MENACTRA

Valsts: Indonēzija

Valoda: indonēziešu

Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktīvā sastāvdaļa:

DIPHTERIA TOXOID PROTEIN; MENINGOCOCCAL POLYSACCHARIDE; MENINGOCOCCAL POLYSACCHARIDE GROUP A; MENINGOCOCCAL POLYSACCHARIDE GROUP W; MENINGOCOCCAL POLYSACCHARIDE GROUP Y

Pieejams no:

AVENTIS PHARMA - Indonesia

SNN (starptautisko nepatentēto nosaukumu):

DIPHTERIA TOXOID PROTEIN; MENINGOCOCCAL POLYSACCHARIDE; MENINGOCOCCAL POLYSACCHARIDE GROUP A; MENINGOCOCCAL POLYSACCHARIDE GROUP W; MENINGOCOCCAL POLYSACCHARIDE GROUP Y

Deva:

4/4/4/48 MCG

Zāļu forma:

CAIRAN INJEKSI

Vienības iepakojumā:

DUS, 5 VIAL @ 0.5 ML (1 DOSIS)

Ražojis:

SANOFI PASTEUR - USA

Autorizācija datums:

2017-10-07

Produkta apraksts

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