Tranquigel 35 mg/g Oral Gel for Dogs and Horses

Summary of Product characteristics

                                Unlimited Renewal: April 2022
AN: 03008/2021
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tranquigel 35 mg/g oral gel for dogs and horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gram contains:
ACTIVE SUBSTANCES:
Acepromazine (as acepromazine maleate)
35.0 mg
EXCIPIENT(S):
Methyl parahydroxybenzoate (E 218)
1.04 mg
Propyl parahydroxybenzoate
0.104 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral gel.
Clear, viscous, orange-yellow gel.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For sedation of dogs and horses
4.3
CONTRAINDICATIONS
Do not use in cases of hypotension, post-traumatic shock or
hypovolemia.
Do not use in animals in a state of severe emotional excitation.
Do not use in animals suffering from hypothermia.
Do not use in animals with haematological disorders/coagulopathies or
anaemia.
Do not use in animals with heart and or lung failure.
Do not use in animals with epilepsy.
Do not use in neonates.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Unlimited Renewal: April 2022
AN: 03008/2021
Page 2 of 7
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Dogs
None
Horses
Sedation lasts for approximately six hours, although the actual time
and depth of
sedation are very dependent on the status of the individual animal.
Increasing the dosage above that recommended results in prolonged
action and side
effects but no greater sedation.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals:
This veterinary medicinal product should be used with caution and with
reduced
dosage in the case of hepatic disease or in debilitated animals.
Acepromazine has negligible analgesic effects. Painful activities
should be avoided
when handling tranquillized animals, unless treated with appropriate
analgesics.
After administration of this veterinary medicinal product, animals
should be kept in a
calm place and sensorial stimu
                                
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