Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Μητρότητα και φάρμακα Ενημερωθείτε για την ασφάλεια χορήγησης ενός φαρμάκου κατά τη διάρκεια της εγκυμοσύνης ή του θηλασμού
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του Galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα

HELICOBACTER Powder for oral solution (2019)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

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 in vivo diagnosis of gastroduodenal Helicobacter pylori infection in: adults, adolescents, who are likely to have peptic ulcer disease. This medicinal product is ...

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

Pharmacotherapeutic group: Other diagnostic agents ATC code: 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 activity ...

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

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) containing 75 mg ^13^C-urea powder for oral solution 1 2 Labelled sample ...

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, Gottfried-Hagen-Str. 60-62, D-51105, 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

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: