Infanrix Tetra indications
Active primary and booster immunisation of infants and toddlers for protection against Diphtheria (Infanrix Tetra), Tetanus (Infanrix Tetra), Pertussis (Infanrix Tetra), Hepatitis B (Infanrix Tetra) and invasive illness caused by H. influenzae type b. Infanrix Tetra is indicated for infants regardless of whether or not they have received Hepatitis B (Infanrix Tetra) vaccination at birth. Based on available evidence and recommendations, it is concluded that Infanrix Tetra can, like similar combination vaccines, be used in infants interchangeably for basic immunisation with other DTP-HepB-Hib vaccines, or components thereof, as well as for boosting children primed in infancy with another combination vaccine.
Infanrix Tetra description
Each 0.5-mL dose of vaccine contains purified Diphtheria (Infanrix Tetra) toxoid not less than 7.5 Lf (not less than 30 IU), purified Tetanus (Infanrix Tetra) toxoid not less than 3.25 Lf (not less than 60 IU), inactivated B. Pertussis (Infanrix Tetra) not less than 15 OU (not less than 4 IU), Hib oligosaccharide 10 mcg conjugated to approximately 25 mcg of cross reacting material (CRM) 197, purified Hepatitis B (Infanrix Tetra) surface antigen 10 mcg, aluminium phosphate (adjuvant) 0.3 mg Al3+. It also contains the following excipients: Sodium chloride, water for injection to make 0.5 mL.
Infanrix Tetra contains aluminium phosphate as adjuvant, forming a whitish sediment.
Infanrix Tetra is free of preservatives. Thiomersal may be present in traces as a residue of the manufacturing process.
Infanrix Tetra is a ready-to-use, fully liquid combined vaccine containing Diphtheria (Infanrix Tetra) and Tetanus (Infanrix Tetra) toxoids, Bordetella Pertussis (Infanrix Tetra) inactivated cellular suspension, Hepatitis B (Infanrix Tetra) surface antigen (HBsAg) and Haemophilus influenzae type b conjugated oligosaccharide. The Diphtheria (Infanrix Tetra) and Tetanus (Infanrix Tetra) toxoids are obtained from Corynebacterium diphtheriae and Clostridium tetani cultures, respectively, by formaldehyde inactivation and purification. The Pertussis (Infanrix Tetra) suspension component is obtained from B. Pertussis (Infanrix Tetra) cultures after inactivation and purification. The HBsAg is produced in genetically engineered yeast cells (Hansenula polymorpha) carrying the relevant gene of the HBsAg. The antigen is purified and inactivated by several physicochemical steps. The H. influenzae type b component is made of purified capsular oligosaccharides conjugated to CRM 197, a nontoxic mutant of Diphtheria (Infanrix Tetra) toxin, prepared from C. diphtheriae cultures.
Infanrix Tetra dosage
Primary Vaccination: The primary vaccination consists of 3 doses of 0.5 mL to be administered at intervals of at least 4 weeks and as per schedule 6, 10, 14 weeks; 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months.
All vaccination schedules including the WHO Expanded Program on Immunisation (EPI) at 6, 10, 14 weeks can be used whether or not a dose of Hepatitis B (Infanrix Tetra) vaccine has been given at birth.
Where a dose of Hepatitis B (Infanrix Tetra) vaccine is given at birth, Infanrix Tetra can be used for supplementary doses of Hepatitis B (Infanrix Tetra) vaccine from the age of 6 weeks. If a 2nd dose of Hepatitis B (Infanrix Tetra) vaccine is required before this age, monovalent Hepatitis B (Infanrix Tetra) vaccine should be used.
The use of Infanrix Tetra should be in accordance with official recommendations.
Booster Vaccination: After a 3-dose primary vaccination with Infanrix Tetra, a booster dose should be given, preferably during the 2nd year of life, at least 6 months after the last priming dose.
Booster doses should be given in accordance with the official recommendations. At the very least, a dose of Hib vaccine must be administered.
After a 3-dose primary vaccination with Infanrix Tetra (2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) and in the absence of Hepatitis B (Infanrix Tetra) vaccination at birth, it is necessary to give a Hepatitis B (Infanrix Tetra) vaccine booster dose. Infanrix Tetra can be considered for the booster.
After a 3-dose WHO EPI schedule with Infanrix Tetra (6, 10, 14 weeks) and in the absence of Hepatitis B (Infanrix Tetra) vaccination at birth, a Hepatitis B (Infanrix Tetra) vaccine booster must be given. At the very least, a booster dose of polio vaccine should be given. Infanrix Tetra can be considered for the booster.
