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Medicine information : INFANRIX IPV- HIB
| Drug class description : | Vaccines (inactivated surface antigens). |
| Generic Name : | Diptheria, tetanus, pertussis, haemophilus influenza type b |
| Drug description : | A 0.5 ml dose of vaccine contains : Diphtheria toxoid1 not less than 30 IU Tetanus toxoid1 not less than 40 IU Bordetella pertussis antigens Pertussis toxoid1 25 µg Filamentous haemagglutinin1 25 µg Pertactin1 8 µg Poliovirus (inactivated) type 1 (Mahoney strain)2 40 D-antigen unit type 2 (MEF-1 strain)2 8 D-antigen unit type 3 (Saukett strain)2 32 D-antigen unit Haemophilus type b polysaccharide (polyribosylribitol phospate)10 µg conjugated to tetanus toxoid as carrier protein approximately 30 µg 1Adsorbed on aluminium hydroxide, hydrated 0.5 milligrams Al3+ 2Propagated in VERO cells |
| Presentation : | INFANRIX-IPV+Hib– powder and suspension for suspension for injection Diphtheria, tetanus, pertussis (acellular component), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed) |
| Indications : | INFANRIX-IPV+Hib is indicated for active immunisation against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b disease from the age of 2 months. INFANRIX-IPV+Hib is not suitable for use in children over 36 months of age. |
| Adult Dosage : | Not recommended. |
| Child Dosage : | Primary vaccination: The primary vaccination schedule consists of two or three doses given in accordance with official recommendations. The minimum age at the time of the first dose is 2 months. Subsequent doses of the primary course should be separated by a minimum interval of four weeks. Booster vaccination: After primary vaccination with two doses, a booster dose of INFANRIX-IPV+Hib must be given at least 6 months after the last priming dose, preferably between 11 and 13 months of age. After primary vaccination with three doses, a booster dose of Hib conjugate vaccine (monovalent or combined) must be administered. The timing of this Hib conjugate vaccine booster dose should be in accordance with official recommendations. INFANRIX-IPV+Hib may be used for this booster dose if administration of the additional antigens at the same time is in accordance with official recommendations. INFANRIX-IPV+Hib may be used as a booster dose for children who have previously been immunised with other vaccines that contain DTP, polio and Hib antigens. Method of administration INFANRIX-IPV+Hib is for deep intramuscular injection, in the anterolateral aspect of the thigh. It is preferable that each subsequent dose is given into alternating limbs. INFANRIX-IPV+Hib should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. Firm pressure should be applied to the injection site (without rubbing) for at least two minutes. INFANRIX-IPV+Hib should under no circumstances be administered intravascularly. |
| Contra Indications : | INFANRIX-IPV+Hib should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, inactivated polio or Hib vaccines (see 6.1). INFANRIX-IPV+Hib contains traces of neomycin, polymyxin and polysorbate 80. The vaccine should not be used in patients with known hypersensitivity to one of these substances. INFANRIX-IPV+Hib is contra-indicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. As with other vaccines, the administration of INFANRIX-IPV+Hib should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, however, 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. If any of the following events have occurred in temporal relation to receipt of any DTP-containing vaccine, the decision to give subsequent doses of vaccine containing a pertussis component should be carefully considered. • Temperature of 40.0 °C (rectal) within 48 hours, not due to another identifiable cause. • Collapse or shock-like state (hypotonic-hyporesponsive 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, particularly since the events are not associated with permanent sequelae. According to available clinical data, the risk of such reactions is lower with acellular pertussis vaccines than with whole cell pertussis vaccines. The Hib component of the vaccine does not protect against diseases due to other types of Haemophilus influenzae nor against meningitis caused by other organisms. A history of febrile convulsions, a family history of convulsions, a family history of Sudden Infant Death Syndrome (SIDS) and a family history of an adverse event following DTP, IPV and/or Hib vaccination do not constitute contra-indications to administration of INFANRIX-IPV+Hib. Human Immunodeficiency Virus (HIV) infection is not considered to be a contra-indication to administration of INFANRIX-IPV+Hib. The expected immunological response may not be obtained after vaccination of immunosuppressed patients, e.g. patients on immunosuppressive therapy. Excretion of capsular polysaccharide antigen in the urine has been described following receipt of Hib vaccines. Therefore false positive antigen detection test results are possible within 1-2 weeks of vaccination. Administration of INFANRIX-IPV+Hib should be recorded in the patient's International Vaccination Certificate. |
