natgillin/translations-raw huggingface dataset:
106 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
102 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 50 IU 10 ampoules
10 ampul
Powder and solvent for solution for injection 10 ampoules each containing powder 10 ampoules each containing 1 ml solvent
Prašek in vehikel za raztopino za injiciranje 10 ampul s praškom 10 ampul po 1 ml vehikla
108 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
104 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
AMPOULE TEXT Puregon 50 IU powder
BESEDILO NA AMPULAH Puregon 50 i. e. prašek
Puregon 50 IU powder for injection follitropin beta
Puregon 50 i. e. prašek za injekcijo folitropin beta
109 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
105 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
AMPOULE TEXT Puregon 50 IU solvent
BESEDILO NA AMPULAH Puregon 50 i. e. vehikel
Puregon 50 IU solvent for parenteral use
Puregon 50 i. e. vehikel za parenteralno uporabo
110 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
106 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 75 IU 1 vial
1 viala
Puregon 75 IU powder and solvent for solution for injection follitropin beta
Puregon 75 i. e. prašek in vehikel za raztopino za injiciranje folitropin beta
1 vial of powder contains: follitropin beta corresponding to 75 IU recombinant follicle stimulating hormone (FSH) activity.
1 viala praška vsebuje: folitropin beta v količini, ki ustreza 75 i. e. aktivnosti rekombinantnega folikle stimulirajočega hormona (FSH).
Powder and solvent for solution for injection 1 vial containing powder 1 ampoule containing 1 ml solvent
Prašek in vehikel za raztopino za injiciranje 1 viala s praškom 1 ampula z 1 ml vehikla
112 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
108 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 75 IU 3 vials
3 viale
Powder and solvent for solution for injection 3 vials each containing powder 3 ampoules each containing 1 ml solvent
Prašek in vehikel za raztopino za injiciranje 3 viale s praškom 3 ampule po 1 ml vehikla
Keep the vials and ampoules in the outer carton.
Viale in ampule shranjujte v zunanji ovojnini.
114 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
110 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 75 IU 5 vials
5 vial
Powder and solvent for solution for injection 5 vials each containing powder 5 ampoules each containing 1 ml solvent
Prašek in vehikel za raztopino za injiciranje 5 vial s praškom 5 ampul po 1 ml vehikla
116 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
112 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 75 IU 10 vials
10 vial
Powder and solvent for solution for injection 10 vials each containing powder 10 ampoules each containing 1 ml solvent
Prašek in vehikel za raztopino za injiciranje 10 vial s praškom 10 ampul po 1 ml vehikla
118 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
114 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL TEXT Puregon 75 IU powder
BESEDILO NA VIALI Puregon 75 i. e. prašek
Puregon 75 IU powder for injection follitropin beta
Puregon 75 i. e. prašek za injekcijo folitropin beta
119 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
115 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
AMPOULE TEXT Puregon 75 IU solvent
BESEDILO NA AMPULAH Puregon 75 i. e. vehikel
Puregon 75 IU solvent for parenteral use
Puregon 75 i. e. vehikel za parenteralno uporabo
120 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
116 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 100 IU 1 ampoule
1 ampula
Puregon 100 IU powder and solvent for solution for injection follitropin beta
Puregon 100 i. e. prašek in vehikel za raztopino za injiciranje folitropin beta
1 ampoule of powder contains: follitropin beta corresponding to 100 IU recombinant follicle stimulating hormone (FSH) activity.
1 ampula praška vsebuje: folitropin beta v količini, ki ustreza 100 i. e. aktivnosti rekombinantnega folikle stimulirajočega hormona (FSH).
122 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
118 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 100 IU 3 ampoules
3 ampule
124 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
120 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 100 IU 5 ampoules
5 ampul
126 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
122 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 100 IU 10 ampoules
10 ampul
Puregon 100 IU powder and solvent for solution for injection follitropin beta
Puregon 100 i. e. prašek in vehikelza raztopino za injiciranje folitropin beta
128 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
124 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
AMPOULE TEXT Puregon 100 IU powder
BESEDILO NA AMPULAH Puregon 100 i. e. prašek
Puregon 100 IU powder for injection follitropin beta
Puregon 100 i. e. prašek za injekcijo folitropin beta
129 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
125 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
AMPOULE TEXT Puregon 100 IU solvent
BESEDILO NA AMPULAH Puregon 100 i. e. vehikel
Puregon 100 IU solvent for parenteral use
Puregon 100 i. e. vehikel za parenteralno uporabo
130 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
126 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 150 IU 1 ampoule
1 ampula
Puregon 150 IU powder and solvent for solution for injection follitropin beta
Puregon 150 i. e. prašek in vehikel za raztopino za injiciranje folitropin beta
1 ampoule of powder contains: follitropin beta corresponding to 150 IU recombinant follicle stimulating hormone (FSH) activity.
