Powder and solvent for suspension for injection of Diphtheria, tetanus, pertussis (acellular, component), polio (inactivated), and Haemophilus influenzae type b conjugated vaccine ( adsorbed )
What Pentavac is and what it is used for
Pentavac is a vaccine. Vaccines are used to protect against infectious diseases.
This vaccine helps protect your child against diphtheria, tetanus, pertussis, polio (poliomyelitis), and serious diseases caused by Haemophilus influenzae type b (often just called Hib infections ).
It is given as a series of primary vaccinations to infants and as a booster vaccination for children who received this vaccine or a similar vaccine when they were younger.
When an injection of Pentavac is given, the body’s natural defenses will produce protection against the following diseases.
- Diphtheria is a contagious disease that usually first affects the throat. In the throat, infection causes pain and swelling, which can lead to suffocation. The bacterium that causes the disease also gives rise to a toxin (poison) that can damage the heart, kidneys, and nerves.
- Tetanus is caused by tetanus bacteria that enter through a deep wound. The bacterium produces a toxin (poison) that causes muscle spasms, leading to an inability to breathe and the risk of suffocation.
- Whooping cough (pertussis) is an infection of the respiratory tract, which can occur at any time in life, but most often affects infants and children. Increasingly severe cough attacks, which can last for several weeks, are characteristic of the disease. The cough attacks can be followed by a choking sound.
- Poliomyelitis (often just called polio) is caused by a virus that affects the nerves. It can lead to paralysis or muscle weakness, most commonly in the legs. Paralysis of the muscle that controls breathing and swallowing can be fatal.
- Haemophilus influenzae type b infections (often just called Hib infections ) are serious and invasive infections of the meninges ( membranes that surround the brain), lungs, throat, blood, skin, joints, and bones.
Important
Pentavac only helps prevent diseases caused by the same bacteria and viruses used to make the vaccine. Your child may still get infectious diseases caused by other bacteria or viruses.
Pentavac does not protect against infectious diseases caused by other types of Haemophilus influenzae or against inflammation of the outer membranes of the brain ( meningitis ) that have other origins.
What you need to know before your child receives Pentavac
It is important to inform your doctor, pharmacist, or nurse if any of the points below apply to your child so that they can ensure that Pentavac is suitable for your child.
Do not use Pentavac if your child
- is allergic to:
- the active substances in Pentavac or any of the other ingredients of Pentavac (see section 6)
- other vaccines containing any of the substances listed in section 6
- any vaccine that protects against pertussis
- have a high fever or an acute illness (eg fever, sore throat, cough, cold, or flu ). Vaccination with Pentavac may need to be postponed until your child gets better
- have an active disease of the brain ( encephalopathy )
- have had a severe reaction to any pertussis vaccine that affected the brain.
Warnings and cautions
Talk to a doctor or nurse before vaccination if:
- your child is allergic (hypersensitive) to glutaraldehyde, neomycin, streptomycin, or polymyxin B. These substances are used in the manufacture of Pentavac, and there may be very small amounts of these substances left in the vaccine;
- your child has a problem with the immune system or is receiving treatment that lowers the immune system. In such cases, it is recommended that vaccination be postponed until such illness or treatment is completed. Giving Pentavac to children with chronic immune system problems (including HIV infection ) is recommended, but protection against infection after vaccination may not be as good as in children with good immunity to infection.
- your child had a temporary loss of mobility and feeling ( Guillain-Barré syndrome ) or loss of mobility, pain, and numbness in the arm and shoulder (brachial neuritis ) after a previous injection of vaccine containing tetanus. Your doctor or nurse will decide whether to give Pentavac to your child
- your child has thrombocytopenia (low platelet count ) or a bleeding disorder (such as hemophilia) because he or she may be bleeding at the injection site
- your child has previously received a pertussis vaccine, and one of the following occurred shortly afterward:
- fever of 40 ° C or more within 48 hours, which was not caused by any other identifiable cause
- episodes with a shock-like condition or pallor, lethargy, and incontestability or fainting (hypotonic-hyporesponsive episodes or collapse,) within 48 hours after vaccination
- persistent and inconsolable crying for more than 3 hours within 48 hours after vaccination
- seizures, with or without fever, within 3 days after vaccination.
Other medicines and Pentavac
Pentavac can be given at the same time as the measles-mumps-rubella vaccine. Your doctor or nurse will give the two injections at different injection sites and will use separate syringes for each injection.
Tell your doctor, nurse, or pharmacist if your child is taking, has recently taken, or might take any other medicines.
Ask your doctor, pharmacist, or nurse to explain if there is something you do not understand.
Pregnancy and breastfeeding
Not relevant. This vaccine is for use in children only
Pentavac contains phenylalanine, ethanol, and sodium
Pentavac contains 12.5 micrograms of phenylalanine per 0.5 ml dose. Phenylalanine can be harmful to people with phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in the body.
Pentavac contains 2 mg alcohol ( ethanol ) per 0.5 ml dose . The small amount of alcohol in this medicine does not produce any noticeable effects.
Pentavac contains less than 1 mmol sodium per dose, ie it is essentially ‘sodium-free’.
How to use Pentavac
Dosage
For the vaccine to be effective, your child must receive several doses of the vaccine at different times before he/she becomes 2 years old. Two alternative schedules for when these doses can be given are shown in the table below. Your doctor will decide what schedule your child will receive.
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| Age at first dose one | Age at second dose one | Age at third dose one | Amplifying dose | |
| Scheme 1 (Booster dose required) | 2 or 3 months | 3 to 5 months | 4 to 7 months | 12 to 24 months |
| Scheme 2(Booster dose not required) | 3 months | 5 months | 12 months | (No booster dose) |
| Injections according to schedule 1 are given at 1-2 month intervals between each of the first three doses. |
If your child misses a dose of Pentavac
If your child misses a scheduled injection, your doctor will decide when to give the current dose.
