Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or neomycin.
Hypersensitivity after previous administration of hepatitis A and/or hepatitis B vaccines.
As with other vaccines, the administration of Ambirix should be postponed in subjects suffering from acute severe febrile illness.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reactions following the administration of the vaccine.
Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.
It is possible that subjects may be in the incubation period of a hepatitis A or hepatitis B infection at the time of vaccination. It is not known whether Ambirix will prevent hepatitis A and hepatitis B in such cases.
The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and other pathogens known to infect the liver.
Ambirix is not recommended for postexposure prophylaxis (e.g. needle stick injury).
If rapid protection against hepatitis B is required, the standard three dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen is recommended. This is because, a higher proportion of subjects are protected in the interval between the second and third dose of the three dose combined vaccine, than after a single dose of Ambirix. This difference is no longer present after the second dose of Ambirix (see section 5.1 for seroprotection rates).
It is recommended that the two-dose regimen of Ambirix be completed prior to start of sexual activity.
The vaccine has not been tested in patients with an impaired immune system. In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs antibody titers may not be obtained after the primary immunisation course.
Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, these routes should be avoided. However, exceptionally Ambirix can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects.
Ambirix should under no circumstances be administered intravascularly.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
No data on concomitant administration of Ambirix with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated. However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins there was no effect on seroconversion rates. Concomitant immunoglobulin administration may result in lower antibody titres.
When Ambirix was administered concomitantly with, but as a separate injection to a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV+Hib) or with a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory (see section 5.1).
Concomitant administration of Ambirix and other vaccines than those listed above has not been studied. It is advised that Ambirix should not be administered at the same time as other vaccines unless absolutely necessary.
Concomitant vaccines should always be administered at separate injection sites and preferably into different limbs.
It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved.
Ambirix can be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus.
Ambirix should only be used during breast-feeding when the possible advantages outweigh the potential risks.
No fertility data are available.
Ambirix has no or negligible influence on the ability to drive and use machines.
Clinical trials involved the administration of 2029 doses of Ambirix to 1027 subjects from 1 year up to and including 15 years of age.
In 2 comparative trials in subjects aged 1-15 years, the incidences of local and general solicited symptoms after a two dose regimen of Ambirix was overall similar to that seen with the three dose combined vaccine containing 360 ELISA Units of HAV and 10 µg of HBsAg.
The most commonly reported adverse reactions following Ambirix administration are pain and fatigue occurring in an approximated per dose frequency of 50% and 30% respectively.
Local and general adverse reactions reported following primary vaccination with Ambirix were categorised by frequency.
Adverse reactions reported are listed according to the following frequency: Very common ≥1/10, Common ≥1/100 to <1/10, Uncommon ≥1/1,000 to <1/100, Rare ≥1/10,000 to <1/1,000, Very rare <1/10,000.
The following adverse reactions were reported during clinical trials with Ambirix.
Clinical trial data:
Very common: appetite lost
Very common: irritability
Very common: headache
Common: drowsiness
Common: gastrointestinal symptoms
Very common: fatigue, pain and redness at the injection site
Common: fever, swelling at the injection site
In addition, the following adverse reactions were reported during clinical trials with GlaxoSmithKline’s other combined hepatitis A and hepatitis B vaccines (given as a 3 or 4 dose schedule).
Uncommon: upper respiratory tract infection
Rare: lymphadenopathy
Uncommon: dizziness
Rare: paraesthesia
Rare: hypotension
Common: diarrhoea, nausea
Uncommon: vomiting, abdominal pain*
Rare: pruritus, rash
Very rare: urticaria
Uncommon: myalgia
Rare: arthralgia
Common: malaise, injection site reaction
Rare: chills, influenza like illness
* refers to adverse reactions observed in clinical trials performed with the paediatric formulation
Post-marketing data:
Because these events were reported spontaneously, it is not possible to reliably estimate their frequency.
The following adverse reactions were reported during post-marketing surveillance following vaccination with Ambirix.
Immune system disorders: Allergic reactions including anaphylactic and anaphylactoid reactions.
Nervous system disorders: Syncope or vasovagal responses to injection, localised hypoaesthesia.
Following widespread use of either GlaxoSmithKline’s combined hepatitis A and hepatitis B vaccines or the monovalent hepatitis A and/or hepatitis B vaccines, the following adverse reactions have additionally been reported.
Infections and infestations: Meningitis.
Blood and lymphatic system disorders: Thrombocytopenic purpura, thrombocytopenia.
Immune system disorders: Allergic reactions including mimicking serum sickness, angioneurotic oedema.
Nervous system disorders: Multiple sclerosis, encephalitis, encephalopathy,polyneuritis such as Guillain-Barré syndrome (with ascending paralysis), myelitis, convulsions, paralysis, facial palsy, neuritis, optic neuritis, neuropathy.
Vascular disorders: Vasculitis.
Hepatobiliary disorders: Abnormal liver function tests.
Skin and subcutaneous tissue disorders: Erythema multiforme, lichen planus.
Musculoskeletal and connective tissue disorders: Arthritis, muscular weakness.
General disorders and administration site conditions: Immediate injection site pain, stinging and burning sensation.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable.
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