Tetraxim

Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed).

One dose (0.5 mL) contains: Diphtheria toxoid⁽¹⁾ ≥30 IU⁽²⁾⁽³⁾; Tetanus toxoid⁽¹⁾ ≥40 IU⁽²⁾⁽³⁾; Bordetella pertussis antigens; Poliomyelitis virus (inactivated).
Bordetella pertussis antigens: Pertussis toxoid⁽¹⁾ 25 micrograms; Filamentous haemagglutinin⁽¹⁾ 25 micrograms.
Poliomyelitis virus (inactivated): Type 1 (Mahoney strain)⁽⁴⁾ 40 DU⁽⁵⁾⁽⁶⁾; Type 2 (MEF-1 strain)⁽⁴⁾ 8 DU⁽⁵⁾⁽⁶⁾; Type 3 (Saukett strain)⁽⁴⁾ 32 DU⁽⁵⁾⁽⁶⁾.
⁽¹⁾ Adsorbed on hydrated aluminium hydroxide 0.3 mg Al³⁺.
⁽²⁾ IU: International Unit.
⁽³⁾ Or equivalent activity determined by evaluation of immunogenicity.
⁽⁴⁾ Produced on VERO cells.
⁽⁵⁾ DU: D-antigen unit.
⁽⁶⁾ Or equivalent antigenic quantity determined by a suitable immunochemical method.
Excipients/Inactive Ingredients: Aluminium hydroxide is included in this vaccine as an adsorbent. Adsorbents are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine.
The other ingredients are: Hanks' medium 199 without phenol red (complex mixture of amino acids including phenylalanine, mineral salts, vitamins and other components such as glucose), glacial acetic acid and/or sodium hydroxide for pH adjustment, formaldehyde, phenoxyethanol, anhydrous ethanol and water for injections.

Pharmacotherapeutic group: bacterial and viral vaccines, combined. ATC code: J07CA02.
TETRAXIM (DTPaP) is a vaccine. Vaccines are used to protect against infectious diseases.
When TETRAXIM is injected, the body's natural defences develop a protection against those diseases.

TETRAXIM is indicated to help protect children against diphtheria, tetanus, pertussis and poliomyelitis.
TETRAXIM is indicated in children from the age of 2 months.

This vaccine is administered to children by a healthcare professional who knows about vaccines.
Dosage: The schedule should be chosen in accordance with current national recommendations: 2 injections with an interval of two months, one at the age of 2 months and one at the age of 4 months, followed by one booster injection at the age of 11 months, then another booster injection at the age of 6 years. Booster vaccination between 11 and 13 years for children who did not receive a vaccine containing the pertussis valence at normal concentration (Pa) at the age of 6 years.
Or 3 injections at an interval of one or two months from the age of 2 months, followed by one booster injection within the second year of life, and another booster injection between 4 through 13 years of age.
Method of administration: For syringes without attached needles, the separate needle must be fitted firmly to the syringe, rotating it by a one-quarter turn.
Shake before injection until a homogeneous whitish-turbid suspension is obtained.
Administer via the intramuscular route (IM).
Administration should preferably be performed in the anterolateral side of the thigh (middle third) in infants and in the deltoid area in children.
This vaccine must never be injected in a blood vessel (intravascular route).
If there are any further questions on the use of this medicine, ask the doctor or pharmacist.

Do not use TETRAXIM: If the child is allergic (hypersensitive) to any of the vaccine components (listed in Description), to glutaraldehyde, neomycin, streptomycin or polymyxin B (used during the manufacturing process and which may be present as traces), or to a pertussis vaccine (acellular or whole cell); If the child had an allergic reaction after an injection of the same vaccine or a vaccine containing the same substances; If the child suffers from evolving encephalopathy (cerebral lesions); If the child suffered from encephalopathy (cerebral lesions) within 7 days of a previous dose of a pertussis vaccine (acellular or whole cell pertussis); If the child has fever or a disease which occurred suddenly (acute disease), in this case it is preferable to postpone the vaccination.

