Torphasol 4 mg/ml Solution for Injection for Dogs and Cats

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Butorphanol

MAH:

aniMedica GmbH

ATC_code:

QN02AF01

INN:

Butorphanol

pharmaceutical_form:

Solution for injection

prescription_type:

POM-V - Prescription Only Medicine – Veterinarian

therapeutic_group:

Cats, Dogs

therapeutic_area:

Neurological Agent analgesic

authorization_status:

Expired

authorization_date:

2009-12-10

SPC

Revised: December 2014
AN: 01142/2014
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Morphasol 4 mg/ml solution for injection for dogs and cats (AT, BE,
DE, EE, EL,
HU, IE, LT, LU, LV, NL, PL)
Morphasol vet 4 mg/ml solution for injection for dogs and cats (DK,
IS, NO)
Torphasol 4 mg/ml solution for injection for dogs and cats (ES, FR,
IT, PT, UK)
Torphasol vet 4 mg/ml solution for injection for dogs and cats (FI)
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.
Revised: December 2014
AN: 01142/2014
Page 2 of 6
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.
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 not been
established.
Use of the product in these groups