MENVEO (meningococcal- groups a, c, y and w-135 oligosaccharide diphtheria crm197 conjugate vaccine kit MENVEO (meningococcal- groups a, c, y and w-135 oligosaccharide diphtheria crm197 conjugate vaccine injection, solution

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (UNII: 3O44U6XYQK) (NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN - UNII:3O44U6XYQK)

Disponibbli minn:

GlaxoSmithKline Biologicals SA

INN (Isem Internazzjonali):

NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Kompożizzjoni:

NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 10 ug in 0.5 mL

Indikazzjonijiet terapewtiċi:

MENVEO is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in individuals 2 months through 55 years of age. MENVEO does not prevent N. meningitidis serogroup B infections. Do not administer MENVEO to individuals with a severe allergic reaction (e.g., anaphylaxis) to a previous dose of MENVEO, to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine. [See Description (11).] Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no adequate and well-controlled studies of MENVEO in pregnant women in the U.S. There was a pregnancy exposure registry conducted from 2014-2017 that included 82 subjects. Available data do not suggest an increased risk of major birth defects and miscarriage in women who received MENVEO within 28 days prior to conception or during pregnancy (see Data) . A developmental toxicity study was performed in female rabbits administered 0.5 mL (at each occasion) of MENVEO prior to mating and during gestation. A single human dose is 0.5 mL. This study revealed no adverse effects on fetal or pre-weaning development (see Data) . Data Human Data: A pregnancy exposure registry (2014 to 2017) included 82 pregnancies with known outcomes with exposure within 28 days prior to conception or during pregnancy. Miscarriage was reported for 12.2% of pregnancies with exposure to MENVEO within 28 days prior to conception or during pregnancy (10/82). Major birth defects were reported for 3.6% of live born infants whose mothers were exposed within 28 days prior to conception or during pregnancy (2/55). The rates of miscarriage and major birth defects were consistent with estimated background rates. Animal Data: In a developmental toxicity study, female rabbits were administered MENVEO by intramuscular injection on Days 29, 15, and 1 prior to mating and on Gestation Days 7 and 20. The total dose was 0.5 mL at each occasion (a single human dose is 0.5 mL). No adverse effects on pre-weaning development up to Postnatal Day 29 were observed. There were no vaccine-related fetal malformations or variations observed. Risk Summary It is not known whether the vaccine components of MENVEO are excreted in human milk. Data are not available to assess the effects of MENVEO in the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for MENVEO and any potential adverse effects on the breastfed child from MENVEO or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. Safety and effectiveness of MENVEO in children aged younger than 2 months have not been established. Safety and effectiveness of the one-vial presentation of MENVEO in children aged younger than 10 years have not been established. [See Dosage and Administration (2).] For children 2 months through 9 years of age, only the two-vial presentation is approved for use. [See Dosage and Administration (2).] Safety and effectiveness of MENVEO in adults aged 65 years and older have not been established.

Sommarju tal-prodott:

MENVEO two-vial presentation is supplied in cartons containing: One vial of MenCYW-135 liquid conjugate component (Vial 1) and one vial of MenA lyophilized conjugate component (Vial 2) must be combined before use to form a single dose (0.5 mL) of MENVEO (packaged without syringes or needles). Each carton contains 5 doses of MENVEO. The container closures (synthetic rubber stoppers) are not made with natural rubber latex. Carton of 10 vials (5 doses) NDC 58160-955-09 5 Vials NDC 58160-959-01 5 Vials NDC 58160-958-01 Storage before Reconstitution Do not freeze. Frozen/previously frozen product should be discarded. Store refrigerated, away from the freezer compartment, at 36°F to 46°F (2°C to 8°C). Protect from light. Vaccine must be maintained at 36°F to 46°F (2°C to 8°C) during transport. Do not use after the expiration date. Storage after Reconstitution The reconstituted vaccine should be used immediately but may be held at 36°F to 77°F (2°C to 25°C) for up to 8 hours. Do not freeze. Discard reconstituted vaccine if it has been frozen or not used within 8 hours. MENVEO one-vial presentation is supplied in cartons containing: Each carton contains 10 single dose vials of MENVEO. Each dose is 0.5 mL. The container closures (synthetic rubber stoppers) are not made with natural rubber latex. Table 12. MENVEO: One-Vial Presentation Carton of 10 vials (10 doses) NDC 58160-827-30 10 Vials NDC 58160-827-03 Do not freeze. Frozen/previously frozen product should be discarded. Store refrigerated, away from the freezer compartment, at 36°F to 46°F (2°C to 8°C). Protect from light. Vaccine must be maintained at 36°F to 46°F (2°C to 8°C) during transport. Do not use after the expiration date.

L-istatus ta 'awtorizzazzjoni:

Biologic Licensing Application

Karatteristiċi tal-prodott

MENVEO- MENINGOCOCCAL (GROUPS A, C, Y AND W-135) OLIGOSACCHARIDE
DIPHTHERIA CRM197 CONJUGATE VACCINE
MENVEO- MENINGOCOCCAL (GROUPS A, C, Y AND W-135) OLIGOSACCHARIDE
DIPHTHERIA CRM197 CONJUGATE VACCINE INJECTION, SOLUTION
GLAXOSMITHKLINE BIOLOGICALS SA
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MENVEO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MENVEO.
MENVEO [MENINGOCOCCAL (GROUPS A, C, Y, AND W-135) OLIGOSACCHARIDE
DIPHTHERIA CRM
CONJUGATE VACCINE] SOLUTION FOR INJECTION, FOR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 2010
INDICATIONS AND USAGE
MENVEO is a vaccine indicated for active immunization to prevent
invasive meningococcal disease caused
by _Neisseria meningitidis_ serogroups A, C, Y, and W-135 in
individuals 2 months through 55 years of age.
MENVEO does not prevent _N. meningitidis_ serogroup B infections. (1)
DOSAGE AND ADMINISTRATION
•
•
•
Primary Vaccination
•
•
•
Booster Vaccination
•
DOSAGE FORMS AND STRENGTHS
Solution for injection. A single dose is 0.5 mL. (3)
CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) to a previous dose of
MENVEO, to any component of this
vaccine, or to any other diphtheria toxoid-containing vaccine. (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
•
•
•
•
197
For intramuscular injection only (0.5 mL). (2)
MENVEO is supplied as either:
Two vials: A vial containing the MenCYW-135 liquid conjugate component
(gray cap) and a vial
containing the MenA lyophilized conjugate component (orange cap). The
contents of the vials must
be combined to form MENVEO prior to administration. This presentation
is for use in individuals 2
months through 55 years of age. (2.1, 2.2),
OR
One vial containing MENVEO (pink cap). This presentation does not
require reconstitution before use.
This presentation is for use in individuals 10 through 55 years of
age. (2.1, 2.2)
In children initiating vaccination at 2 months of age, administer as a
4-dose series at 2, 4, 6, and 1