solution for injection, suspension in the vial
Vaccine against diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), polio (inactivated), and Haemophilus type b conjugate ( adsorbed ).
What Vaxelis is and what it is used for
Vaxelis is a vaccine used to protect your child against diphtheria, tetanus, whooping cough, hepatitis B, polio, and serious diseases caused by Haemophilus influenzae type b. Vaxelis is given to children from 6 weeks of age.
The vaccine works by causing the body to produce its protection ( antibodies ) against bacteria and viruses that cause the following diseases:
- Diphtheria: a bacterial infection that usually first affects the throat and causes pain and swelling that can lead to choking. The bacterium also produces a toxin (poison) that can damage the heart, kidneys, and nerves.
- Tetanus ( tetanus ): caused by tetanus bacteria entering the body through a deep wound. The bacteria produce a toxin (poison) that causes muscle spasms which lead to breathing difficulties and the risk of suffocation.
- Whooping cough (pertussis): a highly contagious disease that affects the respiratory tract. The disease causes a severe cough that can cause problems with breathing. The cough often has a “whooping” sound. The cough may last for one to two months or longer. Whooping cough can also cause ear infections, respiratory tract infections ( bronchitis ) that can last for a long time, pneumonia, convulsions, brain damage, and even death.
- Hepatitis B: caused by the hepatitis B virus. This causes the liver to swell (become inflamed). In some people, the virus can remain in the body for a long time and can eventually cause serious liver problems, e.g. liver cancer.
- Polio (poliomyelitis): caused by viruses that affect the nerves. It can lead to paralysis or muscle weakness, usually in the legs. Paralysis of muscles that control breathing and swallowing can cause death.
- Infections with Haemophilus influenzae type b (often just called Hib infection ) are serious bacterial infections that can cause meningitis ( inflammation of the outer membranes of the brain), which can lead to brain damage, deafness, epilepsy, or partial blindness. Infection can also cause inflammation and swelling in the throat, which in turn leads to breathing and swallowing difficulties; infection can affect other parts of the body such as the blood, lungs, skin, bone tissue, and joints.
Important information about how the vaccine works
- Vaxelis only helps protect against diseases caused by the bacteria and viruses for which the vaccine is intended. Vaxelis does not protect your child against diseases caused by other bacteria and viruses that can cause similar symptoms.
- The vaccine does not contain any live bacteria or viruses and cannot cause any of the infectious diseases it protects against.
- As with all vaccines, it is not certain that Vaxelis protects 100% of the children who receive the vaccine.
What you need to know before your child receives Vaxelis
To ensure that Vaxelis is suitable for your child, it is important to talk to the doctor or nurse if any of the points listed below apply to your child. If there is anything you do not understand, talk to your doctor, pharmacist, or nurse.
Do not use Vaxelis if your child:
- became short of breath or swollen in the face ( anaphylactic reaction ) after the previous administration of a dose of Vaxelis.
- are allergic (hypersensitive)
- against Vaxelis vaccine or other vaccines containing diphtheria, tetanus, pertussis, polio, hepatitis B or Hib,
- against any ingredient listed in section 6,
- against glutaraldehyde, formaldehyde, neomycin, streptomycin, polymyxin B ( antibiotics ), and bovine serum albumin as these substances are used during the manufacturing process.
- have had a serious reaction affecting the brain ( encephalopathy ) within 7 days of a previous dose of a pertussis vaccine (acellular or whole cell pertussis).
- have an uncontrolled medical condition or serious illness affecting the brain and nervous system (uncontrolled neurological disorder) or uncontrolled epilepsy.
Warnings and precautions
Talk to the doctor, pharmacist, or nurse before vaccination if your child:
- have a moderate to severe acute illness, with or without fever (eg sore throat, cough, cold, or flu ). Vaccination with Vaxelis may need to be postponed until your child feels better
- have had any of the following after receiving pertussis (pertussis) vaccine, as the decision to give you an additional dose of pertussis-containing vaccine needs to be carefully considered:
- developed a fever of 40.5°C or higher within 48 hours that is not due to any other identifiable cause
- lost muscle strength became uncontactable or unconscious within 48 hours of the previous vaccination
- cried incessantly and could not be comforted for more than three hours within 48 hours of vaccination
- had convulsions (convulsions) with or without fever, within 3 days of vaccination
- previously had Guillain-Barré syndrome (temporary loss of sensation and movement) after receiving a vaccine containing tetanus toxoid (an inactivated form of tetanus vaccine). The doctor will decide whether your child should be given Vaxelis.
- are receiving treatment (eg steroids, chemotherapy, or radiotherapy) or have a disease that inhibits or reduces the body’s ability to fight infection. It is recommended to postpone vaccination until the end of such treatment or illness. Children with long-term problems with the immune system such as HIV infection ( AIDS ) can still be given Vaxelis but the protection may not be as good as in children with a healthy immune system.
- suffer from any undiagnosed disease of the brain or uncontrolled epilepsy. The doctor or nurse assesses the possible benefit of vaccination once the condition has stabilized.
- have febrile seizures, or if there is a family history of febrile seizures
- have had problems with bleeding for a long time after minor cuts, or bruises easily. Your doctor will tell you if your child can receive Vaxelis.
- was born prematurely (at or before the 28th week of pregnancy). In these infants, longer pauses between breaths may occur for 2 to 3 days after vaccination.
Other medicines or vaccines and Vaxelis
Tell the doctor or nurse if your child is taking, has recently taken, or might take other medicines or vaccines.
