PENTAXIM

Abbreviated Prescribing Information

See local prescribing information for full details prior to prescribing

1. TRADE NAME OF THE MEDICINAL PRODUCT AND PRESENTATION

PENTAXIM powder and suspension for suspension for injection of diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine and Haemophilus type b conjugate vaccine, adsorbed is available in 1 powder in vial and 0.5 mL of suspension in prefilled syringe with 2 separate needles.

2. THERAPEUTIC INDICATIONS

This vaccine is indicated in the joint prevention of diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b (such as meningitis, septicaemia, cellulitis, arthritis, epiglottitis, etc.),

• For primary vaccination in infants from the age of 2 months,

• For booster vaccination, one year after primary vaccination during the second year of life.

This vaccine does not protect against infections caused by the other type of Haemophilus influenzae nor against meningitis due to other microorganisms.

3. POSOLOGY AND METHOD OF ADMINISTRATION

Posology

The usual recommended schedule consists of three primary infant doses of 0.5 mL to be administered at intervals of at least four weeks using a 2, 4, 6 months schedule, followed by a booster injection within the second year of life or at least 6 months after the last priming dose.

The use of this vaccine should be in accordance with official recommendations.

Method of administration

Administer via the intramuscular route (IM).

Administration should preferably be performed in the anterolateral side of the thigh (middle third) in infants and in the deltoid area in children.

4. CONTRA-INDICATIONS

• Hypersensitivity:

• to any of the active substances of PENTAXIM,

• to any of the excipients,

• to glutaraldehyde, neomycin, streptomycin, or polymyxin B (used during the manufacturing process and which may be present as traces),

• to a pertussis vaccine (acellular or “whole cell”).

• Life-threatening reaction after previous injection of the vaccine or a vaccine containing the same substances.

• Vaccination must be postponed in case of febrile or acute disease.

• Evolving encephalopathy.

• Encephalopathy within 7 days of administration of a previous dose of any vaccine containing pertussis antigens (“whole cell” or acellular pertussis vaccines).

• Pertussis 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.

5. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE

- The immunogenicity of PENTAXIM may be reduced by immunosuppressive treatment or immunodeficiency. It is then recommended to wait until the end of the treatment or disease before vaccinating. Nevertheless, vaccination of subjects with chronic immunodeficiency such as HIV infection is recommended even if the immune response may be limited.

- If Guillain-Barre syndrome or brachial neuritis has occurred in subjects following receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks of vaccination. Vaccination is usually justified for infants whose primary immunization schedules are incomplete (i.e. fewer than three doses administered).

- Do not inject via the intravascular route: make sure the needle does not penetrate a blood vessel. Do not inject via the intradermal route.

- As with all injectable vaccines, PENTAXIM must be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.

- Vaccination must be preceded by medical history screening (especially with regard to vaccination history and any occurrence of undesirable events) and a clinical examination.

If any of the following events are known to have occurred in temporal relation to receipt of vaccine, the decision to give further doses of pertussis-containing vaccine should be carefully considered:

• Fever ≥ 40°C 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.

- A history of febrile convulsions not related to a previous vaccine injection is not a contraindication to vaccination. In this respect, it is particularly important to monitor temperature in the 48 hours following vaccination and to give antipyretic treatment regularly for 48 hours.

- A history of afebrile convulsions not related to a previous vaccine injection should be assessed by a specialist before deciding to vaccinate.

- In the event of oedematous reactions occuring in the lower limbs occurring after injection of a Haemophilus influenzae type b containing vaccine, the two vaccines, diphtheria-tetanus- pertussis-poliomyelitis vaccine and the Haemophilus influenzae type b conjugate vaccine should be administered in two separate injection sites and on two different days.

- As with all injectable vaccines, appropriate medical treatment must be readily available and close supervision provided should a rare anaphylactic reaction occur following administration of the vaccine.

- PENTAXIM does not protect against invasive diseases caused by serotypes other than Haemophilus influenzae type b, nor against meningitis from other origins.

