PHARMACOLOGICAL ACTION
Cefuroxime is active against the majority of gram-positive and gram-negative bacteria implicated in mastitis. It is a second generation, semi-synthetic cephalosporin with bactericidal activity and is active in the presence of milk.
Cefuroxime is generally resistant to degradation by beta-lactamase enzymes, produced by both gram-positive and gram-negative bacteria. As a result, it is active against a wide range of gram-positive and gram-negative bacteria. The following strains have been shown to be highly susceptible to cefuroxime and clinical infections of mastitis have been shown to respond to treatment with Spectrazol® Milking Cow: Citrobacter spp., Corynebacterium spp.,
Trueperella pyogenes, Enterobacter spp., E. coli, Klebsiella spp., Micrococcus spp., Staphylococcus spp., Staphylococcus aureus (including penicillin-resistant strains), Streptococcus spp. (including S. agalactiae, S. dysgalactiae and S. uberis). In vitro sensitivity does not necessarily imply in vivo efficacy. Spectrazol® Milking Cow disperses readily in milk and allows rapid distribution of high levels of the antibiotic in both milk and tissues of treated quarters.
INDICATIONS
Spectrazol® Milking Cow is indicated for the treatment of clinical mastitis caused by all the major mastitis pathogens in lactating cows.
CONTRAINDICATIONS
Not for use in dry cows.
WARNINGS
Withdrawal period: Do not slaughter cattle for human consumption within 1 day after the last infusion.
Milk should not be drawn for human consumption until the 5th milking (60 hours) after the last infusion.
FURTHER INFORMATION
If 3 infusions are made at alternate milkings or where cows are milked 3 times daily, milk should still not be drawn for human consumption until 60 hours after the last infusion. The recommended discard time is based on the sole use of Spectrazol® Milking Cow in 1 quarter of a lactating cow. If more than 1 quarter is infused, or any other antibacterial agent is administered, by any route, at the same time as Spectrazol® Milking Cow, a longer milk discard time may be necessary. This can be determined by testing the milk at intervals until antibiotic can no longer be detected.
DOSAGE AND DIRECTIONS FOR USE
The contents of 1 syringe should be infused into the teat canal of the infected quarter, every 12 hours, after each of 3 successive milkings.
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 antiseptic 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.
PRESENTATION
Carton containing 20 single-dose, disposable syringes.
STORAGE
Store at or below 25 °C.
KEEP OUT OF REACH AND SIGHT OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
REGISTRATION NUMBER
83/594 (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 SCIENTIFIC PACKAGE INSERT
21 December 2023