Meningococcal vaccine and haemophilus b vaccine (Intramuscular)

Meningococcal polysaccharide vaccine and Haemophilus B conjugate vaccine is a combination vaccine that helps prevent infections caused by certain types of meningococcal bacteria and Haemophilus influenza type b (Hib) bacteria. The vaccine works by helping your body create its own protection (antibodies) against the disease.

The following information applies only to the meningococcal vaccine used for meningococcal bacteria Groups C and Y

Menhibrix® vaccine is recommended for children aged 6 weeks to 18 months.

This vaccine should only be given by or under the direct supervision of your doctor.

It is very important that your child returns to your doctor’s office at the right time for each dose. Be sure to tell your doctor about any side effects that happen after your child receives this vaccine.

Fainting may happen after getting intramuscular injections, like this vaccine. It may occur along with other symptoms such as: blurred vision, numbness or tingling in your arms, hands, or feet, or seizures.

Check with your doctor right away if your child has a cough, trouble swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, shortness of breath, skin rash, tightness in the chest, or unusual tiredness or weakness. These could be signs of an allergic reaction to the vaccine.

This vaccine may affect lab tests that check for Hib disease. Make sure your doctor knows that your child received the vaccine if a severe infection occurs within 2 weeks after the vaccine is given.

It is important that your child's doctor knows about all other vaccines your child has recently received, including a flu shot.

Make sure your doctor knows if you are using medicines that weaken your immune system, such as cancer medicines, radiation treatment, or steroids.

Menhibrix® vaccine is not a replacement for routine tetanus vaccination and will not treat symptoms of meningococcal infection or flu if your child already has the disease.

In deciding to use a vaccine, it's important to consider the risks of the vaccine against the benefits it may provide. This is a choice you and your doctor will make together. For this vaccine, you should think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how Menhibrix® vaccine affects infants younger than 6 weeks old and children aged 19 months to 16 years. Safety and effectiveness have not been confirmed.

Geriatric

There is no information available on how Menhibrix® vaccine affects older patients.

Breast Feeding

Studies in women indicate that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be used together despite potential interactions. If you are receiving this vaccine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but may not include all possible interactions.

It is usually not recommended to receive this vaccine with any of the following medicines, but it may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or the frequency of use for one or both medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating certain foods, as interactions may happen. Drinking alcohol or using tobacco with some medicines may also cause interactions. Discuss the use of your medicine with food, alcohol, or tobacco with your healthcare professional.

Other Medical Problems

Having other medical issues may affect the use of this vaccine. Be sure to tell your doctor if you have any other medical problems, especially:

• Apnea in premature babies (breathing stops for short periods)—Use with caution. Shots given into the muscle, like this vaccine, may worsen this condition.

• Guillain-Barré syndrome (GBS, a nervous system disorder that causes paralysis), history of after a vaccine with tetanus—Your doctor will decide if your child should receive this vaccine.

• Immunodeficiency disorder or
• Weak immune system—The vaccine may not work as well in patients with these conditions.

Along with its helpful effects, a medicine may cause some unwanted effects. Even though not all of these side effects may happen, if they do, they may require medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Fever

Incidence not known

• Bluish lips
• cough
• difficulty with swallowing
• fainting
• fast heartbeat
• hives
• itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• unusual tiredness or weakness

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Also, your health care professional may be able to provide ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Crying
• drowsiness
• irritability
• loss of appetite
• pain, redness, or swelling at the injection site

Incidence not known

• Hard lump at the injection site
• sleepiness or unusual drowsiness
• welts

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Menhibrix

A nurse or other trained health professional will give your child this vaccine. This vaccine is given as a shot into a muscle (usually in the thighs or upper arms).

The exact schedule for your child's vaccines will vary depending on your child's age at the time of the first dose. In general, your child can receive the first dose of the vaccine as early as 6 weeks to 2 months of age. This is followed by receiving the remaining three doses at 4, 6, and 12 to 15 months of age.

It is important that your child receives all of the doses of vaccine in this series. Try to keep all of your child's scheduled appointments. If your child does miss a dose of this vaccine, make another appointment as soon as possible.

Your child may receive other vaccines at the same time as this one, but in a different body area. You should receive information sheets about all of the vaccines your child receives. Make sure you understand all of the information that is given to you.