qanastek/EMEA-V3 huggingface dataset:
1 vial of powder contains: follitropin beta corresponding to 75 IU recombinant follicle stimulating hormone (FSH) activity.
Kunjett ta 'trab fih: follitropin beta li jikkorispondi għal attività ta ’ 75 IU ta' ormon rikombinanti li jistimula l- follikulu (FSH).
Other ingredients: sucrose, sodium citrate and polysorbate 20; sodium hydroxide and/ or hydrochloric acid as pH adjustment.
Sustanzi oħra: sucrose, sodium citrate u polysorbate 20; sodium hydroxide u/ jew hydrochloric acid għall- aġġustament aġġustatur tal- pH.
Powder and solvent for solution for injection 1 vial containing powder 1 ampoule containing 1 ml solvent
Trab u solvent għal soluzzjoni għall- injezzjoni Kunjett wieħed bi trab Ampulla waħda li fiha 1ml solvent
Keep the vial and ampoule in the outer carton.
Żomm il- kunjett u l- ampulla fil- kartuna ta 'barra.
112 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
123 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 75 IU 3 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 75 IU 3 kunjetti
Puregon 75 IU powder and solvent for solution for injection follitropin beta
Puregon 75 IU trab u solvent għal taħlita għall- injezzjoni follitropin beta
1 vial of powder contains: follitropin beta corresponding to 75 IU recombinant follicle stimulating hormone (FSH) activity.
Kunjett 1 ta 'trab fih: follitropin beta li jikkorispondi għal attività ta ’ 75 IU ta' ormon rikombinanti li jistimula l- follikulu (FSH).
Powder and solvent for solution for injection 3 vials each containing powder 3 ampoules each containing 1 ml solvent
Trab u solvent għal soluzzjoni għal injezzjoni 3 kunjetti kull wieħed minnhom bi trab 3 ampulli kull wieħed minnhom b’ 1 ml solvent
Keep the vials and ampoules in the outer carton.
Żomm il- kunjetti u l- ampulli fil- kartuna ta 'barra.
114 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
125 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 75 IU 5 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 75 IU 5 kunjetti
Other ingredients: sucrose, sodium citrate and polysorbate 20; sodium hydroxide and/ or hydrochloric acid as pH adjustment.
Sustanzi oħra: sucrose, sodium citrate u polysorbate 20; sodium hydroxide u/ jew hydrochloric acid għall- aġġustatment tal- pH.
Powder and solvent for solution for injection 5 vials each containing powder 5 ampoules each containing 1 ml solvent
Trab u solvent għal soluzzjoni għall- injezzjoni 5 kunjetti kull wieħed minnhom bi trab 5 ampulli kull wieħed minnhom b’ 1 ml solvent
116 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
127 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 75 IU 10 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 75 IU 10 kunjetti
Powder and solvent for solution for injection 10 vials each containing powder 10 ampoules each containing 1 ml solvent
Trab u solvent għal soluzzjoni għall- injezzjoni 10 kunjetti kull wieħed minnhom bi trab 10 ampulli kull wieħed minnhom b’ 1 ml solvent
118 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
129 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT Puregon 75 IU powder
KITBA FUQ IL- KUNJETT Puregon 75 IU trab
Puregon 75 IU powder for injection follitropin beta
Puregon 75 IU trab għall- injezzjoni follitropin beta
AMPOULE TEXT Puregon 75 IU solvent
KITBA FUQ L- AMPULLA Puregon 75 IU solvent
Puregon 75 IU solvent for parenteral use
Puregon 75 IU solvent għal użu parenterali
120 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
131 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 100 IU 1 ampoule
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 100 IU ampulla 1
Puregon 100 IU powder and solvent for solution for injection follitropin beta
Puregon 100 IU trab u solvent għal soluzzjoni għall- injezzjoni follitropin beta
1 ampoule of powder contains: follitropin beta corresponding to 100 IU recombinant follicle stimulating hormone (FSH) activity.
