Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: MSD VACCINS, 162 avenue Jean Jaurès, 69007, Lyon, France
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine (see section 4.8).
This vaccine may contain traces of formaldehyde and potassium thiocyanate, which are used during the manufacturing process. Therefore, hypersensitivity reactions may occur (see sections 2 and 4.8).
Use caution when vaccinating latex-sensitive individuals since the vial stopper contains dry natural latex rubber that may cause allergic reactions.
For clinical or laboratory monitoring regarding immunocompromised individuals or individuals with known or presumed exposure to hepatitis B virus, see section 4.2
The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity (see section 4.8). As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination. The vaccine may not prevent hepatitis B infection in such cases.
The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E and other pathogens known to infect the liver.
Caution should be exercised when prescribing to pregnant or breast-feeding women. (see section 4.6).
This medicinal product contains less than 1mmol sodium (23 mg) per dose, and is considered to be essentially sodium free.
This vaccine can be administered:
HBVAXPRO has not been evaluated in fertility studies.
There is no clinical data on the use of HBVAXPRO on pregnant women. The vaccine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
There is no clinical data on the use of HBVAXPRO on breast-feeding women.
No studies on the effects on the ability to drive and use machines have been performed. However, HBVAXPRO is expected to have no or negligible influence on the ability to drive and use machines.
The most common side effects seen are injection-site reactions: transient soreness, erythema, induration.
The following undesirable effects have been reported following the widespread use of the vaccine.
As with other hepatitis B vaccines, in many instances, the causal relationship to the vaccine has not been established.
| Adverse reactions | Frequency |
|---|---|
| General disorders and administration site conditions | |
| Local reactions (injection site): Transient soreness, Erythema, Induration | Common (≥1/100 to, <1/10) |
| Fatigue, Fever, Malaise, Influenza-like symptoms | Very rare (<1/10,000) |
| Blood and the lymphatic system disorders | |
| Thrombocytopaenia, Lymphadenopathy | Very rare (<1/10,000) |
| Immune system disorders | |
| Serum sickness, Anaphylaxis, Polyarteritis nodosa | Very rare (<1/10,000) |
| Nervous system disorders | |
| Paresthesia, Paralysis (including Bell’s palsy, facial paralysis), Peripheral neuropathies (polyradiculoneuritis, Guillain Barre Syndrome), Neuritis (including optical neuritis), Myelitis (including transverse Myelitis), Encephalitis, Demyelinating disease of the central nervous system, Exacerbation of multiple sclerosis, Multiple sclerosis, Seizure, Headache, Dizziness, Syncope | Very rare (<1/10,000) |
| Eye Disorders | |
| Uveitis | Very rare (<1/10,000) |
| Vascular disorders | |
| Hypotension, Vasculitis | Very rare (<1/10,000) |
| Respiratory, thoracic and mediastinal disorders | |
| Bronchospasm-like symptoms | Very rare (<1/10,000) |
| Gastrointestinal disorders | |
| Vomiting, Nausea, Diarrhoea, Abdominal pain | Very rare (<1/10,000) |
| Skin and subcutaneous tissue disorders | |
| Rash, Alopecia, Pruritus, Urticaria, Erythema multiforme, Angioedema, Eczema | Very rare (<1/10,000) |
| Musculoskeletal, connective tissue and bone disorders | |
| Arthralgia, Arthritis, Myalgia, Pain in extremity | Very rare (<1/10,000) |
| Investigations | |
| Elevation of liver enzymes | Very rare (<1/10,000) |
Apnoea in very premature infants (born ≤28 weeks of gestation) (see section 4.4).
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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