Yarvitan
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
04-09-2007
Karatteristiċi tal-prodott
(SPC)
04-09-2007
Rapport ta 'Valutazzjoni Pubblika
(PAR)
04-09-2007
Ingredjent attiv:
mitratapide
Disponibbli minn:
Janssen Pharmaceutica N.V.
Kodiċi ATC:
QA08AB90
INN (Isem Internazzjonali):
mitratapide
Grupp terapewtiku:
Dogs
Żona terapewtika:
Antiobesity preparations, excl. diet products
Indikazzjonijiet terapewtiċi:
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. Introducing appropriate lifestyle changes (e.g. increased exercise), in conjunction with this weight management programme, may provide additional benefits.
Sommarju tal-prodott:
Revision: 3
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2006-11-14
Fuljett ta 'informazzjoni
Medicinal product no longer authorised
B. PACKAGE LEAFLET
16/20
Medicinal product no longer authorised
PACKAGE LEAFLET
YARVITAN 5 MG/ML ORAL SOLUTION FOR DOGS
Read all of this leaflet carefull
y before you start administering the medicine to your dog:
_Keep this leaflet. You may need to read it again _
_If you have further questions, please ask your veterinary surgeon or
your pharmacist _
_This medicine has been prescribed for your dog only and you should
not pass it on to others._
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse
Belgium
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Yarvitan 5 mg/ml oral solution for dogs
Mitratapide
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Mitratapide 5 mg/ml
Butylated hydroxyanisole (E 320)
Yarvitan is a colourless to slightly yellow solution.
4.
INDICATION(S)
Yarvitan is indicated as an aid in the management of overweight and
obesity in adult dogs. The
treatment is part of an overall weight management programme which also
includes a nutrition
programme. Introducing appropriate lifestyle changes (e.g. increased
exercise), in conjunction with
this weight management programme, may provide additional benefits.
5.
CONTRAINDICATIONS
Do not administer Yarvitan:
if your dog has impaired liver function.
if your dog is hypersensitive (allergic) to mitratapide or to any of
the other ingredients.
if your dog is pregnant or during lactation.
in dogs less than 18 months of age.
if overweight or obesity in your dog is caused by a concomitant
systemic disease such as
hypothyroidism (this is due to a malfunction of the thyroid gland) or
hyperadrenocorticism.(this
is due to a malfunction of the adrenal gland).
17/20
Medicinal product no longer authorised
6.
ADVERSE REACTIONS
Tell your veterinary surgeon if you notice any of the following:
significant loss of appetite. Loss of appetite
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
Medicinal product no longer authorised
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1/20
Medicinal product no longer authorised
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Yarvitan 5 mg/ml oral solution for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Mitratapide 5 mg/ml
EXCIPIENT(S):
Butylated hydroxyanisole (E 320) 2 mg/ml
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral solution.
A colourless to slightly 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.
Introducing
appropriate lifestyle changes (e.g. increased exercise), in
conjunction with this weight management
programme, may provide additional benefits.
4.3
CONTRAINDICATIONS
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 during pregnancy and lactation.
Do not use in dogs less than 18 months of age.
Do not use in dogs in which overweight or obesity is caused by a
concomitant systemic disease such
as hypothyroidism or hyperadrenocorticism.
4.4
SPECIAL WARNINGS
None.
2/20
Medicinal product no longer authorised
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The use in dogs for breeding purposes has not been evaluated.
If
vomiting,
significantly
reduced
appetite
or
diarrhoea
repeatedly
occurs,
treatment
should
be
interrupted and the advice of a veterinarian should be sought. Where
treatment is interrupted due to
vomiting, it is recommended that when treatment is resumed, the
product should be administered after
a meal. In addition, treatment should be interrupted and the advice of
a veterinarian should be sought
where the observed body weight loss is severe and rapid.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VE
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