Arixtra 5mg/ml solution for injection

Country: Armenja

Lingwa: Ingliż

Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredjent attiv:

fondaparinux (fondaparinux sodium)

Disponibbli minn:

Aspen Notre Dame de Bondeville

Kodiċi ATC:

B01AX05

INN (Isem Internazzjonali):

fondaparinux (fondaparinux sodium)

Dożaġġ:

5mg/ml

Għamla farmaċewtika:

solution for injection

Unitajiet fil-pakkett:

(10) pre-filled syringes 0.5ml

Tip ta 'preskrizzjoni:

Prescription

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2015-07-31

Fuljett ta 'informazzjoni

ARIXTRA
™
Fondaparinux sodium (fondaparinux)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each syringe contains 2.5 mg of fondaparinux sodium in 0.5 ml solution
for injection.
The solution is a clear and colourless liquid.
Each syringe contains 5.0 mg of fondaparinux sodium in 0.4 ml solution
for injection.
The solution is clear and colourless to slightly yellow.
Each syringe contains 7.5 mg of fondaparinux sodium in 0.6 ml solution
for injection.
The solution is clear and colourless to slightly yellow.
Each syringe contains 10.0 mg of fondaparinux sodium in 0.8 ml
solution for injection.
The solution is clear and colourless to slightly yellow.
PHARMACEUTICAL FORM
Injectable solution for subcutaneous and intravenous use.
CLINICAL PARTICULARS
Indications
Prevention of Venous Thromboembolic Events (VTE) in patients
undergoing major orthopaedic surgery of the lower
limbs such as:
-
hip fracture, including extended prophylaxis;
-
knee replacement surgery;
-
hip replacement surgery.
Prevention of Venous Thromboembolic Events (VTE) in patients
undergoing abdominal surgery who are at risk of
thromboembolic complications.
Prevention of Venous Thromboembolic Events (VTE) in medical patients
who are at risk of thromboembolic
complications due to restricted mobility during acute illness.
Treatment of acute Deep Vein Thrombosis (DVT).
Treatment of acute Pulmonary Embolism (PE).
Treatment of unstable angina or non-ST segment elevation myocardial
infarction (UA/NSTEMI) acute coronary
syndrome for the prevention of death, myocardial infarction and
refractory ischaemia. _ARIXTRA_ has been shown to
reduce all cause mortality in patients with UA/NSTEMI.
Treatment of ST segment elevation myocardial infarction (STEMI) acute
coronary syndrome for the prevention of death
and myocardial re-infarction in patients who are managed with
thrombolytics or who initially are to receive no other
form of reperfusion therapy. _ARIXTRA_ has been shown to reduce all
cause mortality in patients with STEMI.
Dosage and Administration
Method of administr

Karatteristiċi tal-prodott

1
SUMMARY OF PRODUCT CHARACTERISTICS
ARIXTRA™ FONDAPARINUX SODIUM (FONDAPARINUX)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each syringe contains 2.5 mg of fondaparinux sodium in 0.5 ml solution
for injection. The solution
is a clear and colourless liquid.
Each syringe contains 5.0 mg of fondaparinux sodium in 0.4 ml solution
for injection. The solution
is clear and colourless to slightly yellow.
Each syringe contains 7.5 mg of fondaparinux sodium in 0.6 ml solution
for injection. The solution
is clear and colourless to slightly yellow.
Each syringe contains 10.0 mg of fondaparinux sodium in 0.8 ml
solution for injection. The solution
is clear and colourless to slightly yellow.
PHARMACEUTICAL FORM
Injectable solution for subcutaneous and intravenous use.
CLINICAL PARTICULARS
INDICATIONS
Prevention of Venous Thromboembolic Events (VTE) in patients
undergoing major orthopaedic
surgery of the lower limbs such as:
-
hip fracture, including extended prophylaxis;
-
knee replacement surgery;
-
hip replacement surgery.
Prevention of Venous Thromboembolic Events (VTE) in patients
undergoing abdominal surgery
who are at risk of thromboembolic complications.
Prevention of Venous Thromboembolic Events (VTE) in medical patients
who are at risk of
thromboembolic complications due to restricted mobility during acute
illness.
Treatment of acute Deep Vein Thrombosis (DVT).
Treatment of acute Pulmonary Embolism (PE).
2
Treatment of unstable angina or non-ST segment elevation myocardial
infarction (UA/NSTEMI)
acute coronary syndrome for the prevention of death, myocardial
infarction and refractory ischaemia.
_ARIXTRA_ has been shown to reduce all cause mortality in patients
with UA/NSTEMI.
Treatment of ST segment elevation myocardial infarction (STEMI) acute
coronary syndrome for the
prevention of death and myocardial re-infarction in patients who are
managed with thrombolytics or
who initially are to receive no other form of reperfusion therapy.
_ARIXTRA_ has been shown to reduce
all cause mortality in patients with STEMI.
DOSAGE