| Interactions : | If INFANRIX-IPV+Hib is to be given at the same time as another injectable vaccine(s), the vaccines should always be administered at different injection sites. As with other vaccines it may be expected that, in patients receiving immunosuppressive therapy or patients with immunodeficiency, an adequate response may not be achieved. Pregnancy and lactation As INFANRIX-IPV+Hib is not intended for use in adults, information on the safety of the vaccine when used during pregnancy or lactation is not available. |
| Adverse Reactions : | Clinical trials The occurrence of undesirable effects was actively monitored for approximately one month after vaccination. Over 7500 doses of INFANRIX-IPV+Hib were administered in clinical trials involving infants from 2 months to one year of age. The most frequently observed adverse events were reactions at the site of injection (pain, redness, swelling), which occurred after approximately 40% of all doses. Adverse events considered as being at least possibly related to vaccination have been categorised by frequency. No increase in the incidence or severity of these events was seen with subsequent doses of the vaccination series when three doses were administered before one year of age. Frequencies are reported as: Very common: 10% Common: 1% and < 10% Uncommon: 0.1% and < 1% Rare: 0.01% and < 0.1% Very rare: < 0.01% Application site very common: pain, redness, swelling common: injection site mass Body as a whole very common: fever (rectal temperature 38°C), unusual crying uncommon: fever (rectal temperature> 39.5°C), fatigue Central and peripheral nervous system: common: nervousness Gastro-intestinal symptoms very common: loss of appetite common: diarrhoea, vomiting rare: constipation, flatulence Psychiatric very common: restlessness common: somnolence uncommon: insomnia Resistance mechanism rare: otitis media Respiratory system rare: upper respiratory tract infection, pharyngitis, pneumonia, rhinitis Skin and appendages rare: rash erythematous Over 7200 doses of INFANRIX-IPV+Hib have been administered as a fourth, booster dose in clinical trials involving infants in the second year of life. As has been reported for DTPa and DTPa-containing combinations, increases in the incidences of local reactions and fever were observed after booster vaccination with INFANRIX-IPV+Hib compared with the primary course. The injection site reactions (pain, redness, swelling) occurred after approximately 56% of all booster doses; fever> 39.5°C (as measured rectally) increased from 0.3% after the primary course to 1.2% after the fourth, booster dose. Adverse events considered as being at least possibly related to vaccination have been categorised by frequency. Application site very common: pain, redness, local swelling at the injection site ( 50 mm) common: local swelling at the injection site > 50 mm)* uncommon: injection site mass, diffuse swelling of the injected limb, sometimes involving the adjacent joint* Body as a whole very common: fever (rectal temperature 38°C), unusual crying common: fever (rectal temperature> 39.5°C) rare: fatigue Central and peripheral nervous system: uncommon: nervousness Gastro-intestinal symptoms very common: loss of appetite common: diarrhoea, vomiting Platelet bleeding and clotting uncommon: purpura Psychiatric very common: restlessness uncommon: somnolence, sleep disorder rare: insomnia Resistance mechanism rare: otitis media Respiratory system uncommon: upper respiratory tract infection, rhinitis, pharyngitis rare: bronchitis, coughing Skin and appendages uncommon: rash, eczema rare: urticaria, pruritus White cell and reticuloendothelial system uncommon: lymphadenopathy - Post-marketing surveillance Adverse events similar to those observed in the clinical trials have been reported during post-marketing surveillance. Other, less frequent events and their reported incidences were: Application site very rare: swelling of the entire injected limb* Body as a whole very rare: allergic reactions (including anaphylactoid reactions) Central and peripheral nervous system: very rare: collapse or shock-like state (hypotonic-hyporesponsiveness episode), convulsions * Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines. These reactions resolve over an average of 4 days. |
| Manufacturer : | GlaxoSmithKline(GSK) |
| Drug Availability : | (POM) |
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