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Date: Tuesday, August 4, 2020 20:06

Release 3.20
Alzane 5 mg/ml Solution for Injection for Dogs & Cats
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Neurological preparations: Others
Active ingredient: Atipamezole Hydrochloride
Product:Alzane® 5 mg/ml Solution for Injection for Dogs & Cats
Product index: Alzane
Presentation
Alzane 5 mg/ml solution for injection is a clear, colourless sterile aqueous solution containing 5 mg/ml atipamezole hydrochloride and 1 mg/ml methyl parahydroxybenzoate as preservative.
Uses
Atipamezole hydrochloride is a selective α2-antagonist and indicated for reversal of the sedative effects of medetomidine and dexmedetomidine in dogs and cats.
Dosage and administration
For single intramuscular injection. The dose depends on the previously administered medetomidine or dexmedetomidine. Use of an appropriately graduated syringe is recommended to ensure accurate dosing when administering small volumes. Atipamezole is generally administered 15-60 minutes after medetomidine or dexmedetomidine injection.
Dogs: The dose of atipamezole hydrochloride (in µg per kg bodyweight) is five times that of the previous dose of medetomidine hydrochloride or ten times that of the dose of dexmedetomidine hydrochloride. Due to the fivefold concentration of the active ingredient (atipamezole hydrochloride) in this product compared to that of preparations containing 1 mg medetomidine hydrochloride per ml and the tenfold concentration compared to that of preparations containing 0.5 mg dexmedetomidine hydrochloride, an equal volume of each preparation is required.
Due to the 50-fold concentration compared to that of preparations containing 0.1 mg dexmedetomidine hydrochloride, a volume 5 times lower of the Alzane is required.
Dosage example dogs:
Medetomidine 1.0 mg/ml solution for injection dosage
Alzane 5.0 mg/ml solution for injection dosage
0.04 ml/kg bodyweight (bw), corresponding with 40 μg/kg bw
0.04 ml/kg bodyweight (bw), corresponding with 200 μg/kg bw
Dexmedetomidine 0.5 mg/ml solution for injection dosage
Alzane 5.0 mg/ml solution for injection dosage
0.04 ml/kg bodyweight (bw), corresponding with 20 μg/kg bw
0.04 ml/kg bodyweight (bw), corresponding with 200 μg/kg bw
Dexmedetomidine 0.1 mg/ml solution for injection dosage
Alzane 5.0 mg/ml solution for injection dosage
0.2 ml/kg bodyweight (bw), corresponding with 20 μg/kg bw
0.04 ml/kg bodyweight (bw), corresponding with 200 μg/kg bw
Cats: The atipamezole hydrochloride dose (in µg per kg bodyweight) is 2.5 times that of the previous dose of medetomidine hydrochloride or five times that of the dose of dexmedetomidine hydrochloride. Due to the fivefold concentration of the active ingredient (atipamezole hydrochloride) in this product compared to that of preparations containing 1 mg medetomidine hydrochloride per ml and the tenfold concentration compared to that of preparations containing 0.5 mg dexmedetomidine hydrochloride, half the volume of the product to that of the previously administered medetomidine or dexmedetomidine should be given.
Due to the 50-fold concentration compared to that of preparations containing 0.1 mg dexmedetomidine hydrochloride, a volume 10 times lower of Alzane is required.
Dosage example cats:
Medetomidine 1.0 mg/ml solution for injection dosage
Alzane 5.0 mg/ml solution for injection dosage
0.08 ml/kg bodyweight (bw), corresponding with 80 μg/kg bw
0.04 ml/kg bodyweight (bw), corresponding with 200 μg/kg bw
Dexmedetomidine 0.5 mg/ml solution for injection dosage
Alzane 5.0 mg/ml solution for injection dosage
0.08 ml/kg bodyweight (bw), corresponding with 40 μg/kg bw
0.04 ml/kg bodyweight (bw), corresponding with 200 μg/kg bw
Dexmedetomidine 0.1 mg/ml solution for injection dosage
Alzane 5.0 mg/ml solution for injection dosage
0.4 ml/kg bodyweight (bw), corresponding with 40 μg/kg bw
0.04 ml/kg bodyweight (bw), corresponding with 200 μg/kg bw
The recovery time for dogs and cats is shortened to approximately 5 minutes. The animals become mobile after approximately 10 minutes after administration of the product.
Contra-indications, warnings, etc
Do not use in animals with known hypersensitivity to the active substance or to any of the excipients.
Do not use in breeding animals or animals suffering from hepatic, renal or cardiac diseases.
Make sure the animal has regained a normal swallowing reflex before any food or drink is offered.
After administration of the product, the animals should be allowed to rest in a quiet place. During recovery animals should not be left unattended.
Due to different dosing recommendations caution should be taken using the product off label in animals other than the target species.
If sedatives other than medetomidine or dexmedetomidine are given, it must be kept in mind that the effects of those other agents may persist after the reversal of the effect of the α2-agonist.
Simultaneous administration of atipamezole with other centrally acting medicinal products such as diazepam, acepromazine or opiates is not recommended.
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.
The safety of the product has not been established during pregnancy and lactation. Therefore the use is not recommended during pregnancy and lactation.
A transient hypotensive effect has been observed during the first 10 minutes after the injection of atipamezole hydrochloride. In rare cases hyperactivity, tachycardia, salivation, atypical vocalisation, muscle tremor, vomiting, increased respiratory rate, uncontrolled urination and uncontrolled defecation may occur. In very rare cases recurrence of sedation may occur or the recovery time may not be shortened after administration of atipamezole.
In cats, when using a low dose to partially reverse the effects of medetomidine or dexmedetomidine, the possibility of hypothermia (even when aroused from sedation) should be kept in mind.
The frequency of adverse reactions is defined using the following convention:
- Very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment).
- Common (more than 1 but less than 10 animals in 100 animals).
- Uncommon (more than 1 but less than 10 animals in 1,000 animals).
- Rare (more than 1 but less than 10 animals in 10,000 animals).
- Very rare (less than 1 animal in 10,000 animals, including isolated reports).
Over-alertness in the cat is best handled by minimizing external stimuli.
User warnings
Due to the potent pharmacological activity of atipamezole, contact of the product with skin, eyes and mucous membranes should be avoided. In case of accidental contact of the product with skin or eyes rinse abundantly with fresh water. Seek medical attention if irritation persists. Remove contaminated clothes that are in direct contact with the skin.
Care should be taken to avoid accidental ingestion or self-injection. In case of accidental oral intake or self-injection, seek medical advice immediately and show the package insert to the physician. Do not drive. The patient should not be left unattended.
Pharmaceutical precautions
This veterinary medicinal product does not require any special storage conditions.
Shelf-life after first opening the immediate packaging: 28 days.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products in the same syringe.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
Cardboard carton containing 1, 5 or 10 clear glass vials of 10 ml. Not all pack sizes may be marketed.
Further information
Overdose of atipamezole hydrochloride may result in transient tachycardia and over-alertness (hyperactivity, muscle tremor). If necessary, these signs may be reversed by a medetomidine or dexmedetomidine hydrochloride dose which is lower than usually used clinically.
If atipamezole hydrochloride is inadvertently administered to an animal not previously treated with medetomidine or dexmedetomidine hydrochloride, hyperactivity and muscle tremor may occur. These effects may persist for about 15 minutes.
Marketing Authorisation Holder (if different from distributor)
Laboratorios SYVA, Spain
Marketing Authorisation Number
Vm 31592/4003
Significant changes
GTIN
GTIN description:10 ml:
GTIN:05013457079845