CEPHAFORTE 600 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

Safety Data Sheet (SDS)

04-09-2009

Active ingredient:

CEPHALEXIN AS CEPHALEXIN MONOHYDRATE

Available from:

JUROX PTY LIMITED

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:

10x10 Tab; 10x6 Tab; 300 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: [INFECTIONS OF SOFT CUTANEOUS TISSUE, INFECTIONS OF THE DIGESTIVE TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, OSTEOMYELITIS]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [INFECTIONS OF SOFT CUTANEOUS TISSUE, INFECTIONS OF THE DIGESTIVE TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, OSTEOMYELITIS]; For the treatment of infections in dogs caused by cephalexin sensitive organisms, including infections of soft cutaneous tissue, infections of the respiratory, urinary and digestive tracts, and for the prevention and treatment of osteomyelitis.Contraindicated in animals with a history of allergic reactions to cephalosporins or other penicillins. Nausea & vomiting may occasionally occur.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

DIRECTIONS FOR USE:
CONTRAINDICATION: THIS PRODUCT IS CONTRAINDICATED IN ANIMALS WITH A
HISTORY OF ALLERGIC REACTIONS TO CEPHALOSPORINS OR OTHER PENICILLINS.
Administer orally: Give 15 mg/kg bodyweight twice per day (equivalent
to 1
Cephaforte 600 Tablet per 40 kg bodyweight given night and morning).
Duration of treatment is at least 3 days, but may be extended at the
discretion of the veterinarian. Nausea and vomiting in dogs may
occasionally occur, but these effects are unusual and transitory.
FIRST AID: If poisoning occurs, contact a doctor or
Poisons Information Centre. Phone 131 126.
ANTIBIOTIC TABLETS FOR DOGS
ACTIVE CONSTITUENT:
Each tablet contains 600 mg CEPHALEXIN
(as monohydrate)
FOR THE TREATMENT OF INFECTIONS IN DOGS CAUSED
BY CEPHALEXIN SENSITIVE ORGANISMS, INCLUDING
INFECTIONS OF SOFT CUTANEOUS TISSUE, INFECTIONS
OF THE RESPIRATORY, URINARY AND DIGESTIVE TRACTS,
AND FOR THE PREVENTION AND TREATMENT
OF OSTEOMYELITIS.
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
JUROX Pty. Ltd.
85 Gardiner Road
Rutherford NSW 2320
Infoline 1800 023 312
Dispose of empty container
by wrapping with paper and
placing in garbage.
Store below 30°C
(Room Temperature)
APVMA No. 60441/300 Tab/0309
300 TABLETS
CEPHAFORTE 600
407186
APVMA FILE: 60441_46408_300Tab_immediate_MPL_V02.pdf
Dimensions: label = 150mm (wide) x 100mm (high)
Scale: 100% of A4
Date: 28 July 2009
APPROVED
LABEL
Info
PEST

Verified
Cephaforte 600mg antibiotic tablets for dogs
AUG09
page 1/2
[60][100] tablets blister packs
PRIMARY CONTAINER (CARTON) MAIN PANEL
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CEPHAFORTE 600
ANTIBIOTIC TABLETS FOR DOGS
Active Constituent:
Each tablet contains 600 mg CEPHALEXIN (as monohydrate)
FOR THE TREATMENT OF INFECTIONS IN DOGS CAUSED BY CEPHALEXIN SENSITIVE
ORGANISMS, INCLUDING INFECTIONS OF SOFT CUTANEOUS TISSUE, INFECTIONS
OF THE
RESPIRATORY, URINARY AND DIGESTIVE TRACTS, AND FOR THE PREVENTION AND
TREATMENT
OF OSTEOMYELITIS.
[60] [100] TABLETS
[

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Summary of Product characteristics

