FRAGMIN (dalteparin sodium) Dosage Forms, Composition And Packaging

Medical Information
Canada
 

In order to provide you with relevant and meaningful content we need to know more about you.

Please choose the category that best describes you.

This content is intended for Canadian Healthcare Professionals. Would you like to proceed?

Dosage forms

Solution for injection 10 000 IU (anti-factor Xa)/mL, ampoules 10 x 1 mL.
Solution for injection 25 000 IU (anti-factor Xa)/mL, 3.8 mL multi-dose vials.

Solution for injection 2 500 IU (anti-factor Xa)/0.2 mL, single dose syringes* 10 x 0.2 mL
Solution for injection 3 500 IU (anti-factor Xa)/0.28 mL, single dose syringes* 10 x 0.28 mL
Solution for injection 5 000 IU (anti-factor Xa)/0.2 mL, single dose syringes* 10 x 0.2 mL
Solution for injection 7 500 IU (anti-factor Xa)/0.3 mL, single dose syringes*, packages of 5
Solution for injection 10 000 IU (anti-factor Xa)/0.4 mL, single dose syringes*, packages of 5
Solution for injection 12 500 IU (anti-factor Xa)/0.5 mL, single dose syringes*, packages of 5
Solution for injection 15 000 IU (anti-factor Xa)/0.6 mL, single dose syringes*, packages of 5
Solution for injection 16 500 IU (anti-factor Xa)/0.66 mL, single dose syringes*, packages of 5
Solution for injection 18 000 IU (anti-factor Xa)/0.72 mL, single dose syringes*, packages 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 14:
Solution for injection: 1 mL

Dalteparin 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 15:
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.

0-2.7mg

-

-

-

-

-

-

-

Hydrochloric acid

pH adjustment

pH adjustment

pH adjustment

pH adjustment

pH adjustment

pH adjustment

pH adjustment

pH adjustment

pH adjustment

Sodium Hydroxide

pH adjustment

pH adjustment

pH adjustment

pH adjustment

pH adjustment

pH adjustment

pH adjustment

pH adjustment

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).

 

Control #: 230388
July 14, 2020