Torbugesic Injection is a clear colourless, sterile solution containing as active ingredient butorphanol 10 mg/ml (as butorphanol tartrate 14.58 mg/ml). The product also contains 0.1 mg/ml benzethonium chloride as an antimicrobial preservative.

Torbugesic Injection 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 Torbugesic Injection alleviates abdominal pain associated with torsion, impaction, intussusception, parturition and spasmodic and tympanic colic.

When given after the administration of detomidine hydrochloride: Clinical studies have shown that this combination achieved 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 Torbugesic Injection 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 Torbugesic after the administration of romifidine.

For the relief of moderate to severe pain in dogs. Clinical studies have shown that Torbugesic Injection can provide suitable analgesia after a variety of surgical procedures such as orthopaedic and soft tissue surgery.

For sedation in conjunction with medetomidine hydrochloride. Although sedation can occur with Torbugesic Injection alone, clinical studies have verified that deep to profound sedation is achieved by Torbugesic Injection in conjunction with a dose range of medetomidine making it suitable for a range of procedures including ear cleaning, wound management, anal gland flush, cast application, radiography and (at the higher dose rate) as a premedicant to ketamine anaesthesia (see below).

It has also been shown that pre-anaesthetic use of Torbugesic Injection has resulted in a dose-related reduction in the dose of thiopental sodium needed to induce anaesthesia, which will also reduce the risk of anaesthetic respiratory depression.

Clinical studies have verified that the use of Torbugesic Injection in conjunction with acepromazine provides a suitable analgesic and sedative premedicant to general anaesthesia. The dose of the Torbugesic can be adjusted according to the level of analgesia required. The use of the combination has resulted in a dose related reduction in the dose of either thiopental sodium or propofol needed to induce anaesthesia.

Torbugesic Injection may be used as a triple anaesthetic combination with medetomidine and ketamine. This provides surgical anaesthesia suitable for a range of procedures including castrations and spays.

Torbugesic Injection may be used for the relief of pain in the cat. Pre-operative use of Torbugesic Injection can provide analgesia during surgery. Clinical studies have demonstrated that Torbugesic Injection can provide analgesia after a variety of surgical procedures such as spays, orthopaedic and soft tissue surgery.

Although no sedation occurs when using Torbugesic Injection alone in the cat, clinical studies have verified that profound sedation is achieved by using Torbugesic Injection in conjunction with medetomidine, making it suitable for radiography, fracture examination/casting, dematting, ear cleaning, wound management and other minor procedures.

Torbugesic Injection may be used as a triple anaesthetic combination with medetomidine and ketamine. This provides surgical anaesthesia suitable for a range of procedures including castrations and spays.

Dose rate: 5 ml/500 kg (equivalent to 0.1 mg butorphanol/kg) bodyweight, by intravenous injection. The dose may be repeated as required. Analgesic effects are seen within 15 minutes of injection.

A dose rate of 0.1 ml Domosedan™/100 kg (equivalent to 0.012 mg/kg detomidine hydrochlorideg) should be given intravenously followed within 5 minutes by a dose rate of 0.025 mg/kg butorphanol intravenously (equivalent to 0.25 ml Torbugesic Injection/100 kg).

Clinical experience has shown that a total dose 0.5 ml Domosedan and 1.0 ml Torbugesic Injection affords effective, safe sedation in horses above 200 kg bodyweight.

NB. Detomidine should be administered up to 5 minutes before the Torbugesic dose

A dose of 0.4–1.2 ml Sedivet™/100 kg bodyweight (equivalent to 40–120 μg romifidine/kg) followed by 0.2 ml Torbugesic Injection/100 kg bodyweight (equivalent to 20 μg butorphanol/kg) should be administered intravenously.

* Above example based on a dose rate of 60 μg romifidine/kg bodyweight.

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

Administer by intravenous, intramuscular or subcutaneous injection routes using aseptic technique. Rapid IV injection should be avoided.

0.2–0.3 ml/10 kg (equivalent to 0.2–0.3 mg butorphanol/kg) bodyweight. Torbugesic Injection should be administered before terminating anaesthesia to provide analgesia in the recovery phase. Analgesic effects are seen within 15 minutes. For continuous analgesia the dose may be repeated as required.

* Based on a mean dose rate of 0.25 mg butorphanol/kg.

Torbugesic Injection should be administered at 0.1 ml/10 kg bodyweight (equivalent to 0.1 mg butorphanol/kg) together with 0.1–0.25 ml Domitor™/10 kg bodyweight (equivalent to 10–25 μg medetomidine/kg) depending on degree of sedation required, both by intramuscular or intravenous injection. Domitor and Torbugesic may be combined and administered in the same syringe. However, the vials should have separate needles inserted for withdrawal to minimise the risk of cross contamination. Allow 20 minutes for profound sedation to develop before commencing the procedure.