When a Hepatitis B (Infanrix Tetra) vaccine is given at birth, after a 3-dose primary vaccination, Infanrix Tetra or a pentavalent DTaP/IPV/Hib vaccine can be administered for the booster.
Infanrix Tetra may be used as a booster in individuals who have previously been vaccinated with another hexavalent vaccine or pentavalent DTaP-IPV/Hib vaccine associated with a monovalent Hepatitis B (Infanrix Tetra) vaccine.
Administration: Immunisation must be carried out by IM injection. The recommended injection site is preferably the anterolateral area of the upper thigh and the deltoid muscle in older children (possibly from 15 months).
Infanrix Tetra interactions
Data on concomitant administration of Infanrix Tetra with a pneumococcal polysaccharide conjugated vaccine have shown no clinically relevant interference in the antibody response to each of the antigens.
Data on concomitant administration of a booster dose of Infanrix Tetra with measles-mumps-rubella vaccines have shown no clinically relevant interference in the antibody response to each of the antigens. There may be a clinically relevant interference in the antibody response of Infanrix Tetra and a varicella vaccine and these vaccines should not be administered at the same time.
Data on concomitant administration of rotavirus vaccines have shown no clinically relevant interference in the antibody response to each of the antigens.
No data are available on concomitant administration of Infanrix Tetra with meningococcal vaccines.
If co-administration with another vaccine is considered, immunization should be carried out on separate injection sites.
Infanrix Tetra must not be mixed with any other vaccines or other parenterally administered medicinal products.
Except in the case of immunosuppressive therapy, no significant clinical interaction with other treatments or biological products has been reported.
Interference With Laboratory Testing: See Precautions.
Incompatibilities: In the absence of compatibility studies, Infanrix Tetra must not be mixed with other vaccines or medicinal products.
Infanrix Tetra side effects
Clinical Trial Adverse Reactions: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect rates observed in practice. The adverse reaction information from clinical trials dose, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events.
In a randomized, controlled clinical trial conducted in Canada, 339 infants were immunized with Infanrix Tetra at 2, 4 and 6 months. In addition, 301 of these children were immunized as toddlers at 18 months. Injection site reactions were generally mild. Up to 1/3 of children receiving Infanrix Tetra experienced some degree of redness, swelling or tenderness around in a injection site. The frequency of solicited injection site and systemic reactions observed in a clinical trial within 24 hrs of any dose of Infanrix Tetra given at 2, 4, 6 and 18 months are presented as follows: Very common: ≥10%; common: ≥1% and <10%.
Gastrointestinal Disorders: Common: Diarrhea, vomiting.
General Disorders and Administration Site Conditions: Very Common: Injection site tenderness, swelling, redness, fever (≥38°C), crying, eating less, fussiness, less active.
Data from Post-Marketing Experience: The following additional adverse events have been spontaneously reported during the post-marketing use of Infanrix Tetra worldwide. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
Immune System Disorders: Hypersensitivity, anaphylactic reaction (eg, urticaria, angioedema).
Psychiatric Disorders: Irritability, screaming.
Nervous System Disorders: Convulsion (with or without fever), prolonged or unusual high-pitched crying, hypotonic-hyporesponsive episode (infant appears pale, hypotonic (limp) and unresponsive to parents). To date, this condition has not been associated with any permanent sequelae.
Vascular Disorders: Pallor.
Respiratory, Thoracic and Mediastinal Disorders: Apnea.
Skin and Subcutaneous Tissue Disorders: Erythema, rash. Musculoskeletal, Connective Tissue and Bone Disorders: General Disorders and Administration Site Conditions:
Large injection site reactions (>50 mm) including extensive limb swelling which may extend from the injection site beyond one or both joints, have been reported in children following Infanrix Tetra administration. These reactions usually start within 24-72 hrs after vaccination, may be associated with erythema, warmth, tenderness or pain at the injection site and resolve spontaneously within 3-5 days. The risk appears to be dependent on the number of prior doses of acellular Pertussis (Infanrix Tetra) containing vaccine, with a greater risk following the 4th and 5th doses.
Edematous reactions affecting one or both lower limbs have occurred following vaccination with H. influenza type b containing vaccines. When this reaction occurs, it does so mainly after primary injections and is observed within the first few hours following vaccination. Associated symptoms may include cyanosis, redness, transient purpura and severe crying. All events resolved spontaneously without sequelae within 24 hours.
