### Menactra

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## Menactra

#### Menactra

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### CLINICAL PHARMACOLOGY

#### Background

The meningococcus bacterium, *N meningitidis*, causes both endemic and
epidemic disease, principally meningitis and meningococcemia. At least 13 meningococcal
serogroups have been identified based on antigenic differences in their capsular
polysaccharides. Five serogroups (A, B, C, Y and W-135) are responsible for
nearly all cases of meningococcal disease worldwide.^{4,5} Early clinical
manifestations of meningococcal disease are often difficult to distinguish from
other, more common but less serious illnesses.^{6}Onset and progression
of disease can be rapid; in most cases (60%), infected individuals are symptomatic
for less than 24 hours before seeking medical care. Even with administration
of appropriate antimicrobials and other adjunctive therapies, the case-fatality
rate has remained at approximately 10%.^{6,7,8,9} In cases of fulminant
septicemia, the case fatality rate may reach 40%.^{6} Approximately
11-19%^{5} of meningococcal disease survivors have sequelae such as
hearing loss and neurologic disability, or loss of skin, digits or limbs as
a result of ischemia.

#### Mechanism of Action

The presence of bactericidal anti-capsular meningococcal antibodies has been
associated with protection from invasive meningococcal disease.^{10,11}
Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine induces the production of bactericidal antibodies specific
to the capsular polysaccharides of serogroups A, C, Y and W-135.

#### Clinical Studies

Vaccine efficacy was inferred from the demonstration of immunologic equivalence
to a US-licensed meningococcal polysaccharide vaccine, Menomune®-A/C/Y/W-135,
Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined as assessed
by Serum Bactericidal Assay (SBA). The SBA used to test sera contained an exogenous
complement source that was either human (SBA-H) or, when correlated to SBA-H,
baby rabbit (SBA-BR).^{12}

The response to vaccination in children 2-10 years old was evaluated by the proportion of subjects having an SBA-H antibody titer of 1:8 or greater, for each serogroup. In adolescents and adults, the response to vaccination was evaluated by the proportion of subjects with a 4-fold or greater increase in bactericidal antibody to each serogroup as measured by SBA-BR.

Immunogenicity was evaluated in three comparative, randomized, US, multi-center,
active controlled clinical trials that enrolled children (2-10 years old), adolescents
(11-18 years old), and adults (18-55 years old). Participants received a dose
of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine (N=2526) or Menomune-A/C/Y/W-135 vaccine (N=2317). For all
age groups studied, sera were obtained before and approximately 28 days after
vaccination. (Blinding procedures for safety assessments are described in **ADVERSE
REACTIONS** section.)

In each of the trials, there were no substantive differences in demographic characteristics between the vaccine groups, between immunogenicity subsets or the overall study population. In the study of children 2-10 years old, the median age of participants was 3 years old; 95% completed the study. In the adolescent trial, the median age for both groups was 14 years; 99% completed the study. In the adult trial, the median age for both groups was 24 years; 94% completed the study.

#### Immunogenicity in Children

Of 1408 enrolled children 2-10 years old, immune responses evaluated in a subset of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine participants (2-3 years old, n=52; 4-10 years old, n=84) and Menomune-A/C/Y/W-135 vaccine participants (2-3 years old, n=53; 4-10 years old, n=84) were comparable for all four serogroups (Table 1 and Table 2).

**Table 1: Comparison of Bactericidal Antibody Responses* to
Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine and Menomune-A/C/Y/W-135 vaccine 28 Days After Vaccination
for a Subset of Participants Aged 2-3 Years**

Menactra vaccine N‡=48-52 | Menomune-A/C/Y/W-135 vaccineN‡=50-53 | ||||

Serogroup | (95% CI)§ | (95% CI)§ | |||

A | % ≥ 1:8† | 73 | 59,84 | 64 | 50,77 |

GMT | 10 | 8,13 | 10 | 7,12 | |

C | % ≥ 1:8† | 63 | 48,76 | 38 | 25,53 |

GMT | 27 | 14,52 | 11 | 5,21 | |

Y | % ≥ 1:8† | 88 | 75,95 | 73 | 59,84 |

GMT | 51 | 31,84 | 18 | 11,27 | |

W-135 | % ≥ 1:8† | 63 | 47,76 | 33 | 20,47 |

GMT | 15 | 9,25 | 5 | 3,6 | |

* Serum Bactericidal Assay with an exogenous human complement
(SBA-H) source. † The proportion of participants achieving at least an SBA-H titer of 1:8 was assessed using a 10% non-inferiority margin and a one-sided Type I error rate of 0.025. ‡ N = Number of subset participants with at least one valid serology result at Day 0 and Day 28. § The 95% CI for the Geometric Mean Titer (GMT) was calculated based on an approximation to the normal distribution. |

