GC FLU Quadrivalent

Purified split inactivated influenza virus [type A (H1N1), type A (H3N2), type B (Victoria), type B (Yamagata)].

1 pre-filled syringe 0.5 mL contains Purified Inactivated Influenza Virus Antigen Type A [A/Victoria/2570/2019 IVR-215 (H1N1)] 15 µg, Purified Inactivated Influenza Virus Antigen Type A [A/Hong Kong/2671/2019 NIB-121 (H3N2)] 15 µg, Purified Inactivated Influenza Virus Antigen Type B [B/Washington/02/2019] 15 µg, Purified Inactivated Influenza Virus Antigen Type B [B/Phuket/3073/2013] 15 µg, Sodium chloride 4 mg, Potassium chloride 0.1 mg, Disodium hydrogen phosphate dihydrate 0.6 mg, Potassium dihydrogen phosphate 0.1 mg, Water for injection q.s.
This vaccine complies with the WHO recommendations (Northern Hemisphere) for 2021/2022 season.
Excipients/Inactive Ingredients: Sodium chloride, Potassium chloride, Disodium hydrogen phosphate dihydrate, Potassium dihydrogen phosphate, Water for injection.

Pharmacotherapeutic group: Influenza vaccine. ATC code: J07BB02.
Pharmacology: Pharmacokinetics: Not applicable.
Toxicology: Non-clinical safety data: Repeat dose toxicity study (including local tolerance test) and reproductive/developmental toxicity study were conducted in compliance with GLP requirements. Any significant drug-related adverse effect was not observed in the studies.

Prophylaxis against influenza caused by influenza A subtype viruses and type B viruses in adults and children aged 3 years and older.

An intramuscular injection of the following dose and immunization of one dose is necessary in every year at same volume.
Aged 3 years and older: A single dose of 0.5 mL.
The children younger than 9 years of age who have not been vaccinated or have not been infected by influenza should be vaccinated two doses at an interval of at least 4 weeks.

Cases of administration of more than the recommended dose (overdose) have not been reported with this product.

Examine subjects by history taking and visual inspection and if necessary, by auscultation and percussion. Vaccination is prohibited when subject is diagnosed as one of the following cases. However, if it seems to be infected with influenza and determined that there is no concern for disabilities due to vaccination, vaccination may be permitted.
Febrile patient or person with malnutrition.
Patients with cardiovascular disorders, kidney disorders, or liver disease in which the disease is in acute phase, stadium increment, or in active phase.
Patients with acute respiratory disease or other active infectious disease.
Patients in latent and convalescence period of influenza illness.
Person who showed anaphylaxis by the components of the product.
Person with hypersensitivity to egg, chicken, any other chicken component, and the product component.
Person who had fever within 2 days or a symptom of allergy such as generalized rash after the injection at previous vaccination.
Person who showed Guillain-Barre syndrome or person with neurological disorders within 6 weeks from the previous influenza vaccination.
Person in inappropriate condition to be vaccinated. Vaccination should be considered by a physician.

General precautions: Advise the subjects or their guardians that the subjects should keep equilibrium, keep the injection site clean, and when the symptoms of high fever, convulsion appear, they should consult a physician quickly.
Antibody response in patients with endogenous or iatrogenic immunosuppression or person diagnosed with immunodeficiency disease may be insufficient.
Influenza vaccine should be administered before prevailing. Vaccination can be delayed according to epidemiological situation.
Influenza vaccine should be administered with current-year recommended strains.
Special precautions: Person with chronic cardiovascular disorders, chronic respiratory disorders or diabetes can be markedly deteriorated if the person is infected with influenza. Accordingly, inject with care in case vaccination is needed.
Effects on ability to drive and use machines: Some of the effects mentioned under Adverse Reactions may affect the ability to drive or use machines.

Pregnancy: Restricted data on the use of the Inactivated Vaccine (egg-derived) during pregnancy.
No direct or indirect adverse effects related to reproductive toxicity and developmental toxicity were observed in animal studies conducted using this vaccine. However, clinical trials have not evaluated the safety of the pregnant women when administered this vaccine.
Nursing Mothers: Restricted data indicate that the Inactivated Influenza vaccine (egg-derived) is not known whether the product is excreted in human milk. There is no adequate study of vaccination in animals during lactation, and clinical trials have not evaluated the safety of nursing mothers when administered this vaccine.

