PROXYLAZ<sup>®</sup> 2 %

PROXYLAZ® 2 %

  • Xylazine HCl 2%
  • Injectable solution
  • Vials of 25 ml and 50 ml
Cats
Dogs
Cattle
Horses

PACKAGE LEAFLET

PROXYLAZ 2 %, injectable solution of Xylazine 20 mg/ml for veterinary use

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer:
Prodivet pharmaceuticals sa
Hagbenden 39C
B -4731 EYNATTEN

NAME OF THE VETERINARY MEDICINAL PRODUCT

PROXYLAZ 2 %, injectable solution of Xylazine 20 mg/ml for veterinary use

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Active substance: Xylazine hydrochloride 23,32 mg (equivalent to 20 mg of Xylazine base)
Excipients: Sodium Methyl p-Hydroxybenzoate – Sodium Propyl p-Hydroxybenzoate - Sodium Metabisulfite - Citric Acid - Water for injection up to 1 ml.

INDICATION(S)

Proxylaz can be used in 3 ways :
Alone, as tranquillizer, to facilitate animal handling, contention, transport or some clinical examinations (e.g. catheterism, radiography, examination of the cavity of the mouth),
Concomitantly with a local anesthesia to realize operations such as removal of small tumours, teeth scaling, castration, claw ablation
In premedication concomitantly with other anesthetic drugs in certain anesthesia applications

CONTRAINDICATIONS

  • Do not use in the later stages of pregnancy
  • Do not use in animals with oesophageal obstruction, and torsion of the stomach, as the muscle relaxant properties of the drug appear to accentuate the effects of the obstruction and because of possible vomiting.
  • Do not use in animals with renal or hepatic failure, respiratory dysfunction, cardiac abnormalities, hypotension and/or shock. Do not use in diabetic animals.
  • Do not use in animals suffering of an urethral obstruction or a rupture of the bladder
  • Do not use in foals and calves younger than 2 weeks or in puppies and kittens younger than 6 weeks.

ADVERSE REACTIONS

The undesirable effects of the Xylazine are typical for α-adrenergic agonist. In all animal species, bradycardia, reversible arrhythmia and hypotension can occur. A light and transient hypothermia is sometimes observed such as an hyperglycemic effect which needs to be taken into account in diabetic animals
Respiratory depression and/or a respiratory arrest can occur, certainly in cats. The main effects of the administration of the Xylazine during gestation are: a fall of the maternal and foetal oxygen tension, a maternal and foetal bradycardia, an increase in the intrauterine pressure and a reduction in the uterine perfusion (the administration in the end of gestation can cause an abortion), a reversible block of foetal breathing. Some other undesirable effects are more specific to particular animal species, namely:

Horses
  • Muscular tremors or movements in answer to powerful auditive or physical stimuli can occur. Rare violent reactions were described after administration of Xylazine.
  • Sudation on the sides and the collar frequently appears when sedation disappears.
  • Severe bradycardia and reduced respiratory rate are described. The cardiovascular effects can be prevented by the administration of 0,03 to 0,07 mg/kg BW of atropine sulphate which blocks the vasopressor effect and the increase in vagal activity induced by Xylazine.
  • A temporary reduction in intestinal motility  and induction of light colics.
  • An increase in the urine production is possible.
  • Ataxia and a reversible prolapse of the penis may occur.
Bovines
  • Risk of induction of premature parturition and reduction of the implantation of fertilized ovum.
  • Soft or diarrheal feces during 24 hours following the administration of strong doses.
  • Hypersalivation, ruminal atony, atony of the tongue, regurgitation, bloating, hypothermia, bradycardia, increased urine production and reversible prolapse of the penis.

The adverse effects are generally more pronounced after intramuscular administration compared to intravenous administration

Dogs and cats
  • Cats and dogs frequently vomit during the onset of the sedation, especially when the animals have just been fed.
  • Hypersalivation and aerophagia may appear.
  • Other adverse effects include: muscle tremors, bradycardia with auriculo-ventricular block, hypotension, reduced respiratory rate, movement in response to strong auditory stimuli
  • increased urination in cats.
  • In cats Xylazine causes uterine contractions and it may induce premature parturition.

If you notice any  serious  effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon

TARGET SPECIES

Proxylaz is destined to cattle, horses, dogs and cats

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Cattle
Dose I.V. I.M.

I

0,016-0.024 mg/kg
0,08-0,12 ml/100 kg

0,05 mg/kg
0,25 ml/100 kg

II

0,034-0,05 mg/kg
0,17-0,25 ml/100 kg

0,1 mg/kg
0,5 ml/100 kg

III

0,066-0,1 mg/kg
0,33-0,5 ml/100 kg

0,2 mg/kg
1,0 ml/100 kg

IV

 

0,3 mg/kg
1,5 ml/100 kg

By the IV route, the injection is made according to the individual reaction, between ⅓ and ½ of the recommended dose for IM injection. The time to onset of sedation  is accelerated by the IV administration and the duration of action is consequently. As for all the substances acting on the central nervous system, the IV injection of Proxylaz must be done slowly.
If necessary, the effect of the Proxylaz can be increased and/or prolonged, by a second injection administered 10 to 30 minutes after the first; however the total amount of 1,5 ml by 100 kg BW should not be exceeded
Dose I: Clear sedation and analgesia sufficient for small interventions such as calming for transport, grazing, adaptation to a new environment, weighing, medical care, artificial insemination, gynecological operations as well as sedation before the application of a local or troncular anaesthesia for rumenotomy or  Caesarean section.
Dose II: Sedation of medium intensity with analgesia and muscular relaxation for minor interventions such as surgeries  on claws, on teats, desobstruction of the oesophagus, setting of nasal ring
Dose III:  Deep sedation and analgesia allowing important surgical operations such as  amputation of horns, of claws, of teats, as well as sterilizations, castrations, caesarean in lying position, teeth extraction.
In most cases, the animal cannot stay in standing position and a complementary local anesthesia is recommended.
Dose IV: Dose exceptionally used because of the long period of sedation and the intensity of the muscular relaxation : for example in wild animals or for very long surgeries. The dose should only be administered to sober animals

