HEPLISAV B Solution for injection in pre-filled syringe (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

HEPLISAV B 20 micrograms solution for injection in pre-filled syringe. Hepatitis B vaccine (recombinant DNA, adjuvanted).

2. Qualitative and quantitative composition

One dose (0.5 ml) contains: Hepatitis B surface antigen (HBsAg)1,2: 20 micrograms. 1 Adjuvanted with 3000 micrograms CpG 1018 adjuvant, a 22-mer oligonucleotide comprising microbial DNA-like ...

3. Pharmaceutical form

Solution for injection in pre-filled syringe. Clear to slightly opalescent, colourless to slightly yellow solution.

4.1. Therapeutic indications

HEPLISAV B is indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The use of HEPLISAV B should ...

4.2. Posology and method of administration

Posology Adults The vaccine is administrated intramuscularly. Primary vaccination Two doses of 0.5 ml each: an initial dose followed by a second dose 1 month later. Booster dose The need for a booster ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1. Severe allergic reaction, such as anaphylaxis, after a previous dose of any hepatitis B vaccine. Hypersensitivity ...

4.4. Special warnings and precautions for use

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. HEPLISAV B should not be administered ...

4.5. Interaction with other medicinal products and other forms of interaction

There are no data on co-administration of HEPLISAV B with other vaccines, the concomitant use of HEPLISAV B with other vaccines is not recommended. There are no data with HEPLISAV B in individuals with ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are a limited amount of data from the use of HEPLISAV B vaccine in pregnant women. Animal studies do not indicate direct or indirect harmful effects of relevance to humans with respect ...

4.7. Effects on ability to drive and use machines

HEPLISAV B may have a moderate influence on the ability to drive and use machine. Some of the effects mentioned under Section 4.8 Undesirable Effects (e.g., malaise) may affect the ability to drive or ...

4.8. Undesirable effects

Summary of the safety profile The clinical trials safety profile is based on data from 9365 subjects followed in 3 pivotal studies. In two studies, 3777 of the 9365 subjects were monitored for local and ...

4.9. Overdose

No cases of overdose have been reported.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Vaccines, Viral Vaccines, Hepatitis Vaccine ATC code: J07BC01 Mechanism of action HEPLISAV B is comprised of recombinant hepatitis B surface antigen and the CpG ...

5.2. Pharmacokinetic properties

The pharmacokinetic properties of the hepatitis B surface antigen used in HEPLISAV B have not been assessed. Renal Impairment The CpG 1018 adjuvant is cleared from plasma within 24 hours in renally-impaired ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies consisting of single-dose and repeat-dose toxicity (including local tolerance), and reproductive and developmental toxicity. ...

6.1. List of excipients

Sodium chloride Disodium phosphate dodecahydrate Sodium dihydrogen phosphate dihydrate Polysorbate 80 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 to 8°C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light.

6.5. Nature and contents of container

0.5 ml of solution in a pre-filled syringe (Type I glass) with tip cap (synthetic isoprene-bromobutyl rubber blend) and plunger stopper (chlorobutyl rubber). Syringes are provided without needles in packages ...

6.6. Special precautions for disposal and other handling

HEPLISAV B is a clear to slightly opalescent, colourless to slightly yellow liquid and should be essentially free of visible particles. Do not administer if it appears otherwise. Any unused medicinal product ...

7. Marketing authorization holder

Dynavax GmbH, Eichsfelder Strasse 11, D-40595 Düsseldorf, Germany

8. Marketing authorization number(s)

EU/1/20/1503/001

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