Helicobacter Test INFAI

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

urea (13C)

Beschikbaar vanaf:

INFAI, Institut für biomedizinische Analytik NMR-Imaging GmbH

ATC-code:

V04CX

INN (Algemene Internationale Benaming):

13C-urea

Therapeutische categorie:

Diagnostic agents

Therapeutisch gebied:

Breath Tests; Helicobacter Infections

therapeutische indicaties:

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.Helicobacter Test INFAI for children aged three to 11 years may be used for in vivo diagnosis of gastrduodenal Helicobacter pylori infection:for the evaluation of the success of eradication treatment, or;when invasive tests cannot be performed, or;when there are discordant results arising from invasive tests.This medicinal product is for diagnostic use only.

Product samenvatting:

Revision: 20

Autorisatie-status:

Authorised

Autorisatie datum:

1997-08-14

Bijsluiter

33
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON, PACK OF 1 JAR AND 50 JARS
1.
NAME OF THE MEDICINAL PRODUCT
Helicobacter Test INFAI 75 mg powder for oral solution
13
C-urea
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
1 jar containing 75 mg
13
C-urea.
3.
LIST OF EXCIPIENTS
None
4.
PHARMACEUTICAL FORM AND CONTENTS
Powder for oral solution
1 diagnostic test kit contains:
1 jar containing 75 mg
13
C-urea powder for oral solution
4 containers for breath samples
1 bendable straw
Package leaflet
Data sheet for patient documentation
Page of labels and sticker
1 diagnostic test kit contains:
1 jar containing 75 mg
13
C-urea powder for oral solution
2 breath bags for breath samples
1 bendable straw
Package leaflet
Data sheet for patient documentation
Bar code labels and sticker
1 diagnostic test kit contains:
50 jars containing 75 mg
13
C-urea powder for oral solution
100 breath bags for breath samples
50 bendable straws
50 Package leaflet
50 Data sheets for patient documentation
50 Barcode labels and sticker
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
34
For Mass Spectrometry
For Infrared Spectroscopy
Please read enclosed instructions for use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP: {MM/YYYY}
9.
SPECIAL STORAGE CONDITIONS
Do not store above 25

C.
10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
35
11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Marketing Authorisation Holder:
INFAI GmbH
Riehler Str. 36
D-50668 Köln
Germany
12.
MARKETING AUTHORISATION NUMBER(S)
Marketing Authorisation Number:
EU/1/97/045/001
EU/1/97/045/002
EU/1/97/045/004
13.
BATCH NUMBER
Batch:
14.
GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15.
INSTRUCTIONS ON USE
16.
INFORMATION IN BRAILLE
Helicobacter Test INFAI 75 mg
17.
UNIQUE IDEN

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Helicobacter Test INFAI 75 mg powder for oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One jar contains 75 mg of
13
C-urea powder.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White, crystalline powder for oral solution.
4.
CLINICAL PARTICULARS
4.1
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 for diagnostic use only.
4.2
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 from the age of 12 must
take the contents of 1 jar with 75 mg.
Method of administration
For performance of the test, 200 ml 100 % orange juice or 1 g citric
acid in 200 ml water for patients
from the age of 12 and older (as a pre-administered test meal), as
well as tap water (for dissolving the
13
C-urea powder) are necessary.
The patient must have fasted for over 6 hours, preferably overnight.
The test procedure takes
approximately 40 minutes.
In case it is necessary to repeat the test procedure, this should not
be done until the following day.
The suppression of
_Helicobacter pylori_
might give false negative results. Therefore the test shall be
used after at least four weeks without systemic antibacterial therapy
and two weeks after last dose of
acid antisecretory agents. Both might interfere with the
_Helicobacter pylori_
status. This is especially
important after Helicobacter eradication therapy.
It is important to follow the instructions for use adequately (see
section 6.6), otherwise the reliability
of the outcome will become questionable.
3
4.3
CONTRAINDICATIONS
The test must not be used in patients with documented or suspected
gastric infection or