Zenalpha

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

medetomidine hydrochloride, vatinoxan hydrochloride

Available from:

Vetcare Oy

ATC code:

QN05CM99

INN (International Name):

medetomidine hydrochloride, vatinoxan hydrochloride

Therapeutic group:

Dogs

Therapeutic area:

Psycholeptics, hypnotics and sedatives

Therapeutic indications:

To provide restraint, sedation and analgesia during conduct of non-invasive, non-painful or mildly painful procedures and examinations intended to last no more than 30 minutes.

Authorization status:

Authorised

Authorization date:

2021-12-15

Patient Information leaflet

16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
ZENALPHA 0.5 MG/ML + 10 MG/ML SOLUTION FOR INJECTION 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:
Vetcare Oy, P.O. Box 99, 24101 Salo, Finland
Manufacturer responsible for batch release:
Apotek Produktion & Laboratorier AB, Formvägen 5B, SE-90621 Umeå,
Sweden
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zenalpha 0.5 mg/ml +10 mg/ml solution for injection for dogs
medetomidine hydrochloride / vatinoxan hydrochloride
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
1 ml contains:
ACTIVE SUBSTANCES:
Medetomidine hydrochloride
0.5 mg (equivalent to 0.425 mg medetomidine)
Vatinoxan hydrochloride
10 mg (equivalent to 9.2 mg vatinoxan)
EXCIPIENTS:
Methyl parahydroxybenzoate (E 218) 1.8 mg
Propyl parahydroxybenzoate
0.2 mg
Clear, slightly yellow to yellow or brownish yellow solution.
4.
INDICATION(S)
To provide restraint, sedation and analgesia during conduct of
non-invasive, non-painful or mildly
painful procedures and examinations intended to last no more than 30
minutes.
5.
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
Do not use in animals with cardiovascular disease, respiratory disease
or impaired liver or kidney
function.
Do not use in animals that are in shock or severely debilitated.
Do not use in animals that have hypoglycaemia or are at risk of
developing hypoglycaemia.
Do not use as pre-anaesthetic medicine.
Do not use in cats.
6.
ADVERSE REACTIONS
Hypothermia, bradycardia and tachycardia were very commonly observed
in safety and clinical
studies. Diarrhoea/colitis and muscle tremor were commonly observed.
Vomiting/nausea and
involuntary defaecation were uncommonly observed. Cardiac arrhythmias,
such as second-degree AV
18
block and ventricular escape complexes, were seen very commonly in
laboratory safety studies.
Injected sclera were observed v

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zenalpha 0.5 mg/ml + 10 mg/ml solution for injection for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCES:
Medetomidine hydrochloride
0.5 mg (equivalent to 0.425 mg medetomidine)
Vatinoxan hydrochloride
10 mg (equivalent to 9.2 mg vatinoxan)
EXCIPIENTS:
Methyl parahydroxybenzoate (E218) 1.8 mg
Propyl parahydroxybenzoate
0.2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, slightly yellow to yellow or brownish yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
To provide restraint, sedation and analgesia during conduct of
non-invasive, non-painful or mildly
painful procedures and examinations intended to last no more than 30
minutes.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
Do not use in animals with cardiovascular disease, respiratory disease
or impaired liver or kidney
function.
Do not use in animals that are in shock or severely debilitated.
Do not use in animals that have hypoglycaemia or are at risk of
developing hypoglycaemia.
Do not use as pre-anaesthetic medicine.
Do not use in cats.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Nervous or excited dogs with high levels of endogenous catecholamines
may exhibit a reduced
pharmacological response to alpha-2 adrenoceptor agonists like
medetomidine (ineffectiveness). In
agitated animals, the onset of sedative/analgesic effects could be
slowed, or the depth and duration of
effects could be diminished or non-existent. Therefore, the dog should
be given the possibility to calm
3
down before initiation of the treatment and rest quietly after
administration of the product until
evidence of sedation has occurred.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In the absence of available data, treatment of puppies less than