GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Enoxaparin Sodium Injection USP 20mg/0.2ml (Venoxtaj)
B. Enoxaparin Sodium Injection USP 30mg/0.3ml (Venoxtaj)
C. Enoxaparin Sodium Injection USP 40mg/0.4ml (Venoxtaj)
D. Enoxaparin Sodium Injection USP 60mg/0.6ml (Venoxtaj)
E. Enoxaparin Sodium Injection USP 80mg/0.8ml (Venoxtaj)
F. Enoxaparin Sodium Injection USP 100mg/1ml (Venoxtaj)
G. Enoxaparin Sodium Injection USP 120mg/0.8ml (Venoxtaj)
H. Enoxaparin Sodium Injection USP 150mg/1ml (Venoxtaj)
I. Enoxaparin Sodium Injection USP 300mg/3ml (Venoxtaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Enoxaparin Sodium Injection USP 20mg/0.2ml
Each Pre-filled Syringe contains:
Enoxaparin sodium USP……20mg
(Porcine derived)
Equivalent to 2,000 IU anti-Xa activity
Water for Injection USP…………….q.s

B. Enoxaparin Sodium Injection USP 30mg/0.3ml
Each Pre-filled Syringe contains:
Enoxaparin sodium USP……30mg
(Porcine derived)
Equivalent to 3,000 IU anti-Xa activity
Water for Injection USP…………….q.s

C. Enoxaparin Sodium Injection USP 40mg/0.4ml
Each Pre-filled Syringe contains:
Enoxaparin sodium USP……40mg
(Porcine derived)
Equivalent to 4,000 IU anti-Xa activity
Water for Injection USP…………….q.s

D. Enoxaparin Sodium Injection USP 60mg/0.6ml
Each Pre-filled Syringe contains:
Enoxaparin sodium USP……60mg
(Porcine derived)
Equivalent to 6,000 IU anti-Xa activity
Water for Injection USP…………….q.s


E. Enoxaparin Sodium Injection USP 80mg/0.8ml
Each Pre-filled Syringe contains:
Enoxaparin sodium USP……80mg
(Porcine derived)
Equivalent to 8,000 IU anti-Xa activity
Water for Injection USP…………….q.s

F. Enoxaparin Sodium Injection USP 100mg/1ml
Each Pre-filled Syringe contains:
Enoxaparin sodium USP……100mg
(Porcine derived)
Equivalent to 10,000 IU anti-Xa activity
Water for Injection USP…………….q.s

G. Enoxaparin Sodium Injection USP 120mg/0.8ml
Each Pre-filled Syringe contains:
Enoxaparin sodium USP……120mg
(Porcine derived)
Equivalent to 12,000 IU anti-Xa activity
Water for Injection USP…………….q.s

H. Enoxaparin Sodium Injection USP 150mg/1ml
Each syringe contains:
Enoxaparin sodium USP……150mg
(Porcine derived)
Equivalent to 15,000 IU anti-Xa activity
Water for Injection USP…………….q.s

I. Enoxaparin Sodium Injection USP 300mg/3ml
Each multidose cartridge contains:
Enoxaparin sodium USP……300mg
(Porcine derived)
Equivalent to 30,000 IU anti-Xa activity
Benzyl alcohol USP…………………….15mg
(As a Preservative)
Water for Injection USP…………….q.s to 3ml

THERAPEUTIC INDICATIONS:

Enoxaparin injection is used to prevent deep venous thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and can become lodged in the blood vessels of the lungs, causing a condition called pulmonary embolism.

DIRECTION OF USE:

For Subcutaneous Injection Intravascular route during hemodialysis.
See package insert for dosage information and direction for use.

CAUTION & WARNING:

CAUTION:
• Do not use in case any foreign particulate matter is observed inside the vial.
• The content of Multi-Dose Enoxaparin Cartridge should be used within 28 days after the first use.
• Do not inject Intramuscularly.
• Do not use later than the date of expiry.
• KEEP OUT OF REACH AND SIGHT OF CHILDREN.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store below 25°C.
Do not freeze pre-filled syringe.
Dosage: As directed by the Physician.

Enoxaparin Sodium Injection USP 60mg/0.6ml Technical Specification:

Product Name:Enoxaparin Sodium Injection USP
(Low Molecular Weight Heparin)
Brand Name:Venoxtaj
Strength:20mg/0.2ml,  30mg/0.3ml,  40mg/0.4ml,  60mg/0.6ml80mg/0.8ml,  100mg/1ml,  120mg/0.8ml,  150mg/1ml, 300mg/3ml
Dosage Form:Liquid Injection
Packing:1 Pre-filled Syringe
Route of Administration:For Subcutaneous Injection, Intravascular route during hemodialysis.
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Coagulant
Indication: Enoxaparin injection is used to prevent deep venous thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and can become lodged in the blood vessels of the lungs, causing a condition called pulmonary embolism.
Storage:Store below 25°C. Do not freeze pre-filled syringe.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Enoxaparin Sodium Injection USP 60mg/0.6ml (Venoxtaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Enoxaparin Sodium Injection USP 60mg/0.6ml
    Each pre-filled syringe contains:
    Enoxaparin Sodium USP…..60mg
    (Porcine derived)
    Equivalent to 6,000 IU anti-Xa activity
    Water for Injection USP……q.s

THERAPEUTIC INDICATION:

Enoxaparin injection is used to prevent deep venous thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and can become lodged in the blood vessels of the lungs, causing a condition called pulmonary embolism.

DIRECTION OF USE:

For Subcutaneous route, Intravascular route during hemodialysis.
For further information, see enclosed package insert.

CAUTION AND WARNING:

CAUTION:

  • Do not use in case any foreign particulate matter is observed inside the vial.
  • The content of Multi-Dose Enoxaparin Cartridge should be used within 28 days after the first use.
  • Do not inject Intramuscularly.
  • Do not use later than the date of expiry.
  • KEEP OUT OF REACH AND SIGHT OF CHILDREN.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C.
Do not freeze pre-filled syringe.

DOSAGE: As directed by the Physician.