AIM Vaccine Co., ltd.

[Drug Name] Generic name: Group ACYW135 Meningococcal Polysaccharide Vaccine

[Ingredients and Properties] This product is made from the culture fluid of Group A, C, Y, and W135 Neisseria meningitidis, and the capsule polysaccharide antigens are extracted and purified separately, mixed, and then freeze-dried with lactose as a stabilizer. It is a white fluffy substance, and after reconstituted with the provided diluent, it becomes a colorless and clear liquid.

Active ingredients: Each human dose of this vaccine contains 50pμg of polysaccharide from Group A, C, Y, and W135 capsules.

Excipients: Each human dose contains 10.0mg of lactose.

Vaccine diluent: Sterile and pyrogen-free PBS.

[Vaccination Target] At present, it is only recommended for use in high-risk populations of children over 2 years old and adults in the following scope:

1. Those who travel to or live in high-risk areas, such as the African meningitis belt (epidemic areas of Group A, C, Y, and W135 Neisseria meningitidis).

2. Those who may come into contact with Group A, C, Y, and W135 Neisseria meningitidis from the air in laboratory or vaccine production work.

3. High-risk populations in areas where the national health administrative departments predict an outbreak of Group Y and W135 Neisseria meningitidis infection based on epidemiological investigations.

[Effects and Uses] This product is used to prevent epidemic cerebrospinal meningitis caused by Group A, C, Y, and W135 Neisseria meningitidis.

[Specifications] 1. Open the vaccine vial and add the indicated amount of diluent for reconstitution, shake well, and use immediately.

2. Administer the product by subcutaneous injection at the attachment site of the deltoid muscle on the outer side of the upper arm.

3. Dosage: Children over 2 years old and adults are vaccinated once, and each human dose is 0.5ml. Vaccination should be completed before the epidemic season of cerebrospinal meningitis.

4. Booster immunization (recommended abroad): High-risk individuals in epidemic areas, especially children under 4 years old for the first vaccination, should consider revaccination 2 to 3 years after the initial immunization if they continue to be at high risk. Although it has not been determined whether revaccination is necessary for older children and adults, revaccination should be considered within 3 to 5 years after the initial immunization if the antibody level drops rapidly 2 to 3 years after vaccination.

There is no study data on the duration of immunity and booster immunization for this product.

[Adverse Reactions]

Local adverse reactions: Mainly pain at the vaccination site, followed by redness, swelling, and itching.

Systemic adverse reactions: Mainly fever, followed by headache, fatigue, drowsiness, nausea and vomiting, diarrhea, loss of appetite, myalgia, and rash, most of which can be relieved on their own and disappear within 72 hours.

[Contraindications] Do not use this product in the following cases:

1. Those who are known to be allergic to any ingredients of this product.

2. Those with epilepsy, convulsions, brain diseases, and a
history of allergies.

3. Patients with kidney disease, heart disease, active tuberculosis,
 HIV infected, and other acute diseases.

Individuals with severe chronic diseases, or are experiencing the
 acute exacerbation of chronic diseases

4. During any acute infection or febrile illness

5. This product has not been tested for reproductive toxicity in
pregnant women and experimental animals, and it is unknown
whether it will affect the fetus. Therefore, pregnant women
should not be vaccinated for this vaccine, especially in the first
three months of pregnancy.

[Storage] Keep in a dark place at 2-8°C for storage and
transportation.

[Shelf Life] 36 months

[Precautions] [Packaging] [Execution Standard] [Approval Document No.] See the instructions for details.