PHAREPA 25000 I.U 5 ML

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

HEPARIN SODIUM

Saatavilla:

PROPHARM LTD

ATC-koodi:

C05BA03

Lääkemuoto:

SOLUTION FOR INJECTION / INFUSION

Koostumus:

HEPARIN SODIUM 5000 IU/ML

Antoreitti:

I.V

Prescription tyyppi:

Required

Valmistaja:

FISIOPHARMA S.R.L, ITALY

Terapeuttinen alue:

HEPARIN

Käyttöaiheet:

•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)

Valtuutus päivämäärä:

2020-08-25

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_PHAREPA 25,000 IU/5 ML _
Solution for injection or infusion.
For intravenous injection or intravenous infusion after dilution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 5 ml solution for injection or infusion contains 25,000
IU of
heparin sodium.
Excipient with known effect: sodium, methyl p-hydroxybenzoate and
propyl p-
hydroxybenzoate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear solution, visible particles free.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
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, haemodialysis)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Dosage _
Heparin sodium must be individually dosed.
The dosage depends on the coagulation 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.
TREATMENT OF VENOUS OR ARTERIAL THROMBOEMBOLIC DISORDERS
Continuous intravenous administration is recommended if there are
clots in
blood vessels.
Dosage in adults
Generally start with 5000 IU heparin sodium as an intravenous bolus,
followed
by a continuous infusion of 1000 IU heparin sodium per hour using an
infusion
pump.
Dosage in children
Initially 50 IU/kg body weight, then 20 IU/kg body weight per hour.
If a continuous intravenous infusion is not possible, other heparin
product may
be used as subcutaneously alternative.
THERAPY MONITORING
Close monitoring of therapy accompanied by assay of coagulation
parameters
is absolutely essential in all cases. Monitoring of therapy and dose
adjustment
are generally based on activated partial thromboplastin