Sileo

1 x 3 ml
Oromucosal gel
OM

Species

Dogs

Indications

Alleviation of acute anxiety and fear associated with noise in dogs.

Dose to be administered and administration route

Oromucosal use.

The product should be administered onto the oral mucosa between dog’s cheek and gum at a dose of 125 micrograms/m2. The Sileo oral syringe is capable of delivering the product in 0.25 ml increments. Each increment is shown as one dot on the plunger. The dosing table provides the number of dots to be administered corresponding to the dog’s bodyweight.

image

The following dosing table provides the dose volume (in dots) to be administered for the corresponding bodyweight. If the dose for the dog is more than 6 dots (1.5 ml), half of the dose should be administered to the oral mucosa on one side of the dog’s mouth and the other half of the dose onto the other side. Do not exceed the recommended dose.

Bodyweight of dog (kg)

Number of dots

2.0–5.5

1 ●

5.6–12

2 ●●

12.1–20

3 ●●●

20.1–29

4 ●●●●

29.1–39

5 ●●●●●

39.1–50

6 ●●●●●●

50.1–62.5

7 ●●●●●●●

62.6–75.5

8 ●●●●●●●●

75.6–89

9 ●●●●●●●●●

89.1–100

10 ●●●●●●●●●●

The first dose should be given as soon as the dog shows the first signs of anxiety, or when the owner detects a typical stimulus (e.g. sound of fireworks or thunder) for eliciting anxiety or fear in the respective dog. Typical signs of anxiety and fear are panting, trembling, pacing (frequent change of place, running around, restlessness), seeking people (clinging, hiding behind, pawing, following), hiding (under furniture, in dark rooms), trying to escape, freezing (absence of movements), refusing to eat food or treats, inappropriate urination, inappropriate defecation, salivation, etc.

If the fear eliciting event continues and the dog shows signs of anxiety and fear again, re-dosing can be done when 2 hours have passed from the previous dose. The product can be dosed up to 5 times during each event.

Instructions for dosing the gel:

Dosing should be performed by an adult.

PREPARATIONS FOR DOSING:

image1. WEAR GLOVES

Wear impermeable disposable gloves when handling the veterinary medicinal product and handling the oral syringe.

image2. HOLD PLUNGER

Hold the oral syringe plunger so that you can see the dot markings.

DOSE SELECTION AND DOSING:

3. ROTATE RING

Hold the plunger and rotate the ring towards the barrel to select the dose your veterinarian has prescribed to your dog. Do not pull the plunger!

image4. SET THE DOSE

Position the dosing ring so that the side nearest the barrel is in line with the graduation mark (black line), and the required number of dots shows between the dosing ring and the barrel.

image5. CONFIRM THE DOSE

Make sure that you count the dots from the correct part of the plunger (shown in yellow) and that the ring is in line with the graduation mark (shown with the yellow arrow).

image6. FOLLOWING DOSES

To administer following doses from the same syringe: Repeat the previous “4. Set the dose” and “5. Confirm the dose” parts of the instructions.

image7. PULL CAP (TIGHT)

Pull the cap strongly while holding the barrel. Note the cap is very tight (pull, do not twist). Save the cap for replacement.

image8. DOSE INTO CHEEK

Place the oral syringe tip between the dog’s cheek and gum and press the plunger until the dosing ring causes the plunger to stop.

image9. NOT SWALLOWED

IMPORTANT: The gel should not be swallowed. If the gel is swallowed, it may not be effective.

image10. BACK TO PACKAGE

Recap the oral syringe and return it to the outer package as the product is sensitive to light. Make sure that the carton is closed properly. Keep the package out of sight and reach of children at all times. Remove and discard gloves.

Adverse reactions

Due to peripheral vasoconstriction, transient paleness of mucous membranes at the application site was commonly observed. Sedation, emesis and urinary incontinence were commonly observed in clinical trials.

Anxiety, periorbital oedema, drowsiness and signs of gastroenteritis were uncommonly observed in clinical trials.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s)

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

References

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Art. Nr.
EAN 6432100028808
PACKAGES
Sileo
Dômes Pharma
1 x 3 ml
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