PEPTOSYL BISMUTH SALICYLATE ORAL SUSPENSION
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
19-06-2017
Summary of Product characteristics
(SPC)
19-06-2017
Active ingredient:
BISMUTH SUBSALICYLATE
Available from:
CEVA ANIMAL HEALTH PTY LTD
INN (International Name):
bismuth salicylate(17.5mg/mL)
Pharmaceutical form:
ORAL SOLUTION/SUSPENSION
Composition:
BISMUTH SUBSALICYLATE MINERAL-BISMUTH Active 17.5 mg/ml
Units in package:
1L; 200mL; 4.5L; 5L
Class:
VM - Veterinary Medicine
Manufactured by:
CEVA ANIMAL HEALTH
Therapeutic group:
DOG | HORSE | BITCH | CASTRATE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT
Therapeutic area:
ALIMENTARY SYSTEM
Therapeutic indications:
DIARRHOEA | ABSORPTIVE | ACUTE DIARRHOEA | ACUTE INTESTINAL CATARRH | AVIAN BLACKHEAD | BACTERIAL ENTERITIS | BLACKHEAD | CHRONIC DIARRHOEA | COCCIDIOSIS | DIETARY FACTORS | DIETARY UPSET | ENTERITIS | FEED CONVERSION | FLATULANCE | FLUID LOSS | GASTRO-INTESTINAL | GRAM NEGATIVE BACTERIA | GROWTH RATE | K88+ SEROTYPES OF E.COLI | NESTING DIARRHOEA | NON-SPECIFIC IRRITANTS | POISONING | POSTWEANING SCOURS | PROPHYLACTIC | SCOURS | STREPTOMYCIN SENSITIVE BACTERI | SULPHADIAZINE SENSITIVE BACTER | SULPHONAMIDE SENSITIVE BACTERI | TRICHOMONIASIS | TRIMETHOPRIM SENSITIVE BACTERI | WHITE SCOURS
Product summary:
Poison schedule: 0; Withholding period: WHP: MEAT (Horses): 28 days.; Host/pest details: DOG: [DIARRHOEA]; HORSE: [DIARRHOEA]; Poison schedule: 0; Withholding period: ; Host/pest details: DOG: [DIARRHOEA]; HORSE: [DIARRHOEA]; An aid in the treatment of gastroenteritis and diarrhoea in horses and dogs.PRECAUTION: Safety in pregnant animals has not been established.
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
DIRECTIONS FOR USE:
PRECAUTION:
Safety in pregnant
animals has not been established.
Administer orally.
DOSAGE
HORSES: 0.5 - 1.0 mL per kg
DOGS: 0.25 - 0.5 ML
per kg
Repeat dose every 6 hours for 36 hours
and thence at 12 hour intervals for a
further 2 to 3 days.
MEAT
WITHHOLDING
PERIOD
(HORSES): 28 DAYS.
DISPOSAL:
Dispose of empty container by wrapping
with paper and putting in garbage [200
mL]
Break, crush or puncture and bury empty
containers in a local authority landfill. If
no landfill is available, bury the containers
below 500 mm in a disposal pit
specifically marked and set up for this
purpose clear of waterways, vegetation
and roots. Empty containers and product
should not be burned. [114.5/5 L]
FOR ANIMAL TREATMENT ONLY
PEPTOSYL
BISMUTH SALICYLATE ORAL
SUSPENSION
ACTIVE CONSTITUENT:
BISMUTH SALICYLATE 17.5 mg/mL
AN AID IN THE TREATMENT OF GASTROENTERITIS
AND DIARRHOEA IN HORSES AND DOGS.
[200 ML],[1 L],[4.5 L], [5 LJ
FIRST AID:
If
poisoning occurs,
contact
a doctor or Poisons
Information Centre. Phone Australia
131126.
STORE
below
30°C
(Room
Temperature). Protect from light.
Replace lid tightly after use.
KEEP OUT OF REACH OF
CHILDREN
Batch No.:
Expiry Date:
DOM:
APVMA No: 39578/56857
Ceva ANIMAL HEALTH PTY LTD
11 Moores Rd. Glenorie, NSW
Tel: (61) 2 9652 7000
Fax: (61) 2 9652 7001
www.ceva.com.au
RLP
Approved
Product: Peptosyl
Container Label
Date; 6/06/2012
Page 1 of 1
Infopest
Verified
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Summary of Product characteristics
PEPTOSYL
Creation Date: 2002
Revision Date: Feb 2014
Version: 5
Next revision due: Feb 2019
MATERIAL SAFETY DATA SHEET
PEPTOSYL ORAL SUSPENSION
Page 1 of 8
COMPANY DETAILS
COMPANY:
ADDRESS:
Ceva Animal Health
11 Moores Road
ABN 68 131 747 370
Glenorie NSW 2157 Australia
TELEPHONE NUMBER:
FACSIMILE NUMBER:
+61 (02) 9652 7000
+61 (02) 9652 7001
EMERGENCY TELEPHONE NUMBER:
+61 (02) 9652 7000 (Business Hours)
Poisons Information Centre: 131126
SUBSTANCE IDENTIFICATION
PRODUCT NAME: NV PEPTOSYL BISMUTH SALICYLATE ORAL SUSPENSION_ _
_ _
OTHER NAMES: PEPTOSYL
UN NUMBER: None allocated
DANGEROUS GOODS CLASS AND SUBSIDIARY RISK: None allocated
HAZCHEM CODE: None allocated
SUSDP POISONS SCHEDULE NUMBER: Not Scheduled
USE: A suspension for oral administration to aid in the treatment of
gastroenteritis and diarrhoea in
horses and dogs. For animal treatment only.
STATEMENT OF HAZARDOUS NATURE: Not hazardous according to criteria of
NOHSC Australia.
RISK PHRASES: Not hazardous – no risk phrases identified.
SAFETY PHRASES: Not hazardous – no safety phrases identified.
SECTION 2 – HAZARDS IDENTIFICATION
SECTION 1 – IDENTIFICATION OF MATERIAL AND SUPPLIER
PEPTOSYL
Creation Date: 2002
Revision Date: Feb 2014
Version: 5
Next revision due: Feb 2019
MATERIAL SAFETY DATA SHEET
PEPTOSYL ORAL SUSPENSION
Page 2 of 8
INGREDIENTS:
CHEMICAL NAME
CAS NUMBER
PROPORTION % W/W
* Bismuth Subsalicylate
14882-18-9
1.75%
Sodium Bentonite
-
0.33%
Methyl Salicylate
119-36-8
0.08%
Vitamin B12 (Cyanocobalamin)
68-19-9
trace
other ingredients determined not to be
hazardous
<10%
Water
7732-18-5
To volume
_ _
SWALLOWED:
Accidental or deliberate consumption of the product is unlikely to
cause any adverse
effects unless large volumes are consumed (eg an entire container).
May cause darkening of the faeces. In the absence of other effects,
this is not cause for concern.
EYE:
May cause transient irritation. If in eyes, hold eyes open and flood
with water for at
least 15 minutes.
SKIN:
If spilled on skin, remove contaminated clothing and wash skin with
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