Infanrix - Ipv + Hib

Leaflet accompanying the packaging: Information for the user

INFANRIX-IPV+Hib, Powder and suspension for suspension for injection
Vaccine against diphtheria (D), tetanus (T), pertussis (acellular, composite) (Pa),
poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) (conjugated), adsorbed

You should carefully read the contents of this leaflet before using the vaccine, as it contains important information for the patient.

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

Table of contents of the leaflet:

• 1. What INFANRIX-IPV+Hib vaccine is and what it is used for
• 2. Important information before using INFANRIX-IPV+Hib vaccine
• 3. How to use INFANRIX-IPV+Hib vaccine
• 4. Possible side effects
• 5. How to store INFANRIX-IPV+Hib vaccine
• 6. Contents of the packaging and other information

1. What INFANRIX-IPV+Hib vaccine is and what it is used for

INFANRIX-IPV+Hib is a vaccine used to prevent diphtheria, tetanus, pertussis (whooping cough),
poliomyelitis (polio, Heine-Medin disease) and Haemophilus influenzae type b (Hib) infections in children.
The diphtheria, tetanus, pertussis and polio component of the vaccine (DTPa-IPV) is a turbid, white suspension in a syringe (0.5 ml).
The Haemophilus influenzae type b component of the vaccine is a white powder in a glass vial.
Both components of the vaccine must be mixed together before injecting the child.

• Diphtheria:Diphtheria is an infectious disease that usually affects the respiratory tract and sometimes the skin. It often causes inflammation and swelling of the respiratory tract, leading to severe breathing difficulties and sometimes suffocation. The bacteria that cause diphtheria also produce toxins that can cause nerve damage, heart disease, and even death.
• Tetanus:Tetanus bacteria enter the body through a cut, scratch, or wound in the skin. Injuries that pose the greatest risk of tetanus infection include burns, fractures, deep or dirty wounds. These bacteria produce toxins that can cause muscle stiffness, painful muscle spasms, convulsions, and even death. Muscle spasms can be so strong that they lead to spinal fractures.
• Pertussis (whooping cough):Pertussis is a highly contagious respiratory disease. It causes severe coughing fits that can make breathing difficult. The cough is very characteristic - people with pertussis are said to have a "whooping" cough. The cough can last for 1-2 months or longer. Pertussis bacteria can also cause ear infections, bronchitis, pneumonia, convulsions, brain damage, and even death.

The vaccine causes the body to produce its own immunity (antibodies) against these diseases.
Vaccination is the best way to prevent these diseases. None of the vaccine components are infectious.

2. Important information before using INFANRIX-IPV+Hib vaccine

When not to use INFANRIX-IPV+Hib vaccine:

• If the child is allergic to INFANRIX-IPV+Hib or any of the other components of the vaccine (listed in section 6) or to neomycin, polymyxin, or formaldehyde (substances present in the vaccine in trace amounts). Allergic reactions include itching, difficulty breathing, swelling of the face or tongue;
• If the child has ever had an allergic reaction to any vaccine against diphtheria, tetanus, pertussis (whooping cough), polio, or Haemophilus influenzae type b infections;
• If the child has had any neurological disorders within 7 days of receiving a previous pertussis vaccine;
• If the child has a high fever (above 38.0°C). A mild infection, such as a cold, should not be a contraindication to vaccination, but you should tell your doctor first.

Warnings and precautions

Before using INFANRIX-IPV+Hib vaccine, you should discuss it with your doctor:

• If the child has had any health problems after receiving INFANRIX-IPV+Hib vaccine or another pertussis vaccine, especially:
• high fever (≥ 40.0°C) within 48 hours of vaccination,
• collapse or shock-like state within 48 hours of vaccination,
• prolonged, persistent crying lasting at least three hours within 48 hours of vaccination,
• seizures or febrile seizures within 3 days of vaccination,
• If the child has an undiagnosed or progressive brain disease or uncontrolled epilepsy. The vaccine should be given after the disease has been controlled;
• If the child has a history of febrile seizures or if there have been cases of febrile seizures in the family;
• If the child has a tendency to bleed or bruise easily.

In such cases, the doctor will decide on the appropriate time and method of vaccination for the child.
After or even before receiving each vaccine injection, fainting may occur. You should inform your doctor or nurse if the child has fainted during an injection.

Using INFANRIX-IPV+Hib vaccine in patients with immune system disorders

In children with health problems due to immune system disorders, the response to vaccination may be weakened. HIV infection is not a contraindication to vaccination.

INFANRIX-IPV+Hib vaccine and other medicines

You should tell your doctor about all medicines being taken currently or recently, as well as any vaccinations received.
In children taking immunosuppressive medicines, the response to vaccination may be weakened.
Different pediatric vaccines should be administered at different injection sites.

Pregnancy and breastfeeding

Since the vaccine is intended for children, there is no relevant data on its use during pregnancy and breastfeeding in humans.

Driving and operating machinery

Not applicable.

INFANRIX-IPV+Hib vaccine contains para-aminobenzoic acid, phenylalanine, sodium, and potassium

INFANRIX-IPV+Hib contains para-aminobenzoic acid. It may cause allergic reactions (possible late reactions) and, exceptionally, bronchospasm.
This vaccine contains 0.036 micrograms of phenylalanine per dose. Phenylalanine may be harmful to patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates in the body because the body does not eliminate it properly.
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, which means the vaccine is considered "sodium-free".
This vaccine contains potassium, less than 1 mmol (39 mg) of potassium per dose, which means the vaccine is considered "potassium-free".

3. How to use INFANRIX-IPV+Hib vaccine

The child should receive a total of 3 doses of the vaccine at intervals of at least one month.
The first dose can be given in the second month of life, and the full vaccination cycle should be completed within the first 6 months of life.
A booster dose is recommended in the second year of life.
Each dose is given during a separate visit. The doctor or nurse will inform you when to bring the child for the next dose.
If the child does not receive the next dose of the vaccine on time, you should talk to the doctor and schedule another visit.
You should ensure that the child receives the full vaccination consisting of three doses of the vaccine, as otherwise, they may not be fully protected against infectious diseases covered by the vaccination.
INFANRIX-IPV+Hib vaccine will be given as an intramuscular injection.
The vaccine must never be given intravenously.

4. Possible side effects

Like all vaccines, INFANRIX-IPV+Hib may cause side effects, although not every child will experience them.
The following side effects may occur after vaccination:
Very common(may occur in 1 in 10 doses of the vaccine or more often): loss of appetite, irritability, unusual crying, restlessness, drowsiness, pain, redness, and localized swelling (≤ 50 mm) at the injection site, fever (≥ 38°C).
Common(less common than 1 in 10 doses of the vaccine): vomiting, diarrhea, hard lump or localized swelling (> 50 mm) at the injection site.
Uncommon(less common than 1 in 100 doses of the vaccine): upper respiratory tract infection, swelling of the lymph nodes in the neck, armpits, and groin, cough, bronchitis, runny nose, rash, hives, fever (> 39.5°C), fatigue, diffuse swelling of the limb into which the vaccine was injected, sometimes including the adjacent joint.
Rare(less common than 1 in 1,000 doses of the vaccine): itching, skin inflammation.
Very rare(less common than 1 in 10,000 doses of the vaccine):

• Transient apnea (cessation of breathing)
• In very premature infants (born before or at 28 weeks of gestation) within 2-3 days of vaccination, longer-than-normal pauses between breaths may occur.
• Bleeding or easier-than-usual bruising
• Allergic reactions. As with other injectable vaccines, there is a very small risk of allergic reactions (hypersensitivity). This can be recognized by the following symptoms:
• itching rash on the hands and feet,
• swelling of the eyes and face,
• difficulty breathing and swallowing. Such symptoms usually occur before leaving the doctor's office. In any such case, treatment should be started immediately.
• Seizures (with or without fever), collapse, impaired consciousness or loss of consciousness
• Limited swelling, usually localized to the head and neck (angioedema)
• Swelling of the entire limb into which the vaccine was injected
• Blisters at the injection site

If these symptoms persist or worsen, you should inform your doctor.
Do not be concerned by this list of possible side effects. It is possible that no side effects will occur after vaccination.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should 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
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 INFANRIX-IPV+Hib vaccine

Store in a refrigerator (2°C – 8°C). Do not freeze.
Store in the original packaging to protect from light.
The vaccine should be stored out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the packaging. The expiry date (EXP) is the last day of the month stated.
Batch number (Lot).

