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HBVaxPro (hepatitis B, recombinant surface antigen) – Package leaflet - J07BC01

Updated on site: 07-Oct-2017

Medication nameHBVaxPro
ATC CodeJ07BC01
Substancehepatitis B, recombinant surface antigen
ManufacturerMSD VACCINS

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.

-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 is in this leaflet:

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

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

3.How HBVAXPRO 5 micrograms is given

4.Possible side effects

5.How to store HBVAXPRO 5 micrograms

6.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 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.

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 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

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 or your child receives HBVAXPRO 5 micrograms.

Others vaccines and 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.

Tell your doctor, pharmacist or nurse if you or your child is taking, or has 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 breast-feeding 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 5 micrograms contains sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially "sodium- free".

3. How HBVAXPRO 5 micrograms is given

Dosage

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.

Method of administration

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 thrombocytopoenia (diminution of blood platelets) or to persons at risk of haemorrhage.

If you or your child forget one dose of HBVAXPRO 5 micrograms

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.

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 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.

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store HBVAXPRO 5 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 between 2°C and 8°C

Do not freeze

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.

6.

Contents of the pack and other information

 

What HBVAXPRO 5 micrograms contains

 

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.

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

What HBVAXPRO 5 micrograms looks like and contents of the pack

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 Responsible for Batch Release: Merck Sharp and 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.

België/Belgique/Belgien

Lietuva

MSD Belgium BVBA/SPRL

UAB Merck Sharp & Dohme

Tél/Tel: 0800 38 693 (+32(0)27766211) dpoc_belux@merck.com

България

Мерк Шарп и Доум България ЕООД,

тел.: + 359 2 819 3737 info-msdbg@merck.com

Česká republika

Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111 dpoc_czechslovak@merck.com

Danmark

MSD Danmark ApS

Tlf: + 45 4482 4000 dkmail@merck.com

Deutschland

MSD SHARP & DOHME GMBH

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de

Eesti

Merck Sharp & Dohme OÜ, Tel: +372.614.4200 msdeesti@merck.com

Ελλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300 dpoc_greece@merck.com

España

Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com

France

MSD VACCINS

Tél: +33 (0)1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Tel.: +370.5.2780.247 msd_lietuva@merck.com

Luxembourg/Luxemburg

MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com

Magyarország

MSD Pharma Hungary Kft. Tel.: + 36.1.888.5300 hungary_msd@merck.com

Malta

Merck Sharp & Dohme Cyprus Limited. Tel: 8007 4433 (+356 99917558) malta_info@merck.com

Nederland

Merck Sharp & Dohme BV

Tel: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com

Norge

MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no

Österreich

Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 msd-medizin@merck.com

Polska

MSD Polska Sp. z o.o. Tel.: +48.22.549.51.00 msdpolska@merck.com

Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 4465700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 00 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386.1.520.4201

msd.slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o

Sími: + 354 535 7000

Italia

MSD Italia S.r.l. Tel: +39 06 361911

medicalinformation.it@merck.com

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673 (+357 22866700) cyprus_info@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371.67364.224 msd_lv@merck.com

Tel: +421 2 58282010 dpoc_czechslovak@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650 info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

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

The following information is intended for medical or health care professionals only: Instructions

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.

Package leaflet: Information for the user

HBVAXPRO 5 micrograms, suspension for injection in pre-filled syringe

Hepatitis B vaccine (rDNA)

Read all of this leaflet carefully before you or your child is vaccinated because it contains important information.

-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 is in this leaflet:

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

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

3.How HBVAXPRO 5 micrograms is given

4.Possible side effects

5.How to store HBVAXPRO 5 micrograms

6.Content of the pack and other information

1. What HBVAXPRO 5 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 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.

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 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

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 or your child receive HBVAXPRO 5 micrograms.

Others vaccines and 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.

Tell your doctor, pharmacist or nurse if you or your child is taking or has 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 breast-feeding 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 5 micrograms contains sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially "sodium- free".

3. How HBVAXPRO 5 micrograms is given

Dosage

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.

Method of administration

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 thrombocytopoenia (diminution of blood platelets) or to persons at risk of haemorrhage.

