ACT HIB VACCINE
ACT - HIB-VACCINE
Lyophilized (powder) :
• Polysaccharide of Haemophilus influenzae type b *, covalently bound to tetanus protein ............ 10
One immunization dose * strain IM 2164
** Corresponds to the quantity of purified polysaccharide Solvent:
• sodium chloride
• water for injection to an immunization dose (0,5 ml)
Powder and solvent for solution for injection . The solution for injection is obtained after dissolution of the dry mass of single-dose vial of solvent into the syringe (0,5 ml).
This vaccine was recommended for the prevention of invasive infections caused by Haemophilus influenzae type b ( meningitis , septicemia , cellulitis, arthritis , epiglottitis , etc . ) In children aged 2 months to 5 years of age .
The vaccine will not prevent infection caused by other types of Haemophilus influenzae, nor against meningitis caused by other microorganisms.
This medicinal product must not be applied in the following cases:
Hypersensitivity to any component of the vaccine , particularly Ke tetanus protein ( tetanus toxoid ) or allergic reactions experienced by prior injection of the conjugate vaccine against Haemophilus influenzae type b.
If you have any doubt you should consult your doctor or pharmacist.
SPECIAL WARNINGS FOR USE
• Do not inject intravascularly - you should check that the needle does not penetrate a blood vessel.
• Vaccination should be delayed in children with fever , acute , especially infectious disease or chronic disease in acute stage
• Imunosulresivno treatment or immune deficiency can lead to reduced immune response to the vaccine.
• In case of concomitant administration of measles , mumps and rubella and diphtheria , tetanus, pertussis , polio each vaccine should be administered at two different injection sites.
PRECAUTIONS FOR USE
If in doubt, do not hesitate to consult your doctor or pharmacist. Keep out of reach of children !
Interaction with other Interaction
To avoid possible interactions between drugs of any concomitant treatment should be promptly reported to your doctor or pharmacist.
In all cases, strictly follow your doctor's recommendations .
• At the start of immunization before b - months : 3 consecutive injections of 0,5 ml, with one or two intervals between them, followed by a booster with a single dose of 0,5 ml at 18 months of age.
• At the start of immunization between 6 - and 12 months of age : 2 injections of 0,5 ml, fitted with one space between them, followed by a booster with a single dose of 0,5 ml at 18 months of age.
• For immunization of children between 1 - and 5 - years: apply only one immunization dose of 0,5 ml.
ROUTE OF ADMINISTRATION
Reconstitute the lyophilizate ( powder ) from the vial Act- NEW ( 1 dose ) to the solvent of the pre-filled syringe ( NaCl 4% o) or a syringe with vaccines DTCOQ / DTP ( Diphtheria , tetanus and pertussis ) or TETRACOQ ( Diphtheria , tetanus, pertussis and poliomyelitis ( inactivated ) ) .
Shake until complete dissolution of the lyophilised cake. After reconstitution, the vaccine DTCOQ / DTP ( Diphtheria , tetanus and pertussis ) or TETRACOQ ( Diphtheria , tetanus, pertussis and poliomyelitis ( inactivated ) ) is normal to get cloudy suspension whitish. The vaccine is injected intramuscularly ( preferably ) or deep subcutaneous injection. Recommended injection sites are the anterolateral aspect of the thigh ( middle third ) or upper outer part of the gluteal region in children up to one year , and the deltoid region in larger children.
Do not inject into a blood vessel !
Each active substance , this medicine may cause some people to more or less troublesome side effects .
Reactions Injection site : pain, redness and irritation were observed at the 5 % to 30% of the vaccinees . They are usually early , transient and mild . Sometimes observed atypical rashes.
There have been some rare cases of edematous effects of the lower extremities. These are swelling with bruising or pass patchy redness that appear in the first few hours after vaccination and disappear rapidly and spontaneously without consequences. These effects were not accompanied by a cardio - respiratory signs . They have been reported mainly when the vaccine was given concomitantly with other vaccines.
Observed rare cases of allergic reactions such as hives, itching and swelling of the face or larynx anaphylactic reactions.
General symptoms such as fever, rarely over 39 ° C, excited state and crying are the most common symptoms. They are less common when the vaccine was used alone than when co-administered with adsorbed vaccine against diphtheria, tetanus and pertussis ( MRF). In case of concomitant administration of DTP vaccines has been reported neurological disorders, in particular, convulsions . However, the frequency and severity of adverse events were not different from those observed when the vaccine is a DTP alone.
Notify your doctor or pharmacist of all unwanted and distracting effects that may not be listed in this leaflet.
SPECIAL STORAGE CONDITIONS
The vaccine should be stored between +2 ° C and +8 ° C ( in a refrigerator) . Do not freeze !
Keep out of reach of children.
Three years .
Do not use after the expiry date ( the date indicated on the packaging ) .
Reconstituted vaccine should be used immediately .