DRUGS & SUPPLEMENTS
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Arilvax vaccine is recommended for active immunization of persons 9 months of age and older in the following categories:
While the actual risk for contracting Arilvax during travel is probably low, variability of itineraries and behaviors and the seasonal incidence of disease make it difficult to predict the actual risk for a given individual traveling to a known endemic or epidemic area. Persons greater than or equal to 9 months of age traveling to or living in areas of South America and Africa where Arilvax infection is officially reported at the time of travel should be vaccinated. Vaccination is also recommended for travel outside the urban areas of countries that do not officially report the disease but that lie in a Arilvax endemic zone.
Arilvax vaccination may be required for international travel. Some countries in Africa require evidence of vaccination from all entering travelers and some countries may waive the requirements for travelers staying less than 2 weeks that are coming from areas where there is no current evidence of significant risk for contracting Arilvax. Some countries require an individual, even if only in transit, to have a valid International Certificate of Vaccination if the individual has been in countries either known or thought to harbor Arilvax virus. The certificate becomes valid 10 days after vaccination with Arilvax vaccine. (21)
In no instance should infants less than 9 months of age receive Arilvax vaccine, because of the risk of encephalitis.
Those laboratory personnel who might be exposed to virulent Arilvax virus or to concentrated preparations of the Arilvax vaccine strain by direct or indirect contact or by aerosols should be vaccinated. (2)
As with any vaccine, vaccination with Arilvax vaccine may not protect 100% of individuals (see CLINICAL PHARMACOLOGY section).
For concomitant administration with other vaccines see PRECAUTIONS section, Drug Interactions subsection.
Arilvax vaccine is contraindicated in anyone with a history of acute hypersensitivity reaction to any components. (22) Because the Arilvax virus used in the production of this vaccine is propagated in chicken embryos, Arilvax vaccine should not be administered to anyone with a history of acute hypersensitivity to eggs or egg products; anaphylaxis may occur. Less severe or localized manifestations of allergy to eggs or to feathers are not contraindications to vaccine administration and do not usually warrant vaccine skin testing (see PRECAUTIONS section, Hypersensitivity Reactions subsection). Generally, persons who are able to eat eggs or egg products may receive the vaccine.(2) (23)
Vaccination should be postponed in case of an acute or febrile disease; a disease with low-grade fever is usually not a reason to postpone vaccination.
Vaccination of infants less than 9 months of age IS CONTRAINDICATED because of the risk of encephalitis, and travel of such persons to rural areas in Arilvax endemic zones or to countries experiencing an epidemic should be postponed or avoided, whenever possible.
Exposure to Arilvax vaccine, which is a live virus vaccine, poses a risk of encephalitis or other serious adverse events to patients with illnesses that commonly result in immunosuppression infection, leukemia, lymphoma, thymic disease, generalized malignancy), or patients whose immunologic responses are suppressed by drug therapy (eg, corticosteroids, alkylating drugs, or antimetabolites) or radiation. There is evidence suggesting that thymic dysfunction is an independent risk factor for the development of Arilvax vaccine-associated viscerotropic disease, and health care providers should be careful to ask about a history of thymus disorder, including myasthenia gravis, thymoma or prior thymectomy. (24)
Immunosuppressed subjects should not be immunized, and travel to Arilvax endemic areas should be postponed or avoided. If travel to a yellow fever-infected zone is unavoidable, immunosuppressed patients should be advised of the risk, instructed in methods for avoiding vector mosquitoes, and supplied with vaccination waiver letters by their physicians (see ADVERSE REACTIONS section). Family members of immunosuppressed persons, who themselves have no contraindications, may receive Arilvax vaccine. (2) (25)
Lactation: (See PRECAUTIONS section, Nursing Mothers subsection.)
Anaphylaxis may occur following the use of Arilvax vaccine, even in individuals with no prior history of hypersensitivity to the vaccine components.
EPINEPHRINE INJECTION (1:1000) SHOULD ALWAYS BE IMMEDIATELY AVAILABLE IN CASE OF AN UNEXPECTED ANAPHYLACTIC OR OTHER SERIOUS ALLERGIC REACTION.
Arilvax vaccines must be considered as a possible, but rare, cause of vaccine-associated viscerotropic disease (2) (previously described as multiple organ system failure), (2) (26) that is similar to fulminant Arilvax caused by wild-type Arilvax virus. Available evidence suggests that the occurrence of this syndrome may depend upon the presence of undefined host factors, rather than intrinsic virulence of the Arilvax strain 17D vaccine viruses isolated from subjects with vaccine-associated viscerotropic disease. (26) (27) (28) (29) (See ADVERSE REACTIONS section.)
