Infanrix ipv

Package leaflet: Information for the user

Infanrix-IPV, suspension for injection in a pre-filled syringe
Diphtheria, tetanus, acellular pertussis (combined) and poliomyelitis (inactivated) vaccine, adsorbed
Please read all of this leaflet carefully before the vaccine is administered, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This vaccine has been prescribed for a specific individual. Do not pass it on to others.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Infanrix-IPV vaccine is and what it is used for
2. Important information before vaccination with Infanrix-IPV
3. How to use Infanrix-IPV vaccine
4. Possible side effects
5. How to store Infanrix-IPV vaccine
6. Contents of the pack and other information

1. What Infanrix-IPV vaccine is and what it is used for

Infanrix-IPV vaccine is used for booster and reminder vaccination in children to prevent four diseases:

• Diphtheria – a serious bacterial disease that most commonly affects the respiratory tract and sometimes the skin. In the respiratory tract, swelling occurs, causing severe breathing difficulties and sometimes suffocation. Diphtheria bacteria also produce toxins that may damage nerves, cause heart disease, and even lead to death.
• Tetanus – tetanus bacteria enter the human body through cuts, scratches or wounds in the skin. Injuries that pose the greatest risk of tetanus infection include: burns, fractures, deep wounds, or wounds contaminated with soil, dust, horse manure, or wood splinters. These bacteria produce toxins that may cause muscle stiffness, painful muscle spasms, seizures, and even death. Muscle spasms can be so severe that they result in spinal fractures.
• Pertussis (whooping cough) – a highly infectious disease affecting the respiratory tract. It causes severe coughing fits that may lead to breathing difficulties. The cough associated with this disease is very characteristic – it is often said that people with pertussis "cough until they gasp for breath." The cough may persist for 1–2 months or longer. Pertussis bacteria may also cause ear infections, prolonged bronchitis, pneumonia, seizures, brain damage, and even death.
• Poliomyelitis (Polio) – a viral infection. Polio often has a mild course. However, in some individuals it may be severe and cause permanent damage or even death. It may cause muscle paralysis (muscles unable to perform their normal functions), which may affect respiratory muscles or those required for independent movement. Limbs affected by this condition may become deformed and painful.

Infanrix-IPV vaccine is intended for children aged from 16 months up to and including 13 years.
It is not intended for individuals over 14 years of age.
How Infanrix-IPV vaccine works:

• The vaccine stimulates the body to produce its own immunity (antibodies). These will protect the vaccinated person against the diseases listed above.
• The vaccine does not cause the diseases it protects against.

2. Information before using Infanrix-IPV vaccine

When not to use Infanrix-IPV vaccine

• if the child is allergic to any of the components of the Infanrix-IPV vaccine (components are listed in section 6)
• or to neomycin, polymyxin (antibiotics)
• or to formaldehyde. Symptoms of allergy may include itchy rash, difficulty breathing, swelling of the face or tongue.
• if an allergic reaction occurred after any previous diphtheria, tetanus, pertussis or polio vaccine
• if there has been any neurological disorder (encephalopathy) within 7 days after a previous dose of pertussis-containing vaccine
• if there is high fever (above 38.0 °C). A mild infection, such as a cold, should not prevent vaccination, but you should inform the doctor first.

Infanrix-IPV vaccine should not be given in the above cases. If in doubt,
talk to a doctor or pharmacist before your child receives Infanrix-IPV
vaccine.
Warnings and precautions
Before your child receives Infanrix-IPV vaccine, inform the doctor or
pharmacist:

• if any health problems occurred after previous vaccination with Infanrix-IPV or another pertussis-containing vaccine, especially:
• high fever (above 40 °C) within 48 hours after vaccination
• collapse or shock-like state within 48 hours after vaccination
• persistent crying lasting at least 3 hours within 48 hours after vaccination
• seizures or convulsions with or without fever within 3 days after vaccination
• if the child has an undiagnosed or progressive brain disorder or uncontrolled epilepsy. The vaccine should be given only after the condition has been controlled
• if there are bleeding disorders or a tendency to bruise easily
• if there is a history of febrile seizures or such cases in the family
• if the child has an impaired immune system for any reason (including HIV infection). In such cases, Infanrix-IPV vaccine may still be given, but the vaccinated individual may not achieve full protection against infections.

