SUMMARY OF PRODUCT CHARACTERISTICS

Morphasol 10 mg/ml solution for injection for horses (AT, BE, DE, EE, HU, IE, LT, LU, LV, NL, PL)

Morphasol vet 10 mg/ml solution for injection for horses (NO, DK)

Torphasol 10 mg/ml solution for injection for horses (ES, FR, IT, PT, UK)

Torphasol vet 10 mg/ml solution for injection for horses (FI, SE, IS)

Each ml contains:

Active Substance

Butorphanol 10 mg

(as Butorphanol tartrate 14.7 mg/ml)

Excipients

Benzethonium chloride 0.1 mg

For the full list of excipients, see section 6.1

Solution for injection.

Clear and colourless solution.

Horses

For short term relief of pain associated with colic of gastrointestinal tract origin. For information on the onset and duration of analgesia that can be expected following treatment, see section 5.1.

For sedation in combination with certain α2-adrenoceptor agonists (see section 4.9).

Butorphanol – as a sole agent and in any combination:

Do not use in horses with a history of liver or kidney disease.

Do not use in case of known hypersensitivity to the active substance or to any of the excipients.

Do not use in cases of cerebral injury or organic brain lesions (e.g. lesions following cranial trauma) and in animals with obstructive respiratory diseases, heart dysfunction or spastic convulsions.

Butorphanol / detomidine hydrochloride combination:

The combination should not be used in pregnant animals.

Do not use the combination in horses with a pre-existing cardiac dysrhythmia or bradycardia.

Do not use in horses with emphysema due to a possible depressive effect in the respiratory system.

Butorphanol / romifidine combination:

Do not use during the last month of pregnancy

Butorphanol / xylazine combination:

The combination should not be used in pregnant animals.

Any reduction in gastrointestinal motility caused by butorphanol (see section 4.6) may be enhanced by the concomitant use of α2-adrenoceptor agonists. Consequently, such combinations should not be used in cases of colic associated with impaction.

None.

Special precautions for use in animals

Safety and efficacy of butorphanol in foals have not been established. In foals use the product only according to the benefit/risk assessment by the responsible veterinarian.

Due to its antitussive properties, butorphanol may lead to an accumulation of mucous in the respiratory tract. Therefore, in animals with respiratory diseases associated with increased mucous production or in animals that are being treated with expectorants, butorphanol should only be used on the basis of a risk-benefit analysis by the responsible veterinarian.

The use of the product at the recommended dose may lead to transient ataxia and/or excitement. Therefore, to prevent injuries in patient and people, the location for the treatment should be chosen carefully.

Butorphanol / detomidine hydrochloride combination:

Routine cardiac auscultation should be performed prior to use in combination with detomidine.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Direct contact with skin or eye of the user should be avoided since the product might induce irritation and sensitization. Accidental spillage on the skin should be washed immediately with soap and water. When the product comes into contact with the eyes, rinse immediately with plenty of water.

Care should be taken when handling the product to avoid self-injection. In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician, and DO NOT DRIVE, since drowsiness, nausea and dizziness may occur. Effects can be reversed by the administration of an opioid antagonist.

Butorphanol may cause the following side-effects:

- Excitatory locomotor effects (pacing)

- Mild sedation (may occur following the administration of butorphanol as a sole agent)

- Ataxia

- Reduction in gastrointestinal motility

- Depression of cardiovascular system

The safety of this product has not been investigated in the target species during pregnancy and lactation. The use of butorphanol during pregnancy and lactation is not recommended.

For information on use in combination with α2-adrenoceptor agonists, see section 4.3.

See section 4.5

Butorphanol may be used in combination with other sedatives such as α2-adrenoceptor agonists (e.g. romifidine, detomidine, xylazine) where synergistic effects can be expected. Therefore, an appropriate reduction in dose is necessary when used concomitantly with such agents.

Because of its antagonist properties at the opiate mu receptor, butorphanol may inhibit the analgesic effect in animals, which have already received pure opioid mu agonists (morphine/oxymorphine).

Because of the antitussive properties of butorphanol, it should not be used in combination with an expectorant, as this may lead to an accumulation of mucous in the airways.

The combination of butorphanol and α2-adrenoceptor agonists should be used with caution in animals with cardiovascular disease. The concurrent use of anticholinergic drugs, e.g. atropine should be considered.

For intravenous administration only.

For analgesia:

Dose rate: 100 μg butorphanol per kg bodyweight (BW) (equivalent to 1 ml for 100 kg BW), by intravenous injection. Butorphanol is intended for use where short duration analgesia is required. The dose may be repeated as required. The need for and timing of repeat treatment will be based on clinical response. For information on the onset and duration of analgesia see section 5.1. For cases where longer duration analgesia is likely to be required, an alternative therapeutic agent should be used.

For sedation in combination with detomidine hydrochloride:

A dose rate of 12 μg detomidine hydrochloride per kg BW should be given intravenously followed within 5 minutes by a dose rate of 25 μg butorphanol per kg BW (equivalent to 0.25 ml for 100 kg BW) intravenously.

For sedation in combination with romifidine:

A dose of 40-120 μg romifidine per kg BW followed within 5 minutes by a dose rate of 20 μg butorphanol per kg BW (equivalent to 0.2 ml for 100 kg BW) should be administered intravenously.

For sedation in combination with xylazine:

A dose rate of 500 μg xylazine per kg BW followed immediately by a dose of 25-50 μg butorphanol per kg BW (equivalent to 0.25-0.5 ml per 100 kg) should be administered intravenously.

The main sign of overdose is respiratory depression which can be reversed with an opioid antagonist (naloxone). Other possible signs of overdose in the horse include restlessness/excitability, muscle tremor, ataxia, hypersalivation, decrease of gastrointestinal motility and seizure.

Meat and offal: zero days.

Milk: zero days.

Pharmacotherapeutic group: Synthetic opioid (morphinan derivatives), centrally acting analgesic.

ATCvet code QN02AF01

Butorphanol tartrate (R(-) enantiomer) is a centrally acting analgesic. Its action is agonist-antagonist at the opiate receptors in the central nervous system; agonist at the kappa opioid receptor subtype and antagonist at the mu receptor subtype. The kappa receptors control analgesia, sedation without depression of cardiopulmonary system and body temperature, whereas the mu receptors control supraspinal analgesia, sedation and depression of cardiopulmonary system and body temperature. The agonist component of butorphanol activity is ten times more potent than the antagonist component.

Onset and duration of analgesia:

Analgesia generally occurs within 15 minutes following intravenous administration. After a single intravenous dose in the horse, analgesia usually lasts for 15-90 minutes.

Following intravenous injection, butorphanol is well distributed in tissue. Butorphanol is metabolised extensively in the liver and excreted in the urine. In horses, butorphanol administered by intravenous route has a high clearance (21ml/kg/min) and a short terminal half-life (44 minutes),indicating that 97% of a dose will be eliminated after intravenous administration in, on average, less than 5 hours.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzethonium chloride

Citric Acid Monohydrate

Sodium Citrate

Sodium Chloride

Water for injections

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Shelf-life after first opening the immediate packaging: 28 days.

Keep the vial in the outer carton in order to protect from light.

Cardboard box with 1 clear glass vial (type I) of 20 ml with a grey butyl rubber stopper and an aluminium cap.

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

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Vm 24745/4009

21 October 2010

September 2015

29 September 2015