Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1, PNEUMOCOCCAL POLYSACCHARIDE TYPE 2 (2), PNEUMOCOCCAL POLYSACCHARIDE TYPE 3 (3), PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F, PNEUMOCOCCAL POLYSACCHARIDE TYPE 8 (8), PNEUMOCOCCAL POLYSACCHARIDE TYPE 9N, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V, PNEUMOCOCCAL POLYSACCHARIDE TYPE 20 (20), PNEUMOCOCCAL OLIGOSACCHARIDE SEROTYPE 18C, PNEUMOCOCCAL POLYSACCHARIDE
Sanofi Pasteur MSD Ltd
J07AL01
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1, PNEUMOCOCCAL POLYSACCHARIDE TYPE 2 (2), PNEUMOCOCCAL POLYSACCHARIDE TYPE 3 (3), PNEUMOCO
25/0.5 Microgram/ML
Solution for injection in pre-filled syringe
Muscle injection
Pack size of 1 or 10
Product subject to prescription which may not be renewed (A)
Merck Sharp and Dohme B.V
Pneumococcal vaccines
It is recommended for active immunisation against disease caused by the pneumococcal serotypes included in the vaccine
Transfer Pending
2015-05-22
1 PACKAGE LEAFLET: INFORMATION FOR THE USER Pneumovax 23 solution for injection in pre-filled syringe Pneumococcal Polysaccharide Vaccine For adults and children 2 years and above. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD RECEIVE THIS VACCINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This vaccine has been prescribed for you or your child. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours or your child's. If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET _ _ 1. What Pneumovax 23 is and what it is used for 2. What you need to know before you or your child use Pneumovax 23 3. How to use Pneumovax 23 4. Possible side effects 5. How to store Pneumovax 23 6. Contents of the pack and other information 1. WHAT PNEUMOVAX 23 IS AND WHAT IT IS USED FOR Pneumovax 23_ _is a pneumococcal vaccine. Vaccines are used to protect you or your child against infectious diseases. Your doctor has recommended that you or your child (two years of age and older) have the vaccine_ _to help protect against severe infections caused by bacteria that are called pneumococci. Pneumococci can cause infections of the lungs (especially pneumonia) and of the coverings over the brain and spinal cord (meningitis) and in the blood (bacteraemia or septicaemia). The vaccine _ _will only be able to protect you or your child against pneumococcal infections that are due to the types of these bacteri Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pneumovax 23 solution for injection in pre-filled syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The 0.5 mL dose of vaccine contains 25 micrograms of each of the following 23 pneumococcal polysaccharide serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection in pre-filled syringe. The vaccine is a clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pneumococcal polysaccharide vaccine Sanofi Pasteur MSD is recommended 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 specific at risk categories of persons to be immunised are to be determined on the basis of official recommendations. The vaccine is not effective for the prevention of acute otitis media, sinusitis and other common upper respiratory tract infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Primary vaccination: Adults and children of 2 years of age or older- one single dose of 0.5 millilitre by intramuscular or subcutaneous injection. Pneumococcal polysaccharide vaccine Sanofi Pasteur MSD is not recommended for use in children below 2 years of age as the safety and efficacy of the vaccine have not been established and the antibody response may be poor. Special dosing: It is recommended that pneumococcal vaccine should preferably be given at least two weeks before elective splenectomy or the initiation of chemotherapy or other immunosuppressive tr Pročitajte cijeli dokument