AVAXIM 160EU Suspension for injection in pre-filled syringe

Traceability In order to improve the traceability of biological medicinal products, the name of the administered product and the batch number should be clearly recorded. The vaccine must not be administered intravenously: ensure that the needle has not penetrated a blood vessel. As with any other vaccination, it is recommended to have an injectable adrenaline solution available in case of an anaphylactic reaction. Caution is required when administering the vaccine intramuscularly to patients with thrombocytopenia or other bleeding disorders.‍​‍‍‍​‍‍‍‍‍‍‍‍​‍ In such cases, the vaccine may be administered subcutaneously. The vaccine should not be injected into the gluteal region due to the variability of this anatomical site (variable amount of adipose tissue) and should not be administered intradermally, as these routes of administration may result in a lower immune response. Syncope (fainting) may occur after or even before vaccination, particularly in adolescents, as a psychogenic reaction to the needle. This may be associated with various neurological signs such as transient visual disturbance, paraesthesia, and tonic-clonic limb movements during recovery. It is important to ensure in advance that injury cannot occur in the event of fainting. The immune response to the vaccine may be diminished during immunosuppressive therapy or in immunodeficient individuals. In such cases, it is recommended to postpone vaccination until after completion of treatment or to ensure that the individual is adequately protected. However, vaccination of individuals with chronic immunodeficiency, such as HIV infection, is recommended, provided their underlying condition still permits the elicitation of an antibody response, even if limited. If the individual is in the incubation period of the disease, the infection may not be apparent given the length of the incubation period, and vaccination in such cases may not prevent the development of hepatitis A. Caution should be exercised when administering the vaccine to individuals with hepatic disease, as studies in these individuals have not been conducted. The vaccine contains trace amounts of neomycin; caution should be exercised in patients with hypersensitivity to this antibiotic. Avaxim contains ethanol, phenylalanine, potassium, and sodium. Avaxim contains 2 mg of alcohol (ethanol) per 0.5 ml dose. Such a small amount of alcohol in this medicinal product has no noticeable effects. Avaxim contains 10 micrograms of phenylalanine per 0.5 ml dose, equivalent to 0.17 micrograms/kg for a person weighing 60 kg. Phenylalanine may be harmful in individuals with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in tissues because the body cannot properly eliminate it. Avaxim contains less than 1 mmol of potassium (39 mg) and sodium (23 mg) per dose, meaning it is essentially 'potassium-free' and 'sodium-free'.