Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - infanrix

Document Subject

Generated Narrative: MedicinalProductDefinition mp9e9af0d61ae4c0f16f1d8deb4eb5766d

identifier: http://ema.europa.eu/identifier/EU/1/00/152/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Infanrix hexa, Powder and suspension for suspension for injection.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-9e9af0d61ae4c0f16f1d8deb4eb5766d

identifier: http://ema.europa.eu/identifier/EU/1/00/152/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - infanrix

Attesters

What is in this leaflet

1. What Infanrix hexa is and what it is used for
2. What you need to know before your child receives 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

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

Diphtheria: a serious bacterial infection that mainly affects the airways and sometimes the skin. 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.

Tetanus: tetanus bacteria enter the body through cuts, scratches or wounds in the skin. Wounds that are more likely to get tetanus infection are burns, fractures, deep wounds or wounds that have soil, dust, horse manure or wood splinters in them. The bacteria release a poison. This can cause muscle stiffness, painful muscle spasms, fits and even death. The muscle spasms can be strong enough to cause bone fractures of the spine.

Whooping cough (Pertussis): a highly infectious illness that affects the airways. It causes severe coughing that may lead to problems with breathing. The coughing often has a whooping sound. The cough may last for one to two months or longer. Whooping cough can also cause ear infections, chest infections (bronchitis) which may last a long time, lung infections (pneumonia), fits, brain damage and even death.

Hepatitis B: is caused by the hepatitis B virus. It makes the liver swollen. The virus is found in body fluids such as in the vagina, blood, semen or spit (saliva) of infected people.

Polio: a viral infection. Polio is often only a mild illness. However, sometimes it can be very serious and cause permanent damage or even death. Polio can make the muscles unable to move (paralysis). This includes the muscles needed for breathing and walking. The arms or legs affected by the disease may be painfully twisted (deformed).

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.

How Infanrix hexa works 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.

Infanrix hexa should not be given

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.

Warnings and precautions

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.

Other medicines and 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.

Infanrix hexa contains neomycin, polymyxin, para-aminobenzoic acid, phenylalanine, sodium and potassium 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 .

How much is given 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.

How the vaccine is given 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 a dose If your child misses an injection which is due, it is important that you make another appointment. Make sure your child finishes the complete vaccination course. If not, your child may not be fully protected against the diseases.

Like all medicines, this vaccine can cause side effects, although not everybody gets them. The following side effects may happen with this vaccine:

Allergic reactions 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.

See your doctor straight away if your child has any of the following serious side effects:

• 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.

Other side effects include:

Very common (these may occur with more than 1 in 10 doses of the vaccine): sleepiness, loss of appetite, high temperature of 38 C or higher, swelling, pain, redness where the injection was given, unusual crying, feeling irritable or restless.

Common (these may occur with up to 1 in 10 doses of the vaccine): 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 nervous.

Uncommon (these may occur with up to 1 in 100 doses of the vaccine): upper respiratory tract infection, tiredness, cough, large swelling at the injected limb.

Rare (these may occur with up to 1 in 1,000 doses of the vaccine): bronchitis, rash, swollen glands in the neck, armpit or groin (lymphadenopathy), bleeding or bruising more easily than normal (thrombocytopenia), 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), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), swelling of the whole injected limb, blisters.

Very rare (these may happen with up to 1 in 10,000 doses of the 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 the arms and legs (neuropathy), inflammation of some nerves, possibly with pins and needles or loss of feeling or normal movement (Guillain-Barr 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.

Reporting of side effects

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.

What Infanrix hexa contains

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

What Infanrix hexa looks like and contents of the pack

• 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 1-dose vial + pre-filled syringe, pack sizes of 1 and 10 with or without separate needles, and a multipack of 5 packs, each containing 10 vials (1-dose) and 10 pre-filled syringes (1-dose), without separate needles.
• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Biologicals s.a. Rue de l Institut B-1330 Rixensart Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien GlaxoSmithKline Pharmaceuticals SA/NV T l/Tel: + 32 10 85 52 Lietuva GlaxoSmithKline Biologicals SA Tel: +370 80000
GlaxoSmithKline Biologicals SA .: +359 80018Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals SA/NV T l/Tel: + 32 10 85 52 esk republika GlaxoSmithKline s.r.o. Tel: + 420 2 22 00 11 cz.info@gsk.com

Magyarorsz g GlaxoSmithKline Biologicals SA Tel.: +36 80088Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com Malta GlaxoSmithKline Biologicals SA Tel: +356 80065Deutschland GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 360448produkt.info@gsk.com

Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081Eesti GlaxoSmithKline Biologicals SA
Tel: +372 8002
GlaxoSmithKline A.E.B.E. T : + 30 210 68 82 Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com

Espa a GlaxoSmithKline, S.A. Tel: + 34 900 202 es-ci@gsk.com

Polska GSK Services Sp. z o.o. Tel.: + 48 (22) 576 9France Laboratoire GlaxoSmithKline T l: + 33 (0) 1 39 17 84 diam@gsk.com

Portugal Smith Kline & French Portuguesa - Produtos Farmac uticos, Lda. Tel: + 351 21 412 95 FI.PT@gsk.com

Hrvatska GlaxoSmithKline Biologicals SA Tel: +385 800787Rom nia GlaxoSmithKline Biologicals SA Tel: +40 800672Ireland GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 495 5Slovenija GlaxoSmithKline Biologicals SA Tel: +386 80688 sland Vistor hf.
S mi: +354 535 7Slovensk republika GlaxoSmithKline Biologicals SA. Tel: +421 800500Italia GlaxoSmithKline S.p.A. Tel:+ 39 (0)45 7741 Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30
GlaxoSmithKline Biologicals SA : +357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 info.produkt@gsk.com Latvija GlaxoSmithKline Biologicals SA Tel: +371 80205United Kingdom (Northern Ireland) GlaxoSmithKline Biologicals SA Tel: +44(0)800 221customercontactuk@gsk.com

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: