23
IS A SPECIAL NUMBER FOR SOME PEOPLE
The record for the tallest costume worn in a marathon is for a giraffe that measured just over 23 feet!1
Pneumovax®
II includes 23 serotypes of
pneumococcus that most frequently cause serious pneumococcal infection in adults.2
And, for patients aged 65 and over: Pneumovax®
II is the pneumococcal vaccine
currently recommended by the Department of Health.2,3
HELPING TO PROTECT PATIENTS AGAINST 23 SEROTYPES OF PNEUMOCOCCUS
ABRIDGED PRESCRIBING INFORMATION PNEUMOVAX®
II solution for injection in a vial
Pneumococcal Polysaccharide Vaccine Refer to Summary of Product Characteristics for full product information. Presentation: Pneumovax II is supplied as a single dose vial containing 0.5 millilitre of solution. Each dose contains 25 micrograms of each polysaccharide type derived from capsules of the 23 most prevalent pneumococci, dissolved in isotonic saline solution containing 0.25% phenol. Indications: For active immunisation against disease caused by the pneumococcal serotypes included in the vaccine. The vaccine is recommended for individuals 2 years of age or older in whom there is an increased risk of morbidity and mortality from pneumococcal disease. The specifi c at risk categories of persons to be immunised are to be determined on the basis of offi cial recommendations. The vaccine is not effective for the prevention of acute otitis media, sinusitis and other common upper respiratory tract infections. Dosage and administration: One single dose of 0.5 millilitre is administered by intramuscular or subcutaneous injection. Special dosing: It is recommended that pneumococcal vaccine is given at least two weeks before elective splenectomy or the initiation of chemotherapy or other immunosuppressive treatment. Vaccination during chemotherapy or radiation therapy should be avoided, and the vaccine should not be administered any sooner than three months after completion
of such therapy. Persons with asymptomatic or symptomatic HIV infection should be vaccinated as soon as possible after diagnosis is confi rmed. Revaccination: Healthy adults and children should not be revaccinated routinely. Revaccination at intervals of less than three years is not recommended because of an increased risk of adverse reactions. Revaccination may be considered for adults at increased risk of serious pneumococcal infection who were given pneumococcal vaccine more than fi ve years earlier or for those known to have rapid decline in pneumococcal antibody levels. Revaccination after 3 years may be considered for selected populations (e.g. asplenics) who are known to be at high risk of fatal pneumococcal infections and for children 10 years old or younger at high risk of pneumococcal infection. Contraindications: Hypersensitivity to any component of the vaccine. Warnings and precautions: As with any vaccine, adequate medical treatment, including epinephrine (adrenaline), and supervision should always be available in case of an acute anaphylactic reaction. It is not known whether the vaccine can cause foetal harm or affect reproduction capacity when administered to a pregnant woman; the vaccine can be given to pregnant women only if clearly needed (potential benefi t outweighs potential risk). It is not known whether this vaccine is excreted in human milk; caution should be exercised when the vaccine is administered to a nursing mother. Vaccination should be delayed in the presence of signifi cant febrile illness or other active infection, except where delay involves greater risk. The vaccine should never be injected
intravascularly. The vaccine should not be injected intradermally as injection by that route is associated with increased local reactions. If the vaccine is administered to patients who are immunosuppressed due to either an underlying condition or medical treatment (e.g. immunosuppressive therapy), the expected serum antibody response may not be obtained after a fi rst or second dose, so such patients may not be as well protected against pneumococcal disease as immunocompetent individuals. Required prophylactic pneumococcal antibiotic therapy should not be stopped after vaccination. The vaccine may not be effective in preventing infection resulting from basilar skull fracture or from external communication with cerebrospinal fl uid. As with any vaccine, vaccination with Pneumovax II may not result in complete protection in all recipients. Pneumovax II and Zostavax should not be given concurrently because concomitant use in a clinical trial resulted in reduced immunogenicity of Zostavax. Undesirable effects: Very common side effects: Fever and injection site reactions such as pain, soreness, erythema, warmth, swelling and induration. Other reported side effects that may potentially be serious include thrombocytopenia in patients with
stabilised idiopathic thrombocytopenic purpura, haemolytic anaemia in patients who have had other haematologic disorders, leukocytosis, anaphylactoid reactions, serum sickness, angioneurotic oedema, Guillain-Barré Syndrome, radiculoneuropathy, febrile convulsions and injection site cellulitis. For a complete list of undesirable effects please refer to the Summary of Product Characteristics. Package quantities and basic NHS cost: Single pack containing one 0.5 millilitre single dose vial, basic NHS cost £8.32 (single). Marketing authorisation holder: Sanofi Pasteur MSD Limited, Mallards Reach, Bridge Avenue, Maidenhead, Berkshire SL6 1QP. Marketing authorisation number: PL 06745/0103 Legal category: POM Date of last review: August 2013
References: 1. Guinness World Records, 2013. www.
guinnessworldrecords.com Accessed August 2013. 2. Department of Health. Immunisation against infectious disease (Green Book). Chapter 25: Pneumococcal. Updated April 2013. Accessed August 2013. 3. Department of Health. Vaccines update. Issue 186 January/February 2012. Accessed August 2013.
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard Adverse events should also be reported to Sanofi Pasteur MSD, telephone number 01628 785291.
UK16869d 09/13
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