Alzane 5 mg/ml, solution for injection for dogs and cats

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Atipamezole hydrochloride

Διαθέσιμο από:

Laboratorios SYVA, S.A.U

Φαρμακολογική κατηγορία (ATC):

QV03AB90

INN (Διεθνής Όνομα):

Atipamezole hydrochloride

Δοσολογία:

5 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Cats, Dogs

Θεραπευτική περιοχή:

atipamezole

Θεραπευτικές ενδείξεις:

Neurological Preparations

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2011-10-28

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Alzane 5 mg/ml, solution for injection for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active ingredients
Atipamezole hydrochloride
5.0 mg
(equivalent to 4.27 mg atipamezole base)
Excipients
Methyl parahydroxybenzoate (E 218)
1.0 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless sterile aqueous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Atipamezole
hydrochloride
is
a
selective
2-antagonist
and indicated for
reversal
of
the
sedative
effects
of
medetomidine and dexmedetomidine in dogs and cats.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
substance or to any of the excipients.
Do not use in breeding animals or animals suffering from hepatic,
renal or cardiac diseases.
See also section 4.7
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
H
E
A
L
T
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P
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T
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R
E
G
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A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
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4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
After administration of the product,
the animals should be allowed to rest in a quiet place.
During recovery animals
should not be left unattended.
Make sure the animal has regained a normal swallowing