GC Flu

Purified split inactivated influenza virus.

1 pre-filled syringe 0.5 mL and 1 Vial 0.5 mL contains: Purified Inactivated Influenza Virus Antigen 45 μg, purified inactivated influenza virus antigen type A [A/Singapore/GP1908/2015 IVR-180 (H₁N₁)] 15 μg, purified inactivated influenza virus antigen type A [A/Hong Kong/4801/2014 NYMC X-263B (H₃N₂)] 15 µg, purified inactivated influenza virus antigen type B [B/Brisbane/60/2008] 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., needle (sterilized disposable needle) (25G x 5/8 (0.5 x 16 mm)) 1 ea.
GC FLU is pre-filled syringe and vial containing colorless or slightly whitish liquid made by splitting and inactivating influenza virus cultured by inoculating in the allantoic cavity of embryonated egg in order to maintain antigenicity. Influenza virus antigen is inactivated with formaldehyde and this vaccine complies with the WHO recommendations for the 2017 season.

Prophylaxis against influenza.

An intramuscular injection of the following doses and immunization of one dose is necessary in every year at same volume.
6-35 months old: A single dose of 0.25 mL (7.5 µg) intramuscular injection.
3-8 years old: A single dose of 0.5 mL (15 µg) intramuscular injection.
9 years and older: A single dose of 0.5 mL (15 µg) intramuscular injection.
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.

Examine vaccinee by history taking and visual inspection and if necessary, by auscultation and percussion. Then, vaccination is prohibited when vaccinee is diagnosed as one of the following cases. But vaccination can be performed in case that there is a danger of infection with influenza virus and no possibility to cause significant disorder by vaccination.
Febrile patient or the person with malnutrition.
Person with acute, or gradually serious or active cardiovascular, kidney and liver disease.
Patients with acute respiratory disease or other active infectious disease.
Patients in latent period and convalescence.
Person who showed anaphylaxis by the components of GC FLU.
Person with hypersensitivity to egg, chicken, any other chicken component, and GC FLU 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 within 6 weeks from the previous influenza vaccination or person with neurological disorders.
Person whose state is not healthy enough to be vaccinated besides the above cases.

Inject with care on: Pregnant woman or those suspected to be pregnant.
Person who has chronic cardiovascular disorders, chronic respiratory disorders or diabetes can be markedly deteriorated if the person is infected with influenza.
Accordingly, inject with care if vaccination is needed.
General precautions: Advise the vaccinee or their guardians that the vaccinee should keep equilibrium, keep the injection site clean, and when the symptoms of high fever, convulsion appear, they should consult a physician quickly.
Antibody reaction can not be sufficient in endogenous or iatrogenic immune deficient patients.
Influenza should be vaccinated (September-November) before prevailing. Vaccination can be delayed according to epidemiological situation.
Influenza should be vaccinated with the influenza vaccines produced with current-year-recommended strains.
Precautions in administration: 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.

Studies for animals and pregnant women have not been conducted with GC FLU. GC FLU should be given to pregnant or pregnant-suspect women only when necessary.
It is not known whether GC FLU is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GC FLU is administered to a nursing women.

There is the possibility of local reactions such as redness, swelling and pain, or systemic reactions such as fever, rigor, headache, fatigue and vomiting. But they usually disappear within 2-3 days.
Encephalomyelitis: In rare cases, acute diffuse 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 MRl 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. And palsy, neuralgia, cerebral hemorrhage or inflammation of the nervous system (ex. Guillain-Barre syndrome) have been reported.
Safety of GC FLU was evaluated regarding 226 children (6 months-under 18 years), 803 adults (18 years-under 60 years) and 173 elderly (60 years -), and the adverse events are as follows.
849 (70.63%) out of 1, 202 subjects showed adverse events; Children 74.78%, adults 74.10% and elderly 49.13%. Most of them were solicited adverse events (68.55%), and unsolicited adverse events were 139 (11.56%). Drug related adverse events were 48 (3.99%). See table.

Click on icon to see table/diagram/image

Serious adverse events were reported 5 subjects. Except for 1 case (convulsion), the rest were evaluated as 'not related' (acute convulsive abdominal pain: 1 case, atelectasis: 1 case), or 'possibly not related' (gastroenteritis: 2 cases, bronchitis: 1 case).
Adverse events were collected for 21 days after vaccination, and they were reported 139 subjects (11.56%) among 1, 202 subjects. The most frequent events were respiratory adverse events (64 subjects, 5.32%), and all subjects who had experienced adverse events were recovered without sequela. Adverse events of which relativity can not be excluded from GC FLU were 48 subjects (3.99%) as follows.
(Occasionally: 0.1%-<5%; Rare: <0.1%).
Respiratory System: Occasionally: Coryza, rhinorrhoea, throat sore, pharyngitis, rhinitis.
Rare: Upper respiratory tract infection, coughing, bronchitis.
Gastro-Intestinal System: Rare: Gastroenteritis, vomiting, diarrhoea, nausea.
Central and Peripheral Nervous System: Occasionally: Dizziness.
Rare: Cramps legs, migraine, muscle contractions involuntary.
Skin and Appendages: Occasionally: Pruritus.
Rare: Urticaria.
Vision Disorder: Rare: Abnormal sensation in eye, asthenopia.
Metabolic and Nutritional disorder: Rare: Edema uvula.
White Cell and Res Disorders: Rare: WBC abnormal nos.
Psychiatric Disorders: Rare: Sleep disorder.
Local and systemic adverse events: Occasionally: Injection site pruritus, swelling and pruritus.
Rare: Injection site erythema, syncope, fatigue, pallor.
Cardiovascular disorder: Rare: Palpitation.

There is no data or study on co-administration of GC FLU 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.
Immunization can be affected by concomitant immunosuppressive therapy or an existing immunodeficiency.
False positive ELISA serologic tests for HIV-1, Hepatitis C, and especially HTLV-1 may occur following influenza vaccination. These transient false-positive results may be due to cross-reactive lgM elicited by the vaccine.
Advise the vaccinee or their guardians that the vaccinee should keep equilibrium, keep the injection site clean, and when the symptoms of high fever, convulsion appear, they should consult a physician immediately.
Following medicinal products may cause interaction with GC FLU: Medicinal products in order to control epilepsy or paroxysmal (phenytoin, carbamazepine, phenobarbitone).
Theophylline.
Warfarin.
Immune globulin.
Immune inhibitory agents (corticosteroid, cyclosporine, anticancer drug (including radiation therapy) etc.

Precautions in handling: Do not use if the vaccine has been frozen.
The vaccine should be shaken well and mixed homogeneously before use.
The product should be used immediately once opened.

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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