1 ampula praška vsebuje: folitropin beta v količini, ki ustreza 150 i. e. aktivnosti rekombinantnega folikle stimulirajočega hormona (FSH).
132 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
128 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 150 IU 3 ampoules
3 ampule
134 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
130 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 150 IU 5 ampoules
5 ampul
136 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
132 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 150 IU 10 ampoules
10 ampul
138 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
134 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
AMPOULE TEXT Puregon 150 IU powder
BESEDILO NA AMPULAH Puregon 150 i. e. prašek
Puregon 150 IU powder for injection follitropin beta
Puregon 150 i. e. prašek za injekcijo folitropin beta
139 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
135 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
AMPOULE TEXT Puregon 150 IU solvent
BESEDILO NA AMPULAH Puregon 150 i. e. vehikel
Puregon 150 IU solvent for parenteral use
Puregon 150 i. e. vehikel za parenteralno uporabo
140 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
136 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 50 IU/ 0.5 ml 1 vial
BESEDILO NA ZUNANJI OVOJNINI Puregon 50 i. e. / 0, 5 ml 1 viala
Puregon 50 IU/ 0.5 ml solution for injection follitropin beta
Puregon 50 i. e. / 0, 5 ml raztopina za injiciranje folitropin beta
Solution for injection 1 vial containing 0.5 ml
Raztopina za injiciranje 1 viala z 0, 5 ml raztopine
141 Store in a refrigerator.
Shranjujte v hladilniku.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
Bolnik lahko zdravilo Puregon shranjuje tudi pri temperaturi do 25 °C, vendar ne več kot 3 mesece.
Keep the vial in the outer carton.
137 Vialo shranjujte v zunanji ovojnini.
142 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
138 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 50 IU/ 0.5 ml 5 vials
BESEDILO NA ZUNANJI OVOJNINI Puregon 50 i. e. / 0, 5 ml 5 vial
Solution for injection 5 vials each containing 0.5 ml
Raztopina za injiciranje 5 vial po 0, 5 ml raztopine
143 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vials in the outer carton.
139 Viale shranjujte v zunanji ovojnini.
144 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
140 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 50 IU/ 0.5 ml 10 vials
BESEDILO NA ZUNANJI OVOJNINI Puregon 50 i. e. / 0, 5 ml 10 vial
Solution for injection 10 vials each containing 0.5 ml
Raztopina za injiciranje 10 vial po 0, 5 ml raztopine
145 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vials in the outer carton.
141 Viale shranjujte v zunanji ovojnini.
146 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
142 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL TEXT Puregon 50 IU/ 0.5 ml
BESEDILO NA VIALI Puregon 50 i. e. / 0, 5 ml
147 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
143 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 75 IU/ 0.5 ml 1 vial
BESEDILO NA ZUNANJI OVOJNINI Puregon 75 i. e. / 0, 5 ml 1 viala
Puregon 75 IU/ 0.5 ml solution for injection follitropin beta
Puregon 75 i. e. / 0, 5 ml raztopina za injiciranje folitropin beta
148 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vial in the outer carton.
144 Vialo shranjujte v zunanji ovojnini.
149 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
145 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 75 IU/ 0.5 ml 5 vials
BESEDILO NA ZUNANJI OVOJNINI Puregon 75 i. e. / 0, 5 ml 5 vial
150 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vials in the outer carton.
146 Viale shranjujte v zunanji ovojnini.
151 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
147 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 75 IU/ 0.5 ml 10 vials
BESEDILO NA ZUNANJI OVOJNINI Puregon 75 i. e. / 0, 5 ml 10 vial
152 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vials in the outer carton.
148 Viale shranjujte v zunanji ovojnini.
153 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
149 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL TEXT Puregon 75 IU/ 0.5 ml
BESEDILO NA VIALI Puregon 75 i. e. / 0, 5 ml
154 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
150 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 100 IU/ 0.5 ml 1 vial
BESEDILO NA ZUNANJI OVOJNINI Puregon 100 i. e. / 0, 5 ml 1 viala
Puregon 100 IU/ 0.5 ml solution for injection follitropin beta
Puregon 100 i. e. / 0, 5 ml raztopina za injiciranje folitropin beta
155 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vial in the outer carton.
