Balance 2,3% Glucose, 1,25 Mmol/L Calcium
PARTICULARS TO APPEAR ON THE OUTER PACKAGING (CARDBOARD BOXES) Obal platný pouze pro kód SÚKLu 15045
1. NAME OF THE MEDICINAL PRODUCT
2. STATEMENT OF ACTIVE SUBSTANCE(S)
1 litre of ready-to-use solution contains: Sodium chloride 5.640 g Calcium chloride dihydrate 0.1838 g Magnesium chloride hexahydrate 0.1017 g Glucose monohydrate 25.0 g (anhydrous glucose) 22.73 g Sodium lactate 3.925 g
Na + 134 mmol/l Ca++ 1.25 mmol/l Mg++ 0.5 mmol/l Cl- 100.5 mmol/l Lactate 35 mmol/l Glucose 126.1 mmol/l
Theoretical osmolarity 399 mosm/l pH a 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 stay safe 2500 ml x 4 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
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 2,3% glucose, 1,25 mmol/l calcium
PARTICULARS TO APPEAR ON THE THE IMMEDIATE PACKAGING (NON-PVC PLASTIC BAGS)_
1. NAME OF THE MEDICINAL PRODUCT
balance 2.3% glucose, 1.25 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 0.1838 g Magnesium chloride hexahydrate 0.1017 g Glucose monohydrate 25.0 g (anhydrous glucose) 22.73 g Sodium lactate 3.925 g
Na + 134 mmol/l Ca++ 1.25 mmol/l Mg++ 0.5 mmol/l Cl- 100.5 mmol/l Lactate 35 mmol/l Glucose 126.1 mmol/l
Theoretical osmolarity 399 mosm/l pH a 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 stay safe 2500 ml 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
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