País: Singapur
Idioma: anglès
Font: HSA (Health Sciences Authority)
Diphtheria Toxoid Protein; Meningococcal (Serogroup A) Polysaccharide (Monovalent Conjugate); Meningococcal (Serogroup C) Polysaccharide (Monovalent Conjugate); Meningococcal (Serogroup W-135) Polysaccharide (Monovalent Conjugate); Meningococcal (Serogroup Y) Polysaccharide (Monovalent Conjugate)
SANOFI-AVENTIS SINGAPORE PTE. LTD.
J07AH08
48 microgram (Diptheria toxoid quantity is approximate and dependent on the conjugate polysaccharide to protein ratio)
INJECTION, SOLUTION
Diphtheria Toxoid Protein 48 mcg/dose (0.5 ml) (Diphtheria toxoid quantity is approximate and dependent on the conjugate polysaccharide to protein ratio); Meningococcal (Serogroup A) Polysaccharide (Monovalent Conjugate) 4 mcg/dose (0.5 ml); Meningococcal (Serogroup C) Polysaccharide (Monovalent Conjugate) 4 mcg/dose (0.5 ml); Meningococcal (Serogroup W-135) Polysaccharide (Monovalent Conjugate) 4 mcg/dose (0.5 ml); Meningococcal (Serogroup Y) Polysaccharide (Monovalent Conjugate) 4 mcg/dose (0.5 ml)
INTRAMUSCULAR
Prescription Only
Sanofi Pasteur Inc.
ACTIVE
2011-02-24
Menactra Singapore LE6494-6495, 24May13-v0.3 MENINGOCOCCAL (GROUPS A, C, Y AND W-135) POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE VACCINE MENACTRA ® FOR INTRAMUSCULAR INJECTION 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 _Neisseria _ _meningitidis _serogroup B. DOSAGE AND ADMINISTRATION Menactra vaccine should be 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. In children 9 through 23 months of age, 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 (e.g., 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). . 1 Menactra Singapore LE6494-6495, Llegiu el document complet
1 MENINGOCOCCAL (GROUPS A, C, Y AND W-135) POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE VACCINE MENACTRA ® FOR INTRAMUSCULAR INJECTION 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 does not prevent _N _ _meningitidis_ serogroup B disease. DOSAGE AND ADMINISTRATION PREPARATION FOR ADMINISTRATION Menactra is a clear to slightly turbid solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If any of these conditions exist, the vaccine should not be administered. Withdraw the 0.5 mL dose of vaccine from the single-dose vial using a sterile needle and syringe. DOSE AND SCHEDULE Menactra is administered as a single 0.5 mL dose by INTRAMUSCULAR injection, preferably in the anterolateral thigh or deltoid region depending on the recipient's age and muscle mass. Do not administer this product intravenously or subcutaneously. PRIMARY VACCINATION: In children 9 through 23 months of age, Menactra is given as a 2-dose series at least three months apart. Individuals 2 through 55 years of age, Menactra is given as a single dose. BOOSTER VACCINATION: A single booster dose may be given to individuals 15 through 55 years of age at continued risk for meningococcal disease, if at least 4 years have elapsed since the prior dose. DOSAGE FORMS AND STRENGTHS 2 Menactra is a solution supplied in 0.5 mL single-dose vials. [See DESCRIPTION for a complete listing of ingredients.] CONTRAINDICATIONS HYPERSENSITIVITY Severe allergic reaction (e.g., anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid- or CRM 197 -containing vaccine, or to any component of Menactra [se Llegiu el document complet