Torbugesic 10 mg/ml Solution for Injection

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Butorphanol tartrate

Доступна з:

Zoetis Belgium S.A.

Код атс:

QN02AF01

ІПН (Міжнародна Ім'я):

Butorphanol tartrate

Дозування:

10 milligram(s)/millilitre

Фармацевтична форма:

Solution for injection

Тип рецепту:

POM: Prescription Only Medicine as defined in relevant national legislation

Терапевтична група:

Cats, Dogs, Horses

Терапевтична области:

butorphanol

Терапевтичні свідчення:

Neurological Preparations

Статус Авторизація:

Authorised

Дата Авторизація:

2000-10-01

Характеристики продукта

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Torbugesic 10 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Butorphanol 10 mg
(as butorphanol tartrate 14.58 mg/ml)
EXCIPIENTS
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION IS
ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Benzethonium chloride
0.1 mg
Citric acid monohydrate
Sodium citrate dihydrate
Sodium chloride
Benzethonium chloride Water for injection
Clear, colourless liquid.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Horses, dogs and cats.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
HORSES
AS AN ANALGESIC:
The veterinary medicinal product is a centrally acting analgesic and
may be used for the relief of
moderate to severe pain in the horse. Clinical studies in the horse
have shown that the veterinary
medicinal product alleviates abdominal pain, associated with torsion,
impaction, intussusception,
parturition, and spasmodic and tympanic colic.
AS A SEDATIVE:
When given after the administration of detomidine hydrochloride:
Clinical studies have shown that this combination produces a profound
sedation in the horse. The
degree of sedation achieved rendered horses unaffected by sound,
tactile stimuli, or any surrounding
activity.
The sedative combination of the veterinary medicinal product and
detomidine hydrochloride has been
successfully used for the following procedures: radiography, clipping,
wound suturing, dentistry,
standing castration, hoof care, rectal examination, and passing a
stomach tube.
Profound sedation is also achieved using the veterinary medicinal
product after the administration of
romifidine.
DOGS
AS AN ANALGESIC:
For the relief of moderate to severe pain in dogs. Clinical studies
have shown that the veterinary
medicinal product can provide suitable analgesia after a variety of
surgical procedures such as
orthopaedic and soft tissue surgery.
AS A SEDA