FENDRIX Suspension for injection (2022)
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Περιεχόμενα
1. Name of the medicinal product
Fendrix suspension for injection. Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
2. Qualitative and quantitative composition
1 dose (0.5 ml) contains: Hepatitis B surface antigen<sup>1,2,3</sup>: 20 micrograms. 1 adjuvanted by AS04C containing: -3-O-desacyl-4'-monophosphoryl lipid A (MPL)<sup>2</sup>; 50 micrograms 2 adsorbed ...
3. Pharmaceutical form
Suspension for injection. Turbid white suspension. Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
4.1. Therapeutic indications
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 ...
4.2. Posology and method of administration
Posology Primary immunisation 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, ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity after previous administration of other hepatitis B vaccines. The administration of Fendrix should ...
4.4. Special warnings and precautions for use
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine. Because ...
4.5. Interaction with other medicinal products and other forms of interaction
No data on the concomitant administration of Fendrix and other vaccines or with specific hepatitis B immunoglobulin have been generated. If concomitant administration of specific hepatitis B immunoglobulin ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no data from the use of Fendrix in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition ...
4.7. Effects on ability to drive and use machines
Fendrix has moderate influence on the ability to drive and use machine. Some of the undesirable effects mentioned under section 4.8 may affect the ability to drive or use machines.
4.8. Undesirable effects
Summary of the safety profile Clinical trials involving the administration of 2,476 doses of Fendrix to 82 pre-haemodialysis and haemodialysis patients and to 713 healthy subjects ≥15 years of age allowed ...
4.9. Overdose
Limited data on overdose are available.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Vaccines, hepatitis vaccines <b>ATC code:</b> J07BC01 Fendrix induces specific humoral antibodies against HBsAg (anti-HBs antibodies). An anti-HBs antibody titre ≥10 mIU/ml ...
5.2. Pharmacokinetic properties
Pharmacokinetic properties of Fendrix or MPL alone has not been studied in humans.
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional animal studies consisting of acute and repeated dose toxicity, cardiovascular and respiratory safety pharmacology and reproductive ...
6.1. List of excipients
Sodium chloride Water for injections For adjuvants, see section 2.
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light.
6.5. Nature and contents of container
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 ...
6.6. Special precautions for disposal and other handling
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 ...
7. Marketing authorization holder
GlaxoSmithKline Biologicals s.a., Rue de lInstitut 89, B-1330 Rixensart, Belgium
8. Marketing authorization number(s)
EU/1/04/0299/001 EU/1/04/0299/002 EU/1/04/0299/003
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 02 February 2005 Date of latest renewal: 10 December 2009
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