Hexacima

Package leaflet: Information for the user

Hexacima injectable suspension in pre-filled syringe

Conjugate vaccine (adsorbed) against diphtheria, tetanus, pertussis (acellular component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b
Please read 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, pharmacist or healthcare professional.
• If the child experiences any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist or healthcare professional. See section 4.

Contents of this leaflet:

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

1. What Hexacima is and what it is used for

Hexacima (DTaP-HB-IPV-Hib) is a vaccine used to protect against infectious diseases.
Hexacima helps protect children against diphtheria (D), tetanus (T), pertussis (aP), hepatitis B (HB), poliomyelitis (IPV), and serious diseases caused by Haemophilus influenzae type b (Hib).
Hexacima is administered to children from the age of six weeks.
The vaccine works by stimulating the body to produce antibodies against the bacteria and viruses that cause the following infections:

• Diphtheria is an infectious disease that usually initially affects the throat, causing pain and swelling that may lead to suffocation. The bacteria responsible for the disease also produce a toxin (poison) that can damage the heart, kidneys, and nerves.
• Tetanus (often described as "lockjaw") is usually caused by bacteria entering a deep wound. The bacteria produce a toxin (poison) that causes muscle contractions, leading to breathing difficulties and possible suffocation.
• Pertussis (often called whooping cough) is a highly contagious disease affecting the airways. The bacterium causes severe coughing that may lead to breathing problems. The cough is often characterized by a typical "whoop" sound and can last for one or two months, or longer. Pertussis may also cause ear infections, bronchial infections (bronchitis) that can persist for a long time, lung infections (pneumonia), seizures, brain damage, and even death.
• Hepatitis B is caused by the hepatitis B virus, which causes swelling of the liver (inflammation). In some people, the virus can remain in the body for a long time and may eventually lead to serious liver problems, including liver cancer.
• Poliomyelitis (often simply called polio) is caused by viruses that affect the nerves. It can lead to paralysis or muscle weakness, most often in the legs. Paralysis of the muscles controlling breathing and swallowing can result in death.
• Infections caused by Haemophilus influenzae type b (often simply called Hib) are serious bacterial infections that can cause meningitis (inflammation of the outer covering of the brain), which may lead to brain damage, deafness, epilepsy, or partial blindness. The infection can also cause inflammation and swelling of the throat, leading to difficulty in swallowing and breathing. The infection may also affect other parts of the body such as the blood, lungs, skin, bones, and joints.

Important information regarding protection provided

• Hexacima helps prevent only those diseases caused by the specific bacteria or viruses targeted by the vaccine. The child may still contract diseases with similar symptoms if caused by other bacteria or viruses.
• The vaccine does not contain live bacteria or viruses and cannot cause any of the infectious diseases it protects against.
• The vaccine does not protect against infections caused by other types of Haemophilus influenzae or meningitis caused by other microorganisms.
• Hexacima does not protect against liver infections caused by other agents such as hepatitis A, C, or E.
• Since the symptoms of hepatitis B take a long time to develop, it is possible that unrecognized hepatitis B infections may already be present at the time of vaccination. In such cases, the vaccine may not protect against hepatitis B.
• Like any other vaccine, Hexacima may not protect 100% of children who receive it.

2. What you should know before Hexacima is administered to the child

To ensure that Hexacima is suitable for the child, it is important that you inform the doctor or
healthcare professional if any of the following apply. If there is anything you do not
understand, please ask the doctor, pharmacist, or healthcare professional for clarification.
Hexacima must not be administered if the child:

• has had breathing difficulties or facial swelling (anaphylactic reaction) after receiving Hexacima
• 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 vaccine manufacturing process
  • following administration of Hexacima or any other vaccine containing diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib
• has suffered a severe reaction affecting the brain (encephalopathy) within 7 days after a previous dose of a pertussis-containing vaccine (acellular or whole-cell pertussis)
• currently has an uncontrolled disorder or serious illness affecting the brain (uncontrolled neurological disorder) or uncontrolled epilepsy.

Warnings and precautions
Before vaccination, inform the doctor, pharmacist, or healthcare professional if the child:

• has a moderate or high fever or an acute illness (e.g., fever, sore throat, cough, cold, or influenza). Administration of Hexacima may need to be postponed until the child has recovered.
• has experienced any of the following events after receiving a pertussis-containing vaccine. In such cases, the decision to administer further doses of pertussis-containing vaccine should be carefully considered:
  • fever of 40°C or higher within 48 hours after vaccination, not due to another identifiable cause;
  • collapse or shock-like state with episodes of hypotonia-hyporesponsiveness (reduced muscle tone) within 48 hours after vaccination;
  • persistent, inconsolable crying lasting 3 hours or more, within 48 hours after vaccination;
  • seizures with or without fever, within 3 days after vaccination.
  • previously had Guillain-Barré syndrome (temporary inflammation of nerves causing pain, paralysis, and sensory disturbances) or brachial neuritis (severe pain and reduced mobility of the arm and shoulder) after receiving a vaccine containing tetanus toxoid (an inactivated form of the tetanus toxin). In such cases, the decision to administer any further vaccine containing tetanus toxoid should be evaluated by the doctor.
  • is receiving treatment that suppresses the body's natural immune defenses or has a disease that weakens the immune system. In these cases, the immune response to the vaccine may be reduced. Vaccination is generally recommended to be delayed until after completion of treatment or recovery from illness. However, children with chronic immune system disorders, such as HIV infection (AIDS), may still receive Hexacima, although the protection provided may not be as effective as in children with a healthy immune system.
  • has any chronic or acute illness such as chronic renal failure (kidneys unable to function properly).
  • has any undiagnosed brain disorder or uncontrolled epilepsy. The doctor will assess the potential benefit of vaccination.
  • has any blood disorder causing easy bruising or prolonged bleeding after minor cuts. The doctor will advise whether the child can receive Hexacima.

Fainting may occur after or even before any injection with a needle. Therefore, inform the
doctor or nurse if the child has previously fainted after an injection.
Other medicines, vaccines, and Hexacima
Inform the doctor or healthcare professional if the child is taking, has recently taken, or
might take any other medicines or vaccines.
Hexacima may be administered simultaneously with other vaccines such as pneumococcal
vaccines, measles-mumps-rubella vaccines, varicella vaccines, rotavirus vaccines, or meningococcal
vaccines.
If administered at the same time as other vaccines, Hexacima will be given at separate injection sites.
Hexacima contains phenylalanine, potassium, and sodium
Hexacima contains 85 micrograms of phenylalanine in each 0.5-mL dose. Phenylalanine may
be harmful for individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
Hexacima contains less than 1 mmol of potassium (39 mg) and less than 1 mmol of sodium (23 mg) per dose,
i.e., essentially "potassium-free" and "sodium-free".

3. How Hexacima is administered

Hexacima will be administered to the child by a doctor or a healthcare professional trained appropriately in the use of vaccines and equipped to manage any uncommon severe allergic reactions (see section 4 Possible side effects).
Hexacima is administered by injection into a muscle (intramuscular route, IM) in the upper part of the child's leg or arm. The vaccine will never be injected into a blood vessel, the skin, or under the skin.
The recommended dose is as follows:
Primary vaccination cycle (primary immunization)
The child will receive two injections given two months apart, or three injections given one or two months apart (at least four weeks apart). This vaccine should be used in accordance with the local vaccination schedule.
Subsequent injections (booster)
After the primary vaccination cycle, the child will receive a booster dose, in accordance with local recommendations, at least 6 months after the last dose of the primary cycle. The doctor will inform you when this dose should be administered.
If the child has not received a dose of Hexacima
If the child has missed a scheduled injection, it is important to inform the doctor or healthcare professional, who will decide when it should be administered.
It is important to follow the instructions of the doctor or healthcare professional so that the child completes the entire vaccination cycle. Otherwise, the child may not be fully protected against the diseases prevented by Hexacima.
If you have further questions about the use of this vaccine, consult your doctor, pharmacist, or healthcare professional.

4. Possible side effects

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

Severe allergic reactions (anaphylactic reaction)
If any of the following symptoms occur after leaving the place (e.g. hospital, clinic) where the child received the vaccine, seek IMMEDIATE medical attention:

• difficulty breathing
• blue tongue or lips
• skin rash
• swelling of the face or throat
• sudden and severe feeling of being unwell with low blood pressure causing dizziness and loss of consciousness, associated with breathing difficulties and rapid heartbeat.

