solution for injection in vial Pneumococcal
polysaccharide vaccine. For adults and children over 2 years.
What Pneumovax is and what it is used for
Pneumovax is a pneumococcal vaccine. The vaccine is used to protect you or your child against infectious diseases. Your doctor has recommended that you or your child (from the age of two) be given the vaccine to protect you from serious infections caused by bacteria called pneumococci.
Pneumococci can cause infection in the lungs (especially pneumonia ) and in the meninges ( meningitis ) as well as in the blood ( bacteremia or blood poisoning). The vaccine can only protect you or your child against pneumococcal infections caused by the types of bacteria contained in the vaccine. However, the 23 pneumococcal types included in the vaccine include the types that cause almost all (about nine out of ten) infections caused by pneumococci.
When the vaccine is given to you or your child, the body’s natural defenses produce antibodies, which help protect against pneumococcal infections.
Pneumococcal infections occur worldwide and can occur in anyone regardless of age, but are most common in:
- elderly.
- people who have lost their spleen or whose spleen does not work.
- people who have a low resistance to infection due to long-term illness or infection (such as heart disease, lung disease, diabetes, kidney disease, liver disease, or HIV infection ).
- People who have a low resistance to infection are due to the treatment they have received for any disease (such as cancer).
Pneumococcal infections of the meninges ( meningitis ) sometimes occur after the skull has been damaged and ruptured and in rare cases after certain medical procedures. The vaccine may not be able to prevent all of these infections.
Pneumococcal infections can also occur in the sinuses, ears, and other parts of the body. The vaccine will probably not protect you or your baby from these milder types of infection.
What you need to know before you or your child use Pneumovax
Do not use Pneumovax
Pneumovax is intended for people over 2 years. This is because it is not entirely certain that younger children will respond to treatment.
To ensure that the vaccine is suitable for you or your child, it is important to tell your doctor or nurse if any of the points below apply to you or your child. If there is anything you do not understand, or if you are unsure, ask your doctor or nurse to explain. Like other vaccines, Pneumovax may not provide adequate protection to all who receive it.
Do not use Pneumovax if you or your child are allergic (hypersensitive) to the pneumococcal polysaccharide vaccine or any of the ingredients listed in section 6.
Warnings and cautions
Talk to a doctor, pharmacist, or nurse before vaccination about:
- you or your child has an infection with a high fever, as the vaccination may need to be postponed until you or your child is healthy again.
Before vaccination, you must also tell your doctor about:
- You or your child have a low resistance to infection due to a course of treatment (such as medication or radiation for cancer).
- you or your child have a long-term illness or infection that may have reduced resistance to pneumococcal infections.
In such cases, the vaccination may need to be postponed, and even then it may not protect you as well as it protects healthy people.
People who are 65 years old or older do not always tolerate medical measures as well as younger people. Therefore, more and/or more serious reactions in some older individuals can not be ruled out.
Other medicines and Pneumovax
Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
Pneumovax can be given at the same time as the flu vaccine as long as different injection sites are used. Most people can respond to both vaccines at the same time so that they can be protected against both infections.
Talk to your doctor or healthcare provider for information on the concomitant use of Pneumovax and Zostavax.
If you or your child are already taking antibiotics to prevent pneumococcal infection, this treatment should not be stopped after vaccination. It is important to see a doctor quickly to get antibiotic treatment, even after the vaccination if you think that you or your child may have some type of infection and you or your child have been told that you are at high risk of getting a pneumococcal infection (t. eg if the spleen is missing or if it is not working properly).
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby or breastfeeding, ask your doctor or pharmacist for advice before taking this vaccine.
Driving and using machines
There is no information to suggest that the vaccine affects your ability to drive or use machines.
Pneumovax contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose unit, ie it is essentially ‘sodium-free’.
How to use Pneumovax
The vaccination should be performed by a doctor or nurse trained in the use of the vaccine. The vaccine should be given at a healthcare facility as there is equipment to deal with any less common serious allergic reactions to the injection.
Always use this vaccine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The vaccine is given as an injection into a muscle or deep under the skin. The doctor or nurse avoids giving you or your child an injection into the skin or a blood vessel.
