GC Flu

Each dose (0.5 mL) contains the following strains: Active Ingredient: Purified Inactive Influenza Virus Antigen 45 μg, Purified Inactive Influenza Virus Antigen Type A [A/Victoria/4897/2022 IVR-238(H1N1)] 15 μg, Purified Inactive Influenza Virus Antigen Type A [A/Croatia/10136RV/2023 NYMC X-425A(H3N2)] 15 μg, Purified Inactive Influenza Virus Antigen Type B [B/Austria/1359417/2021 BVR-26] 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 16mm)) 1 ea.
GC FLU is pre-filled syringe 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 2025 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 to 35 months old: a single dose of 0.5 mL intramuscular injection.
3~8 years old: A single dose of 0.5 mL intramuscular injection.
9 years and older: A single dose of 0.5 mL 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.

A vaccine overdose is very unlikely, but it is possible to have a severe allergic reactions to a vaccine. Patients should seek medical attention immediately at the first sign of any suspected adverse drug reaction.

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.
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 showed the symptom of convulsion within 1 year before vaccination.
Person who showed Guillain-Barre syndrome within 6 weeks from the previous influenza vaccination or person with neurological disorders.

Take special care: As with other vaccines, the vaccine should be administered with caution to subjects who are taking medicines that affect immune system or having immunodeficiency since it may not be expected to achieve targeted immune response after vaccination. The vaccine should be administered with caution to subjects who are planning to have a blood test during the next few days after vaccination because the vaccination may results in false positive blood test results in few cases. The vaccination does not mean full protection to vaccinee from virus infection like other vaccines.
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 cannot be sufficient in endogenous or iatrogenic immune deficient patients.
Influenza should be vaccinated with the influenza vaccines produced with current-year-recommended strains.

Administration for pregnant and lactating women: The vaccination is acceptable during period of pregnancy. Relatively larger safety data are obtained from second and third trimester of pregnancy to that of first trimester, and data collected from worldwide shows that fetus and pregnant mother did not experience any adverse reaction caused by vaccination. The vaccination during the breast feeding may be acceptable.
WHO recommends "For countries considering the initiation or expansion of programmes for seasonal influenza vaccination, pregnant women should have the highest priority. Pregnant women should be vaccinated with TIV at any stage of Pregnancy. This recommendation is based on evidence of a substantial risk of severe disease in this group and evidence that seasonal influenza vaccine is safe throughout pregnancy and effective in preventing influenza in the women as well as in their young infants, in whom the disease burden is also high." (WHO weekly Epidemiological Record, 23 November 2012, 87th year, No. 47, 2012, 474).

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 MRI and so on.
Severe allergic reactions including anaphylaxis 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, encephalitis/encephalopathy, myelitis, or optic neuritis) have been reported after immunization with influenza vaccines. Myelitis may occur in conjunction with encephalitis and transverse myelitis in conjunction with ADEM. Deferral of further immunization may be considered until the neurologic condition has been diagnosed or is stable.
Vasculitis may occur in very rare cases. Caution should be required when patients with small vessel vasculitis or post-influenza vaccination-reactivated IgA vasculitis receive influenza vaccination again.
Oculo-respiratory Syndrome (ORS), a transient condition that is characterized by bilateral red eyes, facial edema, and upper respiratory symptoms may occur in extremely rare instances after influenza immunization. Individuals who experienced ORS with lower respiratory tract symptoms should have an expert consultation prior to immunization with influenza vaccine.
Vaccination failure, convulsion/seizure, Impaired efficacy by immunosuppressant and Inference with HIV 1, HCV, HTL V1 ELISA (serological test) may occur in very rare cases.
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%).
Adverse events which were collected for 6 days after vaccination are listed as follows. (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 cannot be excluded from GC FLU were 48 subjects (3.99%) as follows.
(Occasionally: 0.1%~<5%; Rare: <0.1%).
Respiratory System: Occasionally: Coryza, rhinorrhoea, sore throat, pharyngitis, rhinitis.
Rare: Upper respiratory tract infection, coughing, bronchitis.
Gastro-Intestinal System: Rare: Gastroenteritis, vomiting, diarrhoea, nausea.
Central & Peripheral Nervous System: Occasionally: dizziness.
Rare: Cramps legs, migraine, involuntary muscle contractions.
Skin & Appendages: Occasionally: Pruritus.
Rare: Urticaria.
Vision Disorder: Rare: Abnormal sensation in eye, asthenopia.
Metabolic and Nutritional Disorder: Rare: Edema uvula.
White Cell and Reticuloendothelial System Disorders: Rare: WBC abnormal nos. (Eosinophils increase).
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 IgM 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 administration: 1. Before use check this product visually for particles or discoloration. If either is present, do not use.
2. 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.
3. Intravenous administration is prohibited.
4. The tip of needle should not penetrate blood vessel.
5. Do not mix with other vaccines in same syringe.
6. Foods, Drugs, Devices, and Cosmetics Act Prohibits dispensing without prescription.
Precautions in handling: 1. Do not use if the vaccine has been frozen.
2. The vaccine should be shaken well and mixed homogeneously before use.
3. The product should be used immediately once opened.

Store at temperatures not exceeding 2-8°C. Do Not Freeze.
Validity: 12 months from the date of manufacture.

Vaccines, Antisera & Immunologicals

J07BB - Influenza vaccines ; Used for active immunizations.

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