Pentaxim

Leaflet attached to the packaging: information for the user

powder and suspension for suspension for injection in a syringe vial
Vaccine against diphtheria, tetanus, pertussis (acellular, combined), poliomyelitis
(inactivated) and Haemophilus influenzae type b (conjugated), adsorbed

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

• Keep this leaflet until the entire vaccination cycle is completed, so that you can read it again if necessary.
• If you have any further doubts, consult a doctor, pharmacist, or nurse.
• This vaccine has been prescribed for a specific person. Do not pass it on to others.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is the vaccine and what is it used for
• 2. Important information before using the vaccine
• 3. How to use the vaccine
• 4. Possible side effects
• 5. How to store the vaccine
• 6. Package contents and other information

1. What is the vaccine and what is it used for

is a vaccine. Vaccines are used to protect against infectious diseases.
After injecting the vaccine (against diphtheria, tetanus, pertussis, poliomyelitis
and invasive infections caused by Haemophilus influenzaetype b) the immune system
causes protection against these diseases.
(DTaP-IPV/Hib) helps protect children against diphtheria, tetanus, pertussis, and poliomyelitis
as well as invasive infections caused by Haemophilus influenzaetype b (meningitis, sepsis, and others) in children from the age of 6 weeks.
This vaccine does not protect against infections caused by other types of Haemophilus influenzae
or against meningitis caused by other microorganisms.

2. Important information before using the vaccine

When not to use the vaccine:

• if the child is allergic (hypersensitive):
• to any of the vaccine components (listed in section 6. "What it contains"),
• to glutaraldehyde, neomycin, streptomycin, and polymyxin B (which are used in the manufacturing process and may be present in trace amounts),
• to pertussis vaccines (acellular or whole cell),
• if the child has had an allergic reaction after previous administration of this vaccine or a vaccine containing the same substances,
• if the child has a progressive encephalopathy (brain damage),
• if the child has had encephalopathy (brain damage) within 7 days of the previous dose of pertussis vaccine (acellular or whole cell),
• if the child has a fever or sudden illness, vaccination should be postponed.

Warnings and precautions

When to exercise special caution when using the vaccine:

• if the child has blood disorders such as low platelet count (thrombocytopenia) or bleeding disorders, as there is a risk of bleeding during intramuscular administration,
• if the child has had febrile seizures in the past, not related to previous vaccination, it is especially important to monitor body temperature within 48 hours of vaccination and administer antipyretic drugs during this period,
• if any of the following symptoms occurred after previous vaccination (the decision to administer subsequent doses of the vaccine containing pertussis should be carefully considered): high fever (40°C or higher) within 48 hours, not caused by another identified cause, collapse or a state similar to shock with hypotensive-hyporeactive syndrome (decreased activity) within 48 hours of vaccination, prolonged, unsoothable crying lasting 3 hours or more, which occurred within 48 hours of vaccination, seizures with or without fever,
• if the child has or has had diseases or allergic reactions, especially allergic reactions after vaccination,
• if the child has had Guillain-Barré syndrome (atypical sensitivity, weakness) or brachial neuritis (weakness, diffuse arm and shoulder pain) after receiving a vaccine containing tetanus toxoid, the decision to administer any vaccine containing tetanus toxoid should be evaluated by a doctor,
• if the child has had swelling (edema) of the lower limbs after receiving a vaccine containing Haemophilus influenzaetype b antigen, these two vaccines, diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzaetype b conjugate vaccine, should be administered at two different body sites, each on a different day,
• in the case of a child with immunodeficiency or undergoing treatment with corticosteroids, cytotoxic drugs, radiation therapy, or other drugs that may lower immunity, the immune response to the vaccine may be weakened. It is recommended to postpone vaccination until the treatment is completed or the child has recovered. However, vaccination of children with chronic immunodeficiency, such as HIV infection, is recommended even if the immune response may be limited,
• it does not protect against invasive diseases caused by serotypes other than Haemophilus influenzaetype b or against meningitis caused by other microorganisms.

Fainting can occur after, or even before, any needle injection. Therefore, you should
tell your doctor or nurse if the patient has experienced fainting during previous injections.