TETRAXIM contains phenylalanine, ethanol and sodium: TETRAXIM contains 12.5 micrograms of phenylalanine in each 0.5 mL dose. Phenylalanine may be harmful for people who have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
TETRAXIM contains 2 mg of alcohol (ethanol) in each 0.5 mL dose. The small amount of alcohol in this medicine will not have any noticeable effects.
TETRAXIM contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium free'.
Driving and using machines: Not applicable. TETRAXIM is intended for paediatric use.
Use in Children: If the child has poor immune defences or if he/she is treated with corticosteroids, cytotoxic medicines, radiotherapy or other medicines that may weaken his/her immune system, the immune response may be diminished. It is then recommended to wait until the end of the treatment or disease before vaccinating. However, vaccination is recommended in subjects with chronic immunodeficiency such as HIV infection, even if the immune response may be limited.
If the child has had Guillain-Barré syndrome (abnormal sensitivity, paralysis) or brachial neuritis (paralysis, diffuse pain in the arm and shoulder) following receipt of a prior vaccine containing tetanus toxoid (vaccine against tetanus), the decision to give any further vaccine containing tetanus toxoid should be evaluated by the doctor.
If the child has blood disorders such as a decrease in platelets (thrombocytopenia) or clotting disorders because of the risk of bleeding which may occur during intramuscular administration.
If the child has or had medical issues or allergies, especially an allergic reaction following an injection of TETRAXIM.
If the child experienced any of the following events after a previous administration of this vaccine, then the decision to give further doses of this pertussis-containing vaccine should be carefully evaluated by the doctor: 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; Convulsions with or without fever, occurring within 3 days of vaccination.
If the child had febrile convulsions unrelated to a previous vaccination; in this case, it is particularly important to monitor his/her temperature for 48 hours after vaccination and regularly give him/her a treatment to lower the fever, for 48 hours.
If the child has experienced swelling (oedematous reactions) in the lower limbs (legs and feet) following injection of a Haemophilus influenzae type b-containing vaccine; TETRAXIM vaccine and Haemophilus influenzae type b conjugate vaccine should be administered into two separate injection sites and on different days.

TETRAXIM is intended for children. For adolescents of childbearing potential, please ask the doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious allergic reactions: Serious allergic reactions, although very rare, may occur following vaccination, generally while the child is still present at the vaccination site.
If any of the signs or symptoms described as follows occur after leaving the place where the child was vaccinated, a doctor or emergency medical services should be contacted immediately: Swelling of the face (face oedema), sudden swelling of the face and neck (angioedema, Quincke's oedema); Sudden and serious malaise with drop in blood pressure causing dizziness and loss of consciousness, accelerated heart rate associated with respiratory disorders (anaphylactic reaction).
Other side effects: If the child experiences any of the side effects described as follows and if the sign(s)/symptom(s) persist or worsen, the doctor or pharmacist should be contacted.
Very common reactions (may affect more than one in 10 children): Loss of appetite; Nervousness, irritability; Abnormal crying; Somnolence; Headache; Vomiting; Muscle pain (myalgia); Injection site redness (erythema); Injection site pain; Injection site swelling (oedema); Fever ≥38°C; Malaise.
Common reactions (may affect up to 1 in 10 children): Insomnia, sleep disorder; Diarrhoea; Injection site hardening (induration).
Uncommon reactions (may affect up to 1 in 100 children): Inconsolable and prolonged crying; Injection site redness and swelling (oedema) ≥5 cm; Fever ≥39°C.
Rare reactions (may affect up to 1 in 1000 children): Fever >40°C.
Reactions for which the frequency is not known (cannot be estimated from the available data): Convulsions with or without fever; Loss of consciousness (syncope); Skin rash, redness (erythema); Itching (urticaria); Increase in volume of the lymph nodes close to the injection site (lymphadenopathy).
Drops in energy or periods during which the child is pale, unresponsive or seems in a shock-like state (hypotony-hyporesponsiveness) were reported after administration of pertussis-containing vaccines.
Also, when TETRAXIM is administered with a Haemophilus influenzae type b-containing vaccine, swelling in the legs and feet (oedematous reactions affecting the lower limbs) were reported, with a bluish discoloration of the skin (cyanosis) or redness, small transient red spots (purpura) occurring within hours of vaccination, and disappearing without treatment and without sequelae. Swelling may be accompanied by severe crying.
Potential side effects (i.e. they have not been reported directly with TETRAXIM, but with other vaccines containing one or more of the antigenic constituents of TETRAXIM) are the following: Guillain-Barré syndrome (abnormal sensitivity, paralysis) and brachial neuritis (paralysis, diffuse pain in the arm and shoulder) following the administration of a vaccine containing tetanus toxoid.
Additional information concerning specific populations: 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.
Reporting of side effects: If any side effects occur, talk to the doctor, pharmacist or nurse. This includes any possible side effects not previously listed. By reporting side effects, more information on the safety of this medicine can be provided.

For primary vaccination and for the 1^st booster dose, TETRAXIM may be administered by reconstituting the Haemophilus influenzae type b conjugate vaccine (Act-HIB) or administered simultaneously with it in two separate injection sites, i.e. in two different parts of the body.
If the child needs to be vaccinated simultaneously with TETRAXIM and another vaccine not mentioned previously, ask the doctor or pharmacist for more information.
Tell the doctor or pharmacist if the child is taking, has recently taken, or might take any other medicines.

Do not use this medicine if an abnormal colour or the presence of foreign particles is noticed.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help to protect the environment.

Store in a refrigerator (2°C - 8°C). Do not freeze.

Vaccines, Antisera & Immunologicals

J07CA02 - diphtheria-pertussis-poliomyelitis-tetanus ; Belongs to the class of combined bacterial and viral vaccines.

P₁S₁S₃, A