Genticin 0.3% w/v Eye/Ear Drops, Solution

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Gentamicin Sulfate

זמין מ:

Amdipharm Limited

קוד ATC:

S02AA; S02AA14

INN (שם בינלאומי):

Gentamicin Sulfate

כמות:

0.3 percent weight/volume

טופס פרצבטיות:

Ear/eye drops, solution

סוג מרשם:

Product subject to prescription which may not be renewed (A)

איזור תרפויטי:

Antiinfectives; gentamicin

מצב אישור:

Marketed

תאריך אישור:

1995-04-20

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
GENTICIN
 0.3% W/V
EYE/EAR DROPS, SOLUTION
Gentamicin
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 only. 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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Genticin 0.3% w/v Eye/Ear Drops Solution is and what it is used
for
2.
What you need to know before you use Genticin 0.3% w/v Eye/Ear Drops
Solution
3.
How to use Genticin 0.3% w/v Eye/Ear Drops Solution
4.
Possible side effects
5.
How to store Genticin 0.3% w/v Eye/Ear Drops Solution
6.
Contents of the pack and other information
1. WHAT GENTICIN 0.3% W/V EYE/EAR DROPS SOLUTION
IS AND WHAT IT IS USED FOR_ _
_ _
The name of your medicine is Genticin 0.3% w/v Eye/Ear Drops Solution.
This medicine
contains the active ingredient gentamicin which belongs to a group of
medicines called
antibiotics.
Genticin 0.3% w/v Eye/Ear Drops Solution is used in adults and
children to treat bacterial
infections in the eye or ear and to prevent infections in an injured
eye or ear.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GENTICIN 0.3% W/V EYE/EAR
DROPS SOLUTION_ _
DO NOT USE GENTICIN 0.3% W/V EYE/EAR DROPS SOLUTION IF YOU:
-
are allergic
to gentamicin, any of the other ingredients of Genticin 0.3% w/v
Eye/Ear Drops Solution (listed in section 6), or to a similar medicine
containing
an aminoglycoside antibiotic;
-
have or suspect you have a burst ear drum, if you are being treated
for a
problem with your ear;
-
suffer from myasthenia gravis, a disease causing muscle weakness.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE

מאפייני מוצר

Health Products Regulatory Authority
10 May 2021
CRN00C8V3
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Genticin 0.3% w/v Eye/Ear Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle contains Gentamicin sulfate equivalent to 0.3% w/v
gentamicin base in 10 ml of solution
Excipients with known effect:
Benzalkonium chloride 0.020% w/v
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye/Ear drops, solution.
A clear, colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Genticin eye/ear drops are indicated in adults and children:
1. For the treatment of superficial eye and ear infections caused by
organisms sensitive to gentamicin.
2. For prophylaxis against infection in trauma of the eye or ear.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, the elderly and the paediatric population_
_Eyes:_ 1 or 2 drops should be instilled in the affected eye up to six
times a day, or more frequently if required. (Severe infections
may require 1 or 2 drops every fifteen to twenty minutes initially,
reducing the frequency of instillation gradually as the
infection is controlled).
_Ears:_ The area should be cleaned and 2 - 3 drops instilled in the
affected ear three to four times a day and at night, or more
frequently if required.
Method of administration
Auricular and ocular use.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
Myasthenia gravis
Known or suspected perforation of the ear drum.
Health Products Regulatory Authority
10 May 2021
CRN00C8V3
Page 2 of 5
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Long-term continuous topical therapy should be avoided. Prolonged use
may lead to skin sensitisation and the emergence of
resistant organisms. Cross sensitivity with other aminoglycoside
antibiotics may occur.
In severe infections, topical use of gentamicin should be supplemented
with appropriate systemic antibiotic treatment.
Gentamicin may cause irreversible parti