Enoxaparin Sodium Injection IP 80mg/0.8ml (Venoxtaj) (Low Molecular Weight Heparin)

GENERIC NAME OF MEDICINAL PRODUCT:

A. Enoxaparin Sodium Injection IP 20mg/0.2ml
B. Enoxaparin Sodium Injection IP 40mg/0.4ml
C. Enoxaparin Sodium Injection IP 60mg/0.6ml
D. Enoxaparin Sodium Injection IP 80mg/0.8ml
E. Enoxaparin Sodium Injection IP 100mg/1ml
F. Enoxaparin Sodium Injection IP 300mg/3ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Enoxaparin Sodium Injection IP 20mg/0.2ml
Each pre-filled syringe contains:
Enoxaparin Sodium IP…..20mg
(Porcine derived)
Equivalent to 2,000 IU anti-Xa activity
Water for Injection IP……q.s

2. Enoxaparin Sodium Injection IP 40mg/0.4ml
Each 0.4ml contains:
Enoxaparin Sodium IP…..40mg
(Porcine derived)
Equivalent to 4,000 IU anti-Xa activity
Water for Injection IP……q.s

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

4. Enoxaparin Sodium Injection IP 80mg/0.8ml
Each 0.8ml contains:
Enoxaparin Sodium IP…..80mg
(Porcine derived)
Equivalent to 8,000 IU anti-Xa activity
Water for Injection IP……q.s

5. Enoxaparin Sodium Injection IP 100mg/ml
Each ml contains:
Enoxaparin Sodium IP…..100mg
(Porcine derived)
Equivalent to 10,000 IU anti-Xa activity
Water for Injection IP……q.s

6. Enoxaparin Sodium Injection IP 300mg/3ml
Each multidose cartridge contains:
Enoxaparin sodium IP……300mg
(Porcine derived)
Equivalent to 30,000 IU anti-Xa activity
Benzyl alcohol IP…………………….1.5%w/v
(As a Preservative)
Water for Injection IP…………….q.s to 3ml

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 SCHEDULE:

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.
SCHEDULE: SCHEDULE 'H PRESCRIPTION DRUG-CAUTION 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.

Enoxaparin Sodium Injection IP 80mg/0.8ml Technical Specification:

Product Name:Enoxaparin Sodium Injection IP
(Low Molecular Weight Heparin)
Brand Name:Venoxtaj
Strength:20mg/0.2ml,   40mg/0.4ml,   60mg/0.6ml,   80mg/0.8ml,   100mg/ml,  300mg/3ml
Dosage Form:Liquid Injection
Packing:1 Pre-filled Syringe
Route of Administration:For Subcutaneous route, Intravascular route during hemodialysis.
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
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 MEDICINAL PRODUCT:

  • Enoxaparin Sodium Injection IP 80mg/0.8ml (Venoxtaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Enoxaparin Sodium Injection IP 80mg/0.8ml
    Each pre-filled syringe contains:
    Enoxaparin Sodium IP…..80mg
    (Porcine derived)
    Equivalent to 8,000 IU anti-Xa activity
    Water for Injection IP……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 SCHEDULE:

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.

SCHEDULE: SCHEDULE ‘H PRESCRIPTION DRUG-CAUTION 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.