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Drug Details

INFANRIX IPV

• Drug Class Description
  Vaccines.
• Generic Name
  Diptheria, tetanus, pertussis
• Presentation
  Suspension for injection in pre-filled syringe. Infanrix-IPV is a turbid white suspension.
• Description
  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
  

  Posology

  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. 

   

  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.

• 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 to the active substances or to any of the excipients or neomycin, polymyxin or formaldehyde.

  Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, or polio vaccines.

  Infanrix-IPV should not be administered to subjects who experienced neurological complications 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.

• Adverse Drug Reactions
  

  Clincical Trials: 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 OPV. Vaccinees 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.

  Frequencies are defined as follows:

  Very common: 10%

  Common: 1% and < 10%

  Uncommon: 0.1% and < 1%

  Rare: 0.01% and < 0.1%

  Not known: cannot be estimated from the available data

  Infections and infestations

  Rare: pharyngitis

  Blood and lymphatic system disorders

  Uncommon: lymphadenopathy

  Metabolism and nutrition disorders

  Very common: loss of appetite

  Psychiatric disorders:

  Very common: irritability, restlessness, unusual crying

  Uncommon: insomnia

  Nervous system disorders:

  Very common: headache, somnolence

  Eye disorders

  Rare: eye pain

  Ear and labyrinth disorders

  Rare: earache

  Respiratory, thoracic and mediastinal disorders

  Uncommon: rhinitis, coughing

  Gastrointestinal disorders:

  Common: nausea, vomiting, diarrhoea

  Uncommon: abdominal pain

  Skin and subcutaneous tissue disorders

  Uncommon: rash

  Rare: pruritis

  Musculoskeletal and connective tissue disorders

  Uncommon: back pain

  Renal and urinary disorders

  Uncommon: urinary incontinence

  General disorders and administration site conditions:

  Very common: pain, redness and swelling at the injection site*, fever, malaise

  Common: asthenia

  * Information on extensive swelling of the injected limb (defined as swelling with a diameter > 50 mm, 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 > 50 mm) occurring around the injection site. A smaller percentage of children (3% and 6% respectively) experiences diffuse swelling of the injected limb, sometimes involving adjacent joint. In general, these reactions began within 48 hours of vaccination and spontaneously resolved over an average of 4 days without sequelae.

  Post marketing surveillance: Not known: For the following adverse events identified during post-marketing surveillance, an exact quantification of frequency cannot be established.

  Immune system disorders

  Allergic reactions, including anaphylactoid reactions

  Nervous system disorders:

  Convulsions, collapse or shock-like state (hypotonic-hyporesponsiveness episode)

  Skin and subcutaneous tissue disorders

  Urticaria