The vaccine is sometimes given before (usually at least two weeks before) the scheduled date to operate on the spleen or to start cancer treatment. If you or your child has already started or stopped special treatments, the vaccination can be postponed for about three months.
When vaccines are given to people who are HIV -positive, it is usually given as soon as the result is known.
You or your child will be given a dose of the vaccine. A second dose of the vaccine is usually not given until at least three years after the first dose. Healthy people usually do not need a second dose. However, additional doses of the vaccine may be recommended for people who are at increased risk of severe pneumococcal infection (such as people who do not have a spleen or whose spleen does not work properly), usually between 3 and 5 years after the first dose. A repeated dose is usually not recommended within 3 years after the first dose due to a greater risk of side effects.
The doctor or nurse will decide if and when you or your child needs an additional dose of the vaccine.
If you use more Pneumovax than you should
No overdose of the vaccine has been reported. Overdose is highly unlikely as the vaccine is supplied in single-dose vials and is given by a doctor or nurse.
Possible side effects
Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them.
Allergic reactions
You must seek medical attention immediately if you or your child experience any of the following symptoms or other serious symptoms after vaccination:
- difficulty breathing, blue discoloration of the tongue or lips,
- low blood pressure (which causes dizziness) and collapse,
- fever, general malaise with pain or even inflammation and swelling in joints and muscle pain,
- swelling of the face, lips, tongue, and / or neck or neck,
- swelling of the hands, feet, or ankles,
- hives (inflamed streaks on the skin) and rash.
If severe allergic reactions occur, they usually do so very soon after injection while you are still in the hospital.
Side effect ar
The most common reactions (which may occur in more than 1 in 10 people) reported are tenderness, pain, redness, feeling hot, swelling and hardening at the injection site, and fever. These reactions tend to be more common after the second dose of the vaccine than after the first.
Other side effects are:
Rare (may affect up to 1 in 1,000 people):
- swelling in the injected extremity one,
Has been reported (can not be calculated from the available data):
- impaired mobility of the injected extremity,
- feeling tired
- general malaise,
- uncontrollable chills,
- nausea or vomiting,
- enlarged and/or inflamed glands,
- pain, inflammation, and swelling in joints and muscle pain,
- decreased number of a certain type of blood cell called platelets ( platelets ) in people who already have a low number of these due to another disease called ITP which causes an increased risk of bleeding and bruising,
- headache, altered sensation of the skin or tingling, impaired mobility of the extremities, numbness, and weakness in the arms and legs (including a disease called Guillain-Barré syndrome ),
- an increase in the value of a blood test that measures inflammation in the body (C-reactive protein (CRP))
- patients who have had blood disorders may develop red blood cell degradation leading to an insufficient number of red blood cells (hemolytic anemia ),
- an increased number of certain types of white blood cells.
- a seizure (convulsions) associated with fever.
How to store Pneumovax
Keep this vaccine out of the reach and sight of children.
Do not use this vaccine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
The doctor or nurse checks that the liquid is clear and colorless and that it does not contain any large particles before the vaccine is given to you or your child.
Vaccines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of vaccines that are no longer in use. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
A dose of 0.5 ml contains the following:
- The active substances are 25 micrograms (a very small amount) of each of the 23 polysaccharide types from bacteria known as pneumococci. The 23 pneumococcal polysaccharide types in the show lar
- e vaccine are 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F.
- The other ingredients are phenol, sodium chloride, and water for injections.
The vaccine contains less than 1 mmol sodium (23 mg) per dose and is essential ‘sodium-free’.
Vaccine appearance and pack sizes
It is supplied as a solution for injection in a vial (0.5 ml).
It is available in packs of 1, 10, or 20 vials.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Merck Sharp & Dohme BV
PO Box 581,
2003 PC Haarlem
Netherlands
Manufacturer:
Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem, The Netherlands.
This medicinal product is authorized in the European Economic Area and the United Kingdom (Northern Ireland) under the names:
| Austria, Belgium, Germany, Greece, Ireland, Luxembourg, Netherlands, Portugal, Spain | Pneumovax 23 |
| Denmark, Finland, France, Iceland, Italy, Norway, Sweden | Pneumovax |
| United Kingdom (Northern Ireland) | Pneumococcal Polysaccharide Vaccine |