Pexion
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
15-08-2018
Vara einkenni
(SPC)
15-08-2018
Opinber matsskýrsla
(PAR)
15-08-2018
Virkt innihaldsefni:
imepitoin
Fáanlegur frá:
Boehringer Ingelheim Vetmedica GmbH
ATC númer:
QN03AX90
INN (Alþjóðlegt nafn):
imepitoin
Meðferðarhópur:
Dogs
Lækningarsvæði:
Other antiepileptics, Antiepileptics
Ábendingar:
For the reduction of the frequency of generalised seizures due to idiopathic epilepsy in dogs for use after careful evaluation of alternative treatment options.
Vörulýsing:
Revision: 6
Leyfisstaða:
Authorised
Leyfisdagur:
2013-02-25
Upplýsingar fylgiseðill
19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET:
PEXION 100 MG TABLETS FOR DOGS
PEXION 400 MG TABLETS 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 and manufacturer responsible for batch
release:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Pexion 100 mg tablets for dogs
Pexion 400 mg tablets for dogs
imepitoin
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
White, oblong, half-scored tablets with embedded logo “I 01” (100
mg) or “I 02” (400 mg) on one
side. The tablet can be divided into equal halves.
One tablet contains:
Imepitoin
100 mg
Imepitoin
400 mg
4.
INDICATION(S)
For the reduction of the frequency of generalised seizures due to
idiopathic epilepsy in dogs for use
after careful evaluation of alternative treatment options.
_ _
For the reduction of anxiety and fear associated with noise phobia in
dogs.
5.
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in dogs with severely impaired hepatic function, severe
renal or severe cardiovascular
disorders.
6.
ADVERSE REACTIONS
IDIOPATHIC EPILEPSY
The following mild and generally transient adverse reactions have been
observed in pre-clinical and
clinical studies for the epilepsy claim in order of decreasing
frequency: ataxia (loss of coordination),
emesis (vomiting), polyphagia (increased appetite) at the beginning of
treatment, somnolence
(drowsiness) (very common); hyperactivity (much more active than
usual), apathy, polydipsia
(increased thirst), diarrhoea, disorientation, anorexia (loss of
appetite), hypersalivation (increased
saliva production), polyuria (increased urine production) (common);
prolapsed nictitating membrane
(visible third eyelid) and decreased sight (isolated reports).
In epileptic dogs, aggression has been uncommonly reported, and
increased sensitivit
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Pexion 100 mg tablets for dogs
Pexion 400 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE:
Imepitoin
100 mg
Imepitoin
400 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, oblong, half-scored tablets with embedded logo “I 01” (100
mg) or “I 02” (400 mg) on one
side.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the reduction of the frequency of generalised seizures due to
idiopathic epilepsy in dogs for use
after careful evaluation of alternative treatment options.
_ _
For the reduction of anxiety and fear associated with noise phobia in
dogs.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in dogs with severely impaired hepatic function, severe
renal or severe cardiovascular
disorders.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
IDIOPATHIC EPILEPSY
The pharmacological response to imepitoin may vary and efficacy may
not be complete. On treatment,
some dogs will be free of seizures, in other dogs a reduction of the
number of seizures will be
observed, whilst others will be non-responders. For this reason,
careful consideration should be given
before deciding to switch a stabilized dog onto imepitoin from a
different treatment. In non-
responders, an increase in seizure frequency may be observed.
_ _
Should seizures not be adequately
controlled, further diagnostic measures and other antiepileptic
treatment should be considered. When
transition between different antiepileptic therapies is medically
required, this should be done gradually
and with appropriate clinical supervision.
3
The efficacy of the veterinary medicinal product in dogs with status
epilepticus and cluster seizures
has not been investigated. Therefore, imepitoin should not be u
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