Apexxnar - patient leaflet, side effects, dosage

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