ANTIDORM 10ML

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
ANTIDORM 5 mg/ml Solution for injection for dogs and cats
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains:
Active substance:
Atipamezole………………………………………………..4,27 mg
(equivalent to 5,0 mg atipamezole hydrochloride)
Excipients:
Methyl parahydroxybenzoate (E 218)………… 1,0 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Injectable solution.
Clear and colorless solution.
4. CLINICAL DATA
4.1 Target species
Dogs and cats.
4.2 Indications for use, specifying the target species
Atipamezole hydrochloride is a selective α2-antagonist indicated to reverse the effects
of sedation from 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.
Do not use in animals suffering from liver, kidney or heart conditions.
See also section 4.7.
4.4 Special warnings for each target species
None.
4.5 Special precautions for use

Special precautions for use in animals
After administration of the veterinary medicinal product, animals should be kept in
rest in a quiet place. During recovery time, patients should not be left
neglected animals. You must ensure that the animal has recovered a reflex of
normal swallowing before offering food or drink.
Due to the different recommended doses, care should be taken when using the
off-label veterinary medicinal product in animals other than
the target species.
If other sedatives are administered in addition to (dex)medetomidine, it should be borne in mind that
the effects of these agents may persist after reversing the effects of the
(dex)medetomidine.
Atipamezole does not reverse the effect of ketamine, which can cause seizures in dogs and
cause cramps in cats when used alone. Do not administer atipamezole in the first
30-40 minutes after a previous administration of ketamine.
Special precautions to be taken by the person administering the medicinal product
vet to animals
Due to the potent pharmacological activity of atipamezole, contact with the
veterinary medicinal product with the skin, eyes and mucous membranes. In case of accidental spillage,
immediately wash affected area with clean running water. Consult a doctor if
the irritation persists. Remove contaminated clothing that is directly in contact with the
skin.
Precautions must be taken in order to avoid any accidental ingestion or self-injection.
In case of accidental ingestion or self-injection, consult a doctor immediately and
show him the package insert or label. Do not drive. Do not leave the patient unattended.
Other precautions
None.
4.6 Adverse reactions (frequency and seriousness)
A transient hypotensive effect has been observed during the first 10 minutes after
Atipamezole hydrochloride injection. On rare occasions, they may occur
hyperactivity, tachycardia, salivation, atypical vocalization, muscle tremors, vomiting,
increased respiratory rate, urinary and intestinal incontinence. In very rare cases, they can
new episodes of sedation occur or that the recovery time is not reduced after the
atipamezole administration.
In cats, when low doses are used to partially neutralize the effects of the
medetomidine or dexmedetomidine, precautions should be taken to avoid the possibility of
hypothermia (including upon awakening from sedation).
4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and
lactation. Thus, its use is not recommended during pregnancy and lactation.
4.8 Interaction with other medicinal products and other forms of interaction
It is recommended not to administer atipamezole concomitantly with other drugs of
central action such as diazepam, acepromazine or opioids.
4.9 Amounts to be administered and administration route
Single intramuscular route.
The dose depends on the previously administered dose of medetomidine or dexmedetomidine.
Atipamezole hydrochloride is administered 15-60 minutes after the administration of the
medetomidine hydrochloride or dexmedetomidine.
Dogs: The dose of atipamezole hydrochloride (in µg per kg of body weight) is five times the
previous dose of medetomidine hydrochloride or ten times the dose of medetomidine hydrochloride
dexmedetomidine.
Due to the 5 times higher concentration of the active substance (atipamezole hydrochloride)
in this veterinary medicinal product compared to preparations containing 1 mg of
medetomidine hydrochloride per ml, and 10 times higher compared to preparations containing
contain 0,5 mg dexmedetomidine hydrochloride, an equal volume of
each preparation. Due to the 50 times higher concentration compared to preparations
containing 0,1 mg dexmedetomidine hydrochloride, 5 times volume is required
bottom of the atipamezole preparation.
Example of dosage in dogs:

