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

Each ml of reconstituted solution contains:
Active substances:
Tiletamine (as hydrochloride) 50.00 mg
Zolazepam (as hydrochloride) 50.00 mg
Excipients:
Each ml of reconstituted solution contains:
Qualitative composition of
excipients and other constituents
Quantitative composition if that
information is essential for proper
administration of the veterinary
medicinal product
Lyophilisate vial:Sodium sulfate, anhydrous Lactose monohydrateSolvent vial:Benzyl Alcohol (E1519)20.00 mgWater for injections
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.
3. CLINICAL INFORMATION
3.1 Target species
Dogs and cats.
3.2 Indications for use for each target species
General anaesthesia.
3.3 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.
3.4 Special warnings
In dogs, since zolazepam is eliminated more quickly than tiletamine, there is a shorter
duration of tranquilisation than there is of anaesthesia.
3.5 Special precautions for use
Special precautions for safe use in the target species:
Animals should be fasted for 12 hours prior to anaesthesia.
Remove anti-parasite collar 24 hours before anaesthesia.
If necessary, hypersalivation can be controlled with the administration of
anticholinergic agents, such as atropine, before the anaesthesia according to the
benefit/risk assessment by the responsible veterinarian.
Please refer to section “Interaction with other medicinal products and other forms of
interaction” in case of the use of pre-anaesthetic agents.
Keep anaesthetised animals away from excessive noise and visual stimuli.
Apneustic breathing may be observed more commonly in cats after intravenous
injection than after intramuscular injection. Especially for high dosages, such abnormal
breathing patterns last for up to 15 minutes and then breathing returns to normal. In
case of prolonged apnea respiratory assistance should be provided.
Close observation of dogs during the first 5-10 minutes after induction is recommended
especially in animals with cardiopulmonary disease.
The veterinary medicinal product may cause hypothermia, in susceptible animals
(small body surface area, low ambient temperature) supplemental heat should be
applied if needed.
In dogs and cats the eyes remain open after receiving the product and should be
protected from injury and excessive drying of the cornea.
Dosage may need to be reduced in geriatric or debilitated animals, or in animals with
renal dysfunction.
Reflexes (e.g. palpebral, pedal, laryngeal) are not abolished during anaesthesia and
therefore use of this product alone may not be adequate if surgery is performed on
these areas.
Redosing may prolong and worsen recovery.
In the event of reinjections, side effects (hyper-reflexia, neurological problems) can be
produced due to tiletamine. It is recommended that the recovery phase occurs in a
calm environment.
The veterinary medicinal product contains benzyl alcohol, which has been documented
to cause adverse reactions in neonates. Therefore, the use of the veterinary medicinal
product is not recommended in very young animals.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
In case of accidental self-injection seek medical advice immediately and show the
package leaflet or the label to the physician.
Do not drive due to risk of sedation.
Wash splashes from skin and eyes immediately. In case of eye irritation, seek medical
advice.
Wash hands after use.
This veterinary medicinal product may cross the placenta and be harmful to the foetus,
therefore women who are pregnant, or are suspected to be pregnant, should not use
the product.
Benzyl alcohol may cause hypersensitivity (allergic) reactions. People with known
hypersensitivity to benzyl alcohol should avoid contact with the veterinary medicinal
product.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Dogs and cats:
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Immediate pain upon injection
Neurological disorder (Convulsions, Coma,
Hyperaesthesia)
, Prolonged anaesthesia

(Myoclonus,
Ataxia, Paresis, Restlessness)
Respiratory tract disorder (Dyspnoea, Tachypnoea,
Bradypnoea)
2, 4
Cardiac disorder (Tachycardia)
2, 4
Systemic disorder
(Prostration, Hypothermia, Hyperthermia)
, Cyanosis
2,
Pupil disorder
Hypersalivation
Agitation
, Vocalisation
Most prevalent in cats.
Mainly during the awakening phase in the dog, and during surgery and the awakening
phase in the cat.
Observed during the recovery phase.
At doses of 20 mg/kg and above.
These adverse effects are reversible and disappear once the active substance is
eliminated from the body.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian,
to either the marketing authorisation holder or its local representative or the
national competent authority via the national reporting system. See the package
leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
Laboratory studies in animals have not produced any evidence of teratogenic effects.
The product crosses the placenta and may cause respiratory depression in newborns
that can be fatal for puppies and kittens.
The safety of the veterinary medicinal product has not been established during
pregnancy or lactation. Do not use during pregnancy. During lactation, use only
according to the benefit-risk assessment by the responsible veterinarian.
3.8 Interaction with other medicinal products and other forms of interaction
The benefit-risk assessment for using the product with other pre-anaesthetic or
anaesthetic agents must take into consideration the dosages of the agents used, the
nature of the intervention and the ASA (American Society of Anaesthesiologists) class
to which the animal belongs. The required dosage of tiletamine-zolazepam is likely to
change depending on which agents are concurrently used.
The dosage of tiletamine – zolazepam may need to be reduced when used
concomitantly with pre-anaesthetic and other anaesthetic agents. Premedication with
phenothiazine tranquilisers (e.g. acepromazine) can cause increased cardio-
respiratory depression and an increased hypothermic effect that occurs in the last
phase of anaesthesia.
Do not use medications containing chloramphenicol during the pre- or intra-operative
period, as this slows down elimination of the anaesthetics.
3.9 Administration routes and dosage
Intramuscular or intravenous use.
Dosage:
The content of the lyophilisate vial is to be diluted in 5 ml of the attached solvent.
The dosage is expressed in mg of the product, on the understanding that the
reconstituted product is at a concentration of 100 mg per ml and contains 50 mg of
tiletamine per ml and 50 mg of zolazepam per ml.
When the product is administered intramuscularly (unable to stand in 3 to 6 minutes)
or intravenously (unable to stand in less than one minute), the recommended
therapeutic dosages are the following:
IN DOGSIntramuscular routeIntravenous routeTests and procedures
causing little pain
7 to 10 mg/kg bw
0.07 to 0.1 mL/kg bw
5 mg/kg bw
0.05 mL/kg bw
Minor surgical procedures,
anaesthesia of short
duration
10 to 15 mg/kg bw
0.1 to 0.15 mL/kg bw
7.5 mg/kg bw
0.075 mL/kg bw
Painful interventions15 to 25 mg/kg bw
0.15 to 0.25 mL/kg bw
10 mg/kg bw
0.1 mL/kg bw
IN CATSIntramuscular routeIntravenous routeTests and procedures
causing little pain
10 mg/kg bw
0.1 mL/kg bw
5 mg/kg bw
0.05 mL/kg bw
Orthopaedic operation15 mg/kg bw
0.15 mL/kg bw
7.5 mg/kg bw
0.075 mL/kg bw
Please refer also to sections “Adverse events” and/or “Symptoms of overdose” since
adverse reaction might occur at therapeutic doses.
Intravenous injections to be repeated, if needed, at between 1/3 and 1/2 of the initial
dose but the total dosage should not exceed 2