Consumer medicine information

HeliCap

Urea (14C)

BRAND INFORMATION

Brand name

HeliCap

Active ingredient

Urea (14C)

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using HeliCap.

What is in this leaflet

This leaflet answers some of the common questions about HELICAP.

i. What HeliCap® is and what it is used for

ii. Before you take HeliCap®

iii. How to take HeliCap®

iv. Possible side effects

v. How to store HeliCap®

vi. Further information

It does not contain all the information that is known about HELICAP.

It does not take the place of talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of taking HELICAP against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor.

Keep this leaflet - you may need to read it again.

What HELICAP is and what it is used for

HELICAP® is for diagnostic use only. The capsule is a part of a breath test examination that can be used to determine whether or not you have a primary or remaining infection in the stomach caused by the bacterium Helicobacter Pylori.

HeliCap® contains 14C -urea, which is mildly radioactive. The test uses the bacterium’s ability to break down urea into carbon dioxide. Following the intake of HeliCap® your breath is collected and analysed. You are infected with Helicobacter Pylori if traces of radioactivity are found in your breath.

How HELICAP works

  1. HELICAP is swallowed with a glass of water on an empty stomach.
  2. Helicap containing 14C –labelled urea disintegrates rapidly in the stomach area and the 14C –urea is dissolved.
  3. In the presence of Helicobacter Pylori, the 14C –urea is metabolized to carbon dioxide and ammonia by the enzyme urease which is produced by the bacteria.
  4. The available 14C isotopes, now in the form of carbon dioxide (14CO2), diffuse into the blood to be transported to the lungs, where it is exhaled in the breath and captured during sampling. A positive sample is conclusive evidence of Helicobacter Pylori infection.
  5. In the absence of Helicobacter Pylori the administered 14C –urea is absorbed in the gastrointestinal tract and subsequently voided.

Before you use HELICAP

Before you use it:

You must tell your doctor if:

  • You have allergies to HELICAP or any of the other ingredients in this product.
  • You have documented or suspected other gastric infection or atrophic gastritis. These conditions can interfere with the test.
  • You are pregnant.

If you have not told your doctor any of the above things, please tell the doctor before taking HELICAP.

When you must not take it:

Do not use HELICAP if you are pregnant or breastfeeding. Although the radiation dose is very low, the test is contraindicated in pregnant women. If you are breast-feeding and the test is deemed to be necessary, you should stop breast-feeding for three days following the test. Pumped milk should be discarded.

Do not use HELICAP if you are allergic (hypersensitive) to 14C-urea or any of the other ingredients of HeliCap® -if you have any infection in the stomach, as it may cause a false result -if you have had your whole stomach or part of your stomach removed

Do not give HELICAP to children. There is no data to support the safety of HELICAP in children.

Do not use HELICAP after the expiry date printed on the pack, or if the packaging is damaged or torn.

Using other Medicines

HeliCap® may be affected by other medicines. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

-The risk for obtaining wrong diagnosis is increased if the test is performed within four (4) weeks after using antibiotics and within one (1) week after the last dose of acid reduction treatments.

Driving and using machines

HeliCap® has no known effects on the ability to drive or to use machines.

Important information about some of the ingredients of HeliCap®

The amount of radioactivity per capsule is low and has a very short range. In plastic, the range is 0.25 mm, and will not penetrate its standard container. The effective dose equivalent you will receive from taking one HeliCap® capsule (one diagnostic test) is less than 3.0 microSv. This is considerably less than what you would receive from a normal X-ray examination of the stomach.

Using HELICAP

How to take it:

The test should be performed in the presence of a registered nurse or doctor.

Stepwise description of the test procedure

  • You should be fasting for at least six (6) hours before the test is performed.
  • The diagnosis is based on the analysis of your breath after you have swallowed the capsule. The usual dose is one capsule as a single dose. The capsule should be swallowed as whole with a small glass of water. If the capsule is chewed, the test must be performed again as the risk of false results increase. A new test may be performed at the earliest the following day.
  • Wait for 10 minutes.
  • You will receive a BreathCard® that contains a mouthpiece into which you should exhale.
  • Exhale into the BreathCard® until the complete surface of the round orange indicator has turned yellow. This will take approximately 1-2 minutes. You can pause to rest for a few breaths without affecting the test results.
  • Please note! You must not inhale through the BreathCard ® since it contains a substance that may cause some irritation to the respiratory tract.
  • If your doctor has access to an analyser in his/her office you will receive the results within a few minutes.

Overdose

Because only one (1) capsule is provided per test, no overdose is expected.

Contact the Poisons Information Centre (Australia 131126, New Zealand 0800764766)

While you are using HELICAP

  • If you have any further questions about HELICAP, please ask your doctor or pharmacist.

Side effects

All medicines can cause side effects, although not everybody gets them.

HeliCap® has no known side effects. If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

After using HELICAP

Storage

Do not use HeliCap® after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Keep out of the reach and sight of children. Store below 25ºC. Store in original package.

Keep the container tightly closed in order to protect from moisture.

Disposal

Radioactive waste shall be disposed of in accordance with local requirements.

Product description

What it contains

The active substance is 14C-urea 37kBq, which is equivalent to approximately 1 to 2 microgram (1 to 2 parts per million of a gram) 14C-urea per capsule.

The other ingredients are citric acid, gelatin, indigo carmine (E 132), and titanium dioxide (E 171).

What it looks like:

Capsule, hard. The capsule is blue, 6mm x16 mm.

HELICAP capsules come in packs of 10 capsules in white, 15 ml polyethylene containers which are sealed with white polyethylene snap-on caps.

Sponsor

Vitramed Pty Ltd
Level1, 229 Great North Rd,
Five Dock NSW 2027

Date of preparation

April 15, 2010

Published by MIMS October 2021

BRAND INFORMATION

Brand name

HeliCap

Active ingredient

Urea (14C)

Schedule

Unscheduled

 

1 Name of Medicine

Urea [14C].

2 Qualitative and Quantitative Composition

Active: 37 kBq, urea [14C].
Each capsule contains 1 - 2 microgram of urea [14C] equivalent to 37 kBq radioactivity. Not less than 99.9% of the radioactivity is due to 14C.
The radiation is emitted as low energy beta particles 49 keV (mean), 156 keV (max). Maximum range in plastic is 0.25 mm. Physical half-life for 14C is 5730 years.
Inactive: Citric acid, gelatin, indigo carmine, titanium dioxide.

3 Pharmaceutical Form

The HeliCap capsule is a blue hard-shell gelatine capsule, 6 x 16 mm, for oral administration.

4 Clinical Particulars

4.1 Therapeutic Indications

HeliCap (urea [14C], 37 kBq capsule) breath test is indicated for use in the detection of gastric urease as an aid in the diagnosis of H. pylori infection in the human stomach.

4.2 Dose and Method of Administration

The medicinal product is for diagnostic use only.

Adults (> 18 years).

One capsule (37 kBq, urea [14C]) should be swallowed together with water as a single administration at the time of the test. Prior to taking the test the patient should have been fasting for at least 6 hours, preferably overnight.
The capsule should be swallowed whole and must not be chewed on.
The HeliCap capsule should be used together with the HeliProbe test system which includes a single-use breath-collecting unit called BreathCard and a 14CO2 analyser, called HeliProbe.
It is necessary for the patient to fast for at least six hours, preferably overnight before the test. The patient should also be off antibiotics and bismuth for 1 month and proton pump inhibitors and sucralfate for 2 weeks prior to the test.
Instruct the patient not to handle the capsule directly as this may interfere with the test result. The capsule should be swallowed intact, and must not be chewed.

HeliProbe system - description and instructions for use.

HeliProbe.