- The potential risk of apnoea and the need for respiratory monitoring for 48-72 h 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.

PENTAXIM contains phenylalanine, ethanol and sodium

PENTAXIM contains 12.5 micrograms of phenylalanine per 0.5 mL dose. Phenylalanine can be dangerous for people with phenylketonuria (PKU), a rare genetic disease characterised by the accumulation of phenylalanine, which cannot be eliminated properly.

PENTAXIM contains 2 mg of alcohol (ethanol) per 0.5 mL dose. The small amount of alcohol in this medicine will not have any noticeable effects.

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Interference with laboratory testing

Since the Hib capsular polysaccharide antigen is excreted in the urine, a positive urine test can be observed within 1 to 2 weeks following vaccination. Other test should be performed in order to confirm Hib infection during this period.

6. INTERACTIONS

This vaccine can be administered simultaneously with the M-M-RVAXPRO vaccine or with the HBVAXPRO vaccine, but in two separate sites.

7. PREGNANCY AND LACTATION

Not applicable.

8. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Not applicable.

9. UNDESIRABLE EFFECTS

- In clinical studies in children who received PENTAXIM as a primary series, the most frequently reported reactions are local injection-site reactions, abnormal crying, irritability and fever. These signs and symptoms usually occur within 48 hours following the vaccination and may continue for 48-72 hours. They resolve spontaneously without requiring specific treatment.

- The frequency of injection-site reactions tends to increase at booster vaccination compared with the frequency observed for primary series.

The following adverse reactions are ranked under headings of frequency and listed as below:

- Very common: loss of appetite, nervousness, irritability, abnormal crying, somnolence, vomiting, injection-site erythema, fever > 38oC, injection-site oedema and injection-site pain.

- Common: insomnia, sleep disturbance, diarrhoea and injection-site induration.

- Uncommon: prolonged inconsolable crying, fever > 39oC, injection-site redness and oedema > 5 cm

- Rare: fever > 40oC

- Not known: Immediate hypersensitivity reaction such as face oedema, angioedema, Quincke's oedema, anaphylactic reactions and shock, convulsions with or without fever, hypotonic-hyporesponsive episodes, rash, erythema and urticarial.

Oedematous reactions on one or on both lower limbs may occur after vaccination with a Haemophilus influenzae type b containing vaccines. These reactions generally occur after primary series, within hours of the vaccination, and resolve without sequelae within 24 hours. These reactions may be accompanied with cyanosis, erythema, transient purpura and severe crying.

Reactions with a Not Known frequency

- Large injection-site reactions (> 50 mm), including extensive limb swelling that may spread from the injection site to one or both adjacent joints. These reactions start within 24-72 hours after vaccination and may be associated with symptoms such as erythema, warmth, tenderness or pain at the injection site. They resolve spontaneously within 3-5 days.

- The risk appears to be dependent on the number of prior doses of acellular pertussis-containing vaccines, with a greater risk following the 4th and 5th doses.

Potential undesirable effects (i.e. that have not been reported directly with PENTAXIM, but with other vaccines containing one or more of the antigenic constituents of PENTAXIM):

• Guillain Barre Syndrome and brachial neuritis after administration of a tetanus toxoid containing vaccine.

Complementary information concerning specific populations

Apnoea in very premature infants (born ≤ 28 weeks of gestation)

10. OVERDOSE

Not documented

11. PHARMACODYNAMIC PROPERTIES

ATC Code: J07CA06

Presentation: Box, 1 powder in vial and 0.5 mL of suspension in prefilled syringe with 2 separate needles.

Manufactured by: Sanofi Pasteur, Parc Industriel d'Incarville, 27100 Val De Reuil, released by Sanofi Pasteur, Lyon, France

Date of reviewed: 16 March 2023 (Based on BPOM Approval on 06 March 2023)

This information is intended for Health Care Professional only. See local product information for full details information