Fraxiparine solution for injection

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

nadroparin calcium

Disponibil de la:

Aspen Notre Dame de Bondeville

Codul ATC:

B01AB06

INN (nume internaţional):

nadroparin calcium

Dozare:

5700IU AXa/0,6ml

Forma farmaceutică:

solution for injection

Unități în pachet:

(10) pre-filled syringes 0,6ml

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2019-12-17

Prospect

FRAXIPARINE™/FRAXIPARINE FORTE™/FRAXODI™
NADROPARIN
QUALITATIVE AND QUANTITATIVE COMPOSITION
_FRAXIPARINE_ [NADROPARIN CALCIUM SOLUTION FOR INJECTION (9,500
ANTI-XA IUPH.EUR./ML)]
_PRE-FILLED SYRINGES: _
- 0.2 ml of solution equivalent to 1,900 anti-Xa IU
- 0.3 ml of solution equivalent to 2,850 anti-Xa IU
- 0.4 ml of solution equivalent to 3,800 anti-Xa IU.
_GRADUATED PRE-FILLED SYRINGES: _
- 0.6 ml of solution equivalent to 5,700 anti-Xa IU
- 0.8 ml of solution equivalent to 7,600 anti-Xa IU
- 1 ml of solution equivalent to 9,500 anti-Xa IU.
_MULTI DOSE VIALS: _
-
2 ml of solution equivalent to 19,000 anti-Xa IU
-
5 ml of solution equivalent to 47,500 anti-Xa IU
-
15 ml of solution equivalent to 142,500 anti-Xa IU.
_FRAXIPARINE FORTE AND FRAXODI [NADROPARIN CALCIUM DOUBLE STRENGTH
SOLUTION FOR _
_INJECTION (19,000 ANTI-XA IU PH.EUR./ML)] _
_GRADUATED PRE-FILLED SYRINGES: _
- 0.6 ml of solution equivalent to 11,400 anti-Xa IU
- 0.8 ml of solution equivalent to 15,200 anti-Xa IU
- 1 ml of solution equivalent to 19,000 anti-Xa IU.
_MULTI-DOSE VIALS: _
-
5 ml of solution equivalent to 95,000 anti-Xa IU.
-
15 ml of solution equivalent to 285,000 anti-Xa IU.
PHARMACEUTICAL FORM
Solution for injection.
CLINICAL PARTICULARS
INDICATIONS
_FRAXIPARINE [NADROPARIN CALCIUM SOLUTION FOR INJECTION (9,500 ANTI-XA
IU/ML)] _
The prophylaxis of thromboembolic disorders, such as:
-
those associated with general or orthopaedic surgery
-
those in high risk medical patients (respiratory failure and/or
respiratory infection and/or
cardiac failure), hospitalised in intensive care unit.
The treatment of thromboembolic disorders.
The prevention of clotting during haemodialysis.
The treatment of unstable angina and non-Q wave myocardial infarction.
_FRAXIPARINE FORTE AND FRAXODI [NADROPARIN CALCIUM DOUBLE STRENGTH
SOLUTION FOR _
_INJECTION (19,000 ANTI-XA IU/ML)] _
The treatment of thromboembolic disorders.
DOSAGE AND ADMINISTRATION
Particular attention should be paid to the specific dosing
instructions for each proprietary Low
Mole

Caracteristicilor produsului

1
SUMMARY OF PRODUCT CHARACTERISTICS
FRAXIPARINE™/FRAXIPARINE FORTE™/FRAXODI™
NADROPARIN
QUALITATIVE AND QUANTITATIVE COMPOSITION
_FRAXIPARINE_
_™ _
[NADROPARIN CALCIUM SOLUTION FOR INJECTION (9,500 ANTI-XA
IUPH.EUR./ML)]
_PRE-FILLED SYRINGES: _
_ _
-
0.2 ml of solution equivalent to 1,900 anti-Xa IU
-
0.3 ml of solution equivalent to 2,850 anti-Xa IU
-
0.4 ml of solution equivalent to 3,800 anti-Xa IU.
_GRADUATED PRE-FILLED SYRINGES: _
_ _
-
0.6 ml of solution equivalent to 5,700 anti-Xa IU
-
0.8 ml of solution equivalent to 7,600 anti-Xa IU
-
1 ml of solution equivalent to 9,500 anti-Xa IU.
_MULTI DOSE VIALS: _
_ _
-
2 ml of solution equivalent to 19,000 anti-Xa IU
-
5 ml of solution equivalent to 47,500 anti-Xa IU
-
15 ml of solution equivalent to 142,500 anti-Xa IU.
_FRAXIPARINE FORTE_
_™ _
AND _FRAXODI_
_™ _
[NADROPARIN CALCIUM DOUBLE STRENGTH
SOLUTION FOR INJECTION (19,000 ANTI-XA IU PH.EUR./ML)]
_GRADUATED PRE-FILLED SYRINGES: _
_ _
-
0.6 ml of solution equivalent to 11,400 anti-Xa IU
-
0.8 ml of solution equivalent to 15,200 anti-Xa IU
-
1 ml of solution equivalent to 19,000 anti-Xa IU.
_MULTI-DOSE VIALS: _
_ _
-
5 ml of solution equivalent to 95,000 anti-Xa IU.
-
15 ml of solution equivalent to 285,000 anti-Xa IU.
PHARMACEUTICAL FORM
Solution for injection.
2
CLINICAL PARTICULARS
INDICATIONS
_FRAXIPARINE [NADROPARIN CALCIUM SOLUTION FOR INJECTION (9,500 ANTI-XA
IU/ML)] _
_ _
The prophylaxis of thromboembolic disorders, such as:
-
those associated with general or orthopaedic surgery
-
those in high risk medical patients (respiratory failure and/or
respiratory infection
and/or cardiac failure), hospitalised in intensive care unit.
The treatment of thromboembolic disorders.
The prevention of clotting during haemodialysis.
The treatment of unstable angina and non-Q wave myocardial infarction.
_FRAXIPARINE FORTE _AND _FRAXODI [NADROPARIN CALCIUM DOUBLE STRENGTH _
_SOLUTION FOR INJECTION (19,000 ANTI-XA IU/ML)] _
_ _
The treatment of thromboembolic disorders.
DOSAGE AND ADMINISTRATION
Particular at