Infanrix Hexa

Package leaflet: Information for the user

Infanrix hexa, Powder and suspension for injectable suspension in pre-filled syringe

Vaccine (adsorbed) against diphtheria (D), tetanus (T), pertussis (acellular component) (Pa),
hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate.
Please read all of this leaflet carefully before the child is vaccinated because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This vaccine has been prescribed for your child only. Never give it to others.
• If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Infanrix hexa is and what it is used for
2. What you need to know before your child is given Infanrix hexa
3. How Infanrix hexa is given
4. Possible side effects
5. How to store Infanrix hexa
6. Contents of the pack and other information

1. What Infanrix hexa is and what it is used for

Infanrix hexa is a vaccine used to protect your child against six diseases:

• Diphtheria: a serious bacterial infection affecting mainly the upper respiratory tract and sometimes the skin, causing severe breathing problems, sometimes leading to suffocation. The bacteria also release a toxin. This can cause damage to the nervous system, heart problems and even death.
• Tetanus: tetanus bacteria, commonly found in soil, dust, horse manure and wood splinters, enter the body through cuts, scratches or skin wounds and release a toxin. This can cause muscle stiffness, painful muscle spasms, seizures and even death.
• Pertussis (whooping cough): a highly contagious bacterial infection affecting the respiratory tract, causing prolonged coughing often with a "whooping" sound. It may also cause ear infections, chest infections (bronchitis), lung infections (pneumonia), seizures, brain damage and even death.
• Hepatitis B: caused by the hepatitis B virus which attacks the liver. The virus can cause chronic infection and may lead to cirrhosis and liver cancer.
• Polio: a viral infection, which sometimes causes nerve damage and permanent injury, potentially leading to muscle paralysis (paralysis), including the muscles involved in breathing and movement. It can cause permanent disability or even death.
• Haemophilus influenzae type b (Hib): a bacterial infection. It can cause meningitis (inflammation of the brain), which may lead to mental retardation, cerebral palsy, deafness, epilepsy and partial blindness. It may also cause swelling of the throat leading to death by suffocation. It can also infect the blood, heart, lungs, bones, joints, eyes and mouth.

How Infanrix hexa works

• Infanrix hexa helps your child's body produce its own protection (antibodies). This will protect the child against these diseases.
• As with all vaccines, Infanrix hexa may not fully protect all vaccinated children.
• The vaccine cannot cause the diseases against which it protects the child.

2. What you should know before your child receives Infanrix hexa

Infanrix hexa must not be given

• if your child is allergic to:
  • Infanrix hexa or any of the components of this vaccine (listed in section 6).
  • formaldehyde
  • neomycin or polymyxin (antibiotics). Signs of an allergic reaction may include itchy red rash, shortness of breath, swelling of the face or tongue.
• if your child has had an allergic reaction to any other vaccine against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, or Haemophilus influenzae type b.
• if your child has experienced neurological problems within 7 days after a previous vaccination with a pertussis-containing vaccine.
• if your child has a severe infection with high fever (over 38°C). A mild infection such as a cold should not be a problem, but discuss this with your doctor first.

Infanrix hexa must not be administered if your child has any of the conditions listed above. If you are unsure, speak to your doctor or pharmacist before your child receives the vaccine.

Warnings and precautions
Talk to your doctor or pharmacist before your child is given Infanrix hexa:

• if your child has experienced health problems after a previous dose of Infanrix hexa or other pertussis-containing vaccines, such as:
  • high fever (over 40°C) within 48 hours after vaccination
  • collapse or shock-like state within 48 hours after vaccination
  • persistent crying lasting 3 hours or more within 48 hours after vaccination
  • seizures with or without fever within 3 days after vaccination.
• if your child has an undiagnosed or progressive brain disorder or uncontrolled epilepsy. The vaccine may be given once the condition is under control.
• if your child has bleeding disorders or bruises easily.
• if your child tends to have seizures when running a fever, or if there is a family history of such events.
• if your child becomes unconscious or has seizures after vaccination, contact your doctor immediately. See also section 4 Possible side effects.
• If your child was born very prematurely (at or before 28 weeks of gestation), longer than normal pauses in breathing may occur for 2–3 days after vaccination. These children may require respiratory monitoring for 48–72 hours after receiving the first two or three doses of Infanrix hexa.

If your child has any of the conditions listed above (or if you are unsure), talk to your doctor or pharmacist before Infanrix hexa is administered.

Other medicines and Infanrix hexa
Your doctor may advise you to give your child a medicine to reduce fever (such as paracetamol) before or immediately after administration of Infanrix hexa. This may help reduce some of the side effects (febrile reactions) of Infanrix hexa.
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, or has recently received any other vaccines.

