Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - hbvaxpro

Document Subject

Generated Narrative: MedicinalProductDefinition mp8f194b3a85e80bebf07798b496672e52

identifier: http://ema.europa.eu/identifier/EU/1/01/183/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: HBVAXPRO 5 micrograms, suspension for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-8f194b3a85e80bebf07798b496672e52

identifier: http://ema.europa.eu/identifier/EU/1/01/183/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - hbvaxpro

Attesters

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

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.

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. Other 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, that is to say essentially sodium- free .

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 thrombocytopaenia (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.

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.

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 (2 C - 8 C). Do not freeze. Store in the original package in order to protect from light. 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.

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.

Amorphous aluminium hydroxyphosphate sulfate is included in this vaccine as an adsorbant. Adsorbants

are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine. The other ingredients are sodium chloride (NaCl), 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. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Merck Sharp & 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. Belgi /Belgique/Belgien MSD Belgium
T l/Tel: +32(0)27766dpoc_belux@merck.com Lietuva UAB Merck Sharp & Dohme Tel.: +370.5.2780.msd_lietuva@merck.com

       , 

.: + 359 2 819 3info-msdbg@merck.com Luxembourg/Luxemburg MSD Belgium
T l/Tel: +32(0)27766dpoc_belux@merck.com esk republika Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 dpoc_czechslovak@merck.com Magyarorsz g MSD Pharma Hungary Kft. Tel.: + 36.1.888.5hungary_msd@merck.com Danmark MSD Danmark ApS Tlf: + 45 4482 4dkmail@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 0) e-mail@msd.de Nederland Merck Sharp & Dohme B.V. Tel: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com Eesti Merck Sharp & Dohme O , Tel: +372.614.4msdeesti@merck.com Norge MSD (Norge) AS Tlf: +47 32 20 73 msdnorge@msd.no

MSD . . . . . : +30 210 98 97 dpoc_greece@merck.com sterreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 dpoc_austria@merck.com Espa a Merck Sharp & Dohme de Espa a, S.A. Tel: +34 91 321 06 msd_info@merck.com Polska MSD Polska Sp. z o.o. Tel.: +48.22.549.51.msdpolska@merck.com France MSD France T l: +33 (0)1 80 46 40 Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465inform_pt@merck.com Hrvatska Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 croatia_info@merck.com Rom nia Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 msdromania@merck.com Ireland Merck Sharp & Dohme Ireland (Human Health) Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Limited Tel: +353 (0)1 2998medinfo_ireland@merck.com Tel: +386.1.520.4msd.slovenia@merck.com sland Vistor hf. S mi: + 354 535 7Slovensk republika Merck Sharp & Dohme, s. r.* Tel: +421 2 58282dpoc_czechslovak@merck.com Italia MSD Italia S.r.l. Tel: 800 23 99 89 (+39 06 361911) medicalinformation.it@msd.com Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 info@msd.fi

Merck Sharp & Dohme Cyprus Limited : 800 00 673 (+357 22866700) cyprus_info@merck.com Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700medicinskinfo@merck.com Latvija SIA Merck Sharp & Dohme Latvija Tel: +371.67364.msd_lv@merck.com United Kingdom (Northern Ireland) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998medinfoNI@msd.com This leaflet was last approved in {MM/YYYY}. 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 (recombinant DNA) 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.