Polivaccinum mite Niesvoista shhepionka bakteriina

Package Leaflet: Information for the Patient

Polyvaccinum mite,nasal drops, suspension
Non-specific bacterial vaccine
Inactivated bacteria: Staphylococcus aureus50 million cells , Staphylococcus epidermidis50 million
cells , Streptococcus salivarius10 million cells , Streptococcus pneumoniae10 million cells ,
Streptococcus pyogenes10 million cells , Escherichia coli20 million cells , Klebsiella pneumoniae
10 million cells , Haemophilus influenzae10 million cells , Corynebacterium pseudodiphtheriticum
20 million cells , Moraxella catarrhalis10 million cells/ 1 ml

Read the package leaflet carefully before using the vaccine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Polyvaccinum mite vaccine and what is it 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. Package contents and other information

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

Polyvaccinum mite nasal drops are a bacterial vaccine used prophylactically in recurrent upper respiratory tract infections in children from 6 months, adolescents, and adults. The vaccine stimulates the immune system because it contains killed bacteria that most often cause infections or accompany inflammatory conditions of the upper respiratory tract.
The dosing schedule is given in section 3.

2. Important information before using Polyvaccinum mite vaccine

When not to use Polyvaccinum mite vaccine:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6),
• if the patient has:
• infectious disease,
• circulatory failure,
• kidney or liver disease,
• proliferative disease of the hematopoietic system (hematopoietic system tumor),
• systemic disease (disease affecting several types of tissues and organs or the entire body),
• if the patient is taking immunosuppressive drugs (drugs that suppress the immune response of the body).

Do not start using the vaccine if the patient has an acute disease condition.

Warnings and precautions

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

Polyvaccinum mite 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 the vaccinations until the end of the therapy.
The vaccine may be used during antibiotic therapy if the doctor considers the administration of an antibiotic necessary.
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding

There are no data on the use of the vaccine during pregnancy and breastfeeding.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

Driving and using machines

The vaccine has no influence or insignificant influence on the ability to drive and use machines.
Polyvaccinum mite vaccine contains 0.15 mg of benzalkonium chloride per 1 ml.
Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Polyvaccinum mite vaccine

Administer the vaccine intranasally, measuring the appropriate number of drops with a dropper.
Note: Before the first use, gently shake the bottle and then, after removing the cap, press the dropper several times until the first drop is obtained (dropper activation). To obtain a uniform dose, the first 10 drops should be discarded. The dropper does not require reactivation before subsequent use.
Instructions for use

• 1. Clean the nose.
• 2. Gently shake the bottle to obtain a uniform suspension.
• 3. Remove the protective cap from the dropper.
• 4. Tilt the head back.
• 5. Administer the drops into the nasal cavity according to the dosing schedule presented in the table below.
• 6. After use, wipe the dropper tip and then put the protective cap back on.

The package of the medicine should be used only by one patient.
Before administration, check the expiration date of the vaccine on the package.
Do not use the vaccine after the expiration date.
Treatment should be carried out twice a year, at 6-month intervals, for a period of at least 2 years.
Administer the vaccine daily for 6 weeks.
If an upper respiratory tract infection occurs during the use of the vaccine, continue its administration without increasing the dose.
The product does not replace anti-inflammatory treatment.
Do not start using the vaccine if the patient has an acute disease condition.

Dosing

Unless the doctor recommends otherwise, use the full vaccination cycle according to the dosing schedule presented in the table.

The dosing regimen depends on the patient's reaction. In patients who have been found to be hypersensitive (allergic) to the bacterial antigens contained in the vaccine, the doctor may extend the period of use of lower doses.
The best prevention of recurrent upper respiratory tract infections is achieved after using the full vaccination cycle with the dosing schedule maintained.

Using a higher dose of Polyvaccinum mite vaccine than recommended

Unless the doctor recommends otherwise, continue dosing according to the schedule.

Missing a dose of Polyvaccinum mite vaccine

In case of doubts, consult your doctor or pharmacist.

Stopping the use of Polyvaccinum mite vaccine

In case of further doubts related to the use of this vaccine, consult your doctor or pharmacist.

4. Possible side effects

Like all vaccines, this vaccine can cause side effects, although not everybody gets them.

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

• local reaction: irritation of the nasal mucosa - burning sensation, itching.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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, website: https://smz.ezdrowie.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 mite vaccine

Store in a refrigerator (2°C - 8°C).
Store the vaccine out of sight and reach of children.
Do not use the vaccine after the expiration date stated on the carton.
The expiration date stated on the carton refers to the last day of the given month.
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 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 are: benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, and water for injections.

What Polyvaccinum mite vaccine looks like and what the package contains

The vaccine is an opalescent, colorless suspension.
Package: one bottle containing 10 ml of suspension with a dropper.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: