Document: HeliCap 37 kBq capsule, hard ENG SmPC change

• HeliCap capsule, hard SmPC
• HeliCap 37 kBq capsule, hard ENG SmPC

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summary of the product characteristics

HeliCap, 37 kBq, capsule, hard

One capsule contains 37 kBq(¹⁴C)urea.

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 ¹⁴Cis 5730 years.

For the full list of excipients, see section 6.1.

Capsule, hard.

The capsule is blue, 6 x 16 mm

This medicinal product is for diagnostic use only.

For in-vivodiagnosis of Helicobacter pylori infection in the gastrointestinal tract (stomach and duodenum).

The medicinal product is for diagnostic use only.

The orally administered HeliCap capsule containing (¹⁴C) urea is used to detect Helicobacter pylori by measuring exhaled radioactive ¹⁴CO₂in a “breath test” following enzymatic hydrolysis of ¹⁴C-labeled urea in the gastrointestinal tract.

Adults (> 18 years): One capsule (37 kBq (¹⁴C) urea) 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.

The Helicap capsule should be used together with a validated breath test system, e.g. the Heliprobe test system which includes a tool for breath sampling and an analyzer, or with any other breath test system provided that the analytical method chosen has been validated and is carried out by a qualified laboratory.

Hypersensitivity to any of the excipients listed in section 6.1.

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.

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.

The test is not recommended in patients with gastrectomy.

Paediatric population

The test is not recommended in patients younger than 18 years.

The urea breath test will be affected by all treatments interfering with Helicobacter pylorisuch 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.

Pregnancy

HeliCap must not be used in pregnant women. Before administering HeliCap, information regarding pregnancy should be sought in women of child-bearing potential.

Breastfeeding

Information about excretion of (¹⁴C)urea in breast-milk is missing. If a test is deemed necessary, breast-feeding should be discontinued after the test for three days.

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

None known.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 via the national reporting system listed in Appendix V*.

No case of overdose has been reported.

One diagnostic test exposes a Helicobacter pylori positive patient to a radiation dose of not more than 3 microSv (see section 5.4), therefore it is not expected that an overdose may occur.

Pharmacotherapeutic group: Other diagnostic agents, ATC code: V04CX

The urea breath test is based on the urease activity of Helicobacter pylorias described below:

After ingestion of HeliCap, the capsule rapidly disintegrates in the stomach and the¹⁴C labeled urea reaches the gastric mucosa. If Helicobacter pyloriare present, the (¹⁴C) urea is metabolized to carbon dioxide and ammonia by the urease enzyme in theHelicobacter pylori.

The carbon dioxide diffuses into the blood vessels and from there it is transported as bicarbonate into the lungs and liberated as ¹⁴CO₂with 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 pylorican thus be determined by measuring if any ¹⁴CO₂ is present in the exhaled air.

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.

The orally applied (¹⁴C) urea 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. The limiting step in the process is thereby the ability of the urease to metabolize (¹⁴C) urea.

Urea is an endogenous substance and nopreclinical safety studies have been conducted.

The doses absorbed in different organs following oral administration of (¹⁴C) urea 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 pyloripositive patient.

Normal patient			Helicobacter pylori positive patient
Organ	(microGy/MBq)		Organ	(microGy/ MBq)
Bladder	120		Bone surfaces	120
Bone surfaces	33		Bladder	110
Stomach	30		Red marrow	97
Red marrow	29		Stomach	83
Adrenals	24		Adrenals	76
Breast	24		Breast	76
Oesophagus	24		Oesophagus	76
Gall bladder	24		Gall bladder	76
Brain	24		Brain	76
Heart	24		Heart	76
Skin	24		Skin	76
Liver	24		Liver	76
Lungs	24		Lungs	76
Spleen	24		Spleen	76
Muscles	24		Muscles	76
Kidneys	24		Kidneys	76
Ovaries	24		Ovaries	76
Pancreas	24		Pancreas	76
Thyroid	24		Thyroid	76
Testes	24		Testes	76
Thymus	24		Thymus	76
Colon	24		Colon	76
Jejunum	24		Jejunum	76
Uterus	24		Uterus	76
Remaining organs	24		Remaining organs	76
Effective dose (microSv/MBq)	31		Effective dose (microSv/MBq)	81

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

Citric acid anhydrous

The capsule shell is composed of

Gelatine

Indigo carmine (E 132)

Titanium dioxide (E 171)

Not applicable.

2 years

Do not store above 25C.

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

HeliCap capsules are kept in white, 15 ml polyethylene containers which are sealed with white polyethylene snap-on caps.

Pack size: 10 capsules, hard.

Handling and use: Not applicable.

Disposal: Radioactive waste should be disposed of in accordance with local requirements.

Kibion AB

(Virdings Allé 32A)

P.O. Box 303

SE-751 05 Uppsala

Sweden

Tel.+46 18 78088 00

19308 (SE)

Date at first authorisation: 16 April 2004

Date of latest renewal: 16 April 2009

2014-09-29