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Medicine information : INFANRIX IPV
| Drug class description : | Vaccines. |
| Generic Name : | Diptheria, tetanus, pertussis |
| Drug description : | One dose (0.5 ml) contains Diphtheria toxoid* 30 IU Tetanus toxoid* 40 IU Bordetella pertussis antigens Toxoid* 25 micrograms Filamentous Haemagglutinin* 25 micrograms Pertactin* 8 micrograms Inactivated poliovirus type 1** 40 DU*** Inactivated poliovirus type 2** 8 DU*** Inactivated poliovirus type 3** 32 DU*** * adsorbed on aluminium oxide hydrated 0.5 mg ** propagated in VERO cells *** DU : D antigen units |
| Presentation : | Infanrix-IPV, suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed) |
| Indications : | This vaccine is indicated for booster vaccination against diphtheria, tetanus, pertussis, and poliomyelitis diseases in individuals from 16 months to 13 years of age inclusive. The administration of Infanrix-IPV should be based on official recommendations. |
| Adult Dosage : | Not recommended. |
| Child Dosage : | A single dose of 0.5 ml should be administered. Infanrix-IPV may be administered to subjects who have previously received whole cell or acellular pertussis-containing vaccines, and oral live attenuated or injected inactivated poliomyelitis vaccines. (See Adverse Reactions). Method of administration The vaccine is for intramuscular injection, usually into the deltoid muscle. However, the anterolateral thigh may be used in very young subjects if preferred. Do not administer intravascularly. |
| Elderly Dosage : | Not recommended. |
| Contra Indications : | Hypersensitivity reaction after previous administration of diphtheria, tetanus, pertussis or polio vaccines. Known hypersensitivity to any component of the vaccineor to neomycin, polymyxin B or formaldehyde (which may be present in the vaccine as trace residues of manufacture). Infanrix-IPV should not be administered to subjects who experienced neurological complications (for convulsions or hypotonic-hyporesponsive episodes, see Special Precautions) following previous immunisation with any of the antigens in the vaccine. Infanrix-IPV should not be administered to subjects who experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with a pertussis containing vaccine. As with other vaccines, administration of Infanrix-IPV should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection is not a contra-indication. |
| Special Precautions : | As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination. A family history of convulsions or a family history of Sudden Infant Death Syndrome (SIDS) does not constitute a contra-indication. If any of the following events are known to have occurred in temporal relation to receipt of pertussis-containing vaccine, the decision to give further doses of pertussis-containing vaccines should be carefully considered: - temperature of 40.0°C within 48 hours, not due to another identifiable cause, - collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination, - persistent, inconsolable crying lasting 3 hours, occurring within 48 hours of vaccination, - convulsions with or without fever, occurring within 3 days of vaccination. There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks. Infanrix-IPV should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. HIV infection is not considered as a contra-indication. The expected immunological response may not be obtained after vaccination of immunosuppressed patients. For children under immunosuppressive treatment (corticosteroid therapy, antimitotic chemotherapy, etc.), it is recommended to postpone vaccination until the end of treatment. Infanrix-IPV should under no circumstances be administered intravascularly. |
| Interactions : | Infanrix-IPV has been administered concomitantly with measles-mumps-rubella vaccine or Hib vaccine in clinical trials. The data available do not suggest any clinically relevant interference in the antibody response to each of the individual antigens. Interaction studies have not been carried out with other vaccines, biological products or therapeutic medications. However, in accordance with commonly accepted immunisation guidelines, since Infanrix-IPV is an inactivated product, there is no theoretical reason why it should not be administered concomitantly with other vaccines or immunoglobulins at separate sites. As with other vaccines it may be expected that in patients receiving immunosuppressive therapy or patients with immunodeficiency, a protective immune response to one or more antigens in the vaccine may not be achieved. Pregnancy and lactation It is anticipated that Infanrix-IPV would only rarely be administered to subjects of child-bearing potential. Adequate human data on the use of Infanrix-IPV during pregnancy and lactation are not available and animal studies on reproductive toxicity have not been conducted. Consequently the use of this combined vaccine is not recommended during pregnancy. It is preferable to avoid the use of this vaccine during lactation. |
| Adverse Reactions : | The safety of Infanrix-IPV has been evaluated in 2030 subjects in clinical studies. All vaccinees had previously received either 3 or 4 doses of a combined diphtheria, tetanus and pertussis vaccine. These vaccines contained either whole cell (Pw) or acellular (Pa) pertussis components as follows: -736 children aged 15-26 months had previously been given 3 doses of DTP –37 had received DTPw, 699 had received DTPa, – 593 children aged 4-7 years had previously been given either 3 or 4 doses of DTP – 128 had received 3 doses of DTPw, 211 had received 3 doses of DTPa, 73 had received 4 doses of DTPw, 181 had received 4 doses of DTPa – 701 children aged 10-14 years had received 4 doses of DTPw All had received a full primary course of either IPV or OPVVaccinees aged 10-14 years had also received an additional dose of diphtheria, tetanus and polio antigens at approximately 5-6 years. Booster doses of DTPa-containing vaccines may be more reactogenic in children who have been previously primed with acellular pertussis-containing vaccines. Adverse reactions reported during these studies were mostly reported within 48 hours following vaccination, were of mild to moderate severity and resolved spontaneously. Very common ( 10%) : Local reactions : pain, redness and swelling at the injection site* General symptoms : fever, headache, malaise, somnolence, irritability, loss of appetite, restlessness, unusual crying Common ( 1% and < 10%) : Nausea, vomiting, diarrhoea, asthenia. Uncommon ( 0.1% and < 1%) Lymphadenopathy, rash, insomnia, rhinitis, coughing, urinary incontinence, abdominal pain, back pain Rare ( 0.01% and < 0.1%) Pruritis, earache, pharyngitis, eye pain * Information on extensive swelling of the injected limb (defined as swelling with a diameter> 50mm, noticeable diffuse swelling or noticeable increase of limb circumference) occurring after Infanrix-IPV was actively solicited in two clinical trials. When Infanrix-IPV was administered as either a fourth dose or a fifth dose of DTPa to children 4-6 years of age, extensive injection site swelling was reported with incidences of 13% and 25% respectively. The most frequent reactions were large, localised swelling (diameter> 50mm) occurring around the injection site. A smaller percentage of children (3% and 6% respectively) experienced diffuse swelling of the injected limb, sometimes involving the adjacent joint. In general, these reactions began within 48 hours of vaccination and spontaneously resolved over an average of 4 days without sequelae. Allergic reactions, including urticaria, rash and anaphylactoid reactions have been reported very rarely during post-marketing surveillance. |
| Manufacturer : | GlaxoSmithKline(GSK) |
| Drug Availability : | (POM) |
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