Barycela inj. varicella vaccine.

Barycela inj. is an effective varicella vaccine for children aged 12 months to 12 years. When administered, the vaccine stimulates the immune system to actively produce specific antibodies, helping protect children against the varicella-zoster virus, reduce the risk of infection, and prevent serious complications.

The vaccine contains live attenuated varicella-zoster virus of the MAV/06 strain. It is formulated as a lyophilized powder for injection and administered by the subcutaneous route. According to the product registration dossier approved by the Drug Administration of Vietnam, each 0.5 ml dose after reconstitution contains a minimum of 3,800 PFU, ensuring consistent protective efficacy and stability throughout its shelf life.

This article provides information about Barycela inj., including its indications, eligible users, dosage, administration, contraindications, warnings, adverse reactions, and storage conditions. The content is compiled from product information and reliable medical references.

Antibiotic-free Barycela inj. varicella vaccine.

According to the manufacturer, Barycela inj. is produced using advanced manufacturing technology aimed at eliminating the use of antibiotics through process improvements. The final vaccine product does not contain antibiotics, helping reduce concerns about the risk of antibiotic-related allergic reactions in children. This may also support healthcare professionals in providing consultations and give parents greater peace of mind when choosing a disease prevention solution.

The composition of 0.5 mL of reconstituted Barycela inj. contains:

Before vaccination, individuals should undergo medical examination and screening in accordance with applicable regulations. This includes assessing factors such as allergy history, immune status, existing medical conditions, current medications, and the contraindications specified in the product information.

Pre-vaccination assessment helps healthcare professionals evaluate the individual’s health status and determine whether the vaccine is appropriate for each specific case.

For more information about the composition of Barycela inj. and the relevant information regarding the varicella vaccine without antibiotics in the finished product, please refer to the detailed article below:

Antibiotic-free Barycela varicella vaccine

Indications and eligible users

Barycela inj. is a live attenuated varicella vaccine indicated for active immunization against chickenpox caused by the varicella-zoster virus.

Barycela inj. is indicated for children aged 12 months to 12 years.

Recommended 2-dose schedule:

• Dose 1: From 12 months of age
• Dose : 3 months after the first dose (minimum interval: 4 weeks)

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

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.

References

1. The approved and licensed package insert for Barycela inj. in Vietnam.
2. World Health Organization (WHO). Varicella and herpes zoster vaccines: WHO position paper, June 2014. Weekly Epidemiological Record, 89(25), 265–287.
3. Centers for Disease Control and Prevention (CDC). Varicella. In: Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book).

WHO and CDC resources provide general information about varicella and varicella vaccines. The indications, dosage, administration, and storage conditions specific to Barycela inj. should be based primarily on the product information approved for use in Vietnam.

Note: This article is for informational purposes only and is not a substitute for medical advice. Vaccination should be preceded by appropriate medical screening and administered based on the assessment and recommendation of a healthcare professional.

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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