Vecuronium Bromide for Injection 10mg Technical Specification:

Product Name:Vecuronium Bromide for Injection 10mg
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 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • 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

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.

Why Taj pharmaceuticals?

Leadership in Pharmaceutical Excellence: Taj Pharmaceuticals is a trusted leader in the pharmaceutical industry, with a long history of innovation and dedication to healthcare. Our reputation as a reliable provider of high-quality medications extends to Vecuronium Bromide for Injection, an essential neuromuscular blocking agent used in surgical and intensive care settings. Healthcare professionals worldwide place their trust in our commitment to delivering safe and effective pharmaceuticals.

Precision and Quality Assurance: Precision is paramount in the administration of neuromuscular blockade, and Taj Pharmaceuticals excels in this aspect. Our cutting-edge manufacturing facilities, staffed by highly skilled professionals, are equipped with state-of-the-art technology. We maintain rigorous quality control standards to ensure that each dose of Vecuronium Bromide for Injection meets the highest criteria for purity, potency, and sterility. We understand the critical importance of precision and reliability in medical procedures and consistently deliver on these commitments.

Safety and Efficacy in Patient Care: Vecuronium Bromide for Injection plays a vital role in patient care by providing controlled muscle relaxation during surgery and mechanical ventilation in intensive care units. Taj Pharmaceuticals places safety at the forefront of our product development and testing. Our stringent protocols minimize the risk of adverse events, enabling healthcare providers to focus on patient well-being with confidence in the medication’s safety and effectiveness.

Global Accessibility and Availability: Healthcare is a universal need, and Taj Pharmaceuticals is dedicated to making Vecuronium Bromide for Injection accessible worldwide. Our commitment to global availability ensures that healthcare facilities across the globe have a consistent supply of this critical medication. Regardless of geographic location, medical professionals can rely on the dependable availability of Vecuronium Bromide for Injection.

Continual Support and Collaboration: Taj Pharmaceuticals goes beyond being a pharmaceutical provider; we are a trusted partner in patient care. We offer ongoing support and foster collaboration with healthcare providers to assist them in delivering the highest standard of care to their patients. Our commitment to advancing medical solutions and improving patient outcomes remains unwavering.

When you choose Taj Pharmaceuticals for Vecuronium Bromide for Injection, you are choosing a partner committed to excellence, precision, and patient well-being. We stand alongside healthcare professionals in their mission to provide safe and effective treatments, and our dedication to delivering quality pharmaceuticals is unwavering.

What is Vecuronium Bromide for Injection and its uses:

Vecuronium Bromide for Injection is a vital medication utilized in anesthesia and critical care medicine. Belonging to the neuromuscular blocking agent class, it serves the crucial purpose of inducing muscle relaxation and temporary paralysis in patients undergoing surgical procedures or requiring mechanical ventilation in intensive care units.

Surgical Anesthesia: One of the primary applications of Vecuronium Bromide for Injection is within the realm of surgical anesthesia. Administered intravenously, it aids in achieving muscle relaxation during surgery. By doing so, it provides several advantages, including improved surgical access, precision, and patient safety. Often used in conjunction with general anesthesia, it facilitates endotracheal intubation, maintains optimal surgical field conditions, and prevents unintended muscle contractions during surgical procedures.

Mechanical Ventilation in Critical Care: In intensive care settings such as intensive care units (ICUs) and emergency departments, Vecuronium Bromide for Injection assumes a crucial role in assisting patients who require mechanical ventilation. By temporarily paralyzing specific muscle groups responsible for respiration, it allows mechanical ventilators to provide controlled and efficient breathing support. This is particularly valuable when patients are unable to breathe adequately on their own due to underlying medical conditions.

Enhancing Patient Safety: Vecuronium Bromide for Injection significantly contributes to patient safety during surgical interventions and critical illnesses. Its ability to induce muscle relaxation and temporary paralysis minimizes the risk of patient movement and complications arising from involuntary muscle contractions. This is of paramount importance during delicate surgical procedures, where precise control of muscle activity is essential, as well as in situations necessitating accurate management of ventilation.

Professional Supervision Required: It’s imperative to emphasize that the administration of Vecuronium Bromide for Injection is carried out exclusively by trained healthcare professionals in controlled clinical environments. The dosage and duration of use are determined based on multiple factors, including the patient’s individual characteristics and the specific medical context. This medication should never be administered without the supervision of qualified healthcare providers experienced in its proper use, as its effects have a direct impact on patient well-being and safety.

How does Vecuronium Bromide for Injection Work:

Vecuronium Bromide for Injection operates by interfering with the transmission of nerve signals at the neuromuscular junction. This critical junction is where motor neurons communicate with muscle cells, initiating muscle contractions. The medication’s primary mechanism of action involves competitive binding. When intravenously administered, Vecuronium Bromide competes with the neurotransmitter acetylcholine for binding to receptors on the muscle cell membrane. By blocking acetylcholine’s action, Vecuronium Bromide effectively occupies these receptor sites, preventing acetylcholine from binding and initiating muscle contractions.

Achieving Controlled Muscle Relaxation: The consequence of Vecuronium Bromide’s action is controlled muscle relaxation and temporary paralysis. This effect is pivotal in clinical settings, such as surgical procedures and intensive care, where precision and patient safety are paramount. During surgery, it allows surgeons to work with enhanced precision by reducing patient movement and preventing unintended muscle contractions that might interfere with the procedure. In intensive care units (ICUs), it facilitates mechanical ventilation by ensuring that the patient’s natural respiratory efforts align harmoniously with the ventilator’s support.

