Vaccine Information: Menveo (Page 6 of 6)

15 REFERENCES

All NCT numbers are as noted in the National Library of Medicine clinical trial database (see clinicaltrial.gov).

1.
NCT00474526 (V59P14).
2.
NCT00806195 (V59P23).
3.
NCT01000311 (V59_33).
4.
NCT00310856 (V59P9).
5.
NCT00626327 (V59P21).
6.
NCT00310817 (V59P7).
7.
NCT00262028 (V59P8).
8.
NCT00329849 (V59P10).
9.
NCT00616421 (V59P20).
10.
NCT01018732 (V59P6).
11.
NCT00329901 (V59P11).
12.
NCT00450437 (V59P13).
13.
NCT00474487 (V59P17).
14.
NCT00518180 (V59P18).
15.
NCT00856297 (V59P13E1).
16.
Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. (1969);129:1307-1326.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

MENVEO is supplied as:

5 Vials containing MenCYW-135 Liquid Conjugate Component (Vial 1; grey cap)
5 Vials containing MenA Lyophilized Conjugate Component (Vial 2; orange cap)

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 of MENVEO (packaged without syringes or needles). The container closures (synthetic rubber stoppers) are not made with natural rubber latex.

Table 11: Product Presentation for MENVEO

Presentation

Carton NDC Number

Components

MenCYW-135 Liquid Conjugate Component

(Vial 1; grey cap)

MenA Lyophilized Conjugate Component (powder)

(Vial 2; orange cap)

Carton of 5 doses

(10 vials)

58160-955-09

5 Vials

NDC 58160-959-01

5 Vials

NDC 58160-958-01

16.2 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 during transport.

Do not use after the expiration date.

16.3 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.

17 PATIENT COUNSELING INFORMATION

Vaccine Information Statements are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization to the patient, parent, or guardian. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

Inform patients, parents or guardians about:

Potential benefits and risks of immunization with MENVEO.
The importance of completing the immunization series.
Potential for adverse reactions that have been temporally associated with administration of MENVEO or other vaccines containing similar components.
Reporting any adverse reactions to their healthcare provider.
The GlaxoSmithKline pregnancy registry, as appropriate.

MENVEO is a trademark owned by or licensed to the GSK group of companies.

The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.

Manufactured by:

GSK Vaccines, Srl

Bellaria-Rosia 53018, Sovicille (SI), Italy

US License No. 1617

Distributed by:

GlaxoSmithKline

Research Triangle Park, NC 27709

©2019 GSK group of companies or its licensor.

MNV:4PI

PRINCIPAL DISPLAY PANEL

NDC 58160-955-09

MENVEO

MENINGOCOCCAL (GROUPS A, C, Y AND W-135)

OLIGOSACCHARIDE DIPHTHERIA CRM197 CONJUGATE VACCINE

Men-ACYW

Rx Only

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

For Use from 2 Months through 55 Years of Age

Contents (5 doses of MENVEO):

5 Vials containing MenCYW-135 Liquid Conjugate Component (Vial 1)

5 Vials containing MenA Lyophilized Conjugate Component (Vial 2)

After reconstitution, a single dose of MENVEO is 0.5 mL

Made in Italy

©2019 GSK group of companies or its licensor.

Rev. 8/19

498608

Menveo Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Vial Label

NDC 58160-958-01

MenA Lyophilized Conjugate Component

485974

Menveo MenA vial label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Vial Label

NDC 58160-959-01

MenCYW-135 Liquid Conjugate Component

486018

Menveo MenCYW-135 vial label
(click image for full-size original)
MENVEO meningococcal (groups a, c, y and w-135) oligosaccharide diphtheria crm197 conjugate vaccine kit
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-955
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-955-09 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 10 VIAL, SINGLE-DOSE 5 mL
Part 2 10 VIAL, SINGLE-DOSE 5 mL
Part 1 of 2
MENA mena vaccine injection, powder, lyophilized, for solution
Product Information
Item Code (Source) NDC:58160-958
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 10 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
Sucrose
Potassium Phosphate, Monobasic
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-958-01 0.5 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125300 03/01/2017
Part 2 of 2
MENCYW menc, y, w-135 vaccine injection, solution
Product Information
Item Code (Source) NDC:58160-959
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEISSERIA MENINGITIDIS GROUP C CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP C CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) NEISSERIA MENINGITIDIS GROUP C CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 5 ug in 0.5 mL
NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 5 ug in 0.5 mL
NEISSERIA MENINGITIDIS GROUP Y CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP Y CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) NEISSERIA MENINGITIDIS GROUP Y CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 5 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
Sodium chloride
Sodium Phosphate, Monobasic, Monohydrate
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-959-01 0.5 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125300 03/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125300 03/01/2017
Labeler — GlaxoSmithKline Biologicals SA (372748392)

Revised: 09/2019 GlaxoSmithKline Biologicals SA

VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Vaccine Sections

Vaccine Information by RSS

As the leading independent provider of trustworthy vaccine information, our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VxLabels.com provides the full vaccine subset of the FDA's repository. Vaccine information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2019. All Rights Reserved.