PACKAGE LEAFLET

PROXYLAZ 20 mg/ml solution for injection.

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

Prodivet pharmaceuticals sa/nv
Hagbenden 39C
4731 Eynatten
Belgium
Tel: 00 32 (0)87 85 20 25
Email: info@prodivet.com

NAME OF THE VETERINARY MEDICINAL PRODUCT

PROXYLAZ 20 mg/ml solution for injection.
Xylazine

STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

Per ml:
Active substance: 20 mg xylazine as hydrochloride
Excipients: Sodium methylparahydroxybenzoate 1.0 mg. Sodium propylparahydroxybenzoate 0.1 mg.

INDICATIONS

PROXYLAZ can be used in 3 ways:

• Alone, as a tranquilliser, to facilitate animal handling, immobilisation, transport as well as to perform certain specific clinical examinations (e.g. catheterisation, radiography, examination of the oral cavity);
• Concomitantly with local anaesthesia to perform operations such as the removal of small tumours, tooth descaling, castration, claw removal;
• As premedication concomitantly with various anaesthetic drugs in certain anaesthesia protocols.

CONTRAINDICATIONS

• Do not use in the later stages of pregnancy.
• Do not use in animals with oesophageal obstruction and stomach torsion, as the muscle relaxant properties of xylazine appear to accentuate the effects of 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 urethral obstruction or rupture of the bladder.
• Do not use in foals and calves younger than 2 weeks or in puppies and kittens younger than 6 weeks.
• Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

ADVERSE REACTIONS

The undesirable effects of xylazine are typical for an α-adrenergic agonist. In all animal species, bradycardia, reversible arrhythmia and hypotension can occur. A light and transient hypothermia is sometimes observed, as is the case for a hyperglycaemic 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 xylazine during gestation are: a decrease of maternal and foetal oxygen tension, maternal and foetal bradycardia, an increase in intrauterine pressure and a reduction of uterine perfusion (administration at the end of gestation can cause abortion) and a reversible block of foetal breathing.
Other adverse reactions are more specific to a given animal species, namely:
 

Horses

• Muscular tremors and movements in response to powerful auditive or physical stimuli can occur. Rare violent reactions were described after administration of xylazine.
• Sudation on the sides and the neck frequently appears when sedation disappears.
• Severe bradycardia and a reduced respiratory rate are described. The cardiovascular effects can be prevented by the administration of 0.03 to 0.07 mg/kg of body weight of atropine sulphate which blocks the vasopressor effect and the increase in vagal activity induced by xylazine.
• Xylazine may induce a temporary reduction in intestinal motility and induction of light colic.
• An increase in urine production is possible.
• Ataxia and a reversible prolapse of the penis may occur.

Cattle

• Risk of induction of premature parturition and reduction of the chance of implantation of a fertilised ovum.
• Soft or diarrheal faeces 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 sedation, especially when the animals have just been fed.
• Hypersalivation and aerophagia may appear.
• Other adverse effects include: muscle tremors, bradycardia with atrio-ventricular block, hypotension, reduced respiratory rate and movement in response to strong auditory stimuli.
• Increased urination in cats.
• Xylazine causes uterine contractions and may induce premature parturition in cats.

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon

TARGET SPECIES

Cattle, horses, dogs and cats

DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION

Xylazine may be administered using intramuscular and intravenous routes. Intravenous injection must be performed slowly, especially in the case of horses.
In all species, xylazine may be used in combination with anaesthetics for painful interventions

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

When using the intravenous route, the injection should be made according to individual reaction, between ⅓ and ½ of the recommended dose for intramuscular injection. The time to onset of sedation is accelerated by the intravenous administration and the duration of action is adjusted accordingly. As for all substances acting on the central nervous system, the intravenous injection of Proxylaz must be done slowly.
If necessary, the effect of 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 of body weight should not be exceeded.
Dose I: clear sedation and analgesia sufficient for interventions such as calming for transport to grazing areas, adaptation to a new environment, weighing, medical care, artificial insemination, gynecological operations as well as sedation before the application of a local or truncal anaesthesia for rumenotomy, Caesarean section, ...
Dose II: sedation of medium intensity with analgesia and muscular relaxation for interventions such as surgeries on teats, claws (paronychia), removal of oesophageal obstruction or placement of a nasal ring.
Dose III: deep sedation and analgesia allowing important surgical operations such as the amputation of horns, claws or teats, as well as sterilisations, castrations, Caesarean sections in a lying position or tooth extractions.
In most cases, the animal cannot stay standing and complementary local anaesthesia is recommended.
Dose IV: dose exceptionally used because of the long period of sedation and the intensity of muscular relaxation. It is for example used in wild animals or for very long surgeries. The dose should only be administered to fasted animals.

Horses

Intravenous use: 3.0 – 5.0 ml of Proxylaz/100 kg body weight meaning 0.6 – 1 mg/kg of body weight of xylazine.
The maximum effect occurs 3 minutes after intravenous injection. Sedation of varying intensity (according to the administered dose) lasts 30 to 40 minutes.
Sedation, muscular relaxation and analgesia sufficient for: transport, shoeing, examinations, wound treatment, obstetrics and operations that are not very painful.

