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Table 5 – Dosage Forms, Strengths, Composition and PackagingRoute of
Administration | Dosage Form / Strength/ Composition | Non-medicinal Ingredients |
|---|
Subcutaneous injection (s.c.)
or
intravenous infusion (i.v.) | Solution Ampoule:
10 000 IU (anti-factor Xa)/1 mL;
Multi-Dose Vial:
25 000 IU (anti-factor Xa)/mL 3.8 mL
Prefilled syringe with safety needle device
2 500 IU (anti-factor Xa)/0.2 mL
3500 IU (anti-factor Xa)/0.28 mL
5 000 IU (anti-factor Xa)/0.2 mL
7 500 IU (anti-factor Xa)/0.3 mL
10 000 IU (anti-factor Xa)/0.4 mL
12 500 IU (anti-factor Xa)/0.5 mL
15 000 IU (anti-factor Xa)/0.6 mL
16 500 IU (anti-factor Xa)/0.66 mL
18 000 IU (anti-factor Xa)/0.72 mL | Benzyl alcohol in Multi-Dose vial only. |
Dosage forms
Solution for injection, 10 000 IU (anti-factor Xa)/mL, 1 mL ampoule, package of 10.
Solution for injection, 25 000 IU (anti- factor Xa)/mL, 3.8 mL multi-dose vial, package of 1.
Solution for injection, 2 500 IU (anti- factor Xa)/0.2 mL, single dose 0.5 mL syringe*, package of 10
Solution for injection, 3 500 IU (anti- factor Xa)/0.28 mL, single dose 0.5 mL syringe*, package of 10
Solution for injection, 5 000 IU (anti- factor Xa)/0.2 mL, single dose 0.5 mL syringe*, package of 10
Solution for injection, 7 500 IU (anti- factor Xa)/0.3 mL, single dose 0.5 mL syringe*, package of 5
Solution for injection, 10 000 IU (anti- factor Xa)/0.4 mL, single dose 1 mL syringe*, package of 5
Solution for injection, 12 500 IU (anti- factor Xa)/0.5 mL, single dose 1 mL syringe*, package of 5
Solution for injection, 15 000 IU (anti- factor Xa)/0.6 mL, single dose 1 mL syringe*, package of 5
Solution for injection, 16 500 IU (anti-factor Xa)/0.66 mL, single dose 1 mL syringe*, package of 5
Solution for injection, 18 000 IU (anti- factor Xa)/0.72 mL, single dose 1 mL syringe*, package of 5
* Prefilled syringe with safety needle device: clear glass barrel with stainless steel needle (27 G 1/2") and preassembled with safety needle guard device.
Fragmin may be administered subcutaneously (s.c.) or intravenously (i.v.)
Composition
Table 6 - Solution for injection: 1 mLDalteparin sodium
(Low molecular weight heparin sodium) | Ampoule
10 000 IU(anti-Xa) | Multi-dose vial
25 000 IU(anti-Xa) |
|---|
| Sodium chloride* | q.s. | - |
| Benzyl alcohol | - | 14 mg |
| Hydrochloric acid | pH adjustment | pH adjustment |
| Sodium hydroxide | pH adjustment | pH adjustment |
| Water for injection | ad 1 mL | ad 1 mL |
* The hypotonicity is adjusted with sodium chloride. The amount is calculated from the result of the osmolality/anti-Xa activity.
|
Table 7 - Prefilled Syringe with Safety Needle Device| Dalteparin sodium | 2 500
IU/
0.2 mL | 3 500
IU/
0.28 mL | 5 000
IU/
0.2 mL | 7 500
IU/
>0.3 mL | 10 000
IU/
0.4 mL | 12 500
IU/
0.5 mL | 15 000
IU/
0.6 mL | 16 500
IU/
0.66 mL | 18 000
IU/
0.72 mL |
| LMWH* | Anti-Xa | Anti-Xa | Anti-Xa | Anti-Xa | Anti-Xa | Anti- Xa | Anti- Xa | Anti- Xa | Anti- Xa |
| Sodium chloride** | q.s. | 0-2.7
mg | - | - | - | - | - | - | - |
| Hydrochloric acid | pH adjustment |
| Sodium Hydroxide | pH adjustment |
Water for injection
| ad 0.2 mL
| ad 0.28 mL
| ad 0.2 mL
| ad 0.3 mL
| ad 0.4 mL
| ad 0.5 mL
| ad 0.6 mL
| ad 0.66 mL
| ad 0.72 mL
|
* Low Molecular Weight Heparin Sodium ** -
The hypotonicity is adjusted with sodium chloride. The amount is calculated from the result of the osmolality/anti-Xa activity.
|
Potency: Potency is described in International anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, weight average molecular weight 6000 Daltons, corresponds to the activity of one unit of the 1st International Standard for LMWH with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-α-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA •2HCl).
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