Vaccine and other medicines

This vaccine can be administered simultaneously with the measles, mumps, and rubella vaccine
(M-M-RVAXPRO) or with the hepatitis B vaccine (HBVAXPRO), but at two different body sites, i.e., two different legs or two different arms.
If the child is to receive other vaccines at the same time, ask your doctor or pharmacist for additional information.
Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines planned for the patient.

The vaccine contains phenylalanine, ethanol, and sodium

The vaccine contains 12.5 micrograms of phenylalanine per 0.5 ml dose.
Phenylalanine may be harmful to patients with phenylketonuria, a rare genetic disorder,
in which phenylalanine accumulates in the body because the body does not remove it properly.
The vaccine contains 2 mg of alcohol (ethanol) per 0.5 ml dose. The small amount of alcohol
in this vaccine will not cause noticeable effects.
The vaccine contains less than 1 mmol of sodium per dose, i.e., the vaccine is considered
“sodium-free”.

3. How to use the vaccine

Dosage

The vaccine is used in children from the age of 6 weeks.
Primary vaccination: 3 injections administered at intervals of 1 to 2 months.
Booster dose: 1 injection given 1 year after the third dose of primary vaccination, usually
between 16 and 18 months of age.

Missing a dose of the vaccine

In case of missing a dose of the vaccine, inform your doctor, who will decide when to administer the missed dose.
Make sure the child has received the full vaccination cycle, otherwise, protection may
be ineffective.

4. Possible side effects

Like any medicine, this vaccine can cause side effects, although not everybody gets them.

Severe allergic reactions

Severe allergic reactions, although rare, can occur after vaccination, usually while the child
is still in the place where they were vaccinated.

If, after leaving the vaccination site, any of the following symptoms occur, contact your doctor or emergency services IMMEDIATELY:

• Swelling of the face (facial edema), sudden swelling of the face or neck (angioedema, Quincke's edema).
• Sudden and severe malaise with a drop in blood pressure causing dizziness and loss of consciousness, rapid heart rate associated with respiratory disorders (anaphylactic reaction and shock).

Other side effects

If the child experiences any of the following side effects, which persist or worsen,
contact your doctor or pharmacist.
Very common reactions (may affect more than 1 in 10 children):

• loss of appetite
• irritability, fussiness
• unusual crying
• drowsiness
• vomiting
• redness at the injection site (erythema)
• fever 38°C or higher
• swelling (edema) at the injection site
• pain at the injection site
• Common reactions (may affect less than 1 in 10 children but more than 1 in 100 children):
• diarrhea
• induration at the injection site
• insomnia, sleep disorders
• Uncommon reactions (may affect less than 1 in 100 children but more than 1 in 1000 children):
• redness and swelling (edema) with a diameter of 5 centimeters or more at the injection site
• fever 39°C and higher
• unsoothable and prolonged crying (lasting longer than 3 hours).

Rare reactions (may affect less than 1 in 1000 children but more than 1 in 10,000 children):

• fever above 40°C
• swelling of the legs and feet (edema reactions affecting the lower limbs) with blue discoloration of the skin (cyanosis) or redness, small transient red spots (petechiae) occurring within a few hours of vaccination and resolving without treatment and without sequelae. Swelling may be accompanied by acute crying.

Reactions with unknown frequency (frequency cannot be estimated, as these reactions are
reported very rarely):

• seizures with or without fever
• decreased activity or periods during which the child is pale, does not respond to stimuli, or appears to be in a state similar to shock (hypotensive-hyporeactive syndrome)
• rash, redness (erythema), itching (urticaria)
• large reactions at the injection site, larger than 5 centimeters, including swelling (edema) of the limb, which may extend to the joints on both sides of the injection site. These reactions occur within 24 to 72 hours of vaccination and may be accompanied by symptoms such as redness (erythema), warmth, tenderness, or pain at the injection site. These reactions resolve spontaneously within 3 to 5 days.

Potential side effects (i.e., not reported directly after vaccination, but after other vaccines containing one or more antigenic components of the vaccine
) are as follows:

• Guillain-Barré syndrome (atypical sensitivity, weakness) and brachial neuritis (weakness, diffuse arm and shoulder pain) after receiving a vaccine containing tetanus toxoid.

