''החלטה אמיצה תחת אש'': לא הנשים את חברו מדובדבן - והציל את חייו  

ותבין שהיתה פה פעולת גבורה רצינית ולא סתם הסתבכות של מעצרים רגילים כמו בכל לילה.

"פורמט עלון זה נקבע ע"י משרד הבריאות ותוכנו נבדק ואושר". עלון מאושר: דצמבר 2010 .
“This leaflet format has been determined by the Ministry of Health and the content thereof has been
checked and approved.” Date of approval: December 2010.

Physician's Package Insert עלון לרופא
=
HEXAKAPRON® INJECTION הקסאקפרון® להזרקה
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Solution for IV Injection להזרקה לתוך הוריד

Composition
Each ampoule of 5 ml contains:

Active Ingredient
Tranexamic acid 500 mg

Other Ingredients
Water for injection, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH
adjustment).

Mechanism of Action
Hexakapron is an antifibrinolytic agent which inhibits conversion of plasminogen to
plasmin.
Intravenous administration is necessary only if it is difficult to give adequate doses
orally.

Indications
General fibrinolysis. This may occur in prostatic and pancreatic carcinoma following
thoracic surgery and other major operative procedures, in obstetrical complications
such as abruptio placentae and post-partum hemorrhage, in connection with
thrombolytic therapy, and in initial and follow-up treatment following prostatectomy
and bladder surgery (see Precautions).
Prior to, and following, dental surgery in hemophiliacs.
Epistaxis.
Conization of the cervix.

Contraindications
- Known hypersensitivity to tranexamic acid or to any other ingredient of the
preparation.
- Patients with thromboembolic disease.
- Patients with active intravascular clotting.
- Severe renal failure because of risk of accumulation.
- Patients with subarachnoid hemorrhage. Anecdotal experience indicates that
cerebral edema and cerebral infarction may be caused by tranexamic acid in such
patients.
- Patients with acquired defective color vision, since this prohibits measuring one
endpoint that should be followed as a measure of toxicity (see Warnings).

Warnings
Focal areas of retinal degeneration have developed in cats, dogs and rats following
oral or intravenous tranexamic acid at doses between 250 to 1600 mg/kg/day (6 to 40
times the recommended usual human dose) from 6 days to 1 year. The incidence of
such lesions has varied from 25% to 100% of animals treated and was dose-related.
At lower doses some lesions have appeared to be reversible.

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Limited data in cats and rabbits showed retinal changes in some animals with doses
as low as 126 mg/kg/day (only about 3 times the recommended human dose)
administered for several days to two weeks.
No retinal changes have been reported or noted in eye examinations in patients
treated with tranexamic acid for weeks to months in clinical trials. However, visual
abnormalities, often poorly characterized, represent the most frequently reported
postmarketing adverse reaction in Sweden. For patients who are to be treated
continually for longer than several days, and in the long-term treatment of patients
with angioneurotic edema, regular eye examinations (e.g., visual acuity, slit lamp,
intraocular pressure, color vision, eye-ground and visual fields) and liver function test
should be performed, before commencing and at regular intervals during the course of
treatment. Tranexamic acid should be discontinued if changes in examination results
are found.
Tranexamic acid should not be administered concomitantly with Factor IX Complex
concentrates or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may
be increased (see Drug Interactions).
Patients with disseminated intravascular coagulation (DIC), who require treatment
with tranexamic acid, must be under strict supervision of a physician experienced in
treating this disorder.

Use in Pregnancy
Safety of use of tranexamic acid in pregnancy has not been established.

Use in Breastfeeding
Tranexamic acid is secreted into the mother's milk at a concentration of about one
hundredth of the corresponding serum level. Therefore, caution should be exercised
when administered to nursing mothers.

Use in Pediatrics
The drug has had limited use in pediatric patients, principally in connection with tooth
extraction. The limited data suggest that dosing instructions for adults can be used for
pediatric patients needing tranexamic acid therapy.

Use in Geriatrics
Clinical studies with tranexamic acid did not include sufficient numbers of subjects
aged 65 and over to determine whether they respond differently from younger
subjects. Other reported clinical experience has not identified differences in
responses between the elderly and younger patients. In general, dose selection for an
elderly patient should be cautious, usually starting at the low end of the dosing range,
reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and
of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic
reactions to this drug may be greater in patients with impaired renal function. Because
elderly patients are more likely to have decreased renal function, care should be taken
in dose selection, and it may be useful to monitor renal function.

Adverse Reactions
Occasionally gastrointestinal disturbances (nausea, vomiting, diarrhea), which
usually disappear on reduction of the dose.
Giddiness and hypotension have been reported occasionally.
Rare instances of color vision disturbances have been reported.
Rare cases of thromboembolic events have been reported.
Rare cases of allergic skin reactions have also been reported. There have been rare
cases of retinal/artery occlusion reported.

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Hypotension has been observed when intravenous injection is too rapid. To avoid
this response, the solution should not be injected more rapidly than 1 ml per minute.
This adverse reaction had not been reported with oral administration.

Precautions
Caution should be exercised in patients with hepatic, cardiac or renal insufficiency,
and in massive hematuria from the upper urinary tract. Ureteral obstruction due to clot
formation in patients with upper urinary tract bleeding has been reported in patients
treated with tranexamic acid.
Caution should also be exercised in patients exhibiting a thrombotic tendency
(patients may be at increased risk for venous or arterial thrombosis), even if an
anticoagulant is administered simultaneously. Venous and arterial thrombosis or
thromboembolism has been reported in patients treated with tranexamic acid.
In addition, cases of central retinal artery and central retinal vein obstruction have
been reported.
Treatment should be discontinued if disturbances in color vision arise.
Tranexamic acid should be withdrawn if the patient develops muscle pain or
weakness.
Caution should be exercised in patients who have undergone transurethral
prostatectomy since intravascular clotting may occur, following pre- and post-
operative tranexamic acid therapy to reduce blood loss.
Patients with irregular menstrual bleeding should not use tranexamic acid until the
cause of irregular bleeding has been established. If menstrual bleeding is not
adequately reduced by tranexamic acid, an alternative treatment should be
considered.

Drug Interactions
Tranexamic Acid/Anti-Inhibitor Coagulant Complex or Factor IX Complex: Although
tranexamic acid is often used in conjunction with clotting factor replacement for the
perisurgical management of hemophilic patients, concurrent use may increase the risk
of thrombotic complications. Some hematologists recommend that administration of
tranexamic acid be delayed for 8 hours following injection of either of the clotting
factor complexes.
Tranexamic Acid/Oral Contraceptives, Estrogen-Containing, or Estrogens: Concurrent
use with tranexamic acid may increase the potential for thrombus formation.
Tranexamic Acid/Thrombolytic agents: The actions of tranexamic acid and of
thrombolytic agents e.g., tissue-type plasminogen activator, streptokinase, or
urokinase are mutually antagonistic; although controlled studies to demonstrate its
efficacy have not been done in humans, tranexamic acid may be useful in treating
severe hemorrhage caused by a thrombolytic agent.

Dosage and Administration
Parenteral drug products should be inspected visually for particulate matter and
discoloration prior to administration, whenever solution and container permit.

Note: Intravenous administration is necessary only if it is difficult to give adequate
doses orally.

The blood levels of tranexamic acid are increased in patients with renal
insufficiency. Therefore doses should be reduced in renal impairment.
Rapid intravenous injection should be avoided.

Adults
The recommended standard dosage is 5-10 ml intravenously, at a rate of
1 ml/minute, or 2-3 Hexakapron tablets, 2-3 times daily.

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For the indications listed below, specific recommendations are made as follows:

General Fibrinolysis
10 ml intravenously, 3-4 times daily.

Prostatectomy
5-10 ml by slow I.V. injection, every 8 hours (the first dose being administered
during the operation), for the first 3 days following surgery. Thereafter, 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, Hexakrapon tablets 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.

Epistaxis
Hexakapron injection may be applied topically to the nasal mucosa, either using a
spray or by soaking a gauze strip in the solution and then packing the nasal cavity.

Conization of the Cervix
1.5 g (3 ampoules), 3 times a day, for 12-14 days postoperatively.

Children
Dosage should be calculated according to body weight, either 25 mg/kg Hexakapron
tablets, or 10 mg/kg Hexakapron injection, intravenously.

Overdosage
There is no known case of overdosage with tranexamic acid tablets and injection.
Symptoms may be nausea, vomiting, orthostatic symptoms and/or hypotension.
Maintain a high fluid intake to promote renal excretion. There is a risk of thrombosis
in predisposed individuals. Anticoagulant treatment should be considered.

Pharmaceutical Precautions

Hexakapron Injection should not be mixed with blood and infusion solutions
containing penicillin.

Storage
Store below 25ºC.

Drug Registration Number: 102 60 20765

Manufacturer
Teva Pharmaceutical Works Private Limited Company,
Hungary