Cats

Intramuscular use: 0.15 ml of Proxylaz/kg of body weight, meaning 3 mg/kg of body weight of xylazine.
The effect of xylazine allows to undertake interventions that are not very painful such as radiological examinations, wound treatment, bandages, tooth descaling and preparation for local or general anaesthesia

Dogs

Intramuscular use: 1.5 ml of Proxylaz/10 kg of body weight, meaning 3 mg/kg of body weight of xylazine.
The effect of xylazine allows to undertake interventions that are not very painful such as wound treatment, bandages, tooth descaling or otitis treatment

ADVICE ON CORRECT ADMINISTRATION

 

WITHDRAWAL PERIODS

 

Cattle and horses: meat and offal: 1 day.
Cattle: milk: 0 days.

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.
Do not store above 25°C.
Keep the bottle tightly closed in the original outer package and protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the outer package after EXP. The expiry date refers to the last day of that month.
Shelf life after first opening of the immediate packaging: 28 days.

SPECIAL WARNINGS

Special warnings for each target species
 

Horses
Xylazine inhibits normal intestinal motility. For this reason, xylazine must only be used in horses suffering from colic only when they do not respond to analgesics. Xylazine should be avoided in horses presenting caecum dysfunction.
Following treatment with xylazine, horses are incapable of moving. As a result, the administration of xylazine should, as much as possible, be performed at the place of treatment or of examination.
The administration of this medicinal product should be carried out with caution in animals with a propensity for laminitis.
Horses with respiratory disease or failure may develop dyspnoea to the extent where it may endanger vital prognostic.
The lowest possible dose should be used.

Cattle
Ruminants are very sensitive to the effects of xylazine. Cattle usually stay standing following the administration of low doses, but certain animals may lay down. At the high doses recommended, most animals will lay down and some may fall into lateral recumbency.
Reticulum and rumen motor functions are inhibited following the injection of xylazine, which may cause tympany. It is recommended to not give water or food for several hours prior to the administration of xylazine.
In cattle, the capacity for eructation, coughing and swallowing are maintained, but reduced during the phase of sedation. For this reason, it is important to carefully supervise animals when in the recovery period: the animals should be maintained in sternal recumbency.
Effects that may endanger vital prognostics can occur at intramuscular doses that are above 0.5 mg/kg of body weight (respiratory failure and circulatory collapse). As a result, very close calibration of the dose is imperative.

Dogs and cats
Xylazine inhibits normal intestinal motility. Sedation using xylazine is not advised before radiography of the upper gastro-intestinal tract as it favours aerophagic-type gastric distension that may compromise proper reading.
Brachycephalic dogs presenting broncho-pneumopathy or respiratory insufficiency may develop dyspnoea that could endanger vital prognostic.

Special precautions for use in animals:

General comments

• 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 down when the ambient temperature is above 25°C and to keep animals warm at low temperatures.
• Avoid intra-arterial administration.
• Xylazine produces ataxia; therefore, xylazine must be used cautiously in procedures involving the distal extremities or in standing castrations of the horse.
• Treated animals should be monitored until the effect has faded totally.

Special comments for each target species

• Cattle: do not exceed 1.5 ml/100 kg for intramuscular and 0.5 ml/100 kg for intravenous.
• Dogs and cats: vomiting is generally seen within 3-5 minutes after administration of xylazine. It is advisable to fast dogs and cats for 12 hours prior to surgery; they may have free access to drinking water.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

• In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician. DO NOT DRIVE A VEHICLE as sedation and changes in arterial blood pressure may occur.
• Irritation, sensitisation and contact dermatitis cannot be excluded after skin contact. Remove the contaminated clothes.
• Wash the exposed skin immediately using large amounts of water.
• In the case of ocular projection, rinse immediately and abundantly with fresh water. If irritation persists, seek the advice of a physician.
• The veterinary medicinal product should not be administered or handled by pregnant women.

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

Pregnancy:
Do not use xylazine in the later stages of pregnancy because it may induce abortion (particularly in cattle and cats). Do not use in cows receiving ovum transplants as the increased uterine tone may reduce the chance of implantation of the fertilised ovum.

Interaction with other medicinal products and other forms of interaction:
Other Central Nervous System (CNS) depressant agents (barbiturates, narcotics, anaesthetics, tranquillisers, etc.) may cause additional 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.

Overdose (symptoms, emergency procedures, antidotes):
Symptoms
Sedation close to narcosis, ataxia, spasmodic convulsions, severe dyspnoea and death due to a cardiac and respiratory arrest.
Treatment
Xylazine can be antagonised by α2-adrenergic antagonists: Atipamezole has been found to be a useful antidote in some cases. The recommended dosage is 0.2 mg/kg intramuscular for dogs and cats, 0.15 mg/kg intramuscular for horses and 0.03 mg/kg intramuscular for cattle. The respiratory depressant effects of xylazine can be treated by mechanical respiratory support with or without a respiratory stimulant.

Incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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

Ask your veterinary surgeon or pharmacist how to dispose medicines no longer required. These measures should help to protect the environment.

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

December 2019.

OTHER INFORMATION

Delivery : on veterinary prescription
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder:
Prodivet pharmaceuticals sa/nv
Hagbenden 39C
4731 Eynatten
Belgium
Tel: 00 32 (0)87 85 20 25
Email: info@prodivet.com

PROXYLAZ_NOT_BE_EN_V4_20191203