Tetraxim

Tetraxim

Manufacturer:

Sanofi Pasteur

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Adsorbed diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine.
Description
Each 0.5-mL dose 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 virus type 3 32 DU*+.
*DU: D antigen unit.
+or equivalent quantity of antigen determined using a suitable immunochemical method.
Tetraxim also contains aluminum hydroxide, phenol red-free Hanks medium, acetic acid and/or sodium hydroxide, formaldehyde, phenoxyethanol and water for injections as other ingredients.
Indications/Uses
Helps protect children against diphtheria, tetanus, pertussis and poliomyelitis from 2 months of age as a primary vaccination and as a booster dose during the 2nd year of life and in children from 5-11 or 11-13 years according to national official recommendations.
Dosage/Direction for Use
The general recommended schedule includes a primary vaccination in 3 injections at 1- to 2-month intervals from 2 months of age, followed by a booster injection 1 year after the primary vaccination during the 2nd year of life, and at 5-11 or 11-13 years of age, as a late booster according to national official recommendations.
Administration: Shake before injection, until a homogenous cloudy, whitish suspension is obtained.
Administer by the IM route.
The vaccine should preferably be administered in the front side of the thigh (middle 3rd) in infants and in the deltoid region in children of 5-11 or 11-13 years.
In the Event of Omission of a Dose of Tetraxim: The doctor will decide when to administer the omitted 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 and poliomyelitis.
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 is following an immunosuppressive treatment or suffers from immune deficiency, this may induce decrease in the immune response to the vaccine.
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 vaccine and conjugated Haemophilus influenzae type b vaccine should be administered at 2 separate injection sites on 2 different days.
List of Excipients with Known Effect: Formaldehyde.
Use of Other Vaccines: For primary vaccination and for the 1st booster dose, Tetraxim may be administered by reconstituting conjugated Haemophilus influenzae type b vaccine (Act-HIB) or administered at the same time as this vaccine, at 2 separate injection sites.
If child is to be vaccinated with Tetraxim 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 sometimes >40°C, 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 (low tonicity) episodes have been reported.
After the administration of Tetraxim with a vaccine 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 Tetraxim 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
J07CA02 - diphtheria-pertussis-poliomyelitis-tetanus ; Belongs to the class of combined bacterial and viral vaccines.
Presentation/Packing
Vaccine (susp for inj in pre-filled syringe) 0.5 mL x 1's.
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