SEPSIVAC 0.6ML INJ

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SEPSIVAC 0.6ML INJ Specification

Dosage Form
Parenteral Injection

Indication
For management of Gram-negative sepsis and septic shock in hospitalized patients

Origin of Medicine
India

Salt Composition
Mycobacterium indicus pranii suspension

Pacakaging (Quantity Per Box)
1 ampoule per box

Drug Type

Ingredients
Heat killed Mycobacterium w (nonpathogenic) suspension

Physical Form
Injection

Function
Immunomodulator and adjunct therapy for managing severe sepsis

Recommended For
Adults diagnosed with Gram-negative sepsis or septic shock

Dosage
0.3 ml (half ampoule) administered intramuscularly every other day for three doses or as prescribed by physician

Dosage Guidelines
Administered under strict medical supervision, by intramuscular injection only

Suitable For
Adults and elderly patients as per physicians recommendation

Quantity
0.6 ml per ampoule

Storage Instructions
Store in a refrigerator at 2C to 8C. Do not freeze.

Approval
Approved for emergency use in sepsis as per DCGI (India) guidelines

Prescription/Non-Prescription
Prescription only

Route of Administration
Intramuscular

Pack Type
Single dose ampoule

Shelf Life
24 months from manufacturing date

Brand Name
SEPSIVAC

Precautions
Use with caution in immunocompromised patients

Registration Number
As per Indian regulatory requirements

Therapeutic Class
Immunotherapy, Biological Response Modifier (BRM)

Contraindications
Hypersensitivity to mycobacteria or any vaccine component

Marketed By
Cadila Pharmaceuticals Ltd.

Side Effects
Local injection site reactions, fever, chills, mild flu-like symptoms

About SEPSIVAC 0.6ML INJ

Sepsivac Injection is used both as a vaccine and as a treatment for certain bacterial infections. This medicine contains Mycobacterium W cells which have been killed by heat. It is used in the treatment of infections like leprosy or to treat or prevent infections in people undergoing treatment for lung cancer. Leprosy is a chronic condition affecting the skin and the nerves, caused by Mycobacterium leprae. Nausea, vomiting, diarrhea, weight loss are some of the common side effects associated with this injection.

Mechanism of Action

SEPSIVAC leverages a suspension of nonpathogenic, heat-killed Mycobacterium indicus pranii to modulate the immune system. It acts as a Biological Response Modifier (BRM), enhancing the body's immune response during life-threatening Gram-negative sepsis and septic shock. Its immunomodulatory function aims to support faster recovery and improved survival.

Administration Guidelines

SEPSIVAC is strictly for intramuscular injection and should be administered by trained medical professionals. The recommended dosage is 0.3 ml from the ampoule, administered every other day for a total of three doses, or as prescribed by the attending physician. Usage must comply with the physician's direction and within a hospital setting only.

Storage and Handling

For optimal efficacy and safety, SEPSIVAC must be kept refrigerated at temperatures between 2C and 8C. Do not freeze the product. The single-dose ampoule should be used immediately upon opening. Always ensure the product is within its 24-month shelf life from the date of manufacturing.

FAQ's of SEPSIVAC 0.6ML INJ:

Q: How is SEPSIVAC administered?

A: SEPSIVAC is administered as an intramuscular injection by qualified healthcare personnel in a hospital setting. It is not suitable for self-administration and should be given under strict medical supervision.

Q: What is the recommended usage and dosage for SEPSIVAC?

A: The typical recommended dosage is 0.3 ml (half the ampoule) administered intramuscularly every other day for three doses, or as directed by your physician. The exact regimen may vary based on clinical evaluation.

Q: When is SEPSIVAC prescribed?

A: SEPSIVAC is prescribed for adults and elderly patients diagnosed with Gram-negative sepsis or septic shock, primarily in emergency situations as outlined by India's DCGI guidelines.

Q: Where should SEPSIVAC be stored prior to use?

A: It should be stored in a refrigerator, kept at temperatures between 2C and 8C. Avoid freezing the ampoule and use the product within its 24-month shelf life.

Q: What are the common side effects associated with SEPSIVAC?

A: Patients may experience local injection site reactions, mild fever, chills, or flu-like symptoms. Most side effects are temporary, but any severe or persistent symptoms should be reported to a doctor immediately.

Q: What precautions should be taken before using SEPSIVAC?

A: SEPSIVAC should not be used in individuals with known hypersensitivity to mycobacteria or any vaccine component. It must be used cautiously in immunocompromised patients and always under medical supervision.

Q: What are the benefits of using SEPSIVAC in sepsis management?

A: SEPSIVAC serves as an immunomodulatory adjunct therapy, helping to enhance the immune response and improve outcomes in patients with severe Gram-negative sepsis or septic shock.

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