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Date: Thursday, May 30, 2024 2:30

Release 3.95
Synulox Lactating Cow Intramammary suspension
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Antimicrobials: Intramammaries: Lactating cow
Active ingredient: Amoxicillin Trihydrate, Clavulanic Acid, Prednisolone
Product:Synulox® Lactating Cow
Product index: Synulox Lactating Cow
Cattle - milk: 84 hours
Cattle - meat: 7 days
Incorporating:
Presentation
Each 3 g intramammary syringe contains:
Active substance:
Amoxicillin (as amoxicillin trihydrate)
200 mg
Clavulanic acid (as potassium clavulanate)
50 mg
Prednisolone
10 mg
Uses
For use in clinical cases of mastitis including cases associated with infections with the following pathogens:
Staphylococci (including β-lactamase producing strains)
Streptococci (including S. agalactiae, S. dysgalactiae, and S. uberis)
Escherichia coli (including β-lactamase-producing strains)
Dosage and administration
Intramammary use.
Before the infusion is made, the teat end should be cleaned and disinfected.
The contents of one syringe should be infused into each affected quarter via the teat canal, immediately after milking, at 12 hour intervals for three consecutive milkings.
In cases of infections caused by Staphylococcus aureus, a longer course of antibacterial therapy may be required. Therefore overall treatment length must be at the veterinarian’s discretion but should be long enough to ensure complete resolution of the intramammary infection.
Contra-indications, warnings, etc
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals which are known to be hypersensitive to β-lactamase antibiotics.
Do not use in cases associated with Pseudomonas.
The product should be used for treatment of clinical mastitis only.
Swab test end with appropriate disinfectant before treatment.
Use of the product should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria and take into account official and local antimicrobial policies.
The use of the product should preferably be based on susceptibility tests.
Avoid use of the product in herds where no β-lactamase producing Staphylococci strains have been isolated. Veterinarians should strive to use narrow spectrum antibiotics if possible. Inappropriate use of the product may increase the prevalence of bacteria resistant to ß-lactam antibiotics and may decrease the effectiveness of treatment with ß-lactam antibiotics, due to the potential for cross-resistance.
No known adverse reactions.
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 also section 16 of the package leaflet for respective contact details.
Withdrawal periods:
Meat and offal: 7 days.
Milk: 84 hours.
With cows milked twice daily, milk for human consumption may only be taken from the 7th milking after the last treatment. Where any other milking routine is followed, milk may be taken for human consumption only after the same period from the last treatment (e.g. with 3 times a day milking, milk may be taken for human consumption at the 11th milking).
User warnings:
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins 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 doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing, are more serious symptoms and require urgent medical attention.
Wash hands after use.
Pharmaceutical precautions
Store in a dry place.
Do not store above 25°C.
Keep out of the sight and reach of children.
For animal treatment only.
Medicines should not be disposed of via wastewater or household waste.
Any unused veterinary medicinal product or waste materials from such veterinary medicinal products should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-V
Packaging quantities
Low density polyethylene intramammary syringes packed in cartons containing 3, 12, 24 or 300 syringes. Not all pack sizes may be marketed.
Further information
Amoxicillin is a broad spectrum bactericidal β-lactam antibiotic. Clavulanic acid inactivates β-lactamases. This combination is effective against β-lactamase producing organisms.
Prednisolone is an anti-inflammatory corticosteroid.
In vitro, clavulanic acid and amoxicillin in combination are active against a wide range of clinically important bacteria including the following organisms which are commonly associated with bovine mastitis:
Staphylococci (including β-lactamase producing strains)
Streptococci (including S. agalactiae, S. dysgalactiae and S. uberis)
Arcanobacteria (including A. pyogenes)
Escherichia coli (including β-lactamase producing strains)
No adverse reactions are to be expected from an accidental overdose.
Marketing Authorisation Number
UK(GB): Vm 42058/5105
UK(NI): Vm 42058/3006
Significant changes
GTIN
GTIN description:12 syringes:
GTIN:05013457076882
GTIN description:24 syringes:
GTIN:05013457076899