vincristine sulfate injection, USP How Supplied/Storage and Handling | Pfizer Medical Information - US

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HOW SUPPLIED

Vincristine Sulfate Injection, USP, is available as follows:

Unit of Sale

Total Strength/Total Volume

(Concentration)

NDC 61703–309–06

Carton of 1 single-dose flip-top vial (blue cap)

1 mg/mL

NDC 61703–309–16

Carton of 1 single-dose flip-top vial (blue cap)

2 mg/2 mL

(1 mg/mL)

This product should be refrigerated between 2°C–8°C (36°F–46°F). Discard unused solution. Protect from light. Store Upright.

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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WARNINGS

Caution–This preparation should be administered by individuals experienced in the administration of Vincristine Sulfate Injection, USP. It is extremely important that the intravenous needle or catheter be properly...

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INDICATIONS AND USAGE

Vincristine Sulfate Injection is indicated in acute leukemia.

Vincristine Sulfate Injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin's disease, non–...

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DOSAGE AND ADMINISTRATION

This preparation is for intravenous use only (see WARNINGS).

Neurotoxicity appears to be dose related. Extreme care must be used in...

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CONTRAINDICATIONS

Patients with the demyelinating form of Charcot–Marie–Tooth syndrome should not be given Vincristine Sulfate Injection. Careful attention should be given to those conditions listed under ...

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WARNINGS

This preparation is for intravenous use only. It should be administered by individuals experienced in the administration of Vincristine Sulfate Injection. The intrathecal...

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ADVERSE REACTIONS

Prior to the use of this drug, patients and/or their parents/guardian should be advised of the possibility of untoward symptoms.

In general, adverse reactions are reversible...

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OVERDOSAGE

Side effects following the use of Vincristine Sulfate Injection are dose related. In pediatric patients under 13 years of age, death has occurred following doses of vincristine sulfate that were 10 times those...

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DESCRIPTION

Vincristine Sulfate Injection, USP is the salt of an alkaloid obtained from a common flowering herb, the periwinkle plant (Vinca rosea Linn). Originally known as leurocristine, it has...

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CLINICAL PHARMACOLOGY

The mechanisms of action of vincristine sulfate remain under investigation. The mechanism of action of vincristine sulfate has been related to the inhibition of microtubule formation in mitotic spindle...

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REFERENCES

1.: OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

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HOW SUPPLIED

Vincristine Sulfate Injection, USP, is available as follows:

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Rx only

PRESERVATIVE FREE SOLUTION

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Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.