国: イスラエル
言語: 英語
ソース: Ministry of Health
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19 F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V
PFIZER PHARMACEUTICALS ISRAEL LTD
J07AL02
SUSPENSION FOR INJECTION
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19 F 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B 4.4 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A 2.2 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 2.2 MCG / 0.5 ML
I.M
Required
PFIZER INC, USA
PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN CONJUGATED
Prevenar 20 is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.
2023-04-24
Prevenar 20 PIL CC 201223 2023-0086866 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only PREVENAR ® 20 SUSPENSION FOR INJECTION Each dose (0.5 ml) contains: 2.2 micrograms of pneumococcal polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F 4.4 micrograms of pneumococcal polysaccharide for serotype 6B conjugated to approximately 51 micrograms CRM 197 carrier protein, adsorbed on aluminium phosphate (0.125 mg aluminium). Inactive ingredients and allergens: See section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6 'Further information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Active immunisation for the prevention of invasive disease and pneumonia caused by _Streptococcus pneumoniae_ in adults 18 years of age and older. THERAPEUTIC GROUP: Pneumococcal vaccine. Prevenar 20 helps to provide protection against infections caused by 20 types (serotypes) of _Streptococcus pneumoniae_ bacteria. Prevenar 20 helps the body to make its own protection (antibodies) against the bacteria. These antibodies help protect you from pneumococcal disease._ _ 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: you are sensitive (allergic) to the active ingredients or to any of the other ingredients in this medicine (see section 6), or to other vaccines containing diphtheria toxoid. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE VACCINATION WITH PREVENAR 20, TELL YOUR DOCTOR IF: you have or have had medical problems after any dose of Prevenar 20, such as an allergi 完全なドキュメントを読む
Prevenar 20 LPD CC 010523 1 PREVENAR 20 1. NAME OF THE MEDICINAL PRODUCT Prevenar 20 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 mL) contains: Pneumococcal polysaccharide serotype 1 1,2 2.2 µg Pneumococcal polysaccharide serotype 3 1,2 2.2 µg Pneumococcal polysaccharide serotype 4 1,2 2.2 µg Pneumococcal polysaccharide serotype 5 1,2 2.2 µg Pneumococcal polysaccharide serotype 6A 1,2 2.2 µg Pneumococcal polysaccharide serotype 6B 1,2 4.4 µg Pneumococcal polysaccharide serotype 7F 1,2 2.2 µg Pneumococcal polysaccharide serotype 8 1,2 2.2 µg Pneumococcal polysaccharide serotype 9V 1,2 2.2 µg Pneumococcal polysaccharide serotype 10A 1,2 2.2 µg Pneumococcal polysaccharide serotype 11A 1,2 2.2 µg Pneumococcal polysaccharide serotype 12F 1,2 2.2 µg Pneumococcal polysaccharide serotype 14 1,2 2.2 µg Pneumococcal polysaccharide serotype 15B 1,2 2.2 µg Pneumococcal polysaccharide serotype 18C 1,2 2.2 µg Pneumococcal polysaccharide serotype 19A 1,2 2.2 µg Pneumococcal polysaccharide serotype 19F 1,2 2.2 µg Pneumococcal polysaccharide serotype 22F 1,2 2.2 µg Pneumococcal polysaccharide serotype 23F 1,2 2.2 µg Pneumococcal polysaccharide serotype 33F 1,2 2.2 µg 1 Conjugated to CRM 197 carrier protein (approximately 51 µg per dose) 2 Adsorbed on aluminium phosphate (0.125 mg aluminium per dose) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. The vaccine is a homogeneous white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Active immunisation for the prevention of invasive disease and pneumonia caused by _ Streptococcus _ _pneumoniae _ in individuals 18 years of age and older. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. Prevenar 20 should be used in accordance with official recommendations. 2 2023-0084870 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Individuals 18 years of age and older _ Prevenar 20 is to be administered as a single dose to _ _ individuals _ _ 18 yea 完全なドキュメントを読む