Product Information by Manufacturer

WYETH AYERST / LEDERLE

Tetramune™ DPT Adsorbed Hib Conjugate   1995 Lederle - Company change Wyeth-Ayerst 1996 - Last year listed 1997

Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed-Haemophilus b Conjugate Vaccine Active Immunizing Agent

Pharmacology: Simultaneous immunization against diphtheria, tetanus and pertussis is a routine practice in Canada. Equally as common is the immunization of young children and infants against invasive disease caused by H. influenzae type b. These vaccines have played a major role in markedly reducing the incidence of cases and deaths from diphtheria, tetanus, pertussis and invasive H. influenza type b disease, including meningitis.

Tetramune combines HibTITER indicated for immunization against invasive H. influenzae type b disease, and Tri-Immunol, indicated for immunization against diphtheria, tetanus and pertussis in a single injection.

Diphtheria is primarily a localized and generalized intoxication caused by diphtheria toxin, an extra cellular protein metabolite of toxinogenic strains of C. diphtherias. While the incidence of diphtheria in Canada has decreased from 9000 cases reported in 1924, before the general use of diphtheria toxoid, to only 3 cases in 1989, the case fatality rate has remained constant at about 5 to 10%.

The highest case fatality rates are in the very young and in the elderly. Following adequate immunization with diphtheria toxoid, it is thought that protection lasts for at least 10 years. Antitoxin levels of at least 0.01 antitoxin units/mL are generally regarded as protective. This significantly reduces both the risk of developing diphtheria and the severity of clinical illness, it does not, however, eliminate carriage of C. diphtheriae in the pharynx or on the skin.

Tetanus is an intoxication manifested primarily by neuro-muscular dysfunction caused by a potent exotoxin elaborated by C. tetani. Currently about 17 persons are hospitalized with tetanus each year in Canada. In 1989 there was only 1 reported case of tetanus. Spores of C. tetani are ubiquitous and there is essentially no natural immunity to tetanus toxin. Thus, universal primary immunization with tetanus toxoid with subsequent maintenance of adequate antitoxin levels, by means of timed boosters, is necessary to protect all age groups. Tetanus toxoid is a highly effective antigen and a completed primary series generally induces serum antitoxin levels of at least 0.01 antitoxin units, a level which has been reported to be protective. It is thought that protection persists for at least 10 years.

The toxoids of tetanus and diphtheria induce neutralizing antibodies to the toxins produced by the infecting organism. In clinical studies with Lederle-produced diphtheria and tetanus toxoids, administered in combination with pertussis vaccine, serum antitoxin levels have been shown to be greater than 0.01 antitoxin units/mL in 97% to 100% of 372 infants following 3 doses. These levels are generally regarded to be protective.

Pertussis is a disease of the respiratory tract caused by B. pertussis. This gram-negative coccobacillus produces a variety of active components including endotoxin and a number of other substances that have been defined primarily on the basis of their biological activity in animals. These active components have been associated with a number of effects, such as lymphocytosis, leukocytosis, sensitivity to histamine, changes in glucose and/or insulin levels, possible neurological effects and adjuvant activity. The roles of each of the different components in either the pathogenesis of, or immunity to, pertussis is not well understood. However, the potency of the pertussis component is measured and shown to be acceptable in the mouse potency test. In addition, serum agglutinin titres have been correlated with protection in clinical trials. The pertussis component induces immunity against pertussis disease in humans.

Tri-Immunol is intended for active immunization against diphtheria, tetanus and pertussis, and is not to be used for treatment of actual infection.

Pertussis (whooping cough) is a highly communicable disease of the respiratory tract that has an attack rate in the unimmunized household contacts of over 90%. During the past 25 years immunization against pertussis (whooping cough) has been widely practised, and the incidence and mortality from pertussis in Canada has declined over the past 5 years, to an annual average of about 2 000 cases and no fatalities recorded. In 1989, of the 2 440 reported cases, approximately half, 1179, involved children between the ages of 0 (infants) to 48 months. Precise data do not exist since bacteriological confirmation of pertussis can be obtained in less than half of the suspected cases. Most reported illness from B. pertussis occurs in infants and young children. Older children and adults, in whom classic signs are often absent, may go undiagnosed and serve as reservoirs of disease.

H. influenzae type b (Haemophilus b) is the most common cause of invasive bacterial disease, including meningitis, in young children. Although nonencapsulated H. influenzae are common and 6 capsular polysaccharide types are known, strains with the type b capsule caused most of the invasive H. influenzae type b diseases prior to the introduction of Haemophilus b conjugate vaccines.

Prior to routine immunization, invasive H. influenzae type b diseases occurred primarily in children under 5 years of age (86% of cases). The incidence of invasive H. influenzae type b disease peaked between 6 months and 1 year of age, and approximately 55% of disease occurred between 6 and 18 months of age. The cumulative risk of developing invasive H. influenzae type b disease during the first 5 years of life is about 1 in 200. Approximately 60% of cases are meningitis. Cellulitis epiglottitis, pericarditis, pneumonia, sepsis or septic arthritis make up the remaining 40%. Between 35 to 40% of cases of invasive disease occur in infants between 2 to 18 months of age.

In Canada between 1979 and 1985, the number of Hib meningitis cases reported annually ranged from 0.94 to 1.65/100,000 population. In 1986. the total number of invasive Hib cases reported in Canada was 2.1/100,000 population, and a total of 14 deaths attributed to Hib meningitis were reported (Ontario 7, Alberta 3, British Columbia 2, Quebec 1 and Nova Scotia 1). Four (28%) were infants under 1 year and 8 (57.1%) were 1 to 4 years of age. The overall death-to-case ratio was 2.6%.

The incidence of invasive H. influenzae type b disease is increased in certain children, such as those who are native Americans, black, or from lower socioeconomic status and those with medical conditions such as asplenia, sickle-cell disease, malignancies associated with immunosuppression and antibody deficiency syndromes.

The protective activity of antibody to Haemophilus b polysaccharide was demonstrated by the efficacy of Haemophilus b polysaccharide (HbPs) vaccine. Data from passive antibody studies indicate that a pre-existing titre or antibody to HbPs of 0.15 µg/mL correlates with protection. Data from a Finnish field trial in children 18 to 71 months of age indicate that a titre of > 1 µg/mL 3 weeks after vaccination is associated with long-term protection.

Linkage of Haemophilus b saccharides to a protein such as CRM 197 converts the saccharide (HbO) to a T dependent (HbOC) antigen, and results in an enhanced antibody response to the saccharide in young infants that is boostable and predominantly of the IgG class. Laboratory evidence indicates that the native state of the CRM197 protein and the use of oligosaccharides in the formulation of HibTITER Haemophilus b Conjugate Vaccine enhances its immunogenicity. No published data are available to support the interchangeability of HbOC and other haemophilus b conjugate vaccines with one another for primary immunization.

Indications: For use in children 2 months through 6 years of age for protection against diphtheria, tetanus, pertussis and invasive H. influenzae type b disease when indications for immunization with DPT vaccine and Haemophilus b conjugate vaccine coincide. Typically, this is at 2, 4, 6 and 15 to 18 months of age.

Children who have recovered from culture-confirmed pertussis need not receive further doses of a vaccine containing pertussis. However, these children should receive additional doses of Diphtheria and Tetanus Toxoids Adsorbed as well as Haemophilus b conjugate vaccine as appropriate to complete the series.

The American Academy of Paediatrics (AAP) has recommended that children who have experienced invasive H. influenzae type b disease when < 24 months of age should continue immunization against H. influenzae type b. Children whose disease occurred at > 24 months need not receive further doses of Haemophilus b conjugate vaccine. However these children should receive additional doses of DPT (or if pertussis is contraindicated, DT should be used) as appropriate to complete the series.

Tetramune is intended for active immunization against diphtheria, tetanus, pertussis and invasive H. influenzae type b diseases and is not to be used for treatment of actual infection.

Tetramune is not routinely recommended (or immunization of persons older than 5 years of age. Under certain circumstances it may be used beyond age 5 years. Because Tetramune contains pediatric DTP vaccine, it is not recommended for use beyond the 7th birthday.

As with any vaccine, Tetramune may not protect 100% of individuals receiving the vaccine. If passive immunization is needed, Tetanus Immune Globulin (human TIG) and/or Diphtheria Antitoxin are recommended for tetanus and diphtheria, respectively (see Dosage).