If you or your child forget one dose of HBVAXPRO 5 micrograms

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.

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 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.

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store HBVAXPRO 5 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 between 2°C and 8°C

Do not freeze

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.

6.

Contents of the pack and other information

 

What HBVAXPRO 5 micrograms contains

 

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.

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

What HBVAXPRO 5 micrograms looks like and contents of the pack

HBVAXPRO 5 micrograms is a suspension for injection in a syringe.

Pack sizes of 1, 10, 20 and 50 pre-filled syringes without needle or with 2 separate needles, Pack sizes of 1 and 10 pre-filled syringes with 1 separate 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 Responsible for Batch Release: Merck Sharp and 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.

België/Belgique/Belgien

MSD Belgium BVBA/SPRL

Tél/Tel: 0800 38 693 (+32(0)27766211) dpoc_belux@merck.com

България

Мерк Шарп и Доум България ЕООД,

тел.: + 359 2 819 3737 info-msdbg@merck.com

Lietuva

UAB Merck Sharp & Dohme Tel.: +370.5.2780.247 msd_lietuva@merck.com

Luxembourg/Luxemburg

MSD Belgium BVBA/SPRL

Tél/Tel: +32(0)27766211

Česká republika

Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111 dpoc_czechslovak@merck.com

Danmark

MSD Danmark ApS

Tlf: + 45 4482 4000 dkmail@merck.com

Deutschland

MSD SHARP & DOHME GMBH

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de

Eesti

Merck Sharp & Dohme OÜ, Tel: +372.614.4200 msdeesti@merck.com

Ελλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300 dpoc_greece@merck.com

España

Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com

France

MSD VACCINS

Tél: +33 (0)1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Sími: + 354 535 7000

Italia

MSD Italia S.r.l.

Tel: +39 06 361911

dpoc_belux@merck.com

Magyarország

MSD Pharma Hungary Kft. Tel.: + 36.1.888.5300 hungary_msd@merck.com

Malta

Merck Sharp & Dohme Cyprus Limited. Tel: 8007 4433 (+356 99917558) malta_info@merck.com

Nederland

Merck Sharp & Dohme BV

Tel: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com

Norge

MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no

Österreich

Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 msd-medizin@merck.com

Polska

MSD Polska Sp. z o.o. Tel.: +48.22.549.51.00 msdpolska@merck.com

Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 4465700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 00 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386.1.520.4201

msd.slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o Tel: +421 2 58282010 dpoc_czechslovak@merck.com

Suomi/Finland

MSD Finland Oy

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

medicalinformation.it@merck.com

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673 (+357 22866700) cyprus_info@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371.67364.224 msd_lv@merck.com

info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

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

The following information is intended for medical or health care professionals only: Instructions

The vaccine should be inspected visually prior to 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 clockwise direction, until the needle fits securely on the syringe.

Package leaflet: Information for the user

HBVAXPRO 10 micrograms, suspension for injection

Hepatitis B vaccine (rDNA)

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

1.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 and hepatitis E and other pathogens known to infect the liver.

2.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.

Others 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 breast-feeding 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, i.e. essentially "sodium- free".

3. 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 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.

For individuals less than 16 years of age, HBVAXPRO 10 micrograms is not recommended. The appropriate strength for administration to individuals from birth through 15 years of age is HBVAXPRO 5 micrograms.

Method of administration

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

The doctor or nurse will give the vaccine as an injection into 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 thrombocytopoenia (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 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 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

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.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 between 2°C and 8°C

Do not freeze

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.

6.

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 hydroxyphosphate sulfate (0.50 milligram Al+)

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

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

What HBVAXPRO 10 micrograms looks like and contents of the pack

HBVAXPRO 10 micrograms is a suspension for injection in a vial.

Pack sizes of 1 and 10 vials.

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 Responsible for Batch Release: Merck Sharp and 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.

België/Belgique/Belgien

MSD Belgium BVBA/SPRL

Tél/Tel: 0800 38 693 (+32(0)27766211) dpoc_belux@merck.com

България

Мерк Шарп и Доум България ЕООД,

тел.: + 359 2 819 3737 info-msdbg@merck.com

Česká republika

Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111

Lietuva

UAB Merck Sharp & Dohme Tel.: +370.5.2780.247 msd_lietuva@merck.com

Luxembourg/Luxemburg

MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com

Magyarország

MSD Pharma Hungary Kft.

