Menomune

DRUG DESCRIPTION

Menomune®- A/C/Y/W-135, Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined, for subcutaneous use, is a freeze-dried preparation of the group-specific polysaccharide antigens from Neisseria meningitidis, Group A, Group C, Group Y and Group W-135. N meningitidis are cultivated with Mueller Hinton agar1 and Watson Scherp2 media. The purified polysaccharide is extracted from the Neisseria meningitidis cells and separated from the media by procedures which include centrifugation, detergent precipitation, alcohol precipitation, solvent or organic extraction and diafiltration. No preservative is added during manufacture.

The 0.78 mL vial of diluent contains sterile, preservative-free, pyrogen-free distilled water and is used for reconstitution of product supplied in 1 mL vials. The 6 mL vial of diluent contains sterile, pyrogen-free distilled water to which thimerosal (mercury derivative) 1:10,000 is added as a preservative. The 6 mL vial is for reconstitution of product supplied in 10 mL vials. After reconstitution with diluent as indicated on the label, the 0.5 mL dose is formulated to contain 50 ?µg of “isolated product” from each of Groups A, C, Y and W-135 in an isotonic sodium chloride solution.

Each dose of vaccine is also formulated to contain 2.5 mg to 5 mg of lactose added as a stabilizer.3 The vaccine when reconstituted is a clear colorless liquid.

Potency is evaluated by measuring the molecular size of each polysaccharide component using a column chromatography method as standardized by the US Food and Drug Administration (FDA) and the World Health Organization (WHO)4 for Meningococcal Polysaccharide Vaccine.

THIS VACCINE CONFORMS TO THE WORLD HEALTH ORGANIZATION (WHO) REQUIREMENTS.

What are the possible side effects of meningococcal polysaccharide vaccine (Menomune A/C/Y/W-135)?

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another meningococcal vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe weakness or unusual...

Read All Potential Side Effects and See Pictures of Menomune »

What are the precautions when taking meningococcal polysaccharide vaccine (Menomune)?

See also How to Use and Drug Interactions sections.

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex or dry natural rubber that can be found in the vial stopper), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: your vaccination/immunization history, recent illness or fever, immune system problems (e.g., due to cancer treatment, organ transplant, HIV).

Some brands of this product may contain a small amount of mercury from a preservative (thimerosal). Consult your doctor for more...

Read All Potential Precautions of Menomune »

What are the possible side effects of meningococcal polysaccharide vaccine (Menomune A/C/Y/W-135)?

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another meningococcal vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe weakness or unusual...

Read All Potential Side Effects and See Pictures of Menomune »

What are the precautions when taking meningococcal polysaccharide vaccine (Menomune)?

See also How to Use and Drug Interactions sections.

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex or dry natural rubber that can be found in the vial stopper), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: your vaccination/immunization history, recent illness or fever, immune system problems (e.g., due to cancer treatment, organ transplant, HIV).

Some brands of this product may contain a small amount of mercury from a preservative (thimerosal). Consult your doctor for more...

Read All Potential Precautions of Menomune »

What are the possible side effects of meningococcal polysaccharide vaccine (Menomune A/C/Y/W-135)?

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another meningococcal vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe weakness or unusual...

Read All Potential Side Effects and See Pictures of Menomune »

What are the precautions when taking meningococcal polysaccharide vaccine (Menomune)?

See also How to Use and Drug Interactions sections.

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex or dry natural rubber that can be found in the vial stopper), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: your vaccination/immunization history, recent illness or fever, immune system problems (e.g., due to cancer treatment, organ transplant, HIV).

Some brands of this product may contain a small amount of mercury from a preservative (thimerosal). Consult your doctor for more...

Read All Potential Precautions of Menomune »

What are the possible side effects of meningococcal polysaccharide vaccine (Menomune A/C/Y/W-135)?

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another meningococcal vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe weakness or unusual...

Read All Potential Side Effects and See Pictures of Menomune »

What are the precautions when taking meningococcal polysaccharide vaccine (Menomune)?

See also How to Use and Drug Interactions sections.

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex or dry natural rubber that can be found in the vial stopper), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: your vaccination/immunization history, recent illness or fever, immune system problems (e.g., due to cancer treatment, organ transplant, HIV).

Some brands of this product may contain a small amount of mercury from a preservative (thimerosal). Consult your doctor for more...

Read All Potential Precautions of Menomune »

What are the possible side effects of meningococcal polysaccharide vaccine (Menomune A/C/Y/W-135)?

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another meningococcal vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe weakness or unusual...

Read All Potential Side Effects and See Pictures of Menomune »

What are the precautions when taking meningococcal polysaccharide vaccine (Menomune)?

See also How to Use and Drug Interactions sections.