Additional information for special populations

In preterm infants (born at 28 weeks of gestation or earlier), within 2-3 days of vaccination, longer pauses between breaths may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products
of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 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 the vaccine.

5. How to store the vaccine

The vaccine should be stored out of sight and reach of children.
Store in a refrigerator (2 ° C - 8 ° C). Do not freeze.
Do not use this vaccine after the expiry date (EXP) stated on the label and carton. The expiry date refers to the last day of the 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 it contains

The active substances of the vaccine in one dose (0,5 ml) after reconstitution are:

Diphtheria toxoid not less than 20 IU (30 Lf)
Tetanus toxoid not less than 40 IU (10 Lf)
Bordetella pertussisantigens:

• toxoid 25 micrograms
• filamentous hemagglutinin 25 micrograms
• Poliomyelitis virus (inactivated)
• type 1 (Mahoney strain) 29 units of antigen D
• type 2 (MEF-1 strain) 7 units of antigen D
• type 3 (Saukett strain) 26 units of antigen D
• Haemophilus influenzaetype b polysaccharide 10 micrograms conjugated with tetanus toxoid

adsorbed on aluminum hydroxide, hydrated (0.3 milligrams Al)
lower limit of the confidence interval (p = 0.95) and not less than 30 IU as the average value
or equivalent activity determined by immunogenicity assessment
lower limit of the confidence interval (p = 0.95)
grown in Vero cells
these antigen amounts are exactly the same as previously expressed as 40-8-32 units of antigen
D, respectively for virus type 1, 2, and 3, measured by another appropriate immunochemical method
Aluminum hydroxide is contained in this vaccine as an adsorbent. Adsorbents are substances contained
in some vaccines to accelerate, improve, and (or) prolong the protective effect of the vaccine.

Other ingredients are:

Suspension for injection:

• Hanks' medium without phenol red
• glacial acetic acid and (or) sodium hydroxide (to adjust pH)
• formaldehyde
• phenoxyethanol
• anhydrous ethanol
• water for injections
• Hanks' medium is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins, and other components (such as glucose) diluted in water.

Powder:

• sucrose
• trometamol
• concentrated hydrochloric acid (to adjust pH)

What the package looks like and what it contains

is available as a powder and suspension for injection (0.5 ml in a syringe vial with a needle or without a needle. Box of 1, 10, or 20).

Marketing authorization holder and manufacturer

Marketing authorization holder

Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly, France

Manufacturer

Sanofi Winthrop Industrie
1541 avenue Marcel Mérieux
69280 Marcy l’Etoile
France
Sanofi Winthrop Industrie
Voie de l’Institut - Parc Industriel d’Incarville
B.P 101
27100 Val de Reuil
France
Date of last update of the leaflet:December 2024

Information intended exclusively for healthcare professionals:

Method of administration:

In the case of syringes without attached needles, a separate needle must be firmly attached to
the syringe by rotating it a quarter turn.
Shake the syringe until a uniform suspension is obtained and reconstitute the vaccine by
injecting the combined diphtheria, tetanus, pertussis (acellular) and poliomyelitis vaccine suspension
into the vial with the Haemophilus influenzaetype b vaccine powder.
Shake the vial until the powder is completely dissolved. After reconstitution, the slightly cloudy appearance of the suspension is normal.
Immediately draw up the reconstituted suspension into the syringe.
The slightly cloudy suspension must be used immediately after reconstitution and shaken before administration.
After reconstitution and drawing up into the syringe, a separation of the suspension into a clear phase and a gel phase may occur. In this case, the syringe contents should be shaken again vigorously before administration.
Administer intramuscularly.
It is recommended to administer in the middle of the anterolateral aspect of the thigh in infants and in the deltoid muscle in children.
This vaccine should never be administered intravascularly (into a blood vessel).
The vaccine should be used immediately after reconstitution and shaken before injection until the contents become slightly cloudy.
Do not use this vaccine if an abnormal color or presence of impurities is observed.

Effect on laboratory test results

After vaccination, the Haemophilus influenzaetype b polysaccharide is excreted in the urine, so within 1-2 weeks,
positive urine test results for Haemophilus influenzaetype b infection may be observed. During this time,
other tests should be performed to confirm Haemophilus influenzaetype b infection.