Sedalin 35 mg/ml Oral Gel

Land: Storbritannia

Språk: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv ingrediens:

Acepromazine

Tilgjengelig fra:

Vetoquinol UK Ltd

ATC-kode:

QN05AA04

INN (International Name):

Acepromazine

Legemiddelform:

Oral gel

Resept typen:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Horses

Terapeutisk område:

Neurological Agent sedative

Autorisasjon status:

Authorized

Autorisasjon dato:

1996-03-25

Preparatomtale

Revised: May 2018
AN: 00005/2018
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sedalin 35 mg/ml Oral Gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH ML CONTAINS
Active substance
Acepromazine 35.0mg (as Acepromazine Maleate 47.5mg)
List of Excipients
Methyl-4-hydroxybenzoate 0.65 mg and Propyl-4-hydroxybenzoate 0.35 mg,
as
preservatives
FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1
3.
PHARMACEUTICAL FORM
Oral gel
Yellow-orange transparent gel for oral administration
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horse
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For sedation of horses
4.3
CONTRA-INDICATIONS
Not for use in animals in shock or post traumatically, or with
existing severe
emotional excitation or epilepsy
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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 results in prolonged action and side effects but
no
greater sedation.
Revised: May 2018
AN: 00005/2018
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Do not use in cases of post traumatic hypovolemia
ii)
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
In case of accidental ingestion contact a physician showing the pack
insert or
product label to the physician. Wash hands and exposed skin thoroughly
after
use. Persons with sensitive skin or in continuous contact are advised
to wear
impermeable gloves. Avoid contact with eyes. If accidental eye contact
occurs,
flush gently with running water for 15 minutes and seek medical advice
if any
irritation persists.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Since acepromazine decreases sympathetic nervous system tone, a
transient
drop in blood pressure may occur after its administration.
Inhibition of temperature regulation.
The following reversible changes are possible in the haemogram:
Tran