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex or dry natural rubber that can be found in the vial stopper), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: your vaccination/immunization history, recent illness or fever, immune system problems (e.g., due to cancer treatment, organ transplant, HIV).

Some brands of this product may contain a small amount of mercury from a preservative (thimerosal). Consult your doctor for more...

Read All Potential Precautions of Menomune »

What are the possible side effects of meningococcal polysaccharide vaccine (Menomune A/C/Y/W-135)?

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another meningococcal vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe weakness or unusual...

Read All Potential Side Effects and See Pictures of Menomune »

What are the precautions when taking meningococcal polysaccharide vaccine (Menomune)?

See also How to Use and Drug Interactions sections.

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex or dry natural rubber that can be found in the vial stopper), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: your vaccination/immunization history, recent illness or fever, immune system problems (e.g., due to cancer treatment, organ transplant, HIV).

Some brands of this product may contain a small amount of mercury from a preservative (thimerosal). Consult your doctor for more...

Read All Potential Precautions of Menomune »


Menomune Consumer (continued)

SIDE EFFECTS: Pain, redness, swelling, and tenderness at the injection site commonly occur and usually last 1-2 days. Headache and fever may also occur. Ask your doctor if you should take a fever/pain reducer (e.g., acetaminophen) to help treat these symptoms. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also How to Use and Drug Interactions sections.

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex or dry natural rubber that can be found in the vial stopper), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: your vaccination/immunization history, recent illness or fever, immune system problems (e.g., due to cancer treatment, organ transplant, HIV).

Some brands of this product may contain a small amount of mercury from a preservative (thimerosal). Consult your doctor for more information.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Menomune Patient Information Including Side Effects

Brand Names: Menomune A/C/Y/W-135

Generic Name: meningococcal polysaccharide vaccine (Pronunciation: me NIN je KOK al POL ee SAK a ride vax EEN)

  • What is meningococcal polysaccharide vaccine (Menomune)?
  • What are the possible side effects of meningococcal polysaccharide vaccine (Menomune)?
  • What is the most important information I should know about meningococcal polysaccharide vaccine (Menomune)?
  • What should I discuss with my healthcare provider before receiving meningococcal polysaccharide vaccine (Menomune)?
  • How is meningococcal polysaccharide vaccine given (Menomune)?
  • What happens if I miss a dose (Menomune)?
  • What happens if I overdose (Menomune)?
  • What should I avoid before or after getting meningococcal polysaccharide vaccine (Menomune)?
  • What other drugs will affect meningococcal polysaccharide vaccine (Menomune)?
  • Where can I get more information?

What is meningococcal polysaccharide vaccine (Menomune)?

Meningococcal disease is a serious infection caused by a bacteria. Meningococcal bacteria can infect the blood, spinal cord, and brain. These conditions can be fatal.

Meningococcal disease can spread from one person to another through small droplets of saliva that are expelled into the air when an infected person coughs or sneezes. The bacteria can also be passed through contact with objects the infected person has touched, such as a door handle, or other surface. The bacteria can also be passed through kissing, or sharing a drinking glass or eating utensil with an infected person.

Meningococcal polysaccharide vaccine is used to prevent infection caused by meningococcal bacteria. The vaccine contains four of the most common types of meningococcal bacteria.

Meningococcal polysaccharide vaccine works by exposing you to a small dose of the bacteria or a protein from the bacteria, which causes your body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Meningococcal polysaccharide vaccine is for use in adults and children who are at least 3 months of age.

Like any vaccine, meningococcal polysaccharide vaccine may not provide protection from disease in every person.

Developing meningitis (infection of the spinal cord and lining of the brain) is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

What are the possible side effects of meningococcal polysaccharide vaccine (Menomune)?

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another meningococcal vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine);
  • high fever; or
  • unusual bleeding.

Less serious side effects may be more likely to occur, such as:

  • low fever, chills;
  • redness, pain, swelling, or a lump where the vaccine was injected;
  • headache;
  • tired feeling;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What is the most important information I should know about meningococcal polysaccharide vaccine (Menomune)?

Developing meningitis (infection of the spinal cord and lining of the brain) is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another meningococcal vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Do not receive this vaccine if you have ever had an allergic reaction to a meningococcal vaccine, or if you are allergic to a preservative called thimerosol.

Before receiving meningococcal polysaccharide vaccine, tell your doctor if you have a weak immune system, if you are allergic to latex rubber, or if you are receiving steroids, chemotherapy, or radiation treatment. If you have any of these conditions, your vaccine may need to be postponed or not given at all.

You can still receive meningococcal polysaccharide vaccine if you have a minor cold. However, if you are moderately or severely ill with a fever or any type of infection, wait until you recover before receiving this vaccine.

Like any vaccine, meningococcal polysaccharide vaccine may not provide protection from disease in every person.

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