Fortrans

LABELING OF PACKAGING

INFORMATION PLACED ON OUTER PACKAGING

Carton Box

1. NAME OF THE MEDICINAL PRODUCT

FORTRANS

Powder for oral solution, in a sachet

2. CONTENT OF ACTIVE SUBSTANCES

1 sachet contains:
Active substances:
Makrogol 4000
64,000 g
Anhydrous sodium sulfate
5,700 g
Sodium bicarbonate
1,680 g
Sodium chloride
1,460 g
Potassium chloride
0,750 g

3. LIST OF EXCIPIENTS

and excipients, including sodium and potassium. Full information, see leaflet.

4. PHARMACEUTICAL FORM AND CONTENT OF PACKAGING

Powder for oral solution
4 sachets
code: 5909990708413

5. METHOD AND ROUTE OF ADMINISTRATION

Method of administration and route of administration:

Oral administration.
In order to obtain one liter of solution, the contents of one sachet should be dissolved
in one liter of cold boiled water or non-carbonated mineral water. Mix
until the powder is completely dissolved.
You should read the contents of the leaflet before using the medicine.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO

CHILDREN

Store the medicine in a place invisible and inaccessible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Do not use the Fortrans medicine after the expiration date stated on the packaging.

8. EXPIRY DATE

Expiry date:

9. STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

Marketing Authorization Holder:

MAYOLY PHARMA FRANCE
3 Place Renault
92500 Rueil-Malmaison
France

12. MARKETING AUTHORIZATION NUMBER

Marketing Authorization Number: R/7084

13. BATCH NUMBER

Batch Number:

14. GENERAL CATEGORY OF AVAILABILITY

Medicinal product available by prescription only – Rp

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE

fortrans

17. UNIQUE IDENTIFIER – 2D CODE

[Includes a 2D code that is a carrier of a unique identifier.]

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

HUMAN-READABLE DATA

PC:
SN:
NN:

INFORMATION PLACED ON OUTER PACKAGING

Carton Box

1. NAME OF THE MEDICINAL PRODUCT

FORTRANS

Powder for oral solution, in a sachet

2. CONTENT OF ACTIVE SUBSTANCES

1 sachet contains:
Active substances:
Makrogol 4000
64,000 g
Anhydrous sodium sulfate
5,700 g
Sodium bicarbonate
1,680 g
Sodium chloride
1,460 g
Potassium chloride
0,750 g

3. LIST OF EXCIPIENTS

and excipients, including sodium and potassium. Full information, see leaflet.

4. PHARMACEUTICAL FORM AND CONTENT OF PACKAGING

Powder for oral solution
50 sachets
code: 5909990708420

5. METHOD AND ROUTE OF ADMINISTRATION

Method of administration and route of administration:

Oral administration.
In order to obtain one liter of solution, the contents of one sachet should be dissolved
in one liter of cold boiled water or non-carbonated mineral water. Mix
until the powder is completely dissolved.
You should read the contents of the leaflet before using the medicine.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO

CHILDREN

Store the medicine in a place invisible and inaccessible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Do not use the Fortrans medicine after the expiration date stated on the packaging.

8. EXPIRY DATE

Expiry date:

9. STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

Marketing Authorization Holder:

MAYOLY PHARMA FRANCE
3 Place Renault
92500 Rueil-Malmaison
France

12. MARKETING AUTHORIZATION NUMBER

Marketing Authorization Number: R/7084

13. BATCH NUMBER

Batch Number:

14. GENERAL CATEGORY OF AVAILABILITY

Medicinal product available by prescription only – Rp.

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE

fortrans

17. UNIQUE IDENTIFIER – 2D CODE

[Includes a 2D code that is a carrier of a unique identifier.]

