Indications / Uses of BARYCELA inj. Varicella Vaccine
BARYCELA inj. is a live attenuated varicella (Varicella-Zoster Virus) vaccine derived from the attenuated MAV/06 strain. It induces an immune response for the prevention of varicella infection.

The vaccine is indicated for active immunization to prevent varicella in children from 12 months to 12 years of age.

Image: BARYCELA inj. Varicella Vaccine (Korea)

Dosage and Administration of BARYCELA inj. Varicella Vaccine

Dosage: 0.5 mL of the vaccine after reconstitution.

Route of administration: Subcutaneous injection; the recommended injection site is the lateral upper arm.

Contraindications

This vaccine is contraindicated to the following patients:

• Patients with known hypersensitivity to any component of the vaccine.
• Patients with primary or acquired immunodeficiency due to conditions such as acute or chronic leukemia, lymphoma, or other disorders affecting the bone marrow or lymphatic system; immunodeficiency due to HIV/AIDS; or cell-mediated immunodeficiency.
• Patients receiving immunosuppressive therapy.
• Patients with untreated active tuberculosis.
• Pregnant women.
• Patients with febrile respiratory illness or other febrile infectious diseases.

Warnings and Precautions

As with all injectable vaccines, appropriate emergency measures—including injectable epinephrine (1:1000)—and close medical supervision must be readily available in case an anaphylactic or hypersensitivity reaction occurs after vaccination. This vaccine must NOT be administered intravenously (IV) or intramuscularly (IM).

If acute conditions such as fever exceeding 38°C are present, postponement of vaccination should be considered.

As with all varicella vaccines, this vaccine does not guarantee absolute prophylactic efficacy in all vaccine recipients.

Viral transmission of this vaccine strain was not identified in clinical trials. However, post-marketing studies of a similar vaccine have confirmed that, in rare cases, the virus may be transmitted through contact between healthy vaccinated individuals who develop a varicella-like rash and healthy but susceptible individuals. Transmission from vaccinated individuals without a varicella-like rash has also been reported.

Therefore, vaccinated individuals should avoid close contact for 6 weeks with the following high-risk susceptible groups:

• Immunocompromised persons

• Pregnant women without a medical history of varicella or laboratory evidence of immunity

• Newborns of pregnant women without a medical history of varicella or laboratory evidence of immunity

Adverse Reactions

Very common (≥10%)

• Local reactions: pain, tenderness, erythema/redness, induration.
• Systemic reactions: cough, fever, anorexia/loss of appetite.
• Infections and infestations: nasopharyngitis.

Common (≥1% to <10%)

• Local reactions: swelling, urticaria, pruritus.
• Systemic reactions: fatigue, headache, vomiting/nausea, constipation, abdominal pain, rash, dyspnea, allergic reactions.
• Infections and infestations: bronchitis, gastroenteritis, hand-foot-mouth disease, pharyngitis, pneumonia, viral pneumonia, rhinitis, upper respiratory tract infection, viral infection.
• Other: diarrhea, dermatitis, vesicular rash.

Uncommon (≥0.1% to <1%)

• Systemic reactions: hypersensitivity.
• Infections and infestations: bronchiolitis, viral gastritis, viral gastroenteritis, impetigo, otitis media, respiratory syncytial virus pneumonia, tonsillitis, gastritis.

Drug Interactions

Nếu truyền máu, hoặc huyết tương, hoặc nếu sử dụng globulin miễn dịch, hoặc globulin miễn dịch varicella-zoster, thì vắc xin này nên được sử dụng sau một khoảng thời gian tối thiểu (từ 3 đến 11 tháng), tùy thuộc vào nhóm, liều lượng và thành phần của các chế phẩm máu và globulin miễn dịch.

Không được dùng Barycela inj. đồng thời với các globulin miễn dịch, kể cả globulin miễn dịch varicella-zoster. Ngoài ra, không được dùng globulin miễn dịch trong vòng 2 tháng sau khi tiêm vắc xin này, trừ khi lợi ích vượt trội so với lợi ích của việc tiêm vắc xin.

Không sử dụng salicylate trong vòng 6 tuần sau khi tiêm vắc xin Barycela inj., do hội chứng Reye đã được báo cáo khi sử dụng salicylate trong thời gian nhiễm bệnh thủy đậu.

If blood or plasma transfusions, immunoglobulins, or varicella-zoster immunoglobulins have been administered, this vaccine should be given only after a minimum interval of 3 to 11 months, depending on the type, dose, and components of the blood products or immunoglobulin preparations.

BARYCELA inj. must not be administered concomitantly with immunoglobulins, including varicella-zoster immunoglobulin. In addition, immunoglobulins must not be administered within 2 months after vaccination unless the benefits of immunoglobulin administration outweigh the benefits of vaccination.

Salicylates must not be used for 6 weeks after the administration of BARYCELA inj., as Reye’s syndrome has been reported in association with salicylate use during natural varicella infection.

Overdose and Management

No data are available regarding overdose with BARYCELA inj.; the recommended dose must not be exceeded.

Precautions for Use

• The vaccine must be stored under refrigeration, and once reconstituted, it must be used immediately and within 30 minutes. The reconstituted vaccine must not be frozen.
• A separate sterile syringe and needle must be used for each individual to prevent the transmission of infectious diseases; needles must not be reused and must be appropriately discarded after use.
• Only the enclosed diluent must be used for reconstitution.
• Transferring the vaccine into another container may lead to errors and is undesirable for maintaining product quality.
• This vaccine must not be mixed with other medicinal products, including other viral vaccines.

Packaging

• Box containing 1 vial of lyophilized vaccine + 1 vial of 0.7 ml diluent
• Box containing 10 vials of lyophilized vaccine + 10 vials of 0.7 ml diluent

Storage Method:

Store under refrigeration at 2–8°C in a light-shielded, airtight container.

Shelf Life: The shelf life is 24 months from the date of manufacture.

Quality Standards: TCCS (lyophilized powder) and current EP (accompanying diluent)

Manufacturer: GC Biopharma Corp. 40 Sandan-gil, Hwasun-eup, Hwasun-gun, Jeollanam-do, Korea.

NAVIVA GROUP – A TRUSTED PARTNER IN MARKETING AND DISTRIBUTION OF VACCINES & BIOLOGICAL PRODUCTS

Naviva Group is currently the exclusive distributor of the BARYCELA inj. Varicella Vaccine, manufactured by GC Biopharma (Korea).
For further information, please contact:

NAVIVA GROUP JOINT STOCK COMPANY

NAM HUNG VIET VACCINE AND BIOLOGICAL PRODUCTS JOINT STOCK COMPANY

• Address: 89 Nguyen Thi Thap Street, Him Lam Area, Tan Hung Ward, Ho Chi Minh City, Vietnam
• Tel: 028 2223 2425

TUONG KHUE PHARMACEUTICAL JOINT STOCK COMPANY

• Address: 33 Le Lai Street, Hai Chau Ward, Da Nang City, Vietnam
• Tel: 0236 3538 666

WINBIO JOINT STOCK COMPANY

• Address: K7TT1 – SH19, Starlake Urban Area, Xuan Dinh Ward, Hanoi Capital, Vietnam
• Tel: 024 3795 6789

NAVIVA GROUP

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