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Presentation
Synulox Ready-To-Use Suspension for Injection is an off-white suspension containing 35 mg/ml clavulanic acid as Potassium clavulanate and 140 mg/ml amoxicillin as Amoxicillin trihydrate.
Uses
Synulox Ready-To-Use Suspension for Injection has a notably broad spectrum of bactericidal activity against the bacteria commonly found in cattle, pigs and small animals.
1.(a) In vitro Synulox is active against a wide range of clinically important bacteria including:
Gram-positive:Staphylococci (including beta-lactamase producing strains), Streptococci, Corynebacteria, Clostridia, Bacillus anthracis, Actinomyces bovis, Peptostreptococcus spp.
Gram-negative: Actinobacillus pleuropneumoniae, Escherichia coli (including beta-lactamase producing strains),Salmonellae (including beta-lactamase producing strains), Bordetella bronchiseptica, Campylobacter spp., Klebsiellae, Proteus spp., Pasteurellae, Fusobacterium necrophorum, Bacteroides (including beta-lactamase producing strains), Haemophilus spp., Moraxella spp. and Actinobacillus lignieresi.
2.Clinically, Synulox has been shown to be effective in treating a wide range of diseases including:
Cattle:
-Respiratory infections
-Soft tissue infections (e.g. joint/navel ill, abscesses etc.)
-Metritis
-Mastitis
Pigs:
-Respiratory bacterial infections in growing pigs
-Colibacillosis
-Periparturient infections in sows (eg mastitis, metritis and agalactia.)
Dogs and cats:
-Respiratory tract infections
-Urinary tract infections
-Skin and soft tissue infections (e.g. abscesses, pyoderma, anal sacculitis and gingivitis).
Contra-indications, warnings, etc
In common with all other penicillins, Synulox should not be administered to rabbits, guinea pigs, hamsters or gerbils. Caution is advised in its use in any other very small herbivores.
Use of the product may occasionally result in pain on injection and/or local tissue reaction.
Operator 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.
Withholding times
Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken only from cows after 60 hours from the last treatment.
Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 42 days from the last treatment. Pigs may be slaughtered for human consumption only after 31 days from the last treatment.
Pharmaceutical precautions
Do not store above 25°C. Keep out of the reach of children. For animal treatment only.
This product does not contain an antimicrobial preservative. Following withdrawal of the first dose, use the product within 28 days. Discard unused material.
Swab the septum before removing each dose.
Clavulanic acid is moisture sensitive. It is very important, therefore, that a completely dry needle and syringe is used when extracting suspension for injection in order to avoid contaminating the remaining contents of the vial with drops of water.
Contamination will result in obvious beads of dark brown discolouration corresponding to the introduced water droplets. Material affected in this way should not be used as it may have significantly reduced potency.
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.
Legal category
POM-V (previously POM)
Packaging Quantities
Packs containing 6 x 100 ml and 12 x 40 ml vials.
Further information
Synulox is a novel concept in antibiotic therapy.
Resistance to many antibiotics is caused by beta-lactamase enzymes which destroy the antibiotic before it can act on the bacteria themselves. The clavulanate in Synulox counteracts this defence mechanism by inactivating the beta-lactamases, thus rendering the bacteria sensitive to amoxicillin’s rapid bactericidal effect, at concentrations readily attainable in the body.
Synulox is effective against Klebsiella infections found in veterinary practice, but it is not indicated for cases involving Pseudomonas species.
Synulox RTU may be used in pregnant animals, subject to observance of the withholding time for milk and meat intending for human consumption.
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Presentation
Synulox Ready-To-Use Injection is an off-white suspension containing 35 mg/ml clavulanic acid as Potassium clavulanate PhEur and 140 mg/ml amoxicillin as Amoxicillin trihydrate PhEur.
Uses
Synulox Ready-To-Use Injection has a notably broad spectrum of bactericidal activity against the bacteria commonly found in cattle, pigs and small animals.
