Revised: July 2014
AN: 00299/2014
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Torbutrol Tablets 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Each tablet contains 10mg butorphanol base as butorphanol tartrate.
Excipients:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
White to off-white tablet, embossed with “636” on one side and “FD” on the
other. The side with “FD” is bisected.
4.
CLINICAL PARTICULARS
4.1. Target species
Dog.
4.2. Indications for use, specifying the target species
As an antitussive: For the relief in dogs of acute or chronic, non-productive
cough associated with tracheobronchitis, tracheitis, tonsillitis, laryngitis and
pharyngitis originating from inflammatory conditions of the upper respiratory
tract in dogs only.
4.3. Contraindications
Since the product can be effective in totally suppressing cough, it should not be
used in conditions of the lower respiratory tract associated with copious mucus
production.
Do not use in cats.
Do not use in dogs with a history of liver disease.
4.4. Special warnings
None.
1
Revised: July 2014
AN: 00299/2014
4.5. Special precautions for use
i)
Special precautions for use in animals
None.
ii)
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
None.
4.6. Adverse reactions (frequency and seriousness)
Cough suppression may be accompanied by mild sedation, which is dose
related. Transient ataxia, anorexia and diarrhoea have been reported as
occurring rarely.
If respiratory depression occurs, naloxone may be used as an antidote.
4.7. Use during pregnancy, lactation or lay
Reproduction studies, performed in mice and rabbits revealed no evidence of
impaired fertility or harm to the foetus due to butorphanol tartrate. In the rat
species the female, on parenteral administration, showed increased
nervousness and decreased care for the new-born, resulting in a decreased
survival rate of the new-born. This nervousness was seen only in the rat
species. There are no well-controlled studies in pregnant bitches but, although
there is no well-defined risk, the use in pregnant bitches is not recommended.
4.8. Interaction with other medicinal products and other forms of interaction
It is undesirable to administer other sedative or analgesic drugs during
treatment with the tablets, as these are likely to produce an additive effect.
4.9. Amounts to be administered and administration route
For oral administration only.
Dose rate: 0.5mg butorphanol per kg bodyweight, i.e. one 10mg tablet per 20kg
bodyweight. Repeat dose at 6-12 hour intervals.
Clinical experience has shown that in the majority of cases a 3-4 day course of
treatment is adequate. The initial treatment period should not exceed 14 days
after which the dog's condition should be reassessed by a veterinary surgeon.
4.10. Overdose (symptoms, emergency procedures, antidotes), if necessary
Toxicity studies indicate that the LD50 in dogs by oral administration is greater
than 50mg/kg.
4.11. Withdrawal period
Not applicable.
2
Revised: July 2014
AN: 00299/2014
5.
PHARMACOLOGICAL PROPERTIES
Synthetic opioid with analgesic and potent antitussive activity.
Orally in dogs, butorphanol is 15 to 20 times more active as an antitussive than
either codeine or dextromethorphan. In conscious dogs it produced minimal
cardiovascular and respiratory effects.
ATCVet Code: QR05DA90
6.
PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Lactose monohydrate
Maize starch
Calcium acid phosphate anhydrous
Calcium hydrogen phosphate anhydrous
Magnesium stearate
6.2. Incompatibilities
None known.
6.3. Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years
6.4. Special precautions for storage
Do not store above 25˚C.
Protect from light.
6.5. Nature and composition of immediate packaging
Amber Type I and Type III glass bottles with desiccant and cotton wad secured
with a polyethylene/polypropylene push fit cap with saran or vinyl seal
containing 25 or 50 tablets.
Not all pack sizes may be marketed.
6.6. Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal products should be disposed of in accordance with local
requirements.
3
Revised: July 2014
AN: 00299/2014
7.
MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
5th Floor, 6 St. Andrew Street
London
EC4A 3AE
8.
MARKETING AUTHORISATION NUMBER
Vm: 42058/4155
9.
DATE OF FIRST AUTHORISATION
Date: 20 April 1990
10. DATE OF REVISION OF THE TEXT
Date: July 2014
APPROVED
4
30/07/14