ZOLETIL 50 (25 mg/ml + 25 mg/ml) lyophilisate and solvent for solution for injection for dogs and cats

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Tiletamine; Zolazepam

Διαθέσιμο από:

Virbac S.A.

Φαρμακολογική κατηγορία (ATC):

QN01AX99

INN (Διεθνής Όνομα):

Tiletamine; Zolazepam

Δοσολογία:

50 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Lyophilisate and solvent for solution for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Cats, Dogs

Θεραπευτική περιοχή:

other general anesthetics, combinations

Θεραπευτικές ενδείξεις:

Anaesthetic/Analgesic

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2016-04-15

Αρχείο Π.Χ.Π.

1
_[Version 8, 10/2012] _
APPENDIX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ZOLETIL 50 (25 mg/ml+25 mg/ml) lyophilisate and solvent for solution
for injection for dogs and cats
(FR / NL / PL / IE / MT)
ZOLETIL 50 VET 25 mg/ml+25 mg/ml lyophilisate and solvent for solution
for injection for dogs and
cats (SE / FI)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 675 mg lyophilisate contains:
Active substances :
Tiletamine (as hydrochloride)
125.00 mg
Zolazepam (as hydrochloride)
125.00 mg
Each vial of 5 ml solvent contains:
Benzyl alcohol (E1519)
0.100 g
Water for injections
5.00 ml
Each ml of reconstituted solution contains:
Active substances:
Tiletamine (as hydrochloride)
25.00 mg
Zolazepam (as hydrochloride)
25.00 mg
Excipient:
Benzyl alcohol (E1519)
20.00 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for solution for injection.
Appearance of the lyophilisate: White to slightly yellow compact mass;
Appearance of the solvent: Clear colourless liquid;
Appearance of the reconstituted solution: Clear, colourless to
slightly green-yellow solution, free from
particles.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
General anaesthesia.
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 severe cardiac or respiratory disease, or
in animals with renal, pancreatic or
hepatic insufficiency.
Do not use in the event of severe hypertension.
Do not use in rabbits.
Do not use in animals with head trauma or intracranial tumours.
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Do not use for caesarean section.
Do not use in pregnant bitches and queens.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
In dogs, since zolazepam is eliminated more quickly than tiletamine,
there is a shorter duration of
tranquilisation than there is of anaesthesia.
4.5
SPECIAL PRECAUTIONS FOR USE
i) Special precautions for use in animals
Ani