Vetemex 10 mg/ml solution for injection for dogs and cats

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Maropitant

Commercializzato da:

CP-Pharma Handelsgesellschaft mbH

Codice ATC:

QA04AD90

INN (Nome Internazionale):

Maropitant

Dosaggio:

10 milligram(s)/millilitre

Forma farmaceutica:

Solution for injection

Tipo di ricetta:

POM: Prescription Only Medicine as defined in relevant national legislation

Area terapeutica:

maropitant

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2019-02-01

Scheda tecnica

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetemex 10 mg/ml solution for injection for dogs and cats (AT, CZ, ES,
FR, HU, IE, IT, NL, PL, PT,
SK, UK)
Vetemex vet 10 mg/ml solution for injection for dogs and cats (BE, DK,
FI, SE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Maropitant
10 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION
IS ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
Benzyl alcohol (E1519)
11.1 mg
Betadex sulfobutyl ether sodium
Citric acid, anhydrous
Sodium hydroxide (for pH-adjustment)
Water for injection
Clear, colourless to light yellow solution for injection.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs and cats.
3.2
INDICATIONS FOR USE FOR EACH 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.
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
Vomiting can be associated with serious, severely debilitating
conditions including gastrointestinal
obstructions; therefore, appropriate diagnostic evaluations should be
employed.
3
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 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
tre