Polivaccinum forte Niesvoista shhepionka bakteriina

Leaflet attached to the packaging: information for the user

Polyvaccinum forte,suspension for injection
Non-specific bacterial vaccine
Inactivated bacteria: Staphylococcus aureus500 million cells , Staphylococcus epidermidis500 million cells , Streptococcus salivarius100 million cells , Streptococcus pneumoniae100 million cells , Streptococcus pyogenes100 million cells , Escherichia coli200 million cells , Klebsiella
pneumoniae100 million cells , Haemophilus influenzae100 million cells , Corynebacterium
pseudodiphtheriticum200 million cells , Moraxella catarrhalis100 million cells/ 1 ml

Read the 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 a doctor, pharmacist, or nurse.
• This vaccine has been prescribed specifically for this person. 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, tell the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Polyvaccinum forte 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 forte vaccine

When not to use Polyvaccinum forte vaccine:

• if the patient is 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, facial swelling and tongue,
• if the patient has:
• 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 entire body),
• if the patient is using immunosuppressive preparations (drugs that suppress the body's immune response),
• if the patient is 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 the patient's general health and previously performed and recorded vaccinations. This procedure allows for predicting the risk of side effects and changing the dosage regimen. Be particularly careful if, after the previous dose of Polyvaccinum forte vaccine, the side effects described in section 4 or any other disturbing reactions occurred. The vaccine can be used in the course of an infection if vaccination treatment was started before the development of the infection. It is not recommended to use Polyvaccinum forte vaccine to prevent pneumonia, as there are no clinical trial data confirming such an effect. For safety reasons, after vaccination, stay under medical observation for 30 minutes.

Polyvaccinum forte 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. Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as about 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 forte vaccine

Polyvaccinum forte 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 along with Polyvaccinum submite and Polyvaccinum mite. 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 in the event of prolonged or severe side effects is described in section 4.

Using a higher dose of Polyvaccinum forte vaccine than recommended

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

Missing a dose of Polyvaccinum forte vaccine

In case of doubt, consult a doctor.

Stopping the use of Polyvaccinum forte vaccine

In case of 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 determined from 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:
If side effects such as headache, nausea, and general weakness persist, extend the time between injections and reduce the dose of the vaccine (return to the vaccine concentration containing ten times fewer bacteria and/or reduce the volume of the vaccine dose).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell 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, e-mail: [email protected]. 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 forte vaccine

Store in a refrigerator (2°C - 8°C).
Keep the vaccine 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Polyvaccinum forte vaccine contains

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

What Polyvaccinum forte vaccine looks like and what the package contains

The vaccine is a milky suspension with a white tint. During storage, a white sediment forms at the bottom of the ampoule, and above it, a clear supernatant (liquid) forms.
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: [email protected]

Date of last update of the leaflet:

------------------------------------------------------------------------------------------------------------------------

Information intended exclusively for healthcare professionals:

Administration of Polyvaccinum forte vaccine

Shake before use. After shaking, Polyvaccinum forte vaccine is a milky suspension with a white tint.
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! Make sure 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 dose of the vaccine (return to the vaccine concentration containing ten times fewer bacteria and/or reduce the volume of the vaccine dose).
Note: Due to the risk of anaphylactic shock associated with the administration of vaccines, the vaccination room should be equipped with a standard emergency kit.