Azyter 15 mg/g eye drops, solution, in single-dose container

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Azithromycin dihydrate

から入手可能:

Laboratoires Thea

ATCコード:

S01AA; S01AA26

INN（国際名）:

Azithromycin dihydrate

投薬量:

15 milligram(s)/gram

医薬品形態:

Eye drops, solution

処方タイプ:

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

治療領域:

Antibiotics; azithromycin

認証ステータス:

Marketed

承認日:

2011-05-20

情報リーフレット

Package Leaflet: Information for the patient
AZYTER 15 MG/G, EYE DROPS, SOLUTION IN SINGLE-DOSE CONTAINER
Azithromycin dihydrate
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 the doctor
treating your child, or pharmacist or nurse.
-
This medicine has been prescribed for you or for your child 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, pharmacist or nurse.
This includes any possible side effects
not listed in this leaflet.
What is in this leaflet:
1.
What AZYTER is and what it is used for
2.
What you need to know before you use AZYTER
3.
How to use AZYTER
4.
Possible side effects
5.
How to store AZYTER
6.
Contents of the pack and other information
1.
WHAT AZYTER IS AND WHAT IT IS USED FOR
Azyter contains azithromycin, which is an antibiotic (macrolide
class).
Azyter is used to treat some eye infections that are caused by
bacteria in adults (including the elderly) and in
children from birth to 17 years of age.
•
purulent bacterial conjunctivitis,
•
trachoma conjunctivitis (a particular infection of the eye caused by
bacteria called
_Chlamydia trachomatis_
,
which is usually found in developing countries).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AZYTER
DO NOT USE AZYTER:
-
If you are allergic to azithromycin, to any other antibiotic from the
macrolide class or to medium-chain
triglycerides.
WARNINGS AND PRECAUTIONS
Talk to your doctor, or the doctor treating your child, or your
pharmacist or nurse before using Azyter
-
If you or your child have an allergic reaction, stop the treatment and
tell your doctor or the doctor treating
your child.
-
If you or your child’s eye infection does not get better after three
days using the drops, or if you notice
anything unusual, tell your doctor or the doctor treating your child

製品の特徴

Health Products Regulatory Authority
17 January 2019
CRN008TNK
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azyter 15 mg/g eye drops, solution, in single-dose container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of solution contains 15 mg of azithromycin dihydrate
equivalent to 14.3
mg of azithromycin.
One single-dose container of 250 mg solution contains 3.75 milligrams
of
azithromycin dihydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution in single-dose container.
Clear, colourless to slightly yellow, oily liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AZYTER 15 mg/g, eye drops, solution in single-dose container is
indicated for the
local antibacterial curative treatment of conjunctivitis caused by
susceptible strains
(see sections 4.4 and 5.1):
- Purulent bacterial conjunctivitis in children (aged from birth to 17
years) and adults,
- Trachomatous conjunctivitis caused by _Chlamydia trachomatis_ in
children (aged
from birth to 17 years) and adults (see section 4.4 “Use in
neonates”).
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Adult population
Instil one drop in the conjunctival fornix twice a day, morning and
evening, during
three days.
It is unnecessary to prolong treatment beyond three days.
Adherence to the dosing regimen is important for the success of
treatment.
Health Products Regulatory Authority
17 January 2019
CRN008TNK
Page 2 of 11
Elderly patients:
No dose adjustment is necessary.
Paediatric population
No dose adjustment is necessary (see section 4.4 and 5.1).
_Method of administration_
Ocular use.
The patient should be advised to:
- thoroughly wash hands before and after the instillation,
- avoid touching the eye or eyelids with the dropper tip of the
single-dose container,
- discard the single-dose container after use, and not keep it for
subsequent use.
4.3 CONTRAINDICATIONS
Hyperse