Introduction
Company name: Dechra Veterinary Products
Address: (A business unit of Dechra Pharmaceuticals PLC)
Cartmel Drive
Harlescott
Shrewsbury SY1 3TB
Telephone: 01743 441632
Fax: 01743 462111
Email: info@dechra-uk.com
Website: www.dechra-uk.com
Atipam 5.0 mg/ml Solution for Injection for Cats and Dogs
Introduction
Company name: Dechra Veterinary Products
Address: (A business unit of Dechra Pharmaceuticals PLC)
Cartmel Drive
Harlescott
Shrewsbury SY1 3TB
Telephone: 01743 441632
Fax: 01743 462111
Email: info@dechra-uk.com
Website: www.dechra-uk.com
Presentation
1 ml clear and colourless aqueous solution for injection contains:
Active substance: Atipamezole hydrochloride 5 mg (equivalent to 4.27 mg atipamezole base)
Excipient: Methyl parahydroxybenzoate (E 218) 1 mg
Uses
Atipamezole hydrochloride is a selective α2-antagonist and is indicated for reversal of the sedative effects of medetomidine and dexmedetomidine in cats and dogs.
Dosage and administration
For single intramuscular injection in cats and dogs. Use of an appropriately graduated syringe is recommended to ensure accurate dosing when administering small volumes. Atipamezole is generally administered 15 - 60 minutes after the medetomidine or dexmedetomidine injection.
Dogs: The 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 product compared to that of preparations containing 1 mg medetomidine hydrochloride per ml, and the 10-fold higher concentration compared to that of preparations containing 0.5 mg dexmedetomidine hydrochloride, an equal volume of each preparation is required.
Dosage example dogs:
Medetomidine 1.0 mg/ml solution for injection Dosage: | Atipam 5.0 mg/ml solution for injection Dosage: |
0.04 ml/kg body weight (bw), i.e. 40 µg/kg bw | 0.04 ml/kg bw, i.e. 200 µg/kg bw |
Dexmedetomidine 0.5 mg/ml solution for injection Dosage: | Atipam 5.0 mg/ml solution for injection Dosage: |
0.04 ml/kg body weight (bw), i.e. 20 µg/kg bw | 0.04 ml/kg bw, i.e. 200 µg/kg bw |
Cats: The atipamezole hydrochloride dose (in µg) is 2.5 times that of the previous medetomidine hydrochloride dose, or 5 times that of the dexmedetomidine hydrochloride dose. Due to the 5-fold higher concentration of the active ingredient (atipamezole hydrochloride) in this product compared to that of preparations containing 1 mg medetomidine hydrochloride per ml, and the 10-fold higher 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.
Dosage example cats:
Medetomidine 1.0 mg/ml solution for injection Dosage: | Atipam 5.0 mg/ml solution for injection Dosage: |
0.08 ml/kg body weight (bw), i.e. 80 µg/kg bw | 0.04 ml/kg bw, i.e. 200 µg/kg bw |
Dexmedetomidine 0.5 mg/ml solution for injection Dosage: | Atipam 5.0 mg/ml solution for injection Dosage: |
0.08 ml/kg body weight (bw), i.e. 40 µg/kg bw | 0.04 ml/kg bw, i.e. 200 µg/kg bw |
The recovery time is shortened to approximately 5 minutes. Animals become mobile after approximately 10 minutes after administration of the product.
Advice on correct administration: In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products in the same syringe.
Contra-indications, warnings, etc
The product should not be used in breeding animals, or animals suffering from liver or renal diseases.
Adverse reactions: A transient hypotensive effect has been observed during the first 10 minutes post-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 low doses to partially reverse the effects of medetomidine or dexmedetomidine, the possibility of hypothermia (even when aroused from sedation) should be guarded against.
If you notice any serious effects or other effects not mentioned in this data sheet, please inform your veterinary surgeon or pharmacist.
Special precautions for use in animals: After administration of the product, the animal should be allowed to rest in a quiet place. During recovery time the animal should not be left unattended. Due to different dosing recommendations caution should be taken if using the product off-label in animals other than the target species.
If sedatives other than 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: Due to the potent pharmacological activity of atipamezole, skin, eye and mucous membrane contact with this product 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 data sheet to the physician.
Use during pregnancy and lactation: The safety of the product has not been documented adequately during pregnancy and lactation. Therefore use is not recommended during pregnancy and lactation.
Interactions with other medicinal products and other forms of interaction: A simultaneous administration of atipamezole with other centrally acting medicinal products, such as diazepam, acepromazine or opiates is not recommended.
Overdose (symptoms, emergency procedures, 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 medetomidine hydrochloride dose which is lower than the usual 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.
General precautions: For animal treatment only.
Pharmaceutical precautions
This veterinary medicinal product does not require any special storage conditions.
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the label after EXP.
Shelf life after first opening the container: 28 days. Any remaining content of the product should be disposed of after this period.
Disposal: Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.
Legal category
POM-V
Packaging Quantities
Pack sizes: 5, 10 or 20 ml. Not all pack sizes may be marketed.
Further information
To be supplied only on veterinary prescription.
UK authorised veterinary medicinal product.
Marketing and manufacturing authorisation holder responsible for batch release: Eurovet Animal Health BV, Handelsweg 25, 5531 AE Bladel, The Netherlands.
Marketing authorisation number
Vm 16849/4011.
Significant Changes
New Product | 16/04/2008 |