Tetraxim

Tetraxim

Manufacturer:

Sanofi Pasteur

Distributor:

Zuellig
Full Prescribing Info
Contents
Diphtheria, Tetanus, Pertussis (acellular, component), Poliomyelitis (inactivated) vaccine (adsorbed).
Description
Active substances: One dose (0.5 ml) contains: Diphtheria toxoid(1) ≥30 IU, Tetanus toxoid(1) ≥40 IU, Bordetella pertussis antigens: Pertussis toxoid(1) 25 micrograms, Filamentous haemagglutinin(1)25 micrograms, Poliomyelitis virus (inactivated) type 1 (Mahoney strain) 40 DU(2)(3)(4), type 2 (MEF-1 strain) 8 DU(2)(3)(4), type 3 (Saukett strain) 32 DU(2)(3)(4), (1) adsorbed on aluminum hydroxide, hydrated 0.3 mg Al3+.
(2)DU: D antigen unit.
(3)or equivalent antigenic quantity determined by a suitable immunochemical method.
(4)produced on VERO cells.
The other components are: Hanks medium without phenol red (a complex mixture of amino acids including phenylalanine, mineral salts, vitamins, vitamins, and other components such as glucose), acetic acid and/or sodium hydroxide for pH adjustment, formaldehyde, phenoxyethanol, ethanol and water for injections.
Indications/Uses
TETRAXIM 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 the child against diphtheria, tetanus, pertussis and poliomyelitis.
TETRAXIM is indicated in children from the age of 2 months.
Dosage/Direction for Use
The vaccine is administered to the child by a healthcare professional who knows about vaccines.
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 he age of 11 months, then another booster injection at the age of 6 years.
Booster vaccination between 11 and 13 years of age for children who received a vaccine containing the pertussis valence at reduced concentration at the age of 6 years, or
3 injections at an interval of one to two months from the age of 2 months, followed by one booster injection one year after primary vaccination i.e. within the second year of life, and another booster injection between 5 and 13 years of age.
Method of administration: Administration should be performed in a muscle (intramuscular route IM) preferably in the thigh in infants and in the upper arm in children.
If you have any further questions on the use of this medicine, ask the doctor or pharmacist.
Contraindications
Never use TETRAXIM: if the child is allergic (hypersensitive): to any of the vaccine components (see Description), to glutaraldehyde, neomycin, streptomycin, or polymyxin B (used during the manufacturing process and which may be present as traces), 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 cells pertussis),
If the child has fever or a disease which occurred suddenly (acute disease), in this case it is preferable to postpone the vaccination.
Special Precautions
Ask the doctor or pharmacist before using TETRAXIM in the cases described below: If the child has poor immune defences, or if he/she is treated with corticosteroids, cytotoxic drugs, radiotherapy or other drugs 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 presented Guillain-Barre 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 will 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 presented swelling (oedematous reactions) in 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.
Use In Pregnancy & Lactation
TETRAXIM is intended for children. For teenage girls, please ask the doctor.
Adverse Reactions
Like all medicines, TETRAXIM can cause side effects, although not everybody gets them.
Serious allergic reaction: Serious allergic reactions, although very rare, may occur following vaccination, generally while the child is still present on the place where he/she was vaccinated.
If any of the symptoms listed below occurs after leaving the place where the child was vaccinated, contact IMMEDIATELY a doctor or the emergency services.
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 following side effects listed below and it persists or gets serious, please contact a doctor or pharmacist.
Very common reactions: Loss of appetite; Nervousness, irritability, abnormal crying; Somnolence, headache; Vomiting; Muscle pain (myalgia); Injection-site redness (erythema), injection-site pain, injection-site swelling, 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 1,000 children): Fever >40°C.
Reactions with a not Known frequency (frequencies cannot be estimated because these reactions are reported very rarely): 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 legs and feet (oedematous reactions affecting 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 with severe crying.
Potential side effects (i.e. children 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-Barre 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 2-3 days after vaccination.
Drug Interactions
For primary vaccination and for the 1st 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.
In case the child should receive TETRAXIM simultaneously with other vaccines than those already mentioned, please ask the doctor or pharmacist for more information.
Please inform the doctor or pharmacist if the child takes, has recently taken, or may take any other medicines, even those not prescribed.
Caution For Usage
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.
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).
Storage
Store in a refrigerator (2°C-8°C). Do not freeze.
Do not use if there is an abnormal colour or the presence of foreign particles.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
ATC Classification
J07CA02 - diphtheria-pertussis-poliomyelitis-tetanus ; Belongs to the class of combined bacterial and viral vaccines.
Presentation/Packing
Inj (pre-filled syringe; cloudy and whitish) 0.5 mL x 1's.
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