Pneumovax 23

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

PNEUMOVAX 23

Pneumococcal polysaccharide vaccine
Solution for injection

Read the leaflet carefully before using the vaccine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What PNEUMOVAX 23 is and what it is used for
• 2. Important information before using PNEUMOVAX 23
• 3. How to use PNEUMOVAX 23
• 4. Possible side effects
• 5. How to store PNEUMOVAX 23
• 6. Contents of the pack and other information

1. What PNEUMOVAX 23 is and what it is used for

PNEUMOVAX 23 is available in a vial containing 0.5 ml of vaccine.
PNEUMOVAX 23 is intended for use in children (aged 2 years and older) and adults to prevent infections caused by Streptococcus pneumoniae.
Vaccination is recommended for the following individuals:
Individuals with normal immune system function

• individuals aged 50 and over;
• individuals aged 2 and over with chronic heart disease and blood vessel disease (including congestive heart failure and cardiomyopathy), chronic respiratory disease (including chronic obstructive pulmonary disease and pulmonary emphysema), or diabetes;
• individuals aged 2 and over with chronic liver disease (including cirrhosis) and alcohol dependence, or those at risk of cerebrospinal fluid leakage;
• individuals aged 2 and over with congenital absence of the spleen or splenic dysfunction (including sickle cell anemia and post-splenectomy);
• individuals aged 2 and over living in certain environments or social groups, e.g., in social care homes. Individuals with impaired immune system function
• individuals aged 2 and over, including those infected with HIV, those with leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized cancer, chronic kidney failure, or nephrotic syndrome; individuals undergoing immunosuppressive chemotherapy (including those treated with corticosteroids); individuals who have undergone organ or bone marrow transplantation.

Pneumococci cause lung infections (mainly pneumonia), infections of the membranes surrounding the brain and spinal cord (meningitis), and blood infections (bacteremia or sepsis).
PNEUMOVAX 23 only protects against infections caused by those pneumococcal serotypes whose antigens are contained in the vaccine. The vaccine contains antigens of 23 serotypes, which are responsible for the majority of pneumococcal infections (about 9 out of 10).
Administration of the vaccine to both children and adults results in the production of antibodies that protect against pneumococcal infection.
Pneumococcal infections occur worldwide, regardless of patient age, and most commonly affect:

• the elderly;
• individuals who have had their spleen removed or have impaired splenic function;
• individuals with reduced immunity to infections due to prolonged illness or infection (e.g., certain types of cancer, HIV infection, heart, lung, kidney, liver disease, or diabetes);
• individuals with reduced immunity to infections due to treatment used for other conditions (e.g., cancer or organ or bone marrow transplantation).

Pneumococcal meningitis may occur after head trauma or skull fracture and rarely after certain surgeries. PNEUMOVAX 23 may not protect against all infections that occur in such circumstances.
PNEUMOVAX 23 does not protect against milder respiratory infections (e.g., sinus or ear infections).

2. Important information before using PNEUMOVAX 23

If any of the following conditions are met, inform your doctor or nurse. They will decide whether PNEUMOVAX 23 can be administered.

If any of the points listed are unclear, ask your doctor or nurse to explain.

When not to use PNEUMOVAX 23

• if the patient is allergic to any of the components of this vaccine (listed in section 6);
• if the patient has had an allergic reaction to any of the components of this vaccine (listed in section 6) in the past.

Warnings and precautions

The vaccine should not be administered in case of severe illness with fever.
Vaccination should be postponed until recovery.
Even if vaccination is postponed, it may not provide the same level of protection against pneumococcal infection as it does for healthy individuals, if:

• there is reduced immunity to infections due to current treatment (e.g., cytotoxic anticancer drugs or ongoing radiation therapy);
• there is prolonged illness or infection that may lead to reduced immunity to infections.

If the answer to any of the above points is yes, vaccination may be performed at the scheduled time or postponed to a later date.

Children and adolescents

PNEUMOVAX 23 can be administered to individuals aged 2 and over. Administration of the vaccine to younger individuals results in an insufficient immune response.

PNEUMOVAX 23 and other medicines

The vaccine can be administered simultaneously with the influenza vaccine.
To obtain information on the administration of PNEUMOVAX 23 simultaneously with the ZOSTAVAX vaccine, consult your doctor or healthcare professional.
Do not discontinue prophylactic antibiotic use against pneumococci. Even after vaccination, it is essential to initiate antibiotic therapy as soon as possible if infection or high risk of pneumococcal infection is suspected (e.g., in individuals who have had their spleen removed or have impaired splenic function).
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription and those you plan to use.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this vaccine.
It is not known whether administration of PNEUMOVAX 23 to a pregnant woman may pose a risk to the fetus. The decision to vaccinate is up to your doctor.
Inform your doctor about ongoing or planned breastfeeding. The decision to vaccinate is up to your doctor.

