MSD COBACTAN LC 15 X 1 ml VET ONLY (S4)

PHARMACOLOGICAL ACTION

Cefquinome is an antibacterial drug of the cephalosporin group which acts by inhibition of cell wall synthesis. It is characterised by its broad spectrum of activity and high stability against beta-lactamases.

In vitro, cefquinome has antibiotic activity against common gram-negative and gram-positive bacteria including Escherichia coli, Staphylococcus aureus, Streptococcus dysgalactiae, Streptococcus agalactiae and Streptococcus uberis.

Table 1 – Activity of cefquinome against bovine mastitis pathogens isolated in the EU (De Jong et al., 2013)

MIC50 µg/mℓ MIC90 µg/mℓ Susceptibility breakpoint % Resistance
Escherichia coli 0,06 0,12 4,0 2,01 %
Staphylococcus aureus 0,5 0,5 4,0 1,08 %
Streptococcus uberis 0,12 0,25 4,0 0
Streptococcus dysgalactiae ≤ 0,008 0,015 4,0 0
Table 2 – MIC’s for South African bovine mastitis pathogens tested against Cobactan® LC (cefquinome)

No. of strains tested No. of strains ≤ European MIC50 data No. of strains ≥ European MIC90 data % Resistance measured against susceptibility breakpoint of 4,0 µg/mℓ
Staphylococcus aureus 30 27 3 0
Escherichia coli 30 14 16 3,3 % (= 1/30 strains)
Streptococci 30 N/A N/A 23,3 % (= 7/30 strains)
Streptococcus agalactiae 15 N/A N/A 20 % (= 3/15 strains)
Streptococcus dysgalactiae 10 0 10 30 % (= 3/10 strains)
Streptococcus uberis 5 3 2 20 % (= 1/5 strains)
As a fourth generation cephalosporin, cefquinome combines high cellular penetration and high beta-lactamases stability. In contrast to cephalosporins from previous generations, cefquinome is not hydrolysed by chromosomally-encoded cephalosporins of the Amp-C type or by plasmid mediated cephalosporinases of some enterobacterial species. Resistance mechanisms in gram-negative organisms due to extended spectrum beta-lactamases and in gram-positive organisms due to alteration of penicillin binding proteins (PBP’s), may lead to cross-resistance with other beta-lactams.

After intramammary administration, a mean concentration of 19 µg/mℓ in milk is observed 12 hours post last infusion. The highest MIC90 value was found for Staphylococcus aureus. This pathogen has a MIC90 in the range of 1 µg/mℓ.

At the second milking following the last infusion, the mean concentration is still approximately 2,5 µg/mℓ and then falls to 0,75 µg/mℓ at the third milking post last infusion.

Resorption from the udder is insignificant.

INDICATIONS

Cobactan® LC is recommended for the treatment of clinical mastitis in lactating dairy cows, caused by the following cefquinome-sensitive organisms: Staphylococcus aureus, Streptococcus uberis, Streptococcus dysgalactiae, Streptococcus agalactiae, Escherichia coli and other enterobacteria susceptible to cefquinome.

CONTRAINDICATIONS

Not to be administered to cattle that are known to be hypersensitive to cephalosporin antibiotics and other beta-lactam antibiotics.

Do not use the cleaning towel if lesions are present on the teat.

WARNINGS

Withdrawal period:

Meat – Do not slaughter cows for human consumption until 4 days after the last treatment.

Milk – Milk must not be taken for human consumption during treatment and for 5 days (120 hours) after the last treatment.

SAFETY IN PREGNANCY AND LACTATION

Cobactan® LC is intended for use during lactation. There is no available information indicating reproductive toxicity (including teratogenicity) in cattle. In reproductive toxicity studies in laboratory animals, cefquinome did not reveal any effect on reproductive or teratogenic potential.

DOSAGE AND DIRECTIONS FOR USE

Gently infuse the contents of 1 syringe into the teat of the infected quarter, every 12 hours after each of 3 consecutive milkings.

Milk out the affected quarter(s). After thoroughly cleaning and disinfecting the teat and teat orifice, gently infuse the contents of 1 syringe into each affected quarter. Dispense the product by gently massaging the teat and the udder of the affected cow.

Clean teat with the enclosed cleaning towel.
For partial insertion, break the top of the cap as shown.
For full insertion, remove the whole cap.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE 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 cephalosporins and vice versa.

Allergic reactions to these substances may occasionally be serious.

Do not handle Cobactan® LC if you know you are sensitised, or if you have been advised not to work with such preparations.
Handle Cobactan® LC with great 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 this package insert to the physician. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
The syringe must only be used once. Partially used syringes should be discarded in a safe manner according to local waste disposal regulations.

SIDE EFFECTS AND SPECIAL PRECAUTIONS

In very rare cases, anaphylactic reactions have been noted in animals after administration of Cobactan® LC.

If you notice any serious effects or other effects not mentioned in this package insert, please inform your veterinarian.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Use of the product should be based on susceptibility testing and take into account official and local antibacterial policies. Inappropriate use may increase the prevalence of bacteria resistant to cefquinome and may decrease the effectiveness of treatment with cephalosporins, due to the potential for cross-resistance.

INTERACTIONS

It is known that cross-sensitivity to cephalosporins exist for bacteria sensitive to the cephalosporin group.

KNOWN SIGNS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

No symptoms are expected, or emergency procedures required.

IDENTIFICATION

Cobactan® LC is a white to slightly yellow, oily viscous homogenous ointment.

PRESENTATION

White opaque polyethylene syringes and cleaning towels packed in paper aluminium co-polymer laminated sachets.

Packs of 3, 15, 20 or 24 syringes and cleaning towels, packed in a cardboard carton.

Not all pack sizes may be marketed.

STORAGE

Store at or below 25 °C.

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

REGISTRATION NUMBER

12/17.1.1.2/03 (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 27 July 2017