Infanrix hexa, Powder and suspension for suspension for injection in a pre-filled syringe Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed).
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This vaccine has been prescribed for your child only. Do not pass it on to others.
If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Infanrix hexa is and what it is used for
What you need to know before your child receives Infanrix hexa
How Infanrix hexa is given
Possible side effects
How to store Infanrix hexa
Contents of the pack and other information
Infanrix hexa is a vaccine used to protect your child against six diseases:
Haemophilus influenzae type b (Hib): can cause brain swelling (inflammation). This can lead to serious problems such as mental slowness (retardation), cerebral palsy, deafness, epilepsy or partial
blindness. It can also cause swelling of the throat. This can cause death by suffocation. Less commonly, the bacteria can also infect the blood, heart, lungs, bones, joints, and tissues of the eyes and mouth.
Infanrix hexa helps your child’s body make its own protection (antibodies). This will protect your child against these diseases.
As with all vaccines, Infanrix hexa may not fully protect all children who are vaccinated.
The vaccine cannot cause the diseases that it protects your child from.
if your child is allergic to:
Infanrix hexa or any of the ingredients of this vaccine (listed in section 6).
formaldehyde.
neomycin or polymyxin (antibiotics).
Signs of an allergic reaction may include itchy skin, rash, shortness of breath and swelling of the face or tongue.
if your child has had an allergic reaction to any vaccine against diphtheria, tetanus, whooping cough, hepatitis B, polio or Haemophilus influenzae type b.
if your child has had problems of the nervous system within 7 days after previous vaccination with a vaccine against whooping cough
if your child has a severe infection with a high temperature (over 38°C).
A minor infection such as a cold should not be a problem, but talk to your doctor first.
Infanrix hexa should not be given if any of the above apply to your child. If you are not sure, talk to your doctor or pharmacist before your child is given Infanrix hexa.
Talk to your doctor or pharmacist before your child is given Infanrix hexa:
if after previously having Infanrix hexa or another vaccine against whooping cough, your child had any problems, especially:
a high temperature (over 40°C) within 48 hours of vaccination
a collapse or “shock-like” state within 48 hours of vaccination
persistent crying lasting 3 hours or more within 48 hours of vaccination
fits with or without a high temperature within 3 days of vaccination
if your child has an undiagnosed or progressive disease of the brain or epilepsy which is not controlled. After control of the disease the vaccine can be given.
if your child has a bleeding problem or bruises easily
if your child tends to have fits when they have a fever, or if there is a history of this in the family.
if your child should become unresponsive or experience seizures (fits) after the vaccination, please contact your doctor immediately. See also section 4 Possible side effects.
if your baby was born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination. These babies may require respiratory monitoring for 48-72h following the administration of the first two or three doses of Infanrix hexa.
If any of the above apply to your child (or you are not sure), talk to your doctor or pharmacist before your child is given Infanrix hexa.
Your doctor may ask you to give your child a medicine that lowers fever (such as paracetamol) before or immediately after Infanrix hexa is given. This can help to lower some of the side effects (febrile reactions) of Infanrix hexa.
Tell your doctor or pharmacist if your child is taking, has recently taken, might take any other medicines or has recently received any other vaccine.
This vaccine contains neomycin and polymyxin (antibiotics). Tell your doctor if your child has had an allergic reaction to these ingredients.
Infanrix hexa contains para-aminobenzoic acid. It may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.
The vaccine contains 0.0298 microgram phenylalanine in each dose. Phenylalanine may be harmful if
you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
The vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. The vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’.
Your child will have a total of two or three injections with respectively at least 2 or 1 month(s) between each injection.
You will be told by the doctor or nurse when your child should come back for their next injections.
If additional injections (boosters) are necessary, the doctor will tell you.
Infanrix hexa will be given as an injection into a muscle.
The vaccine should never be given into a blood vessel or into the skin.
If your child misses an injection which is due, it is important that you make another appointment.
Like all medicines, this vaccine can cause side effects, although not everybody gets them. The following side effects may happen with this vaccine:
If your child has an allergic reaction, see your doctor straight away. The signs may include:
rashes that may be itchy or blistering
swelling of the eyes and face
difficulty in breathing or swallowing
a sudden drop in blood pressure and loss of consciousness.
These signs usually start very soon after the injection has been given. Talk to a doctor straight away if they happen after leaving the doctor’s surgery.
collapse
times when they lose consciousness or have a lack of awareness
fits – with or without fever
These side effects have happened very rarely with Infanrix hexa as with other vaccines against whooping cough. They usually happen within 2 to 3 days after vaccination.
