SUMMARY OF PRODUCT CHARACTERISTICS
1.
Product:
Xylazine 2%
2.
Qualitative and Quantitative Composition:
Xylazine Base
20 mg/ml
Antimicrobial Preservatives:
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
1.8 mg/ml
0.2 mg/ml
3.
Pharmaceutical Form:
Solution for injection
4.
Pharmacological Properties:
Xylazine 2% is an injectable solution containing Xylazine Base 20 mg/ml.
Xylazine is an alpha/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 alpha/2- receptors. Activation
of these central alpha/2- receptors seems to regulate central dopamine and
nerepinephrine 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.
Onset and duration of sedation is species-dependent, varying from 5-15
minutes in horses, to 15-30 minutes in dogs and cats. Duration of sedation
is from 40 minutes to 2 hours. ATC vet code: QN05CM93.
5.
Clinical Particulars:
5.1
Target Species:
Cattle, horses, dogs and cats.
5.2
Indications for use:
Xylazine 2% is a sedative with analgesic and muscle relaxant
proprieties for use in cattle, horses, dogs and cats where
sedation is required including:
1.
2.
3.
4.
Handling fractious animals e.g. for transportation.
Medical examinations e.g. x-ray examinations, removal
of bandages; examination of the penis and oral cavity.
Premedication for minor superficial operations, and
local or regional anaesthesia.
Elimination of defecation when examining and treating
the vagina, uterus and hindquarters.
Summary of Product Characteristics
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5.3
Contra-indications:
Not to be used in horses intended for human consumption.
Not for use in animals from which milk is produced for human
consumption.
Do not administer by the intra-carotid route.
Careful consideration should also be given before administering
to animals exposed to stress conditions such as extreme heat,
cold high altitude or fatigue.
5.4
Undesirable Effects:
Following the use of Xylazine 2% in cattle profuse salivation,
bloat and polyuria may occur.
Side effects such as bradycardia, cardiac arrhythmia and
polyuria may occur in the horse.
Following intravenous administration to horses, a transient rise
followed by a fall in blood pressure usually occurs. Vomiting is
commonly observed in dogs and cats following use of the
product.
Tympany should be avoided in recumbent cattle by maintaining
the animal in sternal recumbency. Provision should also be
made for facilitating dependent drainage from the mouth to
avoid inhalation asphyxia.
5.5
Special precautions for use:
Care should be exercised in administration to aged or
debilitated animals.
5.6
Use during pregnancy and lactation:
Xylazine 2% 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.
5.7
Interaction with other medications and other forms of
medication:
None known.
5.8
Posology and method of administration:
Cattle:
Xylazine 2% is given by intramuscular injection.
The dose rate is 0.05-0.3 mg/kg (0.25-1.5 ml/ 100 kg)
bodyweight, according to the degree of sedation required. Very
Summary of Product Characteristics
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fractious animals may require the higher dose rates not
exceeding 0.3 mg/kg (Dose rate 4).
Dose
1
2
3
4
mg/kg
0.05
0.10
0.20
0.30
mg/50 kg
2.5
5.0
10
15
ml/50 kg
0.12
0.25
0.50
0.75
Horses:
Xylazine 2% is given by slow intravenous injection. Dosage
depends upon the degree of sedation required and the response
of the animal and is 0.6-1 mg/kg (3-5 ml/100 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. The horse
does not usually become recumbent with Xylazine 2% 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. Xylazine 2% may be employed in
the horse as a premedication to barbiturate anaesthesia or in
combination with regional or local anaesthesia.
Dogs:
Xylazine 2% is administered intramuscularly at dose rates of 13 mg/kg (0.05-0.15 ml/kg bodyweight). It may be used in
combination with a local anaesthetic. Premedication with
atropine may be desirable in some cases. Xylazine 2% is
synergistic with the barbiturates and reduces the dosage of the
latter by approximately one half.
Cats:
Xylazine 2% is administered intramuscularly at a dose rate of 3
mg/kg (0.15 ml/kg bodyweight). Premedication with atropine
may occasionally be desirable.
5.9
Overdose:
Alpha-2 blockers such as atipamezole are effective in reversing
the sedation and other physiological effects of xylazine.
5.10
Special warnings for each target species
Cattle are about ten-times more sensitive to Xylazine than
horses and high doses will cause recumbency. Special
precautions to minimize regurgitation, inhalation pneumonia
and bloat should be taken during anaesthesia.
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5.11
Withdrawal periods:
Cattle: Meat – 14 days
Not for use in cattle producing milk for human consumption.
In accordance with the Horse Passport legislation (Commission
Decision 2000/68/EC as implemented in national legislation) a
6 month withdrawal period applies to the use of this product
5.12
Special precautions to be taken by the Person
Xylazine is an alpha adrenoceptor agonist acting primarily on
alpha-2 receptors.
Care should be taken to avoid accidental injection/ self
injection.
Wash splashes from skin and eyes immediately.
In the event of accidental injection/ self injection, seek urgent
medical advice and show the label and other product literature.
DO NOT DRIVE as sedation and changes in blood pressure
may occur.
It is recommended that, once the required dose has been
withdrawn from the vial, the needle should be kept guarded
until the product is administered. Alternatively, it should be
removed from the syringe and immediately inserted into the
injection site and the syringe should then be connected to it.
Advice to doctors
Xylazine is an alpha adrenoceptor agonist whose toxicity may
cause clinical effects including sedation, respiratory depression
and coma, bradycardia and hypotension and hyperglycaemia.
Verticular arrhythmias have also been reported. Treatment
should be supportive with appropriate intensive therapy.
6 Pharmaceutical Particulars
6.1
Incompatibilities
None known
6.2
Shelf-life
5 years
6.3
Special Storage Precautions
Do not store above 25o C.
Following withdrawal of the first dose, use the product within
28 days.
Discard unused material.
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6.4
6.5
7.0
.
Nature and contents of container
Amber vials, Type 1 Ph. Eur glass, containing 25ml.
Elastomeric closures 20 mm.
Aluminium seals with removable centres.
Special precautions for disposal of unused product and
waste material:
Any unused product or waste material should be disposed of in
accordance with national regulations.
Additional Information:
7.1
Name and address of Marketing Authorisation Holder:
Millpledge Pharmaceuticals
Whinleys Estate
Church Lane
Clarborough
Retford
Notts DN22 9NA
Legal Category
Date of revision of SPC
Marketing Authorisation No.:
Date of renewal:
Summary of Product Characteristics
POM
10/10/2005
Vm 04409/4006
12/10/2004
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