The analyser contains two shielded Geiger-Muller counters mounted face to face. An opening in the shiled allows the insertion of the BreathCard. When Breath Card is fully inserted its two pads are correctly lined up with the two counters. Correct positioning is verified by an optical sensor. The analysis sequence can only be initiated if the card is properly inserted. The HeliProbe Manual contains a full description of the operating process and a description of how results are measured and calculated.
Ensure that the HeliProbe Analyser is correctly installed and the set-up procedures specified in the product Manual are carefully followed.
1. Check that the HeliProbe instrument is ready for use, by pressing the start key. The display will light up showing the text "Ready to Measure".
2. The patients should have fasted for six hours, and have had no antibiotics or bismuth, for 1 month before, or acid inhibitors for 1 week before the test.
3. The patient swallows one HeliCap capsule with approximately 50 mL of water.
4. After 10 minutes the patient is instructed to exhales into a BreathCard until it is fully saturated. This is indicated by a built-in indicator which changes colour from orange to yellow.
5. BreathCard is inserted into the HeliProbe analyser and a single button press starts the analysis. The result is presented 250 seconds later as "infected", "not infected" or "borderline".
6. A negative or a positive infection is presented immediately on the LCD, while a borderline result triggers a second measurement cycle. If the average of the first and second measurement results in a negative or positive infection, the analysis is completed and the result is shown on the LCD - but if the second measurement also falls in the borderline range, a third cycle is initiated. On completion the average of all three cycles is calculated and presented as the result.

4.3 Contraindications

Hypersensitivity to any of the excipients.
The test must not be performed in patients with documented or suspected other gastric infection or in patients with atrophic gastritis. These conditions can interfere with the test. Other tests are required to confirm the presence of Helicobacter pylori in these patients.
Pregnancy.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Urease breath tests are unable to detect severity of infection or the presence of associated conditions such as a lymphoma, or gastric carcinoma.
A positive test alone might not constitute indication for eradication therapy. Differential diagnosis with endoscopic methods might be indicated in order to examine the presence of any other illness, e.g. ulcer, autoimmune gastritis and malignancies.
If the content of the capsule is exposed in the mouth during the ingestion, the risk for a false positive result increases and it is recommended that the test be repeated.
If a repeat test is required, it should not be carried out until the following day and after at least 6 hours of fasting.

Limitations of the test.

The test has been evaluated in outpatients before elective endoscopy.
Test results should be evaluated with clinical signs and patient history when diagnosing H. pylori infection.
The performance characteristics of the test have not been established for monitoring the efficacy of antimicrobial therapies for the treatment of H. pylori infection.
A negative result does not completely rule out the possibility of H. pylori infection. If clinical signs and patient history suggest H. pylori infection, repeat the HeliCap test or use an alternative diagnostic method.
The test is not recommended in patients with gastrectomy, or in patients younger than 18 years.

Use in hepatic impairment.

No dose change is recommended for patients with hepatic impairment.

Use in renal impairment.

No dose change is recommended for patients with renal impairment.

Use in the elderly.

No data available.

Paediatric use.

Clinical studies in children have not been conducted however HeliCap is expected to work the same in children as in adults.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The urea breath test will be affected by all treatments interfering with Helicobacter pylori such as antibiotics, bismuth salts, or acid inhibitors.
Suppression of Helicobacter pylori may lead to false negative results. After treatment with antibiotics or bismuth salts one month should pass before the test is performed. After treatment with acid inhibitors at least one week should pass. This is especially important after eradication therapy.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No studies have been conducted with urea [14C] to evaluate its potential for impairment of fertility.
(Category C)
Animal reproduction studies have not been conducted with HeliCap. It is also not known whether HeliCap can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity.
HeliCap should not be used in pregnant women. Before administering HeliCap, information regarding pregnancy should be sought in women of child-bearing potential.
 It is not known whether urea [14C] is excreted in human breast-milk. If a test is deemed necessary, breast-feeding should be discontinued after the test for three days.

4.7 Effects on Ability to Drive and Use Machines

HeliCap has no influence on the ability to drive and use machines.

4.8 Adverse Effects (Undesirable Effects)

In the Australian study 42 adverse events were reported by 23 patients. Of the 23 patients 21 of these were deemed to be unrelated to the study and it was unknown whether 2 were related to the study. Events were mainly mild to moderate in severity, transient and resolved without further treatment.

