HBVAXPRO 5 micrograms INJECTABLE SUSPENSION
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
- What HBVAXPRO 5 micrograms is and what it is used for
- What you need to know before you or your child receives HBVAXPRO 5 micrograms
- How HBVAXPRO 5 micrograms is administered
- Possible side effects
- Storage of HBVAXPRO 5 micrograms
- 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.
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
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 | Lietuva UAB Merck Sharp & Dohme Tel.: +370.5.2780.247 |
???????? ???? ???? ? ???? ???????? ????, ???.: + 359 2 819 3737 | Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 |
Ceská republika Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111 | Magyarország MSD Pharma Hungary Kft. Tel.: + 36.1.888.5300 |
Danmark MSD Danmark ApS Tlf: + 45 4482 4000 | Malta Merck Sharp & Dohme Cyprus Limited. Tel: 8007 4433 (+356 99917558) |
Eesti Merck Sharp & Dohme OÜ, Tel: +372.614.4200 | Norge MSD (Norge) AS Tlf: +47 32 20 73 00 |
Ελλ?δα MSD Α.Φ.Β.Ε.Ε. Τηλ: +30 210 98 97 300 | Österreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 |
España Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 | Polska MSD Polska Sp. z o.o. Tel.: +48.22.549.51.00 |
France MSD VACCINS Tél: +33 (0)1 80 46 40 40 | Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465700 |
Hrvatska Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 333 | România Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 00 |
Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 | Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386.1.520.4201 |
Ísland Vistor hf. Sími: + 354 535 7000 | Slovenská republika Merck Sharp & Dohme, s. r. o Tel: +421 2 58282010 |
Italia MSD Italia S.r.l. Tel: +39 06 361911 | Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 650 |
Κ?προς Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673 (+357 22866700) | Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 |
Latvija SIA Merck Sharp & Dohme Latvija Tel: +371.67364.224 | United Kingdom Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 |
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.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to HBVAXPRO 5 micrograms INJECTABLE SUSPENSIONDosage form: INJECTABLE, 20 mcg Hepatitis B Surface Antigen/ mlActive substance: hepatitis B, purified antigenManufacturer: Glaxosmithkline S.A.Prescription requiredDosage form: INJECTABLE, 10 mcg Hepatitis B Surface Antigen / 0.5 mlActive substance: hepatitis B, purified antigenManufacturer: Glaxosmithkline S.A.Prescription requiredDosage form: INJECTABLE, 20 µgActive substance: hepatitis B, purified antigenManufacturer: Glaxosmithkline BiologicalsPrescription required
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