Ampulla bi trab fiha: follitropin beta li jikkorispondi għal attività ta ’ 100 IU ta 'l- ormon rikombinanti li jistimula l- follikulu (FSH).
1 ampoule of solvent contains:
Ampulla ta 'solvent fiha:
Powder and solvent for solution for injection 1 ampoule containing powder 1 ampoule containing 1 ml solvent
Trab u solvent għal soluzzjoni għall- injezzjoni Ampulla 1 li fiha trab Ampulla 1 li fiha 1 ml ta ’ solvent
122 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
133 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 100 IU 3 ampoules
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 100 IU 3 ampulli
Powder and solvent for solution for injection 3 ampoules each containing powder 3 ampoules each containing 1 ml solvent
Trab u solvent għal soluzzjoni għal injezzjoni 3 ampulli kull wieħed minnhom bi trab 3 ampulli kull wieħed minnhom b’ 1 ml solvent
124 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
135 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 100 IU 5 ampoules
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 100 IU 5 ampulli
Powder and solvent for solution for injection 5 ampoules each containing powder 5 ampoules each containing 1 ml solvent
Trab u solvent għal soluzzjoni għall- injezzjoni 5 kunjetti kull wieħed minnhom bi trab 5 ampulli kull wieħed minnhom b’ 1 ml solvent
126 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
137 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 100 IU 10 ampoules
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 100 IU 10 ampulli
Powder and solvent for solution for injection 10 ampoules each containing powder 10 ampoules each containing 1 ml solvent
Trab u solvent għal soluzzjoni għall- injezzjoni 10 ampullii kull wieħed minnhom bi trab 10 ampulli kull wieħed minnhom b’ 1 ml solvent
AMPOULE TEXT Puregon 100 IU powder
KITBA FUQ L- AMPULLA Puregon 100 IU trab
Puregon 100 IU powder for injection follitropin beta
Puregon 100 IU trab għall- injezzjoni follitropin beta
129 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
140 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
AMPOULE TEXT Puregon 100 IU solvent
KITBA FUQ L- AMPULLA Puregon 100 IU solvent
Puregon 100 IU solvent for parenteral use
Puregon 100 IU solvent għal użu parenterali
130 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
141 TAGĦRIF LI GĦANDU JIDHER FUQ IL - PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 150 IU 1 ampoule
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 150 IU ampulla 1
Puregon 150 IU powder and solvent for solution for injection follitropin beta
Puregon 150 IU trab u solvent għal soluzzjoni għall- injezzjoni follitropin beta
1 ampoule of powder contains: follitropin beta corresponding to 150 IU recombinant follicle stimulating hormone (FSH) activity.
Ampulla bi trab fiha: follitropin beta li jikkorispondi għal attività ta ’ 150 IU ta 'l- ormon rikombinanti li jistimula l- follikulu (FSH).
132 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
143 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 150 IU 3 ampoules
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 150 IU 3 ampulli
134 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
145 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 150 IU 5 ampoules
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 150 IU 5 ampulli
Powder and solvent for solution for injection 5 ampoules each containing powder 5 ampoules each containing 1 ml solvent
Trab u solvent għal soluzzjoni għall- injezzjoni 5 ampulli kull wieħed minnhom bi trab 5 ampulli kull wieħed minnhom b’ 1 ml solvent
136 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
147 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 150 IU 10 ampoules
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 150 IU 10 ampulli
1 ampoule of powder contains: follitropin beta corresponding to 150 IU recombinant follicle stimulating hormone (FSH) activity.
Ampulla bi trab fiha: follitropin beta li jikkorispondi għal attività ta ’ 150 IU ta 'l- ormon rikombinanti li jistimula l- follikulu (FSH)
Other ingredients: sucrose, sodium citrate and polysorbate 20; sodium hydroxide and/ or hydrochloric acid as pH adjustment.
