NOAH Compendium

Printed from NOAH Compendium (https://www.noahcompendium.co.uk). (c) Copyright NOAH Compendium 2024. All Rights Reserved.
Date: Tuesday, April 23, 2024 22:32

Description: MSD-AH
Release 2.98
Cobactan® MC Intramammary suspension 75 mg Milking cow
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Antimicrobials: Intramammaries: Lactating cow
Active ingredient: Cefquinome
Product:Cobactan® MC Intramammary suspension 75 mg Milking cow
Product index: Cobactan® MC
Cattle - milk: 120 hours
Cattle - meat: 4 days
Withdrawal notes: See datasheet, when using Cobactan MC and Cobactan 25 mg/ml in combination.
Incorporating:
Qualitative and quantitative composition
Per 8g syringe:
Active substance:
Cefquinome 75.0 mg (as cefquinome sulphate)
For full list of excipients, see section 'Pharmaceutical Particulars'.
Pharmaceutical form
White to slightly yellow, oily viscous homogeneous intramammary suspension.
Clinical particulars
Target species
Lactating cows.
Indications for use
For the treatment of clinical mastitis in the lactating dairy cow caused by the following cefquinome sensitive organisms: Staphylococcus aureus, Streptococcus uberis, Streptococcus dysgalactiae, and Escherichia coli.
Contraindications
Not to be administered to animals which are known to be hypersensitive to cephalosporin antibiotics and other ß-lactam antibiotics.
Do not use the cleaning towel if lesions are present on the teat.
Special warnings for each target species
None.
Special precautions for use
Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. Inappropriate use of the product 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.
Operator warnings
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross sensitivity to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious.
1. Handle this product with great care to avoid exposure, taking all recommended precautions.
2. Do not handle this product if you are sensitive to such preparations, or if you have been advised not to work them.
3. If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the Doctor this warning. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Wash hands after using the cleaning towels and wear protective gloves if skin irritation due to isopropyl alcohol is known or suspected.
Adverse reactions
In very rare cases anaphylactic reactions have been noted in animals after administration of the product.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy or lactation
The product is intended for use during lactation. There is no available information indicating reproductive toxicity (inc. teratogenicity) in cattle. In reproductive toxicity studies in laboratory animals cefquinome did not reveal any effect on reproduction or teratogenic potential.
Interactions
It is known that a cross sensitivity to cephalosporins exists for bacteria sensitive to the cephalosporin group.
Amounts to be administered and administration route
The contents of one syringe should be infused gently into the teat of the infected quarter every 12 hours after each of three successive milkings.
Milk out the affected quarter(s). After thoroughly cleaning and disinfecting the teat and teat orifice, with the cleaning towel provided, gently infuse the contents of one syringe into each affected quarter. Disperse the product by gentle massage of the teat and udder of the affected animal.
The syringe must only be used once. Partly used syringes should be discarded.
Combined Therapy
For the treatment of E.coli mastitis, experimental challenge studies have shown that the use of this product in combination with Cobactan 25 mg/ml suspension for injection leads to an improvement in efficacy, particularly in terms of bacterial cure rate.
For combined therapy the following treatment regime should be followed:
Description: Cobactan MC
Overdose
No symptoms expected or emergency procedures required.
Withdrawal periods
Meat and offal: 4 days
Milk: 5 days (120 hours)
When using Cobactan MC and Cobactan 25 mg/ml in combination, the withdrawal periods are as follows:
Meat and offal: 5 days;
Milk: 5 days (120 hours).
Pharmacological particulars
ATCvet Code: QJ51DE90
Pharmacotherapeutic group
Antibacterials for intramammary use, fourth-generation cephalosporins.
Pharmacodynamic properties
Cefquinome is an antibacterial drug of the cephalosporin group which acts by inhibition of cell wall synthesis. It is characterised by its broad therapeutic spectrum of activity and a 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.
As a fourth generation cephalosporin, cefquinome combines high cellular penetration and a high beta-lactamases stability. In contrast to cephalosporins of previous generations, cefquinome is not hydrolysed by chromosomally–encoded cephalosporinases of the Amp-C type or by plasmid mediated cephalosporinases of some enterobacterial species. Resistance mechanism in Gram negative organisms due to extended spectrum beta-lactamases (ESBL) and in Gram-positive organisms due to alteration of penicillin binding proteins (PBPs) may lead to cross-resistance with other beta-lactams.
Pharmacokinetic properties
After intramammary administration, a mean concentration of 19 mcg/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 mcg/ml.
At the second milking following the last infusion the mean concentration is still approximately 2.5 mcg/ml and then falls to 0.75 mcg/ml at the third milking post last infusion.
Resorption of cefquinome from the udder is insignificant.
Pharmaceutical particulars
Excipients
White soft paraffin
Liquid paraffin.
Major incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Special precautions for storage
Do not store above 25 °C.
Immediate packaging
White opaque polyethylene syringes and cleaning towels in paper aluminium copolymer laminate sachet.
Packs of 3, 15, 20, 24 and 30 syringes and cleaning towels.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
UK: Vm 01708/4444
Significant changes
Date of the first authorisation or date of renewal
29 May 1997.
Date of revision of the text
March 2021.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Cobactan MC 30x1inj:
GTIN:8713184036469