Lyophilized Rabies Vaccine For Intramuscular Injection

As a leading manufacturer in China, AIM Honor (Ningbo) Biopharmaceutical Co., Ltd. is proud to offer Lyophilized Rabies Vaccine For Intramuscular Injection — a premium freeze-dried vaccine cultivated on Vero cell culture technology, delivering a 100% antibody seroconversion rate within 14 days post-immunization. Formulated without preservatives or antibiotics, this vaccine ensures exceptional safety and stability for both pre-exposure and post-exposure rabies prophylaxis. With a minimum potency of ≥2.5 IU per dose, advanced ultrafiltration purification, and a 36-month shelf life under strict +2 °C to +8 °C cold-chain storage, our product meets the highest international GMP standards. We support bulk procurement and cross-border supply with guaranteed stable production capacity — contact us today for inquiries and partnership opportunities.

Product Overview

The Lyophilized Rabies Vaccine For Intramuscular Injection is a highly purified, freeze-dried biological preparation designed for active immunization against rabies virus infection in humans. Below is a comprehensive overview of its fundamental characteristics and intended applications.

1. Vaccine Type: Lyophilized (freeze-dried) inactivated rabies vaccine cultivated on Vero cell substrate using the aGV fixed virus strain.

2. Primary Function: Active immunization to induce protective immunity against rabies virus in recipients of all ages.

3. Administration Route: Intramuscular (I.M.) injection — deltoid muscle for adults and older children; anterolateral thigh for young children.

4. Immunization Purpose: Suitable for both pre-exposure prophylaxis (high-risk occupational groups) and post-exposure prophylaxis (individuals bitten or scratched by suspected rabid animals).

5. Appearance: White crisp cake in lyophilized form; reconstitutes into a clear, colorless liquid upon addition of sterile water for injection.

Composition and Characteristics

The formulation of Lyophilized Rabies Vaccine is meticulously designed to maximize antigen purity, stability, and safety. Every component has been carefully selected to ensure optimal immunogenic performance while minimizing the risk of adverse reactions.

1. Active Ingredient: Inactivated rabies fixed virus (aGV strain) propagated in Vero cell culture.

2. Stabilizers and Excipients: 1% human albumin, 1% gelatin, and 5% sucrose are incorporated to protect antigen integrity during the lyophilization process and throughout the product's shelf life.

3. Diluent: Sterile water for injection (1.0 ml per vial), provided for reconstitution of the freeze-dried cake.

4. Preservative-Free: The vaccine contains absolutely no preservatives, reducing the risk of hypersensitivity reactions.

5. Antibiotic-Free: No antibiotics are used in the formulation, further enhancing the safety profile for all recipient populations.

Technical Specifications

The Lyophilized Rabies Vaccine is manufactured to precise technical standards that comply with international pharmacopoeia requirements. The following parameter table provides a complete specification overview for procurement and quality assurance reference.

Target Populations

The Lyophilized Rabies Vaccine For Intramuscular Injection is indicated for use in all human populations regardless of age or sex. It serves two distinct immunization purposes, each targeting specific groups based on exposure risk assessment.

Post-Exposure Prophylaxis Candidates:

1. Any individual bitten or scratched by a suspected rabid animal, requiring immediate wound cleaning and vaccination.

2. Persons whose mucous membranes have been contaminated by the saliva of a suspected or confirmed rabid animal.

3. Individuals whose broken skin has been licked by a suspected rabid animal.

Pre-Exposure Prophylaxis Candidates:

1. Veterinarians and animal healthcare professionals who handle potentially rabid animals regularly.

2. Animal breeders and handlers working in high-risk environments.

3. Forestry workers and wildlife personnel with frequent outdoor animal contact.

4. Slaughterhouse workers exposed to animal species capable of carrying rabies virus.

5. Rabies laboratory staff and researchers handling live virus or infected specimens.

Administration and Dosage

Correct administration of Lyophilized Rabies Vaccine is critical to achieving optimal immune protection. The following guidelines detail the reconstitution procedure, injection technique, and immunization schedules for both pre-exposure and post-exposure scenarios.