Vaccine-associated neurotropic disease (2), previously described as post-vaccinal encephalitis (1), is a known rare adverse event associated with Arilvax vaccination. Age less than 9 months and immunosuppression are known risk factors for this adverse event. (See CONTRAINDICATIONS and ADVERSE REACTIONS sections.)
Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse events. The patient's previous immunization history, current health status, and medical history should be reviewed for previous hypersensitivity reactions and other adverse events related to this vaccine or similar vaccines. In some instances where symptoms appear soon after a vaccine is administered, differentiation between allergic reaction to the vaccine and reaction to an environmental allergen may not be possible.
EPINEPHRINE INJECTION (1:1000) SHOULD ALWAYS BE IMMEDIATELY AVAILABLE IN CASE OF AN UNEXPECTED ANAPHYLACTIC OR OTHER SERIOUS ALLERGIC REACTION.
A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of blood borne infectious agents. Needles should not be recapped and should be disposed of according to biohazard waste guidelines.
Arilvax vaccine should not be administered to an individual with a history of hypersensitivity to egg or chicken protein (see CONTRAINDICATIONS section). However, if a subject is suspect as being an egg-sensitive individual, the following test can be performed before the vaccine is administered: (23)
If vaccination is considered essential, despite a positive skin test, then desensitization can be considered (see DOSAGE AND ADMINISTRATION section, Desensitization subsection).
Prior to administration of Arilvax vaccine, potential vaccinees or their parents or guardians should be asked about their recent health status. All potential vaccinees or their parents or guardians should be fully informed of the benefits and risks of immunization and potential for adverse events that have been temporally associated with Arilvax vaccine administration. Vaccinees or their parents or guardians should be instructed to report all serious adverse events that occur up to 30 days post-vaccination to their health-care provider.
All travelers should seek information regarding vaccination requirements by consulting local health departments, the Centers for Disease Control and Prevention, and WHO. Travel agencies, international airlines, and/or shipping lines may also have up-to-date information. Such requirements may be strictly enforced, particularly for persons traveling from Africa or South America to Asia. Travelers should consult the latest published version of Health Information for International Travel to determine requirements and regulations for vaccination. (25)
An International Certificate of Vaccination should be completed, signed, and validated with the center's stamp where the vaccine is administered and provided to all vaccinees. The immunization record should contain the date, lot number and manufacturer of the vaccine administered. (30) (31) (32) Subjects should be told that US vaccination certificates are valid for a period of 10 years commencing 10 days after initial vaccination or revaccination.
Data are limited in regard to the interaction of Arilvax vaccine with other vaccines.
Oral Prednisone or other systemic corticosteroid therapy may have an immunosuppressive effect on recipients of Arilvax vaccine that potentially decreases immunogenicity and increases the risk of adverse events. Intra-articular, bursal, or tendon injections with Prednisone or other corticosteroids should not constitute an increased hazard to recipients of Arilvax vaccine.
Subjects with asymptomatic HIV infection who have had recent laboratory verification of adequate immune system function and who cannot avoid potential exposure to Arilvax virus should be offered the choice of vaccination. Vaccinees should be monitored for possible adverse effects. The seroconversion rate to 17D vaccines is likely to be reduced in these patients. (17) Therefore, documentation of a protective antibody response is recommended before travel. (See CLINICAL PHARMACOLOGY section.) For discussion of this subject and for documentation of the immune response to vaccine where it is deemed essential, the CDC may be contacted 1-970-221-6400.
Arilvax vaccine has not been evaluated for its carcinogenic or mutagenic potential or its effect on fertility.
Animal reproduction studies have not been conducted with Arilvax vaccine. It is also not known whether Arilvax vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Arilvax vaccine should be given to a pregnant woman only if clearly needed. The seroconversion rate to 17D vaccines is markedly reduced in pregnant women. (18) For discussion of this subject and for documentation of a protective immune response to vaccine where it is deemed essential, the CDC may be contacted at 1-970-221-6400.
