Prevomax
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
04-10-2021
Vara einkenni
(SPC)
04-10-2021
Opinber matsskýrsla
(PAR)
06-07-2017
Virkt innihaldsefni:
maropitant
Fáanlegur frá:
Dechra Regulatory B.V.
ATC númer:
QA04AD90
INN (Alþjóðlegt nafn):
maropitant
Meðferðarhópur:
Cats; Dogs
Lækningarsvæði:
Alimentary tract and metabolism, Other antiemetics
Ábendingar:
Dogs:For the treatment and prevention of nausea induced by chemotherapyFor the prevention of vomiting except that induced by motion sicknessFor the treatment of vomiting, in combination with other supportive measuresFor the prevention of perioperative nausea and vomiting and improvement in recovery from general anaesthesia after use of the μ-opiate receptor agonist morphineCats:For the prevention of vomiting and the reduction of nausea, except that induced by motion sicknessFor the treatment of vomiting, in combination with other supportive measures.
Vörulýsing:
Revision: 6
Leyfisstaða:
Authorised
Leyfisdagur:
2017-06-19
Upplýsingar fylgiseðill
15
B.
PACKAGE LEAFLET
16
PACKAGE LEAFLET:
PREVOMAX 10 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Dechra Regulatory B.V.
Handelsweg 25
5531 AE Bladel
The Netherlands
Manufacturer responsible for batch release:
Produlab Pharma B.V.
Forellenweg 16
4941 SJ Raamsdonksveer
The Netherlands
Eurovet Animal Health B.V.
Handelsweg 25
5531 AE Bladel
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prevomax 10 mg/ml solution for injection for dogs and cats
Maropitant
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
1 ml contains:
ACTIVE SUBSTANCE:
Maropitant
10 mg
EXCIPIENTS:
Benzyl alcohol (E1519)
11.1 mg
A clear, colourless to light yellow solution.
4.
INDICATION(S)
Dogs
•
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.
17
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
Pain at injection site may occur when injected subcutaneously.
In cats, moderate to severe response to injection is very commonly
observed (in approximately one
third of cats).
In very rare cases, anaphylactic type reactions (allergic oedema,
urticaria, erythema, collapse,
dyspnoea, pale mucous membranes) may occur.
The frequency of adverse reactions is defined using the following
convention:
-
very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
-
common (more than 1 but less than 10 animals in 100
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prevomax 10 mg/ml solution for injection for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Maropitant
10 mg
EXCIPIENTS:
Benzyl alcohol (E1519)
11.1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
A clear, colourless to light yellow solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs
•
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.
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.
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.
3
The use of the veterinary medicinal product against vomiting due to
motion sickness is not
recommended.
Dogs:
Although maropitant has been demonstrated to be effective in both the
treatment and prevention of
emesis induced by chemotherapy, it was found more efficacious if used
preventively. Therefore, it is
recommended to administer the veterinary medicinal product prior to
administration of the
chemotherapeutic agent
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