Butador

1 x 10 ml

Solution for injection

Active substance

Butorphanol (Butorphanol tartrate) : 10 mg/ml

ATC code

QN02AF01 Butorphanol

QN02AF Morphinan derivatives

QN02A Opioids

QN02 Analgesics

QN Nervous system

Species

Horses, dogs, cats

Indications

Horses

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 α₂-adrenoceptor agonists (detomidine, romifidine, xylazine): For therapeutic and diagnostic procedures such as minor standing surgery and sedation of intractable patients.

Dogs, cats

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 α₂-adrenoceptor agonists (medetomidine).

As a pre-anaesthetic

Part of anaesthetic regime (medetomidine, ketamine).

Dose to be administered and administration route

For intravenous (i.v.), intramuscular (i.m.) or subcutaneous (s.c.) use.

Horses:Intravenous

Dogs: Intravenous, subcutaneous or intramuscular

Cats:Intravenous or subcutaneous

To ensure a correct dosage, body weight should be determined as accurately as possible.

Horses

As an analgesic

Monotherapy:

0.1 mg/kg (1 ml/100 kg bw) i.v.

As a sedative and as a pre-anaesthetic

With detomidine:

Detomidine: 0.012 mg/kg i.v., followed within 5 minutes by

Butorphanol: 0.025 mg/kg (0.25 ml /100 kg bw) i.v.

With romifidine:

Romifidine: 0.05 mg/kg i.v., followed within 5 minutes by

Butorphanol: 0.02 mg/kg (0.2 ml /100 kg bw) i.v..

With xylazine:

Xylazine: 0.5 mg/kg i.v., followed after 3 - 5 minutes by

Butorphanol: 0.05 – 0.1 mg/kg (0.5 - 1 ml /100 kg bw) i.v..

Dogs

As an analgesic

Monotherapy:

0.1 - 0.4 mg/kg (0.01 – 0.04 ml/kg bw) slowly i.v. (in the lower to medium dose range) as well as i.m., s.c..

For post-operative pain control the injection should be administered 15 minutes before the end of anaesthesia in order to achieve sufficient pain relief during the recovery phase.

As a sedative

With medetomidine:

Butorphanol: 0.1 mg/kg (0.01 ml/kg bw) i.v., i.m.

Medetomidine: 0.01 mg/kg i.v., i.m.

As a pre-anaesthetic

With medetomidine and ketamine:

Butorphanol: 0.1 mg/kg (0.01 ml/kg bw) i.m.

Medetomidine: 0.025 mg/kg i.m., followed after 15 minutes by

Ketamine: 5 mg/kg i.m.

It is only possible to use atipamezole 0.1 mg/kg body weight for medetomidineantagonisation when ketamine action has ceased.

Cats

As an analgesic

Monotherapy:

15 minutes prior to recovery either: 0.4 mg/kg (0.04 ml/kg bw) s.c. or: 0.1 mg/kg (0.01 ml/kg bw) i.v.

As a sedative

With medetomidine:

Butorphanol: 0.4 mg/kg (0.04 ml/ kg bw) s.c.

Medetomidine: 0.05 mg/kg s.c.

For wound debridement an additional local anaesthesia is recommended.

Medetomidine-antagonisation is possible with atipamezole 0.125 mg/kg body weight.

As a pre-anaesthetic

With medetomidine and ketamine:

Butorphanol: 0.1 mg/kg (0.01 ml/ kg bw) i.v.

Medetomidine: 0.04 mg/kg i.v. Ketamine: 1.5 mg/kg i.v.

It is only possible to use atipamezole 0.1 mg/kg body weight for medetomidine– antagonisation when ketamine action has ceased.

Butorphanol is intended for use where short (horses and dogs) and short to medium (cats) analgesia is required. The dose may be repeated as required. The need for and timing of repeated treatment will be based on clinical response. For information on the duration of analgesia see section 4.2.

Rapid intravenous injection should be avoided.

The stopper must not be punctured more than 25 times.

Adverse reactions

Horses:

Very common

(>1 animal / 10 animals treated):

Ataxia^{^[1]}, Sedation^{^[2]}.

Undetermined frequency (cannot be estimated from the available data):

Involuntary movement^{^[3]};

Digestive tract hypomotility^{^[4]}; Respiratory depression^{^[5]}; Cardiac depression.

¹ Lasting about 3 to 15 minutes.

² Mild.

³ Running movements.

⁴ Mild and transient. Any reduction of gastrointestinal motility caused by butorphanol may be enhanced by the concomitant use of α₂-agonists.

⁵ The respiratory depressive effects of α₂-agonists may be enhanced by concomitant butorphanol, particularly if respiratory function is already impaired.

Dogs:

Rare

(1 to 10 animals / 10,000 animals treated):

Ataxia; Anorexia;

Diarrhoea.

Undetermined frequency (cannot be estimated from the available data):

Respiratory depression;

Cardiac depression;

Injection site pain¹;

Digestive tract hypomotility.

¹ Associated with intramuscular administration.

Cats:

Rare

(1 to 10 animals / 10,000 animals treated):

Ataxia; Anorexia;

Diarrhoea.

Undetermined frequency (cannot be estimated from the available data):

Respiratory depression;

Cardiac depression;

Injection site pain¹;

Digestive tract hypomotility;

Excitation, Anxiety;

Sedation, Mydriasis, Disorientation; Dysphoria.

¹ Associated with intramuscular administration.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.