Common (≥ 1% and < 10%).

General.

Taste disturbances.

Uncommon (≥ 0.1% and < 1%).

Gastrointestinal.

Stomach ache, wind, abdominal pain, diarrhoea, constipation, nausea, dysphagia, reflux, vomiting, bloating.

Nervous system.

Headache, fatigue, parosmia.

Musculoskeletal, connective tissue and bone.

Back pain, muscle ache, retrosternal pain.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other diagnostic agents ATC code: V04CX.

Mechanism of action.

The urea breath test is based on the urease activity of Helicobacter pylori as described below:
After ingestion of HeliCap, the capsule rapidly disintegrates in the stomach and the 14C labelled urea reaches the gastric mucosa. If Helicobacter pylori are present, the urea [14C] is metabolized to carbon dioxide and ammonia by the urease enzyme in the Helicobacter pylori.
The rate limiting step in the process is thereby the ability of the urease to metabolize urea [14C].
The carbon dioxide diffuses into the blood vessels and from there it is transported as bicarbonate into the lungs and liberated as 14CO2 with exhaled air. Urease is produced in the stomach solely by Helicobacter pylori. Other bacteria producing urease are rarely found in the stomach.
Presence/absence of Helicobacter pylori can thus be determined by measuring if any 14CO2 is present in the exhaled air.

Clinical trials.

De Boer, W, 2002, A longitudinal, non-randomised clinical study, of In-vivo diagnosis of Helicobacter pylori in the GI tract, where each patient served as his/her own control.
Endoscoped patients in whom biopsies were taken to assess the Helicobacter pylori status (gold standard) were asked to return for a urea breath test based in the investigational product (HeliCap) and HeliProbe system. The gold standard diagnosis was based on a rapid urea test, a histological examination and a culture according to a pre-defined method and interpretation. The urea breath test diagnosis was based on the HeliProbe system's qualitative and quantitative assessment.
The primary objectives were to determine if the HeliCap is safe to use, and its accuracy when used together with the HeliProbe breath test system. A further objective was to get an understanding of how the usage of acid suppressants affects the accuracy of the test.
Consecutive unselected patients older than 18 years referred for upper gastrointestinal endoscopy in whom subsequently, biopsies were taken to diagnose Helicobacter pylori infection, were screened for enrolment. Main inclusion criteria were that patients were over 18 years old, were able to perform the HeliProbe UBT, and were able to understand and be willing to sign the informed consent. Due to the mild radioactive properties of HeliCap, pregnant and breast feeding women were excluded from the study. Patients who had for any reason taken systemic antibiotics or bismuth containing medication during the month preceding screening were also excluded. Patients who had taken proton pump inhibitors or H2 receptor antagonists in the week preceding endoscopy were excluded from the main group. A total of 150 patients were enrolled in the study including the side group of 43 patients treated with acid suppressants.
The prevalence of Hp infection in the main group was 36% (42 of 107) (see Table 1). The urea breath test diagnosis provided 104 correctly diagnosed patients, one intermediate result, and two false negative results giving a sensitivity of 95%, confidence interval 84-99, and a specificity of 100%, confidence interval 94-100 (see Table 2).
The side group of patients on acid-suppressant medication had a disease prevalence of 14/33 (33%). Four false negative results, two false positive, and three intermediate results were reported. The sensitivity was calculated to be 67% and specificity 93%.
Borody, T and Wetstein, 2005, conducted a Phase II single centre, singleblind, randomised, comparative cross-over study evaluating the performance of the HeliCap urea [14C] capsules and PYtest urea [14C] capsules used for diagnosing Helicobacter pylori infection compared to endoscopic test results of rapid urease test and histology.

Primary objectives.

1. To determine the sensitivity, specificity, positive and negative predictive values, and accuracy of the HeliCap C14 capsule used in the Urea Breath Test (UBT) for the detection of H. pylori infection.
2. To show equivalence in the sensitivity, specificity, positive and negative predictive values, and accuracy of the HeliCap C14 urea capsule and the currently marketed PYCap.

Secondary objectives.

1. To compare the sensitivity, specificity, positive and negative predictive values, and accuracy of the HeliCap C14 capsule with the invasive testing method (rapid urease test + histopathology).
2. To evaluate the safety of the HeliCap for the detection of exhaled C14 carbon dioxide (CO2).
A total of 204 patients were recruited into the study, of those 204, 19 patients did not meet inclusion/exclusion criteria and were therefore excluded. 185 patients deemed eligible were enrolled into the study, 41 delayed excursions occurred prior to randomisation and 22 patients withdrew consent or were withdrawn by the Investigator from the trial. A total of 122 patients were included in the study. 13 patients were lost-to-follow-up, however 10 of those lost-to-follow-up were included in the efficacy and safety assessment as they had completed both breath tests. Therefore a total of 119 patients were included in the safety and efficacy analysis.
The patient had to meet all of the following criteria to be eligible for inclusion in the trial:
1. Males and females aged 18 to 75 years inclusive.
2. Have provided written fully informed consent as shown per protocol.
3. Scheduled to undergo a panendoscopy.
4. Males and females undergoing H. pylori investigation irrespective of previous H. pylori treatments.
5. Females must not be pregnant or lactating.
6. No clinical evidence of any other disease which might interfere with the patient's ability to enter the trial.
7. Fasted for a minimum of 6 hours prior to enrolment as per standard clinical practice for panendoscopy.
Patients were excluded for any of the following reasons:
1. Patients refusing to consent to participate.
2. Patients taking sucralfate within two weeks of enrolment.
3. Patients taking bismuth or proton pump inhibitors in the week preceding enrolment.
4. Patients taking antibiotics within 4 weeks of enrolment.
5. Clinically relevant abnormalities in physical examination, laboratory screening, medical history and surgical history as assessed by the Investigator. Concomitant administration of phenytoin, warfarin or carbamazepine, unless the patient is adequately monitored for these medications.
6. Patients who have not fasted for 6 hours prior to enrolment, as per standard clinical practice.
7. Unable to communicate well with the Investigators and to comply with the requirements of the entire study.
8. Any contraindication to the colonoscopy or biopsy procedures as assessed by the Investigator e.g. Haemophilia.
9. Patients who are currently or have a history of drug or alcohol abuse.
10. Patients who have been involved in an experimental drug protocol within the past four weeks.
11. Patient's who have taken a non-permitted medication in the month preceding or during study participation.
One hundred and nineteen patients with dyspeptic symptoms undergoing gastroscopy were included in the analysis comparing HeliCap and PYtest for diagnosis of H. pylori infection. The patients were randomised to receive either HeliCap or PYtest UBT test at baseline. They were followed-up for 2 weeks then re-tested in a 'cross-over' fashion to one or the other device. H. pylori infection was confirmed by biopsy tests including rapid urease test (RUT) and histology.
There were 58 (48%, mean age, 48.9±12.5 years) males and 61 females (52%, mean age, 49.3±12.6 years). H. pylori infection was diagnosed by histology (HIST) and by rapid urease test (RUT) in 49 (41%) patients. HeliCap detected active H. pylori infection in 49 (41%) patients while PYtest detected infection in 44 (37%) patients.
Statistical methods were as follows:
Sensitivity, specificity, predictive values of positive and negative results and accuracy and 95% confidence intervals (CIs) of these values were calculated. To establish the gold standard, H. pylori status was defined as positive if biopsies from the antrum and body showed a positive result by rapid urease test and histology or histology on at least two biopsies (antrum and body).
The X2-test and Fisher's exact test were used for comparison of proportions, and the McNemar test to assess statistical differences among sensitivity and specificity of the two C14 UBTs. The logistic regression analysis was done to identify confounding factors such as diagnosis, age, gender, smoking, alcohol consumption and drug use. All P values calculated are two tailed and the alpha level of significance is set at P < 0.05.
The results for sensitivity, specificity, positive predictive value, negative predictive value and accuracy of HeliCap and PYtest against those of RUT + HIST or both as a reference standard are presented in Table 3. The overall accuracy was 99% for HeliCap and 93% for PYtest when comparing them with RUT + HIST, considered to be the "gold standard" for H. pylori positivity. The results of the kappa test were 0.966 (P=0.0001) and 0.810 (P=0.0001), for HeliCap and PYtest respectively.
The value of Kappa is defined as κ = Pr(o)/ 1- Pr(e)/1- Pr(e) where Pr(o) is the observed probability of agreement and Pr (e) is the probability of random agreement. The value was computed using SPSS 10 statistical software. When HeliProbe and PYtest were compared against the gold standard used in this analysis, HeliProbe correlation was κ =0.96, P < 0.001 and PYtest was κ = 0.82, P < 0.001. See Table 4.
Twenty three patients reported adverse events in the study. Excluding two patients whom no documentation was available, no adverse events were due to the study medication/procedure.

Conclusions.

The portable urea [14C] breath test "HeliProbe" is accurate, reliable and simpler to use for the diagnosis of H. pylori infection. It is equivalent to the endoscopic gold standard and ideal for routine clinical practice.

5.2 Pharmacokinetic Properties

Absorption.

In the absence of Helicobacter pylori, unaltered ingested urea [14C] is rapidly absorbed into the gastrointestinal tract.

Distribution.

It is distributed into the extracellular fluids including the lymph, bile, CSF and blood. It is reported to cross the placenta and penetrate the eye.

Metabolism.

The orally applied urea [14C] is metabolized to carbon dioxide and ammonia or is integrated into the body's own urea cycle. Absorption and distribution of the 14CO2 occurs faster than the urease reaction. Urea [14C] is dissolved in the stomach contents. In the presence of Helicobacter pylori, the urea [14C] is metabolized to ammonia and 14C marked carbon dioxide [14CO2] by the enzyme urease, produced by Helicobacter pylori. The available 14CO2 diffuses into the blood to be transported to the lungs where it is exhaled in the breath and captured during sampling.
In the absence of urease, all the urea administered is absorbed from the gastro-intestinal tract and metabolized in the same way as endogenous urea. The ammonia which is formed by the bacterial hydrolyses as described above is metabolized as ammonium ion.

Excretion.

It is excreted unchanged in the urine.

5.3 Preclinical Safety Data

Urea is an endogenous substance and no preclinical safety studies have been conducted.

Genotoxicity.

No studies have been conducted with urea [14C] to evaluate its potential for mutagenesis.

Carcinogenicity.

No studies have been conducted with urea [14C] to evaluate its potential for carcinogenesis.

Radiation dosimetry.

Carbon-14 is a naturally occurring isotope. The effective dose in comparison to X-ray investigation is shown in Figure 1.
The doses absorbed in different organs following oral administration of urea [14C] are shown in the table below. Absorbed doses in microGy per administrated activity unit (microGy/MBq) are provided for the normal patient (negative test) and for the Helicobacter pylori positive patient. See Table 5.
International Commission on Radiological Protection. Radiation dose to patients from Radiopharmaceuticals, Addendum to ICRP 53. ICRP Publication 80.Ann ICRP 1998; Vol 28 No 3.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Container should be tightly closed. Protect from moisture.

6.5 Nature and Contents of Container

Bottles of 10, white HDPE container, snap-on cap.

6.6 Special Precautions for Disposal

Because of the very low radioactivity of HeliCap capsules no special precautions are required for the disposal of small numbers of capsules. Where it is necessary to dispose of larger numbers of capsules these can be disposed of by the user under the Code of practice for the disposal of radioactive wastes by the user (1985) - see http://www.arpansa.gov.au/RadiationProtection/factsheets/is_waste.cfm.

6.7 Physicochemical Properties

Chemical structure.


The structural formula of urea [14C] is identical to that of urea. H2N(CO)NH2.

CAS number.

CAS Number 594-05-8.
The chemical properties of urea [14C] do not differ from those of urea.
It is very soluble in water, soluble in ethanol, molecular weight 60.07.

7 Medicine Schedule (Poisons Standard)

Not Scheduled.

Summary Table of Changes