Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - hexyon

Document Subject

Generated Narrative: MedicinalProductDefinition mp28f119e7c1f3c5870a82540620a72930

identifier: http://ema.europa.eu/identifier/EU/1/13/829/002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Hexyon suspension for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

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-28f119e7c1f3c5870a82540620a72930

identifier: http://ema.europa.eu/identifier/EU/1/13/829/002

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - hexyon

Attesters

What is in this leaflet

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

Hexyon (DTaP-IPV-HB-Hib) is a vaccine used to protect against infectious diseases.

Hexyon helps to protect against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by Haemophilus influenzae type b. Hexyon is given to children from six weeks of age.

The vaccine works by causing the body to produce its own protection (antibodies) against the bacteria and viruses that cause these different infections:

• Diphtheria is an infectious disease that usually first affects the throat. In the throat, the infection causes pain and swelling that can lead to suffocation. The bacterium that causes the disease also makes a toxin (poison) that can damage the heart, kidneys, and nerves.

• Tetanus (often called lock jaw) is usually caused by the tetanus bacterium entering a deep wound. The bacterium makes a toxin (poison) that causes spasms of the muscles leading to inability to breathe and the possibility of suffocation.

• Pertussis (often called whooping cough) is 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) that may last a long time, lung infections (pneumonia), fits, brain damage, and even death.

• Hepatitis B is caused by the hepatitis B virus. It causes the liver to become swollen (inflamed). In some people, the virus can stay in the body for a long time and can eventually lead to serious liver problems, including liver cancer.

• Poliomyelitis (often just called polio) is caused by viruses that affect the nerves. It can lead to paralysis or muscle weakness most commonly of the legs. Paralysis of the muscles that control breathing and swallowing can be fatal.

• Haemophilus influenzae type b infections (often just called Hib) are serious bacterial infections and can cause meningitis (inflammation of the outer covering of the brain), which can lead to brain damage, deafness, epilepsy, or partial blindness. Infection can also cause inflammation and swelling of the throat leading to difficulties in swallowing and breathing. The infection can affect other parts of the body such as the blood, lungs, skin, bones, and joints. Important information about the protection provided

• Hexyon will only help to prevent these diseases if they are caused by the bacteria or viruses targeted by the vaccine. Your child could get diseases with similar symptoms if they are caused by other bacteria or viruses.

• The vaccine does not contain any live bacteria or viruses and it cannot cause any of the infectious diseases against which it protects.

• This vaccine does not protect against infections caused by other types of Haemophilus influenzae nor against meningitis due to other micro-organisms.

• Hexyon will not protect against hepatitis infection caused by other agents such as hepatitis A, hepatitis C, and hepatitis E.

• Because symptoms of hepatitis B take a long time to develop, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination. The vaccine may not prevent hepatitis B infection in such cases.

• As with any vaccine, Hexyon may not protect 100% of children who receive the vaccine.

To make sure that Hexyon is suitable for your child, it is important to talk to your doctor or nurse if any of the points below apply to your child. If there is anything you do not understand, ask your doctor, pharmacist, or nurse to explain.

Do not use Hexyon if your child:

• has had respiratory disorder or swelling of the face (anaphylactic reaction) after administration of Hexyon.
• has had an allergic reaction

• to the active substances,
• to any of the excipients listed in section 6,
• to glutaraldehyde, formaldehyde, neomycin, streptomycin or polymyxin B, as these substances are used during the manufacturing process.
• after previous administration of Hexyon or any other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib containing vaccines.

