HEPARIN SODIUM PANPHARMA 5000 IUML

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

HEPARIN SODIUM

Διαθέσιμο από:

PHARMALOGIC LTD

Φαρμακολογική κατηγορία (ATC):

B01AB01

Φαρμακοτεχνική μορφή:

SOLUTION FOR INJECTION / INFUSION

Σύνθεση:

HEPARIN SODIUM 5000 IU/ML

Οδός χορήγησης:

I.V, S.C

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

PANPHARMA GMBH, GERMANY

Θεραπευτική ομάδα:

HEPARIN

Θεραπευτική περιοχή:

HEPARIN

Θεραπευτικές ενδείξεις:

• Prevention of thromboembolic disorders• As part of the treatment of venous or arterial thromboembolic disorders (including the early treatment of heart attacks as well as unstable angina pectoris)• For anticoagulation during treatment or operation with an extracorporeal circulation (e.g. heart/lung machine, hemodialysis)

Ημερομηνία της άδειας:

2021-07-31

Φύλλο οδηγιών χρήσης

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
:
__________
20 -07-14
__
___________
םושירה רפסמו תילגנאב רישכת םש :
5000
UNITS/ML _ , HEPARIN I NJECTION BP 134-95-31229
םושירה לעב םש
:
KAMADA LTD
! דבלב תורמחהה טורפל דעוימ הז ספוט
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
NAME OF THE
MEDICINAL PRODUCT
SOLUTION FOR INJECTION
.
Active ingredient: Heparin Sodium
25000 I.U. / 5 ML, SOLUTION FOR INJECTION
PHARMACEUTICAL
FORM
Clear colourless to slightly yellowish aqueous
solution
POSOLOGY AND
METHOD OF
ADMINISTRATION
2. As part of the treatment of venous and
artery thrombo-embolic diseases
A close therapy control with the
determination of the coagulation parameters
is required in any case.
3) Anti-coagulation in a treatment or surgery
involving extra-corporeal circulation:
Note
For the determination of the coagulation
values the blood must be centrifuged
immediately.
METHOD OF ADMINISTRATION
The duration of the application is to be
determined by the treating physician.
Regular controls of the activated partial
thromboplastin time (aPTT) as well as
control of the platelet count (see also section
4.4) are necessary in treatment with heparin.
_METHOD OF ADMINISTRATION_
_Infusion:_
HEPARIN INJECTION BP 5000 UNITS/ML can be diluted
for intravenous infusion with the solutions outlined in
section 6.6. In order to reduce lymphatic drainage disorders,
HEPARIN INJECTION BP 5000 UNITS/ML should be
administered to patients undergoing abdominal/urogenital
lymphatic drainage into the upper arm.
CONTRAINDICATIONS
Heparin INJECTION BP 5000
UNITS/ML should not be used in
case of:

Patients with present or previous
thrombocytopenia (type II) caused by
heparin
HEPARIN INJECTION BP 5000 UNITS/MLmust
not be administered in the following cases:
-
heparin-induced thrombocy

Αρχείο Π.Χ.Π.

1.
NAME OF THE MEDICINAL PRODUCT
HEPARIN SODIUM PANPHARMA 5,000 IU/ML
25,000 IU/5 ml, solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
Heparin sodium (pork intestinal mucosa) 5,000 IU
_Other excipients: _
1 ml injectable solution contains 10 mg benzyl alcohol.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear colourless to slightly yellowish aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Prevention of thromboembolic disorders

As part of the treatment of venous or arterial thromboembolic
disorders
(including the early treatment of heart attacks as well as unstable
angina
pectoris)

For anticoagulation during treatment or operation with an
extracorporeal
circulation (e.g. heart/lung machine, hemodialysis)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Heparin sodium must be individually dosed. The dosage depends on the
coagulation
parameters nature and course of the disease, patient’s response,
adverse reactions,
patient’s weight and age. Differences in sensitivity to heparin and
a possible change in
heparin tolerance during the course of treatment need to be
considered.
PROPHYLAXIS OF THROMBOEMBOLISM (LOW-DOSE TREATMENT)
Subcutaneous injection is recommended for the prophylaxis of
thromboembolism. Pre-
filled syringes with an appropriate dosage are available for this.

_Pre- and postoperative prophylaxis of thromboembolism _
Preoperatively 5,000-7,500 IU subcutaneously approximately 2 hours
before the
operation. Postoperatively, depending on the risk of thrombosis,
usually 5,000
IU subcutaneously every 8-12 hours or 7,500 IU subcutaneously every 12
hours
until the patient is mobilized or until vitamin K antagonists have an
adequate
effect. Laboratory monitoring (coagulation parameters) for dose
adjustment may
be required in individual cases.

_Prophylaxis in non-surgical medicine_
(e.g. prolonged bed rest, increased
thrombotic tendency in the patient, d