CONTENTS

Polysaccharide pneumococcal vaccine.

PRESENTATION

Prefilled syringe 0.5 mL x 1's.

DESCRIPTION

Pneumo 23 contains polysaccharides of Streptococcus pneumoniae, serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg for each of the 23 serotypes for one 0.5-mL dose).

It also contains the following ingredients: Phenol buffered solution containing phenol, sodium chloride, dihydrated disodium phosphate, dihydrated monosodium phosphate and water for injections.

INDICATIONS

Prevention of pneumococcal infections, in particular, pneumonia caused by the serotypes contained in the vaccine for subjects at risk from the age of 2 years.

DOSAGE & ADMINISTRATION

Primary Vaccination or Revaccination: 0.5-mL injection.

The preferred route of administration is IM or SC.

CONTRAINDICATIONS

Hypersensitivity to any of the components of Pneumo 23.

It is preferable to postpone vaccination in case of fever, acute disease or a relapse of a chronic disease.

PRECAUTIONS

Vaccination is not recommended for subjects who have been vaccinated within the previous 3 years unless indicated otherwise.

A confirmed or suspected episode of pneumococcal infection is not a contraindication and vaccination should be considered according to the underlying risk status.

Use in pregnancy: Pneumo 23 should only be used during pregnancy on medical advice.

SIDE EFFECTS

Local Reactions at the Injection Site: Pain, erythema (redness), induration and oedema (swelling). These reactions are mild and transient.

Rare reactions eg, Arthus phenomenon (severe local reactions) are reversible without after-effects; they mainly occur in subjects with high initial levels of pneumococcal antibody.

Moderate and transient hyperthermia (fever) sometimes above 39°C which generally occurs very shortly after vaccination and resolves within 24 hrs.

Other General Reactions: Adenopathy (inflammation of the lymph nodes), rashes, arthralgia (pain in the joints) and allergic reactions (urticaria, Quincke's oedema [type of urticaria with sudden swelling of the face and neck], anaphylactoid reactions [severe allergic reactions]), headaches, muscle pain, malaise and fatigue have exceptionally been reported.

INTERACTIONS

The vaccine may be administered simultaneously with a flu vaccine as long as different injection sites are used.

Inform the physician or pharmacist if the patient is taking or have recently taken any other medicines even those not prescribed.

STORAGE

Store between 2°C and 8°C (in a refrigerator). Do not freeze.

Shelf-Life: 24 months.