Sustanzi oħra: sucrose, sodium citrate u polysorbate 20; sodium hydroxide u/ jew hydrochloric acid bħala aġġustament tal- pH.
138 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
149 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
AMPOULE TEXT Puregon 150 IU powder
KITBA FUQ L- AMPULLA Puregon 150 IU trab
Puregon 150 IU powder for injection follitropin beta
Puregon 150 IU trab għall- injezzjoni follitropin beta
139 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
150 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
AMPOULE TEXT Puregon 150 IU solvent
KITBA FUQ L- AMPULLA Puregon 150 IU solvent
Puregon 150 IU solvent for parenteral use
Puregon 150 IU solvent għal użu parenterali
140 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
151 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 50 IU/ 0.5 ml 1 vial
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 50 IU/ 0. 5 ml kunjett 1
Puregon 50 IU/ 0.5 ml solution for injection follitropin beta
Puregon 50 IU/ 0. 5 ml soluzzjoni għall- injezzjoni follitropin beta
50 IU (100 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 50 IU (100 IU/ ml) ta ’ l- ormon rikombinanti li jistimula l- follikulu (FSH)
141 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
152 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
142 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
153 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 50 IU/ 0.5 ml 5 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 50 IU/ 0. 5 ml 5 kunjetti
50 IU (100 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 50 IU (100 IU/ ml) ta ’ l- ormon rikombinanti li jistimula l- follikulu (FSH).
143 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
154 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
MARKETING AUTHORISATION NUMBER
NUMRU TA ’ L - AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
144 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
155 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 50 IU/ 0.5 ml 10 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 50 IU/ 0. 5 ml 10 kunjetti
145 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
156 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
VIAL TEXT Puregon 50 IU/ 0.5 ml
KITBA FUQ IL- KUNJETT Puregon 50 IU/ 0. 5 ml
147 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
158 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 75 IU/ 0.5 ml 1 vial
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 75 IU/ 0. 5 ml kunjett 1
Puregon 75 IU/ 0.5 ml solution for injection follitropin beta
Puregon 75 IU/ 0. 5 ml soluzzjoni għall- injezzjoni follitropin beta
75 IU (150 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 75 IU (150 IU/ ml) ta ’ l- ormon rikombinanti li jistimula l- follikulu (FSH).
148 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
159 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
149 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
160 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 75 IU/ 0.5 ml 5 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 75 IU/ 0. 5 ml 5 kunjetti
75 IU (150 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 75 IU (150 IU/ ml) ta ’ l- ormon rikombinanti li jistimula l- follikulu (FSH)
150 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
161 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
151 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
162 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 75 IU/ 0.5 ml 10 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 75 IU/ 0. 5 ml 10 kunjetti
152 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
163 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
153 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
164 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT Puregon 75 IU/ 0.5 ml
KITBA FUQ IL- KUNJETT Puregon 75 IU/ 0. 5 ml
154 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
165 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 100 IU/ 0.5 ml 1 vial
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 100 IU/ 0. 5 ml kunjett 1
Puregon 100 IU/ 0.5 ml solution for injection follitropin beta
Puregon 100 IU/ 0. 5 ml soluzzjoni għall- injezzjoni follitropin beta
100 IU (200 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta’ 100 IU (200 IU/ ml) ta ’ l- ormon rikombinanti li jistimula l- follikulu (FSH).
155 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
166 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
156 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
167 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 100 IU/ 0.5 ml 5 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 100 IU/ 0. 5 ml 5 kunjetti
100 IU (200 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 100 IU (200 IU/ ml) ta ’ l- ormon rikombinanti li jistimula l- follikulu (FSH).
