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ENGERIX-B
Overview
What is ENGERIX-B?
ENGERIX-B [Hepatitis B Vaccine (Recombinant)] is a noninfectious recombinant DNA hepatitis B vaccine developed and manufactured by GlaxoSmithKline Biologicals. It contains purified surface antigen of the virus obtained by culturing genetically engineered cells, which carry the surface antigen gene of the hepatitis B virus. The surface antigen expressed in cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide. The procedures used to manufacture ENGERIX-B result in a product that contains no more than 5% yeast protein. No substances of human origin are used in its manufacture.
ENGERIX-B is supplied as a sterile suspension for intramuscular administration. The vaccine is ready for use without reconstitution; it must be shaken before administration since a fine white deposit with a clear colorless supernatant may form on storage.
ENGERIX-B is formulated without preservatives.
What does ENGERIX-B look like?
What are the available doses of ENGERIX-B?
Sorry No records found.
What should I talk to my health care provider before I take ENGERIX-B?
Sorry No records found
How should I use ENGERIX-B?
ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus. As hepatitis D (caused by the delta virus) does not occur in the absence of hepatitis B infection, it can be expected that hepatitis D will also be prevented by ENGERIX-B vaccination.
ENGERIX-B will not prevent hepatitis caused by other agents, such as hepatitis A, C, and E viruses, or other pathogens known to infect the liver.
Immunization is recommended in persons of all ages, especially those who are, or will be, at increased risk of exposure to hepatitis B virus, for example:
ENGERIX-B should be administered by intramuscular injection. In adults, the injection should be given in the deltoid region but it may be preferable to inject in the anterolateral thigh in neonates and infants, who have smaller deltoid muscles. ENGERIX-B should not be administered in the gluteal region; such injections may result in suboptimal response. The attending physician should determine final selection of the injection site and needle size, depending upon the patient's age and the size of the target muscle. A 1-inch, 23-gauge needle is sufficient to penetrate the anterolateral thigh in infants younger than 12 months of age. A 5/8-inch, 25-gauge needle may be used to administer the vaccine in the deltoid region of toddlers and children up to, and including, 10 years of age. The 1-inch, 23-gauge needle is appropriate for use in older children and adults.
ENGERIX-B may be administered subcutaneously to persons at risk of hemorrhage (e.g., hemophiliacs). However, hepatitis B vaccines administered subcutaneously are known to result in lower GMTs. Additionally, when other aluminum-adsorbed vaccines have been administered subcutaneously, an increased incidence of local reactions including subcutaneous nodules has been observed. Therefore, subcutaneous administration should be used only in persons who are at risk of hemorrhage with intramuscular injections.
What interacts with ENGERIX-B?
Hypersensitivity to any component of the vaccine, including yeast, is a contraindication (see DESCRIPTION). This vaccine is contraindicated in patients with previous hypersensitivity to any hepatitis B-containing vaccine.
What are the warnings of ENGERIX-B?
6. Cataracts - Subcapsular bilateral cataracts occurred in 10%, and unilateral in 6.3% of male rats treated with gemfibrozil at 10 times the human dose.
The vial stopper is latex-free. The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals.
Hepatitis B has a long incubation period. Hepatitis B vaccination may not prevent hepatitis B infection in individuals who had an unrecognized hepatitis B infection at the time of vaccine administration. Additionally, it may not prevent infection in individuals who do not achieve protective antibody titers.
What are the precautions of ENGERIX-B?
General:
As with other vaccines, although a moderate or severe febrile illness is sufficient reason to postpone vaccination, minor illnesses such as mild upper respiratory infections with or without low-grade fever are not contraindications.
Prior to immunization, the patient's medical history should be reviewed. The physician should review the patient's immunization history for possible vaccine sensitivity, previous vaccination-related adverse reactions, and occurrence of any adverse event–related symptoms and/or signs in order to determine the existence of any contraindication to immunization with ENGERIX-B and to allow an assessment of benefits and risks. Epinephrine injection (1:1,000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.
A separate sterile syringe and needle or a sterile disposable unit should be used for each individual patient to prevent transmission of hepatitis or other infectious agents from one person to another. Needles should be disposed of properly and should not be recapped.