Contraindications: Hypersensitivity to any component of the vaccine, including thimerosal, a mercury derivative, is a contraindication.

Immunization should be deferred during the course of any febrile illness or acute infection. A minor afebrile illness such as a mild upper respiratory infection is not usually reason to defer immunization.

Immunization with Tetramune is contraindicated if the child has experienced any event following previous immunization with a pertussis-containing vaccine, which is considered by the American Academy of Paediatrics (AAP) or the Immunization Practices Advisory Committee (ACIP), in the United States, to be a contraindication to further doses of pertussis vaccine.

These events include: An immediate anaphylactic reaction. Encephalopathy occurring within 7 days following DPT vaccination. This is defined as an acute, severe CNS disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.

The occurrence of any type of neurological symptoms or signs, including one or more convulsions (seizures) following administration of Tetramune is generally a contraindication to further use. Any decision to administer subsequent doses of a vaccine containing diphtheria, tetanus or pertussis antigens should be delayed until the patient's neurological status is better defined.

The presence of any evolving or changing disorder affecting the CNS is a contraindication to administration of pertussis-containing vaccine such as Tetramune regardless of whether the suspected neurological disorder is associated with occurrence of seizure activity of any type.

Studies have indicated that a personal or family history of seizures is associated with increased frequency of seizures following pertussis immunization.

The ACIP and the APP recognize certain circumstances in which children with stable CNS disorders, including well-controlled seizures or satisfactorily explained single seizures, may receive pertussis vaccine. The ACIP and the AAP do not consider a family history of seizures to be a contraindication to pertussis vaccine despite the increased risk of seizures in these individuals.

The decision to administer a pertussis-containing vaccine to such children must be made by the physician on an individual basis, with consideration of all relevant factors, and assessment of potential risks and benefits for that individual. The physician should review the full text of ACIP and AAP guidelines prior to considering vaccination for such children. The parent or guardian should be advised of the potential increased risk involved.

There are no data on whether the prophylactic use of antipyretics can decrease the risk of febrile convulsions. However, data suggests that acetaminophen will reduce the incidence of post vaccination fever. The ACIP and AAP suggest administering acetaminophen at age-appropriate doses at the time of vaccination and every 4 to 6 hours to children at higher risk for seizures than the general population.

Tetramune is not routinely recommended for immunization of persons older than 5 years of age. Under certain circumstances, it may be used beyond age 5 years. Because Tetramune contains pediatric DTP vaccine, it is not recommended for use beyond the 7th birthday.

Routine immunization should be deferred during an outbreak of poliomyelitis providing the patient has not sustained an Injury that increases the risk of tetanus and providing an outbreak of diphtheria or pertussis does not occur simultaneously.

The clinical judgment of the attending physician should prevail at all times.

Warnings: Tetramune is not recommended for immunizing persons on or after their 7th birthday. The ACIP states that "if any of the following events occur in temporal relation to receipt of DTP, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered. Temperature of > 40.5°C within 48 hours not due to another identifiable cause. Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours. Persistent, inconsolable crying lasting > 3 hours, occurring within 48 hours. Convulsions with or without fever occurring within 3 days. Although these events have been considered absolute contraindications, there may be circumstances, such as a high incidence of pertussis, in which the potential benefits outweigh possible risks, particularly because these events are not associated with permanent sequelae."

If a contraindication to any of the components of this combination vaccine exists (see Contraindications) then Tetramune should not be used. For example: If there is a contraindication against the use of a pertussis vaccine component, then a marketed Diphtheria and Tetanus Toxoids Adsorbed, for Pediatric Use (DT) and Haemophilus b Conjugate Vaccine HibTITER should be substituted for each of the remaining doses.

The occurrence of sudden infant death syndrome (SIDS) has been reported following administration of DTP. However, a large case-control study in the U.S. revealed no causal relationship between receipt of DTP vaccine and SIDS. A recent study of 6 497 infants in northern California found no increase in the rate of SIDS among Tetramune recipients. As with any i.m. injection, Tetramune should be given with caution to infants or children with thrombocytopenia or any coagulation disorder that would contraindicate i.m. injection (see Precautions, Drug Interactions).

