CLAVUBACTIN L 625 MG BROAD SPECTRUM ANTIBIOTIC TABLETS
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
20-06-2017
Summary of Product characteristics
(SPC)
01-07-2013
Safety Data Sheet
(SDS)
21-05-2007
Active ingredient:
AMOXYCILLIN (AS THE TRIHYDRATE); CLAVULANIC ACID AS POTASSIUM CLAVULANATE
Available from:
LE VET BEHEER B. V.
INN (International Name):
amoxycillin as trihydrate(500mg/Tb) + others
Pharmaceutical form:
ORAL TABLET
Composition:
AMOXYCILLIN (AS THE TRIHYDRATE) ANTIBIOTIC Active 500.0 mg/Tb; CLAVULANIC ACID AS POTASSIUM CLAVULANATE ANTIBIOTIC Active 125.0 mg/Tb
Units in package:
10 tab; 100 tab; 200 tab; 250 tabs; 4 tablets
Class:
VM - Veterinary Medicine
Therapeutic group:
DOG - LARGE
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 - LARGE: [BACTERIAL INFECTION]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG - LARGE: [BACTERIAL INFECTION]; For the treatment of bacterial infections sensitive to clavulanic acid and amoxycillin in large dogs.Contraindicated in small herbivores (e.g. guinea pigs, rabbits, hamsters or gerbils) or animals with a history of allergic reactions to penicillins.
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
(
(
TEMPLATE FOR RELEVANT
LABEL
PARTICULARS (RLPs)
(Veterinary
Products)
Select appropriate:
[J
New Product (include all applicable RLPs)
OR
IRI
Variation (highlight instructions that are being varied). Approval
no.
of
label being varied:
59957/0806
Signal
heading:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT
OF
REACH
OF
CHILDREN
FOR ANIMAL TREATMENT ONLY
Product
name:
CLAVUBACTIN L
625
mg
Broad
Spectrum
Antibiotic
Tablets
[Common Leaflet for C/avubactin products 59957,
59956
and 59839]
CLAVUBACTIN® S
+
62.5mg Broad Spectrum
Antibiotic
Tablets
CLAVUBACTIN® M
312.5mg Broad Spectrum
Antibiotic
Tablets
RLP
Approved
Active
Each
tablet
contains:
constituenUs:
500mg AMOXYCILLIN (as
the
trihydrate)
125mg 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 large
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 [10, 100, 200, 250] Tablets
Directions for Use
READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
Heading:
DIRECTIONS FOR USE:
FOR ORAL ADMINISTRATION
TO
LARGE DOGS ONLY.
[Common Leaflet for Cfavubactin 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.
GUINEA
PIGS,
RABBI
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Summary of Product characteristics
Page 1 of 7
SAFETY DATA SHEET
A18265/02/AUS
CLAVUBACTIN L 625MG 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
(02) 9391 6000
Full Product Name
CLAVUBACTIN L 625MG BROAD SPECTRUM ANTIBIOTIC
TABLETS
Other Names
Clavubactin Large
Product Use
FOR ANIMAL TREATMENT ONLY
Oral antibiotic tablet
for organisms sensitive to amoxycillin and
clavulanic acid in large dogs.
Creation Date
12
th
April 2011
Revision Date
18 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 (as the trihydrate)
61336-70-7
500mg/tablet
Clavulanic acid as Potassium Clavulanate
61177-45-5
125mg/tablet
This is a commercial product whose exact ratio
of components may vary slightly. Minor
quantities of other non hazardous ingredients are also
present.
A18265/02/AUS CLAVUBACTIN
L 625MG 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 dust
Read the complete document
Safety Data Sheet
CLAVUBACTIN
®
L
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
625 mg Broad Spectrum Antibiotic Tablets
ACTIVE CONSTITUENTS:
Each tablet contains:
500mg AMOXYCILLIN (as the trihydrate)
125mg CLAVULANIC ACID (as Potassium
Clavulanate)
For treatment of bacterial infections sensitive
to Clavulanic Acid and Amoxycillin in
large dogs.
100 TABLETS
READ ENCLOSED LEAFLET BEFORE USING
THIS PRODUCT
DIRECTIONS FOR USE:
For oral administration to large 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
50kg/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
Up to 25.0 kg
½ Tablet Clavubactin L
25.0 to 50.0 kg
1 Tablet Clavubactin L
50.0to 75.0 kg
1 ½ Tablets Clavubactin L
75.0 to 100.0 kg
2 Tablets Clavubactin L
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:
59957/61034
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 Buckenderra Rd,
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