HEXAKAPRON TABLETS

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

TRANEXAMIC ACID

Διαθέσιμο από:

TEVA ISRAEL LTD

Φαρμακολογική κατηγορία (ATC):

B02AA02

Φαρμακοτεχνική μορφή:

TABLETS

Σύνθεση:

TRANEXAMIC ACID 500 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Θεραπευτική ομάδα:

TRANEXAMIC ACID

Θεραπευτική περιοχή:

TRANEXAMIC ACID

Θεραπευτικές ενδείξεις:

Treatment of hemorrhage occuring in some forms of surgery, including prostatectomy. Hematuria. Menorrhagia. Hereditary angioneurotic edema.

Ημερομηνία της άδειας:

2021-05-31

Φύλλο οδηγιών χρήσης

عباط صيخشت بجي !ةمتعلا يف ةيودأ لوانت
زوجي لا اهيف لوانتت ةرم لك يف يئاودلا رادقملا
نم دكأتلاو ءاودلا
.كلذ رملأا مزل اذإ ةيبطلا تاراظنلا عض
.ءاود ،ءاودلا اذه لامعتسإ لوح ةيفاضإ ةلئسأ
كيدل ترفوت اذإ
.يلديصلا وأ بيبطلا رشتسإ
ةيبناجلا ضارعلأا )4
ً
اضارعأ ببسي دق نورپاكاسكه لامعتسإ نإ
،ءاود لكب امك
ضارعلأا ةمئاق نم شهدنت لا .نيلمعتسملا
ضعب دنع ةيبناج
.اهنم
ً
ايأ يناعت لاأ زئاجلا نم .ةيبناجلا
نينيعلا يف تابارطضإ نيلمعتسم 1-10 ىدل رهظت ضارعأ( ةردان
ةيبناج ضارعأ
:)10٫000 نيب نم
ناوللأا ةيؤر يف ةصاخ ،ةيؤرلا يف لكاشم
●
نيعلا يف فزن رملأا اذه ببسي دق .نيعلا
يف ةيومد ةرثخ ●
ةيؤرلا نادقف وأ
يعانملا زاهجلا يف تابارطضإ نم لقأ ىدل رهظت ضارعأ(
ً
ادج ةردان ةيبناج ضارعأ
:)10٫000 نيب نم 1 لمعتسم
سفنتلا يف ةبوعص ىلإ يدؤت يتلا ةيسسحت
لعف دودر لمشت ●
راود ىلإ وأ
ةيومدلا ةيعولأا يف تابارطضإ نم لقأ ىدل رهظت ضارعأ(
ً
ادج ةردان ةيبناج ضارعأ
:)10٫000 نيب نم 1 لمعتسم
ـ راثخ ةلاحلا هذه ىمست( ةيومدلا
ةيعولأا يف ةيومد ةرثخ ●
)
thrombosis
يمضهلا زاهجلا يف تابارطضإ نم لقأ ىدل رهظت ضارعأ(
ً
ادج ةردان ةيبناج ضارعأ
:)10٫000 نيب نم 1 لمعتسم
نايثغ
●
ؤيقت
●
لاهسإ ●
،
ً
ادج
ً
اعيرس لوزتو ةفيفط نوكت ةداع ةيبناجلا
ضارعلأا هذه
.كلذ نع يلديصلا وأ كبيبطل كحإ ،ترمتسإ
اذإ نكل
دلجلا تحت جيس�

Αρχείο Π.Χ.Π.

Hexakapron Tablets OKD 08/2023 Notification
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hexakapron Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Tranexamic acid 500 mg as the active ingredient.
Excipient with known effect:
Each tablet contains 0.504-0.756 mg of sodium.
For excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
White, round flat beveled tablet engraved "TEVA" on one side and
bisecting line on
the other.
The tablet can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of hemorrhage occurring in some forms of surgery, including
prostatectomy.
Hematuria.
Menorrhagia.
Hereditary angioneurotic edema.
4.2
Posology and method of administration
Dosage and Administration
Doses should be reduced in renal impairment.
Adults
The recommended standard dosage is 2-3 tablets, 2-3 times daily .
For the indications listed below, specific recommendations are made as
follows:
(please refer also to the Physicians’ Prescribing Information for
Hexakapron
injection)
Prostatectomy
Following I.V. administration (refer to the Physicians’ Prescribing
Information for the
injection), 2-3 Hexakapron tablets, 2-3 times daily, until macroscopic
hematuria is no
longer present.
Dental Surgery
Factor VIII or IX concentrates and Hexakapron 10 mg/kg body weight
should be
administered intravenously immediately before surgery. Following
surgery, 25 mg/kg
body weight should be administered orally, 3-4 times daily, for 6-8
days. As a rule, it
is not necessary to administer factor VIII or IX concentrates
following surgery
.
Hematuria
2-3 tablets, 2-3 times daily, until macroscopic hematuria is no longer
present.
Hexakapron Tablets OKD 08/2023 Notification
Menorrhagia
2-3 tablets, 3-4 times daily, for 3-4 days. Hexakapron therapy should
be initiated only
after heavy bleeding has started. Use of the drug should be restricted
to not more than
three menstrual cycles .
Hereditary Angioneurotic Edema
Some patients are aware of the onset of the illn