Combiclav Suspension for Injection

Riik: Suurbritannia

keel: inglise

Allikas: VMD (Veterinary Medicines Directorate)

Toimeaine:

Amoxicillin, Clavulanic Acid

Saadav alates:

Norbrook Laboratories Limited

ATC kood:

QJ01CR02

INN (Rahvusvaheline Nimetus):

Amoxicillin, Clavulanic Acid

Ravimvorm:

Suspension for injection

Retsepti tüüp:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutiline rühm:

Cattle

Terapeutiline ala:

Antimicrobial

Volitamisolek:

Authorized

Loa andmise kuupäev:

2003-09-24

Toote omadused

Revised: July 2018
AN: 02259/2017
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Combiclav Suspension for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE(S)
mg/ml
Amoxicillin (as Amoxicillin trihydrate)
140
Clavulanic acid (as Potassium clavulanate)
35
EXCIPIENTS:
Butylated Hydroxyanisole
0.08
Butylated Hydroxytoluene
0.08
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection.
An off-white to cream oily suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Combiclav Injection has a broad spectrum of bactericidal activity
against the bacteria
commonly found in cattle.
(a)
_In vitro_ Combiclav 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._
Revised: July 2018
AN: 02259/2017
Page 2 of 6
(b)
Treats:
Cattle:
Respiratory infections
Soft tissue infections (e.g. joint/navel ill, abscesses etc.)
Metritis
Mastitis.
Combined Therapy for the treatment of bovine mastitis. In the
situation where systemic
treatment as well as intramammary treatment is necessary, Combiclav
Injection can be
administered in combination with Combiclav Lactating Cow Intramammary
Suspension.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to
any of the
excipients.
The product should not be administered to rabbits, guinea pigs,
hamsters or gerbils.
Caution is advised in its use