GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Vecuronium Bromide for Injection 4mg
Each ml contains:
Vecuronium Bromide USP…………………………………….1mg
Citric acid anhydrous, USP……………………………………2.075mg
Sodium Phosphate Dibasic
Anhydrous, USP……………………………………1.625mg
Mannitol, USP
(to adjust toxicity) ……………………………….9.7mg
May contain sodium hydroxide and/or phosphoric acid for pH adjustment.
pH 4(3.5 to 4.5)
This pack is also contains:
One FFS ampule of Sterile Water for Injection USP…….4ml

2. Vecuronium Bromide for Injection 10mg
Each ml contains:
Vecuronium Bromide USP…………………………………….1mg
Citric acid anhydrous, USP……………………………………2.075mg
Sodium Phosphate Dibasic
Anhydrous, USP……………………………………1.625mg
Mannitol, USP
(to adjust toxicity) ……………………………….9.7mg
May contain sodium hydroxide and/or phosphoric acid for pH adjustment.
pH 4(3.5 to 4.5)
This pack is also contains:
One FFS ampule of Sterile Water for Injection USP…….10ml

3. Vecuronium Bromide for Injection 20mg
Each ml contains:
Vecuronium Bromide USP…………………………………….1mg
Citric acid anhydrous, USP……………………………………2.075mg
Sodium Phosphate Dibasic
Anhydrous, USP……………………………………1.625mg
Mannitol, USP
(to adjust toxicity) ……………………………….9.7mg
May contain sodium hydroxide and/or phosphoric acid for pH adjustment.
pH 4(3.5 to 4.5)
This pack is also contains:
One FFS ampule of Sterile Water for Injection USP…….20ml


THERAPEUTIC INDICATIONS:

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.

PACKING:

4mg/4ml, 10mg/10ml, 20mg/20ml

DIRECTION OF USE:

• For Intravenous use only.
• Reconstitute to by adding Sterile Water for Injections USP and use immediately after preparation if it is clear.
For the detail of the Sterile Water for Injection refer the insert.
WHEN RECONSTITUTED WITH BACTERIOSTATIC WATER FOR INJECTION:
CONTAINS BENZYL ALCOHOL, WHICH IS NOT INTENDED FOR USE IN NEWBORNS. USE WITHIN 5 DAYS. MAY BE STORED AT ROOM TEMPERATURE OR REFRIGERATED.
WHEN RECONSTITUTED WITH STERILE WATER FOR INJECTION OR OTHER COMPATIBLE INTRAVENOUS SOLUTIONS:
REFRIGERATE VIAL. USE WITHIN 24 HOURS. SINGLE USE ONLY. DISCARD UNUSED PORTION.

CAUTION & WARNING:

CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
Discard unused portion within 24 hours of date prepared and time.
CONTAINS BENZYL ALCOHOL WHICH IS NOT FOR USE IN NEONATES.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Paralyzing Agent. Causes Respiratory Arrest. Facilities must be immediately available for artificial respiration.

STORAGE & DOSAGE:

Storage: Store dry powder at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Protect from light.
Retain in carton until time of use.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician. For Deep Intramuscular Use.
NOTE:
1mg/ml when reconstituted.
Use within 5 days of date prepared and time. OR
Reconstituted with Sterile Water for Injection USP or other compatible IV solutions (see package inert) discard unused portion within 24 hours of date prepared and time.
Single use only.
The drug should be administered by adequately trained individuals familiar with its actions, characteristics, and hazards.

Vecuronium Bromide for Injection 20mg Technical Specification:

Product Name:Vecuronium Bromide for Injection 20mg
Brand Name:Generic
Strength:4mg, 10mg, 20mg
Dosage Form:Lyophilized Powder for Injection
Packing:1 Single use Vial/Ampoule + 1 WFI Tray
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Neuromuscular Blockers
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 dry powder at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Retain in carton until time of use.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Vecuronium Bromide for Injection 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Vecuronium Bromide for Injection 20mg
    Each ml contains:
    Vecuronium Bromide USP…………………………………….1mg
    Citric acid anhydrous, USP……………………………………2.075mg
    Sodium Phosphate Dibasic
    Anhydrous, USP……………………………………1.625mg
    Mannitol, USP
    (to adjust toxicity) ……………………………….9.7mg
    May contain sodium hydroxide and/or phosphoric acid for pH adjustment.
    pH 4(3.5 to 4.5)
    This pack is also contains:
    One FFS ampule of Sterile Water for Injection USP…….20ml

THERAPEUTIC INDICATIONS:

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.

PACKING:

4mg/4ml, 10mg/10ml, 20mg/20ml

DIRECTION OF USE:

  • For Intravenous use only.
  • Reconstitute to by adding Sterile Water for Injections USP and use immediately after preparation if it is clear.
    For the detail of the Sterile Water for Injection refer the insert.

When reconstituted with bacteriostatic water for injection: CONTAINS BENZYL ALCOHOL, WHICH IS NOT INTENDED FOR USE IN NEWBORNS. Use within 5 days. May be stored at room temperature or refrigerated.

When reconstituted with sterile water for injection or other compatible intravenous solutions: Refrigerate vial. Use within 24 hours. Single use only. Discard unused portion.

CAUTION & Warning:

CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.

Discard unused portion within 24 hours of date prepared and time.

CONTAINS BENZYL ALCOHOL WHICH IS NOT FOR USE IN NEONATES.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

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

Paralyzing Agent. Causes Respiratory Arrest. Facilities must be immediately available for artificial respiration.

STORAGE & DOSAGE:

Storage: Store dry powder at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Protect from light.
Retain in carton until time of use.

Keep all medicines out of reach of children.

Dosage: As directed by the Physician. For Deep Intramuscular Use.

NOTE:
1mg/ml when reconstituted.

Use within 5 days of date prepared and time. OR
Reconstituted with Sterile Water for Injection USP or other compatible IV solutions (see package inert) discard unused portion within 24 hours of date prepared and time.

Single use only.

The drug should be administered by adequately trained individuals familiar with its actions, characteristics, and hazards.