Reconstitution and Injection Technique:

1. Reconstitute the freeze-dried vaccine with the enclosed sterile water for injection (1.0 ml) and shake the container thoroughly until the cake is fully dissolved.

2. Administer via intramuscular injection into the deltoid muscle of the upper arm for adults and older children.

3. For young children, inject into the muscle at the antero-external aspect of the thigh.

Post-Exposure Immunization Schedule:

1. Standard regimen: Five doses administered on days 0, 3, 7, 14, and 28 consecutively. Children follow the identical schedule.

2. Double first dose recommended for: individuals with chronic diseases who received rabies immunoglobulin or antiserum one day or earlier before vaccination; those with congenital or acquired immunodeficiency; those receiving immunosuppressive therapy including antimalarial drugs; the elderly; and cases where vaccination is initiated 48 hours or longer after exposure.

Wound Severity Classification and Treatment:

Pre-Exposure Immunization Schedule:

1. A total of three doses administered on days 0, 7, and 21 or 28.

Re-Immunization Recommendations for Previously Immunized Individuals:

1. Complete schedule within the recent one year: Administer one dose each on days 0 and 3 if bitten by a suspected rabid animal.

2. Complete schedule more than one year ago: Repeat the full immunization schedule if bitten by a suspected rabid animal.

3. Complete schedule within the last 3 years followed by booster doses: Administer one dose each on days 0 and 3 if bitten by a suspected rabid animal.

4. Complete schedule and booster doses given more than three years ago: Execute a full immunization schedule if bitten by a suspected rabid animal.

Quality Assurance and Certification

AIM Honor (Ningbo) Biopharmaceutical Co., Ltd. implements quality control standards for Lyophilized Rabies Vaccine For Intramuscular Injection that are stricter than national pharmacopoeia requirements. Our commitment to excellence is reflected in every aspect of our manufacturing and testing protocols.

1. Endotoxin Control: Strictly limited to ≤10 EU/dose, ensuring minimal pyrogenic risk for recipients.

2. Sterility Assurance: Every batch undergoes validated sterility testing with zero microbial growth confirmed before release.

3. pH Monitoring: Strict pH value control is maintained throughout the entire production process to guarantee product consistency and stability.

4. Advanced Purification: A 20 m² ultrafiltration system combined with a 600 mm chromatography system performs multi-step purification, effectively removing foreign proteins, residual DNA, and other impurities to achieve high antigen purity meeting global standards.

5. Standardized Lyophilization: A 40 m² freeze-drying system is used for formulation, reducing moisture content to extend shelf life to 36 months while maintaining full antigen activity.

6. Clean Environment Production: The entire preparation process is conducted in a B+A grade clean environment, ensuring the highest level of product safety and contamination prevention.

Key Production Processes

The manufacturing of Lyophilized Rabies Vaccine at AIM Honor follows a rigorously controlled, multi-stage production workflow executed entirely within our professional and modern GMP-compliant workshop. Each stage is designed to maximize antigen yield, purity, and safety.

Stage 1 — Bacterial Culture and Cell Passage:

1. Completed in a closed sterile operation system under B+A grade clean environment throughout the entire process.

2. The operation team wears fully enclosed protective equipment and strictly follows sterile standards for strain passage and cell expansion to avoid any external contamination.

3. High-precision culture equipment precisely controls parameters such as temperature and pH to ensure strain activity and cell proliferation stability.

4. This process is one of the core links to ensure the purity and activity of vaccine antigens, laying a high-quality foundation for subsequent purification and formulation processes.

Stage 2 — Harvest, Inactivation, and Purification:

1. Following cultivation, the virus suspension is harvested and chemically inactivated to ensure complete elimination of viral infectivity.

2. The inactivated suspension is concentrated and purified using advanced ultrafiltration and chromatography technology to remove impurities.