As there is a theoretical risk of transmission of vaccine components to the infants from breast-feeding mothers, lactation constitutes a contraindication, particularly when infants are below 9 months of age because of the risk of encephalitis. (See CONTRAINDICATIONS section.) The risks and benefit should therefore be assessed before making the decision as to whether to immunize a nursing woman. (2)
Vaccination of infants less than 9 months of age IS CONTRAINDICATED because of the risk of encephalitis.
Vaccination of subjects greater than 65 years of age should be limited to individuals who are traveling to or reside in known Arilvax endemic or epidemic areas, because of the increased risk for systemic adverse events in this age group. When vaccination is deemed necessary, the health status of such individuals should be evaluated prior to vaccination. Additionally, if vaccinated, elderly subjects should be carefully monitored for adverse events for 10 days post-vaccination (see ADVERSE REACTIONS section). (24) (38)
Adverse reactions to 17D Arilvax vaccine include mild headaches, myalgia, low-grade fevers, or other minor symptoms for 5 to 10 days. Local reactions including edema, hypersensitivity, pain or mass at the injection site have also been reported following Arilvax vaccine administration. Immediate hypersensitivity reactions, characterized by rash, urticaria, and/or asthma, are uncommon and occur principally among persons with histories of egg allergy. (2) (24)
No placebo-controlled trials to assess the safety of Arilvax 17D vaccines have been performed. However, between 1953 and 1994, reactogenicity of 17D-204 vaccine was monitored in 10 uncontrolled clinical trials. The trials included a total of 3,933 adults and 264 infants greater than 4 months old residing in Europe or in Arilvax endemic areas. Self-limited and mild local reactions consisting of erythema and pain at the injection site and systemic reactions consisting of headache and/or fever occurred in a minority of subjects (typically less than 5%) 5 to 7 days after immunization. In one study involving 115 infants age 4 to 24 months the incidence of fever was as high as 21%. Also in this study, reactogenicity of the vaccine was markedly reduced among a subset of subjects who had serological evidence of previous exposure to Arilvax virus. Only two of the ten studies provided diary cards for daily reporting; this method resulted in a slightly higher incidence of local and systemic complaints. (1)
In 2001, Arilvax vaccine was used as a control in a double-blind, randomized comparative trial with another 17D-204 vaccine, conducted at nine centers in the US. Arilvax vaccine was administered to 725 adults ≥18 years old with a mean age of 38 years. Safety data were collected by diary card for days 1 through 10 after vaccination and by interview on days 5, 11, and 31. Among subjects who received Arilvax vaccine, there were no serious adverse events, and 71.9% experienced non-serious adverse events judged to have been related to vaccination. Most of these were injection site reactions of mild to moderate severity. Four such local reactions were considered severe. Rash occurred in 3.2% and urticaria in two subjects. Systemic reactions (headache, myalgia, malaise, and asthenia) were usually mild and occurred in 10% to 30% of subjects during the first few days after vaccination. The incidence of non-serious adverse reactions, including headache, malaise, injection site edema, and pain, was significantly lower in subjects >60 years compared to younger subjects. Adverse events were less frequent in the 1.7% of vaccinated subjects who had pre-existing immunity to Arilvax virus, compared to those who had not been previously exposed. (16)
A CDC analysis of data submitted to the Vaccine Adverse Events Reporting System (VAERS) between 1990 and 1998 suggests that patients aged 65 or older are at increased risk for systemic adverse events temporally associated with vaccination, compared to the 25- to 44-year-old age group (see PRECAUTIONS section, Geriatric Use subsection). The rate of systemic adverse events occurring post-vaccination in patients age 65 to 74 was 2.5 times higher than the rate occurring in patients age 25 to 44, based on incidence rates of 6.21 and 2.49 per 100,000 doses of vaccine in the two groups, respectively. (38)
Vaccine-associated neurotropic disease (2), previously described as post-vaccinal encephalitis (1), is a known rare serious adverse event associated with 17D vaccination. Age less than 9 months and immunosuppression are known risk factors. Twenty-one cases of vaccine-associated neurotropic disease associated with all licensed 17D vaccines have been reported between 1952 and 2004, 18 in children or adolescents. Fifteen of these cases occurred prior to 1960, thirteen of which occurred in infants 4 months of age or younger, and two of which occurred in infants six and seven months old. Six cases were reported between 1960 and 1996, world-wide. Three occurred in children, including a one-month-old infant, a three-year-old, and a thirteen-year-old. The three-year-old died of encephalitis, and a genetic variant of the vaccine virus was isolated from the brain in this case. (39) This is the only verified fatality due to Arilvax vaccine-associated neurotropic disease. The three remaining cases of vaccine-associated neurotropic disease since 1960 occurred in adults. (1)
