Source: European Medicines Agency (EU)
Clivarin 5726 IU anti-Xa/ml, solution for injection, in prefilled syringe.
Clivarin 1432 IU anti-Xa/0.25ml, solution for injection, in prefilled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection in prefilled syringe. Clear, colourless to slightly yellowish, solution. |
1 ml solution contains: reviparin sodium 5726 IU anti-Xa.
0.25 ml contains: reviparin-sodium 1432 IU anti-Xa.
0.6 ml contains: reviparin-sodium 3436 IU anti-Xa.
0.9 ml contains: reviparin-sodium 5153 IU anti-Xa.
This medicinal product contains 80 mg of sodium per ml solution.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Reviparin |
Reviparin is a low molecular weight heparin and in clinical terms its action on blood coagulation is the most important biological effect. Reviparin is involved in different phases of blood coagulation. Because of its marked inhibitory action on factor Xa and comparatively low level of anti IIa activity, low molecular weight heparin is at its most active during the preliminary stages of coagulation. |
| List of Excipients |
|---|
|
Sodium chloride |
Available in the following pack sizes:
Clivarin 1432 IU anti-Xa/0.25 ml, solution for injection in prefilled syringe:
2 × 0.25 ml (0.25 ml = 1432 IU anti-Xa) – ungraduated syringe
5 × 0.25 ml (0.25 ml = 1432 IU anti-Xa) – ungraduated syringe
10 × 0.25 ml (0.25 ml = 1432 IU anti-Xa) – ungraduated syringe
20 × 0.25 ml (0.25 ml = 1432 IU anti-Xa) – ungraduated syringe
100 × 0.25 ml (0.25 ml = 1432 IU anti-Xa) – ungraduated syringe
Clivarin 5726 IU anti-Xa/ml solution for injection in prefilled syringe:
2 × 0.6 ml (0.6 ml = 3436 IU anti-Xa) – graduated syringe
5 × 0.6 ml (0.6 ml = 3436 IU anti-Xa) – graduated syringe*
10 × 0.6 ml (0.6 ml = 3436 IU anti-Xa) – graduated syringe*
20 × 0.6 ml (0.6 ml = 3436 IU anti-Xa) – graduated syringe*
100 × 0.6 ml (0.6 ml = 3436 IU anti-Xa) – graduated syringe*
2 × 0.9 ml (0.9 ml= 5153 IU anti-Xa) - graduated syringe*
5 × 0.9 ml (0.9 ml = 5153 IU anti-Xa) - graduated syringe*
10 × 0.9 ml (0.9 ml = 5153 IU anti-Xa) - graduated syringe*
20 × 0.9 ml (0.9 ml = 5153 IU anti-Xa) - graduated syringe*
100 × 0.9 ml (0.9 ml = 5153 IU anti-Xa) - graduated syringe*
Prefilled syringe (ungraduated and graduated) type I glass with a stainless steel needle. Inner needle shield of natural rubber (latex) or polyisoprene based rubber (latex free). Outer needle shield of polypropylene and a plunger of polypropylene or polycarbonate. Optional ultrasafe passive delivery system.
Not all pack sizes may be marketed.
* Syringe is marked with 0.05 ml graduations
Clivarin 5726 IU anti-Xa/ml (0.6ml/0.9ml): DE/H/2865/002
Clivarin 1432 IU anti-Xa/0.25ml: DE/H/2865/001
Clivarin 5726 IU anti-Xa/ml: 2005-02-17/2010-02-17
Clivarin 1432 IU anti-Xa/0.25ml: 1995-03-15//2010/03-15
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