Method of administration
Vaccination should be given by healthcare professionals who are trained in the use of vaccines, and who can handle any unusually severe allergic reaction to the injection.
Pentavac is given as an injection into a muscle in your child’s thigh or upper arm. Your doctor or nurse will avoid giving this injection into a blood vessel.
Your doctor or nurse will give your child the vaccine immediately after mixing the two components of Pentavac.
If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.
Possible side effects
Like all vaccines and medicines, Pentavac can cause side effects, although not everybody gets them.
Severe allergic reactions are always a rare possibility after receiving a vaccine.
These reactions may include:
- difficulty breathing, blue discoloration of the tongue or lips, low blood pressure (causing dizziness), and fainting (collapse).
- sudden signs of allergy such as swelling of the face, lips, tongue, or other parts of the body ( edema, Quincke’s edema ).
When such signs or symptoms occur, they usually develop very quickly after an injection has been given, and while the affected person is still in the clinic or doctor’s office.
If any of these symptoms occur after you have left the place where your child received an injection, you must contact a doctor IMMEDIATELY.
Very common reactions (affects more than 1 child in 10):
- reduced appetite
- nervousness or irritability
- abnormal crying
- drowsiness
- vomiting (nausea)
- redness at the injection site
- fever of 38 ° C or more
- swelling at the injection site
- injection site pain
After the basic vaccination, the frequency of injection site reactions tends to increase with booster dose one.
Common reactions (affects less than 1 in 10 children):
- diarrhea
- reduced appetite
- hardness (hardening) at the injection site
- restless sleep
Uncommon reactions (affects less than 1 in 100 children):
- redness and swelling of 5 cm or more around the injection site
- fever of 39 ° C or more
- prolonged inconsolable crying (inconsolable crying lasting more than 3 hours)
Rare reactions (affects less than 1 in 1,000 children):
- high fever above 40 ° C
- swelling of one or both legs. This can occur along with blue discoloration of the skin (cyanosis), redness, bleeding in small areas under the skin (transient purpura), and heavy crying. If this reaction occurs, it occurs mainly after the first (primary) injections and can be seen within the first hours after vaccination. All symptoms disappear completely within 24 hours without any need for treatment.
Reactions with unknown frequency (frequency can not be calculated from available data) are:
- cramps with or without fever
- episodes where your child ends up in a shock-like state or is pale, limp, and uncontactable for some time (hypotonic hyporesponsive episodes)
- skin rash, redness, and itching ( erythema, hives)
- major reactions at the injection site (greater than 5 cm), including extensive swelling of the limb where the injection was given, from the injection site past one or both joints. These reactions begin within 24-72 hours after vaccination, may be associated with redness, heat, tenderness, or pain at the injection site, and improve within 3-5 days without the need for treatment.
Other reactions observed with vaccines containing the same active substances as this vaccine:
- temporary loss of mobility or feeling ( Guillain-Barré syndrome ) and loss of mobility, pain, and numbness (brachial neuritis) in the arm and shoulder.
In very premature infants (born at or before 28 weeks of gestation), longer-than-normal breaks between breaths may occur for 2-3 days after vaccination.
How to store Pentavac
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze. If the vaccine has been frozen, it must be discarded.
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.
Contents of the pack and other information
Content declaration
Each 0.5 ml dose of reconstituted vaccine contains: Show larger
| The active substances are: | |
| Purified diphtheria -toxoid | not less than 30 IU 2 3 |
| Purified tetanus toxoid 1 | not less than 40 IU 2 3 |
| Purified pertussis toxoid (PTxd) | 25 micrograms |
| Purified filamentous hemagglutinin (FHA) | 25 micrograms |
| Inactivated poliovirus type 1 4 | D- antigen 5 . 40 units |
| Inactivated poliovirus type 2 4 | D- antigen 5 . 8 units |
| Inactivated poliovirus type 3 4 | D-antigen 5 . 32 units |
| Haemophilus influenzae type b polysaccharide conjugated to tetanus protein | 10 micrograms |
| * IE: International devices** Amount of antigen in the vaccine | |
| 1 Adsorbed on aluminum hydroxide, hydrated (0.3 mg Al 3+ )2 IU: International units3 Or equivalent activity determined by an immunogenicity evaluation4 Made from Vero cells5 Or the equivalent amount of antigen in the vaccine |
Aluminum hydroxide is included in the vaccine as an adsorbent. Adsorbents are substances that are included in certain vaccines to accelerate, improve and / or prolong the protective effects of the vaccine.
The other ingredients are formaldehyde, phenoxyethanol, ethanol anhydrous, Medium 199 Hanks without pheno-red, concentrated acetic acid and / or sodium hydroxide (for pH adjustment), trometamol, sucrose, concentrated hydrochloric acid (for pH adjustment), water for injections. Medium 199 is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins and other components (such as glucose ) diluted in water for injections.
What the medicine looks like and the contents of the pack
Pentavac, powder and suspension for injection , are available as a single dose (0.5 ml) pre-filled syringe with a single-dose vial of Haemophilus influenzae type b vaccine (freeze-dried vaccine) in the same package.
Pack sizes of 1 or 10 without needle, with mounted needle, with 1 separate needle or with 2 separate needles.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Sanofi Pasteur Europe
14 Henry Vallée Space
69007 Lyon
France
Manufacturer
Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France
Local representative:
Sanofi AB
Box 30052
104 25 Stockholm
Tel: +46 8-634 50 00
| Pentavac | Belgium, Denmark, Finland, Greece, Iceland, Luxembourg, Portugal, Sweden |