RILEXINE 300 PALATABLE LIVER FLAVOURED 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)

20-06-2017

Summary of Product characteristics (SPC)

20-06-2017

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:

*1 Tablet; *10 Tablet; *2 Tablets; *3 Tablets; *4 Tablets; *6 Tablets; *Blister; 100 Tabs; 252 Tabs; 259 Tabs; 300 Tabs; 500 Tab

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 the treatment of bacterial infections susceptible to cephalexin.DO NOT use in animals that are hypersensitive to cephalosporins & other penicillins.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

DRAFT LABEL (CARTON FRONT)
June 2008
Page 1 of 3
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
_RILEXINE_
®
_ 300_
_ _
_PALATABLE_
LIVER FLAVOURED 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 TISSUES
- RESPIRATORY AND DIGESTIVE INFECTIONS
-
URINARY INFECTIONS
-
PREVENTION AND TREATMENT OF OSTEOMYELITIS
100 TABLETS
,
252 TABLETS, 300 TABLETS, 500 TABLETS
VIRBAC LOGO
APPROVED
LABEL
Info
PEST

Verified
DRAFT LABEL (CARTON BACK)
June 2008
Page 2 of 3
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: Administer Cephalexin at a dose rate of 15mg/kg bodyweight twice
daily (ie.1 tablet per
20kg bodyweight morning and night)
or
30mg/kg bodyweight once a day (1 tablet per 10kg bodyweight at 24 hour
intervals).
Long term treatment may be necessary for skin and urinary tract
infections. Treatment should be
carried out for at least 3 days or at the discretion of a
veterinarian. Cephalexin is active against
certain strains of Penicillinase producing _ Staphylococcus aureus _
and_ _ also effective for use in
urinary infections by susceptible_ _bacterial species.
_ _
FIRST AID:
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia 131
126._ _
VIRBAC (AUSTRALIA) PTY. LIMITED
361 Horsley Road, Milperra, NSW 2114
Freecall Customer Service Line: 1800 009 847
www.virbac.com.au
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 Trademark of Virbac.
[B]:
CODE:
EXP:
APVMA:
54342/300MGX100/0608
54342/300MGX252/0608
54342/300MGX300/0608
54342/300MGX500/0608
APPROVED
LABEL
DRAFT LABEL (SIDE PANELS AND TOP FLAP

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Summary of Product characteristics

VIRBAC (AUSTRALIA) PTY. LTD.
DOCUMENT NO:
RILEXENE
PALATABLETABLETS
REVISION D
SAFETY DATA SHEET
Product Name:
Rilexine Palatable Liver Flavoured Cephalexin Antibiotic Tablets for
Cats and Dogs
PAGE: 1 OF 5
DATE OF ISSUE
19 NOVEMBER,
2013
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 THE MATERIAL AND SUPPLIER
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
CHEMICAL NATURE:
Active ingredient is a cephalosporin type antibiotic.
TRADE NAME:
Rilexine Palatable Liver Flavoured Cephalexin Antibiotic Tablets for
Cats and Dogs
APVMA CODE:
54343, 54342, 54341
PRODUCT USE:
Treatment of dogs and cats for bacterial infections susceptible to
Cephalosporin.
CREATION DATE:
JUNE, 2002
THIS VERSION ISSUED:
NOVEMBER, 2013
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA
Australia.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S25, S36. Avoid contact with eyes. Wear suitable protective clothing.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P103: Read label before use.
RESPONSE
P337: If eye irritation persists: seek medical attention.
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P332+P313: If skin irritation occurs: Get medical advice.
P337+P313: If eye irritation persists: Get me

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