**Table 2: Comparison of Bactericidal Antibody Responses* to
Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine and Menomune-A/C/Y/W-135 vaccine 28 Days After Vaccination
for a subset of Participants Aged 4-10 Years**

Menactra vaccine N‡=84 | Menomune-A/C/Y/W-135 vaccine N‡=84 | ||||

Serogroup | (95% CI)§ | (95% CI)§ | |||

A | % ≥ 1:8† | 81 | 71,89 | 55 | 44,66 |

GMT | 19 | 14,26 | 7 | 6,9 | |

C | % ≥ 1:8† | 79 | 68,87 | 48 | 37,59 |

GMT | 28 | 19,41 | 12 | 7,18 | |

Y | % ≥ 1:8† | 99 | 94,100 | 92 | 84,97 |

GMT | 99 | 75,132 | 46 | 33,66 | |

W-135 | % ≥ 1:8† | 85 | 75,92 | 79 | 68,87 |

GMT | 24 | 18,33 | 20 | 14,27 | |

* Serum Bactericidal Assay with an exogenous human complement
(SBA-H) source. † The proportion of participants achieving at least an SBA-H titer of 1:8 was assessed using a 10% non-inferiority margin and a one-sided Type I error rate of 0.025. ‡ N = Number of subset participants with at least one valid serology result at Day 0 and Day 28. § The 95% CI for the Geometric Mean Titer (GMT) was calculated based on an approximation to the normal distribution. |

In the subset of participants 2-3 years of age with undetectable pre-vaccination titers (ie, < 4 at Day 0), seroconversion rates (defined as ≥ 8 at Day 28) were similar between the Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine and Menomune-A/C/Y/W-135 vaccine recipients. Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine participants achieved seroconversion rates of: 57%, Serogroup A (n=12/21); 62%, Serogroup C (n=29/47); 84%, serogroup Y (n=26/31); 53%, serogroup W-135 (n=20/38). The seroconversion rates for Menomune-A/C/Y/W-135 vaccine recipients were 55%, Serogroup A (n=16/29); 30%, Serogroup C (n=13/43); 57%, serogroup Y (n=17/30); 26%, serogroup W-135 (n=11/43).

In the subset of participants 4-10 years of age, percentages of participants that achieved seroconversion were similar between the Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine and Menomune-A/C/Y/W-135 vaccine recipients. Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine participants achieved seroconversion rates of: 69%, Serogroup A (n=11/16); 81%, Serogroup C (n=50/62); 98%, serogroup Y (n=45/46); 69%, serogroup W-135 (n=27/39). The seroconversion rates for Menomune-A/C/Y/W-135 vaccine recipients were 48%, Serogroup A (n=10/21); 38%, Serogroup C (n=19/50); 84%, serogroup Y (n=38/45); 68%, serogroup W-135 (n=26/38).

#### Immunogenicity in Adolescents

Results from the comparative clinical trial conducted in 881 adolescents aged 11-18 years showed that the immune responses to Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine and Menomune-A/C/Y/W-135 vaccine were similar for all four serogroups (Table 3).

**Table 3: Comparison of Bactericidal Antibody Responses* to
Menactra (polysaccharide diphtheria toxoid conjugate vaccine) Vaccine and Menomune-A/C/Y/W-135 Vaccine 28 Days after Vaccination
for Participants Aged 11-18 Years**

Menactra vaccine N‡=423 | Menomune-A/C/Y/W-135 vaccine N‡=423 | ||||

Serogroup | (95% CI)§ | (95% CI)§ | |||

A | % ≥ 4-fold rise† | 92.7 | (89.8, 95.0) | 92.4 | (89.5, 94.8) |

GMT | 5483 | (4920,6111) | 3246 | (2910,3620) | |

C | % ≥ 4-fold rise† | 91.7 | (88.7, 94.2) | 88.7 | (85.2,91.5) |

GMT | 1924 | (1662,2228) | 1639 | (1406,1911) | |

Y | % ≥ 4-fold rise† | 81.8 | (77.8, 85.4) | 80.1 | (76.0, 83.8) |

GMT | 1322 | (1162,1505) | 1228 | (1088,1386) | |

W-135 | % ≥ 4-fold rise† | 96.7 | (94.5, 98.2) | 95.3 | (92.8, 97.1) |

GMT | 1407 | (1232,1607) | 1545 | (1384,1725) | |

* Serum Bactericidal Assay with baby rabbit complement
(SBA-BR). † Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine was non-inferior to Menomune-A/C/Y/W-135 vaccine. Non-inferiority was assessed by the proportion of participants with a 4-fold or greater rise in SBA-BR titer for N meningitidis serogroups
A, C, Y and W-135 using a 10% non- inferiority margin and a one-sided
Type I error rate of 0.05.‡ N = Number of participants with valid serology results at Day 0 and Day 28. § The 95% CI for the Geometric Mean Titer (GMT) was calculated based on an approximation to the normal distribution. |