• suffered from a severe reaction affecting the brain (encephalopathy) within 7 days of a prior dose of a pertussis vaccine (acellular or whole cell pertussis).
• has an uncontrolled condition or severe illness affecting the brain and nervous system (uncontrolled neurologic disorder), or uncontrolled epilepsy.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before vaccination if your child:

• has a moderate or high temperature or an acute illness (e.g. fever, sore throat, cough, cold, or flu). Vaccination with Hexyon may need to be delayed until your child is better.
• has had any of the following events after receiving a pertussis vaccine, as the decision to give further doses of pertussis containing vaccine will need to be carefully considered:

• fever of 40 C or above within 48 hours of vaccination not due to another identifiable cause.
• collapse or shock-like state with hypotonic-hyporesponsive episode (drop in energy) within 48 hours of vaccination.
• persistent, inconsolable crying lasting 3 hours or more, occurring within 48 hours of vaccination.
• fits (convulsions) with or without fever, occurring within 3 days of vaccination.

• previously had Guillain-Barr syndrome (temporary inflammation of nerves causing pain, paralysis, and sensitivity disorders) or brachial neuritis (severe pain and decreased mobility of arm and shoulder) after being given a vaccine containing tetanus toxoid (an inactivated form of tetanus toxin). In this case, the decision to give any further vaccine containing tetanus toxoid should be evaluated by your doctor.
• is having a treatment that suppresses her/his immune system (the body s natural defenses) or has any disease that causes the weakness of the immune system. In these cases the immune response to the vaccine may be decreased. It is normally recommended to wait until the end of the treatment or disease before vaccinating. However children with long standing problems with their immune system such as HIV infection (AIDS) may still be given Hexyon, but the protection may not be as good as in children whose immune system is healthy.
• suffers from an acute or chronic illness including chronic renal insufficiency or failure (inability of the kidneys to work properly).
• suffers from any undiagnosed illness of the brain or epilepsy that is not controlled. Your doctor will assess the potential benefit offered by vaccination.
• has any problems with the blood that cause easy bruising or bleeding for a long time after minor cuts. Your doctor will advise you whether your child should have Hexyon.

Fainting can occur following, or even before, any needle injection. Therefore, tell your doctor or nurse your child fainted with a previous injection.

Other medicines or vaccines and Hexyon

Tell your doctor or nurse if your child is taking, has recently taken, or might take any other medicines or vaccines. Hexyon can be given at the same time as other vaccines such as pneumococcal vaccines, measles, mumps, rubella vaccines, varicella vaccines, rotavirus vaccines, or meningococcal vaccines. When given at the same time with other vaccines, Hexyon will be given at different injection sites.

Hexyon contains phenylalanine, potassium and sodium

Hexyon contains 85 micrograms phenylalanine in each 0.5-mL 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. Hexyon contains less than 1 mmol potassium (39 mg) and less than 1 mmol sodium (23 mg) per dose, that is to say essentially potassium-free and sodium-free .

Hexyon will be given to your child by a doctor or nurse trained in the use of vaccines and who are equipped to deal with any uncommon severe allergic reaction to the injection (see section 4 Possible side effects). Hexyon is given as an injection into a muscle (intramuscular route IM) in the upper part of your child s leg or upper arm. The vaccine will never be given into a blood vessel or into or under the skin.

The recommended dose is as follows:

First course of vaccination (primary vaccination) Your child will receive either two injections given at an interval of two months, or three injections given at an interval of one to two months (at least four weeks apart). This vaccine should be used according to the local vaccination programme.

Additional injections (booster) After the first course of injections, your child will receive a booster dose, in accordance with local recommendations, at least 6 months after the last dose of the first course. Your doctor will tell you when this dose should be given.

If your child misses a dose of Hexyon

If your child misses a scheduled injection, it is important that you discuss with your doctor or nurse who will decide when to give the missed dose. It is important to follow the instructions from the doctor or nurse so that your child completes the course of injections. If not, your child may not be fully protected against the diseases.

If you have any further questions on the use of this vaccine, ask your doctor, pharmacist, or nurse.