Reversal with 0.1–0.25 ml Antisedan™/10 kg bodyweight (equivalent to 50–125 μg atipamezole/kg) results in sternal recumbency approximately 5 minutes later and standing approximately a further 2 minutes later.

* Based on a dose rate of 0.1 mg butorphanol/kg and 10 μg medetomidine/kg.

* Based on a dose rate of 0.1 mg butorphanol/kg and 25 μg medetomidine/kg.

Used as a pre-anaesthetic, the Torbugesic Injection dose should be reduced to 0.1-0.2 ml/10 kg (0.1-0.2 mg butorphanol/kg), given 15 minutes prior to induction.

*Pre-anaesthetic doses: based on dose rate of 0.10 mg butorphanol/kg.

Torbugesic Injection should be administered at 0.1 ml/10 kg bodyweight (equivalent to 0.1 mg butorphanol/kg) together with 0.1 ml of 2 mg/ml acepromazine/10 kg bodyweight (equivalent to 0.02 mg acepromazine/kg) by intramuscular or intravenous injection.

Torbugesic and acepromazine may be combined and administered in the same syringe. However the vials should have separate needles inserted for withdrawal to minimise the risk of cross contamination.

Allow at least 20 minutes for onset of action but the time between premedication and induction is flexible from 20-120 minutes.

The dose of butorphanol may be increased to 0.2 mg/kg (equivalent to 0.2 ml Torbugesic Injection/10 kg bodyweight) if the animal is already experiencing pain before the procedure commences, or if a higher plane of analgesia is required during surgery.

* Based on a dose rate of 0.1 mg butorphanol/kg bodyweight.

** Based on a dose rate of 0.02 mg acepromazine/kg bodyweight.

Administer Torbugesic Injection at 0.1 ml/10 kg (equivalent to 0.1 mg butorphanol/kg) and Domitor at 0.25 ml/10 kg (equivalent to 25 μg medetomidine/kg) by intramuscular injection.

Domitor and Torbugesic may be combined and administered in the same syringe. However, the vials should have separate needles inserted for withdrawal to minimise the risk of cross-contamination.

Dogs become recumbent in approximately 6 minutes and lose their pedal reflex in approximately 14 minutes.

Ketamine (100 mg/ml) should be administered 15 minutes following the first injection at 0.5 ml/10 kg (equivalent to 5 mg ketamine/kg) by intramuscular injection.

The pedal reflex returns approximately 53 minutes following administration of the ketamine injection. Sternal recumbency is attained approximately 35 minutes later followed by standing a further 36 minutes later.

* Based on a dose rate of 0.1 mg butorphanol/kg.

** Based on a dose rate of 25 μg medetomidine/kg.

*** Based on a dose rate of 5 mg ketamine/kg.

0.2 ml Torbugesic injection/ 5 kg bodyweight (equivalent to 0.4 mg butorphanol/kg), should be administered either by subcutaneous or intramuscular injection. Clinical studies have shown that administering the butorphanol dose 5 minutes prior to induction with either acepromazine/ketamine or xylazine/ketamine given intramuscularly will provide analgesia when surgery commences. The arousal time will not be significantly altered. With intravenous induction agents, butorphanol should be administered 15–30 minutes prior to administration of the anaesthetic.

0.2 ml Torbugesic Injection/ 5 kg bodyweight (equivalent to 0.4 mg butorphanol/kg), should be administered by either subcutaneous or intramuscular injection 15 minutes prior to recovery. Alternatively, 0.05 ml Torbugesic Injection/5 kg (equivalent to 0.1 mg butorphanol/kg), by intravenous injection can be used.

* Based on a mean dose rate of 0.1 mg butorphanol/kg.

**Based on a mean dose rate of 0.4 mg butorphanol/kg.

Torbugesic Injection should be administered at 0.2 ml/5 kg bodyweight (equivalent to 0.4 mg butorphanol/kg) together with 0.25 ml Domitor/5 kg bodyweight (equivalent to 50 μg medetomidine/kg) both by either intramuscular or subcutaneous injection.

Domitor and Torbugesic may be combined and administered in the same syringe. However, the vials should have separate needles inserted for withdrawal to minimise the risk of cross contamination.

Local anaesthetic infiltration should be used for wound suturing. Reversal with 0.125 ml Antisedan/5 kg bodyweight (equivalent to 125 μg atipamezole/kg) results in sternal recumbency approximately 4 minutes later and standing 1 minute later.

*Based on a dose rate of 0.4 mg butorphanol/kg.

