Sedivet 10 mg/ml Solution for Injection for horses

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Romifidine hydrochloride

Verfügbar ab:

Boehringer Ingelheim Vetmedica GmbH

ATC-Code:

QN05CM93

INN (Internationale Bezeichnung):

Romifidine hydrochloride

Dosierung:

10 milligram(s)/millilitre

Darreichungsform:

Solution for injection

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiebereich:

romifidine

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

1996-03-29

Fachinformation

SEDIVET-SPC-B-12
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sedivet 10mg/ml solution for injection for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Romifidine hydrochloride
10mg
equivalent to 8.76 mg romifidine
Preservative
Chlorocresol
2mg
For a full list of excipients, please see 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Sedative to facilitate handling, examination, minor surgical
interventions and manipulations.
Sedivet may be used as a premedication agent with ketamine or
thiopentone for short duration
anaesthesia, or used with ketamine or thiopentone prior to halothane
inhalation or ‘topping up’
with ketamine or thiopentone for prolonged procedures.
Sedivet has also been used with synthetic opiates (eg. butorphenol) to
provide profound
sedation/analgesia.
4.3
CONTRAINDICATIONS _ _
The product should not be used in horses in the last month of
pregnancy.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In common with other sedatives of this class, defensive movements, ie
kicking, may
occur even in apparently well sedated animals. These occurrences may
be reduced by the
use of opiates, eg. butorphanol.
SEDIVET-SPC-B-12
When used as a pre-anaesthetic agent, sedation should be apparent
before the induction
of anaesthesia.
When the product is used as part of the anaesthetic procedure, care
should be taken
during the recovery phase to ensure that the horse is kept in a warm
and quiet
environment.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals.
In the case of accidental oral intake or self-injection, seek medical
advice immediately
and show the package leaflet to the doctor but DO NOT DRIVE as
sedation and changes
in blood pressure may occur.
Avoid skin, eye or mucosal contact.
Immediately after exposure,