MORPHASOL 10 MG/ML SOLUTION FOR INJECTION FOR HORSES
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
04-07-2015
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Ingredient activ:
BUTORPHANOL TARTRATE
Disponibil de la:
aniMedica GmbH
Codul ATC:
QN02AF01
INN (nume internaţional):
BUTORPHANOL TARTRATE
Dozare:
10 Mg/Ml
Forma farmaceutică:
Solution for Injection
Tip de prescriptie medicala:
POM
Grupul Terapeutică:
Equine - Food
Zonă Terapeutică:
Butorphanol
Indicații terapeutice:
Neurological Preparations
Statutul autorizaţiei:
Authorised
Data de autorizare:
2010-10-29
Caracteristicilor produsului
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).
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 19/06/2015_
_CRN 7019644_
_page number: 1_
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 combination should not be used in pregnant animals.
Do not use the combination in horses with a pre-existing cardiac dysrhythmia or bradycardia.
Do not use in horses with emphysema due to a possible depressive effect in the respiratory system.
_Butorphanol / romifidine combination:_
Do not use during the
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