XYLASED 500 mg lyophilisate for solution for injection with solvent

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Pharmaceutical form

Lyophilisate for solution for injection with solvent.

Lyophilisate of a porous structure and a white or off-white colour.

A clear, colourless solution after reconstitution.

Composition

Xylazinum (ut Xylazini hydrochloridum) 500 mg 

Indication

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: Immobilisation and sedation of freely moving animals with a narcotising shot; premedication before general anaesthesia.

Target animals

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

Dosage and application

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 lyophilisate 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 narcotising shot.

Dilution

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

• 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 lyophilisate is dissolved within three minutes and a clear solution is produced.

Dosage for each target species

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 observed within 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 administration the dose should be applied slowly, for 1-2 minutes.

Cattle, horse: Administration of atropine sulfate 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).

Storage

Store below 25°C.

Protect from light.

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.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after reconstitution: use immediately.

Package

1 x 500 mg + 1 x solvent (2 ml) (to prepare 25 % solution).

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

5 x 500 mg + 5 x solvent (2 ml) (to prepare 25 % solution).

Not all pack sizes may be marketed.