Buprenodale multi-dose 0.3 mg.ml solution for injection for dogs, cats and horses
Country: Austria
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
10-11-2013
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Active ingredient:
buprenorphine 0.3 mg/ml
Available from:
Dechra Limited
ATC code:
QN02AE01
Pharmaceutical form:
Solution for injection
Therapeutic group:
buprenorphine
Therapeutic area:
Cats Non Food, Dogs Non Food, Horses Non Food
Authorization date:
2013-07-31
Summary of Product characteristics
Issue: October 2013
AN: 00696/2012
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Buprenodale Multidose, 0.3 mg/ml solution for injection for dogs, cats and horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Buprenorphine 0.3 mg
As buprenorphine hydrochloride 0.324 mg
EXCIPIENTS:
Chlorocresol
1.35 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs, cats and horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Post-operative analgesia in the dog and cat.
Post-operative analgesia, in combination with sedation, in the horse.
Potentiation of the sedative effects of centrally acting agents in the dog and horse.
4.3 CONTRAINDICATIONS
Do not administer by the intrathecal or peridural route.
Do not use pre-operatively for Caesarean section (see section 4.7).
Do not use in known cases of hypersensitivity to the active substance or any of the
excipients.
Please refer to section 4.11.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Issue: October 2013
AN: 00696/2012
Page 2 of 7
4.5 SPECIAL PRECAUTIONS FOR USE
I.
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Buprenorphine may occasionally cause respiratory depression and as with other opioid
drugs, care should be taken when treating animals with impaired respiratory function or
animals that are receiving drugs that can cause respiratory depression.
In case of renal, cardiac or hepatic dysfunction, or shock, there may be greater risk
associated with the use of the product. The be
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