Full Prescribing Info
Contents
Adsorbed diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis vaccine and conjugate Haemophilus influenzae type b vaccine.
Description
Each 0.5-mL dose, after reconstitution, contains diphtheria toxoid ≥30 IU, tetanus toxoid ≥40 IU, Bordetella pertussis antigens (toxoid 25 mcg, filamentous haemagglutinin 25 mcg), inactivated poliomyelitis virus type 1 40 DU*+, inactivated poliomyelitis virus type 2 8 DU*+, inactivated poliomyelitis type 3 32 DU*+, Haemophilus influenzae type b polysaccharide conjugated with tetanus protein 10 mcg.
*DU: D antigen unit.
+or equivalent quantity of antigen determined using a suitable immunochemical method.
Pentaxim also contains sucrose, trometamol, aluminum hydroxide, phenol red-free Hanks medium, formaldehyde, phenoxyethanol and water for injections as other ingredients.
Indications/Uses
Helps protect children against diphtheria, tetanus, pertussis, poliomyelitis and against invasive infections caused by the Haemophilus influenzae type b bacterium (meningitis, blood infections, etc) in children from 2 months.
Pentaxim does not protect against infections due to other types of Haemophilus influenzae or against meningitis caused by other microorganisms.
Dosage/Direction for Use
The general recommended schedule includes a primary vaccination in 3 injections 1- or 2-month interval from 2 months of age, followed by a booster injection during the 2nd year of life.
Administration: Reconstitute the vaccine by injecting the combined diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine suspension into the vial of Haemophilus influenzae type b conjugate vaccine powder.
Shake until the powder has completely dissolved. The cloudy whitish appearance of the suspension after reconstitution is normal.
The vaccine must be administered immediately after reconstitution.
Administer by the IM route.
The vaccine should preferably be administered in the front side of the thigh (middle 3rd).
Inform the doctor in the event of omission of a Pentaxim dose.
Contraindications
If child suffers from convulsant or nonconvulsant progressive encephalopathy (neurological disease).
If child has experienced a strong reaction occurring within 48 hrs following a previous vaccination: Fever ≥40°C, persistent crying syndrome, febrile or nonfebrile convulsion, hypotonus-hyporeactivity syndrome.
If child has experienced an allergic reaction appearing after a previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b infections.
If child is allergic to the active ingredients, any of the excipients, neomycin, streptomycin and polymyxin B.
Special Precautions
Ensure that the vaccine is not injected by the intravascular route (the needle must not enter a blood vessel) or by the intradermal route.
Vaccination should be postponed in children suffering from fever or acute disease, particularly infectious disease or progressive chronic disease.
If child has a history of febrile convulsions not related to a previous vaccination, it is particularly important to monitor the temperature within 48 hrs following the vaccination and administer an antipyretic treatment to reduce the fever regularly for 48 hrs.
If child has experienced edematous reactions (or swelling) of the lower limbs occurring following an injection of a vaccine containing the Haemophilus influenzae type b component, the diphtheria-tetanus-pertussis-poliomyelitis and conjugated Haemophilus influenzae type b vaccines should be administered at 2 separate injection sites on 2 different days.
If child is following an immunosuppressive treatment or suffers from immune deficiency, this may induce a decrease in the immune response to the vaccine.
List of Excipients with Known Effect: Formaldehyde.
Use of Other Vaccines: This vaccine may be administered at the same time as ROR VAX vaccine or HB-VAX DNA 5 mcg/0.5 mL vaccine, but at 2 separate sites.
If child is to be vaccinated with Pentaxim and vaccines other than those mentioned previously at the same time, ask the doctor or pharmacist for more information.
Inform the doctor or pharmacist if child is taking or has taken any other medicinal product, even in the case of nonprescription medicinal products.
Adverse Reactions
Local reactions eg, pain, erythema (redness), induration may occur at the injection site within 48 hrs following administration.
Systemic Reactions: Fever, irritability, drowsiness, sleeping and eating disorders, diarrhoea, vomiting, inconsolable and prolonged crying. Rarer cases of urticaria, skin eruptions, febrile or nonfebrile convulsions have been observed within 48 hrs following administration.
Hypotonus or hypotonus-hyporeactivity episodes have been reported.
After the administration of vaccines containing the Haemophilus influenzae type b component, edematous reactions (swelling) of the lower limbs have been reported. These reactions are sometimes accompanied by fever, pain and crying.
If undesirable effects not mentioned previously are observed, inform the doctor or pharmacist.
Caution For Usage
Do not use Pentaxim if an abnormal colouration or the presence of foreign particles is observed.
Storage
Store at a temperature between +2°C and +8°C (in a refrigerator). Do not freeze.
ATC Classification
J07CA06 - diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus ; Belongs to the class of combined bacterial and viral vaccines.
Presentation/Packing
Vaccine (powd and susp for inj) 0.5 mL x 1's.
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