Infanrix Tetra contraindications
Hypersensitivity to Diphtheria (Infanrix Tetra), Tetanus (Infanrix Tetra), acellular Pertussis (Infanrix Tetra), Hepatitis B (Infanrix Tetra) (rDNA), inactivated Poliomyelitis (Infanrix Tetra) and adsorbed Hib conjugate vaccine or to any of the excipients of Infanrix Tetra, to trace residuals (glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B), to any Pertussis (Infanrix Tetra) vaccine or after previous administration of Infanrix Tetra or a vaccine containing the same components or constituents.
History of an anaphylactic reaction after a previous administration of Infanrix Tetra.
Vaccination with Infanrix Tetra is contraindicated if the individual has experienced an encephalopathy of unknown aetiology, occurring within 7 days following prior vaccination with a Pertussis (Infanrix Tetra) containing vaccine (whole cell or acellular Pertussis (Infanrix Tetra) vaccines). In these circumstances, Pertussis (Infanrix Tetra) vaccination should be discontinued and the vaccination course should be continued with Diphtheria (Infanrix Tetra), Tetanus (Infanrix Tetra), Hepatitis B (Infanrix Tetra), Poliomyelitis (Infanrix Tetra) and Hib vaccines.
Pertussis (Infanrix Tetra) vaccine should not be administered to individuals with uncontrolled neurologic disorder or uncontrolled epilepsy until treatment for the condition has been established, the condition has stabilized and the benefit clearly outweighs the risk.
Active ingredient matches for Infanrix Tetra:
Diphtheria/Tetanus/Pertussis/Hepatitis B/Poliomyelitis/Haemophilus Type b Conjugate Vaccine in France.
A diphtheria in Greece, Portugal.
Diphtheria/Haemophilus Type b Conjugate Vaccine/Hepatitis B/Pertussis/Poliomyelitis/Tetanus in France.
| Unit description / dosage (Manufacturer) | Price, USD |
| Injectable; Injection; Diphtheria, Tetanus, Pertussis, Poliomyelitis Vaccine | |
List of Infanrix Tetra substitutes (brand and generic names): | |
| Infanrix-hepb/hi (Greece) | |
| InfanrixQuinta (France) | |
| Injectable; Injection; Bordetella Pertussis Antigens 58 mcg; Bordetella Pertussis Toxoid 25 mcg; Diphtheria Toxoid 30 IU; Filamentous Haemagglutinin Bordetella pertussis 25 mcg; Haemophilus Influenzae Type B Polysaccharide 10 mcg; Pertactin 8 mcg; Poliomy (Gsk) | |
| Injectable; Injection; Bordetella Pertussis Antigens 58 mcg; Bordetella Pertussis Toxoid 25 mcg; Diphtheria Toxoid 30 IU; Filamentous Haemagglutinin Bordetella pertussis 25 mcg; Haemophilus Influenzae Type B Polysaccharide 10 mcg; Pertactin 8 mcg; Poliomy (Gsk) | |
| Pediacel (Croatia (Hrvatska), Czech Republic) | |
| Injectable; Injection; Diphtheria Toxoid 15 LF; Filamentous Haemagglutinin 20 mcg; Fimbriae 5 mcg; Haemophilus Influenzae Type B-PRP 10 mcg; Poliomyelitis Vaccine Inactivated / D.C.O. Type 1 Mahoney 40 units; Poliomyelitis Vaccine Inactivated / D.C.O. Typ (sanofi pasteur) | |
| Pediacel / pre-filled syringe 0.5 mL (sanofi pasteur) | |
| Pediacel / vial 1's (sanofi pasteur) | |
| Pediacel / vial; 1 dose 0.5 mL (sanofi pasteur) | |
| Pediacel 0.5 mL (sanofi pasteur) | |
| Pediacel 0.5 mL x 1's (sanofi pasteur) | |
| Pediacel / pre-filled syringe 0.5 mL x 1's (sanofi pasteur) | |
