Butador 10 mg/ml Solution for Injection for Horses, Dogs and Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Butorphanol

Available from:

VetViva Richter GmbH

ATC code:

QN02AF01

INN (International Name):

Butorphanol

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs, Horses

Therapeutic area:

Neurological Agent analgesic

Authorization status:

Authorized

Authorization date:

2011-01-17

Summary of Product characteristics

Revised: January 2023
AN: 02966/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Butador 10 mg/ml solution for injection for horses, dogs and cats
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.
Revised: January 2023
AN: 02966/2022
Page 2 of 8
AS A SEDATIVE
In combination with α
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 α
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 associated with impaction.
Do not use combination during pregnancy.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The precautionary measures required for contact with an