Special care should be taken to prevent injection into a blood vessel.
As with any vaccine administered to immunosuppressed persons or persons receiving immunosuppressive therapy, the expected immune response may not be obtained. For individuals receiving immunosuppressive therapy, deferral of vaccination for at least 3 months after therapy may be considered.
The potential risk of apnea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunization series to very premature infants (born ≤28 weeks of gestation) who remain hospitalized at the time of vaccination and particularly for those with a previous history of respiratory immaturity. It is generally understood that the benefit of vaccination is high in very premature infants. The decision to vaccinate should be based on careful consideration of the potential benefits and possible risks.
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Multiple Sclerosis:
Information for the Patient:
Patients, parents, or guardians should be informed of the potential benefits and risks of the vaccine, and of the importance of completing the immunization series. As with any vaccine, it is important when a subject returns for the next dose in a series that he or she be questioned concerning occurrence of any symptoms and/or signs of an adverse reaction after a previous dose of the same vaccine. Patients, parents, or guardians should be told to report severe or unusual adverse reactions to their healthcare provider.
The parent or guardian should be given the Vaccine Information Materials, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization.
Drug Interactions:
For information regarding simultaneous administration with other vaccines, refer to INDICATIONS AND USAGE.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
ENGERIX-B has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
Pregnancy:
Pregnancy Category C. Animal reproduction studies have not been conducted with ENGERIX-B. It is also not known whether ENGERIX-B can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ENGERIX-B should be given to a pregnant woman only if clearly needed.
Nursing Mothers:
It is not known whether ENGERIX-B is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ENGERIX-B is administered to a nursing woman.
Pediatric Use:
ENGERIX-B has been shown to be well tolerated and highly immunogenic in infants and children of all ages. Newborns also respond well; maternally transferred antibodies do not interfere with the active immune response to the vaccine. (See CLINICAL PHARMACOLOGY for seroconversion rates and titers in neonates and children. See DOSAGE AND ADMINISTRATION for recommended pediatric dosage and for recommended dosage for infants born of HBsAgpositive mothers.)
Geriatric Use:
Clinical studies of ENGERIX-B did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects. Other reports from the clinical literature indicate that hepatitis B vaccines are less immunogenic in adults 65 years of age and older than in younger individuals. Other reported clinical experience has not identified differences in overall safety between these subjects and younger adult subjects.
What are the side effects of ENGERIX-B?
ENGERIX-B is generally well tolerated. As with any vaccine, however, it is possible that expanded commercial use of the vaccine could reveal rare adverse reactions.
Ten double-blind studies involving 2,252 subjects showed no significant difference in the frequency or severity of adverse experiences between ENGERIX-B and plasmaderived vaccines. In 36 clinical studies, a total of 13,495 doses of ENGERIX-B were administered to 5,071 healthy adults and children who were initially seronegative for hepatitis B markers, and healthy neonates. All subjects were monitored for 4 days post-administration. Frequency of adverse experiences tended to decrease with successive doses of ENGERIX-B. Using a symptom checklist, the most frequently reported adverse reactions were injection site soreness (22%) and fatigue (14%). Other reactions are listed below.
Incidence 1% to 10% of Injections:
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Nervous System Disorders:
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General Disorders and Administration Site Conditions:
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Incidence <1% of Injections:
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Infections and Infestations:
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Blood and Lymphatic System Disorders:
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Metabolism and Nutrition Disorders:
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Psychiatric Disorders:
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Nervous System Disorders:
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Vascular Disorders:
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Gastrointestinal Disorders:
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Skin and Subcutaneous Tissue Disorders:
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Musculoskeletal and Connective Tissue Disorders:
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General Disorders and Administration Site Conditions:
Postmarketing Reports:
Additional adverse experiences have been reported with the commercial use of ENGERIX-B. Those listed below are to serve as alerting information to physicians.
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Infections and Infestations:
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Blood and Lymphatic System Disorders:
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Immune System Disorders:
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Nervous System Disorders:
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Eye Disorders:
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Ear and Labyrinth Disorders:
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Cardiac Disorders:
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Vascular Disorders:
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Respiratory, Thoracic and Mediastinal Disorders:
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Gastrointestinal Disorders:
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Skin and Subcutaneous Tissue Disorders:
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Musculoskeletal and Connective Tissue Disorders:
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General Disorders and Administration Site Conditions:
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Investigations:
Reporting Adverse Events:
The National Childhood Vaccine Injury Act requires that the manufacturer and lot number of the vaccine administered be recorded by the healthcare provider in the vaccine recipient’s permanent medical record, along with the date of administration of the vaccine and the name, address, and title of the person administering the vaccine. The Act further requires the healthcare provider to report to the US Department of Health and Human Services via VAERS the occurrence following immunization of any event set forth in the Vaccine Injury Table including: Anaphylaxis or anaphylactic shock within 4 hours, encephalopathy or encephalitis within 72 hours, or any sequelae thereof (including death). In addition, any event considered a contraindication to further doses should be reported. The VAERS toll-free number is 1-800-822-7967.
What should I look out for while using ENGERIX-B?
Hypersensitivity to any component of the vaccine, including yeast, is a contraindication (see DESCRIPTION). This vaccine is contraindicated in patients with previous hypersensitivity to any hepatitis B-containing vaccine.
The vial stopper is latex-free. The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals.
Hepatitis B has a long incubation period. Hepatitis B vaccination may not prevent hepatitis B infection in individuals who had an unrecognized hepatitis B infection at the time of vaccine administration. Additionally, it may not prevent infection in individuals who do not achieve protective antibody titers.
What might happen if I take too much ENGERIX-B?
Sorry No Records found
How should I store and handle ENGERIX-B?
Store bottles of 1000 SINGULAIR 5-mg chewable tablets and 8000 SINGULAIR 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light resistant container. ENGERIX-B is supplied as a slightly turbid white suspension in vials and prefilled TIP-LOK syringes.They are supplied by as follows:Adult Dose (Preservative Free Formulation)This product was Manufactured By: GlaxoSmithKline BiologicalsAnd Repackaged By:Dispensing Solutions Inc.ENGERIX-B is supplied as a slightly turbid white suspension in vials and prefilled TIP-LOK syringes.They are supplied by as follows:Adult Dose (Preservative Free Formulation)This product was Manufactured By: GlaxoSmithKline BiologicalsAnd Repackaged By:Dispensing Solutions Inc.ENGERIX-B is supplied as a slightly turbid white suspension in vials and prefilled TIP-LOK syringes.They are supplied by as follows:Adult Dose (Preservative Free Formulation)This product was Manufactured By: GlaxoSmithKline BiologicalsAnd Repackaged By:Dispensing Solutions Inc.ENGERIX-B is supplied as a slightly turbid white suspension in vials and prefilled TIP-LOK syringes.They are supplied by as follows:Adult Dose (Preservative Free Formulation)This product was Manufactured By: GlaxoSmithKline BiologicalsAnd Repackaged By:Dispensing Solutions Inc.ENGERIX-B is supplied as a slightly turbid white suspension in vials and prefilled TIP-LOK syringes.They are supplied by as follows:Adult Dose (Preservative Free Formulation)This product was Manufactured By: GlaxoSmithKline BiologicalsAnd Repackaged By:Dispensing Solutions Inc.ENGERIX-B is supplied as a slightly turbid white suspension in vials and prefilled TIP-LOK syringes.They are supplied by as follows:Adult Dose (Preservative Free Formulation)This product was Manufactured By: GlaxoSmithKline BiologicalsAnd Repackaged By:Dispensing Solutions Inc.ENGERIX-B is supplied as a slightly turbid white suspension in vials and prefilled TIP-LOK syringes.They are supplied by as follows:Adult Dose (Preservative Free Formulation)This product was Manufactured By: GlaxoSmithKline BiologicalsAnd Repackaged By:Dispensing Solutions Inc.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
According to the CDC, the hepatitis B vaccine is recognized as the first anti-cancer vaccine because it can prevent primary liver cancer.
A clear link has been demonstrated between chronic hepatitis B infection and the occurrence of hepatocellular carcinoma. In a Taiwanese study, the institution of universal childhood immunization against hepatitis B virus has been shown to decrease the incidence of hepatocellular carcinoma among children. In a Korean study in adult males, vaccination against hepatitis B virus has been shown to decrease the incidence of, and risk of, developing hepatocellular carcinoma in adults.
