CLAVUBACTIN M 312.5 MG BROAD SPECTRUM ANTIBIOTIC TABLETS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

AMOXYCILLIN (AS THE TRIHYDRATE); CLAVULANIC ACID AS POTASSIUM CLAVULANATE

Available from:

LE VET BEHEER B. V.

INN (International Name):

amoxycillin as trihydrate(250mg/Tb) + others

Pharmaceutical form:

ORAL TABLET

Composition:

AMOXYCILLIN (AS THE TRIHYDRATE) ANTIBIOTIC Active 250.0 mg/Tb; CLAVULANIC ACID AS POTASSIUM CLAVULANATE ANTIBIOTIC Active 62.5 mg/Tb

Units in package:

10 tabs; 100 tabs; 200 tabs; 250 tabs; 4 tabs

Class:

VM - Veterinary Medicine

Manufactured by:

LE VET BEHEER

Therapeutic group:

DOG - MEDIUM | CASTRATE

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

BACTERIAL INFECTION | AMOXYCILLIN SENSITIVE BACTERIA | ASSOCIATED WITH VIRAL DISEASE | GRAM NEGATIVE ORGANISMS | GRAM POSITIVE ORGANISMS | POST PARTURIENT BACTERIAL INFE | PRIMARY BACTERIAL INFECTION | SULFADIAZINE SENSITIVE BACTERI | TRIMETHOPRIM SENSITIVE BACTERI | TYLOSIN SENSITIVE BACTERIA

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG - MEDIUM: [BACTERIAL INFECTION]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG - MEDIUM: [BACTERIAL INFECTION]; For treatment of bacterial infections sensitive to clavulanic acid and amoxycillin in medium sized dogs.Contraindicated in small herbivores (e.g. Guinea pigs, rabbits, hamsters or gerbils) or animals with a history of allergic reactions to penicillins. NOT indicated for cases involving Pseudomonas spp.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

TEMPLATE FOR RELEVANT
LABEL
PARTICULARS (RLPs)
(Veterinary
Products)
Select appropriate:
Cl
New Product (include all applicable RLPs) OR
IRl
Variation (highlight instructions that are being varied). Approval
no.
of
label being varied:
5983910806
Signal
heading:
Product name:
Active
constituent/s:
Statement
of
claims:
Net
contents:
Directions
for
Use
Heading:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT
OF
REACH
OF
CHILDREN
FOR ANIMAL TREATMENT ONLY
CLAVUBACTIN M
312.5
mg
Broad
Spectrum
Antibiotic
Tablets
[Common Leaflet for Clavubactin products 59957, 59956 and 59839]
CLAVUBACTIN® S
62.5
mg
Broad Spectrum
Antibiotic
Tablets
CLAVUBACTIN® L
625
mg
Broad Spectrum
Antibiotic
Tablets
Each tablet contains:
250mg AMOXYCILLIN (as
the
trihydrate)
62.5mg CLAVULANIC ACID (as Potassium Clavulanate)
{Common Leaflet for Clavubactin products 59957, 59956 and 59839]
Each Clavubactin S 62.5mg Broad Spectrum Antibiotic Tablet contains
50mg
of
AMOXYCILLIN
as
amoxycillin trihydrate and 12.5mg of CLAVULANIC ACID as
potassium clavulanate.
Each Clavubactin M 312.5mg Broad Spectrum Antibiotic Tablet contains
250mg
of
AMOXYCILLIN
as
amoxycillin trihydrate and 62.5mg of CLAVULANIC ACID as
potassium clavulanate.
Each Clavubactin L 625mg Broad Spectrum Antibiotic Tablet contains
500mg
of
AMOXYCILLIN
as
amoxycillin trihydrate and 125mg of CLAVULANIC ACID
as
potassium clavulanate.
For
treatment
of
bacterial
infections
sensitive
to Clavulanic Acid and
Amoxycillin
in
medium
sized dogs.
[Common Leaflet for Clavubactin products 59957, 59956 and 59839]
For
treatment
of
bacterial
infections
sensitive
to
Clavulanic Acid and
Amoxycillin
in small, medium,
1!,
large
dogs,
and cats.
4
[1
0,
100, 200, 250] Tablets
DIRECTIONS FOR USE:
FOR ORAL ADMINISTRATION
TO
MEDIUM SIZED DOGS ONLY.
[Common Leaflet f
or
Clavubactin products 59957, 59956 and 59839]
FOR ORAL ADMINISTRATION TO DOGS AND CATS ONLY.
Restr
ai
nt
s:
Contraindications:
Contraindications
THIS
PRODUCT
IS
CONTRAINDICATED
IN
SMALL
HERBIVORES
(E
.G.
GUINEA
PIGS,
RABBITS, HAMSTERS
OR
GERBILS)
OR
ANIMALS WITH