In participants with undetectable pre-vaccination titers (ie, less than 8 at Day 0), seroconversion rates (defined as a ≥ 4-fold rise in Day 28 SBA titers) were similar between the Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine and Menomune-A/C/Y/W-135 vaccine recipients. Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine participants achieved seroconversion rates of: 100%, Serogroup A (n=81/81); 99%, Serogroup C (n=153/155); 98%, Serogroup Y (n=60/61); 99%, Serogroup W-135 (n=161/164). The seroconversion rates for Menomune-A/C/Y/W-135 vaccine recipients were 100%, Serogroup A (n=93/93); 99%, Serogroup C (n=151/152); 100%, Serogroup Y (n=47/47); 99%, Serogroup W-135 (n=138/139).

#### Immunogenicity in Adults

Results from the comparative clinical trial conducted in 2554 adults aged 18-55 years showed that the immune responses to Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine and Menomune-A/C/Y/W-135 vaccine were similar for all four serogroups (Table 4).

**Table 4: Comparison of Bactericidal Antibody Responses* to
Menactra (polysaccharide diphtheria toxoid conjugate vaccine) Vaccine and Menomune-A/C/Y/W-135 Vaccine 28 Days After Vaccination
for Participants Aged 18-55 Years**

Menactra vaccine N‡=1280 | Menomune-A/C/Y/W-135 vaccine N‡=1098 | ||||

Serogroup | (95% CI)§ | (95% CI)§ | |||

A | % ≥ 4-fold rise† | 80.5 | (78.2, 82.6) | 84.6 | (82.3, 86.7) |

GMT | 3897 | (3647,4164) | 4114 | (3832,4417) | |

C | % ≥ 4-fold rise† | 88.5 | (86.6, 90.2) | 89.7 | (87.8,91.4) |

GMT | 3231 | (2955, 3533) | 3469 | (3148, 3823) | |

Y | % ≥ 4-fold rise† | 73.5 | (71.0,75.9) | 79.4 | (76.9,81.8) |

GMT | 1750 | (1597,1918) | 2449 | (2237, 2680) | |

W-135 | % ≥ 4-fold rise† | 89.4 | (87.6,91.0) | 94.4 | (92.8, 95.6) |

GMT | 1271 | (1172,1378) | 1871 | (1723,2032) | |

* Serum Bactericidal Assay with baby rabbit complement
(SBA-BR). † Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine was non-inferior to Menomune - A/C/Y/W-135 vaccine. Non-inferiority was assessed by the proportion of participants with a 4-fold or greater rise in SBA-BR titer for N meningitidis serogroups
A, C, Y and W-135 using a 10% non-inferiority margin and a one-sided Type
I error rate of 0.05.‡ N = Number of participants with valid serology results at Day 0 and Day 28. § The 95% CI for the GMT was calculated based on an approximation to the normal distribution. |

In participants with undetectable pre-vaccination titers (ie, less than 8 at Day 0), seroconversion rates (defined as a ≥ 4-fold rise in Day 28 SBA titers) were similar between the Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine and Menomune-A/C/Y/W-135 vaccine recipients. Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine participants achieved seroconversion rates of: 100%, Serogroup A (n=156/156); 99%, Serogroup C (n=343/345); 91%, Serogroup Y (n=253/279); 97%, Serogroup W-135 (n=360/373). The seroconversion rates for Menomune-A/C/Y/W-135 vaccine recipients were 99%, Serogroup A (n=143/144); 98%, Serogroup C (n=297/304); 97%, Serogroup Y (n=22½28); 99%, Serogroup W-135 (n=325/328).

