HBVaxPro
hepatitis B vaccine (recombinant DNA)
Hepatitis B vaccine (recombinant DNA)
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
If you or your child 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 HBVAXPRO 5 micrograms is and what it is used for
What you need to know before you or your child receive HBVAXPRO 5 micrograms
How HBVAXPRO 5 micrograms is given
Possible side effects
How to store HBVAXPRO 5 micrograms
Contents of the pack and other information
This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in individuals from birth through 15 years of age 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 and hepatitis E and other pathogens known to infect the liver.
if you or your child is allergic to hepatitis B surface antigen or to any of the other ingredients of HBVAXPRO (see section 6)
if you or your child has a severe illness with fever
The container of this vaccine contains latex rubber. Latex rubber may cause severe allergic reactions. Talk to your doctor, pharmacist or nurse before you or your child receives HBVAXPRO 5 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 may be administered at the same time as with some other vaccines, using separate sites and syringes.
Caution should be exercised when prescribing the vaccine to pregnant or breast-feeding women. Ask your doctor, pharmacist or nurse for advice before taking any medicine.
HBVAXPRO is expected to have no, or negligible, influence on the ability to drive and use machines.
HBVAXPRO 5 micrograms contains sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.
The recommended dose for each injection (0.5 mL) is 5 micrograms for individuals from birth through 15 years of age.
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 a 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.
The vial should be well shaken until a slightly opaque white suspension is obtained.
Once the vial has been penetrated, the withdrawn vaccine should be used promptly, and the vial must be discarded.
The doctor or nurse will give the vaccine as an injection into muscle. The upper side of the thigh is the
preferred site for injection in neonates and infants. The upper arm muscle is the preferred site for injection in children and adolescents.
This vaccine should never be given into a blood vessel.
Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopaenia (diminution of blood platelets) or to persons at risk of haemorrhage.
If you or your child 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 or your child have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
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 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 extremity
Fatigue, Fever, Vague illness, Flu-like symptoms
Elevation of liver enzymes
Inflammation of the eye which causes pain and redness
In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 in order to protect 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.
The active substance is :
Hepatitis B virus surface antigen, recombinant (HBsAg) * ................... 5 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+)#
* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.
# Amorphous aluminium hydroxyphosphate sulfate is included in this vaccine as an adsorbant. Adsorbants 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.
HBVAXPRO 5 micrograms is a suspension for injection in a vial. Pack sizes of 1 and 10 vials without syringe/needle.
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
For any information about this vaccine, please contact the local representative of the Marketing Authorisation Holder.
MSD Belgium
Tél/Tel: +32(0)27766211
UAB Merck Sharp & Dohme Tel.: +370.5.2780.247
Мерк Шарп и Доум България ЕООД,
тел.: + 359 2 819 3737
MSD Belgium
Tél/Tel: +32(0)27766211
Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111
MSD Pharma Hungary Kft. Tel.: + 36.1.888.5300
MSD Danmark ApS Tlf: + 45 4482 4000
Merck Sharp & Dohme Cyprus Limited. Tel: 8007 4433 (+356 99917558)
MSD Sharp & Dohme GmbH
Tel: 0800 673 673 673 (+49 (0) 89 4561 0)
Merck Sharp & Dohme B.V.
Tel: 0800 9999000 (+31 23 5153153)
Merck Sharp & Dohme OÜ, Tel: +372.614.4200
MSD (Norge) AS Tlf: +47 32 20 73 00
MSD Α.Φ.Β.Ε.Ε.
Τηλ: +30 210 98 97 300
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00
MSD Polska Sp. z o.o. Tel.: +48.22.549.51.00
MSD France
Tél: +33 (0)1 80 46 40 40
Merck Sharp & Dohme, Lda Tel: +351 21 4465700
Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 333
Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 00
Merck Sharp & Dohme Ireland (Human Health)
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Limited
Tel: +353 (0)1 2998700
Tel: +386.1.520.4201
Vistor hf.
Sími: + 354 535 7000
Merck Sharp & Dohme, s. r. o Tel: +421 2 58282010
MSD Italia S.r.l.
Tel: +39 06 361911
medicalinformation.it@merck.com
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673 (+357 22866700)
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650
Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488
SIA Merck Sharp & Dohme Latvija Tel: +371.67364.224
Merck Sharp & Dohme Ireland (Human Health) Limited
Tel: +353 (0)1 2998700
The vaccine should be inspected visually prior to administration for any foreign particulate matter and/or abnormal physical appearance. The vial should be well shaken until a slightly opaque white suspension is obtained.