Polivaccinum submite Niesvoista shhepionka bakteriina

Package Leaflet: Information for the User

Polyvaccinum submite,suspension for injection
Non-specific bacterial vaccine
Inactivated bacteria: Staphylococcus aureus5 million cells , Staphylococcus epidermidis5 million
cells , Streptococcus salivarius1 million cells , Streptococcus pneumoniae1 million cells ,
Streptococcus pyogenes1 million cells , Escherichia coli2 million cells , Klebsiella pneumoniae1
million cells , Haemophilus influenzae1 million cells , Corynebacterium pseudodiphtheriticum2 million
cells , Moraxella catarrhalis1 million cells/ 1 ml

Read the package 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, pharmacist, or nurse.
• This vaccine has been prescribed specifically for you. Do not pass it on to others. The vaccine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Polyvaccinum submite vaccine and what is it used for
• 2. Important information before using Polyvaccinum submite vaccine
• 3. How to use Polyvaccinum submite vaccine
• 4. Possible side effects
• 5. How to store Polyvaccinum submite vaccine
• 6. Package contents and other information

1. What is Polyvaccinum submite vaccine and what is it used for

Polyvaccinum submite is a bacterial vaccine that stimulates the immune system because it contains killed bacteria that most often cause various types of infections or are the cause of complications of inflammatory conditions of non-bacterial origin. The vaccine is used prophylactically in recurrent respiratory infections in children from 2 to 14 years and adults.

2. Important information before using Polyvaccinum submite vaccine

When not to use Polyvaccinum submite vaccine:

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6). Allergy symptoms may include: itching rash, shortness of breath, swelling of the face and tongue,
• if you have:
• infectious disease,
• acute inflammatory condition,
• kidney or liver disease,
• circulatory failure,
• systemic disease (a disease that affects several types of tissues and organs or the whole body),
• if you are taking immunosuppressive preparations (drugs that suppress the body's immune response),
• if you are pregnant or breastfeeding,
• in children under 2 years of age.

Warnings and precautions

Vaccination should be preceded by a medical examination and a medical history of overall health and previously performed and recorded vaccinations. This procedure allows for predicting the risk of side effects and changing the dosage regimen. Particular caution should be exercised if, after the previous dose of Polyvaccinum submite vaccine, side effects described in section 4 occurred or any other disturbing reactions. The vaccine may be used during an infection if vaccination treatment was started before the development of the infection. It is not recommended to use Polyvaccinum forte to prevent pneumonia, as there are no clinical trial data confirming such an effect.

For safety reasons, after vaccination, you should remain under medical observation for 30 minutes.

Polyvaccinum submite vaccine and other medicines

In patients undergoing immunosuppressive therapy (inhibiting the activity of the immune system), the response to the vaccine may be reduced. In such a case, the doctor may decide to postpone vaccinations until the end of therapy. The vaccine can be used during antibiotic therapy if the doctor considers the administration of an antibiotic necessary. You should tell your doctor about all medicines you are currently taking or have recently taken, as well as medicines you plan to take.

Pregnancy and breastfeeding

Do not use.

Driving and using machines

No studies have been conducted on the effect of the vaccine on the ability to drive and use machines.

3. How to use Polyvaccinum submite vaccine

Polyvaccinum submite vaccine will be administered by a doctor or nurse as an intramuscular or subcutaneous injection. The vaccine must never be administered intravenously. The vaccine is administered according to the dosage regimen with Polyvaccinum mite and Polyvaccinum forte. The product does not replace anti-inflammatory treatment.

Dosage

Dosage regimen

Dose 14 can be repeated at intervals of 2-4 weeks for a period of 2-3 months. The full vaccination cycle shown in the table should be repeated 2 times a year in the spring and autumn, for at least 2 years. Changing the dosage regimen in the case of prolonged or severe side effects is described in section 4.

Using a higher dose of Polyvaccinum submite vaccine than recommended

In the event of using a higher dose of the vaccine than recommended, you should consult a doctor. Detailed information can be found at the end of the leaflet in the section "Information intended exclusively for healthcare professionals".

Missing a dose of Polyvaccinum submite vaccine

In case of doubt, consult a doctor.

Stopping the use of Polyvaccinum submite vaccine

In case of any further doubts about the use of this vaccine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like any vaccine, this vaccine can cause side effects, although not everyone will experience them.

Frequency not known (frequency cannot be estimated from the available data):

• headache
• nausea
• redness, swelling, pain at the injection site
• transient, lasting 6-8 hours fever (up to 38°C)
• malaise, general weakness
• local inflammatory conditions (exacerbation).

These symptoms usually resolve within 24 hours.
Warning:
In case of prolonged side effects such as headache, nausea, and general weakness, the time between injections should be extended and the vaccine dose reduced (return to the vaccine concentration containing ten times fewer bacteria and/or reduction of the vaccine dose volume).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Polyvaccinum submite vaccine

Store in a refrigerator (2°C - 8°C).
The vaccine should be stored out of sight and reach of children.
Do not use the vaccine after the expiry date stated on the carton.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Polyvaccinum submite vaccine contains

The active substances of the vaccine are inactivated (killed) bacteria:
Staphylococcus aureus, Staphylococcus epidermidis
5 million cells/1 ml
Escherichia coli, Corynebacterium pseudodiphtheriticum
2 million cells/1 ml
Streptococcus salivarius, Streptococcus pneumoniae, Streptococcus pyogenes, Klebsiella pneumoniae, Haemophilus influenzae,
Moraxella catarrhalis
1 million cells/1 ml
Other ingredients are: phenol, sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, and water for injections.

What Polyvaccinum submite vaccine looks like and what the package contains

The vaccine is a clear, colorless suspension. During storage, a white sediment forms at the bottom of the ampoule, and a clear supernatant (liquid) forms above it.
The package contains 5 ampoules of 1 ml each.

Marketing authorization holder and manufacturer

Biomed S.A.
Al. Sosnowa 8
30-224 Kraków
Tel.: +48 12 37 69 200
Fax: +48 12 37 69 205
e-mail: informacjanaukowa@biomed.pl

Date of last update of the leaflet:

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Information intended exclusively for healthcare professionals:

Administration of Polyvaccinum submite vaccine

Shake before use. After shaking, Polyvaccinum submite vaccine is a clear, colorless suspension.
Visually inspect the vaccine for any foreign particles and/or changes in appearance. If any changes are observed, do not use the vaccine.
Administer intramuscularly or subcutaneously.
The recommended injection site is the deltoid muscle.
Do not administer intravenously! Ensure that the needle is not inserted into a blood vessel.
In the event of using a higher dose of the vaccine than recommended, extend the time between injections and reduce the vaccine dose (return to the vaccine concentration containing ten times fewer bacteria and/or reduction of the vaccine dose volume).
Note: due to the risk of anaphylactic shock associated with the administration of vaccines, the vaccination room should be equipped with a standard anti-shock kit.