Drugplain

Ultra-Technekow V4 11 Ci/1

Technetium Tc-99m · INJECTION, SOLUTION · Curium US LLC

No Recall HistoryCurrently in Shortage
Plain English

Ultra-Technekow V4 is a injection, solution containing technetium tc-99m at 11 Ci/1, taken intravenous. Manufactured by Curium US LLC.

Key Facts

Brand Name
Ultra-Technekow V4
Generic Name
Technetium Tc-99m
NDC Code (Product)
69945-110
Manufacturer
Curium US LLC
Strength
11 Ci/1
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA017243
Drug Class
Radioactive Diagnostic Agent [EPC]
Marketing Start
06/10/2014

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective270 reports
no adverse event130 reports
radioisotope scan abnormal80 reports
scan myocardial perfusion abnormal24 reports
nausea17 reports
radiation overdose16 reports
headache15 reports
urticaria15 reports
pruritus14 reports
rash14 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE The Ultra-Technekow™ V4 generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m is used IN ADULTS as an agent for: Thyroid Imaging Salivary Gland Imaging Urinary Bladder Imaging (direct isotopic cystography) for detection of vesico-ureteral reflux Nasolacrimal Drainage System Imaging (dacryoscintigraphy) Sodium Pertechnetate Tc 99m is used IN PEDIATRIC PATIENTS as an agent for: Thyroid Imaging Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux

Dosage & Administration

DOSAGE AND ADMINISTRATION Sodium Pertechnetate Tc 99m is administered by intravenous injection. When imaging the nasolacrimal drainage system, instill the Sodium Pertechnetate Tc 99m by the use of a device such as a micropipette or similar method which will ensure the accuracy of the dose. For imaging the urinary bladder and ureters (direct isotopic cystography), the Sodium Pertechnetate Tc 99m is administered by direct instillation aseptically into the bladder via a urethral catheter, following which the catheter is flushed with approximately 200 mL of sterile saline directly into the bladder. The suggested dose ranges employed for various diagnostic indications in the average ADULT PATIENT (70 kg) are as follows: Vesico-ureteral imaging: 18.5 to 37 MBq (0.5 to 1 mCi) Thyroid gland imaging: 37 to 370 MBq (1 to 10 mCi) Salivary gland imaging: 37 to 185 MBq (1 to 5 mCi) Nasolacrimal drainage system: Maximum dose of 3.7 MBq (100 µCi) The recommended dosages in PEDIATRIC PATIENTS are: Vesico-ureteral imaging: 18.5 to 37 MBq (0.5 to 1 mCi) Thyroid gland imaging: 2.22 to 2.96 MBq (60 to 80 µCi) per kg body weight The patient dose should be measured by a suitable radioactivity calibratio…

Warnings

WARNINGS Radiation risks associated with the use of Sodium Pertechnetate Tc 99m are greater in pediatric patients than in adults and, in general, the younger the patient the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit risk assessments involving pediatric patients. Long-term cumulative radiation exposure may be associated with an increased risk of cancer. Only use generator eluant specified for use with the Ultra-Technekow ™ V4 Generator. Do not use any other generator eluant or saline from any other source.

Contraindications

CONTRAINDICATIONS None.

Adverse Reactions

ADVERSE REACTIONS Allergic reactions including anaphylaxis have been reported infrequently following the administration of Sodium Pertechnetate Tc 99m.

Frequently Asked Questions

What is Ultra-Technekow V4 used for?

Ultra-Technekow V4 contains Technetium Tc-99m. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Ultra-Technekow V4 a controlled substance?

Ultra-Technekow V4 is not classified as a controlled substance by the DEA.

What is the generic name for Ultra-Technekow V4?

The generic name for Ultra-Technekow V4 is Technetium Tc-99m. There are 2 other brand versions of Technetium Tc-99m.

What is the NDC code for Ultra-Technekow V4 11 Ci/1?

The NDC (National Drug Code) for Ultra-Technekow V4 11 Ci/1 is 69945-110, listed by Curium US LLC.

Product NDC

69945-110

Package NDC

69945-110-12

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)