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

HUMAN-READABLE DATA

PC:
SN:
NN:

INFORMATION PLACED ON OUTER PACKAGING

Carton Box containing 48 sachets (collective packaging – 12 boxes of 4 sachets)

1. NAME OF THE MEDICINAL PRODUCT

Fortrans

Powder for oral solution, in a sachet

2. CONTENT OF ACTIVE SUBSTANCES

1 sachet contains:
Active substances:
Makrogol 4000
64,000 g
Anhydrous sodium sulfate
5,700 g
Sodium bicarbonate
1,680 g
Sodium chloride
1,460 g
Potassium chloride
0,750 g

3. LIST OF EXCIPIENTS

and excipients, including sodium and potassium. Full information, see leaflet.

4. PHARMACEUTICAL FORM AND CONTENT OF PACKAGING

Powder for oral solution, in a sachet
48 sachets
code: 3665585003029

5. METHOD AND ROUTE OF ADMINISTRATION

Method of administration and route of administration:

Oral administration.
In order to obtain one liter of solution, the contents of one sachet should be dissolved
in one liter of cold boiled water or non-carbonated mineral water. Mix
until the powder is completely dissolved.
You should read the contents of the leaflet before using the medicine.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO

CHILDREN

Store the medicine in a place invisible and inaccessible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Do not use the Fortrans medicine after the expiration date stated on the packaging.

8. EXPIRY DATE

EXP:
EXP means expiry date.

9. SPECIAL STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

Marketing Authorization Holder:

MAYOLY PHARMA FRANCE
3 Place Renault
92500 Rueil-Malmaison
France
{logo of the marketing authorization holder}

12. MARKETING AUTHORIZATION NUMBER

Marketing Authorization Number: R/7084

13. BATCH NUMBER

Lot:
Lot means batch number.

14. GENERAL CATEGORY OF AVAILABILITY

Medicinal product available by prescription only – Rp

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE

fortrans

17. UNIQUE IDENTIFIER– 2D CODE

Includes a 2D code that is a carrier of a unique identifier.

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

HUMAN-READABLE DATA

PC:
SN:
NN:

MINIMUM INFORMATION TO BE INCLUDED ON SMALL PACKAGING

DIRECT

Carton Box – intermediate packaging (box containing 4 sachets in a collective packaging of 48 sachets)

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

FORTRANS

Powder for oral solution, in a sachet
1 sachet contains:
Active substances:
Makrogol 4000
64,000 g
Anhydrous sodium sulfate
5,700 g
Sodium bicarbonate
1,680 g
Sodium chloride
1,460 g
Potassium chloride
0,750 g
Oral administration

2. METHOD OF ADMINISTRATION

In order to obtain one liter of solution, the contents of one sachet should be dissolved
in one liter of cold boiled water or non-carbonated mineral water. Mix
until the powder is completely dissolved.

3. EXPIRY DATE

Expiry date:

4. BATCH NUMBER

Batch Number:

5. CONTENT OF PACKAGING WITH ADMINISTRATION OF MASS, VOLUME OR

NUMBER OF UNITS

4 sachets

6. OTHER

You should read the contents of the leaflet before using the medicine.
Mayoly Logo

MINIMUM INFORMATION TO BE INCLUDED ON BLISTERS OR FOIL PACKAGING

Sachet with powder

1. NAME OF THE MEDICINAL PRODUCT

FORTRANS

Powder for oral solution, in a sachet
Active substances:
Makrogol 4000
64,000 g
Anhydrous sodium sulfate
5,700 g
Sodium bicarbonate
1,680 g
Sodium chloride
1,460 g
Potassium chloride
0,750 g

2. NAME OF THE MARKETING AUTHORIZATION HOLDER

Marketing Authorization Holder:
MAYOLY PHARMA FRANCE
Mayoly Logo

3. EXPIRY DATE

Expiry date:

4. BATCH NUMBER

Batch Number:

5. OTHER

In order to obtain one liter of solution, the contents of one sachet should be dissolved
in one liter of cold boiled water or non-carbonated mineral water. Mix
until the powder is completely dissolved.
The solution is ready to drink.
Repeat the same procedure when preparing each liter of solution.