Part I. B: Summary of product characteristics page




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Part I.B:

SUMMARY OF PRODUCT CHARACTERISTICS

Page:

I.B -

Product:

Peridale 98 % w/w Granules







Company:

Dechra Limited

Date:

12/07/2007




1. Name of Veterinary Medicinal Product
Peridale 98 % w/w Granules

2. Qualitative and Quantitative Composition

Active ingredient


Sterculia 98.31 % w/w
For a full list of excipients, see section 6.1.

3. Pharmaceutical Form
Granules.

Orange coloured granules.



4. Clinical Particulars
4.1 Target species
Dogs.
4.2 Indications for use, specifying the target species
A traditional herbal remedy for the symptomatic relief of diarrhoea, constipation and non-specific enteritis. For the control of stool consistency following surgery and as an aid in the management of infected anal sacs. For use in dogs.
4.3 Contraindications
Foreign body impaction when enterotomy or enterectomy is urgent.



    1. Special warnings for each target species

In all cases, adequate supportive therapy should be administered where necessary.



    1. Special precautions for use


i) Special precautions for use in animals
During treatment care should be taken to provide an adequate supply of drinking water.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands thoroughly after using this product.
In the case of accidental ingestion, drink plenty of water and seek medical advice.
iii) Other precautions
None.
4.6 Adverse reactions (frequency and seriousness)
Not applicable.
4.7 Use during pregnancy, lactation or lay
No special precautions.
4.8 Interaction with other medicinal products and other forms of interaction
Not applicable.
4.9 Amounts to be administered and administration route
Small dogs (up to 5 kg bodyweight):

1.5 g (½ teaspoonful) to 3 g (1 level teaspoonful) daily.


Medium sized dogs (5-15 kg bodyweight):

3 g (1 level teaspoonful once or twice daily.


Large dogs (over 15 kg bodyweight):

6 g (1 heaped teaspoonful) once or twice daily.


For oral administration. The dose should be sprinkled over food or placed dry on the tongue.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
4.11 Withdrawal periods
Not applicable.
5. Pharmacological Particulars
Pharmacotherapeutic group: Bulk producers

ATC Vet Code: QA06AC03


5.1 Pharmacodynamic properties

Sterculia is a natural traditional herbal remedy. Sterculia has no pharmacological activity, but acts locally in the gastrointestinal tract as a bulking agent.



5.2 Pharmacokinetic properties

The bulk promoting agent exerts its effect mainly by a hydrophilic action. The Sterculia in Peridale takes up as much as 60 times its own volume of water, forming a gelatinous mass. This increases the bulk of the intestinal contents, promotes peristalsis and helps to ensure easy passsage of a soft stool. Sterculia is an otherwise inert substance not absorbed and so not exerting any systemic effect.
6. Pharmaceutical Particulars
6.1 List of excipients

Sorbitol


Sodium chloride

Sunset yellow lake E110

Hazelnut essence, soluble

6.2 Incompatibilities
None known.


    1. Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.


6.4 Special precautions for storage
Do not store above 25ºC

Store in a dry place.



6.5 Nature and contents of immediate packaging
Opaque polypropylene securitainer with a white polypropylene cap (push fit) of 175 g capacity, containing orange granules.
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.



  1. MARKETING AUTHORISATION HOLDER

Dechra Limited

Dechra House

Jamage Industrial Estate

Talke Pits

Stoke-on-Trent

Staffordshire

ST7 1XW


UK

Distributed by:


Dechra Veterinary Products

Cartmel Drive

Harlescott

Shrewsbury

Shropshire

SY1 3TB


UK

8. MARKETING AUTHORISATION NUMBER
Vm 10434/4032

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 29/01/1991

Date of renewal of the authorisation: 29/01/2006




  1. DATE OF ANY REVISION OF THE TEXT

12/07/2007




Date issued: 12/07/2007 Supersedes issue: 30/08/2005



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