Infanrix-IPV+Hib

Infanrix-IPV+Hib

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
Full Prescribing Info
Contents
Combined diphtheria-tetanus-acellular pertussis, enhanced inactivated polio and Haemophilus influenzae type b vaccine.
Description
After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid1 not less than 30 International Units (IU) (25 Lf).
Tetanus toxoid1 not less than 40 International Units (IU) (10 Lf).
Bordetella pertussis antigens: Pertussis toxoid (PT)1 25 micrograms; Filamentous haemagglutinin (FHA)1 25 micrograms; Pertactin (PRN)1 8 micrograms.
Poliovirus (inactivated) (IPV): 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 influenzae type b polysaccharide (polyribosylribitol phosphate) (PRP) 10 micrograms conjugated to tetanus toxoid as carrier protein approximately 25 micrograms.
1adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 0.5 milligrams Al3+.
2propagated in VERO cells.
The Infanrix-IPV component of the vaccine is a turbid white suspension. Upon storage, a white deposit and clear supernatant can be observed.
The Hib component of the vaccine is a white powder.
Excipients/Inactive Ingredients: Lactose; sodium chloride; Medium 199 (as stabilizer including amino acids, mineral salts and vitamins); water for injections. Potassium chloride; disodium phosphate; monopotassium phosphate; polysorbate 80; glycine; formaldehyde; neomycin sulphate; polymyxin sulphate are present as residuals from the manufacturing process.
Action
Pharmaco-therapeutic group: Bacterial and viral vaccines combined. ATC code: J07CA06.
Pharmacology: Pharmacodynamics: Results obtained in the clinical studies for each of the components are summarised in the tables as follows: (See Tables 1 and 2.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

