Tetravac Solution for injection, suspension, Diphtheria, tetanus, polio vaccine (acellular, component), and polio (inactivated) vaccine, adsorbed
What Tetravac Is And What It Is Used For
Tetravac is a vaccine (DTaP-IPV vaccine). Vaccines are used to protect against infectious diseases.
Tetravac vaccine helps protect your child against
- Diphtheria
- Tetanus
- Whooping cough (pertussis)
- Polio (poliomyelitis)
It is given as a series of primary vaccinations for infants and a booster vaccination for children who received this or a similar vaccine when they were younger.
When an injection of Tetravac is given, the body’s natural defenses will produce protection against the following diseases.
- Diphtheria is an infectious disease that usually first affects the throat. In the throat, infection causes pain and swelling, leading to suffocation. The bacterium that causes the disease also produces 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 a risk of suffocation.
- Whooping cough (pertussis) is a respiratory tract infection that can occur at any time in life but most often affects infants and children. Increasingly severe coughing attacks, which can last for several weeks, are characteristic of the disease. A whooping sound may follow the coughing attacks.
- Poliomyelitis (often called polio) is caused by viruses affecting 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.
Important
Petrovac only helps prevent diseases caused by the same bacteria and viruses used to make the Tetravac vaccine. Your child can still get infectious diseases caused by other bacteria or viruses.
What You Need To Know Before Your Child Receives Tetravac
Do Not Use Tetravac If Your Child:
- Are allergic to:
- The active substances in Tetravac or against any of the other ingredients in Tetravac (see section 6)
- Other vaccines containing any of the substances listed in section 6
- Any vaccine that protects against whooping cough
- Have a high fever or any acute illness (e.g., fever, sore throat, cough, cold, or flu ). Vaccination with Tetravac may need to be postponed until your child gets better.
- Have an active brain disease ( encephalopathy )
- Have had a severe reaction to any pertussis vaccine that affected the brain.
It is important to tell the doctor, pharmacist, or nurse if any of the points below apply to your child, so they can make sure that Tetravac is suitable for your child.
Warnings And Precautions
Talk to the doctor or nurse before the Tetravac vaccination about the following:
- Your child is allergic (hypersensitive) to glutaraldehyde, neomycin, streptomycin, or polymyxin B. These substances are used in the production of Tetravac, and very small amounts of these substances may remain in the vaccine
- Your child has problems with the immune system or is receiving treatment that suppresses the immune system. In such cases, it is recommended that vaccination be postponed until such illness or treatment is completed. Giving Tetravac to children with chronic immune system problems (including HIV infection ) is recommended. Still, the protection against infection after Tetravac vaccination may not be as good as in children with good immunity against infection.
- Your child had a temporary loss of movement and feeling ( Guillain-Barré syndrome ) or loss of movement, pain, and numbness in the arm and shoulder ( brachial neuritis ) after a previous injection with a vaccine containing tetanus. Your doctor or nurse will decide whether Tetravac should be given to your child
- Your child has thrombocytopenia (low platelet count ) or a bleeding disorder (such as hemophilia ), as he or she may bleed at the injection site
- Your child previously received a vaccine that protects against whooping cough, and any of the following happened soon after:
- Fever of 40°C or more within 48 hours, which was not caused by any other identifiable reason
- Episodes of a shock-like state or pallor, lethargy, unresponsiveness, 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
- Convulsions, with or without fever, within 3 days of vaccination
Fainting may occur after, or even before, a needle stick. Therefore, tell the doctor or nurse if your child has previously fainted in connection with a needle stick.
Other Medicines And Tetravac
Petrovac can be given simultaneously as the Haemophilus influenza type b vaccine (Act-HIB).
Petrovac can be given at the same time as measles-mumps-rubella and chickenpox vaccines. The doctor or nurse will administer the injections at different injection sites and use separate syringes for each injection.
Tell the doctor, nurse, or pharmacist if your child has recently taken, or might take any other medicines.
Ask the doctor, pharmacist, or nurse to explain if there is something you do not understand.
Pregnancy And Breastfeeding
Not relevant. This vaccine is intended for use in children only.
Petrovac contains Phenylalanine, Ethanol, And Sodium
- Petrovac 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 high levels of phenylalanine in the body.
- Petrovac contains 2 mg of alcohol ( ethanol ) per 0.5 ml dose. The small amount of alcohol in this medicine does not produce any noticeable effects.
- Petrovac contains less than 1 mmol of sodium per dose, i.e., is almost “sodium-free.”
How To Use Tetravac
Dosage
For the vaccine to be effective:
- Your child must receive several doses of the vaccine at different times before he/she is 2 years old. The table below shows two alternative schedules for when these doses may be given. The doctor will decide which schedule your child will receive.
| Age at first dose a | Age at second dose a | Age at third dose a | Booster dose | |
| Scheme 1(booster dose needed) | 2 or 3 months | 3 to 5 months | 4 to 7 months | 12 to 24 months |
| Schedule 2(booster dose not needed) | 3 months | 5 months | 12 months | (No booster dose ) |
Injections according to schedule 1 are given 1-2 months apart between each of the first three doses.
- Your child can also be vaccinated with Tetravac if he/she is between 4 and 13 years old and has previously been vaccinated with the pertussis vaccine.
Usually, a high-dose diphtheria vaccine, such as Tetravac, is used to vaccinate children under 12 years of age. However, in some countries, children under the age of 13 can receive a low-dose diphtheria vaccine.
