Torphadine

1 x 10 ml

Liquid for injection, solution

Active substance

Butorphanol (Butorphanol tartrate) : 10 mg/ml

ATC code

QN02AF01 Butorphanol

QN02AF Morphinan derivatives

QN02A Opioids

QN02 Analgesics

QN Nervous system

Species

Dogs, cats and horses.

Indications

Dog:

As an analgesic:

- For relief of mild to moderate visceral pain.

As an sedative:

- For sedation, when used in combination with certain alpha2-adrenoceptor agonists (medetomidine).

As a premedicant prior to general –anaesthesia:

- For use in combination with acepromazine to provide analgesia and sedation prior to induction of general anaesthesia. A dose-related reduction in the dose of induction-anaesthetic agent (propofol or thiopentone) is also provided.

- For premedication, give as the sole pre-anaesthetic agent.

As an anaesthetic:

- For anaesthesia, when used in combination with medetomidine and ketamine

Cat:

As an analgesic for the relief of moderate pain:

- For pre-operative use to provide analgesia during surgery.

- For post-operative analgesia after small surgical procedures.

As a sedative:

- For sedation when used in combination with certain alpha2-adrenoceptor agonists (medetomidine).

As an anaesthetic:

- For anaesthesia, when used in combination with medetomidine and ketamine, suitable for short painful anaesthetic procedures.

Horse:

As an analgesic:

- For the relief of moderate to severe abdominal pain associated with colic of gastrointestinal origin.

As a sedative:

- For sedation, given after the administration of certain alpha2-adrenoceptor agonists (detomidine, romifidine).

Dose to be administered and administration route

Dog and cat:	Intravenous, intramuscular and subcutaneous use.
Horse:	Intravenous use.

Animals should be weighed to establish an accurate body weight prior to calculation of the appropriate treatment dose.

Dog:

For analgesia:

Route

Dose

butorphanol

Dose product

IV,IM or

0.20-0.30 mg/kg bw

0.02-0.03 ml/kg bw

Comment

IV injection should be slow.

Analgesic effects are seen within 15 minutes of injection. Administer 15 minutes before terminating anesthesia to provide analgesia in the recovery phase.

For continuous analgesia repeat dose as required.

For sedation in combination with medetomidine hydrochloride:

Route

Dose butorphanol

Dose product

Dose medetomidine hydrochloride

IM or IV

0.1 mg/kg bw

0.01 ml/kg bw

0.01*-0.025**mg/kg bw

Comme

Allow 20 minutes for profound sedation to develop before commencing the procedure.

Where compatibility is accepted, products containing medetomidine and butorphanol may be combined and administered in the same syringe (see section 6.2).

*Depending on degree of sedation required: 0.01 mg/kg: For sedation and as a premedicant to barbiturate anaesthesia

**Depending on degree of sedation required 0.025 mg/kg: For profound sedation and as a premedicant to ketamine anaesthesia

For use as a premedicant/pre-anaesthetic:

- When the product is used as the sole agent:

Route

Dose butorphanol

Dose product

IV, IM or

0.1-0.20 mg/kg bw

0.01-0.02 ml/kg bw

Comment

15 minutes prior to induction

- When the product is used together with 0.02 mg/kg acepromazine:

Route	Dose butorphanol	Dose product
IV or IM	0.10 mg/kg bw*	0.01 ml/kg bw*
Comment	Allow at least 20 minutes before the onset of action but the time between pre-medication and induction is flexible from 20-120 minutes. Where compatibility is accepted, products containing butorphanol and acepromazine may be combined and administered in the same syringe (see section 6.2).

* The dose may be increased to 0.2 mg/kg (equivalent to 0.02 ml/kg) if the animal is already experiencing pain before the procedure commences or if a higher plane of analgesia is required during surgery.

For anaesthesia in combination with medetomidine and ketamine:

Route

Dose butorphanol

Dose product

Dose medetomidine

Dose ketamine

0.10 mg/kg bw

0.01 ml/kg bw

0.025mg/kg bw

5.0mg/kg bw*

Comme nt

Reversal with atipamezole is not recommended

Where compatibility is accepted, products containing medetomidine and butorphanol may be combined and administered in the same syringe (see section 6.2).

* Ketamine should be administered 15 minutes after the IM administration of the butorphanol/medetomidine combination.

Cat:

For pre-operative analgesia:

Route

Dose butorphanol

Dose product

IM or

0.4 mg/kg bw

0.04 ml/kg bw

Comment

Administer 15-30 minutes prior to the administration of IV induction anaesthetic agents

Administer 5 minutes before induction with IM induction anaesthetic agents such as combinations of IM acepromazine/ ketamine or xylazine/ketamine

For post-operative analgesia:

Route	Dose butorphanol	Dose product
SC or IM	0.4 mg/kg bw	0.04 ml /kg bw
IV	0.1 mg/kg bw	0.01 ml /kg bw
Comment	Administer 15 minutes befor	e recovery

For sedation in combination with medetomidine hydrochloride:

Route

Dose

butorphanol

Dose product

Dose medetomidine hydrochloride

IM or

0.4 mg/kg bw

0.04 ml/kg bw

0.05 mg/kg bw

Comme nt

Local anaesthetic infiltration should be used for wound suturing.

Where compatibility is accepted, products containing medetomidine and butorphanol may be combined and administered in the same syringe (see section 6.2).

For anaesthesia in combination with medetomidine and ketamine:

Route	Dose butorphanol	Dose product	Dose medetomidine	Dose ketamine
IM	0.40 mg/kg bw	0.04 ml/kg bw	0.08 mg/kg bw	5.0 mg/kg bw*
IV	0.10 mg/kg bw	0.01 ml/kg bw	0.04 mg/kg bw	1.25-2.50 mg/kg bw (depending on depth of anaesthesia required)
Comme nt	Where compatibility is accepted, products containing medetomidine, butorphanol and ketamine may be combined and administered in the same syringe (see section 6.2).

Horse:

For analgesia:

Route	Dose butorphanol	Dose product
IV	0.10 mg/kg bw	1 ml/100 kg bw
Comment	Analgesic effects are seen within 15 minutes of injection. Dose may be repeated as required.

For sedation in combination with detomidine hydrochloride:

Route	Dose of detomidine hydrochloride	Dose butorphanol*	Dose product
IV	0.012 mg/kg bw	0.025 mg/kg bw	0.25 ml/100 kg bw
Comment	Detomidine should be administered up to 5 minutes before the butorphanol dose.

*Clinical experience has shown that a total dose rate of 5 mg detomidine hydrochloride and

10 mg butorphanol affords effective, safe sedation in horses above 200 kg body weight.

For sedation in combination with romifidine:

Route

Dose of romifidine

Dose butorphanol

Dose product

0.04-0.12 mg/kg

0.02 mg/kg bw

0.2 ml/100 kg bw

Comment

Romifidine should be administered up to 5 minutes before the butorphanol dose.

Before this product is combined and administered in the same syringe as another veterinary medicinal product always refer to the section on 'Major incompatibilities' (section 6.2).

The maximum number of vial punctures when using needle sizes 21G and 23G should not exceed 100 and when using a 18G needle, the maximum should not exceed 40.

Adverse reactions

All target species:

There may be some pain on intramuscular injection. Sedation may be noted in treated animals.

Dog:

Respiratory and cardiac depression (as evidenced by a decrease in respiratory rate, development of bradycardia and a decrease in diastolic pressure) may occur (see section 4.5). The degree of depression is dose-dependent. If respiratory depression occurs, naloxone may be used as an antidote. Moderate to marked cardiopulmonary depression may occur if butorphanol is given rapidly by intravenous injection. When using butorphanol as a pre-anaesthetic, the use of an anticholinergic such as atropine, will protect the heart against possible narcotic-induced bradycardia.

Transient ataxia, anorexia and diarrhoea have been reported as occurring rarely. Reduction in gastrointestinal motility may occur.

Cat:

Respiratory depression may occur. If respiratory depression occurs, naloxone may be used as an antidote. Mydriasis is likely to occur.

Butorphanol administration may cause excitation, anxiety, disorientation and dysphoria.

Horse:

The most common side effect is mild ataxia which may persist for 3 to 10 minutes. An increase in motor activity and ataxia produced by butorphanol lasted 1 – 2 hours in some cases.

Restlessness, and shivering and sedation followed by restlessness have both been observed in some horses.

A bolus i.v. injection at the maximum label dose (0.1 mg/kg body weight) may result in excitatory locomotor effects (e.g. pacing) in clinically normal horses.

Mild to severe ataxia may be encountered in combination with detomidine, but horses are unlikely to collapse. Normal precautions should be observed to prevent injury(see section 4.5).

Mild sedation may occur in approximately 15% of horses following administration of butorphanol as a sole agent.

Butorphanol may also have adverse effects on gastrointestinal tract motility in normal horses, although there is no decrease in gastrointestinal transit time. These effects are dose-related, and generally minor and transient.

Depression of the cardiopulmonary system may occur. When used in combination with alpha2-adrenoceptor agonists, cardiopulmonary system depression may be fatal in rare cases.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).