Stage 3 — Formulation and Lyophilization:

1. Human albumin, sucrose, and gelatin are added as stabilizers before the lyophilization process.

2. The 40 m² freeze-drying system reduces moisture content to extend shelf life and preserve antigen activity.

Adverse Reactions

As with all biological products, Lyophilized Rabies Vaccine For Intramuscular Injection may cause adverse reactions in some recipients. The following classification provides clinical reference for healthcare professionals monitoring post-vaccination responses.

Common Adverse Reactions:

1. Local reactions: Redness, swelling, pain, and itching may occur at the injection site within 24 hours after vaccination. These symptoms typically resolve spontaneously without any treatment.

2. Systemic reactions: Low fever, malaise, headache, dizziness, arthralgia, myalgia, vomiting, and bellyache may occur. These reactions can be relieved spontaneously and require no particular treatment.

Rare Adverse Reactions:

1. Recipients experiencing transient moderate or severe fever shall receive physical therapy or symptomatic treatment to prevent febrile convulsions.

Extremely Rare Adverse Reactions:

1. Allergic rash: Urticaria may occur generally within 72 hours after vaccination. Recipients with urticaria shall receive anti-anaphylactic treatment promptly.

2. Anaphylactic shock: May occur within one hour after vaccination. Immediate emergency treatment including prompt injection of adrenaline is required.

3. Allergic purpura: Recipients shall go to the clinic promptly and receive anti-anaphylactic treatment with corticosteroid in time. If treatment is inappropriate or delayed, purpuric nephritis may be complicated.

4. Angioneurotic edema or nervous system reactions: Recipients shall receive medical treatment in time.

Contraindications and Storage

Understanding the contraindications and proper storage requirements for Lyophilized Rabies Vaccine is essential for ensuring both product efficacy and patient safety. The following guidelines must be strictly observed.

Post-Exposure Immunization:

1. Because rabies is a universally fatal disease once clinical symptoms appear, there are absolutely no contraindications for post-exposure immunization.

Pre-Exposure Immunization Contraindications:

1. Individuals with known allergic reactions to any component of the vaccine, including excipients and antibiotics.

2. Patients with acute diseases, severe chronic diseases, and chronic diseases at acute attack stage, as well as those with fever.

3. Individuals with uncontrolled epilepsy or other progressive diseases of the nervous system.

Storage and Transportation Requirements:

1. Store and ship the product between +2 °C and +8 °C, protected from light.

2. The validity period is 36 months from the date of manufacture when stored under recommended conditions.

Why Choose AIM Honor

AIM Honor (Ningbo) Biopharmaceutical Co., Ltd. has built a strong reputation as a reliable vaccine partner for global health programs. Our competitive advantages in producing Lyophilized Rabies Vaccine set us apart in the international market.

1. Proprietary Virus Strain: Domestically developed aG virus strains with high immunogenicity and proven clinical efficacy.

2. Advanced Cell Culture Technology: State-of-the-art Vero cell culture platform ensuring consistent, high-yield antigen production across all batches.

3. GMP-Compliant Facilities: International GMP-standard manufacturing workshops with B+A grade clean environments throughout production.

4. Superior Quality Standards: Internal quality benchmarks that exceed national pharmacopoeia requirements in every critical parameter.

5. Enhanced Safety Profile: Preservative-free and antibiotic-free formulation minimizing adverse reaction risks.

6. Proven Immunogenicity: 100% antibody seroconversion rate achieved within 14 days of completing the immunization schedule.

7. Reliable Cold-Chain Logistics: Stable distribution network supporting global supply at +2 °C to +8 °C.

8. Comprehensive Technical Support: Full immunization guidance, regulatory documentation, and after-sales service for all partners.

Packaging and Delivery

Each shipment of Lyophilized Rabies Vaccine For Intramuscular Injection is carefully packaged to maintain cold-chain integrity and ensure product quality upon arrival at your facility. Our packaging and delivery protocols are designed for global distribution efficiency.

1. Unit Packaging: Each unit contains one vial of lyophilized vaccine and one vial of sterile water for injection (1.0 ml).

2. Cold-Chain Compliance: Packaging is engineered to maintain the required +2 °C to +8 °C temperature range during transit.

