Sedazin®

 Description

Sedative, analgesic and muscle relaxant 2% solution of xylazine for cattle, horses, 
dogs and cats

Qualitative and quantitative composition of active ingredient
Xylazine (in hydrochloride form)         20 mg/ml

Indications
Sedazin is intended for use in cattle, horses, dogs and cats to sedate, relieve pain sensation, muscle relaxation and as an agent for premedication. Xylazine administration facilitates examination of excitable animals, drug administration and it enables performance of short-term surgical procedures.

Contrindications
Do not use in case of ventricular arrythmia, hypotension and shock.
Do not use in respiratory tract diseases.
Do not use during advanced pregnancy (threat of miscarriage), except for the delivery.
Do not use in case of diabetes (xylazine lowers insulin level).
Do not use in case of obstruction of gastrointestinal tract in dogs and cats.

Undesirable effects
Breath attenuation accompanied by acidosis, brachycardia, hypotension, frequent urination. Ataxia in large animals, profuse perspiration in horses. In ruminants, masseter muscle atonia and oedema, salivation and diarhhoea may occur.

In cats, less frequently in dogs, vomiting occurs within 3-5 minutes after administration. 
In cats and dogs, diarrhoea sometimes occurs.

After intramuscular or subcutaneous administration, topical reactions may appear, usually subsiding after 48 hours.

In case of emergence of any adverse effects after administration of this product or upon observation of any alarming symptoms not listed in the product leaflet (including symptoms in humans as a result contacting the product), seek advice of a competent veterinarian, marketing authorization holder or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Report form should be downloaded from the website: http://www.urpl.gov.pl (Department of Veterinary Medicinal Products).

Posology and method of administration
Routes of administration: intramuscularly, intravenously and subcutaneously.

 

Cattle

intramuscularly 0.25–1.5 ml/100 kg b.w. (i.e. 5-30 mg of xylazine/100 kg b.w.)

intravenously 0.08 – 0.5 ml/100 kg b.w. (i.e. 1.6-10 mg of xylazine/100 kg b.w.)

 

Horses

intramuscularly 7.5–15 ml/100 kg b.w. (i.e. 150-300 mg of xylazine/100 kg b.w.)

intravenously 3-5 ml/100 kg b.w. (i.e. 60-100 mg of xylazine/100 kg b.w.)

 

Dogs

intramuscularly, subcutaneously, or intravenously 0.15 ml/kg b.w.

(i.e. 3 mg of xylazine / kg b.w.

 

Cats

 

intramuscularly or subcutaneously 0.15 ml/kg b.w. (i.e. 3 mg/ kg b.w.)

During intravenous administration, the product should be warmed up to body temperature and injected slowly.

In order to establish proper dosage regimen, animal body weight should be determined 
to a possibly most precise extent.

Due to disturbed cardiac performance, the product should be administered with 
atropine.

Xylazine starts to act within 5-10 minutes after intramuscular administration, and within 
3-5 minutes after intravenous administration. Analgesic effect is maintained for 10-15 minutes, and sedating effect for 0.5-4 hours, depending on animal species. After intravenous administration, effects are maintained for a longer perod of time.

 

Indications for proper administration
Not applicable

 


Wihtdrawal period
Cattle and horses: edible tissues – 0 days, milk – 0 days.
Dogs and cats – not applicable.

Special precautions to be taken for storage and transport

Keep out of reach and sight of children.

Store +2 to +8°C. Protect from light.Do not freeze.

Do not use after the expiration date.

The shelf life after the first opening of the primary packaging is 28 days.

 

Special warnings and precautions 

Special precautions related to animal use

Horses:

  • xylazine disturbs peristaltic bowel movement, therefore it should be used in 
    horses solely in colic conditions not responsive to analgesic drugs; its use should be avoided in horses with debilitated motor activity of the caecum.
  • use cautiously in horses susceptible to laminitis,
  • animals with respiratory tract dysfunctions or respiratory tract diseases, may develop 
    life-threatening dyspnoea,
  • possibly smallest recommended doses should be applied.