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

Serious allergic reactions (anaphylactic reaction)

If any of these symptoms occur after leaving the place where your child received his/her injection, you must consult a doctor IMMEDIATELY:

• difficulty in breathing
• blueness of the tongue or lips
• a rash
• swelling of the face or throat
• sudden and serious malaise with drop in blood pressure causing dizziness and loss of consciousness, accelerated heart rate associated with respiratory disorders

When these signs or symptoms (signs or symptoms of anaphylactic reaction) occur they usually develop quickly after the injection is given and while the child is still in the clinic or doctor s surgery.

Serious allergic reactions are a rare possibility (may affect up to 1 in 1 000 people) after receiving this vaccine.

Other side effects

If your child experiences any of the following side effects, please tell your doctor, nurse, or pharmacist.

• Very common side effects (may affect more than 1 in 10 people) are:

• loss of appetite (anorexia)
• crying
• sleepiness (somnolence)
• vomiting
• fever (temperature 38 C or higher)
• irritability
• pain, redness, or swelling at the injection site

• Common side effects (may affect up to 1 in 10 people) are:

• abnormal crying (prolonged crying)
• diarrhoea
• injection site hardness (induration)

• Uncommon side effects (may affect up to 1 in 100 people) are:

• allergic reaction
• high fever (temperature 39.6 C or higher)
• lump (nodule) at the injection site

• Rare side effects (may affect up to 1 in 1 000 people) are:

• rash
• large reactions at the injection site (larger than 5 cm), including extensive limb swelling from the injection site beyond one or both joints. These reactions start within 24-72 hours after vaccination, may be associated with redness, warmth, tenderness, or pain at the injection site, and get better within 3-5 days without the need for treatment.
• fits (convulsions) with or without fever.

• Very rare side effects (may affect up to 1 in 10 000 people) are:

• episodes when your child goes into a shock-like state or is pale, floppy and unresponsive for a period of time (hypotonic reactions or hypotonic hyporesponsive episodes HHE).

Potential side effects

Other side effects not listed above have been reported occasionally with other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib-containing vaccines and not directly with Hexyon:

• Temporary inflammation of nerves causing pain, paralysis and sensitivity disorders (Guillain- Barr syndrome), and severe pain and decreased mobility of arm and shoulder (brachial neuritis) have been reported after administration of a tetanus containing vaccine.
• Inflammation of several nerves causing sensory disorders or weakness of limbs (polyradiculoneuritis), facial paralysis, visual disturbances, sudden dimming or loss of vision (optic neuritis), inflammatory disease of brain and spinal cord (central nervous system demyelination, multiple sclerosis) have been reported after administration of a hepatitis B antigen containing vaccine.
• Swelling or inflammation of the brain (encephalopathy/encephalitis).
• 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.
• Swelling of one or both feet and lower limbs which may occur along with bluish discoloration of the skin (cyanosis), redness, small areas of bleeding under the skin (transient purpura), and severe crying following vaccination with Haemophilus influenzae type b containing vaccines. If this reaction occurs, it is mainly after first injections and within the first few hours following vaccination. All symptoms should disappear completely within 24 hours without need for treatment.

Reporting of side effects

If your child gets any side effects, talk to your doctor, pharmacist, or nurse. 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 and the label after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C 8 C). Do not freeze. Keep the vaccine in the outer carton in order to protect it from the light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What Hexyon contains

The active substances are per dose (0.5 mL)1: Diphtheria Toxoid not less than 20 IU2,4 (30 Lf) Tetanus Toxoid not less than 40 IU3,4 (10 Lf) Bordetella pertussis antigens Pertussis Toxoid 25 micrograms

Filamentous Haemagglutinin 25 micrograms Poliovirus (Inactivated)5

Type 1 (Mahoney) 29 D-antigen units6

Type 2 (MEF-1) 7 D-antigen units6

Type 3 (Saukett) 26 D-antigen units6 Hepatitis B surface antigen7 10 micrograms Haemophilus influenzae type b polysaccharide 12 micrograms (Polyribosylribitol Phosphate)

conjugated to Tetanus protein 22-36 micrograms

1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 2 As lower confidence limit (p= 0.95) and not less than 30 IU as mean value 3 As lower confidence limit (p= 0.95) 4 Or equivalent activity determined by an immunogenicity evaluation 5 Cultivated on Vero cells 6 These antigen quantities are strictly the same as those previously expressed as 40-8-32 D-antigen units, for virus type 1, 2 and 3 respectively, when measured by another suitable immunochemical method 7 Produced in yeast Hansenula polymorpha cells by recombinant DNA technology

The other ingredients are: Disodium hydrogen phosphate, potassium dihydrogen phosphate, trometamol, sucrose, essential amino acids including L-phenylalanine, sodium hydroxide and/or acetic acid and/or hydrochloric acid (for pH adjustment), and water for injections.

The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin, and polymyxin B.

What Hexyon looks like and contents of the pack

Hexyon is provided as a suspension for injection in pre-filled syringe (0.5 mL). Hexyon is available in pack containing 1,10 or 50 pre-filled syringes, without attached needle. Hexyon is available in pack containing 1 or 10 pre-filled syringes, with 1 separate needle. Hexyon is available in pack containing 1 or 10 pre-filled syringes, with 2 separate needles. Hexyon is available in multipack comprising 5 cartons, each containing 10 pre-filled syringes, without attached needle.

Not all pack sizes may be marketed.

After shaking, the normal appearance of the vaccine is a whitish cloudy suspension.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sanofi Pasteur Europe, 14 Espace Henry Vall e, 69007 Lyon, France

Manufacturer: Sanofi Pasteur, 1541 avenue Marcel M rieux, 69280 Marcy l'Etoile, France

Sanofi Pasteur, Parc Industriel d'Incarville, 27100 Val de Reuil, France

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

Belgi / Belgique /Belgien Sanofi Belgium Tel: +32 2 710.54.Lietuva Swixx Biopharma UAB Tel: +370 5 236 91
Swixx Biopharma EOOD
Te .: +359 2 4942 Luxembourg/Luxemburg Sanofi Belgium Tel: +32 2 710.54. esk republika sanofi-aventis, s.r.o. Tel: +420 233 086 Magyarorsz g SANOFI-AVENTIS Zrt Tel: +36 1 505 0Danmark Sanofi A/S Tel: +45 4516 7Malta Sanofi S.r.l. Tel: +39 02 39394 Deutschland Sanofi-Aventis Deutschland GmbH Tel: 0800 54 54 Tel. aus dem Ausland: +49 69 305 21 Nederland Sanofi B.V.
Tel: +31 20 245 4Eesti Swixx Biopharma O
Tel: +372 640 10 Norge Sanofi-aventis Norge AS Tel: + 47 67 10 71
. . : +30.210.8009 sterreich Sanofi-Aventis GmbH Tel: +43 (1) 80185-0

Espa a sanofi-aventis, S.A.
Tel: +34 93 485 94 Polska Sanofi Pasteur Sp. z o. o. Tel: +48 22 280 00 France Sanofi Pasteur Europe Tel: 0800 42 43 Appel depuis l tranger : +33 1 57 63 67 Portugal Sanofi Produtos Farmac uticos, Lda. Tel: + 351 21 35 89 Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 Rom nia Sanofi Romania SRL Tel: +40 21 317 31 Ireland sanofi-aventis Ireland T/A SANOFI Tel: + 353 (0) 1 4035 Slovenija Swixx Biopharma d.o.o Tel: +386 235 51 sland Vistor Tel: +354 535 7Slovensk republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 Italia Sanofi S.r.l. Tel: 800536Suomi/Finland Sanofi Oy Tel: +358 (0) 201 200
C.A. Papaellinas Ltd. .: +357 22 741Sverige Sanofi AB Tel: +46 8-634 50 Latvija Swixx Biopharma SIA
Tel: +371 6 6164 United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2This leaflet was last revised in {MM/YYYY}

Other sources of information

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