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Helicobacter Test INFAI (13C-urea) – Labelling - V04CX

Updated on site: 07-Oct-2017

Medication nameHelicobacter Test INFAI
ATC CodeV04CX
Substance13C-urea
ManufacturerINFAI, Institut für biomedizinische Analytik

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 13C-urea

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 jar containing 75 mg 13C-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 13C-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 13C-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 13C-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

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

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

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing Authorisation Holder:

INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH Universitätsstr. 142

D-44799 Bochum 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

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

INTERMEDIATE CARTON, PACK SIZE 50

1. NAME OF THE MEDICINAL PRODUCT

Helicobacter Test INFAI 75 mg powder for oral solution 13C-urea

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 jar containing 75 mg 13C-urea

3. LIST OF EXCIPIENTS

None

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for oral solution

CLINIPAC 50

50 jars containing 75 mg 13C-urea powder for oral solution

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral 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

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH

Universitätsstr. 142

D-44799 Bochum

Germany

12. MARKETING AUTHORISATION NUMBER(S)

Marketing Authorisation Number:

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

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

JAR LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Helicobacter Test INFAI 75 mg powder for oral solution 13C-urea

Oral use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

4.BATCH NUMBER

Batch:

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Jar contains 75 mg 13C-rea

6.OTHER

Single test

Powder for oral solution

Please read enclosed instructions for use.

Keep out of the sight and reach of children.

Do not store above 25°C.

Medicinal product subject to medical prescription.

Marketing Authorisation Number:

EU/1/97/045/001

EU/1/97/045/002

INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH

Universitätsstr. 142

D-44799 Bochum

Germany

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Helicobacter Test INFAI for children of the age 3-11 45 mg powder for oral solution 13C-urea

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 jar containing 45 mg 13C-urea.

3. LIST OF EXCIPIENTS

None

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for oral solution

1 diagnostic test kit contains:

1 jar containing 45 mg 13C-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

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Please 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.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing Authorisation Holder:

INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH

Universitätsstr. 142

D-44799 Bochum

Germany

12. MARKETING AUTHORISATION NUMBER(S)

Marketing Authorisation Number:

EU/1/97/045/003

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 45 mg

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

JAR LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Helicobacter Test INFAI for children of the age 3-11 45 mg powder for oral solution 13C-urea

Oral use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

4. BATCH NUMBER

Batch:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Jar contains 45 mg 13C-urea

6. OTHER

Single test

Powder for oral solution

Please read enclosed instructions for use.

Keep out of the sight and reach of children.

Do not store above 25°C.

Medicinal product subject to medical prescription.

Marketing Authorisation Number:

EU/1/97/045/003

INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH

Universitätsstr. 142

D-44799 Bochum

Germany

MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BREATH SAMPLE CONTAINERS: GLASS OR PLASTIC

1. NAME OF THE MEDICINAL PRODUCT

Helicobacter Test INFAI

2.NAME OF THE MARKETING AUTHORISATION HOLDER

INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH Universitätsstr. 142

D-44799 Bochum Germany

3. EXPIRY DATE

4. BATCH NUMBER

5.OTHER

Breath sample container

00-minute value

30-minute value

Please stick round barcode label

MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

PAGE OF LABELS AND STICKERS

1. NAME OF THE MEDICINAL PRODUCT

Helicobacter Test INFAI

2. NAME OF THE MARKETING AUTHORISATION HOLDER

INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH Universitätsstr. 142

D-44799 Bochum Germany

3. EXPIRY DATE

4. BATCH NUMBER

5. OTHER

Page of labels and sticker

Barcode for data sheet for patient documentation

Seal-Sticker

Barcodes for 00-minute-value

Barcodes for 30-minute-value

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON, PACK SIZE 50

1. NAME OF THE MEDICINAL PRODUCT

Helicobacter Test INFAI 75 mg powder for oral solution 13C-urea

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 jar containing 75 mg 13C-urea.

3. LIST OF EXCIPIENTS

None

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for oral solution

CLINIPAC BASIC

50 jars containing 75 mg 13C-urea powder for oral solution

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

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

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing Authorisation Holder:

INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH

Universitätsstr. 142

D-44799 Bochum

Germany

12. MARKETING AUTHORISATION NUMBER(S)

Marketing Authorisation Number:

EU/1/97/045/005

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

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

INTERMEDIATE CARTON, PACK SIZE 50

1. NAME OF THE MEDICINAL PRODUCT

Helicobacter Test INFAI 75 mg powder for oral solution 13C-urea

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 jar containing 75 mg 13C-urea

3. LIST OF EXCIPIENTS

None

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for oral solution

CLINIPAC BASIC

50 jars containing 75 mg 13C-urea powder for oral solution

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral 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

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH

Universitätsstr. 142

D-44799 Bochum

Germany

12. MARKETING AUTHORISATION NUMBER(S)

Marketing Authorisation Number:

EU/1/97/045/005

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

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

JAR LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Helicobacter Test INFAI 75 mg powder for oral solution 13C-urea

Oral use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

4. BATCH NUMBER

Batch:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Jar contains 75 mg 13C-urea

6. OTHER

Single test

Powder for oral solution

Please read enclosed instructions for use.

Keep out of the sight and reach of children.

Do not store above 25°C.

Medicinal product subject to medical prescription.

Marketing Authorisation Number:

EU/1/97/045/005

INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH

Universitätsstr. 142

D-44799 Bochum

Germany

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