PARTICULARS TO APPEAR ON THE OUTER PACKAGING (CARDBOARD BOX)    Obal platný pouze pro kód SÚKLu 128838

1. NAME OF THE MEDICINAL PRODUCT

balance 4.25 % glucose, 1.75 mmol/l calcium

Solution for peritoneal dialysis

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 litre of ready-to-use solution contains:

Sodium chloride    5.640 g

Calcium chloride dihydrate    0.2573 g

Magnesium chloride hexahydrate 0.1017 g

Glucose monohydrate    46.75 g

(anhydrous glucose)    42.5 g

Sodium lactate    3.925 g

Na +    134 mmol/l

Ca++    1.75 mmol/l

Mg++ 0.5 mmol/l

Cl-    101.5 mmol/l

Lactate 35 mmol/l

Glucose 235.8 mmol/l

Theoretical osmolarity 511 mosm/l pH - 7.0

3. LIST OF EXCIPIENTS

Water for injections, sodium hydrogen carbonate, sodium hydroxide, hydrochloric acid

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for peritoneal dialysis Sleep safe 5000 ml x 2

Double chamber bag

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Please read the enclosed leaflet carefully prior to using this solution.

For intraperitoneal use only. Solution is not to be used for intravenous infusion.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Sterile and free from bacterial endotoxins.

Do not use unless solution is clear and Container undamaged.

Use as directed by your doctor.

For single use only. Any unused portion of the solution is to be discarded. Instructions for use - please refer to the package insert.

Do not use before mixing both Solutions.

The ready-to-use solution must be used within 24 hours after mixing.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store below 4°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Not applicable

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Fresenius Medical Care Deutschland GmbH 61346 Bad Homburg v.d.H.

Germany

Manufactured by Fresenius Medical Care Deutschland GmbH, Frankfurter Str. 6-8, 66606 St. Wendel, Germany

12. MARKETING AUTHORISATION NUMBER(S)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

Not applicable

16. INFORMATION IN BRAILLE

balance 4,25% glucose, 1,75 mmol/l calcium

PARTICULARS TO APPEAR ON THE THE IMMEDIATE PACKAGING (NON-PVC PLASTIC BAG)_

1. NAME OF THE MEDICINAL PRODUCT

balance 4.25 % glucose, 1.75 mmol/l calcium,

Solution for peritoneal dialysis

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 litre of ready-to-use solution contains:

Sodium chloride    5.640 g

Calcium chloride dihydrate    0.2573 g

Magnesium chloride hexahydrate 0.1017 g Glucose monohydrate    46.75 g

(anhydrous glucose)    42.5 g

Sodium lactate    3.925 g

Na +    134 mmol/l

Ca++    1.75 mmol/l

Mg++ 0.5 mmol/l Cl-    101.5 mmol/l

Lactate 35 mmol/l Glucose 235.8 mmol/l

Theoretical osmolarity 511 mosm/l pH - 7.0

3. LIST OF EXCIPIENTS

Water for injections, sodium hydrogen carbonate, sodium hydroxide, hydrochloric acid

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for peritoneal dialysis Sleep safe 5000 ml x 2

Double chamber bag

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Please read the enclosed leaflet carefully prior to using this solution.

For intraperitoneal use only. Solution is not to be used for intravenous infusion.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Sterile and free from bacterial endotoxins.

Do not use unless solution is clear and Container undamaged.

Use as directed by your doctor.

For single use only. Any unused portion of the solution is to be discarded. Instructions for use - please refer to the package insert.

Do not use before mixing both Solutions.

The ready-to-use solution must be used within 24 hours after mixing.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store below 4°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE_

Not applicable

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Fresenius Medical Care Deutschland GmbH 61346 Bad Homburg v.d.H.

Germany

Manufactured by Fresenius Medical Care Deutschland GmbH, Frankfurter Str. 6-8, 66606 St. Wendel, Germany

12. MARKETING AUTHORISATION NUMBER(S)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

Not applicable

16. INFORMATION IN BRAILLE

Not applicable