Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: GlaxoSmithKline Biologicals s.a., Rue de lInstitut 89, B-1330 Rixensart, Belgium
Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients).
The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine.
As pre-haemodialysis and haemodialysis patients are particularly exposed to HBV and have a higher risk to become chronically infected, a precautionary attitude should be considered i.e. giving a booster dose in order to ensure a protective antibody level as defined by national recommendations and guidelines.
Fendrix can be used as a booster dose after a primary vaccination course with either Fendrix or any other commercial recombinant hepatitis B vaccine.
Data on concomitant administration of Fendrix with specific hepatitis B immunoglobulin (HBIg) have not been generated. However, in circumstances where exposure to HBV has recently occurred (e.g. stick with contaminated needle) and where simultaneous administration of Fendrix and a standard dose of HBIg is necessary, these should be given at separate injection sites.
The safety and efficacy of Fendrix in children aged less than 15 years have not been established.
Fendrix should be injected intramuscularly in the deltoid region.
Limited data on overdose are available.
3 years.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Store in the original package in order to protect from light.
0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger stopper (rubber butyl) with or without separate needle in a pack size of 1, or without needles in a pack size of 10.
Not all pack sizes may be marketed.
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Before administration, the vaccine should be well shaken to obtain a slightly opaque, white suspension.
The vaccine should be visually inspected both before and after re-suspension for any foreign particulate matter and/or change in physical appearance. The vaccine must not be used if any change in the appearance of the vaccine has taken place.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
