Morphasol 10 mg/ml solution for injection for horses

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Butorphanol tartrate

Dostupné s:

aniMedica GmbH

ATC kód:

QN02AF01

INN (Mezinárodní Name):

Butorphanol tartrate

Dávkování:

10 milligram(s)/millilitre

Léková forma:

Solution for injection

Druh předpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické skupiny:

Horses

Terapeutické oblasti:

butorphanol

Terapeutické indikace:

Neurological Preparations

Stav Autorizace:

Authorised

Datum autorizace:

2010-10-29

Charakteristika produktu

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).
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_9_
_/_
_0_
_6_
_/_
_2_
_0_
_1_
_5_
_C_
_R_
_N_
_ _
_7_
_0_
_1_
_9_
_6_
_4_
_4_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_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