**Based on a dose rate of 50 μg medetomidine/kg.

Administer Torbugesic Injection at 0.2 ml/5 kg (equivalent to 0.4 mg butorphanol/kg), 0.4 ml Domitor/5 kg (equivalent to 80 μg medetomidine/kg) and ketamine (100mg/ml) at 0.25 ml/5 kg (equivalent to 5 mg ketamine/kg).

Domitor, Torbugesic and Ketaset may be combined and administered in the same syringe. However, the vials should have separate needles inserted for withdrawal to minimise the risk of cross-contamination.

Cats become recumbent in 2–3 minutes following injection. Loss of the pedal reflex occurs 3 minutes post-injection.

* Based on a dose rate of 0.4 mg butorphanol/kg.

** Based on a dose rate of 80 μg medetomidine/kg.

*** Based on a dose rate of 5 mg ketamine/kg.

Reversal with 0.2 ml Antisedan/5 kg (equivalent to 200 μg atipamezole/kg) results in return of the pedal reflex 2 minutes later, sternal recumbency 6 minutes later and standing 31 minutes later.

Administer Torbugesic Injection at 0.05 ml/5 kg bodyweight (equivalent to 0.1 mg butorphanol/kg), 0.2 ml Domitor/5 kg bodyweight (equivalent to 40 μg medetomidine/kg) and ketamine (100 mg/ml), depending on depth of anaesthesia required, at a dose rate of 0.06–0.13 ml/5 kg (equivalent to 1.25–2.5 mg ketamine/kg) by intravenous injection.

Domitor and Torbugesic and Ketaset may be combined and administered in the same syringe. However, the vials should have separate needles inserted for withdrawal to minimise the risk of cross-contamination.

*In conjunction with butorphanol at 0.1mg/kg and medetomidine at 40 μg/kg.

* Based on a dose rate of 0.1 mg butorphanol/kg bodyweight.

** Based on a dose rate of 40 μg medetomidine/kg bodyweight.

*** Based on a dose rate of 2.5 mg ketamine/kg bodyweight.

Reversal with 0.1 ml Antisedan/5 kg (equivalent to 100 μg atipamezole/kg) results in return of the pedal reflex 4 minutes later, sternal recumbency 7 minutes later and standing 18 minutes later.

Withdrawal Period:

Meat & Offal: Zero days.

Do not use in horses with a history of liver disease. The most commonly observed side-effect is slight ataxia which may persist for 3–10 minutes. Mild sedation may occur in approximately 15% of horses.

Do not use in horses with a history of liver disease. The combination should not be used in pregnant animals nor in animals suffering from colic. Routine cardiac auscultation should be performed prior to use of this combination.

Do not use the combination in horses with a pre-existing cardiac dysrhythmia or bradycardia. Mild to severe ataxia may be encountered but clinical studies have shown that horses are unlikely to collapse. Normal precautions should be observed to prevent patient self-injury.

Do not use in horses with a history of liver disease. The combination should not be used during the last month of pregnancy.

If respiratory depression occurs, naloxone may be used as an antidote. Do not use in dogs with a history of liver disease. Transient ataxia, anorexia and diarrhoea have been reported as occurring rarely. When using Torbugesic as a pre-anaesthetic the use of an anti-cholinergic, such as atropine will protect the heart against possible narcotic-induced bradycardia. When administering as an intravenous injection do not inject as a bolus.

If respiratory depression occurs, naloxone may be used as an antidote. Do not use in cats with a history of liver disease. Cats should be weighed to ensure that the correct dose is calculated. Use of either insulin syringes or 1 ml graduated syringes is recommended to ensure accurate dosing. Marked sedation does not occur in cats when Torbugesic Injection is used as a sole agent. Mydriasis is likely to occur.

Butorphanol has opioid-like activity. Precautions should be taken to avoid accidental injection/self-injection with this potent drug. If accidental self-injection occurs, seek immediate medical attention showing a copy of product literature. Do not drive. The effects of butorphanol include sedation, dizziness and confusion. Effects can be reversed with an opioid antagonist. Wash splashes from skin and eyes immediately.

Do not store above 25°C. Protect from light.

Torbugesic Injection must not be mixed with other products with the exception of the following combinations:

i) Torbugesic and Domitor

ii) Torbugesic, Domitor and Ketaset

iii) Torbugesic and acepromazine

Following withdrawal of the first dose, use the product within 28 days.

When the container is broached (opened) for the first time, using the in-use shelf-life which is specified on this datasheet, the date on which any product remaining in the carton should be discarded should be worked out. The discard date should be written in the space provided.

Keep the container in the outer carton.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

For animal treatment only.

Keep out of the sight and reach of children.

There may be some pain on intramuscular injection.

10 ml and 50 ml amber glass vials. Not all pack sizes may be marketed.

Nil