Haemophilus b conjugate vaccine (Intramuscular)

Haemophilus b conjugate vaccine (tetanus toxoid conjugate) is a vaccine that helps prevent infections caused by the Haemophilus influenza type b (Hib) bacteria. It works by helping your body create its own protection (antibodies) against the disease.

Haemophilus b conjugate vaccine is made by adding a substance related to diphtheria, meningococcus, or tetanus in the process. However, this vaccine does not replace the regular vaccines for diphtheria, tetanus, or meningococcus that both children and adults should receive. All haemophilus b conjugate vaccines work the same way, but they may be given at different ages or on different schedules.

Infections with Haemophilus influenza type b (Hib) bacteria can lead to serious illnesses, such as meningitis (a brain disease), epiglottitis (a throat disease that can cause suffocation), pericarditis (a heart disease), pneumonia (a lung disease), and septic arthritis (a bone and joint disease). Hib meningitis can be fatal or result in serious and lasting damage, like mental retardation, deafness, epilepsy, or partial blindness.

Haemophilus b conjugate vaccine is recommended for all children aged 2 months to 5 years (up to their 6th birthday).

The Hiberix® vaccine is used as a booster for children who have already received the initial series with a haemophilus b conjugate vaccine. This booster will "boost" or enhance the protection that the child gained from the earlier dose.

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 inform your doctor of any side effects that happen after your child gets this vaccine.

This vaccine may affect laboratory tests that check for Hib disease. Make sure your doctor knows that your child received the vaccine if a severe infection happens during the 1 to 2 weeks after the vaccine is given.

The vaccine syringe and vial stopper may contain dry natural rubber (a derivative of latex), which may trigger an allergic reaction in patients who are sensitive to latex. Tell your doctor if your child has a latex allergy before receiving this medicine.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a vaccine, you and your doctor need to consider the risks of the vaccine compared to the benefits. The following points should be taken into account for this vaccine:

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 about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, check the label or package ingredients carefully.

Pediatric

Studies so far have not shown any specific problems in children 2 months to 5 years old that would limit the usefulness of ActHIB®, HibTITER®, or PedvaxHIB®. However, safety and effectiveness have not been confirmed in children 6 years and older and in children younger than 2 months.

Studies so far have not shown any specific problems in children 15 months to 4 years old that would limit the usefulness of the Hiberix® vaccine. However, safety and effectiveness have not been confirmed in children 5 years and older and in children younger than 15 months.

Geriatric

The haemophilus b conjugate vaccine (tetanus toxoid conjugate) is not intended for use in adults or elderly patients.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction could happen. In such situations, your doctor may need to adjust the dose or take other precautions. It is particularly important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this vaccine. The following interactions are based on their potential significance and may not be an exhaustive list.

Using this vaccine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Guillain-Barré syndrome (a serious nerve and muscle condition), history of after a vaccine with tetanus toxoid—Your doctor will decide if you should receive this vaccine.

• Weakened immune system—This vaccine may not work as effectively in patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common

• Diarrhea
• loss of appetite
• vomiting

Less common

• Earache
• redness or swelling in the ear

Rare

• Chest pain
• chills
• cough
• fever over 102 degrees F (39 degrees C)
• lack or loss of strength
• seizures
• sneezing
• sore throat
• tightness in the chest
• troubled breathing

Incidence not known

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• bluish lips or skin
• dizziness
• fast heartbeat
• hives or welts, skin rash
• itching (especially of the feet or hands)
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• reddening of the skin (especially around the ears)
• swelling of the eyes, face, or inside of the nose
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tingling of the hands or feet
• unusual tiredness or weakness (sudden and severe)
• unusual weight gain or loss

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

More common

• Fever less than 102 degrees F (39 degrees C)
• irritability
• redness, pain, swelling, tenderness, or warm feeling at the injection site
• reduced physical activity
• restlessness
• sleepiness

Less common

• Prolonged crying lasting more than 4 hours
• unusual high-pitched crying

Other side effects not listed may also occur 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.

• ActHIB
• Hibtiter
• Pedvaxhib

Available Dosage Forms:

• Powder for Solution
• Powder for Suspension
• Solution

Therapeutic Class: Vaccine

A nurse or other trained health professional will give your child this vaccine in a medical facility. It is given as a shot into a muscle.

The exact schedule for your child's vaccines will vary depending on the brand of medicine used and your child's age at the time of the first dose. In general, your child will receive the first dose at 2 to 6 months of age, followed by 2 more doses at least 8 weeks apart. Your child will usually receive a booster dose at 15 to 18 months of age, although he or she can receive this medicine up until the age of 5 years.

It is important that your child receive all of the doses of the vaccine in this series. Try to keep all of your 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.