RILEXINE 600 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(600mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

CEPHALEXIN AS CEPHALEXIN MONOHYDRATE ANTIBIOTIC Active 600.0 mg/Tb

Units in package:

100 Tabs; 1000 Tabs; 20 Tablets; 300 Tabs; 400 Tabs; 500 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 the treatment of bacteria 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

DRAFT LABEL (FRONT PANEL)
Page 1 of 8 11.2.03
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
_RILEXINE_



_ 600_
_ _
CEPHALEXIN ANTIBIOTIC TABLETS FOR DOGS
ACTIVE CONSTITUENT:
Each tablet contains:
600 mg 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
1000 TABLETS
( 100 FOIL PACKS OF 10 TABLETS )
Info
PEST

Verified
DRAFT LABEL (FRONT PANEL)
Page 2 of 8 11.2.03
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
_RILEXINE_



_ 600_
_ _
CEPHALEXIN ANTIBIOTIC TABLETS FOR DOGS
ACTIVE CONSTITUENT:
Each tablet contains:
600 mg 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
500 TABLETS
( 50 FOIL PACKS OF 10 TABLETS )
DRAFT LABEL (FRONT PANEL)
Page 3 of 8 11.2.03
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
_RILEXINE_



_ 600_
_ _
CEPHALEXIN ANTIBIOTIC TABLETS FOR DOGS
ACTIVE CONSTITUENT:
Each tablet contains:
600 mg 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
400 TABLETS
( 40 FOIL PACKS OF 10 TABLETS )
DRAFT LABEL (FRONT PANEL)
Page 4 of 8 11.2.03
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
_RILEXINE_



_ 600_
_ _
CEPHALEXIN ANTIBIOTIC TABLETS FOR DOGS
ACTIVE CONSTITUENT:
Each tablet contains:
600 mg CEPHALEXIN (as MONOHYDRATE)
FOR TREATMENT OF BACTERIAL INFECTIONS SUSCEPTIBLE TO CEPHALEXIN_ _
•
INFECTIONS OF SOFT CUTANEOUS TISSUES
•

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Summary of Product characteristics

VIRBAC (AUSTRALIA) PTY. LTD.
DOCUMENT NO:
RILEXINE CEPHALEXIN
TABLETS.DOC
REVISION A
MATERIAL SAFETY DATA SHEET
Product Name:
Rilexine Cephalexin Antibiotic Tablets for Dogs and Cats
PAGE: 1 OF 4
DATE OF ISSUE
26 JUNE, 2002
O:\Aphs\IT\Infopest\WorkingFiles\NewMSDS\Virbac Word Doc MSDS\Rilexine
Cephalexin Tablets.doc
12/09/03
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of NOHSC
Australia.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
COMPANY:
VIRBAC (AUSTRALIA) PTY. LTD
ABN 77 003 268 871
ADDRESS
15 Pritchard Place, Peakhurst, NSW 2210, Australia
Locked Bag 1000, Peakhurst Delivery Centre, Peakhurst, NSW 2210,
Australia
TELEPHONE:
(02) 9533 2000 or 1800 242 100
FAX:
(02) 9533 1522
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
PRODUCT CODE:
RILEX075; RILEX300; RILEX600; RILEX603; RILEX620
PRODUCT USE:
For the treatment in dogs and cats of bacterial infections susceptible
to Cephalexin.
CREATION DATE:
JUNE, 2002
REVISION DATE:
JUNE, 2002
SECTION 2 – COMPOSITION/INFORMATION ON INGREDIENTS
INGREDIENTS
CAS NO
CONC,%
TWA (MG/M3)
STEL (MG/M3)
Cephalexin
23325-78-2
40 approx
not set
not set
Other non hazardous ingredients
secret
to 100
not set
not set
This is a commercial product whose exact ratio of components may vary
slightly. Minor quantities of other non
hazardous ingredients are also possible.
The TWA exposure value is the average airborne concentration of a
particular substance when calculated over a normal 8 hour working day
for a 5
day working week. The STEL (Short Term Exposure Limit) is an exposure
value that should not be exceeded for more than 15 minutes and should
not be repeated for more than 4 times per day. There should be at
least 60 minutes between successive exposures at the STEL. The term
"peak "is
used

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