Presentation

Each ml contains Butorphanol 10 mg (equivalent to butorphanol tartrate 14.6 mg)

and benzethonium chloride 0.1 mg.

Uses

Dolorex is intended for use where short duration analgesia is required or as a sedative in combination with certain α2-adrenoceptor agonists. For information on the duration of analgesia that can be expected following treatment, see under Further Information.

Horse:

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

For sedation in combination with certain α2-adrenoceptor agonists, see under Dosage and Administration.

Dog:

For relief of moderate visceral pain.

For sedation in combination with certain α2-adrenoceptor agonists, see under Dosage and Administration.

Dosage and administration

For analgesia:

Horse:

0.5 to 1 ml/100 kg bodyweight, intravenous route (i.e. 0.05 to 0.1 mg/kg).

Dog:               

0.2 to 0.4 ml/10 kg bodyweight, intravenous route (i.e. 0.2 to 0.4 mg/kg).

Rapid intravenous injection should be avoided.

Dolorex is intended for use where short duration analgesia is required. However, repeat treatment 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.

For sedation:

Dolorex 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:

Horse:

Detomidine (10mg/ml): 0.1-0.2 ml/100kg bodyweight (0.01 – 0.02 mg/kg) intravenous route.

Dolorex:           0.1-0.2 ml/100 kg bodyweight, intravenous route (0.01 – 0.02 mg/kg).

Detomidine should be administered up to 5 minutes before Dolorex.

Romifidine (10mg/ml):   0.5 ml/100kg bodyweight intravenous route (0.05 mg/kg).

Dolorex:           0.2 ml/100 kg bodyweight, intravenous route (0.02 mg/kg).

Romifidine can be administered concurrently or 4 minutes before Dolorex.

Dog:               

Medetomidine (1mg/ml): 0.1-0.3 ml/10 kg bodyweight intramuscular route (0.01 – 0.03 mg/kg).

Dolorex:           0.1-0.2 ml/10 kg bodyweight intramuscular route (0.1 – 0.2 mg/kg).

Medetomidine and Dolorex can be administered concurrently.

The stopper should not be pierced more than 25 times.

Contra-indications, warnings, etc.

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

Dolorex/detomidine combination:

The combination should not be used in horses with a pre-existing cardiac dysrhythmia.

The combination will cause a reduction in gastrointestinal motility and consequently should not be used in cases of colic associated with impaction.

The safety of the product in young puppies and foals has not been established. Use of the product in these groups should be on the basis of a risk:benefit analysis by the responsible veterinary surgeon.

Horse:

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 when treating horses, the location for the treatment should be chosen carefully.

Horse and dog:

Due to its anti-tussive 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, Dolorex should only be used on the basis of a risk:benefit analysis by the responsible veterinary surgeon.

Sedation may be noted in treated animals.

The concomitant use of other central nervous depressants would be expected to potentiate the effects of butorphanol and such drugs should be used with caution.  A reduced dose should be used when administering these agents concurrently.

The combination of Dolorex and a2-adrenoceptor agonists should be used with caution in animals with cardiovascular disease.  The concurrent use of anticholinergic drugs, e.g. atropine should be considered.

Dolorex may cause the following side effects:

Horse:

-         Excitatory locomotor effects (pacing)

-         Ataxia

-         Reduction in gastrointestinal motility

-         Depression of the cardiovascular system.

Dog:

-         Depression of the respiratory and cardiovascular system

-         Anorexia and diarrhoea

-         Reduction in gastrointestinal motility

-         Local pain associated with intramuscular injection.

The safety of this veterinary medicinal product has not been established in the target species during pregnancy and lactation.  The use of Dolorex during pregnancy and lactation is not recommended.

Dolorex may be used in combination with other sedatives such as a2-adrenoceptor agonists (e.g. romifidine or detomidine in horses, medetomidine in dogs) where synergistic effects can be expected. Therefore, an appropriate reduction in dose is necessary when used concomitantly with such agents, see under Dosage and Administration.

Because of its antagonist properties at the opiate mu receptor, butorphanol may remove the analgesic effect in animals which have already received pure opioid mu agonists.

User warnings:

Precautions should be taken to avoid accidental injection/self injection.  If accidental self-injection occurs, seek medical advice immediately and show the package leaflet or the label to the physician.  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.

Withdrawal periods:

Horse: 

Meat and offal              Zero days.

Milk                             Zero days.

FOR ANIMAL TREATMENT ONLY.

KEEP OUT OF REACH AND SIGHT OF CHILDREN.

Pharmaceutical precautions

Protect from light. Do not refrigerate or freeze.

Legal category
POM-V     To be supplied only on veterinary prescription. 

Package quantities

Carton containing a 10 or 50 ml glass vial.

Not all pack sizes may be marketed.

Further information

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 – 60 minutes.  In the dog, it lasts for 15-30 minutes after a single intravenous administration.

Marketing Authorisation number

Vm 01708/4535

Marketing Authorisation holder

Intervet UK Ltd.

Walton Manor

Walton

Milton Keynes

Bucks. MK7 7AJ

Date of text preparation:

April 2007.

Item code: 094844                                                                   75203^.May2006/MP