CLAVUBACTIN S 62.5 MG BROAD SPECTRUM ANTIBIOTIC TABLETS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM CLAVULANATE

Available from:

LE VET BEHEER B. V.

INN (International Name):

amoxycillin as trihydrate(50mg/Tb) + others

Pharmaceutical form:

ORAL TABLET

Composition:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE ANTIBIOTIC Active 50.0 mg/Tb; CLAVULANIC ACID AS POTASSIUM CLAVULANATE ANTIBIOTIC Active 12.5 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 - SMALL OR TOY | DOG - SMALL | DOG - TOY

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: CAT: [BACTERIAL INFECTION]; DOG - SMALL OR TOY: [BACTERIAL INFECTION]; Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG - SMALL OR TOY: [BACTERIAL INFECTION]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG - SMALL OR TOY: [BACTERIAL INFECTION]; For the treatment of bacterial infections sensitive to clavulanic acid and amoxycillin in cats & small 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:
[]
New Product (include
all
applicable RLPs) OR
00
Variation (highlight instructions that are being varied). Approval no.
of label being varied:
59956/0806
Signal
heading:
PRESCRIPTION ANIMAL REMEDY
+
KEEP OUT
OF
REACH
OF
CHILDREN
FOR ANIMAL TREATMENT ONLY
Product
name:
CLAVUBACTIN S
lt!J_t:
Approve<
62.5 mg Broad Spectrum
Antibiotic
Tablets
[Common Leaflet for Clavubactin products 59957, 59956 and 59839]
CLAVUBACTIN® M
312.5mg Broad Spectrum
Antibiotic
Tablets
CLAVUBACTIN® L
625mg Broad Spectrum
Antibiotic
Tablets
Active
Each tablet
contains:
constituent/s:
50mg AMOXYCILLIN (as
the
trihydrate)
12.5mg 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.
Statement
of
For
treatment
of
bacterial
infections
sensitive
to
Clavulanic Acid and
claims:
Amoxycillin
in cats and
small
dogs.
[Common Leaflet for Clavubactin products 59957, 59956 and 59839]
For
treatment
of
bacterial
infections
sensitive
to
Clavulanic
Acid and
Amoxycillin
in
small, medium,
&
large dogs, and cats.
Net
contents:
4
[1
0,
100, 200, 250] Tablets
Directions
for
Use
READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
Heading:
DIRECTIONS FOR USE:
FOR ORAL ADMINISTRATION TO CATS AND SMALL DOGS ONLY.
[Common Leaflet for Clavubactin products
59957,
59956 and 59839]
FOR ORAL ADMINISTRATION TO DOGS AND CATS ONLY.
Restraints:
Contraindications:
Contraindications
THIS
PRODUCT
IS
CONTRAINDICATED
IN
SMALL
HERBIVORES
(E.G

Summary of Product characteristics

Page 1 of 7 

SAFETY DATA SHEET 

A18263/02/AUS

CLAVUBACTIN S 62.5 MG 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 S 62.5 MG BROAD SPECTRUM 
ANTIBIOTIC TABLETS 
Other Names 
Clavubactin Small

Product Use 
FOR ANIMAL TREATMENT ONLY 
Oral antibiotic tablet
for organisms sensitive to Amoxycillin and 
Clavulanic Acid in small dogs and cats.  
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 
50mg/tablet 
Potassium Clavulanate equivalent to Clavulanic acid 
61177-45-5 
12.5mg/tablet 
This is a commercial product whose exact ratio
of components may vary slightly. Minor 
quantities of other non hazardous ingredients are also
present.  

A18263/02/AUS  CLAVUBACTIN S 62.5 MG 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 i

Safety Data Sheet

S
CLAVUBACTIN
®
S
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
62.5mg Broad Spectrum Antibiotic Tablets
ACTIVE CONSTITUENTS:
Each tablet contains:
50mg AMOXYCILLIN (as the trihydrate)
12.5mg CLAVULANIC ACID
(as Potassium Clavulanate)
For treatment of bacterial infections sensitive
to Clavulanic Acid and Amoxycillin in cats
and small dogs.
100 TABLETS
READ ENCLOSED LEAFLET BEFORE USING
THIS PRODUCT
DIRECTIONS FOR USE:
For oral administration to cats and small 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
5kg/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/Cat weight
Dosage
Up to 2.5 kg
½ Tablet Clavubactin S
2.5 to 5.0 kg
1 Tablet Clavubactin S
5.0 to 7.5 kg
1 ½ Tablets Clavubactin S
7.5 to 10.0 kg
2 Tablets Clavubactin S
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:
59956/61031
CLAVUBACTIN
®
is a registered
trademark of Le Vet Beheer B.V.,
The Netherlands.
ABBEY LABORATORIES PTY LTD
Distributed by:
Abbey Animal Health Pty Ltd
39