Vaxelis can be given at the same time as other vaccines such as pneumococcal vaccines, measles, mumps, rubella, chicken pox, rotavirus vaccines, or meningococcal C vaccines.
The doctor or nurse will give you these injections in different places and use different syringes and needles for each injection.
Driving ability and use of machinery
It is expected that Vaxelis has no or negligible effect on the ability to drive and use machines.
Wax ice cream contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. is almost “sodium-free”.
How Vaxelis is given
Vaxelis is given to your child by a doctor or nurse trained in the use of vaccines and who can manage less common serious allergic reactions to injections (see section 4. Possible side effects ).
The doctor or nurse will inject Vaxelis into your child’s thigh (in babies from 6 weeks of age) or arm (children over 1 year).
The recommended dose is as follows:
First vaccination series (primary vaccination)
Your child will receive two or three injections at least one month apart. The doctor or nurse will tell you when your child should return for his next injection according to the local vaccination program.
Additional injection (booster)
After the first injection series, your child will receive a booster dose, according to local recommendations, at least 6 months after the last dose of the first vaccination series. Your doctor will tell you when this dose should be given.
If your child misses a dose of Vaxelis
If your child misses a scheduled injection, you must discuss it with your doctor or nurse who will decide when the missed dose should be given.
It is important to follow the instructions given by the doctor or nurse so that your child completes the entire vaccination series. Otherwise, your child may not have complete protection against the diseases.
If you have any further questions about this vaccine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Severe allergic reactions
Contact a doctor IMMEDIATELY if any of these symptoms occur after your child receives their injection:
- breathing difficulties
- bluing of the tongue or lips
- rash
- swelling of the face or neck
- low blood pressure that causes dizziness or collapse.
These signs or symptoms usually occur very soon after the injection is given and while the child is still in the clinic or doctor’s office.
Serious allergic reactions are very rare (may affect up to 1 in 10,000 users) and they can occur after a vaccination.
Other side effects ar
If your child experiences any of the following side effects, talk to a doctor, pharmacist, or nurse.
- Very common side effects (may affect more than 1 in 10 users) are:
- decreased appetite
- irritability
- crying
- vomiting
- sleepiness or drowsiness
- fever (body temperature 38°C or higher).
- pain, redness, and swelling at the injection site
- Common side effects (which may affect up to 1 in 10 users) are:
- diarrhea
- hard lump, lump (knot) at the injection site
- bruising at the injection site
- Uncommon side effects (may affect up to 1 in 100 users) are:
- rash
- heat development, skin rash at the injection site
- increased appetite
- abdominal pain
- increased sweating
- cough
- nasal congestion and runny nose
- pallor
- sleep disorders such as not getting enough sleep
- restlessness
- swollen glands in the neck, armpit, or groin
- feeling of fatigue
- muscle weakness
- Side effects with an unknown frequency (the frequency cannot be calculated from the available data) are:
- seizures (convulsions) with or without fever
- muscle weakness and unresponsive or unconscious and/or pale or bluish skin tone
Single cases of other side effects not listed above have been reported with other vaccines containing diphtheria, tetanus, pertussis, polio, hepatitis B, or Hib:
- allergic reaction, severe allergic reaction (anaphylactic reaction)
- extensive swelling of the arm or leg where the vaccine was given
- episodes of shock-like state or pallor, muscle weakness, and unresponsiveness
How Vaxelis should be stored
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C–8°C). Do not freeze. Store in the outer carton. Light sensitive.
Use before the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
| The active substance per dose (0.5 ml): | |
| Diphtheria toxoid 1 | not less than 20 IU |
| Tetanus toxoid 1 | not less than 40 IU |
| Bordetella pertussis – antigen er 1 | |
| Pertussis toxoid (PT) | 20 micrograms |
| Filamentous hemagglutinin (FHA) | 20 micrograms |
| Pertactin (PRN) | 3 micrograms |
| Fimbria type 2 and 3 (FIM) | 5 micrograms |
| Hepatitis B surface antigen 2,3 | 10 micrograms |
| Poliovirus (inactivated) 4 | |
| Type 1 (Mahoney) | 40 D antigen units 5 |
| Type 2 (MEF-1) | 8 D antigen units 5 |
| Type 3 (Setauket) | 32 D antigen units 5 |
| Haemophilus influenzae type b polysaccharide | |
| (poly ribosyl ribitol phosphate) | 3 micrograms |
| Conjugated to meningococcal protein 2 | 50 micrograms |
1 adsorbed to aluminum phosphate (0.17 mg Al 3+ )
2 adsorbed to amorphous aluminum hydroxyphosphate sulfate (0.15 mg Al 3+ )
3 grown in yeast cells ( Saccharomyces cerevisiae ) using recombinant DNA technology
4 grown in Vero cells
5 or the equivalent amount of antigen as determined by a suitable immunochemical method.
Aluminum phosphate and amorphous aluminum hydroxyphosphate sulfate are included in the vaccine as adjuvants. Adjuvants are included to improve the immune response to vaccines.
Other ingredients are:
Sodium phosphate, water for injections
The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin, polymyxin B, and bovine serum albumin.
Appearance and package sizes of the medicine
The normal appearance of the vaccine is a uniform, white to an off-white suspension that may settle during storage.
Vaxelis is supplied as a solution for injection, a suspension in a vial.
Pack size 10 single-dose vials.
Marketing Authorization Holder and Manufacturer:
MCM Vaccine BV, Robert Boyleweg 4, 2333 CG Leiden, The Netherlands
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
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