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Apexxnar - Patient leaflet, side effects, dosage

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Patient leaflet - Apexxnar

B. PACKAGE LEAFLET

Package Leaflet: Information for the user

Apexxnar suspension for injection

pneumococcal polysaccharide conjugate vaccine (20-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 receive this vaccine 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 Apexxnar is and what it is used for

  • 2. What you need to know before you receive Apexxnar

  • 3. How Apexxnar is given

  • 4. Possible side effects

  • 5. How to store Apexxnar

  • 6. Contents of the pack and other information

1. What Apexxnar is and what it is used for

Apexxnar is a pneumococcal vaccine given to:

  • individuals aged 18 years and older to help prevent disease such as: pneumonia (lung infection), sepsis or bacteraemia (bacteria in the blood stream) and meningitis (inflammation around the brain) caused by 20 types of the bacteria Streptococcus pneumoniae.

Apexxnar provides protection against 20 types of Streptococcus pneumoniae bacteria.

The vaccine works by helping the body to make its own antibodies, which protect you against these diseases.

2. What you need to know before you receive Apexxnar

Apexxnar should not be given

  • if you are allergic (hypersensitive) to the active substances or to any of the other ingredients in

this medicine (listed in section 6), or to any other vaccine that contains diphtheria toxoid.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before the vaccination if you:

  • have any present or past medical problems after any dose of Apexxnar such as an allergic reaction or problems with breathing,
  • have a severe illness or high fever. However, a mild fever or upper respiratory infection (for example having a cold) itself is not a reason to delay vaccination,
  • have any bleeding problems or bruise easily,
  • have a weakened immune system (such as due to HIV infection); you may not get the full benefit from Apexxnar.

As with any vaccine, Apexxnar will not protect all persons who are vaccinated.

Other medicines/vaccines and Apexxnar

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, or have recently received 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 or pharmacist for advice before receiving this vaccine.

Driving and using machines

Apexxnar 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.

Apexxnar contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

  • 3. How Apexxnar is given

The doctor or nurse will inject the recommended dose (0.5 mL) of the vaccine into your arm.

You should receive 1 injection.

Tell your doctor, pharmacist or nurse if you have been given a pneumococcal vaccine before.

If you have any further questions on the use of Apexxnar, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all vaccines, Apexxnar can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor immediately if you notice signs of the following serious side effect (see also section 2):

swelling of the face, lips, mouth, tongue or throat (oedema), shortness of breath (dyspnoea), wheezing (bronchospasm) – these may by signs of a severe allergic reaction such as anaphylaxis, including shock.

Other side effects

Very common: may occur with more than 1 in 10 doses of the vaccine

  • Headache.
  • Joint pain and muscle pain.
  • Pain/tenderness at injection site and tiredness.

Common: may occur up to 1 in 10 doses of the vaccine

  • Swelling at injection site, redness at injection site and fever.

Uncommon: may occur up to 1 in 100 doses of the vaccine

  • Diarrhoea, nausea, and vomiting.
  • Rash and swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema).
  • Itching at injection site, swollen glands in the neck, armpit or groin (lymphadenopathy), hives at the injection site (urticaria), and chills.

The following side effects were seen with Prevenar 13 and may also be seen with Apexxnar:

  • A rash causing itchy red blotches (erythema multiforme).
  • Irritation at injection site.
  • Decreased appetite.
  • Limitation of arm movement.

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.

5. How to store Apexxnar

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C to 8 °C).

Apexxnar should be used as soon as possible after being removed from refrigeration.

Do not freeze. Discard if vaccine has been frozen.

Stability data indicate that the vaccine is stable for 96 hours when stored at temperatures from 8 °C to 25 °C, or 72 hours when stored at temperatures from 0 °C to 2 °C. At the end of these time periods Apexxnar should be used or discarded. These data are intended to guide healthcare professionals in case of temporary temperature excursion only.

Pre-filled syringes should be stored in the refrigerator horizontally to minimise the resuspension time.

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.

