Synulox Ready-to-Use Suspension for Injection

Land: Storbritannia

Språk: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

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Preparatomtale Preparatomtale (SPC)
07-03-2022

Aktiv ingrediens:

Amoxicillin, Clavulanic Acid

Tilgjengelig fra:

Zoetis UK Limited

INN (International Name):

Amoxicillin, Clavulanic Acid

Legemiddelform:

Suspension for injection

Resept typen:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Cats, Cattle, Dogs, Pigs

Terapeutisk område:

Antimicrobial

Autorisasjon status:

Authorized

Autorisasjon dato:

1987-05-27

Preparatomtale

                                Revised: March 2022
AN: 01525/2021
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
SYNULOX Ready-To-Use Suspension for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredients:_
_% w/v_
Amoxicillin
(as amoxicillin trihydrate)
14.0
Clavulanic acid
(as potassium clavulanate)
3.5
For the full list of all other excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, pigs, dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
This product has bactericidal activity against a broad spectrum of
clinically
important bacteria found in large and small animals. _In vitro_ the
product is active
against a wide range of bacteria, including strains resistant to
amoxicillin alone
because of beta-lactamase production:
_Gram-positive_
_Actinomyces bovis_
_Bacillus anthracis_
Clostridia
Corynebacteria
_Peptostreptococcus_ spp.
Staphylococci
Streptococci
_Gram-negative_
_Actinobacillus lignierisi_
_Actinobacillus pleuropneumoniae_
_Bacteroides_
_Bordetella bronchiseptica_
Revised: March 2022
AN: 01525/2021
Page 2 of 7
_Campylobacter_ spp.
_Escherichia coli_
_Fusobacterium necrophorum_
_Haemophilus_ spp.
Klebsiellae
_Moraxella_ spp.
Pasteurellae
_Proteus_ spp.
Salmonellae
Clinically the product is indicated for the treatment of diseases
including:
Cattle
Respiratory infections, soft tissue infections (e.g.
joint-ill/navel-ill, abscesses
etc.), metritis and mastitis.
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 used in combination
with
Synulox Lactating Cow Intramammary.
Pigs
Respiratory bacterial infections in growing pigs.
Colibacillosis.
_Periparturient infections in sows (e.g. mastitis, metritis and
agalactia.)_
Dogs and Cats
Respiratory tract infections, urinary tract infections and skin and
soft tissue
infections (e.g. abscesses, pyoderma, anal sacc
                                
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