Biocard Helicobacter Test

What Helicobacter Test INFAI is and what it is used for Helicobacter Test INFAI is for diagnostic purposes only. It is a breath test for adolescents over 12 years of age and adults to detect the presence of Helicobacter pylori bacteria in the stomach. Why do you need to use Helicobacter Test INFAI? You may have a stomach infection caused by the Helicobacter pylori bacterium. Your doctor recommended that you have a Helicobacter Test INFAI for one of the following reasons: Vashiyat doctor wants to know if you are suffering from infection with Helicobacter pylori, to facilitate diagnose your condition. It has already been established that you have Helicobacter pylori infection and have taken medicines to remove the infection. Your doctor now asks whether the treatment has been successful. How does the test work? All food products contain a substance called carbon-13 (13C). This carbon-13 can be found in the carbon dioxide you exhale from your lungs. The exact carbon-13 content of exhaled air depends on the type of food you eat. Before starting the test, you must accept the so- "Test food". Then take samples of your exhaled air. See "Special Instructions for Use". These samples will be analyzed to measure the "normal" carbon-13 content in the carbon dioxide in the exhaled air. Then you should take a carbon-13 urea solution. After 30 minutes, further samples of your exhaled air will be taken, again measuring the carbon-13 content of the samples. Measurement results are compared and a significant increase in carbon-13 concentration in the second set of samples will suggest your doctor for Helicobacter pylori. 2. What you need to know before using Helicobacter Test INFAI not use Helicobacter Test INFAI • If you suspect you have a gastric infection or a certain type of inflammation of the stomach lining (atrophic gastritis) This inflammation of the stomach lining may give false positive results in the breath test. Studies may be necessary to confirm the presence of Helicobacter pylori. Warnings and precautions Talk to your doctor or pharmacist before taking Helicobacter Test INFAI if you have a disease that can affect or be affected by the test. Even if the result of Helicobacter Test INFAI is positive, additional testing may be required before starting treatment for Helicobacter pylori infection. These are necessary to check for any other complications, for example: • stomach ulcer • inflammation of the stomach lining caused by the immune system • tumors. There is insufficient data on the reliability of Helicobacter Test INFAI to recommend its use in patients with a stomach disorder. If the patient vomits during the test, it is necessary to re-perform the test. This should be done on an empty stomach and no earlier than the next day. Other medicines and Helicobacter Test INFAI Helicobacter Test INFAI is affected by medicines that affect Helicobacter pylori (see section 3, second paragraph, "Method of administration") • the enzyme urease that stimulates the reduction of urea. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. It is expected that the test during pregnancy and breastfeeding will be detrimental. Driving and using machines Helicobacter Test INFAI has no influence on the ability to drive and use machines.
How to use Helicobacter Test INFAI Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The test should be performed in the presence of your doctor or other qualified person. The recommended dose is Patients over 12 years of age accept the contents of one bank per test. Method of administration Prior to administration of the test, you should not take food for 6 hours, preferably overnight. Ask your doctor if this is a problem, for example. in diabetic patients. The test time is about 40 minutes. The test should be performed at the earliest: • 4 weeks after treatment is complete against bacterial infection • 2 weeks after the last dose of a medicine to reduce gastric secretion. Go to drug groups may affect the results of Helicobacter Test INFAI. This is especially important after treatment for Helicobacter pylori removal. It is important to follow the instructions for use exactly as otherwise the result may be dubious. Important things that are not part of the contents of the Helicobacter Test INFAI Before performing the breath test, liquid "test food" is used to delay stomach emptying. "Test Food" is not included in the kit. The following foods are suitable for use as test foods: • 200 ml 100% orange juice or • 1 g citric acid dissolved in 200 ml water If you can not take one of these "test foods", please tell your doctor who will suggested another. Dissolve 13C-urea dust requires a drinking container and tap water. If retesting is required, this should be done early the next day. Special Instructions for Use (for Mass Spectroscopy) The test should be performed after medical advice and under medical supervision. Patient data must be registered with the form provided. It is recommended that the test be carried out in a resting state. 1. The test should be conducted on an empty stomach; food should not be taken for 6 hours, preferably at night. If the test is to be performed later in the day, it is recommended to take only light meals, a cup of tea and a toast of toast. 2. The test begins with sampling to determine baseline values. • Take the straw and test tubes with "sampling time: 00 minutes" from the test kit. • Remove the plug of one tube and place the unpacked straw in the test tube. • Now the patient gently exhales through the straw until the inner wall of the tube is covered with steam. • The patient should continue to exhale while removing the straw from the tube and immediately close the test tube with the stopper. If the test tube does not close within 30 seconds, the test result may be inaccurate • The test tube should be kept in the vertical position and the barcode label and the "00 minute value" label must be stuck so that the barcode lines are horizontal . 3. Now the second tube (labeled "sampling time: value 00 minutes") should be filled with exhaled air as described above.
The patient should then drink the recommended "test meal" (200 ml of 100% orange juice or 1 g of citric acid dissolved in 200 ml of water). 5. Then prepare the solution for the test. • The bank labeled "13C-urea dust" is removed from the test kit, opened and filled up to ¾ of the volume of tap water. • Close the bank and shake gently until all the powder has dissolved. • The contents are poured into a glass, the 13C-urea flask is filled with water for the second and third time and the contents are added to the beaker so as to obtain a test solution of about 30 ml. 6. The patient should drink the prepared test solution immediately. The time of administration should be recorded. 7.30 minutes after the test solution (point 6), samples are taken at 30 minutes in the two tubes remaining in the package (labeled "sampling time: 30 minutes") as described in point 2 and 3. For these samples the bar code labels and the "30 minute value" label shall be used. 8. The corresponding bar code label is placed on the Patient Data Form. All tubes with the breath samples are placed in the original package. This package is sealed with the remaining sticker. 9. Packaging should be sent to a specialized analysis laboratory. Medical and healthcare professionals can find detailed information on respiratory samples and laboratory test specifications in section 6.6 of the Summary of Product Characteristics. If you take more Helicobacter Test INFAI than you need Since only 75 mg of 13C-urea is released, overdose should not be expected. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects No side effects known. Communicating side effects If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Appendix V. As you report side effects, you can contribute to getting more information on the safety of this medicine. 5.How to store Helicobacter Test INFAI Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Do not store above 25 ° C. Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment. 6. Contents of the pack and further information What Helicobacter Test INFAI contains • The active substance is 13C-urea. One bank contains 75 mg of 13C-urea. • No other ingredients. What Helicobacter Test INFAI looks like and contents of the pack Helicobacter Test INFAI is a white, crystalline powder for oral solution. Test kit contents: No. Ingredients Number of Bank (10 ml volume, polystyrene with polyethylene cap) containing 75 mg 13C-urea powder for oral solution Labeled glass or plastic containers for taking, storing and transporting breathing samples for analysis : Sampling time: 00 minute value Sampling time: 30 minute value Folding straw for taking the breath samples in the appropriate sample containers. Patient Information Form Patient Leaflet Labels with bar code and sticker

 

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