Dtp-shhepionka bvoniho-temzhcovo-kzhtushcova adsorbovana

Package Leaflet: Information for the User

DTP - Diphtheria, Tetanus, and Pertussis Vaccine, Adsorbed

Suspension for injection
Diphtheria, tetanus, and pertussis vaccine, adsorbed
Not less than 30 IU of diphtheria toxoid, not less than 40 IU of tetanus toxoid, and not less than 4 IU of inactivated Bordetella pertussissuspension / 0.5 ml
1 dose (0.5 ml)

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed specifically for this person. Do not pass it on to others.
• If the patient experiences any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is DTP - Diphtheria, Tetanus, and Pertussis Vaccine, Adsorbed (hereinafter referred to as DTP vaccine) and what is it used for
• 2. Important information before using DTP vaccine
• 3. How to use DTP vaccine
• 4. Possible side effects
• 5. How to store DTP vaccine
• 6. Package contents and other information

1. What is DTP - Diphtheria, Tetanus, and Pertussis Vaccine, Adsorbed and what is it used for

DTP vaccine protects against three diseases: diphtheria, tetanus, and pertussis
caused by diphtheria bacilli, tetanus bacilli, and pertussis bacilli. The active substances of the vaccine are tetanus and diphtheria toxoids (non-infectious components derived from bacteria)
and inactivated pertussis vaccine (whole-cell pertussis component). After administration of the vaccine, the child's body produces antibodies that protect against these diseases.
The immunizing properties of the vaccine are enhanced by the action of aluminum hydroxide (adjuvant).
The vaccine is used for active immunization of children from the age of 6 weeks to 2 years, in accordance with the National Immunization Program, which contains information on these vaccinations.
Children who have not been vaccinated at the recommended times may be vaccinated up to the age of 3 years, provided there are no contraindications to pertussis vaccination with whole-cell vaccine.

• 3. Children who have not been vaccinated at the recommended times may be vaccinated up to the age of 3 years, provided there are no contraindications to pertussis vaccination with whole-cell vaccine.

Adequate immunity is achieved after administration of all doses of primary vaccination in accordance with the National Immunization Program.

2. Important information before using DTP vaccine

When not to use DTP vaccine:

• if the child has:
• allergy to the active substances or any of the other components of this vaccine (listed in section 6). Symptoms of allergy include:
• rash or blistering rash, which may be itchy,
• swelling of the eyes and face,
• difficulty breathing and swallowing,
• sudden drop in blood pressure and loss of consciousness,
• acute illnesses with fever.
• chronic diseases during exacerbation. In these cases, vaccination should be performed after the exacerbation of the disease has subsided,
• progressive neurological diseases,
• if within 2 days after the previous administration of the vaccine, the child:
• experienced persistent, unrelenting crying or screaming for 3 hours or more,
• had a body temperature above 40.5°C, not caused by other factors,
• experienced loss of consciousness or a hypotonic-hyporeactive episode (limpness or decreased muscle tone, reduced and weakened response to external stimuli, change in skin color (pallor or cyanosis)) that may be accompanied by respiratory disorders.
• if within 3 days after the previous administration of the vaccine, the child:
• experienced neurological symptoms, including impaired consciousness and focal neurological symptoms,
• experienced seizures with or without fever,
• if within 7 days after the previous administration of pertussis vaccine, the child experienced neurological disorders (encephalopathy).

If there are any contraindications to DTP vaccination, the risk of vaccination should be assessed in relation to the risk of infection.

Warnings and precautions

Before starting vaccination with DTP vaccine, discuss it with your doctor. Vaccination should be preceded by a medical examination and interview on the overall health status and previously performed and recorded vaccinations. This approach allows for predicting the risk of side effects after administration of DTP vaccine.
Exercise special caution and inform your doctor if, after the previous dose of the vaccine, the child experienced side effects described in section 4 or any other disturbing reactions.

For safety reasons, after vaccination, the child should remain under medical observation for 30 minutes.

The vaccine contains trace amounts of thiomersal, so your child may experience allergic reactions. Inform your doctor if your child has had or has known allergic reactions. Also, inform your doctor if your child has experienced health disorders after previous vaccination.

DTP vaccine and other medicines

DTP vaccine can be administered at the same time as other vaccines, if it is in accordance with the National Immunization Program, and with immunoglobulins, if necessary (method of administration of DTP with other vaccines and immunoglobulins, see section 3 of the package leaflet).
In children undergoing immunosuppressive therapy (inhibiting the activity of the immune system) or with immune deficiencies, the response to the vaccine may be reduced.
In such cases, the doctor will order the vaccination to be postponed until the end of therapy and determine the level of anti-tetanus, anti-diphtheria, and anti-pertussis antibodies after vaccination.
When administering DTP vaccine simultaneously with conjugated pneumococcal vaccine, the doctor may recommend administering a medicine to reduce fever to the child.
Tell your doctor about all medicines and vaccines your child is currently taking or has recently taken, as well as any medicines and vaccines your child will be taking.