Infanrix hexa contains neomycin, polymyxin, para-aminobenzoic acid, phenylalanine, sodium, and potassium
This vaccine contains neomycin and polymyxin (antibiotics). Inform your doctor if your child has ever had an allergic reaction to these components.
Infanrix hexa contains para-aminobenzoic acid, which may cause allergic reactions (including delayed reactions) and, rarely, bronchospasm.
The vaccine contains 0.0298 micrograms of phenylalanine per dose. Phenylalanine may be harmful if your child has phenylketonuria, a rare genetic disorder that causes phenylalanine to accumulate because the body cannot properly eliminate it.
The vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".
The vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially "potassium-free".

3. How Infanrix hexa is administered

How many doses should be given

• The child will receive a total of two or three injections, with an interval of at least 2 or 1 month(s) between each injection, respectively.
• The doctor or nurse will inform you when the child should return for the next injection.
• If further injections ("booster doses") are needed, the doctor will advise you.

How the vaccination is administered

• Infanrix hexa is given as an intramuscular injection.
• The vaccine must never be administered into a blood vessel or into the skin.

If you interrupt the vaccination schedule

• If a scheduled injection is missed, it is important to arrange another appointment as soon as possible.
• Make sure the child completes the full vaccination course. Otherwise, the child may not be fully protected against the diseases.

4. Possible side effects

Like all medicines, this vaccine may cause side effects, although not everyone experiences them. The following side effects may occur with this vaccine:

Allergic reactions
If the child has an allergic reaction, consult a doctor immediately.
Signs of allergic reactions may include:

• skin rashes, which may be itchy or blistering
• swelling of the eyes and face
• difficulty breathing or swallowing
• sudden drop in blood pressure and loss of consciousness.
  Such reactions usually occur shortly after the injection. Contact a doctor immediately if they occur after leaving the medical office.

Contact a doctor immediately if your child experiences any of the following serious side effects:

• collapse
• periods of unconsciousness or loss of consciousness
• seizures – with or without fever. These side effects occur very rarely with Infanrix hexa, as with other pertussis vaccines. They usually occur within 2 or 3 days after vaccination.

Other side effects include:
Very common (occur in more than 1 in 10 doses of vaccine): drowsiness, loss of appetite, high fever above 38°C, swelling, pain, redness at the injection site, unusual crying, irritability or restlessness.
Common (occur in up to 1 in 10 doses of vaccine): diarrhoea, feeling of nausea (vomiting), high fever above 39.5°C, swelling greater than 5 cm or hard lump at the injection site, feeling of nervousness.
Uncommon (occur in up to 1 in 100 doses of vaccine): upper respiratory tract infection, fatigue, cough, extensive swelling of the limb where the injection was given.
Rare (occur in up to 1 in 1,000 doses of vaccine): bronchitis, skin rash, swelling of the glands in the neck, armpits or groin (lymphadenopathy), bleeding or bruising occurring more easily than normal (thrombocytopenia), in infants born very prematurely (at or before 28 weeks of gestation), abnormally long intervals between breaths, temporary cessation of breathing (apnoea), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), swelling of the entire limb where the injection was given, blisters.
Very rare (occur in up to 1 in 10,000 doses of vaccine): itching (dermatitis).

Experience with hepatitis B vaccine
In extremely rare cases, the following side effects have been reported with hepatitis B vaccine:
paralysis, numbness or weakness of arms and legs (neuropathy), inflammation of certain nerves, possibly causing tingling or loss of normal sensation or movement (Guillain-Barré syndrome), swelling or infection of the brain (encephalopathy, encephalitis), infection of the protective membranes around the brain (meningitis). A causal relationship with the vaccine has not been established.
Cases of bleeding or bruising occurring more easily than normal (thrombocytopenia) have also been reported with hepatitis B vaccines.

Reporting of side effects
If your child experiences any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Infanrix hexa

• Keep this vaccine out of the sight and reach of children.
• Do not use this vaccine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
• Store in a refrigerator (2 °C - 8 °C).
• Keep in the original packaging to protect the medicine from light.
• Do not freeze. Freezing will damage the vaccine.
• Do not dispose of any medicine 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 Infanrix hexa contains
The active substances are:
Diphtheria toxoid not less than 30 International Units (IU)
Tetanus toxoid not less than 40 International Units (IU)
Bordetella pertussis antigens
Pertussis toxoid 25 micrograms
Filamentous haemagglutinin 25 micrograms
Pertactin 8 micrograms
Hepatitis B surface antigen 10 micrograms
Inactivated poliovirus (types)
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
Haemophilus influenzae type b polysaccharide 10 micrograms
(polyribosylribitol phosphate)
conjugated to tetanus toxoid as carrier protein approximately 25 micrograms
adsorbed on hydrated aluminium hydroxide (Al(OH)_) 0.5 milligrams Al
produced from yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
adsorbed on aluminium phosphate (AlPO_) 0.32 milligrams Al
propagated in VERO cells

The other components are:
Hib powder: anhydrous lactose.
DTPa-HBV-IPV suspension: sodium chloride (NaCl), medium 199 (containing amino acids (including phenylalanine), mineral salts (including sodium and potassium), vitamins (including para-aminobenzoic acid) and other substances), and water for injections.

