solution for injection, suspension in a pre-filled syringe
conjugated pneumococcal polysaccharide vaccine (15-valent, adsorbed )
What Vaxneuvance is and what it is used for
Vaxneuvance is a pneumococcal vaccine given to adults from the age of 18 to protect against diseases caused by 15 types of the bacterium Streptococcus pneumoniae, also called “pneumococcus”.
These diseases include lung inflammation ( pneumonia ), inflammation of the membranes around the brain and spinal cord (meningitis/ meningitis ), and serious infection in the blood (blood poisoning/sepsis).
What you need to know before receiving Vaxneuvance
You should not receive Vaxneuvance:
- if you are allergic to the active substances or any other ingredient in this vaccine (listed in section 6), or to any vaccine containing diphtheria toxoid.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Vaxneuvance if:
- your immune system is weak (which means that the body is less able to fight infection ) or if you are taking certain drugs that can weaken the immune system (eg immunosuppressive drugs or steroids ).
- you have a high fever or a severe infection. In such cases, it may be necessary to postpone the vaccination until you have recovered. However, a low fever or a mild infection (e.g. a cold) is no reason to postpone the vaccination.
- you have bleeding problems, bruise easily or take medicines to prevent blood clots.
As with other vaccines, it is not certain that everyone vaccinated with Vaxneuvance will receive full protection.
Children and young people
It has not been determined whether Vaxneuvance can be used in children and adolescents under the age of 18.
Other medicines/vaccines and Vaxneuvance
Vaxneuvance can be given at the same time as the (inactivated) influenza vaccine.
Tell your doctor, pharmacist, or nurse if:
- you are taking, have recently taken, or maybe taking prescription medicines (eg immunosuppressive medicines or steroids, which can weaken the immune system), or any over-the-counter medicines.
- you have recently received or plan to receive any other vaccine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before using this vaccine.
Driving ability and use of machinery
Vaxneuvance has no or negligible effect on the ability to drive and use machines. However, some of the side effects (see section 4 “Possible side effects”) may temporarily affect the ability to drive vehicles and use machines.
Vaxneuvance contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. is almost “sodium-free”.
How to get Vaxneuvance
An injection of Vaxneuvance is given by a doctor or nurse into a muscle (preferably in the upper arm).
Tell the doctor, pharmacist, or nurse if you have been vaccinated against pneumococci before.
Special patient groups
An injection of Vaxneuvance may be given to people who have one or more underlying medical conditions that increase the risk of pneumococcal disease (eg, people living with HIV [human immunodeficiency virus]).
If you have any further questions about this vaccine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all vaccines, Vaxneuvance can cause side effects, but not all users need to get them.
Seek medical attention immediately if you experience symptoms of an allergic reaction, such as:
- wheezing or difficulty breathing
- swelling of the face, lips, or tongue
- hives/rash
- rash
The following side effects may occur after using Vaxneuvance:
Very common (may affect more than 1 in 10 users):
- pain, swelling, or redness at the injection site
- fatigue
- muscle pain
- headache
- joint pain (in users 18 to 49 years old)
Common (may affect up to 1 in 10 users):
- joint pain (in users 50 years and older)
- nausea (in users 18 to 49 years old)
- fever (in users 18 to 49 years old)
- itching at the injection site
- dizziness (in users 18 to 49 years old)
- chills (in users 18 to 49 years old)
Uncommon (may affect up to 1 in 100 users):
- fever (in users 50 years and older)
- the feeling of warmth at the injection site
- bruising at the injection site
- dizziness (in users 50 years and older)
- nausea (in users 50 years and older)
- vomiting
- chills (in users 50 years and older)
- rash
Rare (may affect up to 1 in 1,000 users):
- allergic reactions such as hives, swollen tongue, redness, and swelling/tightness in the throat.
These side effects are generally mild and short-lived.
Tell your healthcare professional if you get any of these side effects, or any other unusual symptoms, after receiving this vaccine.
How to store Vaxneuvance
Keep this vaccine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and syringe label after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C-8 °C). Do not freeze.
Store the pre-filled syringe in the outer carton. Light sensitive.
Vaxneuvance should be administered as soon as possible after removal from the refrigerator.
When temporarily storing Vaxneuvance outside the refrigerator, the vaccine is stable (stable) at temperatures up to 25 °C for 48 hours.
Contents of the packaging and other information
Contents declaration
The active substances are:
- bacterial polysaccharides from pneumococcal types 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F (2.0 micrograms of each type)
- bacterial polysaccharides from pneumococcus type 6B (4.0 micrograms).
Each bacterial polysaccharide (a type of sugar) is linked to a carrier protein (CRM 197 ). The bacterial polysaccharides and carrier proteins are not living and do not cause disease.
One dose (0.5 ml) contains approximately 30 micrograms of carrier protein adsorbed on aluminum phosphate (125 micrograms aluminum [Al 3+ ]). Aluminum phosphate is included in the vaccine as an adjuvant. Adjuvants are added to enhance the immune system’s response to vaccines.
Other ingredients are sodium chloride (NaCl), L-histidine, polysorbate 20, and water for injections.
Appearance and package sizes of the medicine
Vaxneuvance is an opalescent suspension for injection, supplied in a pre-filled disposable syringe (0.5 ml). Vaxneuvance is available in pack sizes of 1 or 10 pre-filled syringes, either without needles, with 1 separate needle per pre-filled syringe, or with 2 separate needles per pre-filled syringe.
Vaxneuvance is also available in multipacks consisting of 5 cartons each containing 10 pre-filled syringes without needles.
Not all pack sizes may be marketed.
Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
Netherlands
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienMSD BelgiumPhone: +32 (0) 27766211dpoc_belux@merck.com | LithuaniaUAB Merck Sharp & DohmeTel.: +370.5.2780.247msd_lietuva@merck.com |
| BulgariaМерк Шарп и Дом Булгария ЕООДtel.: + 359 2 819 3737info-msdbg@merck.com | Luxembourg/LuxembourgMSD BelgiumPhone: +32 (0) 27766211dpoc_belux@merck.com |
| Czech RepublicMerck Sharp & Dohme s.r.oTel.: +420 233 010 111dpoc_czechslovak@merck.com | MagyarországMSD Pharma Hungary Kft.Phone: + 36.1.888.5300hungary_msd@merck.com |
| DenmarkMSD Danmark ApSPhone: + 45 4482 4000dkmail@merck.com | MaltaMerck Sharp & Dohme Cyprus Limited.Phone: 8007 4433 (+356 99917558)malta_info@merck.com |
| DeutschlandMSD Sharp & Dohme GmbHPhone: 0800 673 673 673 (+49 (0) 89 4561 0)e-mail@msd.de | The NetherlandsMerck Sharp & Dohme BVPhone: 0800 9999000 (+31 23 5153153)medicalinfo.nl@merck.com |
| EstoniaMerck Sharp & Dohme OÜTel.: +372 6144 200msdeesti@merck.com | NorwayMSD (Norway) iPhone: +47 32 20 73 00msdnorge@msd.no |
| GreeceMSD Α.Φ.Β.Ε.Ε.Tel: +30 210 98 97 300dpoc_greece@merck.com | AustriaMerck Sharp & Dohme Ges.mbHPhone: +43 (0) 1 26 044dpoc_austria@merck.com |
| SpainMerck Sharp & Dohme de España, SAPhone: +34 91 321 06 00msd_info@merck.com | PolishMSD Polska Sp. z o. oTel.: +48.22.549.51.00msdpolska@merck.com |
| FranceMSD FranceTel: +33 (0) 1 80 46 40 40 | PortugalMerck Sharp & Dohme, LdaPhone: +351 21 4465700inform_pt@merck.com |
| HrvatskaMerck Sharp & Dohme dooPhone: +385 1 66 11 333croatia_info@merck.com | RomaniaMerck Sharp & Dohme Romania SRLPhone: + 4021 529 29 00msdromania@merck.com |
| IrelandMerck Sharp & Dohme Ireland ( Human Health) LimitedPhone: +353 (0)1 2998700medinfo_ireland@merck.com | SlovenijaMerck Sharp & Dohme, inovativna svladíva dooPhone: +386.1.520.4201msd.slovenia@merck.com |
| IcelandVistor hf.Telephone: + 354 535 7000 | Slovenian RepublicMerck Sharp & Dohme, s.r.oPhone: +421 2 58282010dpoc_czechslovak@merck.com |
| ItalyMSD Italia SrlTel: +39 06 361911 medicalinformation.it@merck.com | Finland/FinlandMSD Finland OyPhone/Tel: +358 (0)9 804 650info@msd.fi |
| CyprusMerck Sharp & Dohme Cyprus LimitedTel: 800 00 673 (+357 22866700)cyprus_info@merck.com | SwedenMerck Sharp & Dohme (Sweden) ABPhone: +46 77 5700488medicalinfo@merck.com |
| LatviaSIA Merck Sharp & Dohme LatvijaPhone: +371.67364.224msd_lv@merck.com | United Kingdom (Northern Ireland)Merck Sharp & Dohme Ireland ( Human Health) LimitedPhone: +353 (0)1 2998700medinfoNI@msd.com |