Latanoprost Actavis 50 mikrogrammi/ml Qtar ghall-ghajnejn, soluzzjoni

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

LATANOPROST

متاح من:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC رمز:

S01EE01

INN (الاسم الدولي):

LATANOPROST 50 µg/ml

الشكل الصيدلاني:

EYE DROPS, SOLUTION

تركيب:

LATANOPROST 50 µg/ml

نوع الوصفة الطبية :

POM

المجال العلاجي:

OPHTHALMOLOGICALS

الوضع إذن:

Withdrawn

تاريخ الترخيص:

2012-11-13

نشرة المعلومات

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
LATANOPROST ACTAVIS 50 MIKROGRAMMI/ML QTAR GĦALL-GĦAJNEJN,
SOLUZZJONI 50 MICROGRAMS/ML
EYE DROPS, SOLUTION
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 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 Latanoprost Actavis 50 mikrogrammi/ml Qtar għall-għajnejn,
soluzzjoni is and what it
is used for
2.
What you need to know before you use Latanoprost Actavis 50
mikrogrammi/ml Qtar għall-
għajnejn, soluzzjoni
3.
How to use Latanoprost Actavis 50 mikrogrammi/ml Qtar
għall-għajnejn, soluzzjoni
4.
Possible side effects
5.
How to store Latanoprost Actavis 50 mikrogrammi/ml Qtar
għall-għajnejn, soluzzjoni
6.
Contents of the pack and other information
1.
WHAT LATANOPROST ACTAVIS 50 MIKROGRAMMI/ML QTAR GĦALL-GĦAJNEJN,
SOLUZZJONI IS AND
WHAT IT IS USED FOR
Latanoprost Actavis 50 mikrogrammi/ml Qtar għall-għajnejn,
soluzzjoni are eye drops used in
patients with a condition known as open angle glaucoma which causes an
increase in pressure in the
eye. The active ingredient in Latanoprost Actavis 50 mikrogrammi/ml
Qtar għall-għajnejn,
soluzzjoni is one of a group of medicines known as prostaglandins.
Latanoprost Actavis 50
mikrogrammi/ml Qtar għall-għajnejn, soluzzjoni is a medicine that
lowers the pressure within your
eye by increasing the natural outflow of fluid from inside the eye
into the blood stream.
Latanoprost Actavis 50 mikrogrammi/ml Qtar għall-għajnejn,
soluzzjoni is also used to treat
increased eye pressure and glaucoma in all ages of children and
babies.
2.
W

خصائص المنتج

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_ _
Latanoprost Actavis 50 mikrogrammi/ml Qtar għall-għajnejn,
soluzzjoni.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml eye drops solution contains 50 micrograms of latanoprost.
One drop contains approximately 1.5 micrograms latanoprost.
Excipient with known effect: Benzalkonium chloride 0.2 mg/ml.
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
_Recommended dosage for adults (including the elderly): _
Recommended therapy is one eye drop in the affected eye(s) once daily.
Optimal effect is obtained
if _ Latanoprost Actavis 50 mikrogrammi/ml Qtar għall-għajnejn,
soluzzjoni _ is administered in the
evening.
The dosage of _Latanoprost Actavis 50 mikrogrammi/ml Qtar
għall-għajnejn, soluzzjoni _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.
Page 2 of 12
Method of administration
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 of the eye drops
and may be reinserted after 15
minutes.
If more than one topical ophthalmic medicinal product is being used,
the medicinal products should
be administered at least five minutes apart.
_Paediatric populat