Tel.: + 36.1.888.5300

dpoc_czechslovak@merck.com

Danmark

MSD Danmark ApS

Tlf: + 45 4482 4000 dkmail@merck.com

Deutschland

MSD SHARP & DOHME GMBH

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de

Eesti

Merck Sharp & Dohme OÜ, Tel: +372.614.4200 msdeesti@merck.com

Ελλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300 dpoc_greece@merck.com

España

Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com

France

MSD VACCINS

Tél: +33 (0)1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Sími: + 354 535 7000

Italia

MSD Italia S.r.l. Tel: +39 06 361911

medicalinformation.it@merck.com

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673 (+357 22866700) cyprus_info@merck.com

hungary_msd@merck.com

Malta

Merck Sharp & Dohme Cyprus Limited. Tel: 8007 4433 (+356 99917558) malta_info@merck.com

Nederland

Merck Sharp & Dohme BV

Tel: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com

Norge

MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no

Österreich

Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 msd-medizin@merck.com

Polska

MSD Polska Sp. z o.o. Tel.: +48.22.549.51.00 msdpolska@merck.com

Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 4465700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 00 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386.1.520.4201

msd.slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o Tel: +421 2 58282010 dpoc_czechslovak@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650 info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371.67364.224 msd_lv@merck.com

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

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

The following information is intended for medical or health care professionals only: Instructions

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.

Package leaflet: Information for the user

HBVAXPRO 10 micrograms, suspension for injection in pre-filled syringe

Hepatitis B vaccine (rDNA)

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

1. 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 and hepatitis E and other pathogens known to infect the liver.

2. 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.

Others 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 breast-feeding 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, i.e. essentially "sodium- free".

3. 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 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.

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 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 thrombocytopoenia (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 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 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

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. 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 between 2°C and 8°C

Do not freeze

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.

6.

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 hydroxyphosphate sulfate (0.50 milligram Al+)

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

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

What HBVAXPRO 10 micrograms looks 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: MSD VACCINS

162 avenue Jean Jaurès

69007 Lyon France

Manufacturer Responsible for Batch Release: Merck Sharp and 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.

België/Belgique/Belgien

MSD Belgium BVBA/SPRL

Tél/Tel: 0800 38 693 (+32(0)27766211) dpoc_belux@merck.com

България

Мерк Шарп и Доум България ЕООД,

тел.: + 359 2 819 3737 info-msdbg@merck.com

Česká republika

Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111

Lietuva

UAB Merck Sharp & Dohme Tel.: +370.5.2780.247 msd_lietuva@merck.com

Luxembourg/Luxemburg

MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com

Magyarország

MSD Pharma Hungary Kft.

Tel.: + 36.1.888.5300

dpoc_czechslovak@merck.com

Danmark

MSD Danmark ApS

Tlf: + 45 4482 4000 dkmail@merck.com

Deutschland

MSD SHARP & DOHME GMBH

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de

Eesti

Merck Sharp & Dohme OÜ, Tel: +372.614.4200 msdeesti@merck.com

Ελλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300 dpoc_greece@merck.com

España

Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com

France

MSD VACCINS

Tél: +33 (0)1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Sími: + 354 535 7000

Italia

MSD Italia S.r.l. Tel: +39 06 361911

medicalinformation.it@merck.com

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673 (+357 22866700) cyprus_info@merck.com

hungary_msd@merck.com

Malta

Merck Sharp & Dohme Cyprus Limited. Tel: 8007 4433 (+356 99917558) malta_info@merck.com

Nederland

Merck Sharp & Dohme BV

Tel: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com

Norge

MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no

Österreich

Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 msd-medizin@merck.com

Polska

MSD Polska Sp. z o.o. Tel.: +48.22.549.51.00 msdpolska@merck.com

Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 4465700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 00 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386.1.520.4201

msd.slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o Tel: +421 2 58282010 dpoc_czechslovak@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650 info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371.67364.224 msd_lv@merck.com

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

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

The following information is intended for medical or health care professionals only: Instructions

The vaccine should be inspected visually prior to 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 clockwise direction, until the needle fits securely on the syringe.

