GENERIC NAME OF THE MEDICINAL PRODUCT:

L-Alanyl-L-Glutamine Solution for Infusion (20%w/v)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. L-Alanyl-L-Glutamine Solution for Infusion (20%w/v)
Composition:
Each 100ml of concentrated solution for infusion contains:
N (2)-L-alanyl L-glutamine……………………………20.00g
(=L-alanine 8.20g, L-glutamine 13.46g)
Water for Injection USP………………………………… q.s. to 100ml
Osmolarity (calc.) ………………………………………921mOsmol/L
Titration acidity…………………………………………90-105 mmol NaOH/L
pH value…………………………………………………5.0-7.0

THERAPEUTIC INDICATIONS:

L-Alanyl L-Glutamine is a synthetic glutamine dipeptide administered alone or along with total parenteral nutrition (TPN) in ICU patients, gastrointestinal surgery patients, pancreatitis patients, severe burn patients, cancer chemotherapy patients, etc., to help in the recovery.

DIRECTION OF USE:

To be used with Non-pyrogenic I.V. administration set with aseptic technique.
For I.V. use only.

CAUTION & WARNING:

CAUTION: Not to be used if container is found leaking or if the solution is cloudy or not clear. Solution containing visible solid particles must not be used.
WARNING: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.
Not infuse directly: Dilute the preparation with compatible intravenous solution prior to administration.

STORAGE & DOSAGE:

Storage: Store at a room temperature not exceeding 25°C, protected from light.
Do not refrigerate.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Dosage: As directed by the physician.
For full prescribing information please refer package insert.

L-Alanyl-L-Glutamine Solution for Infusion 20%w/v Technical Specification:

Product Name:L-Alanyl-L-Glutamine Solution for Infusion 20%w/v
Brand Name:Glukoxtaj
Strength:20%w/v
Dosage Form:I.V. Infusion Bottle (LVP)
Packing:100mL, 250mL IV Bottle
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:Anti-bacterial & Antibiotics
Indication: L-Alanyl L-Glutamine is a synthetic glutamine dipeptide administered alone or along with total parenteral nutrition (TPN) in ICU patients, gastrointestinal surgery patients, pancreatitis patients, severe burn patients, cancer chemotherapy patients, etc., to help in the recovery.
Storage:Store at a room temperature not exceeding 25°C, protected from light. Do not refrigerate.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • L-Alanyl-L-Glutamine Solution for Infusion (20%w/v)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • L-Alanyl-L-Glutamine Solution for Infusion (20%w/v)
    Composition:
    Each 100ml of concentrated solution for infusion contains:
    N (2)-L-alanyl L-glutamine……………………………20.00g
    (=L-alanine 8.20g, L-glutamine 13.46g)
    Water for Injection USP………………………………… q.s. to 100ml
    Osmolarity (calc.) ………………………………………921mOsmol/L
    Titration acidity…………………………………………90-105 mmol NaOH/L
    pH value…………………………………………………5.0-7.0

THERAPEUTIC INDICATIONS:

L-Alanyl L-Glutamine is a synthetic glutamine dipeptide administered alone or along with total parenteral nutrition (TPN) in ICU patients, gastrointestinal surgery patients, pancreatitis patients, severe burn patients, cancer chemotherapy patients, etc., to help in the recovery.

DIRECTION OF USE:

To be used with Non-pyrogenic I.V. administration set with aseptic technique.

For I.V. use only.

CAUTION & WARNING:

CAUTION: Not to be used if container is found leaking or if the solution is cloudy or not clear. Solution containing visible solid particles must not be used.

 WARNING: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

Not infuse directly: Dilute the preparation with compatible intravenous solution prior to administration.

STORAGE & DOSAGE:

Storage: Store at a room temperature not exceeding 25°C, protected from light.
Do not refrigerate.

STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.

Keep medicine out of reach of children.
FOR HUMAN USE ONLY

Dosage: As directed by the physician.
For full prescribing information please refer package insert.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals stands as a beacon of excellence in providing L-Alanyl-L-Glutamine Solution for Infusion, a critical component in clinical nutrition and critical care settings. Our unwavering dedication to quality and innovation ensures that every infusion solution meets stringent global standards for safety and efficacy. We understand the importance of reliable and effective solutions in healthcare. Taj Pharmaceuticals is committed to delivering products that healthcare professionals trust, and patients rely on for their nutritional and therapeutic needs. Our state-of-the-art manufacturing facilities and rigorous quality control processes guarantee the highest standards of purity and safety. With Taj Pharmaceuticals, you can rest assured that you are receiving a product that aligns with the most stringent international guidelines. Choose Taj Pharmaceuticals for L-Alanyl-L-Glutamine Solution for Infusion, and experience pharmaceutical excellence that prioritizes your health and well-being. We are here to support healthcare providers and patients, providing the quality and reliability you deserve in critical care and clinical nutrition applications.