Driving and using machines

There is no evidence to suggest that PNEUMOVAX 23 may affect the ability to drive or operate machinery.

PNEUMOVAX 23 contains phenol

PNEUMOVAX 23 contains phenol as an excipient. Inform your doctor if you or your child have ever had an allergic reaction to this component.

PNEUMOVAX 23 contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is considered to be essentially "sodium-free".

3. How to use PNEUMOVAX 23

Vaccination should be performed by a doctor or nurse with experience in vaccine administration. It should be performed in a clinic where emergency medications are available in case of a rare, severe allergic reaction to the vaccine.
PNEUMOVAX 23 is usually administered into the upper arm, as an intramuscular or subcutaneous injection (deeply).

The vaccine should not be administered intradermally or into a blood vessel.

The vaccine is usually administered at least 2 weeks before scheduled splenectomy or before starting planned specialized anticancer therapy.
If such therapy is started or stopped, vaccination may be delayed for about 3 months.
In individuals with HIV infection, the vaccine is usually administered as soon as possible after diagnosis.
There is usually no need for a second dose of the vaccine unless at least 3 years have passed since the first vaccination. Healthy individuals do not need to receive a second dose of the vaccine. In individuals at high risk of developing severe pneumococcal infection (e.g., those with splenectomy or impaired splenic function), a second vaccination may be recommended 3-5 years after the previous dose.
The decision to administer a subsequent dose of the vaccine is up to your doctor.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
If any of the following symptoms occur after vaccination, inform your doctor immediately, as they may indicate an allergic reaction or other serious side effects:

• difficulty breathing
• wheezing
• redness
• rash.

There is a risk of serious, rare allergic reactions after any vaccination. These may include difficulty breathing, blue discoloration of the lips or tongue, low blood pressure (causing dizziness), and fainting. These reactions usually occur immediately after vaccination, while the patient is still under medical supervision. However, if any of these symptoms occur after leaving the doctor's office, seek medical attention immediately.
Other symptoms of an allergic reaction may include fever, general malaise, pain, or swelling, and joint pain or swelling. If any of these symptoms occur, seek medical attention immediately.
Very common side effects (occurring in about 1 in 10 individuals vaccinated) include pain, redness, increased temperature, swelling, induration at the injection site, and elevated temperature. These reactions occur more frequently after the second dose of the vaccine than after the first dose.
Side effects observed during clinical trials and after the vaccine was marketed include:

• fatigue or weakness;
• chills;
• nausea, vomiting;
• enlarged lymph nodes and/or inflammation;
• decreased platelet count in individuals with pre-existing low platelet count due to idiopathic thrombocytopenic purpura, resulting in increased risk of bleeding and bruising; if bruising or bleeding occurs more frequently, inform your doctor immediately, as treatment may be necessary;
• headache, altered skin sensitivity, or tingling, numbness, and weakness of the limbs (including Guillain-Barré syndrome). Inform your doctor if you experience problems with sensation or movement.

Rarely, significant swelling of the limb into which the vaccine was administered has been reported after the vaccine was marketed.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, inform your doctor or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the vaccine.

5. How to store PNEUMOVAX 23

Store out of sight and reach of children.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Do not use this vaccine after the expiry date stated on the label and carton after: "EXP". The expiry date refers to the last day of the month.
Before administration, check that the solution is clear and free of particles.

6. Contents of the pack and other information

What PNEUMOVAX 23 contains

• The active substance of the vaccine is 25 µg of capsular polysaccharide of each of the 23 serotypes of Streptococcus pneumoniae: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F.

The above-mentioned antigens have been purified to be administered in an injection, both to children and adults.

• Other ingredients are: sodium chloride, phenol, and water for injections.

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is considered to be essentially "sodium-free".

What PNEUMOVAX 23 looks like and contents of the pack

The vaccine is a clear, colorless solution.
Solution for intramuscular or subcutaneous injection.
PNEUMOVAX 23 is available in the following packs:

• 1 vial of 0.5 ml;
• 10 vials of 0.5 ml;
• 1 pre-filled syringe of 0.5 ml;
• 10 pre-filled syringes of 0.5 ml.

Vials made of type I glass with a butyl rubber stopper.
Pre-filled syringe made of type I glass with a bromobutyl, fluoropolymer-coated plunger stopper and needle shield (synthetic mixture of isoprene and bromobutyl or styrene-butadiene rubber).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Manufacturer:

MSD Polska Sp. z o.o.
Merck Sharp & Dohme B.V.
ul. Chłodna 51
Waarderweg 39
00-867 Warsaw
2031 BN Haarlem, Netherlands
Tel.: (+48) 22 549 51 00
[email protected]

Date of last revision of the leaflet: 11/2022