Pylobactell
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
04-12-2023
Fachinformation
(SPC)
04-12-2023
Öffentlichen Beurteilungsberichts
(PAR)
14-08-2008
Wirkstoff:
urea (13C)
Verfügbar ab:
Torbet Laboratories Ireland Limited
ATC-Code:
V04CX
INN (Internationale Bezeichnung):
13C-urea
Therapiegruppe:
Diagnostic agents
Therapiebereich:
Breath Tests; Helicobacter Infections
Anwendungsgebiete:
This medicinal product is for diagnostic use only.For in vivo diagnosis of gastroduodenal Helicobacter pylori (H. pylori) infection.
Produktbesonderheiten:
Revision: 12
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
1998-05-07
Gebrauchsinformation
12
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON/CARDBOARD BOX
1.
NAME OF THE MEDICINAL PRODUCT
Pylobactell, 100 mg, soluble tablet
13
C-urea
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
One tablet contains: 100 mg
13
C-urea
3.
LIST OF EXCIPIENTS
Povidone (E1201), Microcrystalline Cellulose (E460i), Colloidal
Anhydrous Silica, Sodium
Benzoate (E211).
4.
PHARMACEUTICAL FORM AND CONTENTS
The kit contains:
A sachet containing one Pylobactell 100 mg soluble tablet.
Six glass tubes, with caps and bar code labels.
30 ml mixing and administration glass vial with cap.
Two straws.
Package Leaflet.
Analysis Request Form.
Security Label and three additional bar code labels.
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
_ _
Diagnostic test kit
FOR ORAL ADMINISTRATION
Read the package leaflet before 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.
8.
EXPIRY DATE
_ _
EXP:
{MM/YYYY}
9.
SPECIAL STORAGE CONDITIONS
_ _
13
Do not store above 25
C
11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Richen Europe S.R.L
VIA San Cristoforo
78-20090
Trezzano Sul Naviglio (Ml)
Italy
12.
MARKETING AUTHORISATION NUMBER(S)
EU/1/98/064/001
13.
BATCH NUMBER
_ _
BN
14.
GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
16.
INFORMATION IN BRAILLE
Pylobactell
17.
UNIQUE IDENTIFIER – 2D BARCODE_ _
Not applicable
18.
UNIQUE IDENTIFIER - HUMAN READABLE DATA_ _
Not applicable
14
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING
UNITS
SACHET LABEL
1.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF
ADMINISTRATION
Pylobactell, 100 mg, soluble tablet
13
C-urea
Oral
2.
METHOD OF ADMINISTRATION
To be dissolved in water and taken orally. Read the package leaflet
before use.
3.
EXPIRY DATE
_ _
EXP {MM/YYYY}
4.
BATCH NUMBER
_ _
Batch
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
One tablet
6.
OTHER
Richen Europe S.R.L
VIA San Cristoforo
78-20090
Trezzano Sul Naviglio (Ml)
Italy
EU/1/98/064/001
15
ADDITIONAL KI
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pylobactell, 100 mg, Soluble Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Quantity per tablet
13
C-urea
100 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soluble tablet
A white, biconvex tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
For
_in vivo_
diagnosis of gastroduodenal
_Helicobacter_
_pylori_
infection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Pylobactell is not recommended for use in children below the age of 18
years due to
insufficient data on efficacy.
The Pylobactell tablet is for oral administration.
_Adults_
: The tablet is to be dissolved in water and taken 10 minutes after
the start of the breath
test procedure.
The patient should fast for at least 4 hours before the test so that
the test is taken on an empty
stomach. If the patient has eaten a heavy meal then it will be
necessary to fast for six hours
prior to the test.
It is important to follow the instructions for use described in
Section 6.6 adequately, otherwise
the validity of the test result will be questionable.
4.3
CONTRAINDICATIONS
The test must not be used in patients with documented or suspected
gastric infection that
might interfere with the urea breath test.
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
A positive urea breath test alone does not clinically confirm that
eradication therapy is
indicated. Alternative diagnosis with invasive endoscopic methods
might be indicated in
3
order to examine the presence of any other complicating conditions,
eg. gastric ulcer,
autoimmune gastritis and malignancies.
In individual cases of atrophic gastritis, the breath test result may
have a false positive
outcome and other tests may be required to confirm the presence of
_H.pylori_
.
If a repeat test is required, it should not be carried out until the
following day
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