Tetramune will protect against invasive H. influenzae type b disease only and will not protect against either other members of the Haemophilus genus or other types of H. influenzae species. Antigenuria has been detected following receipt of Haemophilus b conjugate vaccine and therefore antigen detection may not have diagnostic value in suspected invasive H. influenzae type b disease within 2 weeks of immunization.

As reported with Haemophilus B polysaccharide vaccine, cases of invasive H. influenzae type b disease may occur prior to the onset of the protective effect of this vaccine.

Precautions: General: Care is to be taken by the health care provider for safe and effective use of this product. This product should not be used in individuals older than 5 years of age. Under certain circumstances, Tetramune may be used beyond age 5 years. Because it contains pediatric DTP vaccine, Tetramune is not recommended for use beyond the 7th birthday.

Prior to administration of any dose of Tetramune, the parent or guardian should be asked about the personal history, family history and recent health status. The physician should ascertain previous immunization history, current health status and occurrence of any symptoms and/or signs of an adverse event after previous immunizations in the child to be immunized, in order to determine the existence of any contraindication to immunization with Tetramune and to allow an assessment of benefits and risks.

Urticaria, erythema multiforme or other rash, arthralgias and more rarely, a severe anaphylactic reaction (e.g., urticaria with swelling of the mouth, difficulty breathing, hypotension or shock) have been reported following administration of preparations containing diphtheria, tetanus, and pertussis antigens.

Before the injection of any biological, the physician should take all precautions known for the prevention of allergic reactions or any other side effects. This should include: a review of the patient's history regarding possible sensitivity: the ready availability of epinephrine 1:1000 and other appropriate agents used for control of immediate allergic reactions: and a knowledge of the recent literature pertaining to use of the biological concerned, including the nature of side effects and adverse reactions that may follow its use.

Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents and cytotoxic agents), a genetic defect, human immunodeficiency virus (HIV) infection or other causes, may have reduced antibody response to active immunization procedures. Deferral of administration of vaccine may be considered in individuals receiving immunosuppressive therapy. Other groups should receive this vaccine according to the usual recommended schedule (see Drug Interactions). This product is not contraindicated for use in individuals with HIV.

Any acute infection or febrile illness is reason for delaying use of Tetramune except when in the opinion of the physician, withholding the vaccine entails a greater risk. A minor afebrile illness, such as a mild upper respiratory infection, is not usually reason to defer immunization.

Since this product is a suspension containing an adjuvant, shake vigorously to obtain a uniform suspension prior to withdrawing each dose from the multiple dose vial.

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. The vaccine should not be injected intradermally since the safety and immunogenicity of this route have not been evaluated. The vaccine should be given i.m. Drug Interactions: Children receiving immunosuppressive therapy may have a reduced response to active immunization procedures.

As with other i.m. injections, Tetramune should be given with caution to children on anticoagulant therapy. Tetanus Immune Globulin of Diphtheria Antitoxin, if used, should be given in a separate site with a separate needle and syringe.

The AAP recommends that influenza virus vaccine should not be administered within 3 days of immunization with a pertussis-containing vaccine since both vaccines may cause febrile reactions in young children.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Tetramune has not been evaluated for its carcinogenic, mutagenic potentials or impairment of fertility.

Pregnancy: Animal reproductive studies have not been conducted with Tetramune.

Children: The safety and effectiveness in children below the age of 6 weeks have not been established.

For immunization of children 7 years of age or older, a marketed Tetanus and Diphtheria Toxoids Adsorbed for Adult Use (Td) is recommended. If contraindication of the pertussis component exists, a marketed Diphtheria and Tetanus Toxoids Adsorbed, for Pediatric Use (DT) should be substituted in children who have not reached their 7th birthday.

Full protection against the indicated diseases (tetanus, diphtheria, pertussis and invasive H. influenzae type b) is based on a full course of immunization.

Information to be Provided to the Parent/Guardian: Prior to administration of Tetramune, health care personnel should inform the parent, guardian, or other responsible adult of the recommended immunization schedule for protection against diphtheria, tetanus, pertussis and invasive H. influenzae type b disease and the benefits and risks to the child receiving this vaccine. Guidance should be provided on measures to be taken should adverse events occur, such as, antipyretic measures for elevated temperatures. Parents or guardians should be instructed to report any serious adverse reactions to their health care provider.

