HBVAXPRO 10 Micrograms Suspension Injection Instruction Manual

HBVAXPRO 10 Micrograms Suspension Injection

Product Information

Specifications:

• Recommended for individuals 16 years of age or older
• Indicated for active immunization against hepatitis B virus infection
• Contains less than 1 mmol sodium per dose

Product Usage Instructions

What is HBVAXPRO 10 micrograms and its Use:
HBVAXPRO 10 micrograms is a vaccine used for active immunization against hepatitis B virus infection caused by all known subtypes in individuals aged 16 years or older at risk of exposure to the virus.

Pre-Administration Information:
Do not use HBVAXPRO if you are allergic to hepatitis B surface antigen or any other ingredients. Consult your healthcare provider if you have a severe illness with a fever.

Warnings and Precautions:

• The vaccine container contains latex rubber which may cause severe allergic reactions.
• Inform your healthcare provider about any other medications you are taking.

Pregnancy and Breastfeeding:
Exercise caution when prescribing to pregnant or breastfeeding women. Seek advice from a healthcare professional.

Driving and Machine Usage:
HBVAXPRO is not expected to significantly affect the ability to drive or operate machinery.

Administration of HBVAXPRO 10 micrograms:

Dosage:
Each injection should contain 10 micrograms for individuals aged 16 years or older. A complete vaccination course consists of at least three injections.

Immunization Schedules:

• Two injections with a one-month interval followed by a third injection 6 months later.

Frequently Asked Questions (FAQ):

• Q: Can HBVAXPRO prevent infections caused by other agents like hepatitis A, C, or E?
  A: No, HBVAXPRO is specifically for active immunization against hepatitis B virus infection and does not prevent infections caused by other hepatitis viruses or liver pathogens.

• Q: How should HBVAXPRO be stored?
  A: Store HBVAXPRO according to the instructions provided in section 5 of the leaflet. Typically, vaccines should be stored in a refrigerator at recommended temperatures.

HBVAXPRO® 10 micrograms suspension for injection in pre-filled syringe
Hepatitis B vaccine (recombinant DNA)

Read all of this leaflet carefully before you are vaccinated because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What HBVAXPRO 10 micrograms is and what it is used for
2. What do you need to know before you receive HBVAXPRO 10 micrograms
3. How HBVAXPRO 10 micrograms is given
4. Possible side effects
5. How to store HBVAXPRO 10 micrograms
6. Contents of the pack and other information

What HBVAXPRO 10 micrograms is and what it is used for

• This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis B virus.
• It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D does not occur in the absence of hepatitis B infection.
• The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C hepatitis E and other pathogens known to infect the liver.

What you need to know before you receive HBVAXPRO 10 micrograms

Do not use HBVAXPRO 10 micrograms

• if you are allergic to hepatitis B surface antigen or to any of the other ingredients of HBVAXPRO (see section 6)
• if you have a severe illness with fever

Warnings and precautions

• The container of this vaccine contains latex rubber. Latex rubber may cause severe allergic reactions.
• Talk to your doctor, pharmacist or nurse before you receive HBVAXPRO 10 micrograms.

Other vaccines and HBVAXPRO 10 micrograms

• HBVAXPRO can be administered at the same time as with hepatitis B immunoglobulin, at a separate injection site.
• HBVAXPRO can be used to complete a primary immunisation course or as a booster dose in subjects who have previously received another hepatitis B vaccine.
• HBVAXPRO can be administered at the same time as with other vaccines, using separate sites and syringes.
• Tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

• Caution should be exercised when prescribing the vaccine to pregnant or breastfeeding women.
• Ask your doctor, pharmacist or nurse for advice before taking any medicine.

Driving and using machines
HBVAXPRO is expected to have no or negligible influence on the ability to drive and use machines.

HBVAXPRO 10 micrograms contains sodium:
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

How HBVAXPRO 10 micrograms is given

Dosage

• The recommended dose for each injection (1 mL) is 10 micrograms for individuals 16 years of age or more.
• A course of vaccination should include at least three injections.