157 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
168 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
158 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
169 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 100 IU/ 0.5 ml 10 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 100 IU/ 0. 5 ml 10 kunjetti
159 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
170 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
160 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
171 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT Puregon 100 IU/ 0.5 ml
KITBA FUQ IL- KUNJETT Puregon 100 IU/ 0. 5 ml
161 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
172 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 150 IU/ 0.5 ml 1 vial
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 150 IU/ 0. 5 ml kunjett 1
Puregon 150 IU/ 0.5 ml solution for injection follitropin beta
Puregon 150 IU/ 0. 5 ml soluzzjoni għall- injezzjoni follitropin beta
150 IU (300 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 150 IU (300 IU/ ml) ta ’ l- ormon rikombinanti li jistimula l- follikulu (FSH)
162 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
173 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
163 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
174 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 150 IU/ 0.5 ml 5 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 150 IU/ 0. 5 ml 5 kunjetti
150 IU (300 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 150 IU (300 IU/ ml) ta ’ l- ormon rikombinanti li jistimula l- follikulu (FSH).
164 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
175 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
165 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
176 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 150 IU/ 0.5 ml 10 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 150 IU/ 0. 5 ml 10 kunjetti
Puregon 150 IU/ 0.5 ml solution for injection follitropin beta
Puregon150 IU/ 0. 5 ml soluzzjoni għall- injezzjoni follitropin beta
166 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
177 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
167 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
178 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT Puregon 150 IU/ 0.5 ml
KITBA FUQ IL- KUNJETT Puregon 150 IU/ 0. 5 ml
168 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
179 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 200 IU/ 0.5 ml 1 vial
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 200 IU/ 0. 5 ml kunjett 1
Puregon 200 IU/ 0.5 ml solution for injection follitropin beta
Puregon 200 IU/ 0. 5 ml soluzzjoni għall- injezzjoni follitropin beta
200 IU (400 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 200 IU (400 IU/ ml) ta ’ l- ormon rikombinanti li jistimula l- follikulu (FSH).
169 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
180 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
170 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
181 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 200 IU/ 0.5 ml 5 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 200 IU/ 0. 5 ml 5 kunjetti
171 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
182 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
172 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
183 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 200 IU/ 0.5 ml 10 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 200 IU/ 0. 5 ml 10 kunjetti
173 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
184 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
174 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
185 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT Puregon 200 IU/ 0.5 ml
KITBA FUQ IL- KUNJETT Puregon 200 IU/ 0. 5 ml
175 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
186 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 225 IU/ 0.5 ml 1 vial
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 225 IU/ 0. 5 ml kunjett 1
Puregon 225 IU/ 0.5 ml solution for injection follitropin beta
Puregon 225 IU/ 0. 5 ml soluzzjoni għall- injezzjoni follitropin beta
225 IU (450 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: atività ta ’ 225 IU (450 IU/ ml) ta ’ l- ormon rikombinanti li jistimula l- follikulu (FSH).
176 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
187 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
177 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
188 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 225 IU/ 0.5 ml 5 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 225 IU/ 0. 5 ml 5 kunjetti
225 IU (450 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 225 IU (450 IU/ ml) ta ’ l- ormon rikombinanti li jistimula l- follikulu (FSH)
Solution for injection 5 vials each containing 0.5 ml
Soluzzjoni għall- injezzjoni 5 kunjett ta ’ 0. 5 ml kull wieħed
178 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
189 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
179 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
190 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 225 IU/ 0.5 ml 10 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 225 IU/ 0. 5 ml 10 kunjetti
225 IU (450 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 225 IU (450 IU/ ml) ta ’ l- ormon rikombinanti li jistimula l- follikulu (FSH).
180 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
191 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
181 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
192 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT Puregon 225 IU/ 0.5 ml
KITBA FUQ IL- KUNJETT Puregon 225 IU/ 0. 5 ml
182 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
193 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 250 IU/ 0.5 ml 1 vial
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 250 IU/ 0. 5 ml kunjett 1
Puregon 250 IU/ 0.5 ml solution for injection follitropin beta
Puregon 250 IU/ 0. 5 ml soluzzjoni għall- injezzjoni follitropin beta
250 IU (500 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 250 IU (500 IU/ ml) ta ’ l- ormon rikombinanti li jistimula l- follikulu (FSH).
