Butador 10 mg/ml solution for injection for horses, dogs and cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Butorphanol tartrate

Available from:

Richter Pharma AG

ATC code:

QN02AF01

INN (International Name):

Butorphanol tartrate

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs, Horses

Therapeutic area:

butorphanol

Therapeutic indications:

Neurological Preparations

Authorization status:

Authorised

Authorization date:

2011-05-27

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Butomidor 10 mg/ml solution for injection for horses, dogs and cats
(AT, BE, DE, EL, ES, LT, LV,
NL, PT, SI)
Torpudor vet 10 mg/ml solution for injection for horses, dogs and cats
(FI)
Butomidor vet. 10 mg/ml solution for injection for horses, dogs and
cats (DK, IS, SE, NO)
Butador 10 mg/ml solution for injection for horses, dogs and cats (FR,
IE, UK)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Butorphanol
10 mg
(as butorphanol tartrate
14.58 mg)
EXCIPIENT:
Benzethonium chloride
0.1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to almost colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horse, dog, cat
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
HORSE
AS AN ANALGESIC
For the short term relief of pain such as colic of gastrointestinal
tract origin.
AS A SEDATIVE AND PRE-ANAESTHETIC
In combination with α
2
-adrenoceptor agonists (detomidine, romifidine, xylazine):
For therapeutic and diagnostic procedures such as minor standing
surgery and sedation of
intractable patients.
DOG/CAT
AS AN ANALGESIC
For relief of moderate visceral pain e.g. pre- and post-surgical as
well as post-traumatic pain.
_ _
AS A SEDATIVE
In combination with

2
-adrenoceptor agonists (medetomidine).
AS A PRE-ANAESTHETIC
Part of anaesthetic regime (medetomidine, ketamine).
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients. Do not use
for treatment of animals with severe dysfunction of the liver and
kidneys, in case of cerebral injury or
organic brain lesions and in animals with obstructive respiratory
diseases, heart dysfunctions or spastic
conditions.
For combination use with

2
-agonists in horses:
Do not use in horses with a pre-existing cardiac dysrhythmia or
bradycardia.
The combination will cause a reduction in gastrointestinal motility
and consequently should not be
used in cases of colic associa