VAXELIS- diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

MSP Vaccine Company

Administreringssätt:

INTRAMUSCULAR

Terapeutiska indikationer:

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, inclu

Produktsammanfattning:

Single-dose vial (NDC 63361-243-58) in packages of 10 vials (NDC 63361-243-10). Single-dose, prefilled syringe with Luer lock connection and a tip cap, without needle, 0.5 mL (NDC 63361-243-88). Supplied as package of 10 (NDC 63361-243-15). The vial stopper, syringe plunger stopper, and syringe tip cap are 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. Protect from light. Do not use after expiration date shown on the label. Discard unused portion.

Bemyndigande status:

Biologic Licensing Application

Produktens egenskaper

VAXELIS- DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS,
INACTIVATED
POLIOVIRUS, HAEMOPHILUS B CONJUGATE AND HEPATITIS B VACCINE INJECTION,
SUSPENSION
MSP VACCINE COMPANY
----------
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,
INACTIVATED POLIOVIRUS,
HAEMOPHILUS B CONJUGATE AND HEPATITIS B 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) available in single-dose vials
and prefilled syringes. (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, the risk for Guillain-Barré syndrome may be increased
following VAXELIS. (5.3)
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