If your child misses a dose of Tetravac
If your child misses a scheduled injection, the doctor will decide when the current dose should be given.
Mode of administration
Vaccination should be given by healthcare professionals who are trained in the use of vaccines and who can manage a possible less common allergic reaction to the injection.
Petrovac is given as an injection into your child’s thigh or upper arm muscle. The doctor or nurse will avoid giving this injection into a blood vessel.
If you have any further questions about this medicine, ask your doctor, nurse, or pharmacist.
Possible Tetravac Vaccine Side Effects
Tetravac can cause side effects like all vaccines and medicines, but not all users need them.
Serious 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)
- Fainting (collapse)
Sudden signs of allergy, such as swelling of the face, lips, tongue, or other parts of the body ( edema, angioedema), have been reported after administration of Tetravac (the exact frequency cannot be calculated from the available data).
When such signs or symptoms occur, they usually develop very quickly after the injection, 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 IMMEDIATELY contact a doctor.
Very common reactions (affects more than 1 in 10 children):
- Loss of appetite
- Nervousness or irritability
- Sbnormal crying
- Drowsiness
- Headache
- Vomiting (nausea)
- Muscle pain
- Redness at the injection site
- Pain at the injection site
- Swelling at the injection site
- Fever of 38°C or more
- Uneasiness
After primary immunization, the frequency of injection site reactions tends to increase with booster dose one.
Common reactions (affects less than 1 in 10 children):
- Diarrhea
- Hardness (hardness) at the injection site
- Restless sleep
Uncommon reactions (affects less than 1 in 100 children):
- Redness and swelling of 5 cm or more at the injection site
- Fever of 39°C or more
- Prolonged inconsolable crying (inconsolable crying lasting longer than 3 hours)
Rare reactions (affects less than 1 in 1,000 children):
- High fever above 40°C
Reactions with an unknown frequency (the frequency cannot be calculated from the available data):
- Convulsions with or without fever
- Fainting
- Skin rash
- Redness, and itching ( erythema, hives)
- Large reactions at the injection site (larger than 5 cm), including extensive swelling of the limb where the injection was given, from the injection site past one or both joints. Such reactions begin within 24-72 hours of vaccination, may be associated with redness, warmth, tenderness, or pain at the injection site, and resolve within 3-5 days without treatment.
- Swollen glands in the neck, armpit, or groin ( lymphadenopathy )
Other reactions observed with vaccines containing the same active substances as this vaccine are:
- Temporary loss of movement or feeling ( Guillain-Barré syndrome ) and loss of movement, pain, and numbness (brachial neuritis) in the arm and shoulder.
- Episodes where your child goes into a shock-like state or is pale, limp, and unresponsive for some time (hypotonic hyporesponsive episodes)
Other reactions that may occur when Tetravac is given at the same time as a separate Haemophilus influenzae type b vaccine:
- Swelling of one or both legs. This may occur along with blue discoloration of the skin (cyanosis), redness, bleeding in small areas under the skin (transient purpura), and profuse crying. If this reaction occurs, it mainly occurs after the first (primary) injections and can be seen within the first hours after vaccination. All symptoms disappear completely within 24 hours without requiring treatment.
In very premature babies (born at or before 28 weeks of gestation), longer than normal pauses between breaths may occur for 2-3 days after vaccination.
How To Store Tetravac
- Keep this medicine out of sight and reach of children.
- Use before the expiry date stated on the carton, and labels 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 must not be thrown into the drain or among 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
Each 0.5 ml dose of reconstituted vaccine contains the following:
| The active substances are: | ||
| Purified diphtheria toxoid 1 | not less than 30 IU 2 3 | |
| Purified tetanus toxoid 1 | not less than 40 IU 2 3 | |
| Purified pertussis toxoid (PTxd) 1 | 25 micrograms | |
| Purified filamentous hemagglutinin (FHA) 1 | 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 | |
| 1 Adsorbed on aluminum hydroxide, hydrated (0.3 mg Al 3+ )2 IE: International Units3 Or equivalent activity as determined by an immunogenicity evaluation4 Made from Vero cells5 Or the corresponding amount of antigen in the vaccine |
Aluminum hydroxide is included in the vaccine as an adsorbent. Adsorbents are substances included in some vaccines to accelerate, enhance and prolong the vaccine’s protective effects.
Other ingredients are formaldehyde, phenoxyethanol, and ethanol anhydrous. Medium 199 Hanks without fen red, concentrated acetic acid, and sodium hydroxide (for pH adjustment) in 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.
Appearance And Package Sizes Of The Medicine
- Petrovac, suspension for injection, is available as a single-dose (0.5 ml) pre-filled syringe.
- Pack sizes of 1 or 10 without a needle, with an attached needle, with 1 separate needle, or with 2 separate needles.
- Possibly not all pack sizes will be marketed.
Marketing Authorisation Holder
Sanofi Pasteur Europe
14 Espace Henry Vallée
69007 Lyon
France
Manufacturer
The manufacturer responsible for releasing the medicine is Sanofi Pasteur at the following address:
Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France
Local representative:
Sanofi AB
Box 30052
104 25 Stockholm
Phone: +46 8-634 50 00
This medicine is approved in the European Economic Area under the names and in Great Britain (Northern Ireland) under the name:
| Petrovac | Belgium, Denmark, Finland, Greece, Ireland, Iceland, Italy, Luxembourg, Norway, Portugal, Great Britain (Northern Ireland), Sweden |