Menveo

• Novartis Vaccines and Diagnostics Limited

Tell your healthcare provider if you or your child:

• had a severe allergic reaction (e.g., anaphylaxis) after a previous dose of Menveo, any component of this vaccine, or any other CRM197, diphtheria toxoid or meningococcal-containing vaccine
• are pregnant or plan to become pregnant
• are breastfeeding
• have received other vaccines

Tell you doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Menveo is administered by a healthcare provider in a medical setting. It is unlikely that an overdose will occur in this setting. However, if overdoes is suspected, seek emergency medical attention. 

You should not receive a meningococcal conjugate vaccine if you have ever had an allergic reaction to a meningococcal or a diphtheria vaccine.

If you have any of these other conditions, your vaccine may need to be postponed or not given at all:

• pregnancy or breast-feeding;

• a history of Guillain-Barré syndrome;

• a history of premature birth;

• a condition for which you are receiving steroids, chemotherapy, or radiation treatments; or

• any condition that weakens your immune system (such as HIV, AIDS, or cancer).

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

It is not known whether meningococcal conjugate vaccine will harm an unborn baby. However, if you are pregnant, your doctor should determine whether you need this vaccine.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of this vaccine on the baby.

It is not known whether meningococcal conjugate vaccine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

The Menactra brand of this vaccine should not be given to anyone younger than 9 months or older than 55 years of age. The Menveo brand should not be given to anyone younger than 2 months or older than 65 years of age.

An overdose of this vaccine is not likely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Trouble controlling body movements.
• Not able to move face muscles as much.
• Muscle weakness.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Menveo, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Menveo. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Menveo (meningococcal (groups A / C / Y and W-135) diphtheria conjugate vaccine).

Review Date: October 4, 2017

Reconstitution Instructions

Menveo is supplied in two vials that must be combined prior to administration. Menveo must be prepared for administration by reconstituting the MenA lyophilized conjugate vaccine component with the MenCYW-135 liquid conjugate vaccine component. Using a graduated syringe, withdraw the entire contents of the vial of MenCYW-135 liquid conjugate component and inject into the MenA lyophilized conjugate component vial. Invert the vial and shake well until the vaccine is dissolved and then withdraw 0.5 mL of reconstituted product.

Please note that it is normal for a small amount of liquid to remain in the vial following withdrawal of the dose.

Following reconstitution, the vaccine is a clear, colorless solution, free from visible foreign particles. 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, Menveo should not be administered.

The reconstituted vaccine should be used immediately, but may be held at or below 77°F (25°C) for up to 8 hours.

Administration

For intramuscular injection only. Do not administer Menveo intravenously, subcutaneously or intradermally.

Dose and Schedule

Menveo should be administered as a single 0.5mL intramuscular injection, preferably into the deltoid muscle (upper arm). For children 2 through 5 years of age at continued high risk of meningococcal disease a second dose may be administered 2 months after the first dose (sections 6.1, 14, 14.1). The duration of protection following immunization is not known.

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.
• 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 Novartis Vaccines and Diagnostics Inc. pregnancy registry, as appropriate.

Manufactured by:
Novartis Vaccines and Diagnostics S.r.l.,
Bellaria-Rosia 53018, Sovicille (SI), Italy.

An affiliate of:
Novartis Vaccines and Diagnostics, Inc.
350 Massachusetts Avenue,
Cambridge, MA 02139-4182, USA
1-877-683-4732

Menveo is a registered trademark of Novartis AG.

Principal Display Panel

Principal Display Panel - Vial Label

MenA Lyophilized
Conjugate Component
NOT TO BE USED ALONE
Reconstitute with
MenCYW-135 Liquid Conjugate
Component to form Menveo
NDC 46028-208-01
Novartis Vaccines

Rx Only

Principal Display Panel - Vial Label

MenCYW-135 Liquid
Conjugate Component
Not to be used alone
Use to reconstitute MenA
Lyophilized Conjugate
Component to form Menveo
NDC 46028-208-01
Novartis Vaccines

PRINCIPAL DISPLAY PANEL - PACKAGE LABEL

Meningococcal (Groups A, C, Y and W-135)

Oligosaccharide

Diphtheria CRM197 Conjugate Vaccine

Menveo ®

For use in persons 2 years through 55 years of age

Powder and solvent

for injection

NDC 46028-208-01

Rx Only

Novartis Vaccines

Contains:

Five doses (10 vials) per package. One dose consists of 1 vial of MenA

Lyophilized Conjugate Component to be reconstituted with 1 vial of

MenCYW-135 Liquid Conjugate Component. No preservatives.

NEITHER MenCYW-135 NOR MenA COMPONENT TO BE USED ALONE

One dose (0.5 ml) contains:

Meningococcal group A oligosaccharide........................10 micrograms

Meningococcal group C oligosaccharide.......................... 5 micrograms

Meningococcal group Y oligosaccharide.......................... 5 micrograms

Meningococcal group W-135 oligosaccharide................. 5 micrograms

conjugated to CRM197 protein

Store refrigerated, away from the freezer compartment, at 36°F to 46°F

(2°C to 8°C), protect from light

For intramuscular injection. Read the package leaflet before use.

Manufactured by

Novartis Vaccines and Diagnostics S.r.l. Bellaria-Rosia 53018 Sovicille (SI), Italy

Distributed by

Novartis Vaccines and Diagnostics Inc., 350 Massachusetts Avenue, Cambridge,

MA 02139

US License No. 1751