Pentaxim

The powder is white and the solvent cloudy whitish.
The active substances are: After reconstitution one dose (0.5 ml) contains: Diphtheria toxoid¹ >20 IU^2,3 (30 Lf), Tetanus toxoid¹ >40 IU^3,4 (10 Lf), Bordetella pertussis antigens: Pertussis toxoid¹ 25 micrograms, Filamentous haemagglutinin¹ 25 micrograms, Poliomyelitis virus (inactivated)⁵ Type 1 (Mahoney) 40 D antigen units⁶, Type 2 (MEF-1) 8 D antigen units⁶, Type 3 (Saukett) 32 D antigens units⁶, Haemophilus influenzae type b polysaccharide 10 micrograms, conjugated with tetanus protein 18-30 micrograms.
¹ Adsorbed on hydrated aluminium hydroxide 0.3 mg Al³⁺.
² As lower confidence limit (p=0.95) and not less than 30 IU in mean value.
³ Or equivalent potency determined by immunogenicity assessment.
⁴ As lower confidence limit (p=0.95).
⁵ Produced on VERO cells.
⁶ Or equivalent quantity of antigen determined by an appropriate immunochemical method.
Excipients/Inactive Ingredients: The other ingredients are: Suspension for injection: Hanks' Medium 199 without phenol red, Glacial acetic acid and/or sodium hydroxide (for pH adjustment), Formaldehyde, Phenoxyethanol, Ethanol, anhydrous, Water for injections.
Hanks' Medium 199 is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins and other components (such as glucose) diluted in water for injections.
Powder: Sucrose, Trometamol, Concentrated hydrochloric acid for pH adjustment.

PENTAXIM (DTaP-IPV-Hib) is a vaccine. Vaccines are used to protect against infectious diseases.
When PENTAXIM is injected, the body's natural defenses build up protection against these diseases.
PENTAXIM is indicated to help the child protect themselves against diphtheria, tetanus, whooping cough, poliomyelitis and against invasive infections caused by Haemophilus influenzae type b bacteria (meningitis, blood infection, 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 nor against meningitis caused by other microorganisms.

This vaccine will be given to the child by a healthcare professional.
Dosage: 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 to administer a dose of vaccine, to the child, inform the doctor, who will decide when to administer this dose.
If the patient has any further questions on the use of this medicine, ask a doctor or pharmacist.

Do not use PENTAXIM: if the child is allergic (hypersensitive): to any of the ingredients of this vaccine (listed in Description), glutaraldehyde, neomycin, streptomycin, or polymyxin B (used during manufacture and which may be present in trace amounts), to a pertussis vaccine (acellular or "whole-cell"); if the child has had an allergic reaction after a previous injection of the same vaccine or a vaccine containing the same substances; if the child suffers from evolving encephalopathy (brain damage); if child has had encephalopathy (brain damage) within 7 days of a previous dose of a "whole-cell" or a cellular pertussis vaccine; if the child has a fever or has an illness that occurred suddenly (acute illness), in this case it is better to postpone the vaccination.