6. Contents of the pack and other information

What Apexxnar contains

The active substances are polysaccharide CRM197 conjugates consisting of:

  • 2.2 micrograms of polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14,

15B,18C, 19A, 19F, 22F, 23F and 33F

  • 4.4 micrograms of polysaccharide for serotype 6B

What Apexxnar looks like and contents of the pack

The vaccine is a white suspension for injection, provided in a single-dose, pre-filled syringe (0.5 mL). It is provided in pack sizes of 1 and 10, with or without needles, and a multipack containing 5 packs of 10 pre-filled syringes, with or without needles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Manufacturer responsible for batch release:

Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles

Belgium

Pfizer Manufacturing Belgium N.V.

Rijksweg 12

2870 Puurs

Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien

Luxembourg/Lu­xemburg

Pfizer NV/SA

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje

Tel. + 370 5 251 4000

Tél/Tel: + 32 (0)2 554 62 11

EtnrapuH

n<|)aÜ3ep ^æKceMÔypr C’APÆ Know

Btnrapun

Magyarország

Pfizer Kft

Tel: + 36 1 488 37 00

Ten: +359 2 970 4333

Česká republika

Pfizer, spol. s r.o.

Tel: +420 283 004 111

Malta

Vivian Corporation Ltd.

Tel: + 356 21344610

Danmark

Pfizer ApS

Tlf: + 45 44 20 11 00

Nederland

Pfizer bv

Tel: +31 (0)800 63 34 636

Deutschland

PFIZER PHARMA GmbH

Tel: +49 (0)30 550055–51000

Norge

Pfizer AS

Tlf: +47 67 52 61 00

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel: +372 666 7500

Österreich

Pfizer Corporation Austria Ges.m.b.H

Tel: +43 (0)1 521 15–0

EÀlàôa

Pfizer EÁÁác A.E.

TqX.: +30 210 6785800

Polska

Pfizer Polska Sp. z o.o.

Tel.: +48 22 335 61 00

España

Pfizer, S.L.

Télf: +34 91 490 99 00

Portugal

Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500

France

Pfizer

Tél +33 (0)1 58 07 34 40

România

Pfizer Romania S.R.L

Tel: +40 (0) 21 207 28 00

Hrvatska

Pfizer Croatia d.o.o.

Tel: + 385 1 3908 777

Slovenija

Pfizer Luxembourg SARL

Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana

Tel.: +386 (0)1 52 11 400

Ireland

Pfizer Healthcare Ireland

Tel: +1800 633 363 (toll free)

Tel: +44 (0)1304 616161

Slovenská republika

Pfizer Luxembourg SARL, organizačná zložka

Tel: + 421 2 3355 5500

Ísland

Icepharma hf.

Simi: + 354 540 8000

Suomi/Finland

Pfizer Oy

Puh/Tel: +358 (0)9 430 040

Italia

Pfizer S.r.l.

Tel: +39 06 33 18 21

Sverige

Pfizer AB

Tel: +46 (0)8 550 520 00

Kùnpoç

Pfizer EÁÁác A.E. (Cyprus Branch)

TnÀ: +357 22817690

United Kingdom (Northern Ireland)

Pfizer Limited

Tel: + 44 (0) 1304 616161

Latvija

Pfizer Luxembourg SARL filiale Latvija

Tel.: + 371 670 35 775

This leaflet was last revised in <{MM/YYYY}>

Other sources of information

Detailed information on this product is available on the European Medicines Agency web site:.

The following information is intended for healthcare professionals only:

During storage, a white deposit and clear supernatant may be observed. This does not constitute a sign of deterioration. Pre-filled syringes should be stored horizontally to minimise the resuspension time.

Preparation for administration

Step 1. Vaccine resuspension

Hold the pre-filled syringe horizontally between the thumb and the forefinger and shake vigorously until the contents of the syringe are a homogeneous white suspension. Do not use the vaccine if it cannot be resuspended.

Step 2. Visual inspection

Visually inspect the vaccine for large particulate matter and discolouration prior to administration. Do not use if large particulate matter or discolouration is found. If the vaccine is not a homogenous white suspension, repeat steps 1 and 2.

Step 3. Remove syringe cap

Remove the syringe cap from the Luer lock adapter by slowly turning the cap counter clockwise while holding the Luer lock adapter.

Note: Care should be taken to ensure that the extended plunger rod is not depressed while removing the syringe cap.