Cats and dogs:

  • xylazine blocks proper motor bowel activity, which facilitates accumulation of gas 
    in animal gastrointestinal tract, therefore it is not recommended to use xylazine before X-ray of the stomach and initial sections of bowels, as accumulated gas disables proper interpretation of test results,
  • brachycephalic dog breeds with symptoms of respiratory tract dysfunctions or respiratory tract diseases, may develop life-threatening dyspnoea,

Cattle:

  • as a result of xylazine action, motor activity of proventriculus is inhibited, which 
    may lead to flatulence; for this reason, it is recommended not to give food or 
    water to animals a few hours before xylazine administration.
  • after xylazine administration, eructation, cough and swallowing reflexes are attenuated, that is why cattle must be carefully observed while regaining consciousness and remain in sternum position,
  • in cattle, small and average doses are recommended.

Administration of too large doses should be avoided.

Dosage regimen should consider individual drug sensitivity of treated animals.

Remain highly cautious during administration in convulsive states, acute renal and hepatic failure, and in dehydrated animals.

In order to prevent choking on saliva or vomited matter, animal’s head should be arranged lower than the rest of its body.

Old and exhausted animals may be more susceptible to xylazine action, whereas agitated ones may require larger doses.

During product use, patients should be provided with calmness, as external stimuli may weaken drug response.

Xylazine may cause thermoregulation disturbances. If during product use ambient temperature departs from room temperature, it is recommended to cool down or warm up the patient.

In case of painful procedures, xylazine should always be used in conjunction with topical or general aenesthesia.

Treated animals should be controlled until complete regression of adverse product effects. In that period, they should be kept in a separate room, in order to prevent 
injuries caused by other animals.

Central neurodepressive drugs (anaesthetics, analgesics) intensify xylazine action. Cardiodepressive action is intensified, respiratory functions are attenuated and hypotensive effect is evoked. For that reason, xylazine should be very carefully combined with opioids.

Xylazine should not be combined with thiobarbiturates and halothane, as heart rhythm disorders are intensified.

Due to threat of ventricular arrhythmia, xylazine should not be used in combination with adrenaline and other agents stimulating sympathetic system or immediately after their administration.

Do not use xylazine in advanced pregnancy, as it may evoke miscarriage.

In case of overdose, adverse symptoms are intensified: the risk of respiratory standstill and collapse, convulsive attacks may appear.

They may be partially relieved by intravenous application of alpha-2 agonist of adrenergic receptors in the central nervous system: yohimbine in a dose of 0.1-0.2 
mg/kg b.w. or tolazoline in a dose of 0.5-1.0 mg/kg b.w.

As no conformity studies of this medicinal veterinary product have been conducted, it is forbidden to combine it with other veterinary medicinal products.

Special precautions for individuals administering the veterinary medicinal product to animals

In case of unintended swallowing or self-injection, immediately seek doctor’s advice and present him with a package leaflet, however it is forbidden to DRIVE MOTOR VEHICLES due to possible drug-induced sedation and changes in arterial blood pressure.

Avoid contact with skin, eyes and mucous membranes.

In case of contact with exposed skin, immediately flush skin with profuse amounts of water.

Take off contaminated clothing that is in immediate contact with the skin.

In case of unintended eye contact, flush the eye with profuse amounts of water. In case of symptoms emergence, seek doctor’s advice.

If the product is administered by a pregnant woman, she should take special 
precautions protecting her against self-injection, due to possible emergence of uterine contractions and reduction of fetus arterial blood pressure after accidental systemic exposure.

Instructions for physicians
Xylazine is an alpha-2 agonist of adrenergic receptors; its absorption may evoke clinical symptoms depending on a dose, such as: drug-induced sedation, respiratory centre depression, bradycardia, hypotension, xerostomia and hypoglicemia. Cases of 
ventricular arrythmia have been reported as well. Respiratory and haemodynamic disruptions should be subject to symptomatic treatment.

Special precautions concerning neutralising the not used medicinal veterinary product or wastes originating from this product
The drugs must not be removed into the sewage system or thrown away with litter. 
Ask a veterinary doctor about the methods of disposal of useless drugs. It is crucial for environmental protection

Package
Cardboard carton contains single vials of 20 ml 
Cardboard carton contains single vials of 50 ml.

Exclusively for animals

Prescription-only- medicine(POM)

 

For exclusive use by a veterinary surgeon.

 More details

Name Description
Place of Origin: Poland

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 24-100 Pulawy, Arciucha 2 NIP 716-11-26-796 Biowet Pulawy Ltd.,Poland, Europe
 3 years, 5 months ago
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