Exprosol 50 microgram/ml oogdruppels, oplossing

Страна: Нидерландия

Език: нидерландски

Източник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Активна съставка:

LATANOPROST 50 µg/ml

Предлага се от:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

АТС код:

S01EE01

INN (Международно Name):

LATANOPROST 50 µg/ml

Лекарствена форма:

Oogdruppels, oplossing

Композиция:

BENZALKONIUMCHLORIDE ; DINATRIUMWATERSTOFFOSFAAT 0-WATER (E 339) ; NATRIUMCHLORIDE ; NATRIUMDIWATERSTOFFOSFAAT 1-WATER (E 339) ; STIKSTOF (HEAD SPACE) (E 941) ; WATER, GEZUIVERD,

Начин на приложение:

Oculair gebruik

Терапевтична област:

Latanoprost

Каталог на резюме:

Hulpstoffen: BENZALKONIUMCHLORIDE; DINATRIUMWATERSTOFFOSFAAT 0-WATER (E 339); NATRIUMCHLORIDE; NATRIUMDIWATERSTOFFOSFAAT 1-WATER (E 339); STIKSTOF (HEAD SPACE) (E 941); WATER, GEZUIVERD;

Дата Оторизация:

1900-01-01

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
EXPROSOL 50 MICROGRAMS/ML OOGDRUPPELS, OPLOSSING
Latanoprost
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.
-
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 or the doctor
treating your child or
pharmacist. This includes any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Exprosol is and what it is used for
2. What you need to know before you use Exprosol
3. How to use Exprosol
4. Possible side effects
5. How to store Exprosol
6. Contents of the pack and other information
1. WHAT EXPROSOL IS AND WHAT IT IS USED FOR
Exprosol belongs to a group of medicines known as prostaglandin
analogues. It works by
increasing the natural outflow of fluid from inside the eye into the
bloodstream.
Exprosol
is
used
to
treat
conditions
known
as
OPEN
ANGLE
GLAUCOMA
and
OCULAR
HYPERTENSION in adults. Both of these conditions are linked with an
increase in the pressure
within your eye, eventually affecting your eye sight.
Exprosol is also used to treat increased eye pressure and glaucoma in
all ages of children
and babies.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE EXPROSOL
Exprosol can be used in adult men and women (including the elderly)
and in children from
birth to 18 years of age. Exprosol has not been investigated in
prematurely born infants (less
than 36 weeks gestation).
DO NOT USE EXPROSOL
•
if you are allergic to latanoprost or any of the other ingredients of
this medicine (listed in
section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor, or the doctor treating your child or your
pharmacist before you use
Exprosol or before you give this to y

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Exprosol 50 microgram/ml, oogdruppels, oplossing
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of eye drops contains 50 micrograms of latanoprost.
2.5 ml of eye drops, solution (content of a bottle) contains 125
micrograms of latanoprost.
One drop contains approximately 1.5 micrograms latanoprost.
Excipient with known effect
One
ml
of
eye
drops
solution
contains
0.2 mg
benzalkonium
chloride
and
6.34 mg
phosphates.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops, solution (eye drops).
The solution is a clear colourless liquid.
pH 6.4 - 7.0
Osmolality 240 - 290 mOsm/kg
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in patients with open angle
glaucoma and ocular
hypertension.
Reduction of elevated intraocular pressure in paediatric patients with
elevated intraocular
pressure and paediatric glaucoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including the elderly): _
Recommended therapy is one eye drop in the affected eye(s) once daily.
Optimal effect is
obtained if _Exprosol_ is administered in the evening.
The dosage of _Exprosol_ should not exceed once daily since it has
been shown that more
frequent administration decreases the intraocular pressure lowering
effect.
If one dose is missed, treatment should continue with the next dose as
normal.
_Paediatric population _
_Exprosol_ eye drops may be used in paediatric patients at the same
posology as in adults. No
data are available for preterm infants (less than 36 weeks gestational
age). Data in the age
group < 1 year (4 patients) are limited (see section 5.1).
Method of administration
Ocular use
As with any eye drops, to reduce possible systemic absorption, it is
recommended that the
lachrymal sac be compressed at the medial canthus (punctal occlusion)
for one minute. This
should be performed immediately following the instillation of each
drop.
Contact lenses should be removed before instillatio