Fainting may occur during or even before any injection vaccination (particularly in adolescents). Therefore, inform the doctor or nurse if the patient has ever fainted during or after an injection.
In the above cases or if in doubt, talk to a doctor or pharmacist before your child receives Infanrix-IPV
vaccine.
Infanrix-IPV vaccine and other medicines
Tell the doctor or pharmacist about all medicines the child is currently taking or has recently taken, and any medicines planned for administration.
In particular, inform the doctor or pharmacist if the child is taking:

• medicines that affect the immune system or has undergone radiotherapy. In such cases, the vaccine may still be given, but it may be less effective. If possible, vaccination should be delayed until after completion of treatment.
• other vaccines: Infanrix-IPV may be administered simultaneously with other vaccines. However, they should be given at different injection sites.

Pregnancy and breastfeeding
Administration of Infanrix-IPV vaccine to pregnant or breastfeeding women is highly unlikely, as this vaccine is intended for use in children aged 16 months to 13 years (inclusive).
Vaccination during pregnancy or breastfeeding is not recommended.
Consult a doctor before taking any medicines.
Driving and operating machinery
Administration of Infanrix-IPV vaccine to individuals who drive or operate machinery is highly unlikely, as this vaccine is intended for use in children aged 16 months to 13 years (inclusive).
After vaccination, the child may feel sleepy. If this occurs, the child should not drive, ride a bicycle, or operate machinery or tools.
Infanrix-IPV vaccine contains neomycin, polymyxin (antibiotics), para-
aminobenzoic acid, phenylalanine, sodium, potassium, and formaldehyde.
Do not use the vaccine if the child is allergic to any of these components.
Inform the doctor if the child has ever had an allergic reaction to any of these ingredients.
Infanrix-IPV contains para-aminobenzoic acid. It may cause allergic reactions (including delayed-type reactions) and, very rarely, bronchospasm.
The vaccine contains 0.036 micrograms of phenylalanine per dose. Phenylalanine may be harmful for patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates in the body because it is not properly eliminated.
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, meaning the vaccine is considered "sodium-free".
This vaccine contains potassium, less than 1 mmol (39 mg) of potassium per dose, meaning the vaccine is considered "potassium-free".

3. How to use the Infanrix-IPV vaccine

When the Infanrix-IPV vaccine will be given

• Your doctor or nurse will inform you when your child should receive the vaccine. This depends on official recommendations.

How the Infanrix-IPV vaccine is given

• Your child will receive one dose of the vaccine.
• The Infanrix-IPV vaccine is always administered intramuscularly.
• The vaccine is usually given into the muscle of the arm. However, in small children, it may be given into the thigh.
• The vaccine must never be administered intravenously.

If you have any further questions regarding the use of this medicine, please consult your doctor or pharmacist.

4. Possible side effects

Like any medicine, this vaccine can cause side effects, although they do not occur in everyone. The vaccine may cause the following side effects:
Allergic reactions
If an allergic reaction occurs, contact a doctor immediately.
Symptoms may include:

• skin rash, which may be itchy or blistering
• swelling of the eyes and face
• difficulty breathing and swallowing
• sudden drop in blood pressure
• loss of consciousness

Such reactions usually occur shortly after vaccination. Seek immediate medical attention if symptoms occur after leaving the doctor's office. Allergic reactions are very rare (less frequently than 1 in 10,000 doses of vaccine).

Contact a doctor immediately if any of the following symptoms occur:

• collapse
• loss of consciousness
• lack of awareness
• seizures

Seek immediate medical attention if any of the above symptoms occur. These side effects have occurred after administration of other pertussis-containing vaccines. They usually occur within 2 to 3 days after vaccination.
Other side effects include:
Very common (more than 1 in 10 doses of vaccine): drowsiness, headache, loss of appetite, high fever (38°C or higher), pain, redness and swelling at the injection site, unusual crying, irritability, restlessness.
Common (less than 1 in 10 doses of vaccine): diarrhoea, nausea, vomiting, high fever (39.5°C or higher), malaise, hard lump at the injection site, weakness.
Uncommon (less than 1 in 100 doses of vaccine): skin allergies or rash.
Rare (less than 1 in 1,000 doses of vaccine): swelling of neck, armpit or groin lymph nodes (lymphadenopathy), cough or bronchitis, itching, hives (urticaria).
Very rare (less than 1 in 10,000 doses of vaccine): bleeding or easy bruising (thrombocytopenia), longer than normal pauses between breaths (apnoea), swelling of the face, lips, tongue, or throat which may cause difficulty in swallowing or breathing (angioedema), blisters at the injection site.
Booster doses of Infanrix-IPV vaccine may increase the risk of injection site reactions. Some of these may affect the entire limb into which the vaccine was administered. These reactions usually start within 48 hours after vaccination and resolve within 4 days.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 authorisation holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store the Infanrix-IPV vaccine

• Keep the vaccine out of sight and reach of children.
• Store in a refrigerator (2°C to 8°C).
• Store in the original packaging to protect from light.
• Do not freeze. Freezing will destroy the vaccine.
• Do not use this medicinal product after the expiry date stated on the carton (EXP). The expiry date refers to the last day of the specified month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Infanrix-IPV vaccine contains

• The active substances are:
  Diphtheria toxoid not less than 30 I.U.
  Tetanus toxoid not less than 40 I.U.
  Bordetella pertussis antigens
  Pertussis toxoid 25 micrograms
  Filamentous haemagglutinin 25 micrograms
  Pertactin 8 micrograms
  Poliovirus (inactivated)
  Type 1 (Mahoney strain) 40 antigen D units
  Type 2 (MEF-1 strain) 8 antigen D units
  Type 3 (Saukett strain) 32 antigen D units
  Adsorbed on aluminium hydroxide, hydrated 0.5 milligrams Al
  Grown in VERO cell culture

Aluminium hydroxide acts as an adjuvant in this vaccine. Adjuvants are substances included
in some vaccines to accelerate, enhance and/or prolong the protective effect of the vaccine.

• Other components are: sodium chloride, Medium 199 (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 vaccine looks like and contents of the pack

• Infanrix-IPV is a suspension for injection in a pre-filled syringe (0.5 ml).
• The suspension is a white, slightly milky liquid.
• Infanrix-IPV vaccine is available as a 0.5 ml single-dose pre-filled syringe, in packs of 1 or 10, with needles included or without needles.
• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Biologicals S.A.
rue de l’Institut 89
1330 Rixensart, Belgium

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Cyprus, Greece, Portugal: Infanrix Tetra
Estonia, Finland, Sweden: INFANRIX POLIO
France: INFANRIXTETRA
Hungary: INFANRIX IPV
Ireland: IPV Infanrix
Italy: POLIOINFANRIX
Latvia: Infanrix polio suspensija injekcijām pilnšļircē
Lithuania: Infanrix Polio injekcinė suspensija užpildytame švirkšte
Norway, Slovakia: Infanrix Polio
Poland: INFANRIX-IPV
Spain: INFANRIX-IPV SUSPENSION INYECTABLE EN JERINGA PRECARGADA

Further information
Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Information intended exclusively for healthcare professionals:

A white sediment with a clear supernatant liquid may be observed during storage. This is a
normal phenomenon and does not reduce the vaccine's effectiveness.
Before administration, shake the prefilled syringe vigorously to obtain a homogeneous,
turbid, white suspension.
The suspension should be visually inspected for any foreign particles and (or) physical changes in the appearance of the vaccine. If such are observed, the vaccine must be discarded.

Instructions for the prefilled syringe:
Hold the prefilled syringe by the body, not by the plunger.

Luer Lock adapter
Remove the syringe cap by turning it
counterclockwise.

Plunger
Body
Cap
Needle adapter
Attach the needle to the prefilled syringe by connecting the needle adapter to the
Luer Lock adapter (Luer Lock Adaptor, LLA) and rotating it a quarter turn clockwise until a click is felt, indicating the needle is securely locked.

Do not remove the plunger from the syringe body. If this occurs, do not administer the vaccine.

Disposal
Any unused portions of the medicinal product or waste materials must be disposed of in accordance with local regulations.