Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - apexxnar

Document Subject

Generated Narrative: MedicinalProductDefinition mpd7b1f21254cfe6d481d9f6365694f530

identifier: http://ema.europa.eu/identifier/EU/1/21/1612/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Apexxnar suspension for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d7b1f21254cfe6d481d9f6365694f530

identifier: http://ema.europa.eu/identifier/EU/1/21/1612/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - apexxnar

Attesters

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

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.

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 Apexxnar may be given at the same time as the flu (inactivated influenza) vaccine at different injection sites. Depending on the individual risk assessment of your health care provider, separation of both vaccinations of e.g., 4 weeks might be advised. Apexxnar can be given at the same time as the COVID-19 mRNA vaccine. 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 .

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.

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.

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.

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 One dose (0.5 mL) contains approximately 51 micrograms CRM197 carrier protein, adsorbed on aluminium phosphate (0.125 mg aluminium). The other ingredients are sodium chloride, succinic acid, polysorbate 80 and water for injections. 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, 10 and 50, with or without needles. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Pfizer Europe MA EEIG Boulevard de la Plaine 1050 Bruxelles Belgium Manufacturer responsible for batch release: Pfizer Manufacturing Belgium N.V. Rijksweg 2870 Puurs Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA T l/Tel: + 32 (0)2 554 62 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel. + 370 5 251 4 ,

Te : +359 2 970 4Magyarorsz g Pfizer Kft Tel: + 36 1 488 37 esk republika Pfizer, spol. s r.o. Tel: +420 283 004 Malta Vivian Corporation Ltd. Tel: + 356 21344Danmark Pfizer ApS Tlf: + 45 44 20 11 Nederland Pfizer bv Tel: +31 (0)800 63 34 Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055-51Norge Pfizer AS Tlf: +47 67 52 61 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7 sterreich Pfizer Corporation Austria Ges.m.b.H Tel: +43 (0)1 521 15-0

Pfizer A.E. .: +30 210 6785Polska Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 Espa a Pfizer, S.L. T lf: +34 91 490 99 Portugal Laborat rios Pfizer, Lda. Tel: +351 21 423 5France Pfizer T l +33 (0)1 58 07 34 Rom nia Pfizer Romania S.R.L Tel: +40 (0) 21 207 28 Hrvatska Pfizer Croatia d.o.o. Tel: + 385 1 3908 Slovenija Pfizer Luxembourg SARL Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana Tel.: +386 (0)1 52 11 Ireland Pfizer Healthcare Ireland Tel: +1800 633 363 (toll free) Tel: +44 (0)1304 616Slovensk republika Pfizer Luxembourg SARL, organiza n zlo ka Tel: + 421 2 3355 5 sland Icepharma hf. Simi: + 354 540 8Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 Italia Pfizer S.r.l. Tel: +39 06 33 18 Sverige Pfizer AB Tel: +46 (0)8 550 520 K Pfizer . . (Cyprus Branch) T : +357 22817United Kingdom (Northern Ireland) Pfizer Limited Tel: + 44 (0) 1304 616Latvija Pfizer Luxembourg SARL fili le Latvij Tel.: + 371 670 35 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: http://www.ema.europa.eu.

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/medicinal products in the same syringe. Apexxnar may be given to adults at the same time as the seasonal influenza vaccine (QIV; surface antigen, inactivated, adjuvanted). In individuals with underlying conditions associated with a high risk of developing life-threatening pneumococcal disease, consideration may be given to separating administrations of QIV and Apexxnar (e.g., by approximately 4 weeks). Different vaccination sites should be used. Apexxnar can be given to adults at the same time as the COVID-19 mRNA vaccine (nucleoside modified). Any unused product or waste material should be disposed of in accordance with local requirements.