Dynaclav Suspension for Injection for Cattle

Summary of Product characteristics

                                Revised: October 2012
AN: 00752/2012
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dynaclav Suspension for Injection for Cattle.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
% W/V
Amoxicillin (as Amoxicillin trihydrate).
14.0
Clavulanic acid (as Potassium clavulanate).
3.5
EXCIPIENTS:
Butylated Hydroxyanisole
0.008
Butylated Hydroxytoluene
0.008
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection.
An off-white suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dynaclav Injection has a notably broad spectrum of bactericidal
activity
against the bacteria commonly found in cattle.
(a)
_In vitro_ Dynaclav Injection 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_.
Gram-negative: _Escherichia coli_ (including beta-lactamase producing
strains), _Salmonella_ spp (including beta-lactamase producing
strains),
_Campylobacter_
spp,
_Klebsiella_
spp,
_Proteus_
spp,
_Pasteurella_
spp,
_Fusobacterium_ _ necrophorum_, Bacteroides (including beta-lactamase
producing strains), _Haemophilus_ spp, _Moraxella_ spp and
_Actinobacillus_
_lignieresi._
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Revised: October 2012
AN: 00752/2012
(b)
Clinically Dynaclav Injection is effective in treating:
Cattle:
Respiratory infections
Soft tissue infections (e.g. joint/navel ill, abscesses etc.)
Metritis
Mastitis.
4.3
CONTRAINDICATIONS
The product should not be administered to rabbits, guinea pigs,
hamsters or gerbils. Caution is advised in its use in other very small
herbivores.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Use of the product should be based on susceptibility testing of
the bacteria isolated from the animal. If this is not possible,
therapy should b
                                
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