Synulox Lactating
Active substance
ATC code
Species
Cattle (lactating cows).
Indications
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)
Dose to be administered and administration route
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 intramammary infection.
Adverse reactions
None known.
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 the national competent authority via the national reporting system. See also section 16 of the package leaflet for respective contact details.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
SYNULOX LACTATING COW Intramammary Suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients:
|
One syringe (3 g) contains: |
|
|
Amoxicillin trihydrate equivalent to amoxicillin |
200 mg |
|
Potassium clavulanate equivalent to clavulanic acid |
50 mg |
|
Prednisolone |
10 mg |
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Intramammary suspension.
Pale cream/buff coloured oily suspension.
4. CLINICAL PARTICULARS
4.1. Target species
Cattle (lactating cows).
4.2. Indications for use, specifying the target species
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)
4.3. Contraindications
Do not use in animals which are known to be hypersensitive to β-lactamase antibiotics.
4.4. Special warnings for each target species
Do not use in cases associated with Pseudomonas.
4.5. Special precautions for use
i) Special precautions for use in animals
Swab teat end with appropriate disinfectant before treatment.
Recommendations for prudent use
The product should be used for treatment of clinical mastitis only.
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 ßlactam antibiotics and may decrease the effectiveness of treatment with ß-lactam antibiotics, due to the potential for cross-resistance.
ii) Special precautions to be taken by the person administering the
veterinary medicinal product to animals
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.
4.6. Adverse reactions (frequency and seriousness)
None known.
4.7. Use during pregnancy, lactation or lay
No special precautions.
4.8. Interaction with other medicinal products and other forms of interaction
None known.
4.9. Amounts to be administered and administration route
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 intramammary infection.
4.10.Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions are to be expected from an accidental overdose.
4. 11.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).
5. PHARMACOLOGICAL PROPERTIES
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)
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Calcium Sodium Aluminosilicate (dried) Mineral Oil (Formula A) Formula A:
Emulsifying Wax
White Soft Paraffin
Liquid Paraffin Light
6.2. Incompatibilities
None known.
6.3. Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
6.4. Special precautions for storage
Do not store above 25°C. Store in a dry place.
6.5. Nature and composition of immediate packaging
Low density polyethylene syringes packed in cartons containing 3, 12, 24 or 300 syringes. Not all pack sizes may be marketed.
6.6. Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
1st Floor, Birchwood Building
Springfield Drive
Leatherhead
Surrey
KT22 7LP
8. MARKETING AUTHORISATION NUMBER
Vm 42058/4143
9. DATE OF FIRST AUTHORISATION
11 December 1986
10. DATE OF REVISION OF THE TEXT
December 2019
Approved 03 December 2019
| Art. Nr. | 42058/5105 |
|---|---|
| EAN | 5013457076882 |
