Intervet South Africa (Pty) Ltd.

20 Spartan Road

Spartan, 1619, RSA

Tel: +27(0) 11 923 9300

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF NOTIFICATION OF APPROVAL OF THIS PACKAGE INSERT

29 September 2014