183 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
194 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
184 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
195 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 250 IU/ 0.5 ml 5 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 250 IU/ 0. 5 ml 5 kunjetti
185 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
196 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
186 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
197 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 250 IU/ 0.5 ml 10 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 250 IU/ 0. 5 ml 10 kunjetti
187 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
198 Il- pazjent jista ’ jaħżen Puregon f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
188 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
199 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT Puregon 250 IU/ 0.5 ml
KITBA FUQ IL- KUNJETT Puregon 250 IU/ 0. 5 ml
189 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
200 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 150 IU/ 0.18 ml 1 cartridge
KITBA LI TIDHER FUQ IL- KARTUNA TA 'BARRA Puregon 150 IU/ 0. 18 ml stoċċ 1
Puregon 150 IU/ 0.18 ml solution for injection follitropin beta
Puregon 150 IU/ 0. 18 ml soluzzjoni għall- injezzjoni follitropin beta
Solution for injection 1 cartridge 1 pack with 3 pen needles
Soluzzjoni għall- injezzjoni Stoċċ 1 Pakkett 1 ta ’ 3 labar tal- pinna
Subcutaneous use For use only with the Puregon Pen.
Użu għal taħt il- ġilda Sabiex jintużaw biss mal- Puregon Pen.
Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum of 28 days.
La darba l- lastku ta 'l- inforra ta ’ l- istoċċ ġiet mtaqqba b' labra, il- prodott jista 'jinħażen sa massimu ta' 28 jum.
The patient may store Puregon at or below 25 °C for a single period of not more than 3 months.
Il- pazjent jista ’ jaħżen Puregon fit- temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
191 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
202 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CARTRIDGE TEXT Puregon 150 IU/ 0.18 ml
KITBA LI TIDHER FUQ L- ISTOĊĊ Puregon 150 IU/ 0. 18 ml
Puregon 150 IU/ 0.18 ml solution for injection follitropin beta
Puregon 150 IU/ 0. 18 ml soluzzjoni għall- injezzjoni Follitropin beta
192 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
203 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 300 IU/ 0.36 ml 1 cartridge
KITBA LI TIDHER FUQ IL- KARTUNA TA 'BARRA Puregon 300 IU/ 0. 36 ml stoċċ 1
Puregon 300 IU/ 0.36 ml solution for injection follitropin beta
Puregon 300 IU/ 0. 36 ml soluzzjoni għall- injezzjoni follitropin beta
Solution for injection 1 cartridge 2 packs with 3 pen needles
Soluzzjoni għall- injezzjoni Stoċċ 1 2 pakketti bi 3 labar tal- pinna
Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum of 28 days.
La darba l- lastku ta ’ l- inforra ta ’ l- istoċċ ġiet mtaqqba b 'labra, il- prodott jista' jinħażen sa massimu ta '28 jum.
194 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
205 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CARTRIDGE TEXT Puregon 300 IU/ 0.36 ml
KITBA LI TIDHER FUQ L- ISTOĊĊ Puregon 300 IU/ 0. 36 ml
195 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
206 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 600 IU/ 0.72 ml 1 cartridge
KITBA LI TIDHER FUQ IL- KARTUNA TA 'BARRA Puregon 600 IU/ 0. 72 ml stoċċ 1
Puregon 600 IU/ 0.72 ml solution for injection follitropin beta
Puregon 600 IU/ 0. 72 ml soluzzjoni għall- injezzjoni follitropin beta
Other ingredients: sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water for injections; sodium hydroxide and/ or hydrochloric acid as pH adjustment.
Sustanzi oħra: sucrose, sodium citrate, L- methionine, polysorbate 20 u benzyl alcohol fl- ilma għall - injezzjonijiet; sodium hydroxide u/ jew hydrochloric acid għall- aġġustament tal- pH.
