VAXELIS- diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate (menin

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: IRH51QN26H) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:IRH51QN26H), CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K3W1N8YP13) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:K3W1N8YP13), BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) (UNII: F4TN0IPY37) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) - UNII:F4TN0IPY37),

Available from:

MCM Vaccine Co.

Administration route:

INTRAMUSCULAR

Therapeutic indications:

VAXELIS™ is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae ) type b. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday). Do not administer VAXELIS to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H. influenzae type b vaccine [See DESCRIPTION (11) .] Do not administer VAXELIS to anyone with a history of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine, that is not attributable to another identifiable cause. Do not administer VAXELIS to anyone with a history of progressive neurologic disorder, includ

Product summary:

VAXELIS is supplied in a single dose vial (NDC 63361-245-58) in packages of 10 vials (NDC 63361-245-10). The vial stopper is not made with natural rubber latex. VAXELIS should be stored at 2°C to 8°C (36°F to 46°F). Do not freeze . Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

VAXELIS- DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS
ADSORBED, INACTIVATED
POLIOVIRUS, HAEMOPHILUS B CONJUGATE (MENINGOCOCCAL PROTEIN CONJUGATE)
AND HEPATITIS B
(RECOMBINANT) VACCINE INJECTION, SUSPENSION
MCM VACCINE CO.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VAXELIS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VAXELIS.
VAXELIS™ (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS
ADSORBED, INACTIVATED POLIOVIRUS,
HAEMOPHILUS B CONJUGATE [MENINGOCOCCAL PROTEIN CONJUGATE] AND
HEPATITIS B [RECOMBINANT] VACCINE)
SUSPENSION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 2018
INDICATIONS AND USAGE
VAXELIS is a vaccine indicated for active immunization to prevent
diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B,
and invasive disease due to _Haemophilus influenzae_ type b. VAXELIS
is approved for use as a 3-dose series in children
from 6 weeks through 4 years of age (prior to the 5
birthday). (1)
DOSAGE AND ADMINISTRATION
The 3-dose immunization series consists of a 0.5 mL intramuscular
injection, administered at 2, 4, and 6 months of age.
(2.1)
DOSAGE FORMS AND STRENGTHS
Suspension for injection (0.5 mL dose) supplied in single dose vials.
(3)
CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) to a previous dose of
VAXELIS, any ingredient of VAXELIS, or any other
diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine,
inactivated poliovirus vaccine, hepatitis B vaccine, or
_Haemophilus influenzae_ type b vaccine. (4.1)
Encephalopathy within 7 days of a previous pertussis-containing
vaccine with no other identifiable cause. (4.2)
Progressive neurologic disorder until a treatment regimen has been
established and the condition has stabilized. (4.3)
WARNINGS AND PRECAUTIONS
Carefully consider benefits and risks before administering VAXELIS to
persons with a history of:
-
-
If Guillain-Barré syndrome occurred within 6 weeks of receipt of a
prior vaccine containing tetanus toxoid, th