In extremely rare cases the following side effects have been reported with hepatitis B vaccine: paralysis, numbness or weakness of the arms and legs (neuropathy), inflammation of some nerves, possibly with pins and needles or loss of feeling or normal movement (Guillain-Barré syndrome), swelling or infection of the brain (encephalopathy, encephalitis), infection around the brain (meningitis).
The causal relationship to the vaccine has not been established.
Bleeding or bruising more easily than normal (thrombocytopenia) has been reported with hepatitis B vaccines.
If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Store in the original package in order to protect from light.
Do not freeze. Freezing destroys the vaccine.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines your child no longer uses. These measures will help protect the environment.
The active substances are:
Diphtheria toxoid1 not less than 30 International Units (IU)
Tetanus toxoid1 not less than 40 International Units (IU)
Bordetella pertussis antigens
Pertussis toxoid1 25 micrograms
Filamentous Haemagglutinin1 25 micrograms
Pertactin1 8 micrograms
Hepatitis B surface antigen2,3 10 micrograms
Poliovirus (inactivated)
type 1 (Mahoney strain)4 40 D-antigen unit
type 2 (MEF-1 strain)4 8 D-antigen unit
type 3 (Saukett strain)4 32 D-antigen unit
Haemophilus influenzae type b polysaccharide 10 micrograms (polyribosylribitol phosphate)3
conjugated to tetanus toxoid as carrier protein approximately 25 micrograms
1adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 0.5 milligrams Al3+ 2produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 3adsorbed on aluminium phosphate (AlPO4) 0.32 milligrams Al3+ 4propagated in VERO cells
The other ingredients are:
Hib powder: lactose anhydrous
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
The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) component is a white, slightly milky liquid presented in a pre-filled syringe (0.5 ml).
The Hib component is a white powder presented in a glass vial.
Both components are mixed together just before your child receives the injection. The mixed appearance is a white, slightly milky liquid.
Infanrix hexa is available in packs of 1 and 10 with or without needles, and a multipack of 5 packs, each containing 10 vials and 10 pre-filled syringes, without needles.
Not all pack sizes may be marketed.
GlaxoSmithKline Biologicals s.a. Rue de l’Institut 89
B-1330 Rixensart
Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
GlaxoSmithKline Biologicals SA Tel: +370 80000334
GlaxoSmithKline Biologicals SA
Тел.: +359 80018205
GlaxoSmithKline Biologicals SA Tel.: +36 80088309
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
GlaxoSmithKline Biologicals SA Tel: +356 80065004
GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 360448701
GlaxoSmithKline Biologicals SA Tel: +372 8002640
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. Tηλ: + 30 210 68 82 100
GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0
GSK Services Sp. z o.o. Tel.: + 48 (22) 576 9000
Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44
Smith Kline & French Portuguesa - Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
GlaxoSmithKline Biologicals SA Tel: +385 800787089
GlaxoSmithKline Biologicals SA Tel: +40 800672524
GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 495 5000
GlaxoSmithKline Biologicals SA Tel: +386 80688869
Vistor hf.
Sími: +354 535 7000
GlaxoSmithKline S.p.A. Tel:+ 39 (0)45 7741 111
GlaxoSmithKline Biologicals SA
Τηλ: +357 80070017
GlaxoSmithKline Biologicals SA Tel: +371 80205045
GlaxoSmithKline Biologicals SA Tel: +44(0)800 221441
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
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Upon storage, a clear liquid and white deposit may be observed in the pre-filled syringe containing the DTPa-HBV-IPV suspension. This is a normal observation.
The pre-filled syringe should be well shaken in order to obtain a homogeneous turbid white suspension. The vaccine is reconstituted by adding the entire contents of the pre-filled syringe to the vial containing
the powder. The mixture should then be well shaken until the powder is completely dissolved prior to
administration.
The reconstituted vaccine appears as a slightly more cloudy suspension than the liquid component alone. This is a normal observation.
The vaccine suspension should be inspected visually before and after reconstitution for any foreign particulate matter and/or abnormal physical appearance. If either is observed, do not administer the vaccine.
The pre-filled syringe can be supplied with either a ceramic coated treatment (CCT) of the luer tip or with a plastic rigid tip cap (PRTC) luer lock adaptor.
Instructions for use of pre-filled syringe if supplied with a PRTC luer lock adaptor
2
Needle protector
Syringe plunger
Syringe barrel
Syringe cap
Holding the syringe barrel in one hand (avoid holding the syringe plunger), unscrew the syringe cap by twisting it anticlockwise.
To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock (see picture).
Remove the needle protector, which on occasion can be a little stiff.
Reconstitute the vaccine as described above.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.