197 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
208 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CARTRIDGE TEXT Puregon 600 IU/ 0.72 ml
KITBA LI TIDHER FUQ L- ISTOĊĊ Puregon 600 IU/ 0. 72 ml
198 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
209 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 900 IU/ 1.08 ml 1 cartridge
KITBA LI TIDHER FUQ IL- KARTUNA TA 'BARRA Puregon 900 IU/ 1. 08 ml stoċċ 1
Puregon 900 IU/ 1.08 ml solution for injection follitropin beta
Puregon 900 IU/ 1. 08 ml soluzzjoni għall- injezzjoni follitropin beta
Solution for injection 1 cartridge 3 packs with 3 pen needles
Soluzzjoni għall- injezzjoni Stoċċ 1 3 pakketti bi 3 labar tal- pinna
Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum of 28 days.
La darba l- lastku ta ’ l- inforra ta 'ġewwa l- istoċċ ġiet mtaqqba b' labra, il- prodott jista 'jinħażen sa massimu ta' 28 jum.
200 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
211 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CARTRIDGE TEXT Puregon 900 IU/ 1.08 ml
KITBA LI TIDHER FUQ L- ISTOĊĊ Puregon 900 IU/ 1. 08 ml
202 PACKAGE LEAFLET:
213 FULJETT TA ’ TAGĦRIF:
What Puregon is and what it is used for 2.
X’ inhu Puregon u għalxiex jintuża 2.
Before you use Puregon 3.
Qabel ma tuża Puregon 3.
How to use Puregon 4.
Kif għandek tuża Puregon 4.
How to store Puregon 6.
Kif taħżen Puregon 6.
WHAT PUREGON IS AND WHAT IT IS USED FOR
X’ INHU PUREGON U GĦALXIEX JINTUŻA
Puregon powder and solvent for solution for injection contains follitropin beta, a hormone known as follicle-stimulating hormone (FSH).
Puregon, trab u solvent għall- injezzjoni fih follitropin beta, ormon magħruf bħala ormon li jistimula l - follikulu (FSH).
FSH belongs to the group of gonadotrophins, which play an important role in human fertility and reproduction.
FSH japparjeni fil- kategoija ta ’ gonadotrofini, li għandhom rwol importanti fil- fertilità u fir - riproduzzjoni tal- bniedem.
In men, FSH is needed for the production of sperm.
Fl- irġiel FSH huwa meħtieġ għal produzzjoni ta ’ l- isperma.
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.
Puregon jintuża biex jitratta l- infertilità f’ xi waħda mill- kondizzjonijiet li ġejjin: • Fin- nisa li mhux qed ikollhom ovulazzjoni, Puregon jista ’ jintuża sabiex ikun hemm ovulazzjoni f’ nisa li ma rrispondewx għall- kura bi clomifene citrate. • F’ nisa li qed jieħdu sehem fi programm li jinvolvi t- teknika ta ’ riproduzzjoni assistita, inkluż il - fertilizzazzjoni in vitro (IVF) u metodi oħra, Puregon jista ’ jintuża sabiex jikkawża l- iżvilupp ta ’ follikuli multipli. • Fl- irġiel li huma infertili minħabba n- nuqqas ta ’ ormoni, Puregon jista ’ jintuża għall - produzzjoni ta ’ l- isperma.
BEFORE YOU USE PUREGON
QABEL MA ’ TUŻA PUREGON
Do not use Puregon
Tużax 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.
• jekk għandek tumur ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- glandola pitwitarja jew ta ’ l- ipotalamu. • jekk inti allerġika/ u (tbati minn sensittività eċċessiva) għal follitropin beta jew għal xi wieħed mis- sustanzi l- oħra ta ’ Puregon • jekk għandek emorraġija vaġinali qawwija jew irregolari fejn il- kawża mhix magħrufa • jekk tbati minn indeboliment primarju ta ’ l- ovarji • jekk għandek ċisti fl- ovarji jew ovarji mkabbra li m’ humiex ikkawżati minn mard poliċistiku ta ’ l- ovarji (PCOD) • jekk għandek malformazzjonijiet ta ’ l- organi sesswali li jagħmel tqala normali impossibbli • jekk għandek fibrojdi fl- utru li jagħmel tqala normali impossibli
Take special care with Puregon
Oqgħod attent ħafna b’ Puregon:
203 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
Jekk jogħġbok informa lit- tabib tiegħek jekk qatt kellek xi allerġija għal neomycin u/ jew streptomycin (antibijotiċi) fil- passat.