Cats: The dose of atipamezole hydrochloride (in µg per kg of body weight) is 2,5 times the
previous dose of medetomidine hydrochloride or 5 times the dose of medetomidine hydrochloride
dexmedetomidine. Due to the 5 times higher concentration of the active substance
(atipamezole hydrochloride) in this veterinary medicinal product compared to other
preparations containing 1 mg medetomidine hydrochloride per ml, and 10 times
superior compared to preparations containing 0,5 mg of sodium hydrochloride
dexmedetomidine, half the volume of medetomidine should be administered or

dexmedetomidine. Due to the 50 times higher concentration compared to other
preparations containing 0,1 mg dexmedetomidine hydrochloride, a
10-fold lower volume of the atipamezole preparation.
Example of dosage in cats:

Recovery time in dogs and cats is reduced to approximately 5 minutes. He
animal begins to move approximately 10 minutes after administration of the
veterinary drug.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdoses of atipamezole hydrochloride may cause transient tachycardia and
arousal (hyperactivity, muscle tremors). If necessary, these symptoms can
neutralized with a dose of medetomidine hydrochloride or dexmedetomidine less than the
routinely administered clinical dose.
In case of inadvertent administration of atipamezole hydrochloride to an untreated animal
previously with medetomidine hydrochloride or dexmedetomidine, may cause
hyperactivity and muscle tremors. These effects may persist for
approximately 15 minutes.
The best way to treat arousal in cats is to minimize external stimuli.
4.11 Timeout
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: α2 receptor antagonist (antidote)
ATCvet code: QV03AB90
5.1 Pharmacodynamic properties

Atipamezole is a selective and potent agent that blocks α-2 receptors (α2 antagonist)
and activates the release of the neurotransmitter norepinephrine in the central nervous system and
peripheral, causing activation of the central nervous system through activation
nice. The other pharmacodynamic effects that can be observed, such as the
influence on the cardiovascular system, are slight. However, a
transient drop in blood pressure in the first 10 minutes after the
atipamezole hydrochloride injection.
As an α-2 antagonist, atipamezole is capable of eliminating (or inhibiting) the effects of
α-2 receptor agonists such as medetomidine or dexmedetomidine. So the
Atipamezole reverses the sedative effects of (dex)medetomidine hydrochloride in dogs and
cats, which return to their normal state and may cause a transient increase in heart rate
cardiac.
5.2 Pharmacokinetic data
Atipamezole hydrochloride is rapidly absorbed after intramuscular injection.
It is also rapidly and completely metabolized. The metabolites are mainly excreted in
urine and a small amount in feces.
6. PHARMACEUTICAL DATA
6.1 List of excipients
Methyl parahydroxybenzoate (E 218)
Sodium chloride
Water for injections
6.2 Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed
with other veterinary drugs in the same syringe.
6.3 Validity period
Shelf-life of the veterinary medicinal product packaged for sale: 30 months
Shelf-life after first opening the immediate packaging: 28 days
6.4. Special storage precautions
This veterinary medicinal product does not require special storage conditions.
Once the container is opened, no special storage conditions are required.
6.5 Nature and composition of immediate packaging
Type I transparent glass vial containing 10 ml, closed with a rubber stopper
bromobutyl and sealed with an aluminum and plastic flip-off cap.
6.6 Special precautions for disposal of the veterinary medicinal product not
used or, where appropriate, the residues derived from its use

Any unused veterinary medicinal product or residues derived from it must be disposed of
in accordance with local regulations.
7. MARKETING AUTHORIZATION HOLDER
VETPHARMA ANIMAL HEALTH, SL
C/ Les Corts, 23
08028 Barcelona
Spain
8. MARKETING AUTHORIZATION NUMBER(S)
2886 ESP
9. DATE OF THE FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
Date of first authorization: August 30, 2013
10. DATE OF REVISION OF THE TEXT
PROHIBITION OF SALE, DISPENSATION AND/OR USE
Dispensing conditions: Medicine subject to veterinary prescription.
Administration conditions: Exclusive administration by the veterinarian.

See technical sheet