injection, suspension.
Hepatitis B vaccine ( recombinant DNA )

Read this leaflet carefully before you or your child are vaccinated. It contains important information.

  • Save 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 experience side effects , talk to a doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
1. What HBVAXPRO 5 micrograms are and what is used for
2. What you need to know before you or your child receive HBVAXPRO 5 micrograms
3. How to use HBVAXPRO 5 micrograms
4. Possible side effects
5. How HBVAXPRO 5 micrograms should be stored
6. Contents of the packaging and other information

1. What HBVAXPRO 5 micrograms is and what it is used for

This vaccine is used for active immunization against hepatitis B virus infection caused by all known subtypes of individuals from birth to 15 years of age who are at risk of being exposed to the hepatitis B virus.

The protection with HBVAXBRO probably also includes hepatitis D because hepatitis D does not occur in the absence of hepatitis B infection.

The vaccine does not protect against infection caused by other agents such as hepatitis A, hepatitis C, and hepatitis E, and other pathogens known to infect the liver.

2. What you need to know before you or your child receive HBVAXPRO 5 micrograms

Do not use HBVAXPRO 5 micrograms

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

Warnings and cautions

The container for this vaccine contains latex rubber. Latex rubber can cause severe allergic reactions.

Talk to a doctor, pharmacist, or nurse before you or your child receive HBVAXPRO 5 micrograms.

Other medicines and HBVAXPRO 5 micrograms

HBVAXPRO can be given concomitantly with hepatitis B immunoglobulin, at separate injection sites.

HBVAXPRO can be used to complete a primary immunization or as a booster dose to people who have previously received another hepatitis B vaccine.

HBVAXPRO can be administered concomitantly with certain other vaccines using separate injection sites and syringes.

Tell your doctor, pharmacist, or nurse if you or your child are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breastfeeding

Prescribing of the vaccine to pregnant or lactating women should be done with caution.

Consult a doctor, pharmacist, or nurse before taking any medicine.

Driving and using machines

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

HBVAXPRO 5 micrograms contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free.

3. How to use HBVAXPRO 5 micrograms

Dosage

The recommended dose for each injection (0.5 ml) is 5 micrograms for individuals (from birth to 15 years of age).

A vaccination round must include at least three injections.

Two immunization schedules can be used: –

  • two injections at an interval of one month followed by a third injection 6 months after the first administration one (0,1,6 months). 
  • if rapid immunity is desired: three injections at an interval of one month and a fourth dose 1 year later (0, 1, 2.12 months).

In the event of recent exposure to the hepatitis B virus, the first dose of HBVAXPRO may be co-administered with the appropriate dose of immunoglobulin. 

Some local vaccination schedules today include recommendations for a booster dose. Your doctor, pharmacist, or nurse will inform you if a booster dose should be given. 

Method of administration

The vial should be shaken well until a slightly opaque white suspension is obtained.

Once the vial has penetrated, the vaccine drawn into the syringe should be used immediately and the vial must then be discarded.

A doctor or nurse will give the vaccine as an injection into the muscle. The upper thigh is the best injection site for newborns and infants. The upper arm muscle is the best injection site for children and teens.

This vaccine should never be given to a blood vessel. 

In exceptional cases, this vaccine may be given under the skin to patients with thrombocytopenia (reduction in platelet count ) or persons at risk of bleeding. 

If you or your child miss a dose of HBVAXPRO 5 micrograms

If you or your child misses a scheduled injection, contact your doctor, pharmacist, or nurse. Your doctor or nurse will decide when the missed dose should be given. 

If you or your child have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. 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 cases, the causal relationship between side effects and the vaccine has not been established. 

The most common side effects are injection site reactions: tenderness, redness, and hardening.

Other side effects have been reported very rarely:

  • low platelet count , lymph node disease
  • allergic reactions
  • Nervous system disorders such as numbness and tingling, facial numbness, neuritis including Guillain-Barré syndrome , inflammation of the eye nerve leading to impaired vision, encephalitis, exacerbation of multiple sclerosis , multiple sclerosis , seizures, headache, dizziness and fainting
  • low blood pressure , inflammation of the blood vessels
  • asthma-like symptoms
  • vomiting, nausea, diarrhea, abdominal pain
  • skin reactions such as eczema , rash, hair loss, itching , hives and blisters on the skin
  • joint pain, arthritis, muscle pain, pain in extremities are
  • fatigue, fever, vague feeling of illness, flu-like symptoms
  • increase in liver enzymes.
  • eye inflammation with pain and redness

In very premature infants (born ≤ 28 weeks of gestation), prolonged stays than normal between breaths may occur for 2-3 days after vaccination.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store HBVAXPRO 5 micrograms

Keep this vaccine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP.

Store in a refrigerator (2 ° C – 8 ° C).