6. Contents of the packaging and other information

What INFANRIX-IPV+Hib vaccine contains:

1 dose of the vaccine (0.5 ml) after reconstitution contains:
Diphtheria toxoid
not less than 30 IU
Tetanus toxoid
not less than 40 IU
Pertussis antigens Bordetella pertussis:
Pertussis toxoid
25 micrograms
Filamentous hemagglutinin
25 micrograms
Pertactin
8 micrograms
Inactivated poliovirus:
type 1 (Mahoney strain)
40 D antigen units
type 2 (MEF-1 strain)
8 D antigen units
type 3 (Saukett strain)
32 D antigen units
Haemophilus influenzaetype b polysaccharide
(polyribosylribitol phosphate)
conjugated to tetanus toxoid as a protein carrier
10 micrograms
approximately 25 micrograms
adsorbed on hydrated aluminum hydroxide
0.5 milligrams Al
grown in VERO cell culture
Other ingredients are:
lactose, sodium chloride (see also section 2, "INFANRIX-IPV+Hib vaccine contains sodium"),
199 medium (containing amino acids (including phenylalanine), mineral salts (including sodium and potassium),
vitamins (including para-aminobenzoic acid) and other substances), water for injections.

What INFANRIX-IPV+Hib vaccine looks like and what the packaging contains:

The lyophilized Haemophilus influenzaetype b (Hib) component is a white powder.
The suspension (DTPa-IPV) containing diphtheria toxoid, tetanus toxoid, pertussis antigens, and inactivated poliovirus is a white, turbid suspension.
Before administration, the powder and suspension are mixed together.
INFANRIX-IPV+Hib vaccine is available in a 1-dose vial + syringe, in packs of 1 or 10, with or without needles.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

GlaxoSmithKline Biologicals S.A
rue de l’Institut 89
1330 Rixensart, Belgium
For more detailed information, please contact the representative of the marketing authorization holder.
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
Tel. +48 (22) 576 90 00

Date of last revision of the leaflet: April 2023

-------------------------------------------------------------------------------------------------------------------------
Information intended exclusively for healthcare professionals:
During storage, a white sediment and a clear liquid may form in the suspension. This is a normal phenomenon and does not affect the vaccine's efficacy.
Before reconstituting the vaccine, the syringe containing the DTPa-IPV suspension should be shaken well to obtain a homogeneous suspension.
The DTPa-IPV suspension in the syringe, the Hib powder in the vial, as well as the vaccine after reconstitution, should be inspected for any impurities and/or abnormal appearance before administration. If any abnormalities are observed, the vaccine should be discarded.
The vaccine should be prepared by adding the entire DTPa-IPV suspension to the vial containing the Hib powder. The vaccine should be administered immediately after reconstitution. The reconstituted vaccine is more turbid than the DTPa-IPV suspension. After reconstituting the vaccine and drawing up the suspension into the syringe, the suspension may separate into a clear phase and a gel-like phase.
This is not a sign of reduced vaccine efficacy.

In the event of such an occurrence, the syringe contents should be

shaken vigorously againbefore administration. If any other changes in the appearance of the suspension are observed, the vaccine should be discarded.
Detailed instructions for preparing the vaccine are provided below:

• 1. Shake the syringe containing the DTPa-IPV suspension;
• 2. Attach the needle to the syringe containing the DTPa-IPV suspension and inject its contents into the vial containing the Hib powder;
• 3. Without removing the needle, shake the vial vigorously and check if the powder has dissolved;
• 4. Draw the mixture back into the syringe;
• 5. Replace the attached needle with an injection needle and administer the vaccine immediately;
• 6. If the vaccine is not administered immediately after reconstitution, the syringe contents should be shaken vigorously again before administration.

Instructions for the syringe

Adapter
type Luer Lock
Hold the syringe by the body, not the plunger.
Remove the syringe cap by twisting it in the opposite direction to the arrow.
Plunger
Body
Nozzle
Needle nozzle
Attach the needle to the syringe by screwing the needle nozzle onto the Luer Lock adapter (LLA) and twisting it a quarter turn in the direction of the arrow until it clicks.
Prepare the vaccine according to the instructions above.
Do not pull the plunger out of the syringe body. If this happens, do not administer the vaccine.

Disposal
Any unused product or waste material should be disposed of in accordance with local regulations.