#### Concomitant Vaccine Administration

##### Tetanus and Diphtheria

The concomitant use of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine and Tetanus and Diphtheria Toxoids
Adsorbed, For Adult Use (Td, manufactured by Sanofi Pasteur Inc., Swiftwater,
PA) was evaluated in a double-blind, randomized, controlled clinical trial conducted
in 1021 participants aged 11-17 years. One group received Td and Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccines
(at separate injection sites) at Day 0 and a saline placebo 28 days later (N=509).
The other group received Td and a saline placebo at Day 0 and Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine
28 days later (N=512). Sera were obtained approximately 28 days after each respective
vaccination. As shown in Table 5, for meningococcal serogroups C, Y and W-135,
the proportion of participants with a 4-fold or greater rise in SBA-BR titer
was higher when Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine was given concomitantly with Td than when Menactra (polysaccharide diphtheria toxoid conjugate vaccine)
vaccine was given one month following Td. The clinical relevance of this finding
has not been fully evaluated. No interference was observed in the immune response
to the tetanus and diphtheria components following concomitant vaccination (see
Table 5 and **DOSAGE AND ADMINISTRATION** section).^{13}

**Table 5: Comparison of Antibody Responses for Td* and
Menactra (polysaccharide diphtheria toxoid conjugate vaccine) Vaccinesfor Participants Aged 11-17 Years on Day 28 Following Respective
Vaccinations**

Td + Menactra vaccines at Day 0 Placebo at Day 28 | Td + Placebo at Day 0 Menactra vaccine at Day 28 | ||||||

Antigen | N‡ | (95% CI)§ | N‡ | (95% CI)§ | |||

Tetanus | % > 0.1 IU/mL|| | 464 | 100 | (99.2,100.0) | 477 | 100 | (99.2,100.0) |

GMT | 464 | 11.5 | (10.8,12.2) | 477 | 13.6 | (12.7,14.4) | |

Diphtheria | % > 0.1 IU/mL¶ | 465 | 100 | (99.2,100.0) | 473 | 100 | (99.2,100.0) |

GMT | 465 | 120.9 | (104.6,139.8) | 473 | 8.4 | (7.6, 9.2) | |

Serogroup A | % ≥ 4-fold rise# | 465 | 90.1 | (87.4, 92.8) | 478 | 90.6 | (88.0, 93.2) |

GMT | 466 | 11313 | (10163,12593) | 478 | 10391 | (9523,11339) | |

Serogroup C | % ≥ 4-fold rise# | 465 | 91.2 | (88.6, 93.8) | 478 | 82.4 | (79.0, 85.8) |

GMT | 466 | 5059 | (4404, 5812) | 478 | 2136 | (1811,2519) | |

Serogroup Y | % ≥ 4-fold rise# | 465 | 85.8 | (82.6, 89.0) | 478 | 65.1 | (60.8, 69.3) |

GMT | 466 | 3391 | (2981,3858) | 478 | 1331 | (1170,1515) | |

Serogroup W-135 | % ≥ 4-fold rise# | 465 | 96.3 | (94.6, 98.1) | 478 | 87.7 | (84.7, 90.6) |

GMT | 466 | 4195 | (3719,4731) | 478 | 1339 | (1162,1543) | |

* Response to Td assessed as
follows: Tetanus ELISAand Diphtheria MIT (Micrometabolic Inhibition Test)
(IU/mL). † Response to Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine assessed by Serum Bactericidal Assay with baby rabbit complement (SBA-BR). ‡ N = Total number of participants with valid serology results on Day 28 (and on Day 0 for assessment of % ≥ 4-fold rise). § The 95% CI for the GMT is calculated based on an approximation to the normal distribution. || A serum tetanus antitoxin level of at least 0.01 IU/mL, as measured by neutralization assay, is considered the minimum protective level. ^{14}
A level ≥ 0.1 to 0.2 IU/mL has been considered as protective.^{15}
¶ A serum diphtheria antitoxin level of 0.01 IU/mL is the lowest level giving some degree of protection. Antitoxin levels of at least 0.1 IU/mL are generally regarded as protective. ^{14}# Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine when given concomitantly with Td was non-inferior to Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine when given 28 days after Td. Non- inferiority was assessed by the proportion of participants with a 4-fold or greater rise in SBA-BR titer for N meningitidis serogroups A, C, Y and W-135
using a 10% non-inferiority margin and a one-sided Type I error rate of
0.05. |

##### Typhoid Vi Polysaccharide Vaccine, Typhim Vi®

The concomitant use of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine and Typhim Vi vaccine (recommended
for certain travelers) was evaluated in a double- blind, randomized, controlled
clinical trial conducted in 945 participants aged 18-55 years. One group received
Typhim Vi vaccine and Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine (at separate injection sites) at Day
0 and a saline placebo 28 days later (N=469). The other group received Typhim
Vi vaccine and a saline placebo at Day 0 and Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine 28 days later
(N=476). Sera were obtained approximately 28 days after each respective vaccination.
The immune response to Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine and to Typhim Vi vaccine when given
concurrently was comparable to the immune response when Menactra vaccine or
Typhim Vi vaccine was given alone (see Table 6 and **DOSAGE
AND ADMINISTRATION** section).^{13}

