Morphasol 10 mg/ml solution for injection for horses

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Butorphanol tartrate

Available from:

aniMedica GmbH

ATC code:

QN02AF01

INN (International Name):

Butorphanol tartrate

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Horses

Therapeutic area:

butorphanol

Therapeutic indications:

Neurological Preparations

Authorization status:

Authorised

Authorization date:

2010-10-29

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Morphasol 10 mg/ml solution for injection for horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Substance
Butorphanol
10 mg
(as Butorphanol tartrate 14.7 mg/ml)
Excipients
Benzethonium chloride
0.1 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For short term relief of pain associated with colic of
gastrointestinal tract origin. For information on the onset and
duration of analgesia that can be expected following treatment, see
section 5.1.
For sedation in combination with certain
2-adrenoceptor agonists (see section 4.9).
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4.3 CONTRAINDICATIONS
_Butorphanol – as a sole agent and in any combination:_
Do not use in horses with a history of liver or kidney disease.
Do not use in case of known hypersensitivity to the active substance
or to any of the excipients.
Do not use in cases of cerebral injury or organic brain lesions (e.g.
lesions following cranial trauma) and in
animals with obstructive respiratory diseases, heart dysfunction or
spastic convulsions.
_Butorphanol / detomidine hydrochloride combination_:
The