What is L-Alanyl-L-Glutamine Solution for Infusion and its uses:

L-Alanyl-L-Glutamine Solution for Infusion is a sterile solution that contains the amino acids L-alanine and L-glutamine. It is used in clinical nutrition and critical care settings for various therapeutic purposes. Here’s an overview of L-Alanyl-L-Glutamine Solution for Infusion and its primary uses:

  • Composition: L-Alanyl-L-Glutamine Solution contains the amino acids L-alanine and L-glutamine. Amino acids are the building blocks of proteins and play essential roles in various physiological processes in the body.
  • Uses:
    Nutritional Support:
    L-Alanyl-L-Glutamine Solution is often used in clinical nutrition to provide essential amino acids to patients who cannot obtain adequate nutrition orally. This is common in critically ill patients, those with gastrointestinal disorders, or those who are unable to eat for various reasons.
    Muscle Preservation:
    Glutamine is an amino acid that plays a crucial role in maintaining muscle mass. In critical care settings, this solution may be administered to help preserve muscle mass in patients who are at risk of muscle wasting due to illness or immobility.
    Support for Gastrointestinal Function:
    Glutamine is important for maintaining the integrity and function of the gastrointestinal tract. It may be used in patients with gastrointestinal disorders or those recovering from surgery to support the healing and function of the digestive system.
    Reduction of Muscle Breakdown:
    In certain medical conditions, such as sepsis or severe infections, the body can enter a catabolic state where muscle breakdown is increased. L-Alanyl-L-Glutamine Solution may be used to help counteract this muscle breakdown and promote tissue repair.
    Immunomodulation:
    Glutamine is also involved in the function of the immune system. In some cases, this solution may be used to support the immune response in critically ill patients.
  • Administration:
    L-Alanyl-L-Glutamine Solution is typically administered as an intravenous (IV) infusion, often in a hospital or clinical setting. The dosage and duration of infusion may vary depending on the specific medical condition and treatment plan.
  • Clinical Considerations:
    The use of L-Alanyl-L-Glutamine Solution is determined by healthcare providers based on the patient’s nutritional needs, medical condition, and response to treatment. It is an important tool in providing specialized nutritional support to patients who cannot receive adequate nutrition orally.

It’s important to note that this solution should be administered under the supervision of healthcare professionals who can monitor the patient’s response and adjust the treatment plan as needed. The specific uses and dosages may vary among patients, and decisions about its use should be made in consultation with healthcare providers.

How Does L-Alanyl-L-Glutamine Solution for Infusion Work?

L-Alanyl-L-Glutamine Solution for Infusion works by providing the essential amino acids L-alanine and L-glutamine to the body through intravenous (IV) administration. These amino acids play important roles in various physiological processes, and their administration has several therapeutic mechanisms:

  • Protein Synthesis:
    Amino acids are the building blocks of proteins. L-glutamine and L-alanine are both crucial for protein synthesis, which is essential for the repair and maintenance of various tissues, including muscles and the immune system.
  • Muscle Preservation:
    L-glutamine, in particular, plays a significant role in muscle metabolism. It helps reduce muscle protein breakdown and may support muscle preservation, especially in critically ill patients or those with conditions that lead to muscle wasting.
  • Gastrointestinal Support:
    L-glutamine is known for its role in maintaining the integrity and function of the gastrointestinal tract. It is a primary source of energy for the cells lining the gut and may help support the healing of the digestive system in patients with gastrointestinal disorders or those recovering from surgery.
  • Immune Function:
    L-glutamine is essential for the normal function of immune cells. It can support the immune response, particularly in patients with severe illnesses or conditions that compromise the immune system.
  • Nutritional Support:
    In cases where patients cannot receive adequate nutrition orally due to illness, surgery, or other factors, L-Alanyl-L-Glutamine Solution for Infusion provides essential amino acids directly to the bloodstream, helping meet the body’s nutritional needs.
  • Reduction of Catabolism:
    In certain medical conditions, such as sepsis or severe infections, the body can enter a catabolic state where muscle breakdown is increased. L-Alanyl-L-Glutamine Solution may be used to help counteract this catabolism and promote tissue repair.
  • Energy Source:
    L-glutamine can also serve as a source of energy for various cells in the body, particularly in situations where energy demands are high.

Overall, the administration of L-Alanyl-L-Glutamine Solution for Infusion supports critical physiological processes, including tissue repair, muscle preservation, immune function, and gastrointestinal health. Its use is determined by healthcare providers based on the specific medical condition and nutritional needs of the patient, and it is typically administered under medical supervision to ensure the appropriate dosage and response to treatment.

Benefits of L-Alanyl-L-Glutamine Solution for Infusion:

  • Nutritional Support: This solution provides essential amino acids, L-alanine and L-glutamine, to individuals who are unable to obtain adequate nutrition orally. It helps meet the body’s protein and energy requirements, particularly in critically ill patients or those with gastrointestinal disorders.
  • Muscle Preservation: L-glutamine plays a key role in maintaining muscle mass. In critical care settings, this solution may help preserve muscle tissue and prevent muscle wasting, especially in patients who are immobilized or experiencing severe illness.
  • Gastrointestinal Healing: L-glutamine supports the integrity and function of the gastrointestinal tract. It can aid in the healing of the digestive system’s lining, making it beneficial for patients with gastrointestinal conditions or those recovering from gastrointestinal surgery.
  • Immune System Support: L-glutamine is important for the normal function of immune cells. Administration of this solution may help bolster the immune response, which can be crucial in critically ill patients or those with compromised immune systems.
  • Reduction of Catabolism: In conditions where the body enters a catabolic state, such as severe infections, L-Alanyl-L-Glutamine Solution may help reduce muscle breakdown and promote tissue repair.
  • Energy Source: L-glutamine serves as an energy source for various cells, providing a readily available energy substrate for cells with high energy demands.