Do not freeze.

Store in the original package. Sensitive to light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures are intended to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is:

Hepatitis B virus surface antigen, recombinant (HBsAg) * ………………………. 5 micrograms 

Adsorbed on amorphous aluminum hydroxyphosphate sulfate (0.25 milligrams Al + ) #

* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast cells by recombinant DNA technology.

Amorphous aluminum hydroxyphosphate sulphate is included as an adjuvant in this vaccine. Adjuvants are substances that are included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine.

The other ingredients are sodium chloride, sodium borate, and water for injections.

What the medicine looks like and contents of the pack

HVBAXPRO   micrograms is a suspension in a vial.

Pack sizes of 1 and 10 vials without syringe/needle.

Pack size of 1 vial with syringe and needle.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder: 

MSD VACCINS

162 avenue Jean Jaurès

69007 Lyon

France

Manufacturer:

Merck Sharp and Dohme, BV

Waarderweg 39

2031 BN Haarlem

Netherlands.

Further information on this vaccine can be obtained from the national representative of the marketing authorization holder.

België / Belgique /
Belgien MSD Belgium BVBA / SPRL
Tél / Tel: +32 (0) 27766211
dpoc_belux@merck.com
Lietuva
UAB Merck Sharp & Dohme
Tel .: +370.5.2780.247
msd_lietuva@merck.com
България
Мерк Шарп и Доум България ЕООД,
tel .: + 359 2 819 3737
info-msdbg@merck.com
Luxembourg / Luxemburg
MSD Belgium BVBA / SPRL
Tel: +32 (0) 27766211
dpoc_belux@merck.com
Czech Republic
Merck Sharp & Dohme sro
Tel .: +420 233 010 111
dpoc_czechslovak@merck.com
Magyarország
MSD Pharma Hungary Kft.
Tel .: + 36.1.888.5300
hungary_msd@merck.com
Denmark
MSD Danmark ApS
Tel: + 45 4482 4000
dkmail@merck.com
Malta
Merck Sharp & Dohme Cyprus Limited.
Tel: 8007 4433 (+356 99917558)
malta_info@merck.com
Deutschland
MSD SHARP & DOHME GMBH
Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
e-mail@msd.de
Netherlands
Merck Sharp & Dohme BV
Tel: 0800 9999000 (+31 23 5153153)
medicalinfo.nl@merck.com 
Eesti
Merck Sharp & Dohme OÜ,
Tel: +372.614.4200
msdeesti@merck.com
Norway
MSD (Norway) AS
Tel: +47 32 20 73 00
msdnorge@msd.no
Dλλάδα
MSD Α.Φ.Β.Ε.Ε.
:Ηλ: +30 210 98 97 300
dpoc_greece@merck.com
Austria
Merck Sharp & Dohme Ges.mbH
Tel: +43 (0) 1 26 044
msd-medizin@merck.com
Spain
Merck Sharp & Dohme de España, SA
Tel: +34 91 321 06 00
msd_info@merck.com
Polska
MSD Polska Sp. z oo
Tel .: +48.22.549.51.00
msdpolska@merck.com
France
MSD VACCINS
Tel: +33 (0) 1 80 46 40 40information.medicale@msd.com
Portugal
Merck Sharp & Dohme, Lda
Tel: +351 21 4465700
inform_pt@merck.com
Hrvatska
Merck Sharp & Dohme doo
Tel: +385 1 66 11 333
croatia_info@merck.com
România
Merck Sharp & Dohme Romania SRL
Tel: + 4021 529 29 00
msdromania@merck.com
Ireland
Merck Sharp & Dohme Ireland ( Human Health) Limited
Tel: +353 (0) 1 2998700
medinfo_ireland@merck.com
Slovenia
Merck Sharp & Dohme, innovative zdravila doo
Tel: +386.1.520.4201
msd.slovenia@merck.com
Iceland
Vistor hf.
Phone: + 354 535 7000
Slovak Republic
Merck Sharp & Dohme, sr o
Tel: +421 2 58282010
dpoc_czechslovak@merck.com
Italy
MSD Italia Srl
Tel: +39 06 361911
medicalinformation.it@merck.com
Suomi / Finland
MSD Finland Oy
Puh / Tel: +358 (0) 9 804 650
info@msd.fi
Merπρος
Merck Sharp & Dohme Cyprus Limited
:ηλ: 800 00 673 (+357 22866700)
cyprus_info@merck.com
Sweden
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488
medicinskinfo@merck.com
Latvia
SIA Merck Sharp & Dohme Latvia
Tel: +371.67364.224
msd_lv@merck.com
United Kingdom
Merck Sharp & Dohme Limited
Tel: +44 (0) 1992 467272
medicalinformationuk@merck.com

Muhammad Nadeem

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