Otosporin Ear drops

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

POLYMYXIN B, SULFATE, NEOMYCIN SULFATE, HYDROCORTISONE

थमां उपलब्ध:

Phoenix Labs Suite 12, Bunkilla Plaza, Bracetown Business Park Clonee, County Meath D15 XC64 , Ireland

ए.टी.सी कोड:

S02CA03

INN (इंटरनेशनल नाम):

POLYMYXIN B SULFATE 10000 U/ml NEOMYCIN SULFATE 3400 U/ml HYDROCORTISONE 10000 % (W/V)

फार्मास्यूटिकल फॉर्म:

EAR DROPS, SOLUTION

रचना:

POLYMYXIN B SULFATE 10000 U/ml NEOMYCIN SULFATE 3400 U/ml HYDROCORTISONE 10000 % (W/V)

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

OTOLOGICALS

उत्पाद समीक्षा:

Licence number in the source country: NOT APPLICAPABLE

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2020-01-29

सूचना पत्रक

Phoenix Labs
Otosporin Ear Drops
Patient Information Leaflet – November 2020
PHOENIX LABS
PACKAGE LEAFLET: INFORMATION FOR THE USER
OTOSPORIN® EAR DROPS
POLYMYXIN B SULPHATE, NEOMYCINE SULPHATE AND HYDROCORTISONE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Otosporin is and what it is used for
2.
What you need to know before you use Otosporin
3.
How to use Otosporin
4.
Possible side effects
5.
How to store Otosporin
6.
Contents of the pack and other information
1. WHAT OTOSPORIN IS AND WHAT IT IS USED FOR
The name of your ear drops is Otosporin. It is used to treat ear
infections.
•
Otosporin contains three medicines called: polymyxin B sulphate,
neomycin sulphate and
hydrocortisone
•
Polymyxin B sulphate and neomycin sulphate belong to a group of
medicines called
antibiotics. They kiII the germs that can cause ear infections.
•
Hydrocortisone belongs to a group of medicines called steroids. It
helps to reduce the
swelling and irritation caused by the infection.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OTOSPORIN
DO NOT USE OTOSPORIN:
•
if you are allergic (hypersensitive) to polymyxin B sulphate, neomycin
sulphate,
hydrocortisone or any of the other ingredients of this medicine (see
section 6)
•
if you are allergic (hypersensitive) to aminoglycoside ant biotics
such as framycetin,
kanamycin or gentamicin
•
if you have a perforated ear drum
•
if you have ether a viral, fungal or tubercular (TB) infection
•
for a child under 3 years old.
Do not use if any of the above apply to you.

उत्पाद विशेषताएं

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 Oto