Dexafree 1mg/ml eye drops, solution in single dose container

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

DEXAMETHASONE PHOSPHATE

Beszerezhető a:

Laboratoires Thea

ATC-kód:

S01BA; S01BA01

INN (nemzetközi neve):

DEXAMETHASONE PHOSPHATE

Adagolás:

1 milligram(s)/millilitre

Gyógyszerészeti forma:

Eye drops, solution in single-dose container

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

Corticosteroids, plain; dexamethasone

Engedélyezési státusz:

Marketed

Engedély dátuma:

2012-08-24

Betegtájékoztató

DEXAFREE 1 MG/ML, EYE DROPS, SOLUTION
IN SINGLE-DOSE CONTAINER
Dexamethasone phosphate
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Dexafree is and what it is used for
2.
What you need to know before you use Dexafree
3.
How to use Dexafree
4.
Possible side effects
5.
How to store Dexafree
6.
Contents of the pack and other information
1.
WHAT DEXAFREE IS AND WHAT IT IS USED FOR
Dexafree contains dexamethasone, which is a corticosteroid used to
stop
inflammatory symptoms (such as pain, heat swelling and redness).
Dexafree is used to treat inflammation of your eyes.
If you have an infected eye (red eye, tears, mucous), you will be
given another
medicine to take at the same time as Dexafree. See Section 2.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DEXAFREE
DO NOT USE DEXAFREE
•
if you are suffering from an eye infection that you are not using a
medicine for,
•
if you have damage on the surface of the eye (small holes, ulcers or
injury
which have not healed properly),
•
if you have high pressure in the eye known to be caused by
glucosteroids
(family of corticosteroid medicines),
•
if you are allergic (hypersensitive) to dexamethasone sodium
phosphate, or any
of the other ingredients of this medicine (listed in Section 6).
WARNINGS AND PRECAUTIONS
Tell your doctor, pharmacist or nurse before using Dexafree.
_ _
_DO NOT INJECT, DO NOT SWALLOW. _
_Avoid contact between the dispenser tip and the eye or eyelids. _
•
close monitoring of the eye is required during the use of Dexafree

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexafree 1mg/ml eye drops, solution in single dose container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 1 mg of dexamethasone phosphate as
dexamethasone sodium phosphate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless to slightly brown solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For treatment of non-infectious inflammatory conditions affecting the
anterior segment of the eye.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dexafree 1 mg/ml, eye drops, solution in single-dose container is for
ocular use only.
This product should be used only under close ophthalmic supervision.
Posology
The usual posology is of 1 drop 4 to 6 times daily in the affected
eye.
In severe cases, treatment may be started with 1 drop every hour but
dosage should be reduced to one drop every 4
hours when favourable response is observed. Gradual tapering off is
recommended in order to avoid a relapse.
The duration of treatment will generally vary from a few days to a
maximum of 14 days.
_Elderly patients_
There has been wide experience with the use of dexamethasone eye drops
in elderly patients. The dosage
recommendations given above reflect the clinical data derived from
this experience.
_Paediatric population_
Efficacy and safety has not been established in the paediatric
population.
In children, long-term continuous corticosteroid therapy should be
avoided due to possible adrenal suppression (see
section 4.4).
Method of administration
Dexafree is a sterile solution that
does not
contain a preservative.
The solution from one individual
single dose
container is to be used immediately after opening for administration
to the affected eye(s). For single-use only: since
sterility cannot
be maintained after the individual
single dose container is opened,
any remaining contents must
be
discarded immediately after administration.
Patients should be instructed:
- to wash their hands ca