GENERIC NAME OF MEDICINAL PRODUCT:

A. Vecuronium Bromide for Injection IP 20mg
B. Vecuronium Bromide for Injection IP 10mg
C. Vecuronium Bromide for Injection IP 4mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Vecuronium Bromide for Injection IP 20mg
Each vial contains:
Vecuronium Bromide IP………20mg
Citric Acid IP
Anhydrous Citric Acid ………………2.075mg
Dibasic Sodium Phosphate IP
Equivalent to Anhydrous
Dibasic Sodium Phosphate ………….1.625mg
Mannitol IP………………………………………9.7mg
This pack is also contains:
1 ampoule of Sterile Water for Injections IP…20ml

2. Vecuronium Bromide for Injection IP 10mg
Each vial contains:
Vecuronium Bromide IP………10mg
Citric Acid IP
Anhydrous Citric Acid ………………2.075mg
Dibasic Sodium Phosphate IP
Equivalent to Anhydrous
Dibasic Sodium Phosphate ………….1.625mg
Mannitol IP………………………………………9.7mg
This pack is also contains:
1 ampoule of Sterile Water for Injections IP…10ml

3. Vecuronium Bromide for Injection IP 4mg
Each vial contains:
Vecuronium Bromide IP………4mg
Citric Acid IP
Anhydrous Citric Acid ………………2.075mg
Dibasic Sodium Phosphate IP
Equivalent to Anhydrous
Dibasic Sodium Phosphate ………….1.625mg
Mannitol IP………………………………………9.7mg
This pack is also contains:
1 ampoule of Sterile Water for Injections IP…5ml

THERAPEUTIC INDICATION:

Vecuronium bromide is a peripherally acting, monoquarternary, steroidal, non-depolarizing neuromuscular blocker with an intermediate duration of action used during general anesthesia to facilitate endotracheal intubation, to aid in surgical relaxation, and, less commonly, in the intensive care setting to achieve paralysis to facilitate mechanical ventilation for adequately sedated patients.

DIRECTION OF USE:

• For Intravenous Infusion only.
• Reconstitute to by adding Sterile Water for Injections I.P. and use immediately after preparation if it is clear.
• For the detail of the Sterile Water for Injection refer the insert.
Read enclosed prescribing information.

CAUTION AND SCHEDULE:

CAUTION:
• Paralysing agent may cause paralysis of respiratory muscles as well leading to respiratory arrest. Facilities must be immediately available for artificial respiration.
• After reconstitute, do not use in case any foreign particulate matter is observed inside the vial.
• Reconstituted solution should be use immediately after preparation.
• Discard unused portion.
• FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
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 between 15°C and 25°C preferably in a refrigerator.
Protect from light.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
DOSAGE: As directed by the Physician.

Vecuronium Bromide for Injection IP 4mg Technical Specification:

Product Name:Vecuronium Bromide for Injection IP
Brand Name:Generic
Strength:10mg, 4mg, 20mg
Dosage Form:Lyophilized Powder for Injection
Packing:1 Single Dose Vial/Ampoule + 1WFI Tray
Route of Administration:For I.V. Infusion only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Neuromuscular Blockers, Nondepolarizing
Indication: Vecuronium bromide is a peripherally acting, monoquarternary, steroidal, non-depolarizing neuromuscular blocker with an intermediate duration of action used during general anesthesia to facilitate endotracheal intubation, to aid in surgical relaxation, and, less commonly, in the intensive care setting to achieve paralysis to facilitate mechanical ventilation for adequately sedated patients.
Storage:Store between 15°C and 25°C preferably in a refrigerator. Protect from light.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Vecuronium Bromide for Injection IP 4mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Vecuronium Bromide for Injection IP 4mg
    a. Each vial contains:

    Vecuronium Bromide IP……………………..4mg
    Citric Acid IP
    Anhydrous Citric Acid ……………………..2.075mg
    Dibasic Sodium Phosphate IP
    Equivalent to Anhydrous
    Dibasic Sodium Phosphate ……………..1.625mg
    Mannitol IP…………………………………9.7mg
    b. This pack is also contains:
    1 ampoule of Sterile Water for Injections IP…5ml

THERAPEUTIC INDICATION:

Vecuronium bromide is a peripherally acting, monoquarternary, steroidal, non-depolarizing neuromuscular blocker with an intermediate duration of action used during general anesthesia to facilitate endotracheal intubation, to aid in surgical relaxation, and, less commonly, in the intensive care setting to achieve paralysis to facilitate mechanical ventilation for adequately sedated patients.

DIRECTION OF USE:

For Intravenous Infusion only.
Reconstitute to by adding Sterile Water for Injections I.P. and use immediately after preparation if it is clear.
For the detail of the Sterile Water for Injection refer the insert.
Read enclosed prescribing information.

CAUTION AND SCHEDULE:

CAUTION:

  • Paralysing agent may cause paralysis of respiratory muscles as well leading to respiratory arrest. Facilities must be immediately available for artificial respiration.
  • After reconstitute, do not use in case any foreign particulate matter is observed inside the vial.
  • Reconstituted solution should be use immediately after preparation.
  • Discard unused portion.
  • FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

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 between 15°C and 25°C preferably in a refrigerator.
Protect from light.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.

DOSAGE: As directed by the Physician.