MENACTRA SOLUTION FOR INJECTION

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有效成分:

PURIFIED MENINGOCOCCAL POLYSACCHARIDE GROUP A; PURIFIED MENINGOCOCCAL POLYSACCHARIDE GROUP C; PURIFIED MENINGOCOCCAL POLYSACCHARIDE GROUP Y; PURIFIED MENINGOCOCCAL POLYSACCHARIDE GROUP W135

可用日期:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN（国际名称）:

PURIFIED MENINGOCOCCAL POLYSACCHARIDE GROUP A; PURIFIED MENINGOCOCCAL POLYSACCHARIDE GROUP C; PURIFIED MENINGOCOCCAL POLYSACCHARIDE GROUP Y; PURIFIED MENINGOCOCCAL POLYSACCHARIDE GROUP W135

每包单位数:

3ml5Units mL; 3ml1Units mL

厂商:

SANOFI PASTEUR INC

资料单张

Not Applicable

产品特点

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
_N meningitidis_
serogroups A, C, Y and W-135. Menactra is approved for use in
individuals 9 months through 55 years of age. Menactra vaccine 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 subcutaneously or
intradermally.
PRIMARY VACCINATION:

In children 9 through 23 months of age, Menactra vaccine is given as a
2-dose series at least
three months apart.

Individuals 2 through 55 years of age, Menactra vaccine 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