Polyvaccinum forte nieswoista szczepionka bakteryjna

Package leaflet: Information for the user

Polyvaccinum forte, injectable suspension
Non-specific bacterial vaccine
Inactivated bacteria: Staphylococcus aureus 500 million cells, Staphylococcus epidermidis 500 million cells, Streptococcus salivarius 100 million cells, Streptococcus pneumoniae 100 million cells, Streptococcus pyogenes 100 million cells, Escherichia coli 200 million cells, Klebsiella pneumoniae 100 million cells, Haemophilus influenzae 100 million cells, Corynebacterium pseudodiphtheriticum 200 million cells, Moraxella catarrhalis 100 million cells / 1 ml
Please read all of this leaflet carefully before using this vaccine, because it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for a specific individual. Do not pass it on to others. The vaccine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

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

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

Polyvaccinum forte is a bacterial vaccine which stimulates the immune system by containing inactivated bacteria that are most commonly responsible for various types of infections or are involved in 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 forte vaccine

When not to use Polyvaccinum forte 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, facial swelling, and tongue swelling,
• if the patient has been diagnosed with:
• an infectious disease,
• an acute inflammatory condition,
• kidney or liver disease,
• circulatory failure,
• a systemic disease (a disease affecting several types of tissues and organs or involving the whole body),
• if the patient is receiving 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. This procedure helps predict the risk of adverse reactions and possible changes in the dosing schedule.
Exercise particular caution if, after a previous dose of Polyvaccinum forte vaccine, adverse reactions described in section 4 or any other worrying reactions occurred.
The vaccine may be administered during an infection if vaccination was initiated before the onset of the infection.
The use of Polyvaccinum forte vaccine for the prevention of pneumonia is not recommended, as there are no clinical study data confirming such an effect.
For safety reasons, remain under medical supervision for 30 minutes after vaccination.

Polyvaccinum forte vaccine and other medicines
In patients undergoing immunosuppressive treatment (which suppresses the immune system activity), the response to vaccination may be reduced. In such cases, the physician may decide to postpone vaccination until the end of therapy.
The vaccine may be administered during antibiotic therapy if the physician considers antibiotic administration necessary.
Inform the physician about all medicines currently 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 have been conducted on the effect of the vaccine on the ability to drive vehicles or operate machinery.

3. How to use Polyvaccinum forte vaccine

The Polyvaccinum forte vaccine will be administered by a doctor or nurse as an intramuscular or subcutaneous injection. The vaccine must never be given intravenously. The vaccine is administered according to the dosing schedule together with Polyvaccinum submite and Polyvaccinum mite.
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 schedule presented in the table should be repeated twice a year, in spring and autumn, for at least 2 years.
Dosage modifications in case of long-lasting and/or severe adverse reactions are described in section 4.

Use of a higher than recommended dose of Polyvaccinum forte vaccine
If a dose higher than recommended has been administered, consult a physician.
Detailed information is provided at the end of the leaflet in the section "Information intended exclusively for healthcare professionals".

Missed dose of Polyvaccinum forte vaccine
In case of doubt, consult a physician.

Discontinuation of Polyvaccinum forte vaccine
If you have any further questions regarding the use of this vaccine, consult your physician, pharmacist, or nurse.

4. Possible adverse reactions

As with any vaccine, this vaccine may cause adverse reactions, although
they do not occur in everyone.
Frequency unknown (frequency cannot be determined from 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 (exacerbation).

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 ten times less bacteria and/or reduce the vaccine dose volume).
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 the vaccine.

5. How to store Polyvaccinum forte 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 stated month.
Medicines must 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. Contents of the pack and other information

What Polyvaccinum forte vaccine contains
The active substances in the vaccine are inactivated (killed) bacteria:
Staphylococcus aureus, Staphylococcus epidermidis – 500 million cells each/1 ml
Escherichia coli, Corynebacterium pseudodiphtheriticum – 200 million cells each/1 ml
Streptococcus salivarius, Streptococcus pneumoniae – 100 million cells each/1 ml
Streptococcus pyogenes, Klebsiella pneumoniae, Haemophilus influenzae, Moraxella catarrhalis
Other ingredients: phenol, sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, and water for injections.

What Polyvaccinum forte looks like and contents of the pack
The vaccine is a pearly white 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 with 1 ml each.

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

Information intended exclusively for healthcare professionals:

Administration of Polyvaccinum forte vaccine
Shake before use. After shaking, Polyvaccinum forte vaccine is a white, opalescent 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 case of administration of a higher than recommended vaccine dose, prolong the interval between injections and reduce the vaccine dose (return to the vaccine concentration containing ten times fewer bacteria and/or reduce the vaccine dose volume).
Warning: due to the risk of anaphylactic shock associated with vaccine administration, the vaccination room should be equipped with a standard anaphylaxis emergency kit.