Talk to a doctor before using PENTAXIM.
If child has blood disorders such as a low number of platelets (thrombocytopenia) or clotting disorders due to the risk of bleeding, which may occur during intramuscular administration.
If child has ever had seizures with fever, not related to a previous vaccine injection; it is particularly important in this case to monitor the temperature within 48 hours of vaccination and to give regular treatment to reduce the fever, for 48 hours.
If child has had any of the following events after receiving a vaccine (the decision to give further doses of vaccine containing a pertussis valence should then be carefully evaluated): Fever greater than or equal to 40°C within 48 hours, without any other identifiable cause, Collapse or state suggesting a state of shock with episode of hypotonia-hyporesponsiveness (decrease in tone) within 48 hours of vaccination, Persistent, inconsolable crying for 3 hours or more, occurring within 48 hours after vaccination, Convulsions with or without fever, occurring within 3 days after vaccination.
If child has or has had any medical problems or allergies, in particular an allergic reaction following an injection of PENTAXIM.
If child has had Guillain-Barré syndrome (abnormal sensitivity, paralysis) or brachial plexus neuropathy (paralysis, widespread pain in the arm and shoulder) after injection of a vaccine containing tetanus toxoid (tetanus vaccine), the decision to re-administer a vaccine containing tetanus toxoid in this case will be evaluated by the doctor.
If child has experienced swelling (oedematous reactions) of the lower limbs following an injection of a vaccine containing the Haemophilus influenzae type b valence: the administration of the diphtheria-tetanus-pertussis-poliomyelitis vaccine and the Haemophilus influenzae type b conjugate vaccine must then be carried out at two separate injection sites and on different days.
If child has weakened immune defenses or is undergoing treatment with corticosteroids, cytotoxic medicines, radiotherapy or other treatments that may weaken his immune system: then the immune response may be diminished. It is then recommended to wait until the end of the treatment or the disease to vaccinate. Nevertheless, vaccination is recommended in subjects with chronic immunosuppression, 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 influenzae type b, nor against meningitis of other origins.
Fainting can occur following, or even before, any needle injection. Also, tell the doctor or nurse if the child has fainted from a previous injection.
PENTAXIM contains phenylalanine, ethanol and sodium.
PENTAXIM contains 12.5 micrograms of phenylalanine per 0.5 mL dose. Phenylalanine may be dangerous for people with phenylketonuria (PKU), a rare genetic condition where phenylalanine, builds up and 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 effect.
PENTAXIM contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially 'sodium-free'.
Interference with laboratory testing: Due to the urinary elimination of the Hib polysaccharide capsular antigen, a positive result may be observed in a urine test 1 to 2 weeks after vaccination. Other tests should be done to confirm Hib infection during this time.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions: Severe allergic reactions, although very rare, may occur after vaccination, usually the child is still at the vaccination site.
If any of the signs or symptoms described as follows occur after leaving the place where the child was vaccinated, patient should immediately contact a doctor or medical emergencies.
Swelling of the face (oedema of the face), sudden swelling of the face and neck (angioedema, Quincke's oedema).
Sudden and severe 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 side effects described as follows, or if they persist or worsen, patient should tell the doctor or pharmacist.
Very common reactions (reported in more than one in 10 children): Loss of appetite; Nervousness, irritability; Abnormal crying and screaming; Drowsiness; Vomiting; Redness at the injection site; Fever at 38°C or higher; Swelling (oedema) at the injection site; Pain at the injection site.
Common reactions (reported in less than one in 10 children but more than one in 100 children): Diarrhoea; Hardening (induration) at the injection site; Insomnia, sleep disorders.
Uncommon reactions (reported in less than one in 100 children but more than one in 1,000 children): Redness and swelling (oedema) of 5 cm or more at the injection site; Fever at 39°C or higher; Inconsolable and prolonged crying and screaming (lasting more than 3 hours).
Rare reactions (reported in less than one in 1,000 but more than one in 10,000 children): Fever above 40°C; Swelling of the legs and feet (oedematous reactions of the lower limbs) with bluish discoloration of the skin (cyanosis) or redness, transient small red spots (purpura), occurring within hours of vaccination and disappearing without treatment and without sequelae. These swellings can be accompanied by heavy crying.
Reactions of unknown frequency (frequencies cannot be calculated because these reactions are reported very rarely): Seizures with or without fever; Decline in tone, periods during which the child is pale, unresponsive, seems in shock (episodes of hypotonia-hyporesponsiveness); Skin rashes, redness (erythema), itching (urticaria); Large reactions at the injection site, greater than 5 cm, with swelling (oedema) of the limb, which may extend to the joints on either side of the injection site. These reactions appear 24 to 72 hours after vaccination and may be associated with symptoms such as redness (erythema), warmth, tenderness or pain at the injection site. They disappear spontaneously in 3 to 5 days.
Potential side effects (i.e., not reported directly with PENTAXIM, but with other vaccines containing one or more of the antigenic constituents of PENTAXIM) are as follows: Guillain-Barré syndrome (abnormal tenderness, paralysis) and brachial plexus neuropathy (paralysis, widespread arm and shoulder pain) after administration of a vaccine containing tetanus toxoid.
Additional information concerning particular 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.
Reporting of side effects: If the child gets any side effects, talk to a doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects, patient can help provide more information on the safety of this medicine.

If child must be vaccinated simultaneously with PENTAXIM and vaccines, ask the doctor or pharmacist for more information.
Tell the doctor or pharmacist if the child is taking, has recently taken or might take any other medicines.

The following information is intended for healthcare professionals only: For syringes without a needle attached, the needle should be fitted firmly onto the syringe by rotating it a quarter turn.
Reconstitute the vaccine by injecting the suspension of the combined diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine into the Haemophilus influenzae type b conjugate vaccine powder vial.
Shake until the powder is completely dissolved. The cloudy whitish appearance of the suspension after reconstitution is normal.
The vaccine should be administered immediately after reconstitution.
Administer intramuscularly (IM).
Administration will preferably take place in the anterolateral aspect of the thigh (middle third) in infants and in the deltoid region in children.
This vaccine must never be administered into a blood vessel (intravascular route).

Store in a refrigerator at a temperature (2°C-8°C). Do not freeze.
Do not use this medicine if the patient notices any abnormal colouring or the presence of foreign particles.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer use. These measures will help protect the environment.

Vaccines, Antisera & Immunologicals

J07CA06 - diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus ; Belongs to the class of combined bacterial and viral vaccines.

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