CEPHAFORTE TABLETS
Page 1 of 4
ISSUED:
13 JUNE 2012
MATERIAL SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
CEPHAFORTE TABLETS
PRODUCT CODE:
503190 (300 mg tabs), 503195 (600 mg tabs)
RECOMMENDED USE:
Antibiotic tablets for dogs and cats
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street
Rutherford NSW 2320
Australia
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS INFORMATION CENTRE:
131126 (Australia-wide)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (Monday – Friday, 9.00a.m. – 5.00p.m.)
SECTION 2: HAZARDS IDENTIFICATION
HAZARD CLASSIFICATIONS:
NOT CONSIDERED A HAZARDOUS SUBSTANCE ACCORDING TO THE CRITERIA OF
NOHSC
AUSTRALIA.
NOT CONSIDERED A DANGEROUS GOOD ACCORDING TO THE CRITERIA OF THE
AUSTRALIAN
DANGEROUS GOODS (ADG) CODE.
POISONS SCHEDULE:
S4
RISK PHRASES:
Cephalosporins may cause severe allergic reactions in some sensitive
individuals
Ingestion may produce health damage*
Cumulative effects may result following exposure*
(* limited evidence)
SAFETY PHRASES:
Avoid contact with skin
SECTION 3: COMPOSITION / INFORMATION ON INGREDIENTS
INGREDIENT
CAS NO.
CONTENT
Cephalexin monohydrate
23325-78-2
approx. 40%
Other ingredients determined not to be hazardous
to 100%
CEPHAFORTE TABLETS
Page 2 of 4
SECTION 4: FIRST AID MEASURES
FIRST AID MEASURES:
If swallowed do NOT induce vomiting. If vomiting occurs, lean patient
forward or place on left
side (head-down position, if possible) to maintain open airway and
prevent aspiration. Give
water to rinse mouth, then provide liquid slowly. Contact a doctor or
Poisons Information
Centre, phone 131126. If medical advice is needed, have this MSDS or
product container or
label at hand.
INHALATION:
Product may be irritating, but significant inhalation exposure is
considered to be unlikely. If
dust is inhaled, move patient to fresh air. If irritation persists,
seek medical attention.
INGESTION:
If swallowed DO NOT induce vomiting. For advice, contact a doctor or
Poisons Information
Centre, phone 131126. Seek medical ass

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Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
ACTIVE CONSTITUENTS
Cephalexin 300 mg/tablet, 600 mg/tablet.
ACTIONS
Cephalexin is a broad spectrum cephalosporin antibiotic which is
chemically related to penicillin. Based on its broad spectrum of
activity, cephalexin makes an ideal choice for trauma cases where
diffusion into bone and joints may be important. It provides a good
treatment and prevention for osteomyelitis and supports the needs of
surgical prophylaxis. In cases of persistent infection (pyodermas
and abscesses) cephalexin is ideal for long-term therapy.
MICROBIOLOGY: As cephalexin is resistant to the action of
β-lactamases, Cephaforte is active against strains of _Staphylococcus
aureus_
that are insensitive to penicillin (or related antibiotics such as
ampicillin or amoxycillin). Cephalexin has bactericidal activity
against
a wide range of Gram-positive and Gram-negative bacteria, including
_Staphylococcus_ spp., _Streptococcus_ spp., _Corynebacterium_ spp.,
_Pasteurella multocida, Escherichia coli,_ _Proteus_ spp.,
_Micrococcus _spp. and _Moraxella_ spp., causing death of bacterial
cells through a
diversity of biological and biochemical effects on the cell wall.
PHARMACOKINETICS: Cephalexin is acid stable and active when
administered orally. Cephalexin has an excellent absorption profile,
with distribution through most body fluids and tissues including
kidneys, lungs, joints, bone, soft tissues and biliary tract.
Cephalexin is
excreted unmetabolised in the urine, and so provides high and
sustained antibiotic levels in cases of urinary tract infections
(UTIs), and
such levels are minimally affected by the usual variations in urinary
pH associated with UTIs. Removal of the active agent is primarily
through glomerular filtration through the kidneys as well as some
tubular secretion. The elimination half-life of cephalexin is about
one to two hours in dogs and cats.
INDICATIONS
Treatment of infections in dogs and cats caused by
cephalexin-sensiti

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