SAFLUTAN

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

TAFLUPROST

متاح من:

RAFA LABORATORIES LTD

ATC رمز:

S01EE05

الشكل الصيدلاني:

OPHTHALMIC SOLUTION

تركيب:

TAFLUPROST 15 MCG/ML

طريقة التعاطي:

OCULAR

نوع الوصفة الطبية :

Required

المصنعة من قبل:

MERCK SHARP & DOHME B.V, HOLLAND

المجموعة العلاجية:

TAFLUPROST

المجال العلاجي:

TAFLUPROST

الخصائص العلاجية:

Reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension.As monotherapy in patients • who would benefit from preservative free eye drops • insufficiently responsive to first line therapy • intolerant or contra-indicated to first line therapyAs adjunctive therapy to beta-blockers.

تاريخ الترخيص:

2016-11-30

نشرة المعلومات

[לוגו מדינת ישראל] [http://www.gov.il/]
[http://www.gov.il/] [לוגו משרד הבריאות] [לוגו משרד
הבריאות] [*5400]
[http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx]
[http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx]
הציבור הרחב עסקים ומוסדות עובדים
בבריאות חפש מידע
תפריט *
[סגירה]
סגור *
דף הבית [http://www.health.gov.il/] *
אודות *
אודות המשרד
[http://www.health.gov.il/About/Pages/about_us.aspx] *
תוכנית עבודה
[http://www.health.gov.il/About/Pages/Agenda.aspx] *
תקציב המשרד
[http://www.health.gov.il/About/Pages/budget.aspx] *
תרשים מבנה ארגוני
[http://www.health.gov.il/About/Pages/OrganizationalStructureDiagram.aspx] *
בעלי תפקידים
[http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx] *
יחידות המשרד
[http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] *
לשכות הבריאות
[http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx?tab=3] *
אמנת שירות
[http://www.health.gov.il/About/sla/Pages/default.aspx] *
אותות ופרסים
[http://www.health.gov.il/About/Awards/Pages/mifal.aspx] *
פרוייקטים תשתיתיים
[http://www.health.gov.il/About/projects/shared_medical_info/Pages/default.aspx] *
דרושים
[http://www.health.gov.il/About/Careers/Pages/default.aspx] *
מנכ"לי משרד הבריאות לדורותיהם
[http://www.health.gov.il/About/Pages/GeneralManegerHistory.aspx] *
יחידות המשרד *
יחידות המשרד
[http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] *
לשכות הבריאות
[http://www.health.gov.il/UnitsOffice/LB/Pages/default.aspx] *
וועדות ומועצות
[http://www.health.gov.il/Services/Committee/Pages/CommitteeList.aspx] *
נושאים *
בריאות הנפש
[http://www.health.gov.il/Subjects/mental_health/Pages/default.aspx] *
בריאות הסביבה
[http://www.health.gov.il/Subjects/Environmental_Health/

خصائص المنتج

Saflutan-DL- January2022- rev 04
1.
NAME OF THE MEDICINAL PRODUCT
SAFLUTAN
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of eye drops, solution, contains 15 micrograms of tafluprost.
One single-dose container (0.3 ml) of eye drops, solution, contains
4.5 micrograms of
tafluprost.
One drop (about 30 μl) contains about 0.45 micrograms of tafluprost.
Excipient with known effect: one ml of eye drops solution contains
1.2mg phosphates
and one drop containes approximately 0.04 mg phosphates.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution in single-dose container (eye drops).
A clear, colourless solution, practically free from visible particles
with pH between
5.5 and 6.7, and an osmolality of 250-300 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in open angle glaucoma and
ocular
hypertension.
As monotherapy in patients:
o
who would benefit from preservative free eye drops
o
insufficiently responsive to first line therapy
o
intolerant or contra-indicated to first line therapy.
As adjunctive therapy to beta-blockers.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one drop of SAFLUTAN in the conjunctival sac
of the
affected eye(s) once daily in the evening.
The dose should not exceed once daily as more frequent administration
may lessen
the intraocular pressure lowering effect.
For single use only, one container is sufficient to treat both eyes.
Any unused
solution should be discarded immediately after use.
_Use in elderly: _
No dosage alteration in elderly patients is necessary.
_Paediatric population _
The safety and efficacy of tafluprost in children below age 18 has not
yet been
established. No data are available.
_Use in renal/hepatic impairment _
Tafluprost has not been studied in patients with renal/hepatic
impairment and should
therefore be used with caution in such patients.
_Method of administration_
To reduce the risk of darkening of the eyelid skin the patients should
w