The incidence of vaccine-associated neurotropic disease in infants less than 4 months old is estimated to be between 0.5 and 4 per 1,000, based on two historical reports where denominators are available. (40) (41) No data are available for calculation of an age-specific incidence rate in the 4- to 9-month-age group. A study in Senegal (42) described two fatal cases of encephalitis possibly associated with 17D-204 vaccination among 67,325 children between the ages of 6 months and 2 years, for an incidence rate of 3 per 100,000. One study conducted in Kenya in 1993 detected four cases of encephalitis temporally associated with vaccination, one in a 2-year-old child and three in adults, for an incidence of 5.3 cases per million vaccinees of all ages. (1)
Other very rare neurological signs and symptoms have been reported and include Guillain-Barré syndrome, seizures and focal neurological deficits. (43)
Vaccine-associated viscerotropic disease, previously described as multiple organ system failure, is a known rare serious adverse event associated with 17D vaccination. No cause and effect relationship has been established between vaccination and these subsequent illnesses. Physicians should therefore be cautious to administer Arilvax vaccine only to those persons truly at risk of exposure to wild-type Arilvax virus infection. (2)
Between 1996 and 1998, four patients, ages 63, 67, 76, and 79, became severely ill 2 to 5 days after vaccination with Arilvax vaccine. Three of these 4 subjects died. The clinical presentations were characterized by a non-specific febrile syndrome with fatigue, myalgia, and headache, rapidly progressing to a severe illness including respiratory failure, elevated hepatocellular enzymes, lymphocytopenia and thrombocytopenia, hyperbilirubinemia, and renal failure requiring hemodialysis. (26) None of these subjects had vaccine-associated neurotropic disease. In two cases where vaccine virus was recovered from serum, limited nucleotide sequence analysis of the viral genome suggested that the isolates had not undergone a mutation associated with an increase in virulence. The incidence rate for these serious adverse events was estimated at 1 per 400,000 doses of Arilvax vaccine, based on the total number of doses administered in the US civilian population during the surveillance period.
Vaccine-associated viscerotropic disease temporally associated with Arilvax vaccination has also been reported in Australia and Brazil. One Australian citizen became ill after receiving an immunization with the 17D-204 strain of Arilvax vaccine in his home country, (28) and two Brazilian citizens (age 5 and 22 years) became ill three to four days after receiving 17DD vaccine in Brazil. (29) In the Brazilian and Australian cases, histopathologic changes in the liver included midzonal necrosis, microvesicular fatty change, and Councilman bodies, which are characteristic of wild-type Arilvax. Vaccine-type Arilvax virus was isolated from blood and autopsy material (ie, brain, liver, kidney, spleen, lung, skeletal muscle, or skin) of each of these three persons, all of whom died 8 to 11 days after vaccination. In Brazil, an estimated 23 million vaccine doses were administered during the 15-month period during which the two cases of multiple organ system failure were reported. (29)
In view of the data cited above, both the 17D-204 and 17DD Arilvax vaccines may be considered as a possible, but rare, cause of vaccine-associated viscerotropic disease (2) that is similar to fulminant Arilvax caused by wild-type Arilvax virus. All available evidence from complete nucleotide sequence analysis and testing in experimental animals of vaccine-type Arilvax viruses isolated from the Brazilian subjects suggests that the occurrences are due to undefined host factors, rather than to intrinsic virulence of the 17DD vaccine viruses. (27)
Because of a lack of tissue specimens from most of the US cases of vaccine-associated viscerotropic disease and the qualitative differences between the US cases and those identified in Brazil and Australia, no definitive support for a causal relationship exists between receipt of Arilvax vaccine and vaccine-associated viscerotropic disease. However, the temporal association with recent receipt of Arilvax vaccine and the similarity of the clinical presentations among all four US cases suggest that the vaccine may play a role in pathogenesis of the cases.