Considering the serious consequences of infection, immunization should be considered for all persons at potential risk of exposure to the hepatitis B virus. Mothers infected with hepatitis B virus can infect their infants at, or shortly after, birth if they are carriers of the HBsAg antigen or develop an active infection during the third trimester of pregnancy. Infected infants usually become chronic carriers. Therefore, screening of pregnant women for hepatitis B is recommended. Because a vaccination strategy limited to high-risk individuals has failed to substantially lower the overall incidence of hepatitis B infection, the Advisory Committee on Immunization Practices (ACIP) recommends vaccination of all persons from birth to age 18. The Committee on Infectious Diseases of the American Academy of Pediatrics (AAP) has also endorsed universal infant immunization as part of a comprehensive strategy for the control of hepatitis B infection. The AAP, American Academy of Family Physicians (AAFP), and American Medical Association (AMA) also recommend routine vaccination of adolescents 11 to 12 years of age who have not been vaccinated previously. The AAP further recommends that providers administer hepatitis B vaccine to all previously unvaccinated adolescents. (See INDICATIONS AND USAGE.) There is no specific treatment for acute hepatitis B infection. However, those who develop anti-HBs antibodies after active infection are usually protected against subsequent infection. Antibody titers ≥10 mIU/mL against HBsAg are recognized as conferring protection against hepatitis B. Seroconversion is defined as antibody titers ≥1 mIU/mL.
Non-Clinical Toxicology
Hypersensitivity to any component of the vaccine, including yeast, is a contraindication (see DESCRIPTION). This vaccine is contraindicated in patients with previous hypersensitivity to any hepatitis B-containing vaccine.The vial stopper is latex-free. The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals.
Hepatitis B has a long incubation period. Hepatitis B vaccination may not prevent hepatitis B infection in individuals who had an unrecognized hepatitis B infection at the time of vaccine administration. Additionally, it may not prevent infection in individuals who do not achieve protective antibody titers.
As with other vaccines, although a moderate or severe febrile illness is sufficient reason to postpone vaccination, minor illnesses such as mild upper respiratory infections with or without low-grade fever are not contraindications.
Prior to immunization, the patient's medical history should be reviewed. The physician should review the patient's immunization history for possible vaccine sensitivity, previous vaccination-related adverse reactions, and occurrence of any adverse event–related symptoms and/or signs in order to determine the existence of any contraindication to immunization with ENGERIX-B and to allow an assessment of benefits and risks. Epinephrine injection (1:1,000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.
A separate sterile syringe and needle or a sterile disposable unit should be used for each individual patient to prevent transmission of hepatitis or other infectious agents from one person to another. Needles should be disposed of properly and should not be recapped.
Special care should be taken to prevent injection into a blood vessel.
As with any vaccine administered to immunosuppressed persons or persons receiving immunosuppressive therapy, the expected immune response may not be obtained. For individuals receiving immunosuppressive therapy, deferral of vaccination for at least 3 months after therapy may be considered.
The potential risk of apnea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunization series to very premature infants (born ≤28 weeks of gestation) who remain hospitalized at the time of vaccination and particularly for those with a previous history of respiratory immaturity. It is generally understood that the benefit of vaccination is high in very premature infants. The decision to vaccinate should be based on careful consideration of the potential benefits and possible risks.
Multiple Sclerosis:
ENGERIX-B is generally well tolerated. As with any vaccine, however, it is possible that expanded commercial use of the vaccine could reveal rare adverse reactions.
Ten double-blind studies involving 2,252 subjects showed no significant difference in the frequency or severity of adverse experiences between ENGERIX-B and plasmaderived vaccines. In 36 clinical studies, a total of 13,495 doses of ENGERIX-B were administered to 5,071 healthy adults and children who were initially seronegative for hepatitis B markers, and healthy neonates. All subjects were monitored for 4 days post-administration. Frequency of adverse experiences tended to decrease with successive doses of ENGERIX-B. Using a symptom checklist, the most frequently reported adverse reactions were injection site soreness (22%) and fatigue (14%). Other reactions are listed below.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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