151 Vialo shranjujte v zunanji ovojnini.
156 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
152 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 100 IU/ 0.5 ml 5 vials
BESEDILO NA ZUNANJI OVOJNINI Puregon 100 i. e. / 0, 5 ml 5 vial
157 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vials in the outer carton.
153 Viale shranjujte v zunanji ovojnini.
158 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
154 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 100 IU/ 0.5 ml 10 vials
BESEDILO NA ZUNANJI OVOJNINI Puregon 100 i. e. / 0, 5 ml 10 vial
159 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vials in the outer carton.
155 Viale shranjujte v zunanji ovojnini.
160 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
156 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL TEXT Puregon 100 IU/ 0.5 ml
BESEDILO NA VIALI Puregon 100 i. e. / 0, 5 ml
161 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
157 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 150 IU/ 0.5 ml 1 vial
BESEDILO NA ZUNANJI OVOJNINI Puregon 150 i. e. / 0, 5 ml 1 viala
Puregon 150 IU/ 0.5 ml solution for injection follitropin beta
Puregon 150 i. e. / 0, 5 ml raztopina za injiciranje folitropin beta
162 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vial in the outer carton.
158 Vialo shranjujte v zunanji ovojnini.
163 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
159 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 150 IU/ 0.5 ml 5 vials
BESEDILO NA ZUNANJI OVOJNINI Puregon 150 i. e. / 0, 5 ml 5 vial
164 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vials in the outer carton.
160 Viale shranjujte v zunanji ovojnini.
165 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
161 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 150 IU/ 0.5 ml 10 vials
BESEDILO NA ZUNANJI OVOJNINI Puregon 150 i. e. / 0, 5 ml 10 vial
166 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vials in the outer carton.
162 Viale shranjujte v zunanji ovojnini.
167 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
163 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL TEXT Puregon 150 IU/ 0.5 ml
BESEDILO NA VIALI Puregon 150 i. e. / 0, 5 ml
168 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
164 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 200 IU/ 0.5 ml 1 vial
BESEDILO NA ZUNANJI OVOJNINI Puregon 200 i. e. / 0, 5 ml 1 viala
Puregon 200 IU/ 0.5 ml solution for injection follitropin beta
Puregon 200 i. e. / 0, 5 ml raztopina za injiciranje folitropin beta
169 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vial in the outer carton.
165 Vialo shranjujte v zunanji ovojnini.
170 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
166 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 200 IU/ 0.5 ml 5 vials
BESEDILO NA ZUNANJI OVOJNINI Puregon 200 i. e. / 0, 5 ml 5 vial
171 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vials in the outer carton.
167 Viale shranjujte v zunanji ovojnini.
172 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
168 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 200 IU/ 0.5 ml 10 vials
BESEDILO NA ZUNANJI OVOJNINI Puregon 200 i. e. / 0, 5 ml 10 vial
173 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vials in the outer carton.
169 Viale shranjujte v zunanji ovojnini.
174 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
170 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL TEXT Puregon 200 IU/ 0.5 ml
BESEDILO NA VIALI Puregon 200 i. e. / 0, 5 ml
175 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
171 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 225 IU/ 0.5 ml 1 vial
BESEDILO NA ZUNANJI OVOJNINI Puregon 225 i. e. / 0, 5 ml 1 viala
Puregon 225 IU/ 0.5 ml solution for injection follitropin beta
Puregon 225 i. e. / 0, 5 ml raztopina za injiciranje folitropin beta
1 vial contains 0.5 ml follitropin beta corresponding to:
225 i. e.
225 IU (450 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
(450 i. e. / ml) aktivnosti rekombinantnega folikle stimulirajočega hormona (FSH).
176 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vial in the outer carton.
172 Vialo shranjujte v zunanji ovojnini.
177 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
173 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 225 IU/ 0.5 ml 5 vials
BESEDILO NA ZUNANJI OVOJNINI Puregon 225 i. e. / 0, 5 ml 5 vial
178 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vials in the outer carton.
174 Viale shranjujte v zunanji ovojnini.
179 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
175 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 225 IU/ 0.5 ml 10 vials
BESEDILO NA ZUNANJI OVOJNINI Puregon 225 i. e. / 0, 5 ml 10 vial
180 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vials in the outer carton.
