Urea, C-14 (Pytest)

Trade Name : PYtest

Avent, Inc.

CAPSULE

Strength 1 uCi/1

UREA C-14

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Urea, C-14 (Pytest) which is also known as PYtest and Manufactured by Avent, Inc.. It is available in strength of 1 uCi/1 per ml. Read more

Urea, C-14 (Pytest) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

No data

PYtest (C-urea capsules) is intended for use in the detection of gastric urease as an aid in the diagnosis of () infection in the human stomach. The test utilizes a liquid scintillation counter for the measurement of CO in breath samples. The capsules are to be used when analysis is planned at the site where the sample is taken.
PYtest capsule is a gelatin capsule for oral administration containing 1 u00b5Ci of C labeled urea. The urea is adsorbed on sugar spheres and colored yellow with fluorescein.
Structural Formula (C-urea): NHn CONHn
Radiation emission: beta-emission, 49 keV, 156 keV, no other emissions
External emission: No external radiation hazard. Low-energy beta emissions only.
Maximum range of 0.3 mm in water.
Radiological Half-life: 5730 years
Maximum effective dose equivalent (EDE) : 0.3 mrem/u00b5Ci

The urease enzyme is not present in mammalian cells, so the presence of urease in the stomach is evidence that bacteria are present. The presence of urease is not specific for , but other bacteria are not usually found in the stomach. The principle of the breath test is shown in Figure 1.
Figure 1: Principle of Breath Test
To detect , urea labeled with C is swallowed by the patient. If gastric urease from is present, urea is split to form CO and NH at the interface between the gastric epithelium and lumen and CO is absorbed into the blood and exhaled in the breath.
Following ingestion of the capsule by a patient with , CO excretion in the breath peaks between 10 and 15 minutes and declines thereafter with a biological half-life of about 15 minutes. C-urea that is not hydrolyzed by is excreted in the urine with a half-life of approximately 12 hours. About 10% of the C remains in the body at 72 hours and is gradually excreted with a biological half-life of 40 days.

PYtest (C-Urea breath test) is indicated for use in the detection of gastric urease as an aid in the diagnosis of infection in the human stomach. The test utilizes a liquid scintillation counter for the measurement of CO in breath samples.

None

None

No data

No adverse reactions were reported in clinical trials.

Risk from radiation is negligible even with a 1000 capsule overdose (0.3 rem). If overdose occurs, the patient may drink one glass of water (150 ml) every hour to hasten excretion of the isotope. Maximum excretion of urea is achieved at a urine output of u2265 2.0 ml/min.

No data

One PYtest capsule.

No data

A minimum of 1 mmol of CO is required to perform analysis of a breath sample. The amount of breath required to provide 1 mmol of CO varies depending on the amount of CO the patient is producing. Since a full balloon typically contains at least 1 mmol of CO, the balloon should be completely filled.

The indeterminate result should be evaluated by repeating the PYtest or using an alternative diagnostic method. If repeat breath testing is undertaken, careful history to exclude confounding factors should be obtained. If confounding factors are identified, wait an appropriate time (refer to ) before repeating the PYtest.
The cutoff point of 50 DPM was determined to be the mean +3SD of results obtained in patients who did not have .
DPM = Disintegrations per minute

As shown in Figure 4 approximately 30% of patients tested will be positive for .
Figure 4: Histogram showing DPM distribution for the PYtest.
*Note: DPM groupings were calculated on a logarithmic scale. Empty DPM groupings were not included. Chart includes all patients from Studies 1 and 2. Frequency of DPM group includes samples with DPM < Group Name.
If the capsule is damaged or appears abnormal in any way, it may give inaccurate results.

PYtest Capsules, clear gelatin capsules each containing 1 u03bcCi of 14C-urea in unit dose packages of 1, 10 and 100.
PYtest Kit (C-urea breath test) is also supplied as a kit containing a PYtest Capsule and breath collection equipment.
The PYtest Capsule has a shelf life of two years. The expiration date is printed on the capsule label.
PYtest Capsules and Kit should be stored at 15u201330 u00b0C (59u201386 u00b0F) in an area designated by each individual institution's regulations.

Rx Only (USA)
U.S. Patent Nos. 4,748,113; 4,830,010

No data

AVANOS*
PYtest* n C-UREA BREATH TEST CAPSULES FOR THE DETECTION OF HELICOBACTER PYLORI
Contents u2013 10 PYtest* Capsules each containing 1 u00b5Ci C-Urea
For dosage information, please see package insert
NDC 42536-6044-2
For In Vitro Diagnostic Use
Rx Only
Store at 15u00b0u201330u00b0C (59u00b0u201386u00b0F)
REF 60442

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Urea, C-14 (Pytest)

Trade Name : PYtest

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Urea, C-14 (Pytest)

Trade Name : PYtest

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?