3. Bulk Procurement: We support large-volume orders with stable production capacity and flexible delivery scheduling.

4. Cross-Border Supply: Our logistics network supports international shipping with full regulatory documentation and customs compliance assistance.

FAQ

Q: What is the minimum potency of this rabies vaccine per dose?

A: The potency of Lyophilized Rabies Vaccine  shall not be less than 2.5 IU per single human dose, as verified through standardized testing protocols. This ensures a robust immune response and reliable protection against rabies virus infection for all recipients.

Q: Does the formulation contain any preservatives or antibiotics?

A: No. The product is formulated without any preservatives or antibiotics. The excipients include 1% human albumin, 1% gelatin, and 5% sucrose as stabilizers, with sterile water for injection as the diluent. This preservative-free and antibiotic-free formulation significantly enhances the safety profile for all recipient populations.

Q: What is the recommended storage temperature for the lyophilized preparation?

A: The vaccine must be stored and shipped between +2 °C and +8 °C, protected from light. It maintains a shelf life of 36 months when stored under these recommended conditions. Maintaining the cold chain throughout storage and transportation is critical to preserving antigen activity and ensuring vaccine efficacy.

Q: How is the vaccine administered to patients?

A: The preparation is administered via intramuscular injection. For adults and older children, the deltoid muscle of the upper arm is the recommended injection site. For young children, the anterolateral aspect of the thigh should be used. The freeze-dried cake must first be reconstituted with the enclosed sterile water for injection and shaken thoroughly until fully dissolved before administration.

Q: What is the standard post-exposure immunization schedule?

A: The standard post-exposure schedule consists of five doses administered on days 0, 3, 7, 14, and 28 consecutively. Children follow the identical schedule. In certain high-risk cases — such as immunodeficient individuals, the elderly, those on immunosuppressive therapy including antimalarial drugs, or when vaccination is initiated 48 hours or longer after exposure — it is recommended to double the first dose for enhanced immune response.

Q: Are there any contraindications for post-exposure use?

A: No. Because rabies is a universally fatal disease with no effective cure once clinical symptoms develop, there are absolutely no contraindications for post-exposure immunization. The vaccine should be administered to all exposed individuals regardless of their underlying health status, age, or sex.

Q: What quality control measures does AIM Honor apply during production?

A: AIM Honor implements internal quality standards that are stricter than national pharmacopoeia requirements. These include endotoxin limits of ≤10 EU/dose, mandatory sterility testing with zero microbial growth confirmed, strict pH value control throughout production, and multi-step purification using a 20 m² ultrafiltration system combined with a 600 mm chromatography system. The entire production process is conducted in B+A grade clean environments under full international GMP compliance.

Q: Can this product be used for pre-exposure prophylaxis?

A: Yes. The vaccine is indicated for both pre-exposure and post-exposure prophylaxis. The pre-exposure schedule consists of three doses administered on days 0, 7, and 21 or 28. It is especially recommended for high-risk occupational groups including veterinarians, animal breeders, forestry workers, slaughterhouse personnel, and rabies laboratory staff who face regular exposure risks.

Q: What should be done for Category III rabies exposure?

A: For Category III exposure — which includes single or multiple bleeding wounds, mucous membrane contamination by suspected rabid animal saliva, or broken skin licked by a suspected rabid animal — immediate combined treatment with both the vaccine and rabies antiserum (40 IU/kg) or rabies immunoglobulin (20 IU/kg) is required. The serum or immunoglobulin should be infiltrated around the wound(s) as much as anatomically feasible, with any remaining volume injected intramuscularly. This combination therapy is for single use only.

Q: How can I place a bulk order for this intramuscular injection vaccine?

A: AIM Honor (Ningbo) Biopharmaceutical Co., Ltd. supports bulk purchasing and cross-border supply with guaranteed stable production capacity. Please contact our sales team directly through our official website to discuss your procurement requirements, pricing, packaging specifications, and international shipping arrangements. We are committed to providing competitive terms and reliable supply for partners worldwide.