Zoletil 100 (50 mg/ml+50 mg/ml) Lyophilisate and Solvent for Solution for Injection for Dogs and Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Tiletamine, Zolazepam

Available from:

Virbac

ATC code:

QN01AX99

INN (International Name):

Tiletamine, Zolazepam

Pharmaceutical form:

Lyophilisate and solvent for solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Neurological Agent general anaesthetic

Authorization status:

Authorized

Authorization date:

2016-04-20

Summary of Product characteristics

Revised: April 2023
AN: 00777/2022 & 00782/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ZOLETIL 100 (50 mg/ml+50 mg/ml) Lyophilisate and Solvent for Solution
for Injection
for Dogs and Cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 970 mg lyophilisate contains:
Active substances:
Tiletamine (as hydrochloride)
250.00 mg
Zolazepam (as hydrochloride)
250.00 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)
50.00 mg
Zolazepam (as hydrochloride)
50.00 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.
Revised: April 2023
AN: 00777/2022 & 00782/2022
Page 2 of 7
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.
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
Animals should be fasted for 12 hours prior to anaesthesia.
Re