Tetract - VACCINE
Act-HIV ( powder in a vial )
Polysaccharide of Haemophilus Influenzae type b 10 ?g
conjugated to tetanus protein (24 ?g)
Trometamol 0.6 mg and 42.5 mg sucrose
D.T. COQ / DTP ( suspension in a pre-filled syringe in a dose of 0.5 ml .
Purified diphtheria toxoid - ? 30 IU
Purified tetanus toxoid - ? 60 IU
Bordetella pertussis, inactivated - ? 4 IU
Aluminum hydroxide ( quantity is expressed as aluminum) - 0.65 mg
Thiomersal - ? 0,05 mg
A buffer solution containing sodium chloride , disodium phosphate dihydrate, potassium dihydrogen phosphate, acetic acid and / or sodium hydroxide and water for injection. - Up to 0.5 ml
PHARMACEUTICAL FORM :
Powder in a vial and suspension in pre-filled syringe for injection suspension.
The injectable suspension of TETRAct-HIV was prepared by dissolving the powder of one vial with the Act-HIV suspension of a prefilled syringe DT COQ / DTP ( absorbed vaccine against pertussis , tetanus and diphtheria ) One vial and a prefilled syringe contains one dose of vaccine .
This medicine is a vaccine .
Such combination vaccine is recommended for both the prevention of pertussis, diphtheria and tetanus , and invasive infections caused by Haemophilus Influenzae type b, such as eg meningig , septicemia ( blood infection ) , epiglottitis ( acute inflammation of the pharynx and larynx ) , cellulitis, arthritis , children under the age of 2 months to 5 years of age , non-immunized against any of these diseases.
TETRAct-HIV does not protect against infections caused by other types of Haemophilus influenzae than type b, meningitis or other causes .
This vaccine should not be used in the following cases :
- Progressive encephalopathy with or without seizures ( neurological disease )
- Encephalopathy in the first 7 days after administration of the previous dose of vaccine containing pertussis without any other reason.
- Strong overall reaction occurring within 48 hours after previous administration of a vaccine containing pertussis :
fever above 39,5 ? C ( axillary ) , unless no other reason for this
continuous, inconsolable crying for more than 3 hours
seizures , with or without fever
syndrome of hypertension / hyporesponsive
- Hypersensitivity reactions have been encountered in previous vaccination with this vaccine.
- Known allergy to any component of the vaccine.
Immunisation is done after examination by a physician .
Vaccination should be postponed in case of fever, acute illness or particularly infectious disease , chronic disease in acute stage .
- If there is evidence of seizures , without fever , that are not related to previous vaccination, should seek expert advice before deciding to vaccination.
- If the child has had seizures at a high temperature , which are not related to previous vaccination, it is essential to monitor the temperature for 48 hours after vaccination and in those 48 hours , and given regular lowering drugs temperature .
- In children with congenital or acquired immunodeficiency, vaccination can be done having in mind that the condition of the immune system, the immune response may be weaker .
- In case of edema of the lower limbs , occurring after a previous vaccination against Haemophilus influenzae type b, not apply TETRAct-HIV, and vaccine Defter , tetanus, pertussis and separated from it - conjugate vaccine against Haemophilus influenzae type b. In this case, the individual vaccine is given at two different injection sites and on different days .
- If immunosuppressive treatment or immunodeficiency effect of vaccination may be less .
PRECAUTIONS FOR USE:
Inform the doctor if you or your child have any allergies or have ever had an unusual reaction to a previous vaccination.
There are no contraindications for concomitantly administered vaccine with other routine vaccines matched during use in the immunization calendar , provided that using separate syringes and needles and other injection sites .
Pregnancy and lactation
Seek advice from your doctor before use. This vaccine is for children.
DOSAGE AND ADMINISTRATION :
Primary vaccination: two months of age are administered in three doses , one dose ( 0.5 mL ) vaccine at intervals of one month between them .
Booster : one dose one year after the third injection of the primary vaccination.
The vaccine is administered after reconstitution of the lyophilized powder Act-HIV in the vial with the suspension of a pre-filled syringe (DT COQ / DTP)
Before injection into the vial , syringe DT COQ / DTP must be shaken until complete dissolution of the powder, without the development of foam .
After reconstitution, the suspension is normal to be cloudy whitish.
It is recommended that the vaccine be administered in the anterolateral aspect of the thigh ( middle third ) . Injected immediately after reconstitution.
Do not inject intravascularly.
The injection site can be observed pain, redness , induration and edema, occurring within 48 hours after vaccination and lasting up to several days. Formation of subcutaneous node that disappears within a few weeks , you may accompany these reactions. Rare cases of aseptic abscesses .
Fever over 38 ? C, unusual crying during the first 24 to 48 hours after vaccination.
Allergic reactions: skin rash , urticaria and anaphylactic shock exception ( allergic shock) or Quincke's edema ( a form of urticaria with sudden swelling of the face and neck )
Very rarely, collapse or shock ( low blood pressure or hyporesponsive ) , constant crying , convulsions with or without fever .
Edema of the lower extremities with bruising or redness spotted passing , sometimes accompanied by fever, pain and tears.
SHELF LIFE :
The shelf life is 3 years
Vaccine after reconstitution , be used immediately