Menhibrix

What is Menhibrix?

Menhibrix is used to prevent meningococcal disease. It is used to prevent Haemophilus influenzae type b disease.

Description

MENHIBRIX (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine), for intramuscular injection, is supplied as a sterile, lyophilized powder which is reconstituted at the time of use with the accompanying saline diluent. MENHIBRIX contains Neisseria meningitidis serogroup C and Y capsular polysaccharide antigens and Haemophilus b capsular polysaccharide (polyribosyl-ribitol-phosphate [PRP]). The Neisseria meningitidis C strain and Y strain are grown in semi-synthetic media and undergo heat inactivation and purification.

The PRP is a high molecular weight polymer prepared from the Haemophilus influenzae type b strain 20,752 grown in a synthetic medium that undergoes heat inactivation and purification. The tetanus toxin, prepared from Clostridium tetani grown in a semi-synthetic medium, is detoxified with formaldehyde and purified. Each capsular polysaccharide is individually covalently bound to the inactivated tetanus toxoid. After purification, the conjugate is lyophilized in the presence of sucrose as a stabilizer. The diluent for MENHIBRIX is a sterile saline solution (0.9% sodium chloride) supplied in vials.

When MENHIBRIX is reconstituted with the accompanying vial of saline diluent, each 0.5-mL dose is formulated to contain 5 mcg of purified Neisseria meningitidis C capsular polysaccharide conjugated to approximately 5 mcg of tetanus toxoid, 5 mcg of purified Neisseria meningitidis Y capsular polysaccharide conjugated to approximately 6.5 mcg of tetanus toxoid, and 2.5 mcg of purified Haemophilus b capsular polysaccharide conjugated to approximately 6.25 mcg of tetanus toxoid. Each dose also contains 96.8 mcg of Tris (trometamol)-HCl, 12.6 mg of sucrose, and ≤ 0.72 mcg of residual formaldehyde. MENHIBRIX does not contain preservatives. The lyophilized vaccine and saline diluent vial stoppers are not made with natural rubber latex.

Before taking Menhibrix, tell your doctor:

• If your child has an allergy to meningococcal, H. influenza type B, or tetanus toxoid-containing vaccine or any other part of Menhibrix.
• If your child is allergic to Menhibrix; any part of this medicine; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.

This medicine may interact with other drugs or health problems.

Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take Menhibrix with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while I take Menhibrix?

For all patients taking Menhibrix:

• Tell all of your child’s health care providers that your child is taking Menhibrix. This includes your child’s doctors, nurses, pharmacists, and dentists.
• This medicine may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes Menhibrix.
• If your child was born premature, talk with the doctor. Trouble breathing has happened in these children after getting some vaccines.

If your child is pregnant or breast-feeding a baby:

• Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.

How is Menhibrix best taken?

Give Menhibrix as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle.

What do I do if I miss a dose?

• Call your child’s doctor to find out what to do.

What are the side effects of Menhibrix that I need to call my doctor about immediately?

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 child’s doctor or get medical help right away if your child has 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, swallowing, 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.
• Change in eyesight.
• A burning, numbness, or tingling feeling that is not normal.

What are some other side effects of Menhibrix?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

• Pain where the shot was given.
• Redness or swelling where the shot is given.
• Feeling fussy.
• Feeling sleepy.
• Not hungry.
• Fever.

These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.

If overdose is suspected:

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.

How do I store and/or throw out Menhibrix?

• If you need to store Menhibrix at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.

SRC: NLM .