Full Prescribing Info
Contents
Diphtheria, Tetanus, Pertussis (acellular, component), Poliomyelitis (inactivated) vaccine and Haemophilus type b conjugated vaccine, adsorbed.
Description
The active substances are: After reconstitution one dose (0.5 ml) contains: Diphtheria toxoid(1) ≥30 IU, Tetanus toxoid(1) ≥40 IU, Bordetella pertussis antigens: Pertussis toxoid(1) 25 micrograms, Filamentous haemagglutinin(1) 25 micrograms, Poliomyelitis virus (inactivated) type 1 (Mahoney strain) 40 DU (2)(3)(4), type 2 (MEF-1 strain) 8 DU (2)(3)(4), type 3 (Saukett strain) 32 DU (2)(3)(4), Polysaccharide of Haemophilus influenzae type b 10 micrograms, conjugated to the tetanus protein 18-30 micrograms, (1) adsorbed on aluminum hydroxide, hydrated 0.3 mg Al3+.
(2) DU: D antigen unit.
(3)or equivalent antigenic quantity determined by a suitable immunochemical method.
(4)produced on VERO cells.
Indications/Uses
PENTAXIM is a vaccine. Vaccines are used to protect against infectious diseases.
When PENTAXIM is injected, the body's natural defenses develop a protection against those diseases.
PENTAXIM is indicated to help protect the child against diphtheria, tetanus, pertussis, poliomyelitis and against invasive infections due to Haemophilus influenzae type b bacterium (such as meningitis, blood poisoning, etc.) PENTAXIM is indicated in children from the age of 2 months.
It does not protect against infections caused by other types of Haemophilus influenzae or against meningitis due to other micro-organisms.
Dosage/Direction for Use
The schedule should be chosen in accordance with current national recommendations: 2 injections with an interval of two months, one at the age of 2 months and, one at the age of 4 months, followed by a booster injection at the age of 11 months or 3 injections at an interval of one to two months from the age of 2 months followed by a booster injection within the second year of life.
Method of administration: Administration should be performed into a muscle, preferably in the anterolateral side of the thigh (middle third) in infants, and in the upper arm in children.
If patient forgot to use PENTAXIM: If patient forgot a dose of vaccine, tell the doctor who will decide when to administer the dose.
Contraindications
Never use PENTAXIM: if child is allergic (hypersensitive): to any vaccine components (see Description), 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"); if child had an allergic reaction after a previous injection of the same vaccine or a vaccine containing the same substances; if child suffers from evolving encephalopathy (cerebral lesions); if child suffered from encephalopathy (cerebral lesions) within 7 days of a previous dose of a pertussis vaccine (acellular or "whole cells" pertussis; if child has fever or a disease which occurred suddenly (acute disease), in this case it is preferable to postpone the vaccination.
Special Precautions
If child has blood disorders such as a decrease in platelets (thrombocytopenia) or clotting disorders because of the risk of bleeding which may occur during intramuscular administration.
If child already presented with febrile convulsions, not related to a previous vaccine injection; in this case it is particularly important that temperature be monitored in the 48 hours following vaccination and that antipyretic treatment be regularly administered to help reduce fever, for 48 hours.
If child experienced any of the following events after a previous administration of a vaccine (then the decision to give further doses of this pertussis-containing vaccine will be carefully evaluated): Fever of 40°C or above within 48 hours of vaccination, not due to another identifiable cause.
Collapse or shock-like state with hypotonic-hyporesponsive episode (drop in energy) within 48 hours of vaccination.
Persistent, inconsolable crying lasting 3 hours or more, occurring within 48 hours of vaccination.
Convulsions with or without fever, occurring within 3 days of vaccination.
If child has or had medical issues or allergies, especially an allergic reaction following an injection of PENTAXIM.
If child presented Guillain-Barre syndrome (abnormal sensitivity, paralysis) or brachial neuritis (paralysis, diffuse pain in the arm and shoulder) following receipt of a prior vaccine containing tetanus toxoid should be evaluated by the doctor.
If child presented swelling (oedematous reactions) in lower limbs following injection of a Haemophilus influenzae type b conjugate vaccine should then be administered into two separate injection sites and on different days.
