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EN - Anglická
  • CZ - Česká
  • SK - Slovenská
  • PL - Polská
  • RO - Rumunská
  • RU - Ruská
  • TR - Turecká
  • UA - Ukrajinská

XYLASED 500 lyophilizate for solution for injection with solvent

Homepage Products Veterinary products XYLASED 500 lyophilizate for solution for injection with solvent

Xylazinum. Immobilization and sedation of freely moving animals with a narcotizing shot, premedication before general anaesthesia

type of preparative: Analeptic, anaesthetic, hypnotics
target species animals: Cattle, Sheep, Goat

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STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS:  

a) Lyophilizate

Active substance:  xylazinum (ut Xylazini hydrochloridum) 500 mg

B) Solvent      

Water for injection   

Composition after reconstitution

  • lyophilizate + 2 ml solvent – 250 mg/ml Xylazinum (ut Xylazini hydrochloridum)

            (25% solution)

  • lyophilizate + 5 ml solvent – 100 mg/ml Xylazinum (ut Xylazini hydrochloridum)

            (10% solution)

  • lyophilizate + 10 ml solvent – 50 mg/ml Xylazinum (ut Xylazini hydrochloridum)

           (5% solution)

Xylased 500 mg is a lyophilizate for solution for injection with solvent.

The lyophilizate has a porous structure and a white or off-white colour.

A clear, colourless solution will be produced after reconstitution.

INDICATION(S):

Cattle: Sedation, myorelaxation and analgesia at small surgeries; premedication before general anaesthesia.

Horse: sedation and myorelaxation; premedication before general anaesthesia

Red deer, fallow deer, roe deer: Immobilization and sedation of freely moving animals with a narcotizing shot; premedication before general anaesthesia.

CONTRAINDICATIONS:

Do not administer to animals with cardiovascular and pulmonary insufficiencies and failures and to hypotensive animals.
Do not administer to animals in a shock. Do not administer to animals with renal insufficiency, urinary tract obstructions and to dehydrated animals.
Do not administer to cattle, fallow deer, red deer and roe deer with reticulum dysfunctions, GIT motility failure and metabolic acidosis.
Do not administer to cows in the last trimester of pregnancy. Administration of xylazine to a pregnant cow in the last phase of pregnancy can induce a spontaneous parturition or abortion.

ADVERSE REACTIONS:

Bradycardia, reversible arrhythmia (especially in horses) and hypotension, bradypnoea to respiratory arrest.
Inhibited regulation of body temperature. Hyperaemia, especially in red deer, fallow deer, and roe deer.
Paradox excitation (at higher doses). Hyperglycaemia and polyuria with glycosuria (except horses).
Reversible local irritation at intramuscular administration. Increased salivation, inhibited motility of forestomachs, tympanites, inability to move the tongue, regurgitation in ruminants.
Uterus contractions in cattle. Changes in blood picture and biochemical parameters.

TARGET SPECIES:

Cattle, horse, red deer, fallow deer, roe deer

DOSAGE:

The product may be prepared in 3 different concentrations (5%, 10%, 25%), using different amounts of solvent (10 ml, 5 ml, 2 ml). Dissolve the lyophilizate in a quantity of solvent according to the required concentration of solution. 

5% and 10% solutions are recommended for injection applications, 25% solution for a narcotizing shot.

Dilution

Always measure in a syringe a respective volume of solvent for the reconstitution of lyophilizate:

               10 ml of solvent to prepare 5% solution

               5 ml of solvent to prepare 10% solution

               2 ml of solvent to prepare 25% solution

           

Shake the vial content well during dissolving. The lyophilizate is dissolved within three minutes and a clear solution is produced.

Cattle

Route of administration

mg/kg

ml 5% solution/500 kg bw

ml 10% solution/500 kg bw

ml 25% solution/500 kg bw

Intramuscular

0.05 – 0.3

0.5 – 3.0

0.25 - 1.5

0.1 - 0.6

Intravenous

not recommended

Horse

Route of administration

mg/kg

ml 5% solution/500 kg bw

ml 10% solution/500 kg bw

ml 25% solution/500 kg bw

Intramuscular

0.6 - 1

6.0 - 10.0

3.0 – 5.0

not recommended

Intravenous

2 – 3

20.0 – 30.0

10.0 – 15.0

4.0 – 6.0

Red deer, fallow deer, roe deer

Only intramuscular administration is recommended, in all dilutions.

Target species

mg/kg

ml 5% solution/50 kg bw

ml 10% solution/50 kg bw

ml 25% solution/50 kg bw

Red deer

3 - 5

3.0 - 5.0

1.5 - 2.5

0.6 – 1.0

Fallow deer

4 - 6

4.0 - 6.0

2.0 – 3.0

0.8 – 1.2

Roe deer

2 - 3

2.0 -3.0

1.0 – 1.5

0.4 – 0.6

To prolong the effect or if the effect is decreasing, the administration may be repeated according to the animal species and its physical condition, within the recommended dosage for individual target species.

Effect in target species:

Cattle: The rate of effect depends on an administered dose. The analgesic and anaesthetic effect is growing with an increasing dose. After intramuscular administration, the onset of sedation is established at 5 minutes, with duration of 30–60 minutes. When a dose is increased, deep sedation and marked analgesia occur, the recovery phase is prolonged to 1–2 hours.

