Polyvaccinum submite nonspecific bacterial vaccine

Package leaflet: Information for the user

Polyvaccinum submite, suspension for injection
Non-specific bacterial vaccine
Inactivated bacteria: Staphylococcus aureus 5 million cells, Staphylococcus epidermidis 5 million cells, Streptococcus salivarius 1 million cells, Streptococcus pneumoniae 1 million cells, Streptococcus pyogenes 1 million cells, Escherichia coli 2 million cells, Klebsiella pneumoniae 1 million cells, Haemophilus influenzae 1 million cells, Corynebacterium pseudodiphtheriticum 2 million cells, Moraxella catarrhalis 1 million cells / 1 ml
Please read carefully the entire leaflet before using the vaccine, as it contains information important for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for a specific individual. Do not share it with others. The vaccine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Polyvaccinum submite vaccine is and what it is 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. Contents of the pack and other information

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

Polyvaccinum submite is a bacterial vaccine which stimulates the immune system by containing inactivated bacteria that commonly cause various types of infections or are responsible for complications of inflammatory conditions of non-bacterial origin. The vaccine is used prophylactically in recurrent respiratory tract infections in children aged 2 to 14 years and in adults.

2. Information before using Polyvaccinum submite vaccine

When not to use Polyvaccinum submite vaccine:

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6). Symptoms of allergy may include: itchy rash, shortness of breath, swelling of the face and tongue,
• if the patient has been diagnosed with:
• infectious disease,
• acute inflammatory condition,
• kidney or liver disease,
• circulatory failure,
• systemic disease (a disease affecting multiple tissue types and organs or involving the entire body),
• if the patient is taking immunosuppressive agents (medicines that suppress the body's immune response),
• if the patient is pregnant or breastfeeding,
• in children under two years of age.

Warnings and precautions
Vaccination should be preceded by a medical examination and a review of the patient’s general health status and previously administered and documented vaccinations. Such procedure allows predicting the risk of adverse reactions and modifying the dosing schedule if necessary.
Exercise particular caution if undesirable effects described in section 4 or any other concerning reactions occurred after a previous dose of Polyvaccinum submite vaccine.
The vaccine may be used during infection, provided that vaccination was initiated before the development of the infection.
The use of Polyvaccinum forte vaccine for the prevention of pneumonia is not recommended, as there are no clinical data confirming such an effect.
For safety reasons, remain under medical supervision for 30 minutes after vaccination.

Polyvaccinum submite vaccine and other medicines
In patients undergoing immunosuppressive treatment (which suppresses immune system activity), the response to vaccination may be reduced. In such cases, the physician may decide to postpone vaccination until completion of therapy.
The vaccine may be administered during antibiotic therapy, if the physician considers antibiotic use necessary.
Inform the physician about all medicines currently used or recently taken by the patient, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding
Do not use.

Driving and operating machinery
No studies on the effect of the vaccine on the ability to drive vehicles and operate machinery have been conducted.

3. How to use Polyvaccinum submite vaccine

The 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 dosing schedule together with Polyvaccinum mite and Polyvaccinum forte.
The product does not replace anti-inflammatory treatment.
Dosage
Dosing schedule

Dose 14 may be repeated at intervals of 2-4 weeks for a period of 2-3 months. The complete vaccination cycle presented in the table should be repeated twice a year, in spring and autumn, for at least 2 years.
Adjustment of dosage in case of prolonged and/or severe adverse reactions is described in section 4.
Administration of a higher than recommended dose of Polyvaccinum submite vaccine
If a higher than recommended dose of the vaccine is administered, consult a physician.
Detailed information is provided at the end of the leaflet in the section entitled "Information intended exclusively for healthcare professionals".
Missed administration of Polyvaccinum submite vaccine
In case of doubt, consult a physician.
Discontinuation of Polyvaccinum submite vaccine
If you have any further questions regarding the use of this vaccine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any vaccine, this vaccine may cause adverse reactions, although
not everyone will experience them.
Frequency unknown (frequency cannot be estimated from the available data):

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

These symptoms usually resolve within 24 hours.
Note:
If adverse reactions such as headache, nausea, and general weakness persist, the interval between injections should be extended and the vaccine dose reduced (return to the vaccine concentration containing tenfold less bacteria and/or reduce the vaccine dose volume).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicinal product.

5. How to store Polyvaccinum submite vaccine

Store in a refrigerator (2°C - 8°C).
The vaccine should be kept 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 indicated.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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 each/1 ml
Escherichia coli, Corynebacterium pseudodiphtheriticum – 2 million cells each/1 ml
Streptococcus salivarius, Streptococcus pneumoniae, Streptococcus pyogenes, Klebsiella pneumoniae,
Haemophilus influenzae, Moraxella catarrhalis – 1 million cells each/1 ml
Other components are: phenol, sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, and water for injections.

What Polyvaccinum submite vaccine looks like and contents of the pack
The vaccine is a clear, colourless suspension. During storage, a white sediment forms at the bottom of the ampoule, with a clear supernatant (liquid) above it.
The pack contains 5 ampoules of 1 ml each.

Marketing Authorisation Holder and Manufacturer
Institute of Serum and Vaccine Biotechnology BIOMED Joint Stock Company
Sosnowa Avenue 8
30-224 Kraków
Tel.: +48 12 37 69 200
Fax: +48 12 37 69 205
e-mail: [email protected]

Date of the latest revision of the leaflet:

Information intended exclusively for medical 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 any changes in appearance. Do not use the vaccine if any changes are observed.
Administer intramuscularly or subcutaneously.
The deltoid muscle is recommended as the injection site.
Do not administer intravenously! Ensure that the needle has not entered a blood vessel.
In the event of administration of a higher than recommended dose, the interval between injections should be extended and the vaccine dose reduced (return to a vaccine concentration containing ten times fewer bacteria and/or reduce the volume of the vaccine dose).
Warning: due to the risk of anaphylactic shock associated with vaccine administration, the vaccination room should be equipped with a standard anaphylaxis emergency kit.