Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - vaxneuvance

Document Subject

Generated Narrative: MedicinalProductDefinition mp3f214a4f5ac8e3dc74014e21089eb5bc

identifier: http://ema.europa.eu/identifier/EU/1/21/1591/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: Vaxneuvance suspension for injection in pre-filled syringe

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-3f214a4f5ac8e3dc74014e21089eb5bc

identifier: http://ema.europa.eu/identifier/EU/1/21/1591/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - vaxneuvance

Attesters

What is in this leaflet

1. What Vaxneuvance is and what it is used for
2. What you need to know before you or your child receives Vaxneuvance
3. How Vaxneuvance is given
4. Possible side effects
5. How to store Vaxneuvance
6. Contents of the pack and other information

Vaxneuvance is a pneumococcal vaccine given to:

• children from 6 weeks to less than 18 years of age to help protect against diseases such as lung infection (pneumonia), inflammation of the coverings of the brain and spinal cord (meningitis), a severe infection in the blood (bacteraemia) and ear infections (acute otitis media),
• individuals 18 years of age and older to help protect against diseases such as lung infection (pneumonia), inflammation of the coverings of the brain and spinal cord (meningitis) and a severe infection in the blood (bacteraemia), caused by 15 types of bacteria called Streptococcus pneumoniae or pneumococcus.

Do not receive Vaxneuvance if:

• you or your child is allergic to the active substances or to any of the ingredients of this vaccine (listed in section 6), or to any vaccine that contains diphtheria toxoid. Warnings and precautions Talk to your doctor, pharmacist, or nurse before you or your child receives Vaxneuvance if:
• the immune system is weak (which means the body is less able to fight off infections) or if you or your child is taking certain medicines that may make the immune system weak (for example, immunosuppressants or steroids).
• you or your child has a high fever or severe infection. In these cases, the vaccination may have to be postponed until you or your child has recovered. However, a mild fever or infection (for example having a cold) itself is not a reason to delay vaccination.
• you or your child has any bleeding problems, bruises easily, or is taking medicines to prevent blood clots. If your child is an infant, also tell your doctor if your child was born prematurely (too early). As with any vaccine, Vaxneuvance may not fully protect all persons who are vaccinated. Other medicines/vaccines and Vaxneuvance Your child can be given Vaxneuvance at the same time as other routine childhood vaccines. In adults, Vaxneuvance can be given at the same time as the flu (inactivated influenza) vaccine. Tell your doctor, pharmacist, or nurse if:
• you or your child is taking, has recently taken, or might take any prescription medicines (for example, immunosuppressants or steroids which may make the immune system weak) or any medicines obtained without a prescription.
• you or your child has recently received or plan to receive any other vaccine. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before you receive this vaccine. Driving and using machines Vaxneuvance has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4 Possible side effects may temporarily affect the ability to drive or use machines. Vaxneuvance contains sodium This medicine contains less than 1 mmol sodium (23 milligrams) per dose, that is to say essentially sodium-free .

Tell your doctor, pharmacist, or nurse if you or your child has been given a pneumococcal vaccine before. Your doctor or nurse will give the vaccine into your arm muscle or into your child's arm or leg muscle. Infants and children aged 6 weeks to less than 2 years
Your child should receive an initial course of 2 injections of the vaccine followed by a booster dose.

• The first injection may be given as early as 6 weeks of age.
• A second injection is administered 2 months later.
• A third injection (booster) will be given between 11 through 15 months of age. You will be told when your child should come back for each injection. According to official recommendations in your country, an alternative schedule of 3 injections followed by a booster dose may be used by your healthcare provider. Please speak to your doctor, pharmacist, or nurse for more information. Premature infants (born earlier than 37 weeks of pregnancy) Your child should receive an initial course of 3 injections of the vaccine followed by a booster dose.
• The first injection may be given as early as 6 weeks of age.
• The second and third injections are given thereafter with an interval of 4 to 8 weeks between doses.
• A fourth injection (booster) will be given between 11 through 15 months of age. Infants, children and adolescents starting the vaccination at 7 months of age or older Infants 7 to less than 12 months of age should receive a total of 3 injections. The first two injections will be given at least 1 month apart. The third injection (booster) will be given after 12 months of age and at least 2 months after the second injection. Children 12 months to less than 2 years of age should receive a total of 2 injections. The two injections will be given at least 2 months apart. Children and adolescents 2 to less than 18 years of age should receive 1 injection. Adults Adults should receive 1 injection. Special populations One or more injections of Vaxneuvance may be given to individuals who have one or more underlying conditions that increase their risk for pneumococcal disease (such as individuals with sickle cell disease or living with human immunodeficiency virus [HIV] or recipients of a stem cell transplant). If you have any further questions on the use of Vaxneuvance, ask your doctor, pharmacist, or nurse.

