Otosporin ear drops

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Hydrocortisone; Neomycin sulfate; Polymyxin B sulfate

Disponibil de la:

Phoenix Labs Ltd

Codul ATC:

S02CA03

INN (nume internaţional):

Hydrocortisone; Neomycin sulfate; Polymyxin B sulfate

Dozare:

10mg/1ml ; 3400unit/1ml ; 10000unit/1ml

Forma farmaceutică:

Ear drops

Calea de administrare:

Auricular

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Never Valid To Prescribe As A VMP

Rezumat produs:

BNF: 12010100; GTIN: 5010706002401 5010706002418

Prospect

31040600
Measurement Bar (mm)
February 2017
Measurement Bar (mm)

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Otosporin Ear Drops.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Polymyxin B Sulphate 10,000 units per ml
Neomycin Sulphate 3,400 units per ml
Hydrocortisone 1.0% w/v
Excipient(s) with known effect:
Also contains cetostearyl alcohol and methyl hydroxybenzoate E218
For a full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Liquid for topical application to humans.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Otosporin Ear Drops are indicated for the treatment of otitis externa
due to, or
complicated by, bacterial infection.
Route of Administration
Topical
IN VITRO ACTIVITY
Otosporin Ear Drops are active against a wide range of bacterial
pathogens.
The range of activity includes:-
GRAM-POSITIVE ORGANISMS:
_Staphylococcus epidermis_ and _Staphylococcus aureus_:
GRAM-NEGATIVE ORGANISMS:
_Enterobacter_ Spp.
_Escherichia_ Spp.
_Haemophilus_ Spp.
_Klebsiella_ Spp.
_Proteus_ Spp.
_Pseudomonas aeruginosa _
Otosporin Ear Drops are not expected to be active against
streptococci,
including _Streptococcus_ _pyogenes_.
Hydrocortisone possesses anti-inflammatory, anti-allergic and
antipruritic
activity.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Otosporin ear drops are for topical administration into the ear only.
Adults
Following cleansing and drying of the external auditory meatus and
canal as
appropriate, three drops should be instilled into the affected ear
three or four
times daily. Alternatively, a gauze wick may be introduced into the
external
auditory canal and kept saturated with the solution; the wick may be
left in
place for 24 to 48 hours.
Treatment should not be continued for more than 7 days without medical
supervision.
Soap should not be used for cleansing of the external auditory meatus
and
canal as it may inactivate the antibiotics.
Children
Otosporin Ear Drops are suitable for use in children ( 3 years and
over) at the
same dose as adults. A possibility of increased absorption exists in
very
young children, thus Otosporin Ear Dro