If child has poor immune defenses, or if he/she is treated with corticosteroids, cytotoxic drugs, radiotherapy or other drugs that may weaken his/her immune system: The immune response may be diminished. It is then recommended to wait until the end of the treatment or disease before vaccinating. However vaccination is recommended in subjects with chronic immunodeficiency such as HIV infection, even if the immune response may be limited.
PENTAXIM does not protect against invasive diseases caused by serotypes other than Haemophilus infuenzae type b, or against meningitis of other origins.
Interference with laboratory tests: 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 tests should be performed in order to confirm Hib infection during this period.
Adverse Reactions
Like all medicines, PENTAXIM can cause side effects, although not everybody gets them.
Serious allergic reactions: Serious allergic reactions, although very rare, may occur following vaccination, generally while the child is still present on the place where he/she was vaccinated.
If any of the symptoms listed below occurs after leaving the place where the child was vaccinated, contact the doctor or emergency services IMMEDIATELY.
Swelling of the face (face oedema), sudden swelling of the face and neck (angioedema, Quincke's oedema).
Sudden and serious malaise with drop in blood pressure causing dizziness and loss of consciousness, accelerated heart rate associated with respiratory disorders (anaphylactic reaction and shock).
Other side effects: If the child experiences any of the following side effects listed below and it persists or gets serious, please contact the doctor or pharmacist.
Very common reactions (may affect more than one in 10 children): Loss of appetite; Nervousness, irritability, abnormal crying; Somnolence; Vomiting; Injection-site redness (erythema), fever 38°C or higher, injection-site swelling (oedema), injection-site pain.
Common reactions (may affect less than one in 100 children): Diarrhoea; Injection-site hardening (induration); Insomnia, sleep disorder.
Uncommon reactions (may affect less than one in 100 children but more than one in 1000 children): Injection site redness and swelling (oedema) of 5 cm or more; Fever 39°C or higher; Inconsolable and prolonged crying (for more than 3 hours).
Rare reactions (may affect less than one in 1000 children but more than one in 10 000 children): Fever over 40°C; Swelling in legs and feet (oedematous reactions affecting lower limbs) with a bluish discoloration of the skin (cyanosis) or redness, small transient red spots (purpura) occurring within hours of vaccination, and disappearing without treatment and without sequelae. Swelling may be accompanied with severe crying.
Reactions with a Not Known frequency (frequencies cannot be estimated because these reactions are reported very rarely): Convulsions with or without fever; Drops in energy or periods during which the child is pale, unresponsive or seems in a shock-like state (hypotony-hyporesponsiveness); Skin rash, redness (erythema), itching (urticaria); Large injection-site reactions, larger than 5 cm, including limb swelling (oedema) that may spread to the joints on both sides of the injection site. These reactions start within 24-72 hours after vaccination and may be associated with symptoms such as redness (erythema), warmth, tenderness or pain at the injection site. They resolve spontaneously within 3-5 days.
Potential side 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) are the following: Guillain-Barre syndrome (abnormal sensitivity, paralysis) and brachial neuritis (paralysis, diffuse pain in the arm and shoulder) following the administration of a vaccine containing tetanus toxoid.
Additional information concerning specific populations: In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Drug Interactions
In case the child should receive PENTAXIM simultaneously with other vaccines, please ask the doctor or pharmacist for more information.
Inform the doctor or pharmacist if the child takes or has recently taken any other medicines, even those not prescribed.
Caution For Usage
The following information is intended for healthcare professionals only: For syringes without attached needles, the separate needle must be fitted firmly to the syringe, rotating it by a one-quarter turn.
Reconstitute the vaccine by injecting the suspension of diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine into the vial of powder of the Haemophilus influenzae type b vaccine.
Shake until the powder is completely dissolved. The turbid whitish aspect of the suspension after reconstitution is normal.
The vaccine should be administered immediately after reconstitution.
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.
This vaccine must never be injected in a blood vessel (intravascular route).
Storage
Store in a refrigerator (2°C-8°C). Do not freeze.
Do not use if you notice an abnormal colour or the presence of foreign particles.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
ATC Classification
J07CA06 - diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus ; Belongs to the class of combined bacterial and viral vaccines.
Presentation/Packing
Inj (vial + 0.5 mL pre-filled syringe) 1's.
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