Tetraxim

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

One dose (0.5 mL) contains: Diphtheria toxoid⁽¹⁾ ≥ 30 IU^{(2) (3)}; Tetanus toxoid⁽¹⁾ ≥ 40 IU^{(3) (4)}; Bordetella pertussis antigens: Pertussis toxoid⁽¹⁾ 25 micrograms, Filamentous haemagglutinin⁽¹⁾ 25 micrograms; Poliomyelitis virus (inactivated)⁽⁴⁾: type 1 (Mahoney strain)⁽⁵⁾ 40 DU^{(6) (7)}, type 2 (MEF-I strain)⁽⁵⁾ 8 DU^{(6) (7)}, type 3 (Saukett strain)⁽⁵⁾ 32 DU^{(6) (7)}.
⁽¹⁾ Adsorbed on aluminium hydroxide, hydrated 0.3 mg Al³⁺.
⁽²⁾ As mean value.
⁽³⁾ Or equivalent activity determined by evaluation of immunogenicity.
⁽⁴⁾ As lower confidence limit (p = 0.95).
⁽⁵⁾ Produced on VERO cells.
⁽⁶⁾ DU: D antigen unit.
⁽⁷⁾ Or equivalent antigenic quantity determined by a suitable immunochemical method.
TETRAXIM may contain traces of glutaraldehyde, neomycin, streptomycin and polymyxin B.
Excipients with known effect: Phenylalanine 12.5 micrograms.
Excipients/Inactive Ingredients: Hanks' medium 199 (without phenol red), Glacial acetic acid and/or sodium hydroxide (for pH adjustment), Formaldehyde, Phenoxyethanol, Anhydrous ethanol, Water for injections.
Hanks' 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.

Pharmacology: Pharmacodynamics: Diphtheria and tetanus toxins are detoxified using formaldehyde and then purified.
The poliomyelitis vaccine is obtained from the propagation of poliomyelitis viruses types 1, 2 and 3 on Vero cells, purified, then inactivated using formaldehyde.
The acellular pertussis components (PT and FHA) are extracted from Bordetella pertussis cultures, then purified.
The pertussis toxin (PT) is detoxified by glutaraldehyde and corresponds to the pertussis toxoid (PTxd). The FHA is native.
It has been shown that PTxd and FHA are two components of major importance for protection against pertussis.
After booster vaccination between 5 to 13 years of age, all children developed protective antibody titres against tetanus (> 0.1 IU/mL) and poliomyelitis viruses. Protective antibody titres against diphtheria (> 0.1 IU/mL) were achieved in at least 99.6% of them. Seroconversion rates in pertussis antibodies (titres higher than four-fold the pre-vaccinal titres) are from 89.1% to 98% or PT (EIA) and from 78.7% to 91% for FHA (EIA).

TETRAXIM is indicated in the joint prevention of diphtheria, tetanus, pertussis and poliomyelitis for booster vaccination between 5 and 13 years of age, according to official recommendations.

Posology: For booster vaccination between 5 and 13 years of age: 1 injection.
Method of administration: Shake before injection until a homogenous whitish-turbid suspension is obtained.
Administer via the intramuscular route.
Administration should preferably be performed in the anterolateral side of the thigh (middle third) in infants and in the deltoid area in children aged between 5 and 13 years.

If the child is allergic to one of the vaccine's components, or to pertussis vaccines (acellular or whole cells pertussis), or if the child experienced an allergic reaction after injection of a vaccine containing the same substances.
Known hypersensitive to glutaraldehyde, neomycin, streptomycin, or polymyxin B (used during the manufacturing process and which may be present as traces).
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 a fever or an acute disease (the vaccination must be postponed).

Make sure the vaccine is not injected by intravascular route (the needle must not penetrate a blood vessel) nor by the intradermal route.
If the child suffers from thrombocytopenia or clotting problems as there is a risk of bleeding during intramuscular administration.
If the child already presented with febrile convulsions, not related to a previous vaccine injections; in this case it is particularly important that temperature be monitored in the 48 hours following vaccination and that antipyretic treatment be regularly administered to help reduce fever, for 48 hours.
Syncope can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent falling and injury, and to manage syncope.
If any of the following events are known to have occurred in temporal relation to receipt of vaccine (the decision to give further doses of pertussis-containing vaccine should be carefully considered): Fever ≥ 40°C within 48 hours 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, occurring within 48 hours of vaccination; Convulsions with or without fever, occurring within 3 days of vaccination.
If the child suffers/suffered from medical problems or allergic reactions, especially allergic reactions following injection of TETRAXIM.
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 should be evaluated by the doctor.
If the child presented oedematous reactions (or swelling) occurring in the lower limbs after injection of a vaccine containing the Haemophilus influenzae type b valence, the two vaccines, diphtheria-tetanus-pertussis-poliomyelitis vaccine and the Haemophilus influenzae type b conjugate vaccine should be administered in two separate injection sites and on two different days.
If the child follows a treatment that suppresses their immune defences or if the child presents with immunodeficiency: it is then recommended to wait until the end of the treatment or disease before vaccinating. Nevertheless, vaccination of subjects with chronic immunodeficiency such as HIV infection is recommended even if the antibody response may be limited.
A history of afebrile convulsions not related to a previous vaccine injection should be assessed by a specialist before deciding to vaccinate.
As with all injectable vaccines, appropriate medical treatment must be readily available and close supervision provided should a rare anaphylactic reaction occur following administration of the vaccine.
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'.
Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
EFFECT ON ABILITY TO DRIVE AND USE MACHINES: Not applicable.
TETRAXIM is intended for paediatric only.

Not applicable.
TETRAXIM is intended for paediatric use only.

The most common reactions are: irritability, local reactions at the injection site such as redness and induration greater than 2 cm. These signs and symptoms usually occur within 48 hours following the vaccination and may continue for 48-72 hours. They resolve spontaneously without requiring specific treatment.
In clinical studies, hypotonic-hyporesponsive episodes (hypotonic episodes, hyporesponsiveness, decreased mental awareness) have been reported after administration of pertussis-containing vaccine; they have not been reported with TETRAXIM.
The following side effects have been reported: Fever sometimes above 40°C.
Erythema, induration, pain at the injection site; redness and oedema (swelling) ≥ 5 cm at the injection site.
Oedema (swelling) > 5 cm that spread over the entire limb where the vaccine has been administered. This reaction occurs within 3-5 days. The risk appears to be dependent on the number of prior doses of acellular pertussis containing vaccines, with a greater risk following the 4^th and 5^th doses.
Diarrhea; vomiting.
Loss of appetite.
Somnolence; convulsions with or without fever.
Nervousness, irritability, insomnia, sleep disturbances; abnormal crying, prolonged inconsolable crying.
Allergy-like symptoms, such as rash, erythema, and urticaria.
Furthermore, oedematous reactions (swelling) affecting the lower limbs have been reported when TETRAXIM is administered with Haemophilus influenzae type b containing vaccines. These reactions are sometimes accompanied by fever, pain and crying. They are not accompanied by cardiorespiratory signs. 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 administration of a vaccine containing tetanus toxoid.
Tabulated list of adverse reactions: The adverse events are ranked under headings of frequency using the following convention: Very common: ≥1/10, Common: ≥1/100 and <1/10, Uncommon: ≥1/1000 and <1/100, Rare: ≥1/10000 and <1/1000, Very rare: <1/10000, Not known: cannot be estimated from the available data.
Based on spontaneous reporting, certain undesirable events were very rarely reported following the use of TETRAXIM. Because events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. This is why these undesirable events are ranked under the Not known frequency.
Blood and lymphatic system disorders: Reactions with a Not Known frequency: Lymphadenopathy.
Immune system disorders: Reactions with a Not Known frequency: Immediate hypersensitivity reactions such as face oedema, angioedema, Quincke's oedema, anaphylactic reactions.
Metabolism and nutrition disorders: Very common reactions: Loss of appetite.
Psychiatric disorders: Very common reactions: Nervousness, irritability; Abnormal crying.
Common reactions: Insomnia, sleep disturbances.
Uncommon reactions: Prolonged inconsolable crying.
Nervous system disorders: Very common reactions: Somnolence, Headache.
Reactions with a Not Known frequency: Convulsions with or without fever, Syncope.
Gastro-intestinal disorders: Very common reactions: Vomiting.
Common reactions: Diarrhoea.
Skin and subcutaneous tissue disorders: Reactions with a Not Known frequency: Rash, erythema, urticaria.
Musculoskeletal and connective tissue disorders: Very common reactions: Myalgia.
General disorders and administration site conditions: Very common reactions: Injection-site erythema, Injection-site pain, Injection-site oedema, Fever ≥ 38°C, Malaise.
Common reactions: Injection-site induration.
Uncommon reactions: Injection-site redness and oedema ≥ 5 cm, Fever ≥ 39°C.
Rare reactions: Fever > 40°C.
Reactions with a Not Known frequency: Large injection-site reactions (> 50 mm), including extensive limb swelling from the injection site beyond one or both joints. These reactions start within 24-72 hours after vaccination and may be associated with symptoms such as erythema, warmth, tenderness or pain at the injection site. They resolve spontaneously within 3-5 days. The risk appears to be dependent on the number of prior doses of acellular pertussis-containing vaccines, with a greater risk following the 4^th and 5^th doses.
Hypotonic-hyporesponsive episodes have been reported after administration of pertussis-containing vaccines.
Oedematous reactions on one or on both lower limbs may occur after vaccination with a Haemophilus influenzae type b conjugate-containing vaccine. These reactions generally occur after primary series, within hours of the vaccination, and resolve without sequelae within 24 hours. These reactions maybe accompanied with cyanosis, erythema, transient purpura and severe crying. These reactions may be observed if TETRAXIM is administered simultaneously with the Haemophilus influenzae type b conjugate vaccine.
Potential undesirable 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): Guillain-Barré Syndrome and brachial neuritis after administration of a tetanus toxoid-containing vaccine.
If any side effects not previously mentioned are noticed, tell the doctor or pharmacist.

This vaccine may be administered concomitantly with measles-mumps-rubella (MMR) vaccine, the varicella vaccines, or the hepatitis B vaccine, at separate injection sites.
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.
This vaccine can be administered simultaneously with the MMRV vaccine in two separate sites.
In case the child should receive TETRAXIM simultaneously with other vaccines than those already mentioned, ask the doctor or pharmacist if the child has recently taken any other medicines, even those not prescribed.

Do not use TETRAXIM if the patient notices an abnormal colour or the presence of foreign particles.

Store in refrigerator (2°C-8°C). Do not freeze.
SHELF LIFE: 3 years.

Vaccines, Antisera & Immunologicals

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

G