GNH USA

Europe — EMA

Helicobacter Test Infai For Children Of The Age 3-11

Helicobacter Test Infai for Children (age 3‑11) is a 13C‑Urea breath test kit for detecting Helicobacter pylori infection in pediatric patients.

13c-Urea

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What is 13c-Urea?

Helicobacter Test Infai for Children aged 3‑11 is an in‑vitro diagnostic kit that utilizes the 13C‑Urea breath test principle. The kit contains the stable‑isotope 13C‑Urea as the active ingredient and is designed for oral administration to detect Helicobacter pylori infection in pediatric patients. It is marketed in the European Union and supplied as a ready‑to‑use kit. The test follows clinical protocols and offers a non‑invasive option for confirming infection.

What is 13c-Urea used for?

Helicobacter Test Infai for Children is indicated for the detection of Helicobacter pylori infection in pediatric patients aged 3 to 11 years. The 13C‑Urea breath test kit is used as a diagnostic tool to support clinical decisions regarding eradication therapy.

- Assess presence of active H. pylori infection in children. - Aid in confirming successful eradication after treatment. - Provide a non‑invasive alternative to endoscopic biopsy for diagnosis. - Suitable for use in primary care, pediatric gastroenterology, and hospital settings. - Complement other diagnostic methods such as serology or stool antigen testing when needed.

What are the side effects of 13c-Urea?

The 13C‑Urea breath test is generally well tolerated, but some individuals may experience mild or, rarely, serious reactions.

Common: - A temporary metallic or sweet taste in the mouth lasting a few minutes after ingestion. - Mild abdominal discomfort, bloating, or gas that resolves without treatment. - Slight nausea or an upset stomach that does not require medication. - Brief headache that subsides within an hour.

Serious: - Allergic reaction such as skin rash, itching, hives, or facial swelling. - Severe respiratory difficulty, wheezing, or throat tightness indicating possible anaphylaxis. - Persistent vomiting or diarrhea lasting more than several hours. - Unexplained fainting, dizziness, or loss of consciousness requiring medical attention.

What precautions apply to 13c-Urea?

When using the Helicobacter Test Infai for Children, certain precautions should be observed to ensure accurate results and patient safety.

- Verify the child is within the approved age range (3‑11 years) before testing. - Ensure the child has fasted according to the test protocol, typically 2‑4 hours before administration. - Review any recent antibiotic, proton‑pump inhibitor, or bismuth use, as these may affect test accuracy. - Consider underlying medical conditions such as severe asthma or chronic lung disease that could influence breath sample collection. - Inform the caregiver about the need to avoid certain foods or drinks containing carbon‑13 labeled substances prior to the test. - Document any known allergies to urea or related compounds before administration.

What does 13c-Urea interact with?

Certain substances and medications can interfere with the 13C‑Urea breath test results or increase the risk of adverse reactions.

Avoid: - Recent use (within 2 weeks) of antibiotics targeting H. pylori, such as clarithromycin, amoxicillin, or metronidazole. - Proton‑pump inhibitors (e.g., omeprazole, lansoprazole) taken within 2 weeks prior to testing. - Bismuth‑containing compounds (e.g., bismuth subsalicylate) used within the preceding week. - Consumption of carbon‑13 enriched foods or supplements on the day of the test.

Use with caution: - Over‑the‑counter antacids taken within 24 hours before the test. - Herbal remedies that may affect gastric acidity, such as peppermint or ginger extracts. - Chronic respiratory conditions that could alter breath sample composition.

Frequently asked questions

What is the purpose of Helicobacter Test Infai for Children?+
The test is used to detect active Helicobacter pylori infection in children aged 3 to 11 years by measuring the metabolism of 13C‑Urea after oral ingestion.
How does the 13C‑Urea breath test work in children?+
After the child drinks a solution containing 13C‑Urea, H. pylori bacteria if present break down the urea, releasing 13C‑labelled carbon dioxide that is measured in the exhaled breath.
What preparation is required before the test?+
Children should fast for the period recommended by the test protocol (usually 2‑4 hours) and avoid antibiotics, proton‑pump inhibitors, and bismuth compounds for the specified wash‑out periods.
Can the test be used to confirm successful treatment?+
Yes, a repeat 13C‑Urea breath test performed after the eradication regimen can confirm whether H. pylori infection has been cleared.
Is the test safe for children with food allergies?+
The test contains 13C‑Urea, which is generally well tolerated, but any known allergy to urea or related substances should be disclosed to the healthcare provider before administration.
What are common side effects after the test?+
Mild side effects may include a temporary metallic taste, mild abdominal discomfort, slight nausea, or a brief headache, all of which usually resolve quickly.
What serious reactions should prompt immediate medical attention?+
Signs of an allergic reaction such as rash, swelling, difficulty breathing, or loss of consciousness require urgent medical care.
How long does it take to get results from the breath test?+
Results are typically available within a few hours after the breath samples are collected and analyzed in the laboratory.
Can other medications affect the accuracy of the test?+
Yes, recent use of antibiotics, proton‑pump inhibitors, or bismuth compounds can suppress H. pylori activity and lead to false‑negative results.
Is the test covered by health insurance in the EU?+
Coverage varies by country and insurance plan; it is advisable to check with the local health authority or insurer for reimbursement details.
What age range is the Helicobacter Test Infai approved for?+
The kit is specifically validated for children between 3 and 11 years of age.
Can the test be performed at home?+
The kit requires specialized equipment to analyze the breath sample, so collection is usually done in a clinical setting, while the analysis is performed by a laboratory.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
13c-Urea
Route
Oral Use
Manufacturer
Infai Gmbh
Origin
EU

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