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HBVAXPRO 5 micrograms INJECTABLE SUSPENSION

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About the medicine

How to use HBVAXPRO 5 micrograms INJECTABLE SUSPENSION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

HBVAXPRO 5 micrograms, suspension for injection

Hepatitis B vaccine (rDNA)

Read all of this leaflet carefully before you or your child is 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 or your child experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. See section 4.

Contents of the pack

  1. What HBVAXPRO 5 micrograms is and what it is used for
  1. What you need to know before you or your child receives HBVAXPRO 5 micrograms
  2. How HBVAXPRO 5 micrograms is administered
  1. Possible side effects
  2. Storage of HBVAXPRO 5 micrograms
  1. Contents of the pack and other information

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

This vaccine is indicated for active immunization against hepatitis B virus infection caused by all known subtypes, in individuals from birth to 15 years of age considered at risk of exposure to hepatitis B virus.

It can be expected that immunization with HBVAXPRO will also prevent hepatitis D, since hepatitis D does not occur in the absence of hepatitis B infection.

The vaccine does not prevent infections caused by other agents such as hepatitis A, hepatitis C, and hepatitis E, or by other pathogens known to infect the liver.

Doctor consultation

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

Do not use HBVAXPRO 5 micrograms

  • if you or your child is allergic to hepatitis B surface antigen or to any of the other components of HBVAXPRO (see section 6).
  • if you or your child has a severe illness with fever.

Warnings and precautions

May cause severe allergic reactions because it contains latex in the packaging.

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

Other vaccines and HBVAXPRO 5 micrograms

HBVAXPRO can be administered at the same time as hepatitis B immunoglobulin, in different injection sites.

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

HBVAXPRO can be administered at the same time as some other vaccines, using different injection sites and syringes.

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

Pregnancy and lactation

Caution should be exercised when prescribing the vaccine to pregnant or breastfeeding women.

Talk to your doctor, pharmacist, or nurse before using any medicine.

Driving and using machines

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

HBVAXPRO 5 micrograms contains sodium:this medicine contains less than 23 mg of sodium (1 mmol) per dose; this is essentially “sodium-free”.

3. How HBVAXPRO 5 micrograms is administered

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Dose

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

A vaccination cycle should include at least three injections.

Two vaccination schedules can be recommended:

  • two injections with a one-month interval followed by a third injection six months after the first administration (0, 1, 6 months).
  • if rapid immunity is required: three injections with a one-month interval and a fourth dose one year later (0, 1, 2, 12 months).

In the event of recent exposure to hepatitis B virus, a first dose of HBVAXPRO can be administered along with the appropriate dose of immunoglobulin.

Some local vaccination schedules currently recommend a booster dose.

Your doctor, pharmacist, or nurse will inform you if you need a booster dose.

Method of administration

The vial should be shaken well until a slightly opaque white suspension is obtained. Once the vial is pierced, the extracted vaccine should be administered immediately and the vial discarded.

The doctor or nurse will administer the vaccine by injection into the muscle. The preferred injection site in newborns and infants is the upper part of the thigh. The preferred injection site in older children and adolescents is the muscle of the upper arm.

This vaccine should never be administered into a blood vessel.

Exceptionally, the vaccine can be administered subcutaneously in patients with thrombocytopenia (decreased blood platelets) or in individuals at risk of bleeding.

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

If you or your child misses a planned injection, talk to your doctor, pharmacist, or nurse. Your doctor or nurse will decide when to administer the missed dose.

If you or your child has any further questions about 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, a causal relationship between the side effects and the vaccine has not been established.

The most frequently observed side effects are reactions at the injection site:

discomfort, redness, and induration.

Other side effects reported very rarely are:

  • Low platelet count, Lymph node disease
  • Allergic reactions
  • Nervous system disorders such as Tingling, Facial paralysis, Inflammations of the nerves including Guillain-Barré syndrome, Optic neuritis causing vision disturbances, Brain inflammation, Exacerbation of multiple sclerosis, Multiple sclerosis, Seizures, Headache, Dizziness, and Fainting
  • Low blood pressure, Inflammation of blood vessels
  • Symptoms similar to asthma
  • Vomiting, Nausea, Diarrhea, Abdominal pain
  • Skin reactions such as Eczema, Rash, Itching, Hives, and Blistering of the skin, Hair loss
  • Joint pain, Arthritis, Muscle pain, Pain in a limb
  • Fatigue, Fever, Undiagnosed illness, Symptoms similar to the flu
  • Elevation of liver enzymes
  • Inflammation of the eyes causing pain and redness

In children born very prematurely (at 28 weeks of gestation or earlier), longer intervals between breaths than normal may occur during the 2 or 3 days following vaccination.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of HBVAXPRO 5 micrograms

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

Do not use this vaccine after the expiry date stated on the label.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of HBVAXPRO 5 micrograms

  • The active substance is:

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

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

  • produced in yeast Saccharomyces cerevisiae(strain 2150-2-3) by recombinant DNA technology.
  • The amorphous aluminum hydroxyphosphate sulfate is included in this vaccine as an adjuvant. Adjuvants are substances included in certain vaccines to accelerate, enhance, and/or prolong the protective effects of the vaccine.

