CANAURAL EAR DROPS, SUSPENSION FOR DOGS AND CATS

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Beli Sekarang

Karakteristik produk Karakteristik produk (SPC)
09-02-2017

Bahan aktif:

DIETHANOLAMINE FUSIDATE, FRAMYCETIN SULFATE, NYSTATIN, PREDNISOLONE

Tersedia dari:

Dechra Veterinary Products A/S

Kode ATC:

QS02CA01

INN (Nama Internasional):

DIETHANOLAMINE FUSIDATE, FRAMYCETIN SULFATE, NYSTATIN, PREDNISOLONE

Dosis:

5

Bentuk farmasi:

Ear Drops Suspension

Jenis Resep:

POM

Kelompok Terapi:

Canine, Feline

Area terapi:

Prednisolone and antiinfectives

Indikasi Terapi:

Antibacterial

Status otorisasi:

Authorised

Tanggal Otorisasi:

2004-10-01

Karakteristik produk

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Canaural ear drops, suspension for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EXCIPIENTS:
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Ear drops, suspension.
A yellow oily suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of otitis externa including the ear mite_ Otodectes
cynotis_ infestation in the dog and cat.
4.3 CONTRAINDICATIONS
Do not use in animals with a perforated ear drum.
Do not use concomitantly with products known to be ototoxic.
Do not use in animals with known hypersensitivity to the active
substances or the excipient.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
For external use only.
To be used under veterinary supervision.
1 g of suspension contains:
ACTIVE SUBSTANCES:
Diethanolamine fusidate
5
mg
Framycetin sulphate
5
mg
Nystatin
100,000
IU
Prednisolone
2.5 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_
_1_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_5_
_0_
_5_
_8_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.5 SPECIAL PRECAUTIONS FOR USE
Official, national and regional antimicrobial policies should be taken
into account when the product is used.
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Following recovery the ears should be checked at regular intervals for
any sign of re-infection.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PE
                                
                                Baca dokumen lengkapnya