Cerenia
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
18-08-2021
Produktets egenskaber
(SPC)
18-08-2021
Offentlige vurderingsrapport
(PAR)
08-07-2015
Aktiv bestanddel:
maropitant citrate
Tilgængelig fra:
Zoetis Belgium SA
ATC-kode:
QA04AD90
INN (International Name):
maropitant
Terapeutisk gruppe:
Dogs; Cats
Terapeutisk område:
Alimentary tract and metabolism
Terapeutiske indikationer:
Tablets Dogs:For the prevention of nausea induced by chemotherapy.For the prevention of vomiting induced by motion sickness.For the prevention and treatment of vomiting, in conjunction with Cerenia solution for injection and in combination with other supportive measures.Solution for injectionDogs:For the treatment and prevention of nausea induced by chemotherapy.For the prevention of vomiting except that induced by motion sickness.For the treatment of vomiting, in combination with other supportive measures.For the prevention of perioperative nausea and vomiting and improvement in recovery from general anaesthesia after use of the μ-opiate receptor agonist morphine.Cats:For the prevention of vomiting and the reduction of nausea, except that induced by motion sickness.For the treatment of vomiting, in combination with other supportive measures.
Produkt oversigt:
Revision: 21
Autorisation status:
Authorised
Autorisation dato:
2006-09-28
Indlægsseddel
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cerenia 16 mg tablets for dogs
Cerenia 24 mg tablets for dogs
Cerenia 60 mg tablets for dogs
Cerenia 160 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains 16 mg, 24 mg, 60 mg or 160 mg maropitant as
maropitant citrate monohydrate.
EXCIPIENTS:
Each tablet contains 0.075% w/w Sunset Yellow (E110) as a colorant.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pale orange tablet
The tablets have a score line allowing the tablet to be halved, with
the letters “MPT” and figures
denoting the quantity of maropitant on one side, the reverse side is
blank.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
•
For the prevention of nausea induced by chemotherapy.
•
For the prevention of vomiting induced by motion sickness.
•
For the prevention and treatment of vomiting, in conjunction with
Cerenia solution for injection
and in combination with other supportive measures.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vomiting can be associated with serious, severely debilitating
conditions including gastrointestinal
obstructions; therefore, appropriate diagnostic evaluations should be
employed.
Cerenia tablets have been shown to be effective in the treatment of
emesis, however where the
frequency of vomiting is high, orally administered Cerenia may not be
absorbed before the next
vomiting event occurs. It is therefore recommended to initiate the
treatment of emesis with Cerenia
solution for injection.
Good veterinary practice indicates that antiemetics should be used in
conjunction with other veterinary
and supportive measures, such as dietary control and fluid replacement
therapy while addressing the
underlying causes of the vomiting. The safety of maropitant during
treatment beyond 5 days has not
been explored in the target population (i.e. young dogs suffering from
vira
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Cerenia 16 mg tablets for dogs
Cerenia 24 mg tablets for dogs
Cerenia 60 mg tablets for dogs
Cerenia 160 mg tablets for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Each tablet contains 16 mg, 24 mg, 60 mg or 160 mg maropitant as maropitant citrate monohydrate.
Excipients:
Each tablet contains 0.075% w/w Sunset Yellow (E110) as a colorant.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Pale orange tablet .
The tablets have a score line allowing the tablet to be halved , with the letters “MPT” and figures
denoting the quantity of maropitant on one side, the reverse side is blank.
4. CLINICAL PARTICULARS
4.1 Target species
Dogs.
4.2 Indications for use, specifying the target species
• For the prevention of nausea induced by chemotherapy.
• For the prevention of vomiting induced by motion sickness.
• For the prevention and treatment of vomiting, in conjunction with Cerenia solution for injection
and in combination with other supportive measures.
4.3 Contraindications
None.
4.4 Special warnings for each target species
Vomiting can be associated with serious, severely debilitating conditions includ ing gastrointestinal
obstructions; therefore, appropriate diagnostic evaluations should be employed.
Cerenia tablets have been shown to be effective in the treatment of emesis, however where the
frequency of vomiting is high, orally administered Cerenia may not be absorbed before the next
vomiting event occurs. It is therefore recommended to initiate the treatment of emesis with Cerenia
s olution for injection.
Good veterinary practice indicates that antiemetics should be used in conjunction with other veterinary
and supportive measures, such as dietary control and fluid replacement therapy while addressing the
underlying causes of the vomiting. The safety of maropitant during treatment beyond 5 days has not
been explored in the target population (i.e. young dogs suffering from
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