Horses

Intravenous administration
Posology: 3 - 5 ml of Proxylaz for 100 kg BW means 0.6 - 1 mg/kg BW of Xylazine.
The maximum effect occurs 3 minutes after intravenous injection and sedation varying according to  administered  dose is lasting 30 to 40 minutes.
Sedation, muscular relaxation and analgesia sufficient for : transport, shoeing, examinations, wound treatment, obstetrics and not very painful operations.

Cats

Intramuscular administration
Posology: 0.15 ml of Proxylaz/kg BW, means 3 mg/kg BW of Xylazine.
The effect of Xylazine  allows  to undertake not very painful interventions such as radiological examinations, wound treatment, bandages, teeth scaling, preparation to local or general anesthesia

Dogs

Intramuscular administration
Posology: 1,5 ml of Proxylaz /10 kg BW, means 3 mg/kg BW of Xylazine.
The effect of Xylazine gives the possibility to undertake not very painful interventions such as wound treatment, bandages, teeth scaling or otitis treatment.

ADVICE ON CORRECT ADMINISTRATION

Special precautions for use in animals

  • Older and exhausted animals are more sensitive to Xylazine, whilst nervous or highly excitable animals may require a relatively high dose.
  • In case of dehydration, Xylazine should be used cautiously
  • It is advised to cool animals when the ambient temperature is above 25°C and to keep animals warm at low temperatures.
  • Avoid intra-arterial administration
  • Xylazine produces an ataxia; therefore, Xylazine must be used cautiously in procedures involving the distal extremities and in standing castrations in the horse.
  • Treated animals should be monitored until the effect has faded totally

Special warnings for each target species

  • Bovine: do not exceed 1.5 ml / 100 kg in IM and 0.5 ml/100 Kg in IV
  • Dogs and cats: Vomiting is generally seen within 3-5 minutes after Xylazine administration in cats and dogs. It is advisable to fast dogs and cats for 12 hours prior to surgery; they may have free access to drinking water

Use during pregnancy lactation or lay

Xylazine may not be administered in the later stages of pregnancy (particularly in cattle and cats), because it may induce abortion.
Do not use in cattle receiving ovum transplants as the increased uterine tone may reduce the chance of implantation of the ovum

Interaction with other medicinal products and other forms of interaction

Other CNS depressant agents (barbiturates, narcotics, anesthetics, tranquillizers, etc.) may cause additive CNS depression if used simultaneously with Xylazine. Dosages of these agents may need to be reduced. Xylazine should not be used in combination with sympathomimetic drugs (such as adrenaline) as ventricular arrhythmia may appear.

Incompatibilities

Proxylaz should not be mixed with other veterinary medicinal products in the same syringe.

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

Symptoms

Sedation close to narcosis, ataxia, spasmodic convulsions, severe dyspnoa and death due to a cardiac or respiratory standstill.

Treatment

Xylazine can be antagonized by α2-adrenergic antagonists: Atipamezole has been found to be a useful antidote in some cases. The recommended dosage is: 0.2 mg/kg IM for dogs and cats, 0.15 mg/kg IM for horses and 0.03 mg/kg for cattle.
The respiratory depressant effects of Xylazine, can be treated by mechanically respiratory support with or without respiratory stimulants (e.g. doxapram).

WITHDRAWAL PERIOD

Bovine and horses: Meat and offals: 1 day
Bovine: Milk: 0 day

SPECIAL STORAGE PRECAUTIONS

Store below 25° C in the original packaging, carefully closed, protected from light.
Do not use after the expiration date reproduced on the package, behind the abbreviation EXP (month/year)
Shelf life after first opening of the container: 28 days

SPECIAL WARNING(S)

Special precautions to be taken by the person administering the veterinary medicinal product to animals
  • In the case of accidental oral intake or self-injection, seek medical advice immediately and show the package leaflet or label to the physician but DO NOT DRIVE A VEHICLE as sedation and changes in arterial blood pressure may occur.
  • Irritation, sensitisation, contact dermatitis cannot be excluded after skin contact. Remove the contaminated clothes.
  • Wash the exposed skin immediately after exposure with large amounts of water.
  • In the case of accidental projection of the product into the eyes, rinse immediately and abundantly with fresh ater. If irritation persists, seek the advice of a physician.
  • Pregnant women will not handle the product.
Advice to doctors:

Xylazine is an α-adrenoreceptor agonist whose toxicity may cause clinical effects including sedation, respiratory depression and coma, bradycardia, hypotension and hyperglycaemia. Ventricular arrhythmias have also been reported. Treatment should be supportive with appropriate intensive therapy

Keep out of reach and sight of children

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY

Any unutilised veterinary medicinal product or waste derived from this drug must be eliminated in accordance with the local requirements

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

June 2010

OTHER INFORMATIONS

available on prescription only

PROXYLAZ_NOT GB_V3_20110608