Otisur

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Miconazole nitrate ; Prednisolone acetate; Polymyxin b sulfate

Pieejams no:

Chanelle Pharmaceuticals Manufacturing Limited

ATĶ kods:

QD01AC52

SNN (starptautisko nepatentēto nosaukumu):

Miconazole nitrate ; Prednisolone acetate; Polymyxin b sulfate

Zāļu forma:

Ear drops, suspension

Receptes veids:

POM: Prescription Only Medicine as defined in relevant national legislation

Ārstniecības joma:

miconazole, combinations

Autorizācija datums:

2023-02-23

Produkta apraksts

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Otisur 23.0 mg/ml + 5.0 mg/ml + 5500 IU/ml ear drops, suspension for
cats and dogs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
Miconazole Nitrate
23.0 mg (equivalent to 19.98 mg miconazole)
Prednisolone Acetate
5.0 mg (equivalent to 4.48 mg prednisolone)
Polymyxin B Sulfate
5500 IU polymyxin B sulfate
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS
Silica, Colloidal Anhydrous
Paraffin, liquid
White to off-white ear drops, suspension.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cats and dogs
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the treatment of otitis externa and small, localised, superficial
skin infections caused by mixed
infections with the following miconazole and polymixin B susceptible
bacteria and fungi:
−
Gram-positive bacteria:
_Staphylococcus _
spp. and
_Streptococcus _
spp.
−
Gram-negative bacteria:
_Pseudomonas _
spp. and
_Escherichia coli _
−
Fungi:
_Malassezia pachydermatis_
,
_Candida _
spp.,
_Microsporum _
spp. and
_Trichophyton _
spp.
Treatment of
_Otodectes cynotis _
(ear mites) infestations where there is concurrent infection with
bacteria and fungi susceptible to polymyxin B and miconazole.
3.3
CONTRAINDICATIONS
Do not use:
-
in cases of hypersensitivity to the active substances of the
veterinary medicinal product, as
well as to other corticosteroids, to other azole antifungal agents, or
to any of the excipients;
-
in cases of skin viral infection;
-
in cases of large skin lesions and of poorly healing or fresh wounds;
-
in animals with perforation of the tympanic membrane;
-
in animals where resistance of causative agents to polymyxin B and/or
miconazole is known;
-
on the mammary glands of lactating bitches and queens.
3.4
SPECIAL WARNINGS
Bacterial and fungal otitis is often secondary in nature. The
underlying cause should be identified and
treated. Cross-resistance has been shown between polymyxin B and
colistin in
_E. coli_
. Use of the
product should be carefully