powder and liquid for injection, suspension in pre-filled syringe
Vaccine against diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), polio (inactivated) (IPV), and Haemophilus influenzae type b (Hib) (conjugated), adsorbed.
1. What Infanrix hexa is and what it is used for
Infanrix hexa is a vaccine used to protect your baby against six different diseases.
- Diphtheria: a serious bacterial infection that mainly affects the airways and sometimes the skin. The airways become swollen, causing severe breathing problems and sometimes suffocation. The bacteria also release a poison. This can cause nerve damage, heart problems and even death.
- Tetanus ( Tetanus ): Tetanus bacteria enter the body through cuts, scratches or wounds in the skin. Injuries that are particularly prone to tetanus infection are burns, fractures , deep wounds and wounds that have received soil, dust, horse manure / manure or wood chips. The bacteria release a toxin that can cause muscle stiffness, painful muscle spasms, seizures and even death. Muscle spasms can be so severe that they cause bone fractures in the spine.
- Whooping cough (pertussis): is a highly contagious disease that affects the respiratory tract. The disease causes severe attacks of coughing that can cause breathing problems. The cough often has a “peeping” sound and can last for one to two months or longer. Whooping cough can also cause ear infections, respiratory infections ( tracheitis ) that can last for a long time, pneumonia , seizures, brain damage and even death.
- Hepatitis B : Caused by the hepatitis B virus, which causes the liver to swell. The virus is found in body fluids such as in the vagina , blood, semen or saliva (infected) of infected people.
- Polio : is a viral infection. Polio is often only a mild disease but can sometimes be very serious and cause permanent damage or even death. Polio can prevent the muscles from moving (paralysis of the muscles). This also includes the muscles needed to breathe and to be able to walk. Arms or legs affected by the disease can become painfully twisted (deformed).
- Haemophilus influenzae type b(Hib):may cause brain swelling (inflammation). This can cause serious problems such as impaired mental capacity (developmental disorder),cerebral palsy, deafness,epilepsyorpartialblindness. The disease can also cause swelling of the pharynx, which in turn can lead to death by suffocation. In less common cases, the bacterium can also infect the blood, heart, lungs, bone tissue, joints and eye and mouth tissue.
How Infanrix hexa works
- Infanrix hexa helps your baby’s body produce its own protection ( antibodies ). This protects your child from these diseases.
- As with all vaccines, Infanrix hexa does not provide complete protection for all children who are vaccinated.
- The vaccine can not cause the disease that it protects your child against.
2. What you need to know before your child receives Infanrix hexa
Do not use Infanrix hexa
- if your child is allergic to:
- Infanrix hexa or any of the other 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, pertussis, hepatitis B, polio or Haemophilus influenzae type b.
- if your child has a disease of the nervous system within 7 days after previous vaccination with pertussis vaccine.
- if your child has a severe infection with a high fever (above
38 ° C). A mild infection such as a common cold is probably not a problem, but talk to your doctor first.
Infanrix hexa should not be given if any of the above apply to your baby. If you are not sure, talk to your doctor or pharmacist before taking your child Infanrix hexa.
Warnings and cautions
Talk to your doctor or pharmacist before your child receives Infanrix hexa:
- if your child has had any illness after previous administration of Infanrix hexa or any other pertussis vaccine such as:
- high fever (above 40 ºC) within 48 hours after vaccination
- collapse or shock-like condition within 48 hours after vaccination
- persistent crying that lasted 3 hours or longer within 48 hours after vaccination
- seizures with or without high fever within 3 days after vaccination
- if your child has an undiagnosed brain disease or epilepsy that is out of control. When the disease is under control, the vaccine can be given.
- if your child has any bleeding disorder or is prone to bruising.
- if your child tends to have seizures associated with fever or if there are such ailments within the family.
- If your child has a seizure or is absent after vaccination, contact a doctor immediately. See also section 4 Possible side effects .
If any of these apply to your child (or you are not sure) talk to your doctor or pharmacist before taking your child Infanrix hexa.
Other medicines and Infanrix hexa
Your doctor may ask you to give your child an antipyretic (such as paracetamol ) before or immediately after giving Infanrix hexa. This can help reduce certain side effects (fever reactions) with Infanrix hexa.
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines, or has recently been given any other vaccine.
Infanrix hexa contains neomycin and polymyxin
This vaccine contains neomycin and polymyxin ( antibiotics ). Tell your doctor if your child has previously had an allergic reaction to these ingredients.
How to use Infanrix hexa
How much is given
- Your child will receive a total of 2 or 3 injections at an interval of at least 2 and 1 month (s) between each injection .
- You will receive information from your doctor or nurse about when to return for the following injection .
- If you need further injections (refill doses) your 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 in a blood vessel or in the skin.
If your child misses a dose
- If your child misses an appointment for vaccination, it is important that you book a new appointment.
- Make sure your child completes the entire vaccination program, otherwise your child will not have complete protection against the diseases.
