Polyvaccinum mite nieswoista szczepionka bakteryjna

Package leaflet: Information for the user

Polyvaccinum mite, injectable suspension
Non-specific bacterial vaccine
Inactivated bacteria: Staphylococcus aureus 50 million cells, Staphylococcus epidermidis 50 million cells, Streptococcus salivarius 10 million cells, Streptococcus pneumoniae 10 million cells, Streptococcus pyogenes 10 million cells, Escherichia coli 20 million cells, Klebsiella pneumoniae 10 million cells, Haemophilus influenzae 10 million cells, Corynebacterium pseudodiphtheriticum 20 million cells, Moraxella catarrhalis 10 million cells / 1 ml
Please read this leaflet carefully before using the vaccine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, 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 identical.
• 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.

Leaflet contents

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

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

Polyvaccinum mite is a bacterial vaccine that stimulates the immune system by containing inactivated bacteria commonly responsible for various infections or contributing to complications of non-bacterial inflammatory conditions. 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 mite vaccine

When not to use Polyvaccinum mite 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, difficulty breathing, 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 several types of tissues and organs or the entire body),
• if the patient is using 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 medical history regarding general health
status and previously administered and recorded vaccinations. This procedure allows
prediction of the risk of adverse reactions and possible modification of the dosing schedule.
Exercise special caution if, after a previous dose of Polyvaccinum mite vaccine, adverse reactions described in section 4 or any other worrying reactions occurred.
The vaccine may be used during infection if vaccination was initiated before
the onset of infection.
The use of Polyvaccinum mite vaccine for 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 mite vaccine and other medicines
In patients undergoing immunosuppressive treatment (suppressing the activity of the immune
system), the response to vaccination may be reduced. In such cases, the physician may
decide to postpone vaccination until completion of the therapy.
The vaccine may be administered during antibiotic treatment, if the physician considers antibiotic use 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
and operate machinery.

3. How to use Polyvaccinum mite vaccine

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

Dose 14 may be repeated at 2-4 week intervals 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.
Changes in dosing regimen in the case of long-lasting adverse reactions and/or adverse reactions of severe intensity are described in section 4.
Use of a higher than recommended dose of Polyvaccinum mite vaccine
If a higher than recommended dose of the vaccine is administered, consult a physician.
Detailed information is provided at the end of this leaflet in the section "Information intended exclusively for healthcare professionals".
Missed administration of Polyvaccinum mite vaccine
If in doubt, consult a physician.
Discontinuation of Polyvaccinum mite vaccine
If you have any further doubts 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 experiences them.
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 fewer bacteria and/or reduce the vaccine volume).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a 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 responsible entity.
Reporting adverse reactions helps to gather more information on the safety of using the medicinal product.

5. How to store Polyvaccinum mite 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 package and other information

What Polyvaccinum mite vaccine contains
The active substances of the vaccine are inactivated (killed) bacteria:
Staphylococcus aureus, Staphylococcus epidermidis – 50 million cells/1 ml each
Escherichia coli, Corynebacterium pseudodiphtheriticum – 20 million cells/1 ml each
Streptococcus salivarius, Streptococcus pneumoniae, Streptococcus pyogenes,
Klebsiella pneumoniae, Haemophilus influenzae,
Moraxella catarrhalis – 10 million cells/1 ml each

Other ingredients: phenol, sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, and water for injections.

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

Marketing Authorisation Holder and Manufacturer
Institute of Serum and Vaccine Biotechnology 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 medical professionals:

Administration of Polyvaccinum mite vaccine
Shake well before use. After shaking, Polyvaccinum mite vaccine is a colorless, opalescent suspension.
Visually inspect the vaccine for any foreign particles and/or 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 dose, prolong the interval between injections and reduce the vaccine dose (return to a vaccine concentration containing tenfold less 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 must be equipped with a standard anaphylaxis kit.