FRAGMIN 6 Dosage Forms, Strengths, Composition And Packaging

dalteparin sodium

(
Table 5 – Dosage Forms, Strengths, Composition and Packaging
Route of 
Administration		Dosage Form / Strength/ CompositionNon-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 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 acidpH adjustmentpH adjustment
Sodium hydroxidepH adjustmentpH adjustment
Water for injectionad 1 mLad 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 sodium2 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-XaAnti-XaAnti-XaAnti-XaAnti-XaAnti- XaAnti- XaAnti- XaAnti- 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).

)

Find FRAGMIN medical information:

Find FRAGMIN medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

FRAGMIN Quick Finder

Product Monograph
Download Product Monograph

Health Professional Information

6 Dosage Forms, Strengths, Composition And Packaging

Table 5 – Dosage Forms, Strengths, Composition and Packaging
Route of 
Administration		Dosage Form / Strength/ CompositionNon-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 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 acidpH adjustmentpH adjustment
Sodium hydroxidepH adjustmentpH adjustment
Water for injectionad 1 mLad 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 sodium2 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-XaAnti-XaAnti-XaAnti-XaAnti-XaAnti- XaAnti- XaAnti- XaAnti- 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).

Resources

Didn’t find what you were looking for? 

Contact us

Call 1-800-463-6001*

*Contact Medical Information. 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: 1 866 723-7111.

To report an adverse event related to COMIRNATY, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

Canada Vigilance Program 

You may also contact the Canada Vigilance Program directly to report adverse events or product quality concerns at 1-866-234-2345 or www.healthcanada.gc.ca/medeffect.