Like all vaccines, Vaxneuvance can cause side effects, although not everybody gets them. Get medical care right away if you or your child has symptoms of an allergic reaction, which may include:

• Wheezing or trouble breathing
• Swelling of the face, lips, or tongue
• Hives
• Rash The following side effects can be seen after the use of Vaxneuvance in infants, children and adolescents: Very common (may affect more than 1 in 10 people):
• Fever (temperature of 38 C or higher in those 6 weeks to less than 2 years of age)
• Irritability (in those 6 weeks to less than 2 years of age)
• Drowsiness (in those 6 weeks to less than 2 years of age)
• Pain, redness or swelling at the injection site
• Decreased appetite (in those 6 weeks to less than 2 years of age)
• Hardness at the injection site (in those 6 weeks to less than 2 years of age)
• Muscle aches (in those 2 to less than 18 years of age)
• Feeling tired (in those 2 to less than 18 years of age)
• Headache (in those 2 to less than 18 years of age) Common (may affect up to 1 in 10 people):
• Hardness at the injection site (in those 2 to less than 18 years of age)
• Hives
• Fever (temperature of 38 C or higher in those 2 to less than 18 years of age)
• Vomiting (in those 6 weeks to less than 2 years of age)
• Rash (in those 6 weeks to less than 2 years of age)
• Irritability (in those 2 to less than 18 years of age)
• Drowsiness (in those 2 to less than 18 years of age)
• Decreased appetite (in those 2 to less than 18 years of age)
• Bruising at the injection site
• Nausea (in those 2 to less than 18 years of age) Uncommon (may affect up to 1 in 100 people):
• Vomiting (in those 2 to less than 18 years of age) Not known (cannot be estimated from the available data):
• Rash (in those 2 to less than 18 years of age) The following side effects can be seen after the use of Vaxneuvance in adults: Very common (may affect more than 1 in 10 people):
• Pain, swelling, or redness at the injection site
• Feeling tired
• Muscle aches
• Headaches
• Joint pain (in those 18 to 49 years of age) Common (may affect up to 1 in 10 people):
• Joint pain (in those 50 years of age and older)
• Nausea (in those 18 to 49 years of age)
• Fever (in those 18 to 49 years of age)
• Itchiness at the injection site
• Dizziness (in those 18 to 49 years of age)
• Chills (in those 18 to 49 years of age) Uncommon (may affect up to 1 in 100 people):
• Fever (in those 50 years of age and older)
• Warmth at the injection site
• Bruising at the injection site
• Dizziness (in those 50 years of age and older)
• Nausea (in those 50 years of age and older)
• Vomiting
• Chills (in those 50 years of age and older)
• Rash Rare (may affect up to 1 in 1,000 people):
• Allergic reaction such as hives, tongue swelling, flushing, and throat tightness These side effects are generally mild and last a short time. Reporting of side effects If you or your child gets 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 carton and syringe label after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C 8 C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light. Vaxneuvance should be administered as soon as possible after being removed from the refrigerator. However, in circumstances where Vaxneuvance is temporarily held outside of refrigeration, the vaccine is stable at temperatures up to 25 C for 48 hours.

What Vaxneuvance contains The active substances are:

• bacterial sugars from pneumococcus types 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F (2.0 micrograms of each type);

• bacterial sugar from pneumococcus type 6B (4.0 micrograms). Each bacterial sugar is linked to a carrier protein (CRM197). The bacterial sugars and the carrier protein are not alive and do not cause disease. One dose (0.5 mL) contains approximately 30 micrograms carrier protein, adsorbed on aluminium phosphate (125 micrograms aluminium [Al3+]). Aluminium phosphate is included in the vaccine as an adjuvant. Adjuvants are included to improve the immune responses of vaccines. The other ingredients are sodium chloride (NaCl), L-histidine, polysorbate 20, and water for injections. What Vaxneuvance looks like and contents of the pack Vaxneuvance is an opalescent suspension for injection, provided in a single-dose, pre-filled syringe (0.5 mL). Vaxneuvance is available in pack sizes of 1 or 10, either without needles, with 1 separate needle, or with 2 separate needles. Vaxneuvance is also available in multipacks comprising 5 cartons, each containing 10 pre-filled syringes without needles. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Merck Sharp & Dohme B.V. Waarderweg 2031 BN Haarlem The Netherlands For any information about this medicine, 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 6144 msdeesti@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) Limited Tel: +353 (0)1 2998medinfo_ireland@merck.com Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. 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 United Kingdom (Northern Ireland) SIA Merck Sharp & Dohme Latvija Tel: +371.67364.msd_lv@merck.com Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998medinfoNI@msd.com This leaflet was last revised in {MM/YYYY}. Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. <------------------------------------------------------------------------------------------------------------------------> The following information is intended for healthcare professionals only: Vaxneuvance must not be injected intravascularly.

• Immediately prior to use, hold the pre-filled syringe horizontally and shake vigorously to obtain an opalescent suspension. Do not use the vaccine if it cannot be resuspended.
• Inspect the suspension visually for particulate matter and discolouration prior to administration. Discard the vaccine if particulates are present and/or if it appears discoloured.
• Attach a needle with Luer lock connection by twisting in a clockwise direction until the needle fits securely on the syringe.
• Inject immediately using the intramuscular (IM) route, preferably in the anterolateral aspect of the thigh in infants or in the deltoid area of the upper arm in children and adults.
• Exercise care to avoid harm from an accidental needle stick. No data are available for administration via the intradermal route. Vaxneuvance must not be mixed with any other vaccines in the same syringe. Vaxneuvance can be given concomitantly with other routine childhood vaccines. Vaxneuvance can be administered concomitantly with seasonal quadrivalent influenza vaccine (split virion, inactivated) in adults. Different injectable vaccines should always be administered at different injection sites. Store in a refrigerator (2 8 ). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light. Vaxneuvance should be administered as soon as possible after being removed from the refrigerator. In the event of temporary temperature excursions, stability data indicate that Vaxneuvance is stable at temperatures up to 25 for 48 hours. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.