MORPHASOL 4 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-01-2015
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Active ingredient:
BUTORPHANOL TARTRATE
Available from:
aniMedica GmbH
ATC code:
QN02AF01
INN (International Name):
BUTORPHANOL TARTRATE
Dosage:
4 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Canine, Feline
Therapeutic area:
Butorphanol
Therapeutic indications:
Neurological Preparations
Authorization status:
Authorised
Authorization date:
2009-12-18
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Morphasol 4 mg/ml solution for injection for dogs and cats.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Butorphanol
4 mg
(as Butorphanol tartrate 5.83 mg)
Excipients
Benzethonium chloride
0.1 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection.
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
DOGS:
As an analgesic: for the relief of mild to moderate visceral pain.
As a sedative: in combination with medetomidine.
CATS:
As an analgesic: for the relief of mild to moderate visceral pain.
4.3 CONTRAINDICATIONS
Do not use in case of known hypersensitivity to the active substance or to any of the excipients in the product.
Do not use in animals with known or suspected liver or kidney disease.
Use of butorphanol is contraindicated in case of cerebral injury or organic brain lesions and in animals with obstructive
respiratory diseases, heart dysfunction or spastic conditions.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 19/12/2014_
_CRN 7019497_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Butorphanol is intended for use where short (dog) and short to medium (cat) analgesia is required. For information on
the duration of analgesia that can be expected following treatment, see section 5.1.
However, repeat treatments of butorphanol may be administered. For cases where longer duration analgesia is likely to
be required, an alternative therapeutic agent should be used.
The safety of the product in young puppies and kittens has
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