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

Appearance and pack of HBVAXPRO 5 micrograms

HBVAXPRO 5 micrograms is a suspension for injection 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 authorisation holder and manufacturer

Marketing Authorisation Holder:

MSD VACCINS

162 avenue Jean Jaurès

69007 Lyon

France

Manufacturer:

Merck Sharp and Dohme, B.V.

Waarderweg, 39

2031 BN Haarlem

Netherlands

You can obtain further information on this vaccine by contacting the local representative of the marketing authorisation holder.

België/Belgique/Belgien

MSD Belgium BVBA/SPRL

Tél/Tel: +32(0)27766211

[email protected]

Lietuva

UAB Merck Sharp & Dohme

Tel.: +370.5.2780.247

[email protected]

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???? ???? ? ???? ???????? ????,

???.: + 359 2 819 3737

[email protected]

Luxembourg/Luxemburg

MSD Belgium BVBA/SPRL

Tél/Tel: +32(0)27766211

[email protected]

Ceská republika

Merck Sharp & Dohme s.r.o.

Tel.: +420 233 010 111

[email protected]

Magyarország

MSD Pharma Hungary Kft.

Tel.: + 36.1.888.5300

[email protected]

Danmark

MSD Danmark ApS

Tlf: + 45 4482 4000

[email protected]

Malta

Merck Sharp & Dohme Cyprus Limited.

Tel: 8007 4433 (+356 99917558)

[email protected]

Eesti

Merck Sharp & Dohme OÜ,

Tel: +372.614.4200

[email protected]

Norge

MSD (Norge) AS

Tlf: +47 32 20 73 00

[email protected]

Ελλ?δα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300

[email protected]

Österreich

Merck Sharp & Dohme Ges.m.b.H.

Tel: +43 (0) 1 26 044

[email protected]

España

Merck Sharp & Dohme de España, S.A.

Tel: +34 91 321 06 00

[email protected]

Polska

MSD Polska Sp. z o.o.

Tel.: +48.22.549.51.00

[email protected]

France

MSD VACCINS

Tél: +33 (0)1 80 46 40 40

[email protected]

Portugal

Merck Sharp & Dohme, Lda

Tel: +351 21 4465700

[email protected]

Hrvatska

Merck Sharp & Dohme d.o.o.

Tel: +385 1 66 11 333

[email protected]

România

Merck Sharp & Dohme Romania S.R.L

Tel: + 4021 529 29 00

[email protected]

Ireland

Merck Sharp & Dohme Ireland (Human Health)

Limited

Tel: +353 (0)1 2998700

[email protected]

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: +386.1.520.4201

[email protected]

Ísland

Vistor hf.

Sími: + 354 535 7000

Slovenská republika

Merck Sharp & Dohme, s. r. o

Tel: +421 2 58282010

[email protected]

Italia

MSD Italia S.r.l.

Tel: +39 06 361911

[email protected]

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650

[email protected]

Κ?προς

Merck Sharp & Dohme Cyprus Limited

Τηλ: 800 00 673 (+357 22866700)

[email protected]

Sverige

Merck Sharp & Dohme (Sweden) AB

Tel: +46 77 5700488

[email protected]

Latvija

SIA Merck Sharp & Dohme Latvija

Tel: +371.67364.224

[email protected]

United Kingdom

Merck Sharp & Dohme Limited

Tel: +44 (0) 1992 467272

[email protected]

This leaflet was approved by

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 [email protected]

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

This information is intended only for healthcare professionals:

Instructions

A visual inspection of the vaccine should be performed to detect any foreign particles and/or abnormal physical appearance of the contents before administration. The vial should be shaken well until a slightly opaque white suspension is obtained.

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General medicine 11 years exp.

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Family medicine 13 years exp.

Dr. Anastasiia Shalko is a general practitioner with a background in both paediatrics and general medicine. She graduated from Bogomolets National Medical University in Kyiv and completed her paediatric internship at the P.L. Shupyk National Medical Academy of Postgraduate Education. After working as a paediatrician in Kyiv, she relocated to Spain, where she has been practising general medicine since 2015, providing care for both adults and children.

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Dermatology 21 years exp.

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Frequently Asked Questions

Is a prescription required for HBVAXPRO 5 micrograms INJECTABLE SUSPENSION?
HBVAXPRO 5 micrograms INJECTABLE SUSPENSION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in HBVAXPRO 5 micrograms INJECTABLE SUSPENSION?
The active ingredient in HBVAXPRO 5 micrograms INJECTABLE SUSPENSION is hepatitis B, purified antigen. This information helps identify medicines with the same composition but different brand names.
Who manufactures HBVAXPRO 5 micrograms INJECTABLE SUSPENSION?
HBVAXPRO 5 micrograms INJECTABLE SUSPENSION is manufactured by Merck Sharp & Dohme B.V.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of HBVAXPRO 5 micrograms INJECTABLE SUSPENSION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether HBVAXPRO 5 micrograms INJECTABLE SUSPENSION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to HBVAXPRO 5 micrograms INJECTABLE SUSPENSION?
Other medicines with the same active substance (hepatitis B, purified antigen) include ENGERIX-B 20 micrograms/1 ml, PRE-FILLED SYRINGE SUSPENSION FOR INJECTION, ENGERIX-B JUNIOR 10 micrograms/0.5 ml, PRE-FILLED SYRINGE SUSPENSION, FENDRIX, INJECTABLE SUSPENSION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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