| Injectable; Injection; Diphtheria Toxoid 15 LF; Filamentous Haemagglutinin 20 mcg; Fimbriae 5 mcg; Haemophilus Influenzae Type B-PRP 10 mcg; Poliomyelitis Vaccine Inactivated / D.C.O. Type 1 Mahoney 40 units; Poliomyelitis Vaccine Inactivated / D.C.O. Typ (sanofi pasteur) | |
| Pediacel vaccine inj / vial 0.5 mL x 1's (sanofi pasteur) | |
| Pentaxim (Colombia, Latvia, Turkey) | |
| Pentaxim / pre-filled syringe 0.5 mL x 1's (Sanofi Pasteur) | |
| Pentaxim 1 Bottle boät 1 lieà u Act-Hib in bôm tieâm 1 lieà u DTacP-IPV 0.5 mL (Sanofi Pasteur) | |
| 0.5ml (Sanofi Pasteur) | $ 24.89 |
| Pentaxim / vial + 0.5 mL pre-filled syringe 1's (Sanofi Pasteur) | $ 42.00 |
| PENTAXIM INJECTION 1 vial / 0.5 ML injection each (Sanofi Pasteur) | $ 30.06 |
| Pentaxim vaccine / inj / vial + pre-filled syringe / 0.5 mL 2's (Sanofi Pasteur) | $ 42.00 |
| Pentaxim vaccine / inj / / vial + pre-filled syringe 0.5 mL x 2's (Sanofi Pasteur) | |
| Pentaxim vaccine / pre-filled syringe / + 1 vial / lyophilised powd 0.5 mL x 2's (Sanofi Pasteur) | |
| PENTAXIM inj 0.5ml (Sanofi Pasteur) | $ 22.81 |
| Pentaxim vaccine / inj / Vial + Pre-filled syringe 0.5 mL x 2's (Sanofi Pasteur) | |
| Pentaxim vaccine / inj 0.5 mL x 2's (Sanofi Pasteur) | |
| Quinvaxem (Thailand) | |
| Quinvaxem / vial 0.5 mL x 1's (GlaxoSmithKline) | $ 23.20 |
| Quinvaxem 0.5 mL x 50's (GlaxoSmithKline) | $ 1160.00 |
| QUINVAXEM 30IU/60IU INJECTION 1 vial / 1 ML injection each (GlaxoSmithKline) | $ 10.48 |
| Quinvaxem vaccine / inj 0.5 mL x 1's (GlaxoSmithKline) | $ 31.11 |
| Quinvaxem vaccine / inj 0.5 mL x 50 x 1's (GlaxoSmithKline) | |
| Quinvaxem vaccine / vial 0.5 mL x 1's (GlaxoSmithKline) | |
| QUINVAXEM 30IU/60IU INJECTION 1 vial / 0.5 ML injection each (GlaxoSmithKline) | $ 10.48 |
| Quinvaxem Injection (GlaxoSmithKline) | $ 10.48 |
| Shan5 (Georgia) | |
| Tétravac (France, Belgium, Switzerland, Italy, Ireland, Sweden, Finland, Portugal) | |
| Injectable; Injection; Bordetella Pertussis Toxoid 25 mcg; Diphtheria Toxoid 30 IU; Filamentous Haemagglutinin Bordetella Pertussis 25 mcg; Inactivated Poliomyelitis Virus Type 1 40 UD; Inactivated Poliomyelitis Virus Type 2 8 UD; Inactivated Poliomyeliti (Sanofi pasteur) | |
| Injectable; Injection; Bordetella Pertussis Toxoid 25 mcg; Diphtheria Toxoid 30 IU; Filamentous Haemagglutinin Bordetella Pertussis 25 mcg; Inactivated Poliomyelitis Virus Type 1 40 UD; Inactivated Poliomyelitis Virus Type 2 8 UD; Inactivated Poliomyeliti (Sanofi pasteur) | |
| Tetraxin (Thailand) | |
| Tritanrix HB+Hiberix (Chile) | |
| Tritanrix-hepb (Netherlands) | |
| Vacina adsorvida contra dif, tet, coq acel, polio inat hepat b (rec) e hib conj (Brazil) | |
| Vacina comb contra dif-tet,-pert acel (Brazil) | |
| Vacina comb contra dif-tet,-pert acel e hib (Brazil) | |
| Vacina comb contra dif-tet,-pert acel hepatb r-dna, polio inat e hib (Brazil) | |
| Vacina comb contra dif-tet,-pert acel, polio inat e hib (Brazil) | |
See 56 substitutes for Infanrix Tetra | |
Reviews
The results of a survey conducted on ndrugs.com for Infanrix Tetra are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Infanrix Tetra. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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| Users | % | ||
|---|---|---|---|
| 1-5 | 1 | 100.0% | |
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Information checked by Dr. Sachin Kumar, MD Pharmacology
