NOAH Compendium

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Date: Friday, July 30, 2021 16:07

Release 2.145
Antisedan 5 mg/ml Solution for Injection
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Neurological preparations: Others
Active ingredient: Atipamezole Hydrochloride
Product:Antisedan® 5 mg/ml Solution for Injection
Product index: Antisedan 5 mg/ml Solution for Injection
Presentation
A clear, colourless solution for injection containing atipamezole hydrochloride 5 mg/ml. Methyl hydroxybenzoate is included as an antimicrobial preservative.
Uses
Atipamezole is a selective alpha-2 adrenoceptor antagonist which is indicated for the reversal of the sedative and analgesic effects of medetomidine or dexmedetomidine in dogs and cats. It also reverses all other effects of medetomidine or dexmedetomidine, such as cardiovascular and respiratory effects.
Dosage and administration
For intramuscular injection. Atipamezole (Antisedan) is quickly absorbed and is generally administered 15–60 minutes after the medetomidine or dexmedetomidine.
Dogs
The optimal dose of Antisedan, in micrograms per kilogram (mcg/kg), is five times that of the previous medetomidine dose or ten times that of the previous dexmedetomidine dose. The Antisedan dose in millilitres is the same as that of medetomidine 1mg/ml solution or dexmedetomidine 0.5mg/ml solution. The Antisedan dose in millilitres is one fifth (1/5) of the dose volume of dexmedetomidine 0.1mg/ml solution.
Where medetomidine (Domitor) or dexmedetomidine (Dexdomitor) has been used, with or without butorphanol, as a premedicant to thiopentone-halothane anaesthesia in dogs, or as a premedicant to propofol anaesthesia in dogs, Antisedan may be administered in the post-operative phase to reverse the effects of medetomidine or dexmedetomidine and hasten recovery. Antisedan in the post-operative phase rapidly causes arousal to full awareness and thus radically reduces the period of possible cardiovascular depression and hypothermia.
Cats
The optimal dose of Antisedan, in micrograms per kilogram (mcg/kg), is two-and-a-half times that of the previous medetomidine dose or five times that of the previous dexmedetomidine dose. The Antisedan dose in millilitres is half of the dose volume of medetomidine 1mg/ml solution or dexmedetomidine 0.5mg/ml solution and one tenth (1/10) of the dose volume of dexmedetomidine 0.1mg/ml solution.
The dose of Antisedan in micrograms per kilogram (mcg/kg) should not exceed four times that of the previously administered medetomidine or eight times that of dexmedetomidine.
When cats have been anaesthetised with medetomidine (Domitor) or dexmedetomidine (Dexdomitor), with or without butorphanol, and ketamine, Antisedan may be administered to reverse the effects of medetomidine or dexmedetomidine and so speed recovery from anaesthesia.
Contra-indications, warnings, etc
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
After administration of this veterinary medicinal product, the animals should be allowed to rest in a maximally quiet place.
Antisedan has only been administered to a limited number of pregnant dogs and cats and therefore cannot be recommended in pregnancy.
In dogs, a transient hypotensive effect has been observed during the first ten minutes post-injection.
Vomiting, panting, defaecation and muscle tremors (possibly shivering) have been reported, but these effects appear to be rare.
In dogs when a combination of butorphanol, medetomidine (Domitor) or dexmedetomidine (Dexdomitor) and ketamine has been used Antisedan should not be used.
In cats, when using low doses of Antisedan to partially reverse the effects of medetomidine or dexmedetomidine, the possibility of hypothermia (even when aroused from sedation) should be guarded against.
In cats, Antisedan should not be administered within 30-40 minutes of the administration of ketamine. If the effect of the alpha-2 agonist is eliminated earlier, the residual effect of ketamine may cause convulsions.
No harmful interactions with other agents have been encountered in clinical trials. However, concurrent use of drugs affecting the CNS is not recommended, apart from those in the data sheet.
Transient over-alertness and tachycardia may be observed after a possible overdosage. Over-alertness in the cat is best handled by minimising external stimuli.
Operator Warnings
Due to the potent pharmacological effect of Antisedan, skin contact should be avoided and impervious gloves should be worn during administration. Care should be taken to avoid accidental self-injection. If accidental self-injection occurs, seek immediate medical attention showing a copy of the product literature. Do not drive. The patient should not be left unattended. In case of accidental spillage, wash the affected area immediately with clean running water. Seek medical attention if irritation persists. In case of accidental ingestion, seek medical advice immediately.
Pharmaceutical precautions
Do not store above 25°C. Protect from light.
Following withdrawal of the first dose use the product within 3 months. Discard any unused material.
Avoid the introduction of contamination during use.
Keep out of the reach and sight of children.
For animal treatment only.
Any unused veterinary medicinal product or waste materials derived from such products should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-V
Packaging quantities
Antisedan is provided in colourless glass vials containing 10 ml.
Further information
Marketing Authorisation Holder (if different from distributor)
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Marketing Authorisation Number
Vm 06043/4004
Significant changes
GTIN
GTIN description:ANTISEDAN 5 MG/ML VET INJ 10 ML GB
GTIN:05012674902110