(a)In vitro Synulox is active against a wide range of clinically important bacteria including:
Gram-positive:Staphylococci (including beta-lactamase producing strains), Streptococci, Corynebacteria, Clostridia, Bacillus anthracis, Actinomyces bovis, Peptostreptococcus spp.
Gram-negative: Actinobacillus pleuropneumoniae, Escherichia coli (including beta-lactamase producing strains),Salmonellae (including beta-lactamase producing strains), Bordetella bronchiseptica, Campylobacter spp., Klebsiellae, Proteus spp., Pasteurellae, Fusobacterium necrophorum, Bacteroides (including beta-lactamase producing strains), Haemophilus spp., Moraxella spp. and Actinobacillus lignieresi.
(a)Clinically, Synulox has been shown to be effective in treating a wide range of diseases including:
Cattle:
Respiratory infections
Soft tissue infections (e.g. joint/navel ill, abscesses etc.)
Metritis
Mastitis
Pigs:
Respiratory bacterial infections in growing pigs
Colibacillosis
Periparturient infections in sows (eg mastitis, metritis and agalactia.)
Dogs and cats:
Respiratory tract infections
Urinary tract infections
Skin and soft tissue infections (e.g. abscesses, pyoderma, anal sacculitis and gingivitis).
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Dosage and administration
The recommended dosage rate is 8.75 mg/kg bodyweight (7.0 mg amoxicillin, 1.75 mg clavulanic acid), equivalent to 1 ml of suspension per 20 kg bodyweight.
Treatment should be administered once daily for 3 to 5 days.
Shake the vial well before use. Inject by the subcutaneous or intramuscular route in dogs and cats, and by the intramuscular route only in cattle and pigs. After injection, massage the injection site.
The suspension is not suitable for intravenous or intrathecal administration. Great care should be taken to avoid contaminating the remaining contents of the vial with water (see 'Pharmaceutical precautions').
Combined therapy for the treatment of bovine mastitis: In the situation where systemic treatment as well as intramammary treatment is necessary, Synulox Ready-to-Use injection can be administered in combination with Synulox Lactating Cow Intramammary using the following minimum treatment regime:
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Contra-indications, warnings, etc
In common with all other penicillins, Synulox should not be administered to rabbits, guinea pigs, hamsters or gerbils. Caution is advised in its use in any other very small herbivores.
Use of the product may occasionally result in pain on injection and/or local tissue reaction.
Operator 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.
Withholding times
Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken only from cows after 60 hours from the last treatment.
Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 42 days from the last treatment. Pigs may be slaughtered for human consumption only after 31 days from the last treatment.
Pharmaceutical precautions
Do not store above 25°C. Keep out of the reach of children. For animal treatment only.
This product does not contain an antimicrobial preservative. Following withdrawal of the first dose, use the product within 28 days. Discard unused material.
Swab the septum before removing each dose.
Clavulanic acid is moisture sensitive. It is very important, therefore, that a completely dry needle and syringe is used when extracting suspension for injection in order to avoid contaminating the remaining contents of the vial with drops of water.
Contamination will result in obvious beads of dark brown discolouration corresponding to the introduced water droplets. Material affected in this way should not be used as it may have significantly reduced potency.
Any unused product or waste material should be disposed of in accordance with national requirements.
|
|
Legal category
POM-V (previously POM).
Packaging Quantities
Packs containing 6 x 100 ml and 12 x 40 ml vials.
Further information
Synulox is a novel concept in antibiotic therapy.
Resistance to many antibiotics is caused by beta-lactamase enzymes which destroy the antibiotic before it can act on the bacteria themselves. The clavulanate in Synulox counteracts this defence mechanism by inactivating the beta-lactamases, thus rendering the bacteria sensitive to amoxicillin’s rapid bactericidal effect, at concentrations readily attainable in the body.
Synulox is effective against Klebsiella infections found in veterinary practice, but it is not indicated for cases involving Pseudomonas species.
Synulox RTU may be used in pregnant animals, subject to observance of the withholding time for milk and meat intending for human consumption.
Marketing authorisation number
Vm 00057/4152.
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