Step 4. Attach a sterile needle

Attach a needle appropriate for intramuscular administration to the pre-filled syringe by holding the Luer lock adapter and turning the needle clockwise.

Administer the entire dose.

Apexxnar is for intramuscular use only.

Apexxnar must not be mixed with any other vaccines in the same syringe.

Any unused product or waste material should be disposed of in accordance with local requirements.

36

The drug is classified in the ATC tree:

Frequently Asked Questions

What is Apexxnar and what does it protect against?

Apexxnar is a vaccine that protects against infections caused by pneumococcus, a type of bacteria that can lead to serious illnesses like pneumonia, meningitis, and bloodstream infections.

Who should receive the Apexxnar vaccine?

Apexxnar is recommended for adults 65 years and older, as well as individuals aged 18 to 64 with certain medical conditions that increase their risk of pneumococcal disease.

How does the Apexxnar vaccine work?

Apexxnar works by introducing a small, harmless piece of the pneumococcus bacteria into your body. This stimulates your immune system to recognize and fight off the actual bacteria if you are exposed in the future.

Are there any side effects associated with Apexxnar?

Common side effects may include soreness at the injection site, redness, swelling, fatigue, and mild fever. Most side effects resolve on their own within a few days.

Can I get the Apexxnar vaccine if I am currently sick?

If you are moderately or severely ill, it is recommended to wait until you recover before getting vaccinated. Check with your healthcare provider for personalized advice.

How many doses of Apexxnar do I need?

Typically, adults may need one dose of Apexxnar; however, your healthcare provider will determine the appropriate vaccination schedule based on your age and health status.

Is Apexxnar safe for pregnant or breastfeeding women?

The safety of Apexxnar during pregnancy or breastfeeding has not been fully established. Consult your healthcare provider for guidance specific to your situation.

Can I receive other vaccines at the same time as Apexxnar?

Yes, in many cases you can receive other vaccines along with Apexxnar. It’s best to consult with your healthcare provider for personalized recommendations.

What should I do if I miss my appointment for the Apexxnar vaccine?

If you miss your appointment, contact your healthcare provider to reschedule as soon as possible. It’s important to get vaccinated at the earliest opportunity.

How long does it take for my body to build protection after receiving the Apexxnar vaccine?

It usually takes about two weeks after vaccination for your body to build up sufficient protection against pneumococcal infections.

Can children receive Apexxnar?

No, Apexxnar is not approved for use in children. It's specifically designed for adults aged 18 and older who are at higher risk.

What should I do if I have an allergic reaction after receiving ApeXXNar?

If you experience symptoms of an allergic reaction (such as difficulty breathing or swelling) after receiving the vaccine, seek immediate medical attention.

Will getting vaccinated with ApeXXNar guarantee that I won't get sick from pneumococcus?

While vaccination significantly reduces your risk of pneumococcal disease, it does not offer 100% protection. Maintaining overall health practices is also important.

What are some conditions that might lead my doctor to recommend the ApeXXNar vaccine?

Conditions such as chronic lung disease, heart disease, diabetes, and weakened immune systems can increase the risk of pneumococcal disease and prompt recommendations for vaccination.

Where can I get the ApeXXNar vaccine?

ApeXXNar can typically be obtained through doctors' offices, clinics, and some pharmacies. Check with local healthcare providers for availability.

Is there a cost associated with getting vaccinated with ApeXXNar?

The cost may vary based on insurance coverage and location. Check with your insurance provider or local health department about potential costs.

What if I've had another pneumococcal vaccine before—can I still get the ApeXXNar vaccine?

If you've received another type of pneumococcal vaccine in the past, consult your healthcare provider about whether it's appropriate to receive ApeXXNar based on timing and circumstances.

Can lifestyle choices affect my need for the ApeXXNar vaccine?

Yes! Factors such as smoking or having a poor diet can increase vulnerability to infections. Discuss lifestyle changes with your doctor that may impact your health status.

How can I stay informed about new vaccines like ApeXXNar in the future?

Stay connected with health organizations like the CDC or WHO and consult with your healthcare provider regularly for updates on vaccines and public health recommendations.