Tranquiline 35mg/ml Oral Gel for Dogs
Land: Østerrike
Språk: engelsk
Kilde: HMA (Heads of Medicines Agencies)
Preparatomtale
(SPC)
29-03-2012
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Aktiv ingrediens:
acepromazine 35 mg
Tilgjengelig fra:
Floris Veterinaire Produkten BV
ATC-kode:
QN05AA04
Legemiddelform:
Oral gel
Terapeutisk gruppe:
Acepromazine
Terapeutisk område:
Dogs Non Food
Autorisasjon dato:
2011-11-23
Preparatomtale
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tranquiline 35 mg/ml Oral Gel for Dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral gel.
Clear yellow gel.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For sedation and anaesthetic pre-medication.
Neuroleptanalgesia in combination with a morphine derivative.
Anti-emetic effect, symptomatic therapy in case of vomiting and motion sickness.
4.3 CONTRAINDICATIONS
Do not use in dogs weighing less than 17.5 kg body weight.
Do not use in animals in shock, in severe emotional excitation, with an existing tendency to convulsion or during _Status_
_epilepticus._
Do not use in case of hypersensitivity to the active substance or any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Acepromazine can precipitate fainting in brachycephalic dogs. Large breeds of dog are particularly sensitive to
acepromazine and the minimum dose possible should be used in these breeds.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Acepromazine has little, if any, analgesic effect, so painful procedures must be avoided.
ACTIVE SUBSTANCE
Acepromazine
(as Acepromazine maleate)
35.00 mg
(47.50 mg)
EXCIPIENTS
Preservatives
Methyl parahydroxybenzoate (E218)
0.65 mg
Propyl parahydroxybenzoate (E216)
0.35 mg
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/03/2012_
_CRN 7010059_
_page number: 1_
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
In case of accidental ingestion, seek medical advice immediately informing the health prof
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