The effectiveness of the Hib component (when combined with DTPa, DTPa-IPV or DTPa-HBV-IPV) was investigated via an extensive post-marketing surveillance study conducted in Germany. Over a 4.5 year follow-up period, the effectiveness of DTPa+Hib or DTPa-IPV+Hib vaccines was 96.7% for a full primary series and 98.5% for a booster dose (irrespective of priming). Over a seven year follow-up period, the effectiveness of the Hib components of two hexavalent vaccines was 89.6% for a full primary series and 100% for a full primary series plus booster dose (irrespective of the Hib vaccine used for priming).
Pharmacokinetics: Evaluation of pharmacokinetic properties is not required for vaccines.
Toxicology: Preclinical safety data: Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, local tolerance and repeated dose toxicity.
Indications/Uses
Infanrix-IPV+Hib is indicated for active immunisation in infants from the age of 2 months against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b.
Infanrix-IPV+Hib is also indicated as a booster dose for children who have previously been immunised with diphtheria, tetanus, pertussis (DTP), polio and Hib antigens.
The Hib component of the vaccine does not protect against diseases due to other serotypes of Haemophilus influenzae nor against meningitis caused by other organisms.
Dosage/Direction for Use
Posology: The primary vaccination schedule consists of three doses in the first 6 months of life and can start from the age of 2 months. An interval of at least 1 month should be respected between subsequent doses.
A booster dose is recommended in the second year of life, with an interval of at least 6 months after completion of primary vaccination schedule.
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 at alternate sites.
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.
Overdosage
Some cases of overdose have been reported during post-marketing surveillance. Adverse events, when reported following overdosage, were similar to those observed after administration of the recommended dose of Infanrix-IPV+Hib.
Contraindications
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.
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.
Special Precautions
As with other vaccines, the administration of Infanrix-IPV+Hib should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contra-indication.
It is good clinical practice that 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.
If any of the following events occur in a temporal relation to receipt of DTP-containing vaccine, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered. 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 benefit ratio of acellular pertussis vaccine is better than the risk benefit ratio of whole cell pertussis vaccine. The following events were previously considered contra-indications for DTPw and can now be considered precautions: 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.
In children with progressive neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy, it is better to defer pertussis (Pa or Pw) immunization until the condition is corrected or stable. However, the decision to give pertussis vaccine must be made on an individual basis after careful consideration of the risks and benefits.
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.
Human Immunodeficiency Virus (HIV) infection is not considered as a contra-indication.
The expected immunological response may not be obtained after vaccination of immunosuppressed patients, e.g. patients on immunosuppressive therapy.
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.
Infanrix-IPV+Hib contains traces of neomycin and polymyxin. The vaccine should be used with caution in patients with known hypersensitivity to one of these antibiotics.
The use of Infanrix-IPV+Hib is not recommended in adults, adolescents or children above 5 years of age.
As with all diphtheria, tetanus, and pertussis vaccines, the vaccine should be administered by deep intramuscularly. The vaccine should be given in the anterolateral aspect of the thigh. It is preferable that each subsequent dose is given at alternate sites.
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.
Excretion of capsular polysaccharide antigen in the urine has been described following receipt of Hib vaccines, and therefore antigen detection may not have a diagnostic value in suspected Hib disease within 1-2 weeks of vaccination.
Infanrix-IPV+Hib should under no circumstances be administered intravenously.
The vaccination should be recorded in the patient's International Vaccination Certificate.
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.
Effects on ability to drive and use machines: Not relevant.
Use In Pregnancy & Lactation
Pregnancy: As Infanrix-IPV+Hib is not intended for use in adults, information on the safety of the vaccine when used during pregnancy is not available.
Lactation: As Infanrix-IPV+Hib is not intended for use in adults, information on the safety of the vaccine when used during lactation is not available.
Adverse Reactions
Clinical Trial Data: The safety profile presented below is based on data from more than 3500 subjects.
As has been observed for DTPa and DTPa-containing combinations, an increase in local reactogenicity and fever was reported after booster vaccination with Infanrix-IPV+Hib with respect to the primary course.
Adverse reactions reported are listed according to the following frequency: Very common: ≥ 1/10; Common: ≥ 1/100 and < 1/10; Uncommon: ≥ 1/1000 and < 1/100; Rare: ≥ 1/10000 and < 1/1000; Very rare: < 1/10000.
Infections and infestations: Uncommon: Upper respiratory tract infection.
Blood and lymphatic system disorders: Uncommon: lymphadenopathy.
Metabolism and nutrition disorders: Very common: appetite lost.
Psychiatric disorders: Very common: irritability, crying abnormal, restlessness.
Nervous system disorders: Very common: somnolence.
Respiratory, thoracic and mediastinal disorders: Uncommon: cough, bronchitis, rhinorrhoea.
Gastrointestinal disorders: Common: diarrhoea, vomiting.
Skin and subcutaneous tissue disorders: Uncommon: rash, urticaria.
Rare: pruritus, dermatitis.
General disorders and administration site conditions: Very common: injection site reactions such as pain and redness, local swelling at the injection site (≤50 mm), fever (≥38.0°C).
Common: injection site reactions including induration, local swelling at the injection site (>50 mm)1.
Uncommon: fever >39.5°C2, fatigue, diffuse swelling of the injected limb, sometimes involving the adjacent joint1.
Post-marketing data: Respiratory, thoracic and mediastinal disorders: Apnoea3 [see Precautions for apnoea in very premature infants (≤ 28 weeks of gestation)].
Blood and lymphatic system disorders: Thrombocytopenia4.
Immune system disorders: Allergic reactions (including anaphylactic3 and anaphylactoid reactions).
Nervous system disorders: Convulsions (with or without fever), collapse or shock-like state (hypotonic-hyporesponsiveness episode).
Skin and subcutaneous tissue disorders: Angioneurotic oedema3.
General disorders and administration site conditions: Swelling of the entire injected limb1, injection site vesicles3.
1Children 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.
2common with booster vaccination.
3reported with GSK's DTPa containing vaccines.
4reported with D and T vaccines.
Drug Interactions
It is current practice in paediatric vaccination to coadminister different vaccines during the same session, where injectable vaccines should always be given at different injection sites.
Infanrix-IPV+Hib can be administered concomitantly with hepatitis B vaccine, the injection being applied 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.
Caution For Usage
Instructions for use and handling, and disposal (if appropriate): The Hib powder, the Infanrix-IPV suspension and the reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine.
Since a white sediment may form during storage, the Infanrix-IPV suspension should be shaken before reconstitution.
The vaccine must be reconstituted by adding the entire contents of the supplied container of the Infanrix-IPV component to the vial containing the Hib powder. Only the components of the vaccine should be mixed together and not with other vaccines or other batches of components. After the addition of the DTPa-IPV component to the Hib powder, the mixture should be well shaken.
The reconstituted Infanrix-IPV+Hib vaccine presents as a slightly more cloudy suspension than the liquid Infanrix-IPV component alone. This is normal and does not impair the performance of the vaccine. In the event of other variation being observed, discard the vaccine.
After reconstitution, the vaccine should be injected immediately.
Withdraw the entire contents of the vial.
Any unused product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: Reconstituted Infanrix-IPV+Hib should not be mixed with other vaccines in the same syringe.
Storage
The Hib component and the DTPa-IPV component should be stored at between +2°C to +8°C.
The Infanrix-IPV vaccine should not be frozen. Discard if the vaccine has been frozen.
ATC Classification
J07CA06 - diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus ; Belongs to the class of combined bacterial and viral vaccines.
Presentation/Packing
Pre-filled syringe (turbid white DTPa-IPV vaccine suspension) 0.5 mL x 1's + vial (white powd Hib vaccine).
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