Kaogel Vp 19.72% W/V Oral Suspension
Revised: April 2014
AN: 01718/2013
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Kaogel VP 19.72% w/v Oral Suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance %
w/v
Kaolin, light 19.72
Excipients
Sorbic Acid 0.10
Methyl Parahydroxybenzoate 0.20
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Oral suspension.
An off-white suspension
4. CLINICAL PARTICULARS
4.1 Target species
Dogs and cats.
4.2 Indications for use, specifying the target species
For treatment of diarrhoea of non-specific origins in dogs and cats.
4.3 Contra-indications
Contra-indicated in cases of intestinal obstruction.
Special warnings for each target species
None.
4.5 Special precautions for use
Special
precautions for use in animals
Shake the bottle before
use.
Special
precautions to be taken by the person administering the veterinary
medicinal product to animals
Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
None.
Use during pregnancy, lactation or lay
No restriction.
4.8 Interaction with other medicinal products and other forms of interaction
May adsorb other oral medications when given concurrently therefore reducing bioavailability.
4.9 Amounts to be administered and administration route
Shake the bottle before use. By oral administration. 0.5–1 ml/kg
bodyweight as a total daily dose. May be given as a divided dose
3-4 times daily.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdose may lead to mild constipation.
Withdrawal period
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
ATCVet Code:QA07BC02
The active principal is kaolin light which is a well-established gastro-intestinal adsorbent of toxins and other substances. It also increases the bulk of the faeces to aid peristalsis.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sorbic Acid
Methyl Parahydroxybenzoate
Saccharin Sodium
Citric Acid Monohydrate or Citric Acid Anhydrous
Pectin
Bentonite
Flavour Product No: 167
Water, Purified
Citric Acid Monohydrate or Citric Acid Anhydrous or Sodium Citrate Dihydrate (for pH adjustment)
6.2 Incompatibilities
None known.
6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 5 years.
6.4. Special precautions for storage
Do not store above 25ºC.
Nature and composition of immediate packaging
480 ml white opaque high density polyethylene bottle with white opaque high density polyethylene cap (screw fit).
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
5th Floor, 6 St. Andrew Street
London
EC4A 3AE
8. MARKETING AUTHORISATION NUMBER
Vm42058/4073
9. DATE OF THE FIRST AUTHORISATION
Date:31 January 1985
10. DATE OF REVISION OF THE TEXT
Date:April 2014
03 April 2014