Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your pharmacist.
This vaccine has been prescribed for your child. Do not pass it on to others.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What Infanrix Penta is and what it is used for
Before your child receives Infanrix Penta
How Infanrix Penta is given
Possible side effects
How to store Infanrix Penta
Further information
Infanrix Penta is a vaccine used to protect your child again five diseases:
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The airways become swollen causing serious breathing problems and sometimes suffocation. The bacteria also release a poison. This can cause nerve damage, heart problems, and even death.
Infanrix Penta helps your child’s body make its own protection (antibodies). This will protect your child against these diseases.
As with all vaccines, Infanrix Penta may not fully protect all children who are vaccinated.
The vaccine cannot cause the diseases that it protects your child from.
your child is allergic (hypersensitive) to
Infanrix Penta, or any ingredients in Infanrix Penta (listed in Section 6)
neomycin or polymyxin (antibiotics).
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
your child has had an allergic reaction to any vaccine against diphtheria, tetanus, whooping cough, hepatitis B or polio.
your child has had problems of the nervous system within 7 days after previous vaccination with a vaccine against whooping cough.
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 Penta 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 Penta.
Check with your doctor or pharmacist before your child is given this vaccine if:
after previously having Infanrix Penta or another vaccine against whooping cough, your child had any problems, especially:
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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
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.
your child has a bleeding problem or bruises easily
your child tends to have fits when they have a fever, or if there is a history of this in the family. 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 Penta.
Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently had any other vaccine.
This vaccine contains neomycin and polymyxin (antibiotics). Please tell your doctor if your child has had an allergic reaction to these ingredients.
Your child will have a total of two or three injections with at least 1 month 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 Penta 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, Infanrix Penta 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 – this may be when they have a fever
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These side effects have happened very rarely with other vaccines against whooping cough. They usually happen within 2 to 3 days after vaccination.
feeling tired
loss of appetite
high temperature of 38°C or higher
swelling, pain and redness where the injection was given
unusual crying
feeling irritable or restless.
diarrhoea
being sick (vomiting)
high temperature of more than 39.5°C
swelling larger than 5 cm or hard lump where the injection was given.
feeling sleepy
cough
itching (dermatitis), rash
large swelling at the injected limb
feeling nervous.
in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination
temporarily stopping breathing (apnoea)
lumpy rash (hives)
swelling of the whole injected limb.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use Infanrix Penta 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
The active substances are:
Diphtheria toxoid1 not less than 30 IU
Tetanus toxoid1 not less than 40 IU
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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
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) 0.2 milligrams Al3+ 4propagated in VERO cells
The other ingredients in Infanrix Penta are: sodium chloride (NaCl), medium 199 containing principally amino acids, mineral salts, vitamins and water for injections.
Infanrix Penta is a white, slightly milky liquid presented in a pre-filled syringe (0.5 ml).
Infanrix Penta is available in packs of 1, 10, 20 and 50 with or 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:
Тел. + 359 2 953 10 34
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
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GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 360448701
GlaxoSmithKline Eesti OÜ Tel: +372 667 6900
GlaxoSmithKline Pharma GmbH. Tel: + 43 1 970 75-0
GlaxoSmithKline A.E.B.E. Tηλ: + 30 210 68 82 100
GSK Commercial Sp. z.o.o. Tel.: + 48 (22) 576 9000
Smith Kline & French Portuguesa, Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44
GlaxoSmithKline (GSK) SRL Tel: +40 (0)21 3028 208
GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 4955000
GlaxoSmithKline S.p.A. Tel:+ 39 04 59 21 81 11
GlaxoSmithKline (Cyprus) Ltd
Τηλ: + 357 22 39 70 00
GlaxoSmithKline Latvia SIA Tel: + 371 67312687
GlaxoSmithKline UK
Tel: + 44 (0)808 100 9997
GlaxoSmithKline Lietuva UAB Tel. +370 5 264 90 00
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Upon storage, a white deposit and clear supernatant can be observed. This does not constitute a sign of deterioration.
The syringe should be well shaken in order to obtain a homogeneous turbid white suspension.
The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) suspension should be inspected visually for any foreign particulate matter and/or variation of physical aspect. In the event of either being observed, discard the container.