Comvax

DRUG DESCRIPTION

COMVAX [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine] is a sterile bivalent vaccine made of the antigenic components used in producing PedvaxHIB* [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] and RECOMBIVAX HB* [Hepatitis B Vaccine (Recombinant)]. These components are the Haemophilus influenzae type b capsular polysaccharide [polyribosylribitol phosphate (PRP)] that is covalently bound to an outer membrane protein complex (OMPC) of Neisseria meningitidis and hepatitis B surface antigen (HBsAg) from recombinant yeast cultures.

Haemophilus influenzae type b and Neisseria meningitidis serogroup B are grown in complex fermentation media. The primary ingredients of the phenol-inactivated fermentation medium for Haemophilus influenzae include an extract of yeast, nicotinamide adenine dinucleotide, hemin chloride, soy peptone, dextrose, and mineral salts and for Neisseria meningitidis include an extract of yeast, amino acids and mineral salts. The PRP is purified from the culture broth by purification procedures which include ethanol fractionation, enzyme digestion, phenol extraction and diafiltration. The OMPC from Neisseria meningitidis is purified by detergent extraction, ultracentrifugation, diafiltration and sterile filtration.

The PRP-OMPC conjugate is prepared by the chemical coupling of the highly purified PRP (polyribosylribitol phosphate) of Haemophilus influenzae type b (Haemophilus b, Ross strain) to an OMPC of the B11 strain of Neisseria meningitidis serogroup B. The coupling of the PRP to the OMPC is necessary for enhanced immunogenicity of the PRP. This coupling is confirmed by analysis of the components of the conjugate following chemical treatment which yields a unique amino acid. After conjugation, the aqueous bulk is then adsorbed onto an amorphous aluminum hydroxyphosphate sulfate adjuvant (previously referred to as aluminum hydroxide).

HBsAg is produced in recombinant yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Merck Research Laboratories. The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The fermentation process involves growth of Saccharomyces cerevisiae on a complex fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids and mineral salts.

The HBsAg protein is released from the yeast cells by mechanical cell disruption and detergent extraction, and purified by a series of physical and chemical methods, which includes ion and hydrophobic chromatography, and diafiltration. The purified protein is treated in phosphate buffer with formaldehyde and then coprecipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate. The vaccine contains no detectable yeast DNA, and 1% or less of the protein is of yeast origin.

The individual PRP-OMPC and HBsAg adjuvanted bulks are combined to produce COMVAX (haemophilus b conjugate and hepatitis b vaccine) . Each 0.5 mL dose of COMVAX (haemophilus b conjugate and hepatitis b vaccine) is formulated to contain 7.5 mcg PRP conjugated to approximately 125 mcg OMPC, 5 mcg HBsAg, approximately 225 mcg aluminum as amorphous aluminum hydroxyphosphate sulfate, and 35 mcg sodium borate (decahydrate) as a pH stabilizer, in 0.9% sodium chloride. The vaccine contains not more than 0.0004% (w/v) residual formaldehyde.

The potency of the PRP-OMPC component is measured by quantitating the polysaccharide concentration by an HPLC method. The potency of the HBsAg component is measured relative to a standard by an in vitro immunoassay.

The product contains no preservative.

COMVAX (haemophilus b conjugate and hepatitis b vaccine) is a sterile suspension for intramuscular injection.

What are the possible side effects of this vaccine (Comvax)?

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with haemophilus B or hepatitis A is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side...

Read All Potential Side Effects and See Pictures of Comvax

What are the precautions when taking haemophilus b conjugate and hepatitis b vaccine (Comvax)?

Before using this medication, tell the doctor or pharmacist if your child is allergic to it; or to yeast or latex; or if your child have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell the doctor or pharmacist your infant's medical history, especially of: bleeding problems (e.g., hemophilia, low platelets, anticoagulant treatment), current illness with fever.

If your child has decreased immune function from other medications (see also Drug Interactions) or other illness (e.g., HIV, leukemia, lymphoma, other cancer), the child's body may not make enough antibodies to protect them from Haemophilus influenza b or hepatitis B...