Side Effects of L-Alanyl-L-Glutamine Solution for Infusion:

  • Allergic Reactions: While allergic reactions are rare, they can occur. Signs of an allergic reaction may include rash, itching, swelling, severe dizziness, or difficulty breathing. Seek immediate medical attention if these symptoms occur.
  • Electrolyte Imbalances: In some cases, the infusion of this solution may lead to electrolyte imbalances. Monitoring of electrolyte levels and appropriate adjustments to the infusion rate are important to prevent this.
  • Fluid Overload: Infusion of large volumes of any solution can potentially lead to fluid overload, especially in patients with compromised kidney function or heart conditions. Healthcare providers carefully assess fluid balance during administration.
  • Metabolic Changes: High doses or prolonged use of L-glutamine may lead to metabolic changes, including increases in ammonia levels in the blood.
  • Hyperglycemia: L-glutamine can be converted to glucose in the body, potentially leading to elevated blood sugar levels. This is especially important to monitor in patients with diabetes.
  • Infection Risk: In rare cases, the use of any IV solution can increase the risk of infection at the injection site.

It’s important to note that the benefits of L-Alanyl-L-Glutamine Solution for Infusion are generally realized when it is used as part of a comprehensive treatment plan under the supervision of healthcare professionals. The potential side effects are typically closely monitored, and treatment adjustments are made as needed to ensure patient safety and well-being. Patients should communicate any concerns or unusual symptoms to their healthcare team during infusion.

Frequently Asked Questions About L-Alanyl-L-Glutamine Solution for Infusion:

Certainly, here are some frequently asked questions (FAQs) about L-Alanyl-L-Glutamine Solution for Infusion:

  1. What is L-Alanyl-L-Glutamine Solution for Infusion used for?

L-Alanyl-L-Glutamine Solution is used for clinical nutrition and critical care applications. It provides essential amino acids to support patients who cannot obtain adequate nutrition orally.

  1. How is L-Alanyl-L-Glutamine Solution administered?

It is typically administered as an intravenous (IV) infusion, which means it is delivered directly into the bloodstream through a vein. The dosage and infusion rate are determined by healthcare providers based on the patient’s specific needs.

  1. Who might benefit from L-Alanyl-L-Glutamine Solution for Infusion?

Patients who may benefit include those who are critically ill, unable to eat or digest food normally, undergoing surgery, or at risk of malnutrition due to certain medical conditions.

  1. What are the primary amino acids in this solution, and why are they important?

The primary amino acids are L-alanine and L-glutamine. These amino acids are essential for protein synthesis, maintaining muscle mass, supporting gastrointestinal health, and contributing to immune function.

  1. Can L-Alanyl-L-Glutamine Solution cause allergic reactions?

While allergic reactions are rare, they can occur. Patients receiving the infusion should be monitored for signs of allergic reactions, such as rash, itching, or difficulty breathing.

  1. Are there potential side effects associated with this solution?

Yes, potential side effects may include electrolyte imbalances, fluid overload, metabolic changes, hyperglycemia (elevated blood sugar), and infection risk. These side effects are typically closely monitored during infusion.

  1. How long does an infusion typically take, and how often is it administered?

The duration of an infusion and the frequency of administration can vary depending on the patient’s condition and treatment plan. Some infusions may be relatively short, while others may be longer and given daily or intermittently.

  1. Is this solution safe for use during pregnancy or breastfeeding?

The use of L-Alanyl-L-Glutamine Solution during pregnancy or breastfeeding should be discussed with healthcare providers, as it depends on the individual patient’s medical condition and nutritional needs.

  1. Can this solution interact with other medications or treatments?

It’s important to inform healthcare providers about all medications, supplements, and treatments the patient is receiving to avoid potential interactions. Close monitoring can help manage any possible interactions.

  1. How is the effectiveness of L-Alanyl-L-Glutamine Solution monitored in patients?

The effectiveness of the solution is typically assessed by monitoring the patient’s clinical response, nutritional status, and laboratory parameters, including amino acid levels.

Patients and their healthcare providers should maintain open communication and discuss any questions or concerns related to L-Alanyl-L-Glutamine Solution for Infusion to ensure safe and effective treatment.

As L-Alanyl-L-Glutamine Solution for Infusion Exporters; We can cater to export business queries from the following geographies. We are exporting our L-Alanyl-L-Glutamine Solution for Infusion product in the 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

L-Alanyl-L-Glutamine Solution for Infusion 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 L-Alanyl-L-Glutamine Solution for Infusion, 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