Usually ultrasound scans of the ovaries are regularly made, and blood or urine samples are regularly taken.
Ġeneralment isiru skanijiet ta ’ l- ovarji bl- ultrasound u jittieħdu kampjuni tad- demm u ta ’ l- awrina b’ mod regolari.
The results of these tests allow your doctor to choose the correct dose of Puregon from day to day.
Ir- riżultati ta ’ dawn it - testijiet jippermettu lit- tabib li jagħżel l- aħjar dożaġġ ta ’ Puregon minn jum għal jum.
Regular monitoring of the response to FSH-treatment helps your doctor to prevent ovarian overstimulation.
Monitoraġġ regolari tar- rispons għall- kura bl- FSH jgħin lit- tabib tiegħek sabiex jevita li jkun hemm stimulazzjoni żejda ta ’ l- ovarji.
So contact your doctor without delay if you are experiencing significant abdominal pain, also if this occurs some days after the last injection has been given.
Għalhekk ikkuntattja lit- tabib tiegħek mingħajr dewmien jekk tħoss uġigħ sinifikanti fl - addome, u anke jekk dan jiġri wara ftit jiem li tkun ngħatat l- aħħar injezzjoni.
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).
Il- kura b’ Puregon (bħat- tqala nnifisha) tista ’ żżid ir- riskju ta ’ trombożi (il- formazzjoni ta ’ embolu tad - demm f’ vina jew arterja l- aktar fil- vini tas- saqajn jew fil- pulmuni).
Puregon is usually not effective in such cases.
Ġeneralment, Puregon m’ huwiex effettiv f’ dawn il- każi.
To monitor treatment, your doctor may ask you for a semen analysis to be performed 4 to 6 months after the beginning of treatment.
Sabiex jissorvelja l- kura tiegħek it- tabib tiegħek jista ’ jitolbok għall- analiżi tas - semen li għandha ssir minn 4 sa 6 xhur li tkun bdiet il- kura.
Using other medicines
Meta tieħu mediċini oħra:
If Puregon is used in combination with clomifene citrate there may be an increased follicular response.
Jekk Puregon jintuża flimkien ma ’ clomifene citrate jista ’ jkun hemm rispons follikulari ogħla.
If a GnRH agonist has been given, higher doses of Puregon may be needed to achieve a response.
Jekk jingħata agonista tal- GnRH, jista ’ ikun hemm bżonn dożi aktar għolja ta ’ Puregon sabiex ikun hemm rispons.
Pregnancy
Tqala:
There is neither clinical experience nor evidence from studies in animals that use of Puregon during pregnancy might lead to congenital abnormalities.
Għad m’ hemmx esperjenza klinika lanqas evidenza minn studji f’ annimali li l- użu ta ’ Puregon waqt it - tqala jista ’ jwassal għal abnormalitajiet konġenitali.
Nevertheless, you should not use Puregon if you are already pregnant, or suspect that you might be pregnant.
Madankollu, m’ għandekx tuża Puregon jekk int diġà tqila jew taħseb li tista ’ tkun tqila.
After treatment with gonadotrophin preparations, there is an increased risk of having multiple pregnancies.
Wara l- kura b’ sustanzi tal- gonadotrofini, hemm riskju ogħla ta ’ tqala multipla.
Multiple pregnancies carry an increased health risk for both the mother and her babies around the time of birth.
Tqala multipla iġġorr riskju ogħla kemm għas- saħħa ta ’ l- omm kif ukoll għal dik tat- trabi fil- perijodu tat- twelid.