Adverse Effects: The safety of Tetramune has been evaluated in 6 793 children at 2, 4 and 6 months of age or at 15 to 18 months of age. The percent of doses administered associated with injection site reactions within 72 hours, or common systemic symptoms within 4 days is summarized in Table I.

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Table 1

(1) within 72 hours of immunization
(2) within 4 days of immunization
(3) data for this study all collected within 24 hours of immunization
(4) perceived fever

Based on review of the Kaiser-Permanente Medical Care Program utilization database of hospitalizations (within 60 days) and emergency room visits (within 30 days of immunization), in 6497 infants who received Tetramune, the most common reasons for seeking care include: trauma, viral illness and respiratory illnesses (e.g., upper respiratory infection, otitis media, bronchitis/bronchiolitis and pneumonia). One child who received Tetramune became transiently pale and tremulous without loss of responsiveness 4 hours after immunization and was hospitalized with a diagnosis of seizure. No other hospital visits (or seizure or hypotonic, hyporesponsive episodes were reported within 72 hours of immunization. These results were not different from those observed in 3935 infants who received DTP and HbOC at separate injection sites. As with other aluminum-containing vaccines, a nodule may occasionally be palpable at the injection site for several weeks. Although not seen in studies with Tetramune, sterile abscess formation or s.c. atrophy at the injection site may also occur. The following significant adverse events have occurred following administration of DPT vaccine: persistent, inconsolable crying > 3 hours (1/100 doses), high-pitched unusual crying (1/1 000 doses), fever > 40.5°C (1/330 doses), transient shock-like (hypotonic hyporesponsive) episode (1/1 750 doses), convulsions (1/1 750 doses).

The ACIP states: "Although DPT may rarely produce symptoms that some have classified as acute encephalopathy, a causal relation between DPT vaccine and permanent brain damage has not been demonstrated. If the vaccine ever causes brain damage, the occurrence of such an event must be exceedingly rare. A similar conclusion has been reached by the Committee on Infectious Diseases of the American Academy of Paediatrics, the Child Neurology Society, the Canadian National Advisory Committee on Immunization, the British Joint Committee on Vaccination and Immunization, the British Pediatric Association and the Institute of Medicine."

The occurrence of sudden-infant death syndrome (SIDS) has been reported following administration of DPT. However, a large case-control study in the U.S. revealed no causal relationship between receipt of DPT vaccine and SIDS. A recent study in Northern California found no increase in the rate of SIDS among Tetramune recipients.

Onset of infantile spasms has occurred in infants who have recently received DPT or DT. Analysis of data from this National Childhood Encephalopathy Study on children with infantile spasms showed that receipt of preparations containing diphtheria, tetanus and/or pertussis antigens was not casually related to infantile spasms. The incidence of onset of infantile spasms increases at 3 to 9 months of age, the time period in which the second and third doses of DPT are generally given. Therefore, some cases of infantile spasms can be expected to be related by chance alone to recent receipt of vaccines containing DPT.

Bulging fontanelle has been reported after DPT immunization, although no cause and effect relationship has been established.

Cardiac effects and respiratory difficulties, including apnea have been reported rarely following DPT immunization. Other events that have been reported following administration of vaccines containing diphtheria, tetanus, pertussis or Haemophilus b antigens include: urticaria, erythema multiforme or other rash, arthralgias and, more rarely, a severe anaphylactic reaction (e.g., urticaria with swelling of the mouth, difficulty breathing, hypotension, or shock) and neurological complications, such as convulsions, encephalopathy and various mono- and poly-neuropathies, including Guillain-Barre syndrome.

Permanent neurological disability and death have been reported rarely in temporal relation to immunization with vaccines containing pertussis antigens.

Dosage: For i.m. use only.

For infants beginning at 2 months of age. the immunization series for Tetramune consists of 3 doses of 0.5 mL each at approximately 2-month intervals, followed by a fourth dose of 0.5 mL at approximately 15 to 18 months of age (see Table II).

