Latanoprost STADA 50 microgram/ml oogdruppels, oplossing

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LATANOPROST

Beschikbaar vanaf:

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

ATC-code:

S01EE01

INN (Algemene Internationale Benaming):

LATANOPROST

farmaceutische vorm:

Oogdruppels, oplossing

Samenstelling:

BENZALKONIUMCHLORIDE ; DINATRIUMWATERSTOFFOSFAAT 0-WATER (E 339) ; NATRIUMCHLORIDE ; NATRIUMDIWATERSTOFFOSFAAT 1-WATER (E 339) ; WATER, GEZUIVERD,

Toedieningsweg:

Oculair gebruik

Therapeutisch gebied:

Latanoprost

Product samenvatting:

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

Autorisatie datum:

2010-10-28

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
LATANOPROST STADA 50 MICROGRAM/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 Latanoprost STADA is and what it is used for
2. What you need to know before you use Latanoprost STADA
3. How to use Latanoprost STADA
4. Possible side effects
5. How to store Latanoprost STADA
6. Contents of the pack and other information
1. WHAT LATANOPROST STADA IS AND WHAT IT IS USED FOR
Latanoprost STADA 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.
Latanoprost STADA 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.
Latanoprost STADA 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 LATANOPROST STADA
Latanoprost STADA can be used in adult men and women (including the
elderly) and in
children from birth to 18 years of age. Latanoprost STADA has not been
investigated in
prematurely born infants (less than 36 weeks gestation).
DO NOT USE LATANOPROST STADA
•
if you are allergic to latanoprost or any of the other ingredients of
this medicine (listed in
section 6)
WARNINGS AND PRECAUTIONS
Talk to yo

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
_Lateye 50 micrograms/ml eye drops, solution_.
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 _Lateye_ is administered in the evening.
The dosage of _ Lateye_ 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 _
_Lateye _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 instillation