176 Viale shranjujte v zunanji ovojnini.
181 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
177 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL TEXT Puregon 225 IU/ 0.5 ml
BESEDILO NA VIALI Puregon 225 i. e. / 0, 5 ml
182 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
178 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 250 IU/ 0.5 ml 1 vial
BESEDILO NA ZUNANJI OVOJNINI Puregon 250 i. e. / 0, 5 ml 1 viala
Puregon 250 IU/ 0.5 ml solution for injection follitropin beta
Puregon 250 i. e. / 0, 5 ml raztopina za injiciranje folitropin beta
1 vial contains 0.5 ml follitropin beta corresponding to:
250 i. e.
250 IU (500 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
(500 i. e. / ml) aktivnosti rekombinantnega folikle stimulirajočega hormona (FSH).
183 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vial in the outer carton.
179 Vialo shranjujte v zunanji ovojnini.
184 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
180 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 250 IU/ 0.5 ml 5 vials
BESEDILO NA ZUNANJI OVOJNINI Puregon 250 i. e. / 0, 5 ml 5 vial
185 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vials in the outer carton.
181 Viale shranjujte v zunanji ovojnini.
186 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
182 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 250 IU/ 0.5 ml 10 vials
BESEDILO NA ZUNANJI OVOJNINI Puregon 250 i. e. / 0, 5 ml 10 vial
187 Store in a refrigerator.
Shranjujte v hladilniku.
Keep the vials in the outer carton.
183 Viale shranjujte v zunanji ovojnini.
188 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
184 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL TEXT Puregon 250 IU/ 0.5 ml
BESEDILO NA VIALI Puregon 250 i. e. / 0, 5 ml
189 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
185 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 150 IU/ 0.18 ml 1 cartridge
BESEDILO NA ZUNANJI OVOJNINI Puregon 150 i. e. / 0, 18 ml 1 vložek
Puregon 150 IU/ 0.18 ml solution for injection follitropin beta
Puregon 150 i. e. / 0, 18 ml raztopina za injiciranje folitropin beta
Solution for injection 1 cartridge 1 pack with 3 pen needles
Raztopina za injiciranje 1 vložek 1 pakiranje s 3 iglami za peresnik
Subcutaneous use For use only with the Puregon Pen.
subkutana uporaba Za uporabo le s peresnikom Puregon Pen.
190 9.
186 9.
EU/ 1/ 96/ 008/ 040
EU/ 196/ 008/ 040
191 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
187 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
CARTRIDGE TEXT Puregon 150 IU/ 0.18 ml
BESEDILO NA VLOŽKU Puregon 150 i. e. / 0, 18 ml
192 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
188 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 300 IU/ 0.36 ml 1 cartridge
BESEDILO NA ZUNANJI OVOJNINI Puregon 300 i. e. / 0, 36 ml 1 vložek
Puregon 300 IU/ 0.36 ml solution for injection follitropin beta
Puregon 300 i. e. / 0, 36 ml raztopina za injiciranje folitropin beta
Solution for injection 1 cartridge 2 packs with 3 pen needles
Raztopina za injiciranje 1 vložek 2 pakiranji s 3 iglami za peresnik
193 9.
189 9.
194 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
190 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
CARTRIDGE TEXT Puregon 300 IU/ 0.36 ml
BESEDILO NA VLOŽKU Puregon 300 i. e. / 0, 36 ml
195 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
191 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 600 IU/ 0.72 ml 1 cartridge
BESEDILO NA ZUNANJI OVOJNINI Puregon 600 i. e. / 0, 72 ml 1 vložek
Puregon 600 IU/ 0.72 ml solution for injection follitropin beta
Puregon 600 i. e. / 0, 72 ml raztopina za injiciranje folitropin beta
196 9.
192 9.
197 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
193 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
CARTRIDGE TEXT Puregon 600 IU/ 0.72 ml
BESEDILO NA VLOŽKU Puregon 600 i. e. / 0, 72 ml
198 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
194 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON TEXT Puregon 900 IU/ 1.08 ml 1 cartridge
BESEDILO NA ZUNANJI OVOJNINI Puregon 900 i. e. / 1, 08 ml 1 vložek
Puregon 900 IU/ 1.08 ml solution for injection follitropin beta
Puregon 900 i. e. / 1, 08 ml raztopina za injiciranje folitropin beta
Solution for injection 1 cartridge 3 packs with 3 pen needles
Raztopina za injiciranje 1 vložek 3 pakiranja s 3 iglami za peresnik
199 9.
195 9.
200 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
196 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
CARTRIDGE TEXT Puregon 900 IU/ 1.08 ml
BESEDILO NA VLOŽKU Puregon 900 i. e. / 1, 08 ml
INFORMATION FOR THE USER
198 NAVODILO ZA UPORABO
What Puregon is and what it is used for 2.
Kaj je zdravilo Puregon in za kaj ga uporabljamo 2.
Before you use Puregon 3.
Kaj morate vedeti, preden boste uporabili zdravilo Puregon 3.
How to use Puregon 4.
Kako uporabljati zdravilo Puregon 4.
Further information
Možni neželeni učinki 5 Shranjevanje zdravila Puregon 6 Dodatne informacije
WHAT PUREGON IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO PUREGON IN ZA KAJ GA UPORABLJAMO
Puregon powder and solvent for solution for injection contains follitropin beta, a hormone known as follicle-stimulating hormone (FSH).
Puregon prašek in vehikel za raztopino za injiciranje vsebuje folitropin beta, hormon, ki je poznan kot folikle stimulirajoči hormon (FSH).
Puregon is used to treat infertility in any of the following situations: • In women who are not ovulating, Puregon can be used to cause ovulation in women who have not responded to treatment with clomifene citrate. • In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, Puregon can be used to bring about the development of multiple follicles. • In men who are infertile due to a hormonal deficiency, Puregon can be used for the production of sperm.
Zdravilo Puregon uporabljamo za zdravljenje neplodnosti v kateremkoli od naslednjih primerov: • Za sprožitev ovulacije pri ženskah, pri katerih je bilo zdravljenje s klomifenijevim citratom neuspešno. • Pri ženskah, ki so v postopku oploditve z biomedicinsko pomočjo, vključno z zunajtelesno oploditvijo (IVF) in drugimi metodami, se Puregon lahko uporablja za razvoj večkratnih foliklov. • Pri moških, ki so neplodni zaradi pomanjkanja hormonov, se Puregon lahko uporablja za nastajanje sperme.
BEFORE YOU USE PUREGON
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO PUREGON
• if you have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus • if you are allergic (hypersensitive) to follitropin beta or any of the other ingredients of Puregon • if you have heavy or irregular vaginal bleeding where the cause is not known • if you suffer from primary ovarian failure • if you have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD) • if you have malformations of the sexual organs which make a normal pregnancy impossible • if you have fibroids in the uterus which make a normal pregnancy impossible • if you suffer from primary testicular failure.
• če imate tumor jajčnikov, dojk, maternice, testisov, hipofize ali hipotalamusa • če ste alergični (preobčutljivi) na folitropin beta ali katerokoli sestavino zdravila Puregon • če imate močne ali neredne nepojasnjene krvavitve iz nožnice • če imate primarno odpoved jajčnikov • če imate ciste na jajčnikih ali povečane jajčnike, ki niso povezani s policistično boleznijo jajčnikov (PCOD) • če imate malformacije spolnih organov, ki niso združljive z nosečnostjo • če imate fibrome maternice, ki preprečujejo normalno nosečnost • če imate primarno odpoved testisov.
Take special care with Puregon
Bodite posebno pozorni pri uporabi zdravila Puregon
203 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
199 Opozorite zdravnika, če ste bili v preteklosti alergični na neomicin in/ ali streptomicin (antibiotika).
The results of these tests allow your doctor to choose the correct dose of Puregon from day to day.
Izvidi preiskav bodo vašemu zdravniku omogočili izbiro pravega odmerka zdravila Puregon od dne do dne.
Treatment with Puregon (like pregnancy itself) may increase the risk of thrombosis (the formation of a blood clot in a blood vessel, most often in the veins of the legs or the lungs).
Zdravljenje z zdravilom Puregon (prav tako kot sama nosečnost) povečuje nevarnost tromboze (nastanek krvnega strdka v krvni žili, najpogosteje v venah na nogi ali v pljučih).
If Puregon is used in combination with clomifene citrate there may be an increased follicular response.
Če uporabljate zdravilo Puregon v kombinaciji s klomifenijevim citratom, se lahko pojavi povečan folikularni odziv.
If a GnRH agonist has been given, higher doses of Puregon may be needed to achieve a response.
Če sočasno prejemate agonist GnRH, potrebujete večje odmerke zdravila Puregon, da bi dosegli pravi odziv.