When signs or symptoms of anaphylactic reaction occur, they usually appear immediately after the injection while the child is still in the hospital or clinic.
Severe allergic reactions are rare (may affect up to 1 in 1,000 children) following administration of this vaccine.

Other side effects
If the child experiences any of the following side effects, inform your doctor, healthcare professional or pharmacist.

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

  • loss of appetite
  • crying
  • sleepiness

• vomiting

• fever (temperature of 38°C or higher)

• irritability

• pain, redness or swelling at the injection site

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

  • prolonged or unusual crying
  • diarrhoea
  • hardening at the injection site

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

  • allergic reactions
  • high fever (temperature of 39.6°C or higher)
  • nodule at the injection site

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

  • skin rash
  • extensive local reactions at the injection site (more than 5 cm), including extensive swelling of the limb from the injection site extending beyond one or both joints. These reactions occur within 24–72 hours after vaccination, may be associated with redness, warmth, excessive tenderness or pain at the injection site, and resolve within 3–5 days without treatment.
  • seizures with or without fever

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

  • episodes resembling shock or pallor, muscle weakness and reduced responsiveness for a period of time (hypotonic-hyporesponsive episodes, HHE).

Potential side effects
Other side effects not listed above have been reported occasionally with the use of other vaccines containing diphtheria, pertussis, poliomyelitis, hepatitis B or Hib, but not directly with Hexacima:

• Temporary inflammation of nerves causing pain, paralysis and sensory abnormalities (Guillain-Barré syndrome), severe pain and reduced mobility of the arm and shoulder (brachial neuritis) have been reported following administration of tetanus-containing vaccines.
• Inflammation of certain nerves causing sensory disturbances or limb weakness (polyradiculoneuritis), facial paralysis, visual disturbances, diminished or loss of vision (optic neuritis), inflammatory disease of the brain and spinal cord (demyelination of the central nervous system, multiple sclerosis) have been reported following administration of vaccines containing hepatitis B antigen.
• Swelling or inflammation of the brain (encephalopathy/encephalitis).
• In very premature infants (born at 28 weeks of gestation or earlier), prolonged episodes of breathing interruptions may occur, appearing for 2–3 days after vaccination.
• Swelling of one or both feet and lower limbs. This reaction may occur together with bluish skin colouring (cyanosis), redness, small areas of bleeding under the skin (transient purpura) and severe crying following vaccination with Haemophilus influenzae type b-containing vaccines. If these reactions occur, they usually follow the first injections and appear within the first few hours after vaccination. All symptoms should completely resolve within 24 hours without requiring treatment.

Reporting of side effects
If the child experiences any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or healthcare professional. You can also report side effects directly via the national 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 Hexacima

Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the carton and label following
EXP. The expiry date refers to the last day of the month.
Store in a refrigerator (between 2°C and 8°C).
Do not freeze.
Keep the vaccine in its carton to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Hexacima contains
The active substances are, per dose (0.5 mL):
Diphtheria toxoid not less than 20 IU (30 Lf)
Tetanus toxoid not less than 40 IU (10 Lf)
Bordetella pertussis antigens
Pertussis toxoid 25 micrograms
Filamentous haemagglutinin 25 micrograms
Inactivated poliovirus
Type 1 (Mahoney) 29 antigen D units
Type 2 (MEF-1) 7 antigen D units
Type 3 (Saukett) 26 antigen D units
Hepatitis B surface antigen 10 micrograms
Haemophilus influenzae type b polysaccharide 12 micrograms
(polyribosylribitol phosphate)
conjugated to tetanus protein 22-36 micrograms
Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al)
As the lower limit of the confidence interval (p = 0.95) and not less than 30 IU as mean value
As the lower limit of the confidence interval (p = 0.95)
Or equivalent activity determined by immunogenicity assessment
Grown on Vero cells
These antigen quantities are strictly the same as those previously expressed as 40-8-32 antigen D units,
respectively for type 1, 2 and 3 viruses, when measured with another suitable immunochemical method
Produced in Hansenula polymorpha yeast cells by recombinant DNA technology

The other components are:
Disodium phosphate, monopotassium 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.

Description of the appearance of Hexacima and contents of the pack
Hexacima is supplied as an injectable suspension in a pre-filled syringe (0.5 mL).
Hexacima is available in packs of 1 or 10 pre-filled syringes without attached needle.
Hexacima is available in packs of 1 or 10 pre-filled syringes with one separate needle.
Hexacima is available in packs of 1 or 10 pre-filled syringes with two separate needles.
Hexacima is available in packs of 1 or 10 pre-filled syringes with one separate safety needle.
Not all pack sizes may be marketed.
After shaking the pre-filled syringe, the vaccine normally appears as a homogeneous, whitish, turbid suspension.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi Winthrop Industrie, 82 Avenue Raspail, 94250 Gentilly, France

Manufacturers
Sanofi Pasteur, 1541 avenue Marcel Mérieux, 69280 Marcy l’Etoile, France
Sanofi Pasteur, Parc Industriel d’Incarville, 27100 Val de Reuil, France

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.
The latest approved information on this vaccine is available at the following URL:
https://hexacima.info.sanofi or by scanning the QR code with a smartphone:
insert QR code

The following information is intended exclusively for healthcare professionals:

• Shake the pre-filled syringe to make the contents homogeneous.
• Do not mix Hexacima with other medicinal products.
• Hexacima must be administered by intramuscular injection. The recommended injection site is preferably the anterolateral thigh area, or the deltoid muscle in older children (preferably from 15 months of age). Do not administer intradermally or intravenously. Do not administer by intravascular injection: ensure that the needle has not penetrated a blood vessel.
• Do not use the pre-filled syringes if the packaging is damaged.

Preparation for administration
The syringe containing the injectable suspension must be inspected visually before administration. Discard the pre-filled syringe if foreign particles, leakage, premature plunger activation, or a defective tip seal are observed.
The syringe is for single use only and must not be reused.
Instructions for use of the Luer Lock pre-filled syringe
Figure A: Luer Lock syringe with rigid tip cap

Step 1: Holding the Luer Lock adapter in one hand (avoid touching the plunger or the syringe barrel), unscrew the tip cap by rotating it.
Step 2: To attach the needle to the syringe, gently rotate the needle into the syringe's Luer Lock adapter until slight resistance is felt.

Instructions for use of the safety needle with pre-filled syringe with Luer Lock
Figure B: Safety needle Figure C: Components of the safety needle (prepared for use)
(inside the protective case)

Follow steps 1 and 2 above to prepare the Luer Lock syringe and the needle for connection.
Step 3: Remove the safety needle from the
protective case. The needle is covered by the
safety shield and the needle cap.

Step 4:
A: Remove the safety shield from the needle
and align it toward the syringe barrel at the
angle shown.
B: Remove the needle cap.
Step 5: After completing the injection, lock

(activate) the safety shield using one of the three (3)
illustrated one-handed activation techniques:
surface, thumb, or fingers.
Note: Activation is confirmed by an audible and/or
tactile "click".
Step 6: Visually inspect

the activation of the safety shield. The safety
shield must be fully locked (activated) as shown
in Image C.
Note: When fully locked (activated), the needle
should be at an angle relative to the safety shield.

Image D shows that the safety shield is NOT fully locked (not activated).
Warning: Do not attempt to unlock (deactivate) the safety device by forcing the needle out of the safety shield.
Unused medicine and waste material must be disposed of in accordance with local regulations.

Package leaflet: information for the user

Hexacima injectable suspension

Conjugate vaccine (adsorbed) against diphtheria, tetanus, pertussis (acellular component), hepatitis B (recombinant DNA), poliomyelitis (inactivated) and Haemophilus influenzae type b
Please read this leaflet carefully before the child is vaccinated, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist or healthcare professional.
• If the child experiences any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist or healthcare professional. See section 4.

Contents of this leaflet:

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

1. What Hexacima is and what it is used for

Hexacima (DTaP-HB-IPV-Hib) is a vaccine used to protect against infectious diseases.
Hexacima helps protect children from diphtheria (D), tetanus (T), pertussis (aP), hepatitis B (HB), poliomyelitis (IPV), and serious diseases caused by Haemophilus influenzae type b (Hib).
Hexacima is administered to children starting from the age of six weeks.
The vaccine works by stimulating the body to produce antibodies against the bacteria and viruses that cause the following infections:

• Diphtheria is an infectious disease that usually begins by affecting the throat, causing pain and swelling that may lead to suffocation. The bacteria responsible for the disease also produce a toxin (poison) that can damage the heart, kidneys, and nerves.
• Tetanus (often described as "lockjaw") is usually caused by bacteria entering a deep wound. The bacteria produce a toxin (poison) that causes muscle contractions, leading to breathing difficulties and possible suffocation.
• Pertussis (often called whooping cough) is a highly contagious disease affecting the airways. The pertussis bacterium causes severe coughing that may lead to breathing problems. The cough is often characterized by a typical "whoop" sound and can last for one or two months, or even longer. Pertussis may also cause ear infections, bronchial infections (bronchitis) that can persist for a long time, lung infections (pneumonia), seizures, brain damage, and even death.
• Hepatitis B is caused by the hepatitis B virus, which leads to swelling of the liver (inflammation). In some people, the virus may remain in the body for a long time and may eventually lead to serious liver problems, including liver cancer.
• Poliomyelitis (often simply called polio) is caused by viruses that affect the nerves. It may lead to paralysis or muscle weakness, most commonly in the legs. Paralysis of the muscles controlling breathing and swallowing can result in death.
• Infections caused by Haemophilus influenzae type b (often simply called Hib) are serious bacterial infections and may cause meningitis (inflammation of the outer covering of the brain), which can lead to brain damage, deafness, epilepsy, or partial blindness. The infection may also cause inflammation and swelling of the throat, leading to difficulty in

swallowing and breathing, and the infection can affect other parts of the body such as the blood,
lungs, skin, bones, and joints.

Important information about protection provided

• Hexacima helps prevent only those diseases caused by the specific bacteria or viruses targeted by the vaccine. The child may still contract diseases with similar symptoms if caused by other bacteria or viruses.
• The vaccine does not contain live bacteria or viruses and cannot cause any of the infectious diseases it protects against.
• The vaccine does not protect against infections due to other types of Haemophilus influenzae or meningitis caused by other microorganisms.
• Hexacima does not protect against liver infections caused by other agents such as hepatitis A, C, and E.
• Since symptoms of hepatitis B take a long time to develop, unrecognized hepatitis B infections may already be present at the time of vaccination. In such cases, the vaccine may not protect against hepatitis B.
• As with any other vaccine, Hexacima may not protect 100% of children who receive it.

2. What you should know before Hexacima is given to the child

To ensure that Hexacima is suitable for the child, it is important that you inform the doctor or
healthcare professional if any of the following apply. If there is anything you do not
understand, ask your doctor, pharmacist or healthcare professional for clarification.
Hexacima must not be administered if the child:

• has had breathing difficulties or facial swelling (anaphylactic reaction) after receiving Hexacima
• 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 vaccine manufacturing process
  • following administration of Hexacima or any other vaccine containing diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib
• has suffered a severe reaction affecting the brain (encephalopathy) within 7 days of a previous dose of a pertussis-containing vaccine (acellular or whole-cell pertussis)
• has an uncontrolled disorder or serious illness affecting the brain (uncontrolled neurological disorder) or uncontrolled epilepsy.

Warnings and precautions
Before vaccination, inform the doctor, pharmacist or healthcare professional if the child:

• has a moderate or high fever or has an acute illness (e.g. fever, sore throat, cough, cold or flu). Vaccination with Hexacima may need to be postponed until the child has recovered.
• has experienced any of the following events after receiving a pertussis vaccine. In such cases, the decision to administer further doses of pertussis-containing vaccine should be carefully considered:
  • fever of 40°C or higher within 48 hours of vaccination not due to another identifiable cause;
  • collapse or shock-like state with episodes of hypotonia-hyporesponsiveness (decreased muscle tone) within 48 hours of vaccination;
• persistent, inconsolable crying lasting 3 hours or more, within 48 hours of vaccination;
• seizures with or without fever, within 3 days of vaccination.
  • has previously had Guillain-Barré syndrome (temporary inflammation of nerves causing pain, paralysis and altered sensation) or brachial neuritis (severe pain and reduced mobility of the arm and shoulder) after receiving a vaccine containing tetanus toxoid (an inactivated form of the tetanus toxin). In such cases, the decision to administer any further vaccine containing tetanus toxoid should be evaluated by the doctor.
  • is receiving treatment that suppresses the body's natural immune defenses or has a disease that weakens the immune system. In these cases, the immune response to the vaccine may be reduced. It is generally recommended to wait until the end of treatment or recovery from the illness before proceeding with vaccination. However, children with long-term immune system problems, such as HIV infection (AIDS), may still receive Hexacima, although the protection may not be as good as in children with a healthy immune system.
  • has any chronic or acute illness such as chronic renal failure (inability of the kidneys to function properly).
  • has any undiagnosed brain disorder or uncontrolled epilepsy. The doctor will assess the potential benefit of vaccination.
  • has any blood disorder causing easy bruising or prolonged bleeding after minor cuts. The doctor will advise whether the child can receive Hexacima.

Fainting may occur after or even before any injection with a needle. Therefore, inform the
doctor or nurse if the child has previously fainted after an injection.
Other medicines, vaccines and Hexacima
Inform the doctor or healthcare professional if the child is taking, has recently taken, or
might take any other medicines or vaccines.
Hexacima may be administered simultaneously with other vaccines such as pneumococcal
vaccines, measles-mumps-rubella vaccines, varicella vaccines, rotavirus vaccines or
meningococcal vaccines.
If administered simultaneously with other vaccines, Hexacima will be given at separate
injection sites.
Hexacima contains phenylalanine, potassium and sodium
Hexacima contains 85 micrograms of phenylalanine in each 0.5-mL dose. Phenylalanine may
be harmful for individuals with phenylketonuria (PKU), a rare genetic disorder in which
phenylalanine accumulates because the body cannot eliminate it properly.
Hexacima contains less than 1 mmol of potassium (39 mg) and less than 1 mmol of sodium (23 mg) per dose,
i.e. essentially "potassium-free" and "sodium-free".

3. How Hexacima is administered

Hexacima will be administered to the child by a doctor or a healthcare professional trained appropriately in the use of vaccines and equipped to manage any uncommon severe allergic reactions (see section 4 Possible side effects).
Hexacima is given by injection into a muscle (intramuscular route, IM) in the upper part of the child’s leg or arm. The vaccine will never be injected into a blood vessel, into the skin, or under the skin.
The recommended dose is as follows:
Primary vaccination cycle (primary vaccination)
The child will receive two injections given two months apart, or three injections given one or two months apart (at least four weeks apart). This vaccine should be used in accordance with the local vaccination schedule.
Subsequent injections (booster)
After the primary vaccination cycle, the child will receive a booster dose, in accordance with local recommendations, at least 6 months after the last dose of the primary cycle. Your doctor will inform you when this dose should be administered.
If the child has not received a dose of Hexacima
If the child has missed a scheduled injection, it is important to inform the doctor or healthcare professional, who will decide when it should be administered.
It is important to follow the instructions of the doctor or healthcare professional so that the child completes the entire vaccination course. Otherwise, the child may not be fully protected against the diseases prevented by Hexacima.
If you have further questions about the use of this vaccine, consult your doctor, pharmacist, or healthcare professional.

4. Possible side effects

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

Serious allergic reactions (anaphylactic reaction)
If any of the following symptoms occur after leaving the place (e.g. hospital, clinic) where the child was vaccinated, seek IMMEDIATE medical help:

• difficulty in breathing
• blue-coloured tongue or lips
• skin rash
• swelling of the face or throat
• sudden and severe feeling of illness with low blood pressure causing dizziness and loss of consciousness, accompanied by breathing difficulties and rapid heartbeat.

When these signs or symptoms of anaphylactic reaction occur, they usually appear immediately after the injection, while the child is still in the hospital or clinic.
Serious allergic reactions are rare (may affect up to 1 in 1,000 children) following administration of this vaccine.

Other side effects
If the child experiences any of the following side effects, inform your doctor, healthcare professional, or pharmacist.

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

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

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

  • unusual (prolonged) crying
  • diarrhoea
  • hardening at the injection site

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

  • allergic reactions
  • high fever (temperature of 39.6°C or higher)
  • nodule at the injection site

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

  • skin rash
  • extensive local reactions at the injection site (more than 5 cm), including extensive swelling of the limb from the injection site extending beyond one or both joints. These reactions occur within 24–72 hours after vaccination, may be associated with redness, warmth, excessive tenderness or pain at the injection site, and improve within 3–5 days without the need for treatment.
  • seizures with or without fever.

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

  • episodes resembling shock or pallor, muscle weakness and reduced responsiveness for a period of time (hypotonic-hyporesponsive episodes, HHE).

Potential side effects
Other side effects not listed above have been reported occasionally with the use of other vaccines containing diphtheria, pertussis, poliomyelitis, hepatitis B or Hib, but not directly with Hexacima:

• Temporary inflammation of nerves causing pain, paralysis and sensory disturbances (Guillain-Barré syndrome), severe pain and reduced mobility of the arm and shoulder (brachial neuritis) have been reported following administration of tetanus-containing vaccines.
• Inflammation of certain nerves causing sensory disturbances or limb weakness (polyradiculoneuritis), facial paralysis, visual disturbances, diminished or loss of vision (optic neuritis), inflammatory disease of the brain and spinal cord (demyelination of the central nervous system, multiple sclerosis) have been reported following administration of vaccines containing hepatitis B antigen.
• Swelling or inflammation of the brain (encephalopathy/encephalitis).
• In very premature infants (born at 28 weeks of gestation or earlier), episodes of breathing pauses longer than normal may occur, lasting for 2–3 days after vaccination.
• Swelling of one or both feet and lower limbs. This reaction may occur together with bluish skin discolouration (cyanosis), redness, small areas of bleeding under the skin (transient purpura), and severe crying following vaccination with Haemophilus influenzae type b-containing vaccines. If these reactions occur, they usually appear after the first injections and are observed within the first hours after vaccination. All symptoms should completely resolve within 24 hours without the need for treatment.

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

5. How to store Hexacima

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 label after
EXP. The expiry date refers to the last day of the month.
Store in the refrigerator (between 2°C and 8°C).
Do not freeze.
Keep the vaccine in its carton to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Hexacima contains
The active substances are, per dose (0.5 mL):
Diphtheria toxoid not less than 20 IU (30 Lf)
Tetanus toxoid not less than 40 IU (10 Lf)
Bordetella pertussis antigens
Pertussis toxoid 25 micrograms
Filamentous haemagglutinin 25 micrograms
Inactivated poliovirus
Type 1 (Mahoney) 29 D-antigen units
Type 2 (MEF-1) 7 D-antigen units
Type 3 (Saukett) 26 D-antigen units
Hepatitis B surface antigen 10 micrograms
Haemophilus influenzae type b polysaccharide 12 micrograms
(polyribosylribitol phosphate)
conjugated to tetanus protein 22-36 micrograms
Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al)
As lower limit of the confidence interval (p = 0.95) and not less than 30 IU as mean value
As lower limit of the confidence interval (p = 0.95)
Or equivalent activity determined by immunogenicity assessment
Grown on Vero cells
These antigen quantities are strictly the same as those previously expressed as
40-8-32 D-antigen units, respectively for type 1, 2 and 3 viruses, when measured by another suitable
immunochemical method
Produced in Hansenula polymorpha yeast cells by recombinant DNA technology

The other components 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.

Description of the appearance of Hexacima and contents of the pack
Hexacima is supplied as an injectable suspension in a vial (0.5 mL).
Hexacima is available in packs of 10 vials.
After shaking the vial, the vaccine normally appears as a white, cloudy, homogeneous suspension.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi Winthrop Industrie, 82 Avenue Raspail, 94250 Gentilly, France

Manufacturers
Sanofi Pasteur, 1541 avenue Marcel Mérieux, 69280 Marcy l’Etoile, France
Sanofi Pasteur, Parc Industriel d’Incarville, 27100 Val de Reuil, France

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.
The most up-to-date approved information on this vaccine is available at the following URL:
https://hexacima.info.sanofi or by scanning the QR code with a smartphone:
insert QR code

The following information is intended exclusively for healthcare professionals:

• The vial is for single use only and must not be reused.
• Shake the vial to ensure the contents become homogeneous.
• A 0.5 mL dose should be drawn up into a syringe for injection.
• Do not mix Hexacima with other medicinal products.
• Hexacima must be administered by intramuscular injection. The recommended injection site is preferably the anterolateral aspect of the thigh; in older children (preferably from 15 months of age), the deltoid muscle may be used. Do not administer by intradermal or intravenous route. Do not administer by intravascular injection: ensure that the needle has not entered a blood vessel.
• Do not use vials if the packaging is damaged.

Any unused medicine and waste material derived from this medicine must be disposed of in accordance with
local regulatory requirements.