Latanostad 50 microgram/ml oogdruppels, oplossing

देश: नीदरलैंड

भाषा: डच

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

सक्रिय संघटक:

LATANOPROST 50 µg/ml

थमां उपलब्ध:

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

ए.टी.सी कोड:

S01EE01

INN (इंटरनेशनल नाम):

LATANOPROST 50 µg/ml

फार्मास्यूटिकल फॉर्म:

Oogdruppels, oplossing

रचना:

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

प्रशासन का मार्ग:

Oculair gebruik

चिकित्सीय क्षेत्र:

Latanoprost

उत्पाद समीक्षा:

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

प्राधिकरण की तारीख:

1900-01-01

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
LATANOSTAD 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 is and what it is used for
2. What you need to know before you use
3. How to use
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
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.
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.
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
can be used in adult men and women (including the
elderly) and in
children from birth to 18 years of age. Latanoprost has not been
investigated in prematurely
born infants (less than 36 weeks gestation).
DO NOT USE
•
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 y

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Latanostad 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 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 is administered in the evening.
The dosage of 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 _
_ _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 remov