Dormostop 5 mg/ml Solution for Injection for Dogs and Cats

Excipients:
Qualitative composition of
excipients and other constituents
Quantitative composition if that
information is essentialfor proper
administration of the veterinary
medicinal product
Methyl parahydroxybenzoate (E218)1.0mgSodium chlorideHydrochloric acid, diluted (for pH-
adjustment)
Sodium hydroxide (for pH-
adjustment)
Water for injections
Clear colourless, practically free from particles solution.
3. CLINICAL INFORMATION
3.1 Target species
Dogs, cats
3.2 Indications for use for each target species
Reversal of the sedative effects of medetomidine and dexmedetomidine.
3.3 Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
Do not use in animals suffering from hepatic or renal diseases.
3.4 Special warnings
None.
3.5 Special precautions for use
Special precautions for safe use in the target species:
After administration of the veterinary medicinal product, the animals should be
allowed to rest in a quiet place.
Atipamezole reverses all effects of (dex)medetomidine, thus the sedative, analgesic
and cardiovascular effects which may lead to a transient increase in heart rate.
If sedatives other than (dex)medetomidine are given, it must be kept in mind that the
effects of those other agents may persist after reversal of (dex)medetomidine.
Atipamezole does not reverse the effect of ketamine, which may cause seizures in
dogs and elicit cramps in cats when used alone. Do not administer atipamezole
within 30 – 40 minutes of prior administration of ketamine.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
The veterinary medicinal product may cause irritation to the skin, eyes, and mucous
membranes. Dermal and ocular exposure should therefore be avoided. In case of
accidental dermal or ocular exposure, rinse the skin and/or the eye with water. Seek
medical attention if irritation persists and show the package leaflet or the label to the
physician.
This veterinary medicinal product may cause adrenergic effects. Care should be
taken to avoid accidental self-injection. In case of accidental self-injection, seek
medical advice immediately and show the package leaflet or the label to the
physician.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Dogs and cats:
Rare
(1 to 10 animals / 10,000
animals treated):
Hyperactivity;
Tachycardia, arrhythmias;
Increased salivation, vomiting, diarrhoea, and
involuntary defecation;
Atypical vocalisation;
Muscle tremor;
Increased respiratory rate;
Uncontrolled micturition.
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Sedation
.Undetermined
(frequency cannot be
estimated from the available
data)
Hypotension
.
Recurrence of sedation may occur or the recovery time may not be shortened.
Transient, during the first 10 minutes post injection of atipamezole hydrochloride.
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:
The safety of the veterinary medicinal product has not been established during
pregnancy and lactation. The use is not recommended during pregnancy and
lactation.
3.8 Interaction with other medicinal products and other forms of interaction
A simultaneous administration of atipamezole with other centrally acting medicinal
products as diazepam, acepromazine or opiates is not recommended.
3.9 Administration routes and dosage
For single intramuscular use.
Atipamezole hydrochloride is administered 15-60 min after medetomidine or
dexmedetomidine hydrochloride administration.
Dogs: the intramuscular atipamezole hydrochloride dose [in µg] is five times that of
the previous medetomidine hydrochloride dose or ten times that of the
dexmedetomidine hydrochloride dose. Due to the 5-fold higher concentration of the
active ingredient (atipamezole hydrochloride) in this veterinary medicinal product
compared to that of veterinary medicinal products containing 1 mg medetomidine
hydrochloride per ml and the 10-fold higher concentration compared to that of
veterinary medicinal products containing 0.5 mg dexmedetomidine hydrochloride, an
equal volume of each veterinary medicinal product is required.
The concentration of atipamezole hydrochloride in the veterinary medicinal product
being 50-fold higher compared to that of veterinary medicinal products containing 0.1
mg/ml dexmedetomidine hydrochloride, the volume of the veterinary medicinal
product that is required is 5-fold lower than of the solution of dexmedetomidine
hydrochloride.
Dosage example dogs:
Dose
Medetomidine
HCl
1 mg/ml
Dose
Dexmedetomidine
HCl
0.5 mg/ml
Dose
Dexmedetomidine
HCl
0.1 mg/ml
Dose
Atipamezole
HCl
5 mg/ml
40 µg/kg20 µg/kg20 µg/kg 200 µg/kg= 0.04 ml/kg= 0.04 ml/kg= 0.2 ml/kg= 0.04 ml/kg
Cats: the intramuscular atipamezole hydrochloride dose [in µg] is two-and-a-half
times that of the previous medetomidine hydrochloride dose or five times that of the
dexmedetomidine hydrochloride dose. Due to the 5-fold higher concentration of the
active ingredient (atipamezole hydrochloride) in this veterinary medicinal product
compared to that of veterinary medicinal products containing 1 mg medetomidine
hydrochloride per ml and the 10-fold higher concentration compared to that of
veterinary medicinal products containing 0.5 mg dexmedetomidine hydrochloride,
half the volume of the veterinary medicinal product to that of the previously
administered medetomidine or dexmedetomidine should be given.
The concentration of atipamezole hydrochloride in the veterinary medicinal product
being 50-fold higher compared to that of veterinary medicinal products containing 0.1
mg/ml dexmedetomidine hydrochloride, the volume of the veterinary medicinal
product that is required is 10-fold lower than of the solution of dexmedetomidine
hydrochloride.
Dosage example cats:
Dose
Medetomidine
HCl
1 mg/ml
Dose
Dexmedetomidine
HCl
0.5 mg/ml
Dose
Dexmedetomidine
HCl
0.1 mg/ml
Dose
Atipamezole
HCl
5 mg/ml
80 µg/kg40 µg/kg40 µg/kg200 µg/kg= 0.08 ml/kg= 0.08 ml/kg= 0.4 ml/kg= 0.04 ml/kg
The recovery time is shortened to approximately 5 minutes. The animals become
mobile after approximately 10 minutes after administration of the veterinary
medicinal product.
Do not exceed a maximum of 1 ml per injection site. The dose to be administered
should preferably be divided over 2 injection sites.
The stoppers should not be broached more than 30 times.
3.10 Symptoms of overdose (and where applicable, emergency procedures
and antidotes)
Overdose of atipamezole hydrochloride may result in transient tachycardia and over-
alertness (hyperactivity, muscle tremor). If necessary, these symptoms may be
reversed by a (dex)medetomidine hydrochloride dose which is lower than the usually
used clinical dose.
If atipamezole hydrochloride is inadvertently administered to an animal not
previously treated with (dex)medetomidine hydrochloride, hyperactivity and muscle
tremor may occur. These effects may persist for about 15 minutes.
Over-alertness in the cat is best handled by minimising external stimuli.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary
medicinal products in order to limit the risk of development of resistance
For administration only by a veterinarian.
3.12 Withdrawal periods
Not applicable.
4.