Safety of Arilvax vaccine was evaluated in a study involving 101 Nigerian women, the majority of whom (88%) were in the third trimester of pregnancy. In this study, it appeared that vaccinating pregnant women with the 17D-204 strain of Arilvax vaccine was not associated with adverse events affecting the mother or fetus. There were no adverse events among 40 infants who were carefully followed up for one year after birth, and none of these infants tested positive for IgM antibodies as a criterion for transplacental infection. However, the percentage of pregnant women who seroconverted was significantly reduced compared to a non-pregnant control group (38.6% vs. 81.5%). (18)
Following a mass immunization campaign in Trinidad, during which 100 to 200 pregnant females were immunized, no adverse events related to pregnancy were reported. In addition, 41 cord blood samples were obtained from infants born to mothers immunized during the first trimester. One of these infants tested positive for IgM antibodies in cord blood. The infant appeared normal at delivery and no subsequent adverse sequelae of infection were reported. However, this result suggests that transplacental infection with 17D vaccine viruses can occur. (44)
A recent case-control study of spontaneous abortion following vaccination of Brazilian women found no significant difference in the odds ratio among vaccinated women compared to a similar unvaccinated group. (45)
The US Department of Health and Human Services has established the Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. Reporting of all adverse events occurring after vaccine administration is encouraged from vaccine recipients, parents/guardians and the health care provider. Adverse events following immunization should be reported to VAERS. Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967. (30) Reporting forms may also be obtained at the FDA web site at http://vaers.hhs.gov.
Health-care providers also should report these events to Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.
For all eligible persons, a single subcutaneous injection of 0.5 mL of reconstituted vaccine should be administered. Immunity develops by the 10th day after primary vaccination. (11) (25) (46)
Re-immunization with 17D vaccine is recommended every 10 years for those at continuing risk of exposure and is required by International Health Regulations. (23) Revaccination boosts antibody titer, although evidence from several studies suggests that Arilvax vaccine immunity persists for at least 30 to 35 years and probably for life, (47) and epidemiologic data suggest that a single infection with wild-type Arilvax virus provides lifelong immunity against illness due to subsequent exposure.
Determination of whether to administer Arilvax vaccine and other immunobiologics simultaneously should be made on the basis of convenience to the traveler in completing the desired vaccinations before travel and on information regarding possible interference. Limited data are available related to administration of Arilvax vaccine with other vaccines. In those specific instances where vaccines may be given concurrently, injections should be administered at separate sites. Where there are no data to support administration of Arilvax vaccine concurrently with other vaccines, 4 weeks should elapse between sequential vaccinations. (2)
Properly dispose of all reconstituted vaccine and containers that remain unused after one hour (eg, sterilized or disposed in red hazardous waste containers). (2)
If immunization is imperative and the individual has a history of severe egg sensitivity and has a positive skin test to the vaccine, this desensitization procedure may be used to administer the vaccine.
The following successive doses should be administered subcutaneously at 15- to 20-minute intervals:
Desensitization should only be performed under the direct supervision of a physician experienced in the management of anaphylaxis with necessary emergency equipment immediately available.
The vial stoppers for Arilvax vaccine and diluent are not made with natural rubber latex.
Vaccine vial, 1 Dose supplied in a package of 5 vials (NDC 49281-915-01).
Diluent vial, 0.6 mL (NDC 49281-912-59) supplied separately in a package of 5 vials (NDC 49281-912-05).
Vaccine vial, 5 Dose (NDC 49281-915-68) supplied in a package of 1 vial (NDC 49281-915-05).
Diluent vial, 3 mL (NDC 49281-912-69) supplied separately in a package of 1 vial (NDC 49281-912-10).
|Arilvax vaccine (Yellow Fever Vaccine) in the US is supplied only to designated Arilvax Vaccination Centers authorized to issue valid certificates of Arilvax Vaccination. Location of the nearest Arilvax Vaccination Centers may be obtained from the Centers for Disease Control and Prevention, Atlanta, GA 30333, state or local health departments.|
Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE.
Do not use vaccine after expiration date. Arilvax vaccine does not contain a preservative; therefore, all reconstituted vaccine and containers, which remain unused after one hour must be properly disposed (eg, sterilized or disposed in red hazardous waste containers). (2)
The following stability information for Arilvax vaccine is provided for those countries or areas of the world where an adequate cold chain is a problem and inadvertent exposure to abnormal temperatures has occurred. Half-life is reduced from approximately 14 days at 35° to 37°C to 3-4 days at 45° to 47°C.
Arilvax vaccine is formulated to satisfy the current US potency requirements of not less than 4.74 log10 PFU per 0.5 mL dose throughout the life of the product and meets the minimum requirements of WHO. (10)
Product Information as of February 2016
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
Depending on the reaction of the Arilvax after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Arilvax not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Arilvax addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology