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EN - Anglická
  • CZ - Česká
  • SK - Slovenská
  • PL - Polská
  • RO - Rumunská
  • RU - Ruská
  • TR - Turecká
  • UA - Ukrajinská

SEDAN 35 mg/ml oral gel for dogs

Homepage Products Veterinary products SEDAN 35 mg/ml oral gel for dogs

Sedation of animals for reasons of restlessness, tetanus, lumbago. Sedation for the purpose of fixation before and during treatment, sedation before transport of the animal (reduction of transport stress).

type of preparative: Analeptic, anaesthetic, hypnotics
target species animals: Horse, Dog

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STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

1 g of the gel contains:
Active substance:

Acepromazine                   35.0 mg (as acepromazine maleate 47.5 mg)

Excipients:
Methylparaben (E 218)     0.65 mg
Propylparaben                   0.35 mg

Transparent, orange-yellow gel.


INDICATION(S)

Sedation of animals for reasons of restlessness, tetanus, lumbago. Sedation for the purpose of fixation before and during treatment, sedation before transport of the animal (reduction of transport stress).


CONTRAINDICATIONS

Spasmophilia, epilepsy, shock, persistent excitement.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.


ADVERSE REACTIONS

Hypothermia may occur temporarily after administration of acepromazine. Reversible changes may also be shown in a blood count where there may be a transient decrease in the number of erythrocytes and leukocytes, hemoglobin and platelet counts.

Acepromazine increases secretion of prolactin and may cause fertility disorders.

In males, acepromazine causes relaxation of the retractor penis muscle, leading to penile prolapse from the preputial sheath. The condition is reversible, the penis can be retracted again within 2-3 hours. If reposition does not occur within a short time, a veterinarian should be contacted. Occasionally, acepromazine may cause strangulation of the glans penis, resulting in prolonged erection (priapism).

In dogs, reduced arterial blood pressure and bradycardia may occur, brachycephalic breeds (especially boxers) are most sensitive.


TARGET SPECIES

Dogs, horses.


DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Oral administration.

One division on the plunger scale corresponds to 1 ml of gel. The dose is determined by setting the ring on the appropriate plunger mark. Move the grooved dosing ring on the plunger so that the bottom edge of the ring is aligned with the mark of the desired dose. Remove the cap, insert the applicator into the animal’s mouth and apply the gel to the root of the tongue. After application, lift the animal’s head immediately for a few seconds and make sure that the animal has swallowed the dose.

Degree of sedation Acepromazine dose 
[mg/kg bw]
Number of divisions
Mild 1.0 0.5 divisions/17.5 kg bw
Moderate 2.0 1 divisions/17.5 kg bw
Deep 3.0 1.5 divisions/17.5 kg bw

 

 

 

 

0.5 division corresponds to 0.5 ml on the applicator plunger scale.


SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Protect from frost.

Protect from light.

Do not use this veterinary medicinal product after the expiry date which is stated on the label.

Shelf life after first opening the container: 3 months.


SPECIAL WARNING(S)

Special warnings for each target species:

The effect of acepromazine after oral administration occurs in 30-60 minutes in large animals and in 15-25 minutes in small animals. Its duration of action is 4 hours on average, depending on the depth of sedation and the individual response of the animal.

Apply with caution to boxers and other brachycephalic breeds.

Special precautions for use in animals:

The use of this veterinary medicinal product in dogs with a body weight of less than 17.5 kg should be based on a careful assessment of the therapeutic benefit/risk ratio by the veterinarian concerned. The reason is the calibration of the applicator from 17.5 kg bw.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Acepromazine may cause sedation. Prevent accidental ingestion of the product.

After use, close the syringe immediately with the cover. To ensure proper closure, you must hear a “click”. Keep the full syringe in the original carton and make sure it is properly closed. Keep the package out of the sight and reach of children all the time.

In case of accidental ingestion seek medical advice immediately and show the package leaflet or label to the practitioner, but DO NOT DRIVE A MOTOR VEHICLE as sedation may occur.

Wash your hands and stained skin thoroughly with water and soap after using the product.

People with sensitive skin or in continuous contact with the medicinal product are recommended to use impermeable gloves.

Prevent accidental contact with eyes and mucous membranes. In case of accidental eye or mucous membrane staining, rinse the affected area with running water for 15 minutes. In case of persistent irritation seek medical advice and show the package leaflet or label to a practitioner.

Pregnancy and lactation:

Do not use during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction:

Concomitant administration with organic esters of phosphoric acid (antiparasitics such as chlorfenvinphos, dichlorophos etc.) increases toxicity.

Acepromazine decreases sympathetic tone, therefore it should not be coadministered with blood pressure lowering products.

Acepromazine potentiates the effect of centrally acting drugs (barbiturates, anaesthetics etc.).

Overdose (symptoms, emergency procedures, antidotes):

Dosage can be adjusted according to the expected effect. Because of the low toxicity of acepromazine, it is possible to increase the dose, but it does not always increase sedation.

The toxicity test in dogs with a 12 to 24-fold clinical dose (3 mg/kg bw) did not lead to any negative effects.

Incompatibilities:

Not applicable.


SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.


OTHER INFORMATION

Pack size: 1 x 1ml, 1 x 10 ml.

Veterinary medicinal product subject to prescription.

For animal treatment only.


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