Application for Marketing Authorisation for Parallel Import (Mapi) of Veterinary Medicine

SUMMARY OF PRODUCT CHARACTERISTICS

Name of the veterinary medicinal product

ANTISEDAN

2.Qualitative and quantitative composition

% w/vmg/ml

Active ingredients

Atipamezole hydrochloride 0.505.0

Other ingredients

Contains methyl parahydroxybenzoate 0.101.0

as antimicrobial preservative.

Pharmaceutical form

Solution for infection

Pharmacological properties

Antipamezole is a selective α-2 adrenoceptor antagonist which is capable of reversing 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.

Atipamezole is quickly absorbed and is generally administered 15 - 60 minutes after the medetomidine or dexmedetomidine.

Clinical Particulars

5.1Target species:

Dogs and cats

5.2Therapeutic indications

Atipamezole is indicated for the reversal of the sedative & 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.

5.3Contra-indications

Not recommended for use in pregnant dogs and cats. (See also 5.6 below). Concurrent use of drugs affecting the CNS is not recommended, apart from those in the SPC (see also 6.1, below).

5.4Undesirable effects

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 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.

5.5Special precautions for use.

None

5.6Use during pregnancy and lactation

The product has only been administered to a limited number of pregnant dogs and cats and therefore cannot be recommended in pregnancy.

5.7Interaction with other medicaments and other forms of interaction

No harmful interactions with other agents have been encountered in clinical trials, however concurrent use of those drugs affecting the CNS is not recommended apart from those in the SPC.

5.8.Posology and method of administration

For intramuscular injection

Dogs: The optimal dose in micrograms per kilogram is five times that of the previous medetomidine dose or 10 times the dexmedetomidine dose. Thus an equal volume to that of the previously administered medetomidine or dexmedetomidine should be given.

When medetomidine or dexmedetomidine 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. The product may be administered in the post-operative phase to reverse the effects of medetomidine or dexmedetomidine and hasten recovery.

In the post-operative phase rapidly causes arousal to full awareness and thus radically reduces the period of possible cardiovascular depression and hypothermia.

Suggested dose rates after use of medetomidine in dogs:

Use of medetomidine / Recommended dose of medetomidine / Recommended dose of Antisedan
μg/kg / per 10 kg / μg/kg / per 10 kg
Alone: sedation / 10-80 / 0.1-0.8 ml / 50-400 / 0.1-0.8 ml
Alone: pre-anaesthesia / 10-20 / 0.1-0.2 ml / 50-100 / 0.1-0.2 ml
With butorphanol / 10-25 / 0.1-0.25 ml / 50-125 / 0.1-0.25 ml
With butorphanol and
thiopentone / 10 / 0.1 ml / 50 / 0.1 ml
With propofol / 10-40 / 0.1-0.4 ml / 50-200 / 0.1-0.4 ml
With thiopentone / 10-40 / 0.1-0.4 ml / 50-200 / 0.1-0.4 ml

Suggested dose rates after use of dexmedetomidine in dogs:

Use of dexmedetomidine / Recommended dose of dexmedetomidine / Recommended dose of Antisedan
μg/kg / per 10 kg / μg/kg / per 10 kg
Alone: sedation / 5-40 / 0.1-0.8 ml / 50-400 / 0.1-0.8 ml
Alone: pre-anaesthesia / 5-10 / 0.1-0.2 ml / 50-100 / 0.1-0.2 ml
With butorphanol / 5-12.5 / 0.1-0.25 ml / 50-125 / 0.1-0.25 ml
With butorphanol and
thiopentone / 5 / 0.1 ml / 50 / 0.1 ml
With propofol / 5-20 / 0.1-0.4 ml / 50-200 / 0.1-0.4 ml
With thiopentone / 5-20 / 0.1-0.4 ml / 50-200 / 0.1-0.4 ml

Cats: The optimal dose of the product, in micrograms per kg is two-and-a-half times that of the previous medetomidine dose or five times the dexmedetomidine dose. Thus half the volume of the product to that of the previously administered medetomidine or dexmedetomidine should be given.

The dose in micrograms per 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 or dexmedetomidine, with or without butorphanol, and ketamine or medetomidine or dexmedetomidine and alfaxalone/alfadolone. The product may be administered to reverse the effects of medetomidine or dexmedetomidine and so speed recovery from anaesthesia. Half the volume of the product to that of the previously administered medetomidine or dexmedetomidine should be given.

Suggested dose rates after use of medetomidine in cats:

Use of medetomidine / Recommended dose of medetomidine / Recommended dose of Antisedan
μg/kg / per 5 kg / μg/kg / per 5 kg
Alone: sedation / 50-150 / 0.25-0.75 ml / 125-375 / 0.125-0.375 ml
With butorphanol / 50 / 0.25 ml / 125 / 0.125 ml
With ketamine / 80 / 0.4 ml / 200 / 0.2 ml
With butorphanol and
Ketamine IV / 40 / 0.2 ml / 100 / 0.1 ml
With butorphanol and
Ketamine IM / 80 / 0.4 ml / 200 / 0.2 ml
With alphaxolone/alphadalone / 80 / 0.34 ml / 200 / 0.2 ml

Suggested dose rates after use of dexmedetomidine in cats:

Use of dexmedetomidine / Recommended dose of dexmedetomidine / Recommended dose of Antisedan
μg/kg / per 5 kg / μg/kg / per 5 kg
Alone: sedation / 25-75 / 0.25-0.75 ml / 125-375 / 0.125-0.375 ml
With butorphanol / 25 / 0.25 ml / 125 / 0.125 ml
With ketamine / 40 / 0.4 ml / 200 / 0.2 ml
With butorphanol and
Ketamine IV / 20 / 0.2 ml / 100 / 0.1 ml
With butorphanol and
Ketamine IM / 40 / 0.4 ml / 200 / 0.2 ml
With alphaxolone/alphadalone / 40 / 0.4 ml / 200 / 0.2 ml

5.9Overdose (symptoms, emergency procedures, antidotes)

Transient over-alertness and tachycardia may be observed after a possible over-dosage.

Over-alertness in the cat is best handled by minimising external stimuli.

5.10Special warnings for each target species

When any combination of butorphanol or medetomidine or dexmedetomidine and ketamine have been used, atipamezole should not be used to reverse the effects in dogs.

5.11Withdrawal period

Not applicable

5.12Special safety precautions to be taken by the person administering the product to animals

Due to the potent pharmacological activity of atipamezole, skin contact with this product should be avoided and impervious gloves should be worn during administration. Care should be taken to avoid accidental self-injeciton. 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.

6. Pharmaceutical particulars

6.1Incompatibilities (major)

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.

6.2Shelf life

3 years.

Following withdrawal of the first dose, use the product within 28 days. Discard any unused material.

6.3Special precautions for storage

Do not store above 25°C. Protect from light.

6.4Nature and contents of container.

Colourless glass Type I vial containing 10 ml.

6.5Special precautions for the disposal of unused product or waste material.

Any unused product or waste material should be disposed of in accordance with national requirements.

Final Information

7.a)Name or style and permanent address or registered place of business of the holder of the marketing authorisation

Quvera Limited

Unit 8 Brember Road

Harrow

Middlesex

HA2 8AX

United Kingdom

Marketing Authorisation Number

Vm 20860/4008

7.b)Date of first authorisation:

April 2006

7.c)Conditions of supply of the veterinary medicinal product:

Antisedan1