Sileo 0.1 mg for dogs 3ml
Alleviation of acute anxiety and fear associated with noise in dogs
Sileo 0.1 mg/ml oromucosal gel for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each ml of the oromucosal gel contains: Active substance: Dexmedetomidine hydrochloride 0.1 mg (equivalent to 0.09 mg dexmedetomidine).
3. PHARMACEUTICAL FORM:
Oromucosal gel. Translucent, green gel.
4. CLINICAL PARTICULARS:
4.1 Target species:
4.2 Indications for use Sileo, specifying the target species:
Alleviation of acute anxiety and fear associated with noise in dogs.
4.3 Contraindications Sileo:
Do not use in dogs with severe cardiovascular disorders. Do not use in dogs with severe systemic disease (graded as ASA III-IV) e.g. end stage renal or liver failure. Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs obviously sedated from previous dosing.
4.4 Special warnings for each target species:
4.5 Special precautions for use.
Special precautions for use in animals:
If the oromucosal gel is swallowed it will become ineffective. Therefore feeding the dog or giving it treats within 15 minutes after administration of the gel should be avoided.
In case the gel is swallowed the dog can be given another dose if necessary 2 hours after the previous dose. In extremely nervous, excited or agitated animals, the levels of endogenous catecholamines are often high. The pharmacological response elicited by alpha-2 agonists (e.g. dexmedetomidine) in such animals may be reduced.
The safety of administering dexmedetomidine to puppies younger than 16 weeks and dogs over 17 years of age has not been studied.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental ingestion or prolonged mucosal contact, seek medical advice immediately and show the package leaflet or the label to the physician.
Do not drive as sedation and changes in blood pressure may occur.
Avoid skin, eye or mucosal contact. Wear impermeable disposable gloves when handling the veterinary medicinal product. In case of skin contact wash the exposed skin immediately after exposure with large amounts of water and remove contaminated clothes.
In case of eye or oromucosal contact, rinse abundantly with fresh water. If symptoms occur, seek the advice of a physician. People with known hypersensitivity to dexmedetomidine or any of the excipients should avoid contact with the veterinary medicinal product.
Pregnant women should avoid contact with the product. Uterine contractions and decreased foetal blood pressure may occur after systemic exposure to dexmedetomidine.
Advice to the physician:
Dexmedetomidine, the active ingredient of Sileo is an alpha-2 adrenoceptor agonist. Symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia. Ventricular arrhythmias have also been reported. Since effects are dose dependent they are more pronounced in small children than adults. Respiratory and haemodynamic symptoms should be treated symptomatically. The specific alpha-2 adrenoceptor antagonist, atipamezole, which is approved for use in animals, has been used in humans but only experimentally to antagonize dexmedetomidine-induced effects.
4.6 Adverse reactions (frequency and seriousness) Sileo:
Common adverse reactions: Due to peripheral vasoconstriction, transient paleness of mucous membranes at the application site may be observed. Other commonly observed adverse events in clinical trials were sedation, emesis and urinary incontinence. Uncommon adverse reactions in clinical trials were anxiety, periorbital oedema, drowsiness and signs of gastroenteritis.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
4.7 Use during pregnancy, lactation or lay:
The safety of this veterinary medicinal product has not been established during pregnancy and lactation in the target species.
Therefore the use of the product during pregnancy and lactation is not recommended.
4.8 Interaction with other medicinal products and other forms of interaction:
The use of other central nervous system depressants is expected to potentiate the effects of dexmedetomidine and therefore an appropriate dose adjustment should be made.
4.9 Amounts to be administered and administration route:
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.
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(kg) 1 ●
5,6–12(kg) 2 ●●
12,1–20 (kg)3 ●●●
20,1–29(kg) 4 ●●●●
29,1–39(kg) 5 ●●●●●
39,1–50(kg) 6 ●●●●●●
50,1–62,5(kg) 7 ●●●●●●●
62,6–75,5(kg) 8 ●●●●●●●●
75,6–89(kg) 9 ●●●●●●●●●
89,1–100(kg) 10 ●●●●●●●●●●
5. Nature and composition of immediate packaging Sileo:
Pre-filled 3 ml HDPE oral syringes with graduations from 0.25 ml (1 dot) to 3 ml (12 dots). The oral syringe is fitted with a plunger, dosing ring and end cap (for sealing it). Each oral syringe is packed in an individual child-resistant carton. Pack sizes: single pack of 1 oral syringe and multipacks of 3 (3 packs of one), 5 (5 packs of one), 10 (10 packs of one) and 20 (20 packs of one). Multipacks of 5, 10 and 20 oral syringes are intended to be supplied only to veterinarians. Not all pack sizes may be marketed.