Torbuphanol 10mg/ml solution for injection for horses, dogs and cats
Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
06-08-2013
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Active ingredient:
butorphanol 10 mg/ml
Available from:
Pfizer Animal Health
ATC code:
QN02AF01
Pharmaceutical form:
Solution for injection
Therapeutic group:
butorphanol
Therapeutic area:
Cats Non Food, Dogs Non Food, Horses Non Food
Authorization date:
2012-10-24
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Torbuphanol Vet 10 mg/ml Solution for injection for horses, dogs and cats.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Butorphanol
10 mg
(as butorphanol tartrate 14.58 mg/ml)
EXCIPIENTS:
Benzethonium chloride
0.1 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horse, dog and cat.
IRISH MEDICINES BOARD
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_Date Printed 12/11/2012_
_CRN 7011595_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
HORSE
AS AN ANALGESIC
For relief of pain associated with colic of gastrointestinal tract origin.
AS A SEDATIVE
For sedation when given after the administration of certain alpha2-adrenoreceptor agonists (detomidine,
romifidine).
For therapeutic and diagnostic procedures such as minor standing surgery.
DOG
AS AN ANALGESIC
For relief of mild to moderate visceral pain and pain associated with post-surgical procedures.
AS A SEDATIVE
In combination with medetomidine hydrochloride.
AS A PRE-ANAESTHETIC
Pre-anaesthetic use of the product has resulted in a dose related reduction in the dose of induction anaesthetic agents,
such as thiopentone sodium.
As part of an anaesthetic regimen in combination with medetomidine and ketamine.
CAT
AS AN ANALGESIC
For relief of mild to moderate visceral pain. For pre-operative use to provide analgesia during surgery. For post-
operative analgesia after a variety of surgical procedures.
AS A SEDATIVE
In combination with medetomidine hydrochloride.
As part of anaesthetic regimen in combination with medetomidine and ketamine.
4.3 CONTRAINDICATION
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