Country: Ինդոնեզիա
language: ինդոնեզերեն
source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DIPHTERIA TOXOID PROTEIN; MENINGOCOCCAL POLYSACCHARIDE; MENINGOCOCCAL POLYSACCHARIDE GROUP A; MENINGOCOCCAL POLYSACCHARIDE GROUP W; MENINGOCOCCAL POLYSACCHARIDE GROUP Y
AVENTIS PHARMA - Indonesia
DIPHTERIA TOXOID PROTEIN; MENINGOCOCCAL POLYSACCHARIDE; MENINGOCOCCAL POLYSACCHARIDE GROUP A; MENINGOCOCCAL POLYSACCHARIDE GROUP W; MENINGOCOCCAL POLYSACCHARIDE GROUP Y
4/4/4/48 MCG
CAIRAN INJEKSI
DUS, 5 VIAL @ 0.5 ML (1 DOSIS)
SANOFI PASTEUR - USA
2017-10-07
MENACTRA POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE VACCINE MENINGOCOCCAL (GROUPS A, C, Y AND W-135) FOR INTRAMUSCULAR INJECTION Composition: Each 0.5 mL dose contains 4 mcg of each polysaccharide per serogroup A,C, Y and W-135 conjugated to approximately 48 mcg diphtheria toxoid. List of excipients Sodium chloride, sodium phosphate dibasic anhydrous, and sodium phosphate monobasic. The vaccine contains no preservative. INDICATIONS AND USAGE Menactra®, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra is approved for use in individuals 9 months through 55 years of age. Menactra vaccine is not indicated for the prevention of meningitis caused by other microorganisms or for the prevention of invasive meningococcal disease caused by N meningitidis serogroup B. DOSAGE AND ADMINISTRATION Menactra is administered as a single 0.5 mL injection by the intramuscular route, preferably in the anterolateral thigh or deltoid region depending on the recipient's age and muscle mass. PRIMARY VACCINATION: In children 9 through 23 months of age who travel or living in endemic areas. Menactra is given as a 2- dose series at least three months apart Individuals 2 through 55 years of age receive a single dose. Do not administer this product intravenously, subcutaneously, or intradermally. The need for, or timing of, a booster dose of Menactra vaccine has not yet been determined. Parenteral drug products should be inspected visually for container integrity, particulate matter, and discoloration prior to administration, whenever solution and container permit. CONTRAINDICATIONS HYPERSENSITIVITY Severe allergic reaction (eg, anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid- or CRM 197 -containing vaccine, or to any component of Menactra vaccine (see DESCRIPTION). GUILLAIN-BARRÉ SYNDROME Known histo read_full_document