Pregnancy and breastfeeding

Not applicable. The vaccine is used only in children.

Driving and using machines

Not applicable. The vaccine is used only in children.

3. How to use DTP vaccine

This vaccine should always be used as directed by your doctor. If you are unsure, consult your doctor.
The DTP vaccine will be administered by a doctor or nurse as an intramuscular injection.
The vaccine must never be administered intravenously.
In infants up to 12 months of age, the dose of 0.5 ml should be administered intramuscularly into the anterolateral thigh. It is recommended to change the injection site for the next dose (other lower limb). In children over 12 months of age, the vaccine can be administered intramuscularly into the deltoid muscle, if the muscle mass of the child allows it.
Different vaccines and immunoglobulins administered at the same time should be injected into different parts of the body, using separate syringes and needles.

Dosage

According to the applicable National Immunization Program, the vaccination schedule includes 3 primary doses administered in the first 6 months of life, injected at 6-8 week intervals, and a fourth dose as a booster in the 2nd year of life, with the possibility of booster vaccination up to the age of 3 years.

Administration of a higher dose of DTP vaccine than recommended

Overdose is unlikely, as the packaging is single-dose.
If you are unsure, consult your doctor.

Discontinuation of DTP vaccine

If you have any further questions about the use of this vaccine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, this vaccine can cause side effects, although not everyone will experience them.

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

• enlargement and/or tenderness of lymph nodes,
• allergic reaction in the form of:
• hives,
• rash (maculopapular, papular, or maculopapular),
• swelling (including facial swelling with difficulty breathing - dyspnea),
• anaphylactic shock,
• decreased or lost appetite,
• unrelenting, persistent crying or screaming for 3 hours or more,
• increased irritability, which usually resolves within 24-48 hours, restlessness,
• decreased sensitivity to stimuli,
• seizures with or without fever, tetany, increased and then decreased muscle tone (hypertonia),
• hypotonic-hyporeactive episode, characterized by limpness or decreased muscle tone, reduced and weakened response to external stimuli, change in skin color (pallor or cyanosis),
• neurological disorders,
• flaccid paralysis of the upper limb, which may be a symptom of brachial plexus inflammation,
• limited mobility and/or pain in the upper limb,
• muscle atrophy,
• hypersensitivity,
• drowsiness,
• tremors,
• swelling or discoloration of the lower limbs (redness, cyanosis), sometimes with accompanying mottling of the skin or petechiae, observed in cases of concurrent administration of DTP vaccine and Haemophilus influenzaetype b vaccine, and resolving spontaneously without leaving permanent consequences,
• pallor, cyanosis, mottling of the skin, petechiae,
• apnea in very premature infants (born before or at 28 weeks of gestation),
• breathing disorders,
• upper respiratory tract infection,
• cough,
• bronchitis,
• vomiting,
• diarrhea,
• chills,
• fever up to 39-40°C or higher,
• local reactions: redness, pain, swelling. Fever and local reactions usually resolve within 24-48 hours,
• decreased or lost thirst,
• the presence of adjuvant (aluminum hydroxide) in the vaccine may lead to the formation of subcutaneous nodules (very rare, with a frequency of 1/100,000) that sometimes transform into sterile abscesses. Subcutaneous nodules that do not resolve within 6 weeks may be a result of allergy to aluminum.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, ul. 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.
Reporting side effects will allow for the collection of more information on the safety of the vaccine.

5. How to store DTP vaccine

Store upright, in a refrigerator (2°C - 8°C).
Do not freeze. If frozen, the vaccine should be discarded.
The vaccine should be stored out of sight and reach of children.
Do not use this vaccine after the expiry date stated on the carton.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers.
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 DTP vaccine contains

The active substances of the vaccine are:
Diphtheria toxoid
not less than 30 IU
Tetanus toxoid
not less than 40 IU
Inactivated Bordetella pertussissuspension
not less than 4 IU
adsorbed on aluminum hydroxide, hydrated
not more than 0.7 milligrams of Al
Other ingredients are: sodium chloride and water for injections.

What DTP vaccine looks like and what the package contains

The vaccine is a white or almost white suspension in glass ampoules.
During storage, a white sediment forms at the bottom of the ampoule, and above it, a clear supernatant (liquid) forms.
The vaccine is available in a package of 25 ampoules of 0.5 ml, in a cardboard box.

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: [email protected]

Date of last update of the package leaflet:

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Information intended for healthcare professionals only

Administration of DTP vaccine

Before use, shake to obtain a uniform suspension.
Visually inspect the vaccine for any foreign particles or changes in appearance. If any changes are observed, do not use the vaccine.
Administer the dose of 0.5 ml intramuscularly.
The recommended injection site is the deltoid muscle or the anterolateral thigh.
Do not administer intravenously! Ensure that the needle is not inserted into a blood vessel.
There are no data on immunogenicity and reactogenicity in the case of subcutaneous administration of the vaccine in patients with coagulation disorders.
Note: Due to the risk of anaphylactic shock associated with vaccine administration, the vaccination room should be equipped with a standard anaphylaxis kit.