Hexaxim

After shaking, the normal appearance of the vaccine is a whitish cloudy suspension.
The active substances are per dose (0.5 mL)¹: Diphtheria Toxoid not less than 20 IU^2,4 (30Lf); Tetanus Toxoid not less than 40 IU^3,4 (10Lf); 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 (Polyribosylribitol Phosphate) 12 micrograms conjugated to Tetanus protein 22-36 micrograms.
¹Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al³⁺).
²As lower confidence limit (p=0.95) and not less than 30 IU as mean value.
³As lower confidence limit (p=0.95).
⁴Or equivalent activity determined by an immunogenicity evaluation.
⁵Cultivated on Vero cells.
⁶These 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.
⁷Produced in yeast Hansenula polymorpha cells by recombinant DNA technology.
The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B.
Excipients/Inactive Ingredients: The other ingredients are: Disodium hydrogen phosphate, potassium dihydrogen phosphate, trometamol, saccharose, 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 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: Hexaxim will only help to prevent these diseases if they are caused by the bacteria or viruses targeted by the vaccine. Children 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.
Hexaxim 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, Hexaxim may not protect 100% of children who receive the vaccine.

Hexaxim (DTaP-IPV-HB-Hib) is a vaccine used to protect against infectious diseases.
Hexaxim helps to protect against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by Haemophilus influenzae type b. Hexaxim is given to children from six weeks of age.

Hexaxim will be given to the 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 Side Effects).
Hexaxim is given as an injection into a muscle (intramuscular route IM) in the upper part of the 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): The 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, the child will receive a booster dose, in accordance with local recommendations, at least 6 months after the last dose of the first course. Parents must be advised when this dose should be given.
If one dose of Hexaxim is forgotten: If the child misses a scheduled injection, it is important that parents discuss with the 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 the child completes the course of injections. If not, the child may not be fully protected against the diseases.
If the parents have any further questions on the use of this vaccine, they must be advised to ask the doctor, pharmacist, or nurse.

To make sure that Hexaxim is suitable for the child, it is important to advise the parents to inform the doctor or nurse if any of the points apply to the child. If there is anything not understood, parents must be advised to ask the doctor, pharmacist, or nurse to explain.
Do not use Hexaxim if: The child has had respiratory disorder or swelling of the face (anaphylactic reaction) after administration of Hexaxim.
The child has had an allergic reaction to the active substances; to any of the excipients listed in Description; to glutaraldehyde, formaldehyde, neomycin, streptomycin or polymyxin B, as these substances are used during the manufacturing process; after previous administration of Hexaxim or any other diphtheria-, tetanus-, pertussis-, poliomyelitis-, hepatitis B- or Hib-containing vaccines.
The child 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).
The child has an uncontrolled condition or severe illness affecting the brain and nervous system (uncontrolled neurologic disorder) or uncontrolled epilepsy.

Parents must be advised to inform the doctor, pharmacist or nurse before vaccination if: The child has a moderate or high temperature or an acute illness (e.g. fever, sore throat, cough, cold or flu). Vaccination with Hexaxim may need to be delayed until the child is better.
The child 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.
The child previously had Guillain-Barré 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 a doctor.
The child 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 Hexaxim, but the protection may not be as good as in children whose immune system is healthy.
The child suffers from an acute or chronic illness including chronic renal insufficiency or failure (inability of the kidneys to work properly).
The child suffers from any undiagnosed illness of the brain or epilepsy that is not controlled. The doctor will assess the potential benefit offered by vaccination.
The child has any problems with the blood that causes easy bruising or bleeding for a long time after minor cuts. The doctor will advise the parent whether the child should have Hexaxim.
Fainting can occur following, or even before, any needle injection. Therefore, parents must be advised to inform the doctor or nurse if the child fainted with a previous injection.
Hexaxim contains phenylalanine, potassium and sodium: Hexaxim contains 85 micrograms phenylalanine in each 0.5 ml dose. Phenylalanine may be harmful if the patient has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Hexaxim 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".

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 the child received his/her injection, parents must be advised to 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 the child experiences any of the following side effects, parents must be advised to inform the 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 the 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 previously listed have been reported occasionally with other diphtheria-, tetanus-, pertussis-, poliomyelitis-, hepatitis B- or Hib-containing vaccines and not directly with Hexaxim: Temporary inflammation of nerves causing pain, paralysis and sensitivity disorders (Guillain-Barré 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: Parents must be advised to talk to the doctor, pharmacist or nurse if the child gets any side effects. This includes any possible side effects not listed in the monograph. By reporting side effects, more information on the safety of this medicine can be provided.

Parents must be advised to inform the doctor or nurse if the child is taking, has recently taken or might take any other medicines or vaccines.
Hexaxim 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, Hexaxim will be given at different injection sites.

Do not throw away any medicines via wastewater or household waste. Ask a pharmacist how to throw away medicines no longer used. These measures will help to protect the environment.
The following information is intended for healthcare professionals only: Shake the pre-filled syringe so that the contents become homogenous.
Hexaxim should not be mixed with other medical products.
Hexaxim must be administered intramuscularly. The recommended injection sites are the antero-lateral area of the upper thigh (preferred site) or the deltoid muscle in older children (possibly from 15 months of age).
The intradermal or intravenous routes must not be used. Do not administer by intravascular injection: ensure that the needle does not penetrate a blood vessel.
Do not use the pre-filled syringes if the carton is damaged.
Preparation for administration: The syringe with suspension for injection should be visually inspected prior to administration. In the event of any foreign particulate matter, leakage, premature activation of the plunger or faulty tip seal, discard the pre-filled syringe.
The syringe is intended for single use only and must not be reused.
Instructions for use of Luer Lock pre-filled syringe: Step 1: Holding the Luer Lock adapter in one hand (avoid holding the syringe plunger or barrel), unscrew the tip cap by twisting it.
Step 2: To attach the needle to the syringe, gently twist the needle into the Luer Lock adapter of the syringe until slight resistance is felt.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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.

Vaccines, Antisera & Immunologicals

J07CA09 - diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B ; Belongs to the class of combined bacterial and viral vaccines.

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