Dolorex vet.

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

Horses, dogs and cats.

Indications

Butorphanol is intended for use where short (horses and dogs) and short to medium (cats) duration analgesia is required.

For information on the duration of analgesia that can be expected following treatment, see section 4.2.

Horses:

For relief of pain associated with colic of gastrointestinal tract origin.

For sedation in combination with certain α2-adrenoceptor agonists (see section 3.9).

Dogs:

For relief of moderate visceral pain.

For sedation in combination with certain α2-adrenoceptor agonists (see section 3.9).

Cats:

For the relief of moderate pain associated with soft tissue surgery.

Dose to be administered and administration route

For analgesia:

Horses:

Intravenous use.

0.05 to 0.1 mg/kg

(i.e. 2.5 to 5 ml for 500 kg bw)

Dogs:

Intravenous use.

0.2 to 0.4 mg/kg

(i.e. 0.2 to 0.4 ml/10 kg bw)

Rapid intravenous injection should be avoided.

Butorphanol is intended for use where short duration analgesia is required. For information on the duration of analgesia that can be expected following treatment see section 4.2. However, repeat treatments of butorphanol may be administered. The need for, and timing of repeat treatment will be based on clinical response. For cases where longer duration analgesia is likely to be required, an alternative therapeutic agent should be used.

Cats:

Subcutaneous use. 0.4 mg/kg,

(i.e. 0.2 ml/5 kg bw)

Cats should be weighed to ensure that the correct dose is calculated. An appropriate graduated syringe must be used to allow accurate administration of the required dose volume (e.g. insulin syringe or 1 ml graduated syringe).

In the cat, butorphanol is intended for use where short to medium duration analgesia is required. For information on the duration of analgesia that can be expected following treatment see section 4.2. Depending on the clinical response, veterinary medicinal product administration may be repeated within six hours. In the absence of an adequate analgesic response (see section 3.5), use of an alternative analgesic agent, such as another suitable opioid analgesic and/or a non-steroidal anti-inflammatory drug, should be considered. Any alternative analgesia should take account of the action of butorphanol on opioid receptors, as described in section 3.8.

If repeated administrations are required, use different injection sites.

For sedation:

Butorphanol can be used in combination with an α2-adrenoceptor agonist (e.g.

(me)detomidine or romifidine).

Adjustment of the dose will then be necessary according to the following recommendations:

Horses:

Intravenous use.

Detomidine: 0.01 - 0.02 mg/kg

Butorphanol: 0.01 - 0.02 mg/kg

Detomidine should be administered up to 5 min before butorphanol.

Romifidine: 0.05 mg/kg

Butorphanol: 0.02 mg/kg

Romifidine can be administered concurrently or 4 min before butorphanol.

Dogs:

Intramuscular use.

Medetomidine: 0.01 - 0.03 mg/kg

Butorphanol: 0.1 - 0.2 mg/kg

Medetomidine and butorphanol can be administered concurrently.

The stopper should not be pierced more than 25 times.

Adverse reactions

Horses:

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Pacing^¹;

Ataxia, Sedation;

Digestive tract hypomotility;

Cardiac depression.

¹ Excitatory locomotor effects.

Dogs:

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Cardiac depression;

Respiratory depression¹ ;

Anorexia;

Diarrhoea, Digestive tract hypomotility; Injection site pain²;

Sedation.

¹ Naloxone may be used as an antidote.

² Associated with intramuscular injection.

Cats:

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Mydriasis, Disorientation, Sedation; Injection site irritation¹, Immediate pain on injection;

Agitation²;

Dysphoria.

¹In case of repeated administrations.

²Mild.

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 the national competent authority via the national reporting system. See also the package leaflet for respective contact details.