Slentrol

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

dirlotapide

Available from:

Zoetis Belgium SA

ATC code:

QA08AB91

INN (International Name):

dirlotapide

Therapeutic group:

Dogs

Therapeutic area:

Antiobesity preparations, excl. diet products

Therapeutic indications:

As an aid in the management of overweight and obesity in adult dogs. To be used as part of an overall weight-management programme that also includes appropriate dietary changes and exercise practice.

Product summary:

Revision: 7

Authorization status:

Withdrawn

Authorization date:

2007-04-13

Patient Information leaflet

15
B. PACKAGE LEAFLET
Medicinal product no longer authorised
16
PACKAGE LEAFLET FOR:
SLENTROL 5 MG/ML ORAL SOLUTION FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium
Manufacturer responsible for batch release:
Pfizer Service Company
Hoge Wei 10
1930 Zaventem
Belgium
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Slentrol 5 mg/ml oral solution for dogs
Dirlotapide
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT
Dirlotapide 5 mg/ml is a colourless to pale yellow solution.
4.
INDICATION
As an aid in the management of overweight and obesity in adult dogs.
Your veterinary surgeon will
identify a target weight and explain how Slentrol should be used as
part of an overall weight
management programme which also includes appropriate dietary changes
and exercise practice.
5.
CONTRAINDICATIONS
Do not use in dogs in the growth phase.
Do not use during pregnancy or lactation.
Do not use in dogs with impaired liver function.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in dogs in which overweight or obesity is caused by a
concomitant systemic disease such
as hypothyroidism or hyperadrenocorticism.
Do not use in cats due to the risk of development of hepatic
lipidosis.
6.
ADVERSE REACTIONS
Some dogs may show one or more vomiting events, sometimes accompanied
by signs of tiredness,
disinterest in food or diarrhoea, which reoccur occasionally during
the course of treatment. These
signs typically started during the first month of treatment (about 30%
of dogs showed at least one
Medicinal product no longer authorised
17
vomiting event and up to 12% showed any of the other signs) and
decreased continuously during the
course of treatment. Some dogs (less than 10%) experienced repeated
vomiting (i.e. mo

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Slentrol_ _5 mg/ml oral solution for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Dirlotapide
5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
A colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
As an aid in the management of overweight and obesity in adult dogs.
To be used as part of an overall
weight management programme which also includes appropriate dietary
changes and exercise
practice.
4.3
CONTRAINDICATIONS
Do not use in dogs in the growth phase.
Do not use during pregnancy or lactation.
Do not use in dogs with impaired liver function.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in dogs in which overweight or obesity is caused by a
concomitant systemic disease such
as hypothyroidism or hyperadrenocorticism.
Do not use in cats due to the risk of development of hepatic
lipidosis.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
In clinical trials, treated dogs rapidly regained weight following
cessation of treatment when diet was
not restricted. In order to avoid this rebound weight gain, it is
necessary to feed the dogs to
maintenance energy requirements. Thus, during treatment or at the end
of treatment at the latest, an
appropriate feeding and exercise regimen should be implemented in
order to ensure long term
maintenance of the bodyweight.
Medicinal product no longer authorised
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The liver function of dogs suspected of suffering from a liver disease
or dysfunction should be
evaluated before commencing treatment with the veterinary medicinal
product.
Any clinical indication of liver disease or dysfunction during
treatment should be investigated through
the evaluation of liver function