There is possibility of local reactions such as redness, swelling and pain, or systemic reactions such as fever, chills, headache, fatigue and vomiting. But they usually disappear within 2-3 days.
In rare cases, acute disseminated encephalomyelitis (ADEM) may occur.
Fever, headache, convulsions, dyskinesia and consciousness disorder usually occur within 2 weeks following the administration of the vaccine. When these symptoms are suspected, appropriate medical treatment should be available by diagnosis with MRI and so on.
Allergic reaction or anaphylactic shock may occur in very rare cases.
Transient disorders of systemic and local nervous system may rarely occur. Palsy, neuralgia, cerebral hemorrhage or inflammation of the nervous system (ex: Guillain-Barre syndrome) have been reported.
Safety of the vaccine was evaluated for the three clinical studies performed with healthy adults, children-adolescent and elderly.
In children-adolescent aged 3 through 18 years who received the vaccine, 218 subjects (68.3%) out of 319 subjects showed adverse events. Adverse drug reactions were 63.9% and no serious adverse drug reactions were reported.
In adults aged 19 through 64 years who received the vaccine, 415 (71.18%) subjects out of 583 subjects showed adverse events. Adverse drug reactions were 68.4% and no serious adverse drug reactions were reported.
In adults aged 65 years and older who received the vaccine, 148 (43.79%) subjects out of 338 subjects showed adverse events. Adverse drug reactions were 41.42% and no serious adverse drug reactions were reported.
Solicited adverse drug reactions within 7 days of vaccination are listed in the table as follows. (See table.)

Click on icon to see table/diagram/image

Unsolicited adverse drug reactions occurring within 28 days or 21 days of vaccination were reported in 3 subjects (0.9%) from children-adolescent (General disorders and administration site conditions: 2 subjects, Infections: 1 subject), 13 subjects (2.23%) from adults (Infections: 5 subjects, investigations: 2 subjects, Respiratory thoracic and mediastinal disorders: 2 subjects, Musculoskeletal and connective tissue disorders: 1 subject, Nervous system disorders: 1 subject, Skin and subcutaneous tissue disorders: 1 subject, General disorders and administration site conditions: 2 subjects), and 4 subjects (1.18%) from elderly (Infections: 1 subject, General disorders and administration site conditions: 1 subject, investigations: 1 subject, Nervous system disorders: 1 subject).
Serious adverse events occurring within 6 months of vaccination were reported in 5 subjects (1.6%) from children-adolescent (Pharyngitis: 1 case, Headache: 1 case, Mesenteric lymphadenitis: 1 case, Acute gastroenteritis: 1 case, Peritonsillar Abscess: 1 case, Acute appendicitis: 1 case), 5 subjects (0.86%) from adults (Cystitis: 1 case, Pulmonary Tuberculosis: 1 case, Breast mass: 1 case, Ileus: 1 case, Gastric cancer: 1 case), and 4 subjects (1.18%) from elderly (Pain: 1 case, Arthralgia: 1 case, Herpes zoster: 1 case, Gastric cancer: 1 case), but they were evaluated as 'not related' to the product.

There is no data or study on co-administration of this product with other vaccines. If co-administration is inevitably required, injection site should be different. It should be noted that the adverse events may be increased.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Following influenza vaccination, false positive results in serologic tests using the ELISA method to detect antibodies against HIV-1, Hepatitis C, and especially HTLV-1 have been observed (The Western Blot technique disproves the false-positive ELISA test results). These transient false-positive results could be due to the IgM response by the vaccine.

Incompatibilities: Incompatibilities with other drugs have not been evaluated.
Special precautions for disposal and other handling: Before use check this product visually for particles or discoloration. If either is present, do not use.
The injection site is usually lateral upper arm and disinfected with ethanol or tincture of iodine. Repeated injections at the same site should be avoided.
Intravenous administration is prohibited.
The tip of needle should not penetrate blood vessel.
Do not mix with other vaccines in same syringe.
The vaccine should be shaken well and mixed homogeneously before use.
Pre-filled syringes are disposable and should not be reused.

Store at 2-8°C without freezing in hermetic container and protect from light.
Shelf-life: 12 months from the date of manufacture.

Vaccines, Antisera & Immunologicals

J07BB02 - influenza, inactivated, split virus or surface antigen ; Belongs to the class of influenza viral vaccines.

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