Vaccine Information: Typhim Vi (Page 3 of 3)

Solicited Injection Site and Systemic Reactions When Given With Menactra Vaccine

The majority (70%-77%) of solicited injection site reactions at the Typhim Vi and at the Menactra injection sites were reported as Grade 1 and resolved within 3 days post-vaccination. The most common systemic reactions were headache (41% when Menactra and Typhim Vi were given concomitantly; 42% when Typhim Vi was given with Placebo, and 33% when Menactra vaccine was given alone one month after Typhim Vi vaccination) and fatigue (38% when Menactra vaccine and Typhim Vi were given concomitantly; 35% when Typhim Vi was given with Placebo, and 27% when Menactra vaccine was given alone one month after Typhim Vi vaccination). Fever ≥40.0°C and seizures were not reported.

DATA FROM WORLDWIDE POST-MARKETING EXPERIENCE

In addition to reports in clinical trials, worldwide voluntary adverse events reports received since market introduction of Typhim Vi vaccine are listed below. This list includes serious events and/or events which were included based on severity, frequency of reporting or a plausible causal connection to Typhim Vi vaccine. Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to vaccination.

  • Gastrointestinal disorders
    Nausea, vomiting, diarrhea, abdominal pain
  • General disorders and administration site condition
    Injection site pain, inflammation, induration, and erythema; lymphadenopathy, fever, asthenia, malaise, flu-like episode
  • Immune system disorders
    Anaphylaxis, allergic-type reactions such as pruritus, rash, urticaria, angioedema, difficulty breathing, hypotension; serum sickness
  • Musculoskeletal and connective tissue disorders
    Myalgia, arthralgia, cervical pain
  • Nervous system disorders
    Syncope with and without convulsions, headache, loss of consciousness, tremor
  • Respiratory system disorders
    Asthma

Additional Adverse Events

Post-marketing reports of glomerulonephritis, neutropenia, bilateral retinitis, and polyarthritis have been reported in patients who had also received other vaccines; however, a causal relationship has not been established.

REPORTING OF ADVERSE EVENTS

Reporting by parents and patients of all adverse events occurring after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by the health-care provider to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (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 or visit the VAERS website at http//www.vaers.org. (17)

Health-care providers also should report these events to the Pharmocovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370, or call 1-800-822-2463.

DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The syringe or vial and its packaging should also be inspected prior to use for evidence of leakage, premature activation of the plunger, or a faulty tip seal. If any of these conditions exists, the vaccine should not be administered.

For intramuscular use only. Do NOT inject intravenously.

The immunizing dose for adults and children is a single injection of 0.5 mL. The dose for adults is typically given intramuscularly in the deltoid, and the dose for children is given IM either in the deltoid or the anterolateral thigh. The vaccine should not be injected into the gluteal area or areas where there may be a nerve trunk.

A reimmunizing dose is 0.5 mL. Reimmunization consisting of a single dose for US travelers every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time. (14)

The syringe is intended for single use only, must not be reused, and must be disposed of properly and promptly following its use.

The skin at the site of injection first should be cleansed and disinfected. Tear off upper seal of vial cap. Cleanse top of rubber stopper of the vial with a suitable antiseptic and wipe away all excess antiseptic before withdrawing vaccine.

HOW SUPPLIED

Syringe, without needle, 0.5 mL, NDC 49281-790-88. Packaged as NDC 49281-790-51.

Vial, 20 Dose, NDC 49281-790-38. Packaged as NDC 49281-790-20.

STORAGE

Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE.