Horse: After intravenous administration, the onset of xylazine effect is fast, within 1 minute. The effect persists for 15–20 minutes, the recovery phase is 10–15 minutes. Normal condition is restored within 1 hour. After intramuscular administration the onset period is prolonged to 10–15 minutes and the normal condition is restored within 2 hours after administration.

Red deer, fallow deer, roe deer: The onset of effect is established at 5 minutes, the duration of effect is about 20 minutes and the normal condition is restored within 2-3 hours after administration.

Horse: At intravenous application the dose should be applied slowly, for 1–2 minutes.

Cattle, horse: Administration of atropine sulphate 10 minutes before xylazine application reduces side effects (in particular on the heart). Atropine is administered intramuscularly at a dose of 0.01 mg/kg bw (horse) and 0.1 mg/kg bw (cattle).

ADVICE ON CORRECT ADMINISTRATION:

Dilute the lyophilizate before use with the enclosed solvent.

Shake the vial content well during dissolving.

WITHDRAWAL PERIOD:

Cattle: meat 3 days, milk 3 milkings.
Horse: Do not use in horses the meat of which is intended for human consumption.
Red deer, fallow deer, roe deer: Do not use in animals the meat of which is intended for human consumption.

SPECIAL STORAGE PRECAUTIONS:

Keep out of the reach and sight of children. Store below 25 °C. Protect from light. Do not use after the expiry date stated on the package. Intended for immediate consumption after reconstitution according to the instruction.

SPECIAL WARNING(S):

Special precautions for use in animals

The animals should not be disturbed until a full onset of the product effect. Treat carefully the animals sedated with xylazine, because they may be waked up with outside stimuli and may move suddenly in defence.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
  1. In case of accidental ingestion or self-injection seek medical advice immediately and show the doctor the package leaflet.  DO NOT DRIVE A CAR as you may be sedated and your blood pressure may be changed.
  2. When handling the product avoid contact with skin and use impermeable gloves.
  3. After contact with skin, wash immediately with plenty of water.
  4. In case of contact with eyes, rinse immediately with plenty of water. If irritation persists, seek medical advice.
  5. Take off all contaminated clothing.
  6. Pregnant women should not work with this product.
  7. TO THE PHYSICIAN: Xylazine is agonist of alpha2-adrenoreceptors, the toxicity of which may cause clinical effects including sedation, respiratory depression and coma, bradycardia, hypotension and hyperglycaemia. Ventricular arrhythmias were also reported. Treatment should be supportive, with a corresponding intensive therapy.

Irritation, sensitisation, contact dermatitis and systemic effects cannot be excluded after contact with skin.

OTHER INFORMATION:

Animals should be monitored during the effect of xylazine and treated adequately in case of any complication. Because of the absence of studies, xylazine should be administered to the progeny only after assessment of the risk-benefit ratio.

Horse: At intravasal administration, intravenous administration is preferred. Intraarterial administration may produce a collapse. At intravenous application the dose should be applied slowly, for 1–2 minutes.
Red deer, fallow deer, roe deer: To prevent aspiration of food and saliva, the head and the neck of lying ruminants should be laid down. The sedated animals should be placed in the left lateral position. To minimize the risk of regurgitation, the animals should be fasted and should have a reasonably limited access to water 24 hours prior to administration.
Red deer, fallow deer, roe deer: The narcotizing shot should be directed to hit optimally deep gluteal or arm muscles. Subcutaneous, intraperitoneal or adipose tissue applications do not ensure an optimum and expected effect.
Use in the last trimester is contraindicated in cows with respect to the proved effect of xylazine on the uterus.
Safety of the veterinary medicinal product has not been determined for use during pregnancy and lactation. Use only upon assessment of the risk-benefit ratio by a respective veterinary surgeon.

Cattle: The effect of xylazine on the milk yield has not been proved. Do not use concurrently with other tranquilizers. Xylazine potentiates the effect of other CNS-active drugs (barbiturates, narcotics, anaesthetics).
Xylazine is suitable for premedication before general anaesthesia, or may be combined with anaesthetics. In combination with these drugs a dose of xylazine should be reduced by a third or a half.
Xylazine effects may be reduced by administration of substances with the alpha2-antagonistic effect.
Cattle, horse: Side effects may be minimized preventively by administration of atropine sulphate.
Overdose may result in the onset of any of the following adverse effects – arrhythmia, hypotension, apnoea, inhibited regulation of body temperature, paradox excitation, muscle tremor, tissue necrosis at the injection site, convulsions in horses, inhibited motility of forestomachs in ruminants, tympanites, regurgitation. Overdose prolongs the wakening period and deepens sedation up to coma.
At overdose the xylazine effect must be antagonized by administration of centrally active alpha2-adrenolytics.

Xylazine is resorbed well and rapidly after administration, including distribution in the body. Resorbption and the onset of effect are influenced by the route of administration. The onset is faster after intravenous administration than after intramuscular administration. Bioavailability after administration differs in individual species. Xylazine is metabolized in the body, 2,6-dimethylaniline is a primary metabolite. Xylazine is excreted in the urine and faeces.

PACKAGE:

1 x 500 mg + 1 x solvent (2 ml) (to prepare 25% solution), 1x 500 mg + 1 x solvent (10 ml) (to prepare 5%, 10%, 25% solution)


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