HELICOBACTER Powder for oral solution (2023)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Helicobacter Test INFAI 75 mg powder for oral solution.
Qualitative and quantitative composition
One jar contains 75 mg of <sup>13</sup>C-urea powder. For the full list of excipients, see section 6.1.
Pharmaceutical form
White, crystalline powder for oral solution.
Therapeutic indications
Helicobacter Test INFAI may be used for <em>in vivo</em> diagnosis of gastroduodenal Helicobacter pylori infection in: adults, adolescents, who are likely to have peptic ulcer disease. This medicinal ...
Posology and method of administration
This medicinal product should be administered by a healthcare professional and under appropriate medical supervision. Posology Helicobacter Test INFAI is a breath test for single administration. Patients ...
Contraindications
The test must not be used in patients with documented or suspected gastric infection or atrophic gastritis, which might interfere with the urea breath test (see section 4.2).
Special warnings and precautions for use
A positive test alone does not constitute indication for eradication therapy. Differential diagnosis with invasive endoscopic methods might be indicated in order to examine the presence of any other complicating ...
Interaction with other medicinal products and other forms of interaction
Helicobacter Test INFAI will be affected by all treatments interfering with Helicobacter pylori status or urease activity.
Pregnancy and lactation
It is not expected that the test procedure may be harmful during pregnancy or lactation. It is recommended to take notice of the product information of eradication therapy products for their use during ...
Effects on ability to drive and use machines
Helicobacter Test INFAI has no influence on the ability to drive and use machines.
Undesirable effects
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 ...
Overdose
Due to the fact that only 75 mg of <sup>13</sup>C-urea is delivered, an overdose is not expected.
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other diagnostic agents <b>ATC code:</b> VO4CX For the amount of 75 mg <sup>13</sup>C-urea, which is administered per unit in the course of the breath test, no pharmacodynamic ...
Pharmacokinetic properties
The orally applied <sup>13</sup>C-urea is metabolised to carbon dioxide and ammonia or is integrated into the bodys own urea cycle. Any increase in <sup>13</sup>CO<sub>2</sub> will be measured by isotopic ...
Preclinical safety data
No concerns in relation to the clinical use of the product.
List of excipients
None.
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
A test set contains the following parts: No. Component Quantity 1 Jar (10 ml volume, polystyrene with polyethylene snap cap)<br /> containing 75 mg <sup>13</sup>C-urea powder for oral solution 1 2 ...
Special precautions for disposal and other handling
1. The test is to be performed in the presence of a qualified person. 2. Each patient should be documented according to the provided data sheet. It is recommended to perform the test with the patient being ...
Marketing authorization holder
INFAI GmbH, Riehler Str. 36, D-50668 Köln, Germany
Marketing authorization number(s)
EU/1/97/045/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 14 August 1997 Date of latest renewal: 14 August 2007
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