Medicines Vaxneuvance Suspension for Injection In Pre Filled Syringe Instructions

Suspension for Injection In Pre Filled Syringe
Instructions

Vaxneuvance Suspension for Injection In Pre Filled Syringe

Package leaflet: Information for the user
Vaxneuvance® suspension for injection in pre-filled syringe
Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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.
– This vaccine has been prescribed for you only. Do not pass it on to others.
– If you 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.
What is in this leaflet

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

What Vaxneuvance is and what it is used for

Vaxneuvance is a pneumococcal vaccine given to help protect against diseases caused by 15 types of bacteria called Streptococcus pneumoniae or pneumococcus in individuals 18 years of age and older.
These diseases include lung infection (pneumonia), inflammation of the coverings of the brain and spinal cord (meningitis), and a severe infection in the blood (bacteraemia).

What you need to know before you receive Vaxneuvance

Do not receive Vaxneuvance if:

• you are 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 receive Vaxneuvance if:

• your immune system is weak (which means your body is less able to fight off infections) or if you are taking certain medicines that may make your immune system weak (for example, immunosuppressants or steroids).
• you have a high fever or severe infection. In these cases, the vaccination may have to be postponed until you have recovered. However, a mild fever or infection (for example having a cold) itself is not a reason to delay vaccination.
• you have any bleeding problems, bruise easily, or are taking medicines to prevent blood clots.

As with any vaccine, Vaxneuvance may not fully protect all persons who are vaccinated.
Children and adolescents
It has not been established whether Vaxneuvance can be used in children and adolescents younger than 18 years of age.
Other medicines/vaccines and Vaxneuvance
Vaxneuvance can be given at the same time as the flu (inactivated influenza) vaccine.
Tell your doctor, pharmacist, or nurse if:

• you are taking, have recently taken, or might take any prescription medicines (for example, immunosuppressants or steroids which may make your immune system weak) or any medicines obtained without a prescription.
• you have 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’.

How Vaxneuvance is given

One injection of Vaxneuvance is given by your doctor, pharmacist or nurse into your muscle (preferably in your upper arm).
Tell your doctor, pharmacist, or nurse if you have been given a pneumococcal vaccine before.
Special populations
One injection of Vaxneuvance may be given to individuals who have one or more underlying conditions that increase their risk for pneumococcal disease (such as those living with human immunodeficiency virus [HIV]).
If you have any further questions on the use of Vaxneuvance, ask your doctor, pharmacist, or nurse.

Possible side effects

Like all vaccines, Vaxneuvance can cause side effects, although not everybody gets them.
Get medical care right away if you have 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:
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.

Tell your healthcare provider about these side effects or any other unusual symptoms that develop after you receive this vaccine.
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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Vaxneuvance

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 (2º C – 8º 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 25º C for 48 hours.

Contents of the pack and other information

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
Marketing Authorisation Holder:
Merck Sharp & Dohme (UK) Limited
120 Moorgate
London EC2M 6UR
United Kingdom
Manufacturer:
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
For any information about this medicine, please contact:
Merck Sharp & Dohme (UK) Limited
Tel: +44 (0)208 1548000
[email protected]

This leaflet was last revised in May 2022.
© 2022 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.
PIL.VAX.22.GB.8175.IB-001.RCN023651
<————————————————–>
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 deltoid area of the upper arm.
• Exercise care to avoid harm from an accidental needle stick.

No data are available for administration via the subcutaneous or intradermal routes.
Vaxneuvance must not be mixed with any other vaccines in the same syringe.
Vaxneuvance can be administered concomitantly with seasonal quadrivalent influenza vaccine (split virion, inactivated). Different injectable vaccines should always be administered at different injection sites.
Store in a refrigerator (2º C – 8º 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.
In the event of temporary temperature excursions, stability data indicate that Vaxneuvance is stable at temperatures up to 25º C for 48 hours.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© 2022 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.
PIL.VAX.22.GB.8175.IB-001.RCN023651

References

• Yellow Card | Making medicines and medical devices safer

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