natgillin/translations-raw huggingface dataset:
One ampoule of solvent contains 0.7 ml of water for injections.
O fiolă solvent conţine 0, 7 ml apă pentru preparate injectabile
1 vial of powder, 1 ampoule of solvent 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 4 vials of powder, 4 ampoules of solvent 4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs 6 vials of powder, 6 ampoules of solvent 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs 50 micrograms/0.5 ml
1 flacon cu pulbere, 1 fiolă cu solvent 1 flacon cu pulbere, 1 fiolă cu solvent, 1 seringă, 2 ace pentru injecţie şi 1 tampon dezinfectant 4 flacoane cu pulbere, 4 fiole cu solvent 4 flacoane cu pulbere, 4 fiole cu solvent, 4 seringi, 8 ace pentru injecţie şi 4 tampoane dezinfectante 6 flacoane cu pulbere, 6 fiole cu solvent 12 flacoane cu pulbere, 12 fiole cu solvent, 12 seringi, 24 ace pentru injecţie şi 12 tampoane dezinfectante 50 micrograme/ 0, 5 ml
EXP After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
EXP După reconstituire, a se utiliza soluţia reconstituită imediat sau în timp de 24 ore dacă este păstrată la frigider (2°C - 8°C).
236 9.
248 9.
EU/1/00/131/001 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/002 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/131/003 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/004 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/131/005 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/026 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 131/ 001 (1 flacon cu pulbere, 1 fiolă cu solvent) EU/ 1/ 00/ 131/ 002 (1 flacon cu pulbere, 1 fiolă cu solvent, 1 seringă, 2 ace pentru injecţie şi 1 tampon dezinfectant) EU/ 1/ 00/ 131/ 003 (4 flacoane cu pulbere, 4 fiole cu solvent) EU/ 1/ 00/ 131/ 004 (4 flacoane cu pulbere, 4 fiole cu solvent, 4 seringi, 8 ace pentru injecţie şi 4 tampoane dezinfectante) EU/ 1/ 00/ 131/ 005 (6 flacoane cu pulbere, 6 fiole cu solvent) EU/ 1/ 00/ 131/ 026 (12 flacoane cu pulbere, 12 fiole cu solvent, 12 seringi, 24 ace pentru injecţie şi 12 tampoane dezinfectante)
237 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
249 MINIMUM DE INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJELE PRIMARE MICI
PegIntron 50 micrograms powder for injection SC
PegIntron 50 micrograme pulbere pentru soluţie injectabilă SC
50 micrograms/0.5 ml
50 micrograme/ 0, 5 ml
238 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
250 INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJUL SECUNDAR
PegIntron 80 micrograms powder and solvent for solution for injection peginterferon alfa-2b
PegIntron 80 micrograme pulbere şi solvent pentru soluţie injectabilă peginterferon alfa- 2b
One vial of powder contains 80 micrograms of peginterferon alfa-2b and provides 80 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Un flacon cu pulbere conţine peginterferon alfa- 2b 80 micrograme şi eliberează peginterferon alfa- 2b 80 micrograme/ 0, 5 ml, după reconstituire conform recomandării.
One ampoule of solvent contains 0.7 ml of water for injections.
O fiolă solvent conţine 0, 7 ml apă pentru preparate injectabile.
1 vial of powder, 1 ampoule of solvent 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 4 vials of powder, 4 ampoules of solvent 4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs 6 vials of powder, 6 ampoules of solvent 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs 80 micrograms/0.5 ml
1 flacon cu pulbere, 1 fiolă cu solvent 1 flacon cu pulbere, 1 fiolă cu solvent, 1 seringă, 2 ace pentru injecţie şi 1 tampon dezinfectant 4 flacoane cu pulbere, 4 fiole cu solvent 4 flacoane cu pulbere, 4 fiole cu solvent, 4 seringi, 8 ace pentru injecţie şi 4 tampoane dezinfectante 6 flacoane cu pulbere, 6 fiole cu solvent 12 flacoane cu pulbere, 12 fiole cu solvent, 12 seringi, 24 ace pentru injecţie şi 12 tampoane dezinfectante 80 micrograme/ 0, 5 ml
239 After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
EXP După reconstituire, a se utiliza soluţia reconstituită imediat sau în timp de 24 ore dacă este păstrată la frigider (2°C - 8°C).
EU/1/00/131/006 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/007 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/131/008 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/009 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/131/010 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/027 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 131/ 006 (1 flacon cu pulbere, 1 fiolă cu solvent) EU/ 1/ 00/ 131/ 007 (1 flacon cu pulbere, 1 fiolă cu solvent, 1 seringă, 2 ace pentru injecţie şi 1 tampon dezinfectant) EU/ 1/ 00/ 131/ 008 (4 flacoane cu pulbere, 4 fiole cu solvent) EU/ 1/ 00/ 131/ 009 (4 flacoane cu pulbere, 4 fiole cu solvent, 4 seringi, 8 ace pentru injecţie şi 4 tampoane dezinfectante) EU/ 1/ 00/ 131/ 010 (6 flacoane cu pulbere, 6 fiole cu solvent) EU/ 1/ 00/ 131/ 027 (12 flacoane cu pulbere, 12 fiole cu solvent, 12 seringi, 24 ace pentru injecţie şi 12 tampoane dezinfectante)
240 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
252 MINIMUM DE INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJELE PRIMARE MICI
PegIntron 80 micrograms powder for injection SC
PegIntron 80 micrograme pulbere pentru soluţie injectabilă SC
80 micrograms/0.5 ml
80 micrograme/ 0, 5 ml
241 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
253 INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJUL SECUNDAR
PegIntron 100 micrograms powder and solvent for solution for injection peginterferon alfa-2b
PegIntron 100 micrograme pulbere şi solvent pentru soluţie injectabilă peginterferon alfa- 2b
One vial of powder contains 100 micrograms of peginterferon alfa-2b and provides 100 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Un flacon cu pulbere conţine peginterferon alfa- 2b 100 micrograme şi eliberează peginterferon alfa - 2b 100 micrograme/ 0, 5 ml, după reconstituire conform recomandării.
1 vial of powder, 1 ampoule of solvent 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 4 vials of powder, 4 ampoules of solvent 4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs 6 vials of powder, 6 ampoules of solvent 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs 100 micrograms/0.5 ml
1 flacon cu pulbere, 1 fiolă cu solvent 1 flacon cu pulbere, 1 fiolă cu solvent, 1 seringă, 2 ace pentru injecţie şi 1 tampon dezinfectant 4 flacoane cu pulbere, 4 fiole cu solvent 4 flacoane cu pulbere, 4 fiole cu solvent, 4 seringi, 8 ace pentru injecţie şi 4 tampoane dezinfectante 6 flacoane cu pulbere, 6 fiole cu solvent 12 flacoane cu pulbere, 12 fiole cu solvent, 12 seringi, 24 ace pentru injecţie şi 12 tampoane dezinfectante 100 micrograme/ 0, 5 ml
242 9.
254 9.
EU/1/00/131/011 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/012 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/131/013 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/014 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/131/015 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/028 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 131/ 011 (1 flacon cu pulbere, 1 fiolă cu solvent) EU/ 1/ 00/ 131/ 012 (1 flacon cu pulbere, 1 fiolă cu solvent, 1 seringă, 2 ace pentru injecţie şi 1 tampon dezinfectant) EU/ 1/ 00/ 131/ 013 (4 flacoane cu pulbere, 4 fiole cu solvent) EU/ 1/ 00/ 131/ 014 (4 flacoane cu pulbere, 4 fiole cu solvent, 4 seringi, 8 ace pentru injecţie şi 4 tampoane dezinfectante) EU/ 1/ 00/ 131/ 015 (6 flacoane cu pulbere, 6 fiole cu solvent) EU/ 1/ 00/ 131/ 028 (12 flacoane cu pulbere, 12 fiole cu solvent, 12 seringi, 24 ace pentru injecţie şi 12 tampoane dezinfectante)
243 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
255 MINIMUM DE INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJELE PRIMARE MICI
PegIntron 100 micrograms powder for injection SC
PegIntron 100 micrograme pulbere pentru soluţie injectabilă SC
100 micrograms/0.5 ml
100 micrograme/ 0, 5 ml
244 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
256 INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJUL SECUNDAR
PegIntron 120 micrograms powder and solvent for solution for injection peginterferon alfa-2b
PegIntron 120 micrograme pulbere şi solvent pentru soluţie injectabilă peginterferon alfa- 2b
One vial of powder contains 120 micrograms of peginterferon alfa-2b and provides 120 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Un flacon cu pulbere conţine peginterferon alfa- 2b 120 micrograme şi eliberează peginterferon alfa- 2b 120 micrograme/ 0, 5 ml, după reconstituire conform recomandării.
1 vial of powder, 1 ampoule of solvent 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 4 vials of powder, 4 ampoules of solvent 4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs 6 vials of powder, 6 ampoules of solvent 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs 120 micrograms/0.5 ml
1 flacon cu pulbere, 1 fiolă cu solvent 1 flacon cu pulbere, 1 fiolă cu solvent, 1 seringă, 2 ace pentru injecţie şi 1 tampon dezinfectant 4 flacoane cu pulbere, 4 fiole cu solvent 4 flacoane cu pulbere, 4 fiole cu solvent, 4 seringi, 8 ace pentru injecţie şi 4 tampoane dezinfectante 6 flacoane cu pulbere, 6 fiole cu solvent 12 flacoane cu pulbere, 12 fiole cu solvent, 12 seringi, 24 ace pentru injecţie şi 12 tampoane dezinfectante 120 micrograme/ 0, 5 ml
245 After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
EXP După reconstituire, a se utiliza soluţia reconstituită imediat sau în timp de 24 ore dacă este păstrată la frigider (2°C - 8°C).
EU/1/00/131/016 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/017 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/131/018 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/019 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/131/020 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/029 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 131/ 016 (1 flacon cu pulbere, 1 fiolă cu solvent) EU/ 1/ 00/ 131/ 017 (1 flacon cu pulbere, 1 fiolă cu solvent, 1 seringă, 2 ace pentru injecţie şi 1 tampon dezinfectant) EU/ 1/ 00/ 131/ 018 (4 flacoane cu pulbere, 4 fiole cu solvent) EU/ 1/ 00/ 131/ 019 (4 flacoane cu pulbere, 4 fiole cu solvent, 4 seringi, 8 ace pentru injecţie şi 4 tampoane dezinfectante) EU/ 1/ 00/ 131/ 020 (6 flacoane cu pulbere, 6 fiole cu solvent) EU/ 1/ 00/ 131/ 029 (12 flacoane cu pulbere, 12 fiole cu solvent, 12 seringi, 24 ace pentru injecţie şi 12 tampoane dezinfectante)
246 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
258 MINIMUM DE INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJELE PRIMARE MICI
PegIntron 120 micrograms powder for injection SC
PegIntron 120 micrograme pulbere pentru soluţie injectabilă SC
120 micrograms/0.5 ml
120 micrograme/ 0, 5 ml
247 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
259 INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJUL SECUNDAR
PegIntron 150 micrograms powder and solvent for solution for injection peginterferon alfa-2b
PegIntron 150 micrograme pulbere şi solvent pentru soluţie injectabilă peginterferon alfa- 2b
One vial of powder contains 150 micrograms of peginterferon alfa-2b and provides 150 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Un flacon cu pulbere conţine peginterferon alfa- 2b 150 micrograme şi eliberează peginterferon alfa - 2b 150 micrograme/ 0, 5 ml, după reconstituire conform recomandării.
1 vial of powder, 1 ampoule of solvent 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 4 vials of powder, 4 ampoules of solvent 4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs 6 vials of powder, 6 ampoules of solvent 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs 150 micrograms/0.5 ml
1 flacon cu pulbere, 1 fiolă cu solvent 1 flacon cu pulbere, 1 fiolă cu solvent, 1 seringă, 2 ace pentru injecţie şi 1 tampon dezinfectant 4 flacoane cu pulbere, 4 fiole cu solvent 4 flacoane cu pulbere, 4 fiole cu solvent, 4 seringi, 8 ace pentru injecţie şi 4 tampoane dezinfectante 6 flacoane cu pulbere, 6 fiole cu solvent 12 flacoane cu pulbere, 12 fiole cu solvent, 12 seringi, 24 ace pentru injecţie şi 12 tampoane dezinfectante 150 micrograme/ 0, 5 ml
248 After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
EXP După reconstituire, a se utiliza soluţia reconstituită imediat sau în timp de 24 ore dacă este păstrată la frigider (2°C - 8°C).
EU/1/00/131/021 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/022 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/131/023 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/024 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/131/025 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/030 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 131/ 021 (1 flacon cu pulbere, 1 fiolă cu solvent) EU/ 1/ 00/ 131/ 022 (1 flacon cu pulbere, 1 fiolă cu solvent, 1 seringă, 2 ace pentru injecţie şi 1 tampon dezinfectant) EU/ 1/ 00/ 131/ 023 (4 flacoane cu pulbere, 4 fiole cu solvent) EU/ 1/ 00/ 131/ 024 (4 flacoane cu pulbere, 4 fiole cu solvent, 4 seringi, 8 ace pentru injecţie şi 4 tampoane dezinfectante) EU/ 1/ 00/ 131/ 025 (6 flacoane cu pulbere, 6 fiole cu solvent) EU/ 1/ 00/ 131/ 030 (12 flacoane cu pulbere, 12 fiole cu solvent, 12 seringi, 24 ace pentru injecţie şi 12 tampoane dezinfectante)
249 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
261 MINIMUM DE INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJELE PRIMARE MICI
PegIntron 150 micrograms powder for injection SC
PegIntron 150 micrograme pulbere pentru soluţie injectabilă SC
150 micrograms/0.5 ml
150 micrograme/ 0, 5 ml
250 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
262 MINIMUM DE INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJELE PRIMARE MICI
251 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
263 INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJUL SECUNDAR
Carton 50 micrograms powder and solvent for solution for injection
Cutie PegIntron 50 micrograme pulbere şi solvent pentru soluţie injectabilă
PegIntron 50 micrograms powder and solvent for solution for injection pre-filled pen peginterferon alfa-2b
PegIntron 50 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut peginterferon alfa- 2b
One PegIntron pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 50 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Un stilou injector (pen) preumplut PegIntron conţine o cantitate suficientă de peginterferon alfa- 2b pentru a elibera 50 micrograme peginterferon alfa 2b în 0, 5 ml, după reconstituire conform recomandării.
1 pen, 1 injection needle and 2 cleansing swabs 4 pens, 4 injection needles and 8 cleansing swabs 6 pens, 6 injection needles and 12 cleansing swabs 12 pens, 12 injection needles and 24 cleansing swabs 50 micrograms/0.5 ml
1 stilou injector (pen), 1 ac pentru injecţie şi 2 tampoane dezinfectante 4 stilouri injectoare (pen- uri), 4 ace pentru injecţie şi 8 tampoane dezinfectante 6 stilouri injectoare (pen- uri), 6 ace pentru injecţie şi 12 tampoane dezinfectante 12 stilouri injectoare (pen- uri), 12 ace pentru injecţie şi 24 tampoane dezinfectante 50 micrograme/ 0, 5 ml
252 9.
264 9.
After injection of the dose, discard the pen in an appropriate container.
După administrarea dozei, stiloul injector (pen- ul) trebuie aruncat într- un spaţiu special.
EU/1/00/131/031 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/032 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/033 (6 pens, 6 injection needles and 12 cleansing swabs) EU/1/00/131/034 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/ 1/ 00/ 131/ 031 (1 stilou injector (pen), 1 ac pentru injecţie şi 2 tampoane dezinfectante) EU/ 1/ 00/ 131/ 032 (4 stilouri injectoare (pen- uri), 4 ace pentru injecţie şi 8 tampoane dezinfectante) EU/ 1/ 00/ 131/ 033 (6 stilouri injectoare (pen- uri), 6 ace pentru injecţie şi 12 tampoane dezinfectante) EU/ 1/ 00/ 131/ 034 (12 stilouri injectoare (pen- uri), 12 ace pentru injecţie şi 24 tampoane dezinfectante)
253 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
265 MINIMUM DE INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJELE PRIMARE MICI
PegIntron 50 micrograms powder and solvent for injection SC
PegIntron 50 micrograme pulbere şi solvent pentru soluţie injectabilă SC
254 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
266 INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJUL SECUNDAR
Carton 80 micrograms powder and solvent for solution for injection
Cutie PegIntron 80 micrograme pulbere şi solvent pentru soluţie injectabilă
PegIntron 80 micrograms powder and solvent for solution for injection pre-filled pen peginterferon alfa-2b
PegIntron 80 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut peginterferon alfa- 2b
One PegIntron pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 80 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Un stilou injector (pen) preumplut PegIntron conţine o cantitate suficientă de peginterferon alfa- 2b pentru a elibera 80 micrograme peginterferon alfa- 2b în 0, 5 ml după reconstituire conform recomandării.
1 pen, 1 injection needle and 2 cleansing swabs 4 pens, 4 injection needles and 8 cleansing swabs 6 pens, 6 injection needles and 12 cleansing swabs 12 pens, 12 injection needles and 24 cleansing swabs 80 micrograms/0.5 ml
1 stilou injector (pen), 1 ac pentru injecţie şi 2 tampoane dezinfectante 4 stilouri injectoare (pen- uri), 4 ace pentru injecţie şi 8 tampoane dezinfectante 6 stilouri injectoare (pen- uri), 6 ace pentru injecţie şi 12 tampoane dezinfectante 12 stilouri injectoare (pen- uri), 12 ace pentru injecţie şi 24 tampoane dezinfectante 80 micrograme/ 0, 5 ml
255 9.
267 9.
EU/1/00/131/035 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/036 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/037 (6 pens, 6 injection needles and 12 cleansing swabs) EU/1/00/131/038 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/ 1/ 00/ 131/ 035 (1 stilou injector (pen), 1 ac pentru injecţie şi 2 tampoane dezinfectante) EU/ 1/ 00/ 131/ 036 (4 stilouri injectoare (pen- uri), 4 ace pentru injecţie şi 8 tampoane dezinfectante) EU/ 1/ 00/ 131/ 037 (6 stilouri injectoare (pen- uri), 6 ace pentru injecţie şi 12 tampoane dezinfectante) EU/ 1/ 00/ 131/ 038 (12 stilouri injectoare (pen- uri), 12 ace pentru injecţie şi 24 tampoane dezinfectante)
256 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
268 MINIMUM DE INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJELE PRIMARE MICI
PegIntron 80 micrograms powder and solvent for injection SC
PegIntron 80 micrograme pulbere şi solvent pentru soluţie injectabilă SC
257 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
269 INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJUL SECUNDAR
Carton 100 micrograms powder and solvent for solution for injection
Cutie PegIntron 100 micrograme pulbere şi solvent pentru soluţie injectabilă
PegIntron 100 micrograms powder and solvent for solution for injection pre-filled pen peginterferon alfa-2b
PegIntron 100 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut peginterferon alfa- 2b
One PegIntron pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 100 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Un stilou injector (pen) preumplut PegIntron conţine o cantitate suficientă de peginterferon alfa- 2b pentru a elibera 100 micrograme peginterferon alfa- 2b în 0, 5 ml după reconstituire conform recomandării.
1 pen, 1 injection needle and 2 cleansing swabs 4 pens, 4 injection needles and 8 cleansing swabs 6 pens, 6 injection needles and 12 cleansing swabs 12 pens, 12 injection needles and 24 cleansing swabs 100 micrograms/0.5 ml
1 stilou injector (pen), 1 ac pentru injecţie şi 2 tampoane dezinfectante 4 stilouri injectoare (pen- uri), 4 ace pentru injecţie şi 8 tampoane dezinfectante 6 stilouri injectoare (pen- uri), 6 ace pentru injecţie şi 12 tampoane dezinfectante 12 stilouri injectoare (pen- uri), 12 ace pentru injecţie şi 24 tampoane dezinfectante 100 micrograme/ 0, 5 ml
After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
270 După reconstituire, a se utiliza soluţia reconstituită imediat sau în timp de 24 ore dacă este păstrată la frigider (2°C - 8°C).
EU/1/00/131/039 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/040 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/041 (6 pens, 6 injection needles and 12 cleansing swabs) EU/1/00/131/042 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/ 1/ 00/ 131/ 039 (1 stilou injector (pen), 1 ac pentru injecţie şi 2 tampoane dezinfectante) EU/ 1/ 00/ 131/ 040 (4 stilouri injectoare (pen- uri), 4 ace pentru injecţie şi 8 tampoane dezinfectante) EU/ 1/ 00/ 131/ 041 (6 stilouri injectoare (pen- uri), 6 ace pentru injecţie şi 12 tampoane dezinfectante) EU/ 1/ 00/ 131/ 042 (12 stilouri injectoare (pen- uri), 12 ace pentru injecţie şi 24 tampoane dezinfectante)
259 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
271 MINIMUM DE INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJELE PRIMARE MICI
PegIntron 100 micrograms powder and solvent for injection SC
PegIntron 100 micrograme pulbere şi solvent pentru soluţie injectabilă SC
260 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
272 INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJUL SECUNDAR
Carton 120 micrograms powder and solvent for solution for injection
Cutie PegIntron 120 micrograme pulbere şi solvent pentru soluţie injectabilă
PegIntron 120 micrograms powder and solvent for solution for injection pre-filled pen peginterferon alfa-2b
PegIntron 120 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut peginterferon alfa- 2b
One PegIntron pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 120 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Un stilou injector (pen) preumplut PegIntron conţine o cantitate suficientă de peginterferon alfa- 2b pentru a elibera 120 micrograme peginterferon alfa- 2b în 0, 5 ml, după reconstituire conform recomandării.