INJECTABLE SOLUTION
COMPOSITION
Xylazine (sf . hydrochloride) 2 g (corresponding to 2.332 g of xylazine hydrochloride)
Excipient qsp 100 ml
PHARMACEUTICAL PROPERTIES
Xylazine hydrochloride is an a2-adrenergic receptor agonist. It is a sedative and anesthetic for domestic and wild animals. It is the most widely used anesthetic product in ruminants. It is the first IM injectable anesthetic in veterinary medicine.
Xylazine acts by stimulation of the presynaptic receptors at 2 central adrenergics which leads to the inhibition of the release of norepinephrine thus leading to the inhibition of the perception of pain at the origin of the sedative, analgesic and myorelaxant effects.
It is a good visceral analgesic (“morphine”), but less good on the skin, hence its association with ketamine and local anesthetics. It is also useful for controlling colic.
Sensitivity to Xylazine depends on the animal species, ruminants being more sensitive than equines. Xylazine is marketed in the form of an injectable solution that can be used by all routes (IM, IV, SC, local (epidural)). Well tolerated by IM and SC routes. Absorption is rapid by IM route and action is rapid (10 to 15 min). Xylazine is a weak base weakly bound to serum proteins, which gives it a wide tissue distribution.
Its elimination is rapid with half-life times of 20-50 min. It is done by hepatic metabolism and excretion takes place partly by the renal route in the form of metabolites.
TARGET SPECIES
Equidae, Cattle, Dogs and Cats.
INDICATIONS
- Sedation, analgesia, and muscle relaxation.
- Premedication during general anesthesia.
- Tranquilization of nervous animals during examinations or treatments.
ADMINISTRATION AND DOSAGE
The dose should be adjusted according to the desired effect according to the classification below:
- Cattle:
- Intramuscular injection :
Dose |
mg/Kg |
ml/100Kg |
Desired effects |
I |
0.05 |
0.25 |
Clear and sufficient sedation and analgesia for small minor surgeries. |
II |
0.1 |
0.5 |
Medium intensity sedation with analgesia and muscle relaxation; it is sufficient for surgical operations. |
III |
0.2 |
1.0 |
All the effects being very marked, this dose allows surgical interventions. |
IV |
0.3 |
1.5 |
Long-term sedation and intense muscle relaxation, for exceptional cases Effects sought (as much as possible in fasting animals). |
If necessary, the action of SEDAZIN can be increased by a second administration, approximately 10 to 30 minutes after the first injection. However, in all cases, the total dose injected should not exceed 1.5 ml/100 kg.
- Slow intravenous injection :
|
The doses recommended for the intravenous route of SEDAZIN are 1/3 of those recommended for the IM route depending on the individual reaction of the animal and the stage of sedation sought. In this case, the injection should be done gently.
- Horses:
Intravenous route.
The recommended dose is 0.6 to 1.0 mg/kg corresponding to 3 to 5 ml of product/100 kg. These doses allow variable sedation (mild to strong) depending on the dose, with variable analgesia from one animal to another, and marked muscle relaxation.
Depending on the dose administered, mild to heavy sedation is achieved with varying individual degrees of analgesia and pronounced muscle relaxation, sufficient for loading and unloading, shoeing, clinical examinations, wound treatment, surgery obstetrics, and interventions that are not too painful.
SEDAZIN can be used in combination with other preparations for painful procedures on standing or lying animals.
- Dogs :
SEDAZIN is injected intramuscularly and, under certain conditions, intravenously. The dosage varies from 1 to 3 mg/kg, i.e. 0.05-0.15 ml/kg. These doses allow variable sedation, analgesia and muscle relaxation (mild to strong) depending on the dose and the individual sensitivity of each animal. Generally, the effect obtained allows quite painful interventions.
- Cats:
SEDAZIN is recommended intramuscularly or subcutaneously at doses of 2 to 4 mg/kg, corresponding to 0.1-0.2 ml/kg. The effects obtained (sedation, analgesia, muscle relaxation) depend on the dose and the individual sensitivity of each animal.
SEDAZIN is generally combined with other preparations for painful procedures.
CONTRAINDICATIONS AND INTERACTIONS
- Do not use in case of severe renal, hepatic or cardiac insufficiency.
- In dogs and cats, do not use in case of esophageal obstruction, gastric torsion or hernia.
- Caution with lung disease.
- Avoid injecting the specialty during the last month of gestation, in all species, as uterine contractions induced by the product may cause premature birth.
- Simultaneous administration of other drugs such as local anesthetics, narcotics, tranquilizers, antibiotics, sulfonamides, saline and calcium preparations is compatible.
SIDE EFFECTS
- In anesthetized animals, mainly during and after the awakening phase, in very rare cases, cardio-respiratory disorders (cardiac arrest, dyspnea, bradypnea, pulmonary oedema, hypotension as well as neurological disorders (convulsions, depression, pupillary disorder, tremors) were observed.
- In dogs and cats, administration generally causes vomiting. This effect can be reduced by fasting the animals.
PRECAUTIONS FOR USE
Precautions for use in animals :
- Avoid injecting the specialty during the last month of gestation, in all species, as uterine contractions induced by the product may cause premature birth.
- The drug causes a hypnotic state with sedation, accompanied by generalized muscle relaxation and analgesia (anesthesia) of varying degree from species to species and from individual to individual. This individual disposition can lead to reactions justifying, before the administration of the drug, to have a precise idea of the general status of the animal to be treated.
- The action of the drug can be reduced under the influence of external stimuli, the animal should be left at rest, protected from noise and excitement until the action reaches full development.
- The combination with other pre-anaesthetic or anesthetic agents must be the subject of a benefit-risk assessment which will take into account the composition of the drugs used and their doses, the nature of the intervention as well as the ASA class ( American Society of Anesthesiologists) to which the animal belongs. Recommended doses may vary depending on the anesthetic combination used.
- The tympanism sometimes observed in ruminants in the supine position will be suppressed by the prone position. To avoid aspiration of saliva and food, place the head and neck in a sloping position.
- When using high doses, keep animals fasting .
Precautions to be taken by the person administering the veterinary medicinal product to animals:
- In the event of accidental oral absorption or injection, seek medical advice immediately and show the package leaflet to the physician, but DO NOT DRIVE a vehicle, as sedation and changes in blood pressure may occur.
- Avoid contact with skin, eyes and mucous membranes.
- Wash exposed skin immediately after exposure with plenty of water.
- Remove contaminated clothing which is in direct contact with the skin.
- In case of accidental contact of the product with the eyes, rinse abundantly with clear water. If symptoms occur , seek medical attention.
- If pregnant women handle the product, they should take special precautions not to self-inject the product, as it may cause uterine contractions and decreased fetal blood pressure after inadvertent systemic exposure.
Advice to doctors:
- Xylazine is an alpha 2 adrenergic receptor agonist; symptoms appearing after its absorption may consist of clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, dry mouth and hyperglycaemia; ventricular arrhythmias have also been reported. Respiratory and hemodynamic symptoms should be treated symptomatically .
WITHDRAWAL PERIOD
- Meat and offal: Nil.
- Milk: None.
STORAGE CONDITIONS
- Unopened container: Keep the product in the original packaging, protected from light and at a temperature < 25°C.
- After opening the bottle: 4 weeks.
PHARMACEUTICAL FORM AND PRESENTATION
Solution for injection.
50ml and 100ml bottles.