Selective Targeting and Minimal Systemic Effects: Vecuronium Bromide for Injection exhibits a high degree of selectivity, primarily targeting the neuromuscular junction’s receptors without significantly affecting other nerve functions elsewhere in the body. This selectivity ensures that the medication’s effects are localized to the muscles, sparing the patient from experiencing widespread neural disruption.

Controlled Recovery and Reversibility: An advantageous characteristic of Vecuronium Bromide is its intermediate duration of action. It provides the necessary muscle paralysis during medical procedures, yet allows for relatively rapid recovery once its administration is ceased. If required, the effects of Vecuronium Bromide can be reversed using specific medications like neostigmine or sugammadex, allowing patients to regain muscle function promptly and safely.

Vecuronium Bromide for Injection’s precise mechanism of action, along with its ability to provide controlled muscle relaxation, contributes significantly to patient safety and the optimal conditions required for medical procedures. It is, however, imperative that the administration of this medication is carried out exclusively by trained healthcare professionals who can closely monitor its effects to ensure patient well-being.

Benefits of Vecuronium Bromide for Injection:

Vecuronium Bromide for Injection offers several notable advantages in clinical practice. First and foremost, it provides precise and controlled muscle relaxation and paralysis, making it an invaluable tool in surgical settings. Surgeons benefit from enhanced access and improved procedural precision, as involuntary muscle contractions are minimized. Additionally, the medication’s role in facilitating mechanical ventilation in intensive care units (ICUs) ensures that patient-ventilator synchronization is optimized, enhancing patient comfort and respiratory support. Importantly, Vecuronium Bromide prioritizes patient safety by preventing unintended muscle contractions during medical procedures, a critical aspect of minimizing complications.

Common Side Effects:

While Vecuronium Bromide for Injection offers substantial benefits, it is not without potential side effects, primarily due to its neuromuscular blocking properties. These side effects include respiratory depression, which can reduce lung function and necessitate careful monitoring during administration. Hypotension, or a drop in blood pressure, may occur, particularly during anesthesia induction or maintenance, necessitating appropriate management. Patients may experience bradycardia, a slow heart rate, which can be managed with medications or interventions. Prolonged paralysis or delayed recovery of muscle function may be observed in some cases, often requiring the use of reversal agents. Although rare, allergic reactions, such as hives, itching, swelling, or breathing difficulties, may occur, warranting immediate medical attention. In specific neurological cases, Vecuronium Bromide may increase intracranial pressure, requiring vigilant monitoring. Additionally, the medication can influence potassium levels, potentially leading to electrolyte imbalances that necessitate correction. It’s essential to acknowledge the potential for interactions with other medications, including anesthetics and antibiotics, which healthcare providers must consider when administering Vecuronium Bromide.

In practice, Vecuronium Bromide for Injection is a valuable asset in clinical settings where controlled muscle relaxation is essential. The decision to use this medication is made by trained healthcare professionals who carefully assess the risk-benefit profile for each patient, ensuring expert supervision and close monitoring throughout its administration. Patient safety remains paramount, and the benefits of Vecuronium Bromide often outweigh the potential side effects, especially when employed with precision and expertise.

Frequently Asked Questions About Vecuronium Bromide for Injection:

Certainly, here are some frequently asked questions (FAQs) about Vecuronium Bromide for Injection:

  1. What is Vecuronium Bromide for Injection used for?

Vecuronium Bromide for Injection is a neuromuscular blocking agent used to induce muscle relaxation and temporary paralysis in patients during surgical procedures and mechanical ventilation in intensive care units (ICUs).

  1. How does Vecuronium Bromide for Injection work?

Vecuronium Bromide blocks the transmission of nerve signals at the neuromuscular junction, preventing muscle contractions and inducing muscle relaxation and paralysis.

  1. Is Vecuronium Bromide for Injection safe?

Vecuronium Bromide is generally safe when administered by trained healthcare professionals in controlled clinical settings. However, it can have potential side effects, and its use requires careful monitoring.

  1. What are the common side effects of Vecuronium Bromide for Injection?

Common side effects may include respiratory depression, hypotension (low blood pressure), bradycardia (slow heart rate), and the possibility of prolonged paralysis. Allergic reactions are rare but possible.

  1. How long does the effect of Vecuronium Bromide for Injection last?

The duration of action varies, but Vecuronium Bromide typically provides controlled muscle relaxation during the procedure and allows for relatively rapid recovery once it is discontinued.

  1. Can the effects of Vecuronium Bromide for Injection be reversed?

Yes, the effects of Vecuronium Bromide can be reversed using medications such as neostigmine or sugammadex if necessary to accelerate the recovery of muscle function.

  1. Is Vecuronium Bromide for Injection administered outside of clinical settings?

No, Vecuronium Bromide for Injection is administered exclusively by trained healthcare professionals in controlled clinical environments due to its potential side effects and the need for careful monitoring.

  1. Are there any contraindications or interactions with other medications?

Vecuronium Bromide can interact with certain medications, including anesthetics and antibiotics. It should not be used in patients with known hypersensitivity to the drug, and caution is advised in individuals with specific medical conditions.

  1. Can Vecuronium Bromide for Injection be used during pregnancy and breastfeeding?

Its use during pregnancy and breastfeeding should be carefully evaluated by healthcare providers, considering the potential risks and benefits.

  1. How is Vecuronium Bromide for Injection administered?

Vecuronium Bromide is administered intravenously by healthcare professionals. The dosage and duration of administration depend on the patient’s individual characteristics and the specific medical context.

Patients and caregivers should consult with healthcare providers for personalized information and guidance regarding Vecuronium Bromide for Injection in their specific medical situations.

Vecuronium Bromide for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Vecuronium Bromide for Injection product in Following Countries:

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Vecuronium Bromide for Injection Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Vecuronium Bromide for Injection, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274

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.