RILEXINE 300 CEPHALEXIN ANTIBIOTIC TABLETS FOR DOGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

19-06-2017

Active ingredient:

CEPHALEXIN AS CEPHALEXIN MONOHYDRATE

Available from:

VIRBAC (AUSTRALIA) PTY LTD

INN (International Name):

cephalexin as monohydrate(300mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

CEPHALEXIN AS CEPHALEXIN MONOHYDRATE ANTIBIOTIC Active 300.0 mg/Tb

Units in package:

252 Tabs

Class:

VM - Veterinary Medicine

Therapeutic group:

DOG | BITCH | CASTRATE | PUPPY

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), INFECTIONS OF SOFT CUTANEOUS TISSUE, INFECTIONS OF THE DIGESTIVE TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, KLEBSIELLA SPP., OSTEOMYELITIS, PROTEUS SPP., SALMONELLA, SHIGELLA SPP., STAPHYLOCOCCUS AUREUS]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), INFECTIONS OF SOFT CUTANEOUS TISSUE, INFECTIONS OF THE DIGESTIVE TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, KLEBSIELLA SPP., OSTEOMYELITIS, PROTEUS SPP., SALMONELLA, SHIGELLA SPP., STAPHYLOCOCCUS AUREUS]; For treatment of bacterial infections susceptible to cephalexin.DO NOT use in animals that are hypersensitive to cephalosporins & other penicillins. Some dogs may exhibit nausea, vomiting & diarrhoea.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

INFOPEST VERIFIES THAT THIS LABEL IS CONSISTENT WITH THE
NRA APPROVED TEXT LABEL OF 27/3/97 ________
DRAFT LABEL (FRONT PANEL)
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
_RILEXINE 300_
CEPHALEXIN ANTIBIOTIC TABLETS FOR DOGS
ACTIVE CONSTITUENT: Each tablet contains:
300mg CEPHALEXIN (as MONOHYDRATE)
FOR TREATMENT OF BACTERIAL INFECTIONS SUSCEPTIBLE TO CEPHALEXIN
•
INFECTIONS OF SOFT CUTANEOUS TISSUE
•
RESPIRATORY AND DIGESTIVE INFECTIONS
•
URINARY INFECTIONS
•
PREVENTION AND TREATMENT OF OSTEOMYELITIS
252 TABLETS
(42 FOIL PACKS OF 6 TABLETS WITH DISPENSING ENVELOPES)
Back Panel
DIRECTIONS FOR USE:
THIS
PRODUCT
IS
CONTRAINDICATED
IN
ANIMALS
THAT
ARE
HYPERSENSITIVE
TO
CEPHALOSPORINS AND OTHER PENICILLINS.
SIDE EFFECTS: Some dogs may exhibit nausea, vomiting and diarrhoea.
DOSAGE AND ADMINISTRATION
DOGS: 30mg/kg/day at 12 hourly intervals (i.e. 1 tablet per 20kg
bodyweight morning and
night). In refractory cases, dose may be increased to 40mg/kg/day at
12 hourly intervals
(i.e. 1 tablet per 15kg bodyweight morning and night).
Treatment should be carried out for at least 3 days at discretion of
Veterinarian.
Is
active
against
certain
strains
of
Penicillinases
producing
_Staphylococcus _
_aureus._
Effective
against
susceptible_ _
_E.coli, _
_Klebsiella, _
_Proteus, _
_Salmonella, _
_Shigella _
_and_
_Enterobacter._
VIRBAC AUSTRALIA PTY. LIMITED
15 Pritchard Place, Peakhurst NSW 2210
DISPOSAL:
Dispose of empty container by wrapping with paper and putting in
garbage.
S
S
T
T
O
O
R
R
A
A
G
G
E
E
:
:
Store below 30
º
C (Room Temperature).

Registered Trade Mark of Virbac.
[B]:
CODE: 9262 B
EXP:
NRA: 40380/01
11.10.96
Draft Label (Blister Foil Pack)
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
_RILEXINE_


 300
CEPHALEXIN ANTIBIOTIC TABLETS FOR DOGS
ACTIVE CONSTITUENT: 300mg CEPHALEXIN
(as MONOHYDRATE) per tablet
[B] EXP:
Space
Required
22mm x 22mm

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Summary of Product characteristics

VIRBAC (AUSTRALIA) PTY. LTD.
DOCUMENT NO:
RILEXINE CEPHALEXIN
TABLETS
REVISION C
MATERIAL SAFETY DATA SHEET
Product Name:
Rilexine Cephalexin Antibiotic Tablets for Dogs and Cats
PAGE: 1 OF 4
DATE OF ISSUE
17 SEPTEMBER,
2008
EMERGENCY: VIRBAC: 02 9772 9772 OR 1800 242 100 (BUSINESS HOURS ONLY)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
COMPANY:
VIRBAC (AUSTRALIA) PTY. LTD
ABN 77 003 268 871
ADDRESS
361 Horsley Rd, Milperra, NSW 2214, Australia
Locked Bag 6000, Milperra Business Centre, NSW 1891, Australia
TELEPHONE:
(02) 9772 9772 or 1800 242 100
FAX:
(02) 9772 9773
EMERGENCY PHONE
As above during business hours; answering machine after hours
SUBSTANCE:
Cephalexin is an antibiotic
TRADE NAME:
Rilexine Cephalexin Antibiotic Tablets for Dogs and Cats
APVMA CODE:
40379: Rilexine 75 Cephalexin Antibiotic Tablets For Dogs And Cats
40380: Rilexine 300 Cephalexin Antibiotic Tablets For Dogs And Cats
PRODUCT USE:
For the treatment in dogs and cats of bacterial infections susceptible
to Cephalexin.
CREATION DATE:
JUNE, 2002
REVISION DATE:
JANUARY, 2008
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of ASCC
Australia.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
Not Hazardous - No criteria found.
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good.
UN NUMBER:
None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: White to off-white tablets (some are scored).
ODOUR:
No data.
MAJOR HEALTH HAZARDS:
No major health hazards are known.
POTENTIAL HEALTH EFFECTS
INHALATION
SHORT TERM EXPOSURE:
This product may be irritating, but is unlikely to cause anything more
than mild transient
discomfort.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CON

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