Two immunisation schedules can be recommended:

• two injections with an interval of one month followed by a third injection 6 months after the first administration (0, 1, 6 months)
• if immunity is needed quickly: three injections with an interval of one month and a fourth dose 1 year later (0, 1, 2, 12 months).
• In case of recent exposure to the hepatitis B virus, a first dose of HBVAXPRO together with the appropriate dose of immunoglobulin can be given.
• Some local vaccination schedules currently include recommendations for a booster dose. Your doctor, pharmacist or nurse will inform you if a booster dose should be given.
• For individuals less than 16 years of age, HBVAXPRO 10 micrograms is not recommended. The appropriate strength for administration to individuals from birth to 15 years of age is HBVAXPRO 5 micrograms.

Method of administration

• The doctor or nurse will give the vaccine as an injection into a muscle. The upper arm muscle is the preferred site for injection in adults and adolescents.
• This vaccine should never be given into a blood vessel.
• Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia (diminution of blood platelets) or to persons at risk of haemorrhage.

If you forget one dose of HBVAXPRO 10 micrograms

• If you miss a scheduled injection, talk to your doctor, pharmacist or nurse. Your doctor or nurse will decide when to give the missed dose.
• If you have any further questions about the use of this product, ask your doctor, pharmacist or nurse.

Possible side effects

• Like all medicines, this vaccine can cause side effects, although not everybody gets them.
• As with other hepatitis B vaccines, in many instances, the causal relationship of the side effects to the vaccine has not been established.
• The most common side effects seen are injection-site reactions: soreness, redness and hardening.

Other side effects are reported very rarely:

• Low platelet count, lymph node disease
• Allergic reactions
• Nervous system disorders such as pins and needles, facial paralysis, nerve inflammations including Guillain-Barre Syndrome, inflammation of the nerve of the eye that leads to impaired vision, brain inflammation, exacerbation of multiple sclerosis, multiple sclerosis, convulsions, headache, dizziness and fainting
• Low blood pressure, blood vessel inflammation
• Asthma-like symptoms
• Vomiting, nausea, diarrhoea, abdominal pain
• Skin reactions such as eczema, rash, itching, hives and skin blistering, hair loss
• Joint pain, arthritis, muscle pain, pain in extremities
• Fatigue, fever, vague illness, flu-like symptoms
• Elevation of liver enzymes
• Inflammation of the eye which causes pain and redness

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store HBVAXPRO 10 micrograms

• Keep this vaccine out of the sight and reach of children.
• Do not use this vaccine after the expiry date which is stated on the label.
• Store in a refrigerator (2°C – 8°C).
• Do not freeze.
• Store in the original package to protect it from light.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What HBVAXPRO 10 micrograms contains

The active substance is:

• Hepatitis B virus surface antigen, recombinant (HBsAg) * ………………. 10 micrograms
• Adsorbed on amorphous aluminium hydroxy phosphate sulphate (0.50-milligram Al+)#
  • produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.
• Amorphous aluminium hydroxy phosphate sulphate is included in this vaccine as an adsorbent. Adsorbents are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine.
• The other ingredients are sodium chloride (NaCl), borax and water for injections.

What do HBVAXPRO 10 micrograms look like and contents of the pack

• HBVAXPRO 10 micrograms is a suspension for injection in a syringe.
• Pack sizes of 1, 10 and 20 pre-filled syringes with 2 separate needles.
• Pack sizes of 1 and 10 pre-filled syringes without needle, or with 1 separate needle.
• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

• Marketing Authorisation Holder: Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, United Kingdom.
• Manufacturer: Merck Sharp and Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands.

For any information about this vaccine, please contact:

• Merck Sharp & Dohme (UK) Limited
• Tel: +44 (0) 208 154 8000
• Email: [email protected].

This leaflet was last revised in October 2023.
The following information is intended for medical or healthcare professionals only:

Instructions

• The vaccine should be inspected visually before administration for any foreign particulate matter and/or abnormal physical appearance. The syringe should be well shaken until a slightly opaque white suspension is obtained.
• The needle is attached by twisting in a clockwise direction until the needle fits securely on the syringe.

© 2023 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved. PIL.HBV.10MCG.PFS.23.GB.8487.Art61-3.RCN024417.RCN021777.

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