Sedanol 40 mg/ml Solution for Injection for Pigs

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: VMD (Veterinary Medicines Directorate)

العنصر النشط:

Azaperone

متاح من:

VetViva Richter GmbH

ATC رمز:

QN05AD90

INN (الاسم الدولي):

Azaperone

الشكل الصيدلاني:

Solution for injection

نوع الوصفة الطبية :

POM-V - Prescription Only Medicine – Veterinarian

المجموعة العلاجية:

Pigs

المجال العلاجي:

Neurological Agent sedative

الوضع إذن:

Authorized

تاريخ الترخيص:

2020-02-26

خصائص المنتج

Revised: January 2023
AN: 02966/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sedanol 40 mg/ml solution for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Azaperone
40 mg
EXCIPIENTS:
Sodium metabisulfite (E 223)
2.0 mg
Methyl parahydroxybenzoate (E 218)0.5 mg
Propyl parahydroxybenzoate
0.05 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, pale yellow to yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
A neuroleptic sedative for pigs:
For the use in animals with aggressive behaviour
-
following re-grouping
-
in sows (devouring of piglets by the sow)
For the use in animals with stress and prevention of stress
-
cardiovascular stress
-
transport-related stress
Obstetrics
As pre-medication in local or general anaesthesia
For relief of symptoms in animals with nutritional muscular dystrophy
4.3
CONTRAINDICATIONS
Do not use in very cold conditions as cardiovascular collapse and
hypothermia
(increased by inhibition of hypothalamic heat regulation centre) due
to peripheral
vasodilation may occur.
Revised: January 2023
AN: 02966/2022
Page 2 of 6
The veterinary medicinal product is contraindicated for use in
transport or for re-
grouping of pigs which will be slaughtered prior to the end of the
withdrawal period.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
During onset of action treated animals should be left alone in a quiet
environment.
Injection into adipose tissue may lead to apparent insufficient
effect.
Occasional deaths have been observed in Vietnamese Pot Bellied pigs.
It is thought
this may be caused by injection into the fat leading to slow induction
and tendency to
use additional doses, leading to overdosage. It is important with this
breed not to
exceed the stated dose.
Do not re-inject if the a