Read All Potential Precautions of Comvax


Comvax Consumer (continued)

SIDE EFFECTS: Pain/redness/swelling at the injection site, fever, irritability, increased crying, loss of appetite, and increased sleeping may occur. Less common side effects may include bruising at the injection site, vomiting, runny nose, stuffy nose, cold symptoms, cough, and diarrhea. If any of these effects persist or worsen, tell your infant's doctor or pharmacist promptly.

Remember that your child's doctor has prescribed this medication because he or she has judged that the benefit to your infant is greater than the risk of side effects. Many infants using this medication do not have serious side effects. Report all side effects to the doctor before your infant receives the next injection.

Tell your infant's doctor immediately if any of these unlikely but serious side effects occur: unusually fast/irregular heartbeat, fainting.

Tell your infant's doctor immediately if any of these rare but very serious side effects occur: inability to make muscles of the legs/arms/face work (paralysis), seizures, easy bruising/bleeding, mental/mood changes (e.g., unusual behavior, severe drowsiness, stiff neck, closing eyes/turning away from bright light).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice your infant having any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), 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: Before using this medication, tell the doctor or pharmacist if your child is allergic to it; or to yeast or latex; or if your child have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell the doctor or pharmacist your infant's medical history, especially of: bleeding problems (e.g., hemophilia, low platelets, anticoagulant treatment), current illness with fever.

If your child has decreased immune function from other medications (see also Drug Interactions) or other illness (e.g., HIV, leukemia, lymphoma, other cancer), the child's body may not make enough antibodies to protect them from Haemophilus influenza b or hepatitis B infection. Antibody levels should be checked after the vaccine series.


Comvax Patient Information Including Side Effects

Brand Names: Comvax

Generic Name: haemophilus b and hepatitis B vaccine (Pronunciation: hem OFF il us B and HEP a TYE tis)

  • What is haemophilus B and hepatitis B vaccine (Comvax)?
  • What are the possible side effects of this vaccine (Comvax)?
  • What is the most important information I should know about this vaccine (Comvax)?
  • What should I discuss with my healthcare provider before receiving this vaccine (Comvax)?
  • How is this vaccine given (Comvax)?
  • What happens if I a dose is missed (Comvax)?
  • What happens if there is an overdose (Comvax)?
  • What should be avoided before or after receiving this vaccine (Comvax)?
  • What other drugs will affect haemophilus B and hepatitis B vaccine (Comvax)?
  • Where can I get more information?

What is haemophilus B and hepatitis B vaccine (Comvax)?

Haemophilus B is a type of influenza (flu) caused by bacteria.

Haemophilus B bacteria can infect the lungs or throat, and can also spread to the blood, bones, joints, brain, or spinal cord. It can cause breathing problems or meningitis, and these infections can be fatal.

Hepatitis B is a serious disease caused by virus.

Hepatitis B is a disease of the liver that is spread through blood or bodily fluids, sexual contact or sharing IV drug needles with an infected person, or during childbirth when a baby is born to a mother who is infected. Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

The haemophilus B and hepatitis B vaccine is used to help prevent these diseases in children.

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

Haemophilus B and hepatitis B vaccine is for use in children between the ages of 6 weeks and 15 months old.

Like any vaccine, the haemophilus B and hepatitis B vaccine may not provide protection from disease in every person.

What are the possible side effects of this vaccine (Comvax)?

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with haemophilus B or hepatitis A is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if your child has 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 the child has any of these serious side effects:

  • extreme drowsiness, fainting;
  • fussiness, irritability, crying for an hour or longer;
  • seizure (black-out or convulsions); or
  • high fever.

Less serious side effects include:

  • redness, pain, tenderness, swelling, or a hard lump where the shot was given;
  • diarrhea, loss of appetite, mild vomiting;
  • mild fussiness or crying;
  • joint pain, body aches; or
  • mild fever.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about this vaccine (Comvax)?

The haemophilus B and hepatitis B vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. Booster shots may be given at 4 months and 12 to 15 month of age. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with haemophilus B or hepatitis A is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

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