**Table 6: Comparison of Antibody Responses for Typhim
Vi* and Menactra (polysaccharide diphtheria toxoid conjugate vaccine) † Vaccinesfor Participants Aged 18-55 Years on Day 28 Following
Respective Vaccinations**

Typhim Vi + Menactra vaccines at Day 0 Placebo at Day 28 | Typhim Vi vaccine + Placebo at Day 0 Menactra vaccine at Day 28 | ||||||

Antigen | N‡ | (95% CI)§ | N‡† | (95% CI)§ | |||

Typhoid Vi | GMT | 418 | 2.4 | (2.2, 2.7) | 418 | 2.1 | (1.9, 2.3) |

Serogroup A | % ≥ 4-fold rise || | 418 | 79.7 | (75.8, 83.5) | 419 | 75.2 | (71.0, 79.3) |

GMT | 419 | 5138 | (4490, 5879) | 420 | 5110 | (4523, 5772) | |

Serogroup C | % ≥ 4-fold rise || | 418 | 89.5 | (86.5, 92.4) | 419 | 88.3 | (85.2, 91.4) |

GMT | 419 | 3061 | (2525, 3711) | 420 | 3145 | (2635, 3755) | |

Serogroup Y | % ≥ 4-fold rise || | 418 | 74.4 | (70.2, 78.6) | 419 | 65.2 | (60.6, 69.7) |

GMT | 419 | 1821 | (1534, 2161) | 420 | 1742 | (1455, 2086) | |

Serogroup W-135 | % ≥ 4-fold rise || | 418 | 85.2 | (81.8, 88.6) | 419 | 83.8 | (80.2, 87.3) |

GMT | 419 | 1002 | (823, 1220) | 420 | 929 | (750, 1150) | |

* Response to Typhim Vi vaccine assessed by Anti Typhoid
Vi RIA (Radioimmunoassay) (µg/mL). † Response to Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine assessed by Serum Bactericidal Assay with baby rabbit complement (SBA-BR). ‡ N = Number of participants with valid serology results at Day 28 (and Day 0 for assessment of % ≥ 4-fold rise). § The 95% CI for the GMT is calculated based on an approximation to the normal distribution. || Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine when given concomitantly with Typhim Vi vaccine was non-inferior to Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine when given 28 days after Typhim Vi vaccine. Non-inferiority was assessed by the proportion of participants with a 4-fold or greater rise in SBA-BR titer for N meningitidis serogroups A, C, Y and W-135 using a 10% non-inferiority margin and a one-sided Type I error rate of 0.05. |

**REFERENCES**

4. Granoff DM, et al. Meningococcal Vaccines. Plotkin SA, Orenstein WA, eds. Vaccines 4th ed. Philadelphia: WB Saunders Co 2004:960.

5. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Prevention and Control of Meningococcal Disease and Meningococcal Disease and College Students. MMWR 2000;49(RR-7).

6. Rosenstein NE, et al. Meningococcal Disease. N Engl J Med 2001;344:1378-1388.

7. World Health Organization (WHO). Group A and C meningococcal vaccines. Wkly Epidemiol Rec 1999;74:297-303.

8. Brassier N, et al. Meningococcal meningitis and meningococcemia: epidemiological study, France (1985-1991). Med Maklad Infect 1995;25:584-593.

9. Sorensen HT, et al. Outcome of Pre-hospital Antibiotic Treatment of Meningococcal Disease. J Clin Epidemiol 1998;51:717- 721.

10. Makela PH, et al. Evolution of conjugate vaccines. Expert Rev Vaccines 2002;1(3):399-410.

11. Goldschneider I, et al. Human immunity to the meningococcus. I. The Role of Humoral Antibodies. J Exp Med 1969; 129:1307-1326.

12. Maslanka SE, et al. Standardization and a Multilaboratory Comparison of Neisseria meningitidis Serogroup A and C Serum Bactericidal Assays. Clin and Diag Lab Immunol 1997;156-167.

13. Data on file, Sanofi Pasteur Inc. - 092503.

14. Department of Health and Human Services (DHHS), Food and Drug Administration (FDA). Biological Products; Bacterial vaccine and toxoids; Implementation of efficacy rule; Proposed Rule. Federal Register December 13, 1985;50(240);51002- 51117.

15. CDC. General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR02):1-36.

*Last reviewed on RxList: 10/30/2007*

This monograph has been modified to include the generic and brand name in many instances.

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