inner label B. Braun Vet Care hypertonic NaCl-Solution (7.5 g/100 ml) DRAFT-PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
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1 inner label DRAFT-PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Ecoflac plus bottle 500 ml 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Hipertónico Salino 7.5 g/100 ml solución para perfusión para bovino, equino, ovino, caprino, porcino, perros y gatos (ES) Hypertone Natriumchlorid-Lösung 7.5 g/100 ml B. Braun Vet Care Infusionslösung für Pferde, Rinder, Schafe, Ziegen, Schweine, Hunde und Katzen (DE/AT) Solution for infusion for horses, cattle, sheep, goats, pigs, dogs and cats (UK/IE) B. Braun Vet Care hypertonique NaCl-Solution (7.5 g/100 ml) Solution pour perfusion pour chevaux, bovins, moutons, chèvres, porcins, chiens et chats (FR/BE) B. Braun Vet Care hypertonic NaCl-Oplossing (7.5 g/100 ml) Oplossing voor infusie voor paarden, runderen, schapen, geiten, varkens, honden en katten (NL) B. Braun Vet Care ipertonica NaCl-Soluzione (7.5 g/100 ml) Soluzione per infusione per cavalli, bovini, pecore, capre, porci, cani e gatti (IT)) 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES 100 ml solution for infusion contain: Active substances: Sodium chloride Excipients: Water for injection to Electrolytes Na Cl Theoretical osmolarity: 7.5 g 100 ml 2566 mosm/l 1
2 inner label 3. PHARMACEUTICAL FORM Solution for infusion. Free from bacterial endotoxins 4. PACKAGE SIZE 500 ml 5. TARGET SPECIES To be used in horses, cattle, sheep, goats, pigs, dogs and cats. 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use. 8. WITHDRAWAL PERIOD Horses, cattle, sheep, goats and pigs: meat and offal: Zero days milk: Zero hours 9. SPECIAL WARNING(S), IF NECESSARY Cloudy solutions or solutions containing visible solid particles should not be administered. Do not use if container or closure is damaged. For single use only. Do not reconnect partially used infusion bottles. Discard any unused contents. 2
3 inner label 10. EXPIRY DATE Expiry date {month/year} 11. SPECIAL STORAGE CONDITIONS Protect from direct sunlight. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Disposal: read package leaflet 13. THE WORDS FOR ANIMAL TREATMENT ONLY AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only To be supplied only on veterinary prescription. In Spain only: To be administered only by a veterinary surgeon. 14. THE WORDS KEEP OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER B. Braun Melsungen AG, Melsungen, Germany In Spain : B. Braun VetCare SA, Rubí (Barcelona), Spain 16. MARKETING AUTHORISATION NUMBER(S) Manuf. Authorisation no.: xxxxxxx 17. MANUFACTURER S BATCH NUMBER 3
4 inner label Batch no.: 4
5 outer label (1 X 500 ml) DRAFT-PARTICULARS TO APPEAR ON THE OUTER PACKAGE Ecoflac plus bottles 1 x 500 ml 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Hipertónico Salino 7.5 mg/100 ml solución para perfusión para bovino, equino, ovino, caprino, porcino, perros y gatos (ES) Hypertone Natriumchlorid-Lösung 7.5 g/100 ml B. Braun Vet Care Infusionslösung für Pferde, Rinder, Schafe, Ziegen, Schweine, Hunde und Katzen (DE/AT) Solution for infusion for horses, cattle, sheep, goats, pigs, dogs and cats (UK/IE) B. Braun Vet Care hypertonique NaCl-Solution (7.5 g/100 ml) Solution pour perfusion pour chevaux, bovins, moutons, chèvres, porcins, chiens et chats (FR/BE) B. Braun Vet Care hypertonic NaCl-Oplossing (7.5 g/100 ml) Oplossing voor infusie voor paarden, runderen, schapen, geiten, varkens, honden en katten (NL) B. Braun Vet Care ipertonica NaCl-Soluzione (7.5 g/100 ml) Soluzione per infusione per cavalli, bovini, pecore, capre, porci, cani e gatti (IT)) 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES 100 ml solution for infusion contain: Active substances: Sodium chloride Excipients: Water for injection to Electrolytes Na Cl Theoretical osmolarity: 7.5 g 100 ml 2566 mosm/l 5
6 outer label (1 X 500 ml) 3. PHARMACEUTICAL FORM Solution for infusion. Free from bacterial endotoxins 4. PACKAGE SIZE 1 x 500 ml 5. TARGET SPECIES To be used in horses, cattle, sheep, goats, pigs, dogs and cats. 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use. 8. WITHDRAWAL PERIOD Horses, cattle, sheep, goats and pigs: meat and offal: Zero days milk: Zero hours 9. SPECIAL WARNING(S), IF NECESSARY Cloudy solutions or solutions containing visible solid particles should not be administered. Do not use if container or closure are damaged. For single use only. Do not reconnect partially used infusion bottles. Discard any unused contents. 10. EXPIRY DATE Expiry date {month/year} 6
7 outer label (1 X 500 ml) 11. SPECIAL STORAGE CONDITIONS Protect from direct sunlight. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Disposal: read package leaflet 13. THE WORDS FOR ANIMAL TREATMENT ONLY AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only To be supplied only on veterinary prescription. In Spain only: To be administered only by a veterinary surgeon. 14. THE WORDS KEEP OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER B. Braun Melsungen AG, Melsungen, Germany In Spain: B. Braun VetCare SA, Rubí (Barcelona), Spain In Italy: Manufacturer responsible for batch release: B. Braun Medical SA Rubi (Barcelona) - Spain 16. MARKETING AUTHORISATION NUMBER(S) Manuf. Authorisation no.: xxxxxxx 17. MANUFACTURER S BATCH NUMBER Batch no.: 7
8 outer label 10 x 500 ml DRAFT-PARTICULARS TO APPEAR ON THE OUTER PACKAGE Ecoflac plus bottles 10 x 500 ml 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Hipertónico Salino 7.5 g/100 ml solución para perfusión para bovino, equino, ovino, caprino, porcino, perros y gatos (ES) Hypertone Natriumchlorid-Lösung 7.5 g/100 ml B. Braun Vet Care Infusionslösung für Pferde, Rinder, Schafe, Ziegen, Schweine, Hunde und Katzen (DE/AT) Solution for infusion for horses, cattle, sheep, goats, pigs, dogs and cats (UK/IE) B. Braun Vet Care hypertonique NaCl-Solution (7.5 g/100 ml) Solution pour perfusion pour chevaux, bovins, moutons, chèvres, porcins, chiens et chats (FR/BE) B. Braun Vet Care hypertonic NaCl-Oplossing (7.5 g/100 ml) Oplossing voor infusie voor paarden, runderen, schapen, geiten, varkens, honden en katten (NL) B. Braun Vet Care ipertonica NaCl-Soluzione (7.5 g/100 ml) Soluzione per infusione per cavalli, bovini, pecore, capre, porci, cani e gatti (IT)) 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES 100 ml solution for infusion contain: Active substances: Sodium chloride Excipients: Water for injection to Electrolytes Na Cl Theoretical osmolarity: 7.5 g 100 ml 2566 mosm/l 8
9 outer label 10 x 500 ml 3. PHARMACEUTICAL FORM Solution for infusion. Free from bacterial endotoxins 4. PACKAGE SIZE 10 x 500 ml 5. TARGET SPECIES To be used in horses, cattle, sheep, goats, pigs, dogs and cats. 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use. 8. WITHDRAWAL PERIOD Horses, cattle, sheep, goats and pigs: meat and offal: Zero days milk: Zero hours 9. SPECIAL WARNING(S), IF NECESSARY Cloudy solutions or solutions containing visible solid particles should not be administered. Do not use if container or closure are damaged. For single use only. Do not reconnect partially used infusion bottles. Discard any unused contents. 10. EXPIRY DATE Expiry date {month/year} 9
10 outer label 10 x 500 ml 11. SPECIAL STORAGE CONDITIONS Protect from direct sunlight. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Disposal: read package leaflet 13. THE WORDS FOR ANIMAL TREATMENT ONLY AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only To be supplied only on veterinary prescription. In Spain only: To be administered only by a veterinary surgeon. 14. THE WORDS KEEP OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER B. Braun Melsungen AG, Melsungen, Germany In Spain: B. Braun VetCare SA, Rubí (Barcelona), Spain In Italy: Manufacturer responsible for batch release: B. Braun Medical SA Rubi (Barcelona) - Spain 16. MARKETING AUTHORISATION NUMBER(S) Manuf. Authorisation no.: xxxxxxx 17. MANUFACTURER S BATCH NUMBER Batch no.: 10
FINAL Package leaflet B. Braun Vet Care hypertonic NaCl-Solution (7.5 g/100 ml)
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