AURIZON EAR DROPS, SUSPENSION

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
10-05-2017

Viambatanisho vya kazi:

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE (AS DEXAMETHASONE ACETATE)

Inapatikana kutoka:

Vetoquinol UK Limited

ATC kanuni:

QS02CA06

INN (Jina la Kimataifa):

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE (AS DEXAMETHASONE ACETATE)

Kipimo:

Unknown

Dawa fomu:

Ear Drops Suspension

Dawa ya aina:

POM

Kundi la matibabu:

Canine

Eneo la matibabu:

Dexamethasone and antiinfectives

Matibabu dalili:

Antibacterial

Idhini hali ya:

Authorised

Idhini ya tarehe:

2016-03-24

Tabia za bidhaa

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
AURIZON ear drops, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ML OF AURIZON CONTAINS:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ear drops, suspension
Homogenous beige to yellow oily suspension
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
-
Treatment
of
otitis
externa of
both bacterial
and fungal
origin -
respectively due to bacteria sensitive to
marbofloxacin, and fungi especially_ Malassezia pachydermatis_
sensitive to clotrimazole.
The product should be used based on susceptibility testing.
4.3 CONTRAINDICATIONS
Do not
administer to dogs suffering from perforation of the tympanic
membrane.
Do not
administer to dogs with
known hypersensitivity to any of the ingredients.
Do not administer to pregnant or lactating bitches.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
ACTIVE SUBSTANCES:
Marbofloxacin
3.0
mg
Clotrimazole
10.0 mg
Dexamethasone acetate
1.0
mg
(equivalent to dexamethasone 0.9
mg)
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_
_ _
_2_
_5_
_/_
_0_
_4_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_6_
_1_
_3_
_3_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.5 SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Heavy reliance on a single class of antibiotic may result in the
induction of resistance in a bacterial population.
It is
prudent to reserve the fluoroquinolo
                                
                                Soma hati kamili