Summary of Product characteristics

Page 1 of 7 

SAFETY DATA SHEET 

A18264/02/AUS

CLAVUBACTIN M 312.5MG BROAD SPECTRUM ANTIBIOTIC TABLETS 

SECTION 1 – IDENTIFICATION, CONTACTS, HAZARDOUS NATURE 

Bayer Australia Ltd 
875 Pacific Highway  
Pymble NSW 2073

EMERGENCY TELEPHONE NUMBER  
1800 033 111  
24 hour Emergency Service Australia Wide, Toll Free 

CONTACT POINT (FOR NON-EMERGENCY CALLS)  
Animal Health Division 
[phone]  
Full Product Name 
CLAVUBACTIN M 312.5MG BROAD SPECTRUM 
ANTIBIOTIC TABLETS 
Other Names 
Clavubactin Medium

Product Use 
FOR ANIMAL TREATMENT ONLY 
Oral antibiotic tablet
for organisms sensitive to Amoxycillin and 
Clavulanic Acid in medium dogs.  
Creation Date 
12
th
 April 2011

Revision Date 
19 June 2013 (SDS is current for 5 years from this date) 

SECTION 2 – HAZARDS IDENTIFICATION 
Hazard Classification 
CLASSIFIED AS A NON HAZARDOUS SUBSTANCE 
CLASSIFIED AS A NON DANGEROUS GOOD 
according to criteria of NOHSC Australia and ADG Code. 
Poison Schedule 4 
Risk Phrases 
None allocated

Safety Phrases 
None allocated 

SECTION 3 – COMPOSITION 
INGREDIENTS 
CAS NO 
PROPORTION 
Amoxycillin trihydrate equivalent to Amoxycillin 
61336-70-7 
250mg/tablet 
Potassium Clavulanate equivalent to Clavulanic acid 
61177-45-5 
62.5mg/tablet 
This is a commercial product whose exact ratio
of components may vary slightly. Minor 
quantities of other non hazardous ingredients are also
present.  

A18264/02/AUS  CLAVUBACTIN M 312.5MG
BROAD SPECTRUM ANTIBIOTIC TABLETS          Page 2 of 7 

SECTION 4 – FIRST AID MEASURES 
Label Regulated First 
Aid Statement 
Nil. 
Scheduled Poisons 
Poison Schedule 4. 
Poisons Information Centres in each State capital city can
provide 
additional assistance for scheduled poisons. Phone 131126. 
Inhalation 
Avoid inhaling 

Safety Data Sheet

CLAVUBACTIN
®
M
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
312.5mg Broad Spectrum Antibiotic Tablets
ACTIVE CONSTITUENTS:
Each tablet contains:
250mg AMOXYCILLIN (as the trihydrate)
62.5mg CLAVULANIC ACID
(as Potassium Clavulanate)
For treatment of bacterial infections sensitive
to Clavulanic Acid and Amoxycillin in
medium sized dogs.
100 TABLETS
READ ENCLOSED LEAFLET BEFORE USING
THIS PRODUCT
DIRECTIONS FOR USE:
For oral administration to medium sized dogs only.
Contraindications
This product is contraindicated in small herbivores (e.g.
Guinea pigs, rabbits, hamsters or gerbils) or animals
with a history of allergic reactions to penicillins.
DOSAGE AND ADMINISTRATION
The standard dosage rate is 12.5mg/kg of combined
active substance per kg bodyweight (1 tablet per
25kg/bw) twice daily.
In persistent infections (i.e. respiratory infections) it
is recommended to double the dosage (25mg/kg
bodyweight twice daily).
Treatment should be carried out for at least
5-10 days for the majority of infections at discretion
of the Veterinarian.
In chronic cases, a longer course of therapy is
recommended as follows:
*Chronic skin infections 10-30 days or longer in clinical
refractory cases or in deep bacterial pyodermas
(up to 6-8 weeks) depending on clinical response.
*Chronic cystitis 10-28 days
Dog weight
Dosage
10.0 to 12.5 kg
½ Tablet Clavubactin M
12.5 to 25.0 kg
1 Tablet Clavubactin M
25.0 to 37.5 kg
1 ½ Tablets Clavubactin M
37.5 to 50.0 kg
2 Tablets Clavubactin M
Clavubactin is not indicated for cases involving
_Pseudomonas _spp_._
FIRST AID:
If poisoning occurs, contact a doctor
or Poisons Information Centre. Phone
Australia 131 126.
DISPOSAL:
Dispose of empty container by
wrapping with paper and putting in
the garbage.
STORAGE:
Store below 25°C (air conditioning).
Protect from light. Airtight.
APVMA Approval No:
59839/61030
CLAVUBACTIN
®
is a registered trademark of
Le Vet Beheer B.V., The Netherlands.
ABBEY LABORATORIES PTY LTD
Distributed by:
Abbey Animal Health Pty Ltd