Medine.co.uk

Virbaxyl 10% W/V Solution For Injection

Revised: 10 September 2009

AN: 00876/2009

SUMMARY OF PRODUCT CHARACTERISTICS



1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Virbaxyl 10% w/v Solution for Injection


2. QUALITATIVE AND QUANTITATIVE COMPOSITION


Active substance % w/v

Xylazine………………………………..100 mg/ml


Excipients:

Methyl Parahydroxybenzoate………….1.8 mg/ml

Propyl Parahydroxybenzoate…………..0.2 mg/ml


For a full list of excipients, see section 6.1.


3. PHARMACEUTICAL FORM


Solution for injection.

Clear, colourless solution.


4. CLINICAL PARTICULARS


4.1 Target species


Horses.


4.2 Indications for use, specifying the target species


Xylazine is a sedative with analgesic and muscle relaxant properties. The product is for use in horses only, in cases where sedation is required including:


1. Handling fractious animals e.g. for transportation.

2. Medical examinations e.g. X-ray examinations, removal of bandages; examination of the penis and oral cavity.

3. Premedication for minor superficial operations, and local or regional anaesthesia.

4. Elimination of defaecation when examining and treating the vagina, uterus and hindquarters.


4.3 Contraindications


Do not administer by the intra-carotid route.

Careful consideration should be given before administering to animals exposed to stress conditions such as extreme heat, cold, high altitude or fatigue.


4.4 Special warnings for each target species


None.



4.5 Special precautions for use


(i) Special precautions for use in animals


Should be used with caution when pulmonary disease is suspected.

Do not exceed the recommended dosage


(ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals


Horses sedated with xylazine usually remain standing and may still kick with accuracy.

Xylazine is an alpha adrenoceptor agonist acting primarily on alpha-2 receptors. Precaution should be taken to avoid accidental injection/self-injection.

Precautionary Phrases:

In the case of accidental oral intake or self-injection, seek medical advice immediately and show the package leaflet to the doctor but DO NOT DRIVE as sedation and changes in blood pressure may occur.

Avoid skin, eye or mucosal contact

Immediately after exposure, wash the exposed skin with large amounts of fresh water.

Remove contaminated clothes that are in direct contact with the skin.

In the case of accidental contact of the product with the eyes, rinse with large amounts of fresh water. If symptoms occur, seek the advice of a doctor.

If pregnant women handle the product, special precaution should be observed not to self-inject as uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure.

Advice to Doctors

Xylazine is an alpha2-adrenoceptor agonist. Symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, brachycardia, hypotension, a dry mouth, and hyperglycaemia. Ventricular arrhythmias have also been reported. Respiratory and haemodynamic symptoms should be treated symptomatically.


4.6 Adverse reactions (frequency and seriousness)


Side effects of bradycardia, cardiac arrhythmia and polyuria may occur.

Following intravenous administration a transient rise followed by a fall in blood pressure usually occurs.


4.7 Use during pregnancy, lactation or lay


Xylazine should not be administered during the later stages of pregnancy because of the risk of inducing premature parturition.

As the safety of xylazine use during organogenesis has not been fully demonstrated by current methods it should be used with caution during the first month of pregnancy.


4.8 Interaction with other medicinal products and other forms of interaction


None known.


4.9 Amounts to be administered and administration route



The product is given by slow intravenous injection. Dosage depends on the degree of sedation required and the response of the animal, and is 0.5 – 1 ml/100 kg

(0.5 - 1 mg/ kg bodyweight). Nervous or excitable horses may require higher doses. Older horses and those having undergone severe physical exertion before treatment should receive the lowest dose rate.

Animals do not usually become recumbent after administration and light to deep sedation with variable degree of analgesia is obtained. Effects are usually seen within 5 minutes and persist for approximately 20 minutes. The product may be employed as a premedication to barbiturate anaesthesia or in combination with regional or local anaesthesia.


4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary


Sedation is dose dependent and the occurrence of side effects will increase and worsen at higher dosage than recommended.


4.11 Withdrawal period


Not to be used in horses intended for human consumption.

Treated horses may never be slaughtered for human consumption.

The horse must have been declared as not intended for human consumption under national horse passport legislation.


5. PHARMACOLOGICAL PROPERTIES


Sedative, analgesic and muscle relaxing properties

ATCvet code: QN05CM92


Pharmacodynamic properties


Xylazine is an 2-adrenergic drug with sedative, analgesic and muscle relaxing properties which acts via the CNS. Xylazine is thought to act by activation of the central presynaptic 2-receptors. Activation of these central 2-receptors seems to regulate central dopamine and norepinephrine storage or release. Xylazine's analgesic and sedative actions are related to its central nervous system depression, while the muscle relaxant effects are due to the inhibition of the intraneural transmission of impulses in the central nervous system.


6. PHARMACEUTICAL PARTICULARS


6.1 List of excipients



Methyl Parahydroxybenzoate

Propyl Parahydroxybenzoate

Hydrochloric Acid, Concentrated

Sodium Citrate

Citric Acid Monohydrate

Water for Injection


6.2 Incompatibilities


None known.


6.3 Shelf life



Shelf life of the veterinary medicinal product as packaged for sale: 5 years.

Shelf life after first opening of the immediate packaging: 28 days.


6.4. Special precautions for storage


Do not store above 25°C.

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


6.5 Nature and composition of immediate packaging


50 ml amber glass (Type 1) vial with chlorobutyl rubber bung with aluminium overseal.


6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products


Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.


7. MARKETING AUTHORISATION HOLDER


Virbac Limited

Woolpit Business Park

Windmill Avenue

Woolpit

Bury St Edmunds

Suffolk IP30 9UP


8. MARKETING AUTHORISATION NUMBER


Vm 11188/4001


9. DATE OF FIRST AUTHORISATION


09/11/1992


10. DATE OF REVISION OF THE TEXT


September 2009