Urilin 40 mg/ml syrup for dogs

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Phenylpropanolamine

MAH:

Dechra Ltd

ATC_code:

QG04BX91

INN:

Phenylpropanolamine

dosage:

40 milligram(s)/millilitre

pharmaceutical_form:

Syrup

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_group:

Dogs

therapeutic_area:

phenylpropanolamin

therapeutic_indication:

Hormone

authorization_status:

Authorised

authorization_date:

2010-09-03

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Urilin 40 mg/ml syrup for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
Active substance:
Phenylpropanolamine
40.29 mg
(equivalent to 50.0 mg phenylpropanolamine hydrochloride)
Excipients:
Sodium methyl parahydroxybenzoate (E219)
1.5 mg
Sodium propyl parahydroxybenzoate
0.15 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
Clear viscous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (bitches).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of urinary incontinence associated with acquired
urethral sphincter incompetence in the bitch only.
The efficacy of phenylpropanolamine has only been demonstrated in
ovariohysterectomised bitches.
4.3 CONTRAINDICATIONS
Please see section 4.7.
Do not use in animals treated with non-selective monoamine oxidase
inhibitors.
Do not use in cases of known hypersensitivity to the active substance
or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
It is not appropriate to use the product for the behavioural cause of
inappropriate urination.
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_
_4_
_/_
_0_
_9_
_/_
_2_
_0_
_1_
_5_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_1_
_6_
_1_
_2_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Because phenylpropanolamine is a sympathomimetic agent, it may affect
the card