TETRACT-HIB
CONTENTS
Haemophilus influenzae type B conjugate vaccine, adsorbed diphtheria, tetanus and pertussis vaccine.
PRESENTATION
Vial 10 mcg/0.5 mL (Act-HIB) x 1 dose + syringe (DT COQ/DTP) 1 dose.
DESCRIPTION
Tetract-HIB contains 1 vial of Act-HIB (lyophilisate for 1 immunizing dose) containing Haemophilus influenzae type b polysaccharide conjugated with tetanus protein 10 mcg, sucrose and trometamol; plus 1 syringe of DTP (suspension for injection for 1 immunizing dose) containing purified diphtheria toxoid not less than 30 iu, purified tetanus toxoid not less than 60 iu and Bordetella pertussis not less than 4 iu, aluminium hydroxide, thiomersal and buffer solution containing sodium chloride, dihydrate sodium hydrogen phosphate, potassium dihydrogen phosphate, acetic acid and/or sodium hydroxide and water for injections.
INDICATIONS
Combined prevention of invasive Haemophilus influenzae type b infections (meningitis, septicaemia, cellulitis, arthritis, epiglottis, etc), diphtheria, tetanus and pertussis.
Tetract-HIB does not protect against infections due to other types of Haemophilus influenzae or against meningitis of other origins.
DOSAGE & ADMINISTRATION
Primary Vaccination: 3 injections at 1- or 2-months interval from 2 months of age.
Booster: 1 injection a year after the 3rd injection of the primary vaccination.
Administration: Reconstitute the Act-HIB powder with 1 syringe or 1 ampoule of D.T.COQ/D.T.P. suspension. Shake until the powder has completely dissolved without producing too much foam. The whitish, cloudy appearance of the suspension after reconstitution is normal.
Given that the vaccine is adsorbed, it is preferable to administer it by the IM route in order to minimize local reactions. The vaccine is preferably administered in the anterolateral side of the thigh (middle third).
Do not inject by the intravascular route.
CONTRAINDICATIONS
Hypersensitivity to any of the components of Tetract-HIB or following a previous vaccination against diphtheria, tetanus and pertussis.
Convulsant or non-convulsant progressive encephalopathy (neurological disease); strong reaction occurring within 48 hrs following a previous vaccination: Fever ³40°C, persistent crying syndrome, febrile or non-febrile convulsion, hypotonus-hyporeactivity syndrome.
PRECAUTIONS
Do not inject by the intravascular route; ensure that the needle does not enter a blood vessel.
Vaccination should be postponed in those sufferring from fever or acute disease, particularly infectious disease or progressive chronic disease.
In the event of a history of febrile convulsions not related to a previous vaccination, it is particularly important to monitor the temperature in 48 hrs following the vaccination and administer an antipyretic treatment regularly for 48 hrs.
In the event of oedematous reactions of the lower limbs occurring following an injection of a vaccine containing the Haemophilus influenzae type b component, the diphtheria-tetanus-pertussis and Act-HIB vaccines should be administered at 2 separate injection sites on 2 different days.
An immunosuppressive treatment or immune deficiency may induce a decrease in the immune response to the vaccine.
Use in pregnancy & lactation: As a general rule, during pregnancy and lactation, it is recommended to always consult with the physician or pharmacist before taking a medicinal product.
SIDE EFFECTS
Pain, erythema (redness), induration and oedema (swelling) may occur within 48 hrs at the injection point or persist for several days. The formation of a SC nodule, persisting for several weeks, may accompany these reactions. Rare cases of amicrobic abscesses have been reported.
Fever above 38°C, unusual crying within 24-48 hrs following vaccination.
Allergic Symptoms: Rash (skin eruption), urticaria and in exceptional cases, anaphylactic shock (allergic shock) or Quincke's oedema (variety of urticaria with sudden swelling of face and neck).
Very rarely, attacks of hypotonus-hyporeactivity, persistent crying syndrome, convulsions with or without fever.
Exceptionally, acute encephalopathy (neurological disease).
Neurological disorders following vaccination tend to be attributed to the pertussis component.
Edematous reactions of the lower limbs. These reactions are sometimes accompanied by fever, pain and crying.
Tetract-HIB contains thiomersal as preservative and as a consequence, allergic reactions may occur.
INTERACTIONS
There is no known contraindication to the simultaneous administration of Tetract-HIB with other standard vaccines during the same vaccination session, provided that a different syringe and needle and a separate injection site are used.
In order to avoid possible interactions between several drugs, any other ongoing treatment should be systematically reported to the doctor or pharmacist.
STORAGE
Store at a temperature between 2°C and 8°C (in a refrigerator). Do not freeze.
Shelf-Life: 3 years.