Vaccine Information: Typhim Vi (Page 3 of 4)

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 disordersAsthma

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

For intramuscular use only.

Dosage

The immunizing dose for adults and children is a single injection of 0.5 mL.

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)

Preparation for Administration

The syringe or vial and its packaging should 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, do NOT administer the vaccine.

  • Syringe

Picture A: Luer-Lok™ syringe

Picture A
(click image for full-size original)
Step 1: Holding the syringe cap in one hand (avoid holding the syringe plunger or barrel), unscrew the tip cap by twisting it counterclockwise.
Figure
(click image for full-size original)
Step 2: To attach the needle to the syringe, gently twist the needle clockwise into the syringe until slight resistance is felt.
Figure
(click image for full-size original)

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

  • Vial

Tear off upper seal of vial cap. Cleanse top of rubber stopper of the vial with a suitable antiseptic.

Use a separate sterile syringe and needle or a sterile disposable unit for each individual patient to prevent the transmission of infectious agents from person to person. Needles should not be recapped and should be properly disposed.

Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If any of this conditions exists, do NOT administer the vaccine.

In adults, the intramuscular injection is typically given in the deltoid. In children, the intramuscular injection is given either in the deltoid or the anterolateral thigh.

Do NOT inject this vaccine into the gluteal area or areas where there may be a nerve trunk.

Do NOT inject intravenously.

HOW SUPPLIED

Single-dose syringe, without needle, 0.5 mL, NDC 49281-790-88. Packaged as NDC 49281-790-51.

Multi-dose 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. Discard if the vaccine has been frozen.

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 March 2020.

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
Typhoid Vi
Polysaccharide
Vaccine
Typhim Vi®

single-dose
(0.5 mL)

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

Typhoid Vi Polysaccharide Vaccine
Typhim Vi®

Single-dose prefilled syringe

FOR INTRAMUSCULAR ADMINISTRATION.

For indications and directions see enclosed package circular.

Typh

single-dose
prefilled syringe (0.5 mL)

Rx only

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

multi-dose
vial
(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. DISCARD IF FROZEN.

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)

VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Vaccine Sections

Vaccine Information by RSS

As the leading independent provider of trustworthy vaccine information, our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VxLabels.com provides the full vaccine subset of the FDA's repository. Vaccine information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.