REFERENCES

1
Levine MM, et al. New knowledge on pathogenesis of bacterial enteric infections as applied to vaccine development. Microbiol. Rev. 47: 510-550, 1983
2
Levine MM. Typhoid Fever Vaccines. p 333-361. In Vaccines, Plotkin SA, Mortimer EA, eds. W.B. Saunders, 1988
3
Levine MM, et al. Typhoid Fever Chapter 5, In: Vaccines and Immunotherapy. Stanley J. Cryz, Jr., Editor. pp 59-72, 1991
4
CDC. Summary of Notifiable Diseases, United States 1992. MMWR 41: No. 55, 1993
5
Ryan CA, et al. Salmonella typhi infections in the United States, 1975-1984: Increasing Role of Foreign Travel. Rev Infect Dis 11:1-8, 1989
6
Woodruff BA, et al. A new look at typhoid vaccination. Information for the practicing physician. JAMA 265: 756-759, 1991
7
Ames WR, et al. Age and sex as factors in the development of the typhoid carrier state, and a method for estimating carrier prevalence. Am J Public Health 33: 221-230, 1943
8
CDC. Typhoid fever — Skagit County, Washington. MMWR 39: 749-751, 1990
9
Acharya IL, et al. Prevention of typhoid fever in Nepal with the Vi capsular polysaccharide of Salmonella typhi. N Engl J Med 317: 1101-1104, 1987
10
Unpublished data available from Sanofi Pasteur Inc., compiled 1991
11
Unpublished data available from Sanofi Pasteur SA
12
Klugman KP, et al. Protective activity of Vi capsular polysaccharide vaccine against typhoid fever. The Lancet, 1165-1169, 1987
13
Keitel WA, et al. Clinical and serological responses following primary and booster immunization with Salmonella typhi Vi capsular polysaccharide vaccines. Vaccines 12: 195-199, 1994
14
Recommendations of the Immunization Practices Advisory Committee (ACIP). Typhoid Immunization. MMWR 43: No. RR-14, 1994
15
CDC. Health Information for International Travel 2001-2002. Atlanta: US Department of Health and Human Services, Public Health Service, 2001
16
ACIP: Use of vaccines and immune globulins in persons with altered immunocompetence. MMWR 42: No. RR-4, 1993
17
CDC. Vaccine Adverse Event Reporting System — United States. MMWR 39: 730-733, 1990
18
ACIP: Update on Adult Immunization. MMWR 40: No. RR-12, 1991

Product Information as of May 2018.

Manufactured by:
Sanofi Pasteur SA
Lyon, France
US Govt License #1724

Distributed by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
1-800-VACCINE (1-800-822-2463)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Label

NDC 49281-790-88

Typh
0.5 mL

Typhoid Vi
Polysaccharide
Vaccine
Typhim Vi®

IM only Rx only

Sanofi Pasteur

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Package

NDC 49281-790-51
Typh

Typhoid Vi Polysaccharide Vaccine
Typhim Vi®

0.5 mL

Single Dose Prefilled Syringe Rx only

FOR INTRAMUSCULAR ADMINISTRATION.

For indications and directions see enclosed package circular.

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Package
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 Dose Vial Label

NDC 49281-790-38

Typhoid Vi
Polysaccharide
Vaccine – Typhim Vi®

Typh
20 DOSES

IM only
For indications and directions see
enclosed package insert.
Store at 2° to 8°C (35° to 46°F).
DO NOT FREEZE.

Rx only

US Govt License #1724
Manufactured by:
Sanofi Pasteur SA
Lyon France

Distributed by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA 1-800-VACCINE (1-800-822-2463)

Sanofi Pasteur

PRINCIPAL DISPLAY PANEL -- 20 Dose Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 Dose Vial Package

NDC 49281-790-20
Typh

20
DOSES

Typhoid Vi
Polysaccharide Vaccine Typhim Vi®

Rx only

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 20 Dose Vial Package
(click image for full-size original)
TYPHIM VI salmonella typhi ty2 vi polysaccharide antigen injection, solution
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-790
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN (SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN) SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 4.15 mg in 0.5 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 0.065 mg in 0.5 mL
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 0.023 mg in 0.5 mL
PHENOL 1.25 mg in 0.5 mL
WATER 0.5 mL in 0.5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-790-51 1 SYRINGE in 1 PACKAGE contains a SYRINGE (49281-790-88)
1 NDC:49281-790-88 0.5 mL in 1 SYRINGE This package is contained within the PACKAGE (49281-790-51)
2 NDC:49281-790-20 1 VIAL, MULTI-DOSE in 1 PACKAGE contains a VIAL, MULTI-DOSE (49281-790-38)
2 NDC:49281-790-38 10 mL in 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (49281-790-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103936 11/28/1994
Labeler — Sanofi Pasteur Inc. (086723285)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur SA 578763542 MANUFACTURE

Revised: 01/2020 Sanofi Pasteur Inc.

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