XALATAN EYE DROPS
البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
نشرة المعلومات
(PIL)
12-12-2022
خصائص المنتج
(SPC)
20-09-2022
تقرير التقييم الجمهور
(PAR)
02-08-2017
العنصر النشط:
LATANOPROST
متاح من:
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
ATC رمز:
S01EE01
الشكل الصيدلاني:
EYE DROPS, SOLUTION
تركيب:
LATANOPROST 50 MCG/ML
طريقة التعاطي:
OCULAR
نوع الوصفة الطبية :
Required
المصنعة من قبل:
PFIZER MANUFACTURING BELGIUM NV/SA
المجموعة العلاجية:
LATANOPROST
المجال العلاجي:
LATANOPROST
الخصائص العلاجية:
Reduction of elevated intraocular pressure as a first line treatment in patients with open-angle galucoma and ocular hypertension.
تاريخ الترخيص:
2021-02-28
نشرة المعلومات
Xalatan Eye Drops PIL CC 061222
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
XALATAN
® EYE DROPS
LATANOPROST 50 MCG/ML
Inactive ingredients and allergens: See section 2 under “Important
information about
some of this medicine’s ingredients” and section 6 “Further
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains
concise information about the medicine. If you have any further
questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
This medicine is intended for the treatment of adults over 18 years of
age.
1.
WHAT IS THE MEDICINE INTENDED FOR?
For reducing intraocular pressure in patients with open-angle glaucoma
and
intraocular hypertension.
THERAPEUTIC GROUP: belongs to the prostaglandin F2 analogue group. It
increases
the flow of the intraocular fluid into the bloodstream.
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other
ingredients in this medicine (listed in section 6).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH XALATAN, TELL THE DOCTOR IF:
•
You are suffering, or have suffered in the past, from eye problems
(such as eye
pain, inflammation, irritation, blurred vision).
•
You suffer from dry eyes.
•
You suffer from severe asthma or the asthma is not adequately
controlled.
•
You are about to undergo, or have recently undergone, eye surgery,
including
surgery for cataract removal.
•
You wear contact lenses. You can still use Xalatan, however, please
see
directions for using the drops in section 3: “How to use this
medicine?”
•
You are suffering, or have suffered in the past, from a viral
infection of the eye
caused by the herpes simplex virus (HSV).
DRUG INTERACTIONS
I
اقرأ الوثيقة كاملة
خصائص المنتج
Xalatan Eye Drops LPD CC 280822
2022-0077005
XALATAN
® EYE DROPS
1.
NAME OF THE MEDICINAL PRODUCT
Xalatan
®
Eye drops
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of eye drops, solution contains 50 micrograms of latanoprost.
2.5 mL of eye drops, solution (content of a dropper container)
contains 125 micrograms of latanoprost.
One drop contains approximately 1.5 micrograms latanoprost.
Excipients with known effect
Benzalkonium chloride 0. 2mg/mL is included as a preservative.
Sodium dihydrogen phosphate monohydrate 4.60 mg/mL.
Disodium phosphate anhydrous 4.74 mg/mL.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops, solution.
The solution is a clear, colourless liquid.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure as a first line treatment
in patients with open angle glaucoma
and ocular hypertension.
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
Xalatan is administered in the evening.
The dosage of Xalatan 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.
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.
Xalatan Eye Drops LPD CC 280822
2022-0077005
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.
4.3 CONTRAINDICATIONS
Hypersensitivity to latanoprost or to any of the excipients listed in
section 6.1
اقرأ الوثيقة كاملة
