Haemophilus b conjugate and hepatitis b vaccine (Intramuscular)

Haemophilus b conjugate vaccine and hepatitis B vaccine is a combination shot that helps protect against infections caused by the Haemophilus influenzae type b (Hib) bacteria and the hepatitis B virus. The vaccine helps your body make its own defense (antibodies) against these diseases.

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

HBV infection is a leading cause of serious liver diseases, including hepatitis and cirrhosis, and a type of liver cancer called primary hepatocellular carcinoma.

Pregnant women with hepatitis B infection or those who carry the hepatitis B virus can pass the disease to their babies at birth. These babies often experience serious long-term health issues due to the disease.

Vaccination against hepatitis B disease is advised for all newborns, infants, and young children.

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

It is very important that your child return to your doctor’s office at the right time for the second and third dose. Be sure to notify your child's doctor of any unwanted effects that occur after he or she receives the vaccine.

If your child develops a skin rash, hives, or any allergic reaction after receiving this vaccine, tell your child's doctor right away.

Tell your child's doctor right away if your child is allergic to latex rubber. The vaccine vials may contain dry natural latex rubber. This may cause an allergic reaction in patients who are sensitive to latex.

Before your child has any medical tests, tell the medical doctor in charge that your child is receiving this vaccine. The results of some tests may be affected by this vaccine.

This vaccine may not protect your child against diseases caused by haemophilus influenzae type b or hepatitis B infection if your child is already infected with the virus at the time he or she receives the shot.

In deciding to use a vaccine, you and your doctor need to consider the risks of the vaccine compared to the benefits it provides. Here are important points to think about for this vaccine:

Allergies

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

Pediatric

There have not been enough studies on how the Comvax® vaccine affects infants younger than 6 weeks and older than 15 months. Its safety and effectiveness are not known for these age groups.

Geriatric

The Comvax® vaccine is not recommended for adults or older patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the possible risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be taken together at all, while others may be used together even if interactions could occur. In such cases, your doctor may adjust the dose or take other precautions. It's very important that your healthcare professional knows if you are taking any of the following medicines while receiving this vaccine. The following interactions are highlighted for their potential significance but may not include all possible interactions.

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

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at the same time as eating or with specific types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

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 conditions, especially:

• Allergy to yeast—This vaccine should not be used in patients with this allergy.

• Bleeding problems (e.g., hemophilia, thrombocytopenia)—Use with caution. There may be a higher risk of bleeding at the injection site.

• Severe illness with a fever—Your child's dose may need to be postponed.

• Weak immune system due to a disease or medication (e.g., those receiving steroids, chemotherapy for cancer, or who have HIV infection)—The vaccine may not be as effective in these patients.

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

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

More common

• Fever more than 103 degrees F

Less common

• Body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

Incidence not known

• Black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• convulsions
• diarrhea
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives
• itching
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red, irritated eyes
• shortness of breath
• skin rash
• sores, ulcers, or white spots in the mouth or on the lips
• tightness in the chest
• unusual bleeding or bruising
• wheezing

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. Your health care professional may also 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, are bothersome, or if you have any questions about them:

More common

• Hard lumps, pain, redness, soreness, swelling, or warmth at the injection site
• irritability
• sleepiness or unusual drowsiness
• unusual, high-pitched crying

Less common

• Earache
• loss of appetite
• redness or swelling in the ear
• vomiting
• weight loss

Rare

• Sore mouth or tongue
• white patches in the mouth or throat or on the tongue
• white patches with diaper rash

Incidence not known

• Hives or welts
• redness of the skin

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.

• Comvax

A nurse or other trained health professional will give your child this vaccine. This vaccine is given as a shot into one of your child's muscles, usually in the thighs.

This vaccine is usually given as 3 doses. It is usually given at 2, 4, and 12 to 15 months of age, unless your child's doctor tells you otherwise.

It is important that your child receive all of the doses of 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.