4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
The following side effects may occur when using this vaccine:
Allergic reactions
If your child has an allergic reaction, contact a doctor immediately. Signs of this may include:
- itchy rash and / or blistering
- swelling of eyes and face
- difficulty breathing or swallowing
- sudden drop in blood pressure and unconsciousness
These signs are usually seen very soon after getting an injection. Contact a doctor immediately if this happens after the reception has been left.
Contact your doctor immediately if your child gets any of the following side effects:
- collapse
- periods of unconsciousness or impaired consciousness
- seizures (with or without fever).
These side effects have been very rare with Infanrix hexa and other pertussis vaccines. They usually occur within 2 to 3 days after vaccination.
Other side effects include:
Very common (these may occur in more than 1 in 10 vaccine doses): drowsiness, loss of appetite, high fever, 38 ° C or higher, swelling, pain, redness at which injection was given, inconsolable crying, feeling of irritability or restlessness.
Common (these may occur in up to 1 in 10 vaccine doses): diarrhea, nausea (vomiting), high fever, 39.5 ° C or higher, swelling, over 5 cm or a hard lump where the injection was given, feeling of anxiety.
Uncommon (these may occur in up to 1 in 100 vaccine doses): upper respiratory tract infection, fatigue, cough, extensive swelling at the injection site.
Rare (may occur in up to 1 in 1000 vaccine doses): bronchitis, skin rash, swollen glands in the neck, armpit, and groin ( lymphadenopathy ),
in very premature babies (born 28 weeks or earlier in pregnancy) there may be longer breaks between breaths than normal for 2-3 days after vaccination, temporary respiratory arrest ( apnea ), swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing ( angioedema ),
swelling of the entire injected body part, blisters.
Very rare (may affect up to 1 in 10,000 vaccine doses): pruritus (skin inflammation).
Experience with hepatitis B vaccine
In extremely rare cases, the following rare side effects have been reported with the hepatitis B vaccine: paralysis, numbness or weakness in the arms and legs ( neuropathy ), inflammation of certain nerves, possibly with tingling or loss of sensation or normal mobility ( Guillain-Barré syndrome ). , swelling or infection of the brain ( encephalopathy, encephalitis ), infection around the brain ( meningitis ).
The association with the vaccine has not been established.
Bleeding or bruising that occurs more easily than normal ( thrombocytopenia ) has been reported with the hepatitis B vaccine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Infanrix hexa
- Keep this vaccine out of the reach and sight of children.
- Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
- Store in a refrigerator (2 o > C-8 o C).
- Store in the original package. Sensitive to light.
- Do not freeze. Freezing destroys the vaccine.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration for Infanrix hexa
| The active substances are: | |||
| Diphtheria toxoid 1 | less than 30 international units (IU) | ||
| Tetanus toxoid 1 | not less than 40 international units (IU) | ||
| Bordetella pertussis – antigen | |||
| Pertussis toxoid 1 | 25 micrograms | ||
| Filamentous hemagglutinin 1 | 25 micrograms | ||
| Pertactin 1 | 8 micrograms | ||
| Hepatitis B surface antigen 2.3 | 10 micrograms | ||
| Poliovirus (disabled) | |||
| type 1 (Mahoney strain) 4 | 40 D antigen units | ||
| type 2 (MEF-1 strain) 4 | 8 D antigen units | ||
| type 3 (Saukett strain) 4 | 32 D antigen units | ||
| Haemophilus influenzae type b polysaccharide | 10 micrograms | ||
| (polyribosyl ribitol phosphate) 3 | |||
| conjugated to tetanus toxoid as a carrier protein | about 25 micrograms | ||
| 1 adsorbed to hydrated aluminum hydroxide (Al (OH) 3 ) | 0.5 milligrams Al 3+ | ||
| 2 produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology | |||
| 3 adsorbed to aluminum phosphate (AlPO 4 ) | 0.32 milligrams Al 3+ | ||
| 4 grown in VERO cells | |||
| Other ingredients are: | |||
| Hib powder: anhydrous lactose | |||
| DTPa-HBV-IPV suspension: sodium chloride (NaCl), medium 199 (containing mainly amino acids , mineral salts, vitamins ) and water for injections |
What the medicine looks like and contents of the pack
- Diphtheria , tetanus , acellular pertussis, hepatitis B, inactivated polio (DTPa-HBV-IPV) component is a white, slightly milky liquid provided in a pre-filled syringe (0.5 ml).
- The Hib component is a white powder supplied in a glass vial .
- Both components are mixed just before your child receives an injection . Mixture one is a white, slightly milky solution.
- Infanrix hexa is supplied in packs of 1, 10, 20 and 50 with or without needles, and a multiple pack of 5 packs, each containing 10 vials and 10 pre-filled syringes, without needles.
- Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
GlaxoSmithKline Biologicals sa
Rue de l’Institut 89
B-1330 Rixensart
Belgium
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