Description of the appearance of Infanrix hexa and contents of the pack

• The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis component (DTPa-HBV-IPV) is a white, slightly opalescent liquid contained in a pre-filled syringe (0.5 ml).
• The Hib component is a white powder contained in a glass vial.
• The two components are mixed together immediately before injecting the vaccine to the child. The appearance of the mixed product is a white, slightly opalescent liquid.
• Infanrix hexa is available in vial + pre-filled syringe presentations for 1 dose, packs of 1 and 10 with or without separate needles, and a multiple pack of 5 boxes, each containing 10 vials (1 dose each) and 10 pre-filled syringes (1 dose each), without separate needles.
• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Biologicals s.a.
Rue de l’Institut 89
B-1330 Rixensart
Belgium
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals SA/NV GlaxoSmithKline Biologicals SA
Tél/Tel: + 32 10 85 52 00 Tel. +370 80000334

България Luxembourg/Luxemburg
GlaxoSmithKline Biologicals SA GlaxoSmithKline Pharmaceuticals SA/NV
Тел. +359 80018205 Tél/Tel: + 32 10 85 52 00

Česká republika Magyarország
GlaxoSmithKline s.r.o. GlaxoSmithKline Biologicals SA
Tel: + 420 222 001 111 Tel.: +36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Biologicals SA
Tlf.: + 45 36 35 91 00 Tel: +356 80065004
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel: + 49 (0)89 360448701 Tel: + 31 (0)33 2081100
[email protected]

Eesti Norge
GlaxoSmithKline Biologicals SA GlaxoSmithKline AS
Tel: +372 8002640 Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E GlaxoSmithKline Pharma GmbH.
Tηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (22) 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline Smith Kline & French Portuguesa - Produtos
Tél: + 33 (0) 1 39 17 84 44 Farmacêuticos, Lda.
[email protected] Tel: + 351 21 412 95 00
[email protected]

Hrvatska România
GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA
Tel.: +385 800787089 Tel: +40 800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Ltd GlaxoSmithKline Biologicals SA
Tel: + 353 (0)1 4955000 Tel: +386 80688869

Ísland Slovenská republika
Vistor hf. GlaxoSmithKline Biologicals SA
Sími: +354 535 7000 Tel: +421 800500589

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741111 Puh/Tel: + 358 (0)10 30 30 30

Κύπρος Sverige
GlaxoSmithKline Biologicals SA GlaxoSmithKline AB
Τηλ: +357 80070017 Tel: + 46 (0) 8 638 93 00
[email protected]

Latvija United Kingdom (Northern Ireland)
GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA
Tel: +371 80205045 Tel: +44(0)800 221441
[email protected]

This leaflet was last revised on

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.
This leaflet is available in all EU/EEA languages on the website of the European Medicines Agency.

The following information is intended for healthcare professionals only:

During storage, a clear liquid and a white deposit may be observed in the pre-filled syringe containing the DTPa-HBV-IPV suspension. This is normal.
The pre-filled syringe must be shaken well to obtain a homogeneous, white, cloudy suspension.

To reconstitute the vaccine, add the entire contents of the pre-filled syringe to the vial containing the powder. The mixture must be shaken well until completely dissolved, prior to administration.

The reconstituted vaccine appears as a slightly cloudier suspension than the liquid component alone. This is normal.

The vaccine suspension must be inspected visually before and after reconstitution for the presence of particles and/or any change in physical appearance. If any such phenomena are observed, do not administer the vaccine.

Instructions for use of the pre-filled syringe

Hold the syringe by the barrel, not by the plunger.
Unscrew the syringe cap by rotating it counterclockwise.

To attach the needle to the syringe, gently connect the needle hub to the Luer Lock adapter and rotate one-quarter turn clockwise until a click is felt, indicating secure attachment.
Do not remove the plunger from the syringe barrel. If this occurs, do not administer the vaccine.

Disposal
Any unused medicine or waste material must be disposed of in accordance with local regulations.