Package leaflet: Information for the user

HBVAXPRO 40 micrograms, suspension for injection

Hepatitis B vaccine (rDNA)

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 40 micrograms is and what it is used for

2.What you need to know before you receive HBVAXPRO 40 micrograms

3.How HBVAXPRO 40 micrograms is given

4.Possible side effects

5.How to store HBVAXPRO 40 micrograms

6.Contents of the pack and other information

1.What HBVAXPRO 40 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 predialysis and dialysis adult patients.

It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D (caused by the delta agent) 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.

2. What you need to know before you use HBVAXPRO 40 micrograms

Do not use HBVAXPRO 40 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 40 micrograms.

Others vaccines and HBVAXPRO 40 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 breast-feeding 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 40 micrograms contains sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially "sodium- free".

3. How HBVAXPRO 40 micrograms is given

Dosage

The recommended dose for each injection (1 ml) is 40 micrograms for predialysis and dialysis adult patients

A course of vaccination should include three injections.

The schedule is two injections with an interval of one month followed by a third injection 6 months after the first administration (0, 1, 6 months).

A booster dose must be considered in these vaccinees if the antibody level against hepatitis B virus surface antigen is less than 10 IU/l.

Method of administration

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

The doctor or nurse will give the vaccine as an injection into muscle. The upper arm muscle is the preferred site for injection in adults.

This vaccine should never be given into a blood vessel.

Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopoenia (diminution of blood platelets) or to persons at risk of haemorrhage.

If you forget one dose of HBVAXPRO 40 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 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 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

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store HBVAXPRO 40 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 between 2°C and 8°C

Do not freeze

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.

6.

Contents of the pack and other information

 

What HBVAXPRO 40 micrograms contains

 

The active substance is:

 

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

40 micrograms

Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)

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

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

What HBVAXPRO 40 micrograms looks like and contents of the pack

HBVAXPRO 40 micrograms is a suspension for injection in a vial.

Pack size of 1 vial.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: MSD VACCINS

162 avenue Jean Jaurès

69007 Lyon France

Manufacturer Responsible for Batch Release: Merck Sharp and 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.

België/Belgique/Belgien

MSD Belgium BVBA/SPRL

Tél/Tel: 0800 38 693 (+32(0)27766211) dpoc_belux@merck.com

България

Мерк Шарп и Доум България ЕООД,

тел.: + 359 2 819 3737 info-msdbg@merck.com

Česká republika

Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111 dpoc_czechslovak@merck.com

Danmark

MSD Danmark ApS

Lietuva

UAB Merck Sharp & Dohme Tel.: +370.5.2780.247 msd_lietuva@merck.com

Luxembourg/Luxemburg

MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com

Magyarország

MSD Pharma Hungary Kft. Tel.: + 36.1.888.5300 hungary_msd@merck.com

Malta

Merck Sharp & Dohme Cyprus Limited.

Tlf: + 45 4482 4000 dkmail@merck.com

Deutschland

MSD SHARP & DOHME GMBH

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de

Eesti

Merck Sharp & Dohme OÜ, Tel: +372.614.4200 msdeesti@merck.com

Ελλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300 dpoc_greece@merck.com

España

Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com

France

MSD VACCINS

Tél: +33 (0)1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Sími: + 354 535 7000

Italia

MSD Italia S.r.l. Tel: +39 06 361911

medicalinformation.it@merck.com

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673 (+357 22866700) cyprus_info@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371.67364.224 msd_lv@merck.com

Tel: 8007 4433 (+356 99917558) malta_info@merck.com

Nederland

Merck Sharp & Dohme BV

Tel: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com

Norge

MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no

Österreich

Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 msd-medizin@merck.com

Polska

MSD Polska Sp. z o.o. Tel.: +48.22.549.51.00 msdpolska@merck.com

Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 4465700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 00 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386.1.520.4201

msd.slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o Tel: +421 2 58282010 dpoc_czechslovak@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650 info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

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

The following information is intended for medical or health care professionals only: Instructions

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.

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