HBVAXPRO 40 micrograms INJECTABLE SUSPENSION
Ask a doctor about a prescription for HBVAXPRO 40 micrograms INJECTABLE SUSPENSION
How to use HBVAXPRO 40 micrograms INJECTABLE SUSPENSION
Introduction
Package Leaflet: Information for the user
HBVAXPRO40micrograms, 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 experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
Contents of the package leaflet
- What is HBVAXPRO 40 micrograms and what is it used for
- What you need to know before you receive HBVAXPRO 40 micrograms
- How HBVAXPRO 40 micrograms is administered
- Possible side effects
- Storage of HBVAXPRO 40 micrograms
- Contents of the pack and further information
1. What is HBVAXPRO 40 micrograms and what is it used for
This vaccine is indicated for active immunization against hepatitis B virus infection caused by all known subtypes, in adult patients on pre-dialysis and dialysis.
It can be expected that immunization with HBVAXPRO will also prevent hepatitis D, since hepatitis D (caused by the delta agent) 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.
2. What you need to know before you receive HBVAXPRO 40 micrograms
Do not use HBVAXPRO40micrograms
- if you are allergic to the hepatitis B surface antigen or to any of the other components of HBVAXPRO (see section 6).
- if you have a severe illness with fever.
Warnings and precautions
May cause severe allergic reactions because it contains latex in the packaging.
Consult your doctor, pharmacist, or nurse before receiving HBVAXPRO 40 micrograms.
Other vaccines and HBVAXPRO40micrograms
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 other vaccines, using different injection sites and syringes.
Tell your doctor, pharmacist, or nurse if you are taking or have 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.
Consult 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.
HBVAXPRO40microgramscontains sodium:this medicine contains less than 23 mg of sodium (1 mmol) per dose; it is essentially “sodium-free”.
3. How HBVAXPRO 40 micrograms is administered
Dose
The recommended dose per injection (1 ml) is 40 micrograms in adult patients on pre-dialysis and dialysis.
A vaccination cycle should include at least three injections.
The schedule used is two injections with a one-month interval followed by a third injection six months after the first administration (0, 1, 6 months).
A booster dose should be considered in these vaccinated individuals if the level of antibodies against the hepatitis B surface antigen is less than 10 IU/l.
Method of administration
The vial should be shaken well until a slightly opaque white suspension is obtained.
The doctor or nurse will administer the vaccine by injection into the muscle. The preferred site for injection in adults 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 miss a dose of HBVAXPRO 40 micrograms
If you miss a scheduled injection, consult your doctor, pharmacist, or nurse. Your doctor or nurse will decide when to administer 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 cases, a causal relationship between the side effects and the vaccine has not been established.
The most frequently observed side effects are injection site reactions: pain, 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, Inflammation 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, Flu-like symptoms
- Elevation of liver enzymes
- Inflammation of the eyes causing pain and redness
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are 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. Storage of HBVAXPRO 40 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 further information
Composition of HBVAXPRO40micrograms
The active substance is:
Recombinant hepatitis B surface antigen (HBsAg)* …..... 40 micrograms Adsorbed on amorphous aluminum hydroxyphosphate sulfate (0.50 milligrams Al+)
- produced in yeast Saccharomyces cerevisiae (strain 2150-2-3) using recombinant DNA technology.
The 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 size of HBVAXPRO40micrograms
HBVAXPRO 40 micrograms is a suspension for injection in a vial.
Pack size of 1 vial.
Marketing authorisation holder and manufacturer
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Netherlands
For further information on this vaccine, please contact the local representative of the marketing authorisation holder.
België/Belgique/BelgienMSD BelgiumTél/Tel: +32(0)[email protected] | LietuvaUAB Merck Sharp & DohmeTel. +370 5 2780 [email protected] |
| Luxembourg/LuxemburgMSD BelgiumTél/Tel: +32 (0) [email protected] |
Ceská republikaMerck Sharp & Dohme s.r.o.Tel.: +420 233 010 [email protected] | MagyarországMSD Pharma Hungary Kft.Tel.: + [email protected] |
DanmarkMSD Danmark ApSTlf.: +45 4482 [email protected] | MaltaMerck Sharp & Dohme Cyprus Limited.Tel: 8007 4433 (+356 99917558)[email protected] |
DeutschlandMSD Sharp & Dohme GmbHTel.: +49 (0) 89 20 300 [email protected] | NederlandMerck Sharp & Dohme B.V.Tel: 0800 9999000 (+31 23 5153153)[email protected] |
EestiMerck Sharp & Dohme OÜTel: +372 614 [email protected] | NorgeMSD (Norge) ASTlf: +47 32 20 73 [email protected] |
Ελλ?δαMSD Α.Φ.Ε.Ε.Τηλ: +30 210 98 97 [email protected] | ÖsterreichMerck Sharp & Dohme Ges.m.b.H.Tel: +43 (0) 1 26 [email protected] |
EspañaMerck Sharp & Dohme de España, S.A.Tel: +34 91 321 06 [email protected] | PolskaMSD Polska Sp. z o.o.Tel.: +48 22 549 51 [email protected] |
FranceMSD FranceTél: +33 (0)1 80 46 40 40 | PortugalMerck Sharp & Dohme, LdaTel: +351 21 [email protected] |
HrvatskaMerck Sharp & Dohme d.o.o.Tel: +385 1 66 11 [email protected] | RomâniaMerck Sharp & Dohme Romania S.R.LTel: + 4021 529 29 [email protected] |
IrelandMerck Sharp & Dohme Ireland (Human Health) LimitedTel: +353 (0)1 [email protected] | SlovenijaMerck Sharp & Dohme, inovativna zdravila d.o.o.Tel: +386 1 520 [email protected] |
ÍslandVistor ehf.Sími: + 354 535 7000 | Slovenská republikaMerck Sharp & Dohme, s. r. o.Tel: +421 2 [email protected] |
ItaliaMSD Italia S.r.l.Tel: 800 23 99 89 (+39 06 361911)[email protected] | Suomi/FinlandMSD Finland OyPuh/Tel: +358 (0)9 804 [email protected] |
Κ?προςMerck Sharp & Dohme Cyprus LimitedΤηλ: 800 00 673 (+357 22866700)[email protected] | SverigeMerck Sharp & Dohme (Sweden) ABTel: +46 77 [email protected] |
LatvijaSIA Merck Sharp & Dohme LatvijaTel.: +371 [email protected] |
Date of last revision of this leaflet:
Detailed information on this medicine is available on the European Medicines Agency website: https://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 possible appearance of 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.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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