Tetramune may be substituted for DPT and HibTITER administered separately, whenever the recommended schedule for use of these 2 vaccines coincide (see DPT and HibTITER dosage recommendations below). However, no published data are available to support the interchangeability of the Haemophilus b conjugate vaccine in Tetramune and HibTITER with other Haemophilus b conjugate vaccines for the primary series. Therefore, it is recommended that the same conjugate vaccine be used throughout the primary series, consistent with the data supporting licensure of the vaccine.

Table ll

* Children 15-18 months of age may receive DTP plus a Haemophilus b conjugate vaccine at separate injections.

For previously unvaccinated older children, immunization schedules should be considered on an individual basis for children not vaccinated according to the recommended schedule. Three doses of a product containing DTP, given at approximately 2-month intervals, are required followed by a 4th dose of a product containing DTP approximately 12 months later and a 5th dose of a product containing DTP, at 4 to 6 years of age. If the 4th dose of a pertussis-containing vaccine is not given until after the 4th birthday, no further doses of a pertussis-containing vaccine are necessary. The number of doses of an HbOC-containing product indicated depends on the age that immunization is begun. A child 7 to 11 months of age should receive 3 doses of a product containing HbOC. A child 12 to 14 months of age should receive 2 doses of a product containing HbOC. A child 15 to 59 months of age should receive 1 dose of a product containing HbOC.

As indicated previously, Tetramune may be substituted for DTP and HibTITER administered separately, whenever the recommended schedule for use of these 2 vaccines coincides.

Pre-term infants may be immunized with Tetramune at the usual chronological age from birth.

Interruption of the recommended schedules with a delay between doses does not interfere with the final immunity achieved; nor does it necessitate starting the series over again, regardless of the length of time elapsed between doses. If a contraindication to the pertussis vaccine component occurs, a marketed Diphtheria and Tetanus Toxoids, Adsorbed (DT) and Haemophilus b Conjugate Vaccine should be substituted for each of the remaining doses.

The use of reduced volume (fractional doses) is not recommended. The effect of such practices on the frequency of serious adverse events and on protection against disease has not been determined.

Shake vigorously to obtain a uniform suspension prior to withdrawing each 0.5 mL dose from the multiple dose vial. The vaccine should not be used if it cannot be resuspended. After shaking, the vaccine is a homogeneous white suspension.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

The vaccine should be injected i.m. The preferred sites are the anterolateral aspect of the thigh (the preferred site for infants) or the deltoid muscle of the upper arm. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk. Before injection, the skin at the injection site should be cleansed and prepared with a suitable germicide.

After insertion of the needle, aspirate to help avoid inadvertent injection into a blood vessel.

For either primary or booster immunization against tetanus and diphtheria of individuals 7 years of age and older, the use of marketed Tetanus and Diphtheria Toxoids Adsorbed for Adult Use (Td) is recommended.

For passive immunization against tetanus and diphtheria, human TIG and/or Diphtheria Antitoxin are recommended. A separate syringe and site of injection should be used.

Supplied: Each single dose of 0.5 mL contains: diphtheria toxoid 12.5 Lf, tetanus toxoid 5 Lf (both toxoids induce not less than 2 units of antitoxin per mL in the guinea pig potency test), purified Haemophilus b saccharide 10 µg and CRM197 protein approximately 25 µg . After shaking, the vaccine is a homogeneous white suspension. Each 0.5 mL dose of vaccine is formulated to contain > 16 OPUs (Opacity Units) of inactivated pertussis cells. The total human immunizing dose (the first three 0.5 mL doses given) contains an estimate of 12 units of pertussis vaccine with an estimate of 4 protective units per single human dose, as determined by the mouse pertussis potency test. The potency for the Haemophilus b conjugate component is determined by gas chromatography assay for total saccharide. Each component of the vaccine diphtheria, tetanus, pertussis and Haemophilus b conjugate - meets the required potency standards and contains no other active ingredients.

Nonmedicinal ingredients: thimerosal (as preservative), Multidose vials of 5 mL.

Stability studies indicate that Tetramune can be shipped at ambient temperatures. Do not freeze. Store refrigerated away from freezer compartment at 2 to 8°C.

New Product 1994