Furthermore, multiple pregnancies and characteristics of the patients undergoing fertility treatment (e. g. age of the female, sperm characteristics) may be associated with an increased risk of congenital abnormalities.
Barraminhekk, tqala multipla u l- karatteristiċi tal- pazjenti li jkunu qed jingħataw kura għal fertilità (eż. età tal- mara, karatteristiċi ta ’ l- isperma) jistgħu jkunu assoċjati ma ’ riskju ogħla ta ’ anormalitajiet konġenitali.
Breast-feeding
Jekk qed tredda ’:
You should not use Puregon if you are breast-feeding.
M’ għandekx tuża Puregon jekk qed tredda ’.
HOW TO USE PUREGON
KIF GĦANDEK TUŻA PUREGON
204 Always use Puregon exactly as your doctor has told you.
Dejjem għandek tuża Puregon skont il- parir eżatt tat- tabib.
Dosage in women
Dożaġġ fin- nisa:
Your doctor will decide on the dose of Puregon to be given.
It- tabib tiegħek ser jiddeċiedi fuq id- doża ta ’ Puregon li għandek tingħata.
Further details on the treatment schedule are given below.
Aktar dettalji ta ’ l- iskeda tal- kura huma mogħtija hawn isfel.
There are large differences between women in the response of the ovaries to FSH, which makes it impossible to set a dosage schedule which is suitable for all patients.
Hemm differenzi kbar bejn mara u oħra fir- rispons ta ’ l- ovarji għal FSH li jagħmilha impossibbli li jkun hemm skeda ta ’ dożaġġ adattata għall- pazjenti kollha.
To find the right dosage, follicle growth is checked by means of ultrasound scanning, and measurement of the amount of estradiol (female sex hormone) in blood or urine. • Women who are not ovulating Initially, a starting dose is set by your doctor.
Sabiex tinsab id- doża adattata, it- tkabbir follikulari jiġi ċċekjat permezz ta ’ skanijiet bl- ultrasound, u bil- kejl ta ’ l- ammont ta ’ estradjol (ormon tas- sess tan- nisa) fid- demm u fl- awrina. • Nisa li mhux qed ikollhom ovulazzjoni Fil- bidu, doża inizjali tiġi ssettjata mit- tabib tiegħek.
This dose is continued for at least seven days.
Din id- doża tibqa tinżamm għal ta ’ l- anqas sebat ijiem.
If there is no ovarian response, the daily dose will then be gradually increased until follicle growth and/ or plasma estradiol levels indicate an adequate response.
Jekk ma jkunx hemm rispons mill- ovarji, id- doża ta ’ kuljum tiżdid gradwalment sakemm it- tkabbir follikulari u/ jew il- livelli ta ’ l- estradjol fil- plażma jindikaw rispons xieraq.
The administration of Puregon is then stopped and ovulation can be induced by administering human chorionic gonadotrophin (hCG). • Medically assisted reproduction programs, e. g.
Puregon imbagħad jitwaqqaf u l - ovulazzjoni tista ’ tiġi stimulata bl- għoti tal- gonadotrofina korjonika umana (hCG). • Programmi ta ’ riproduzzjoni medikament assistiti, eż.
After this, the dose may be adjusted for the individual patient, based upon their ovarian response.
Wara dan, id- doża tkun tista ’ tiġi aġġustata għall- pazjent individwali, abbażi tar- rispons ta ’ l - ovarji tagħhom.
Dosage in men
Dożaġġ fl- irġiel:
Puregon is usually prescribed at a dose of 450 IU/ week, mostly in 3 dosages of 150 IU, in combination with another hormone (hCG), for at least 3 to 4 months.
Ġeneralment, Puregon huwa preskritt f’ doża ta ’ 450 IU/ ġimgħa, l- aktar fi tliet dożaġġi ta ’ 150 IU, flimkien ma ’ ormon ieħor (hCG), għal ta ’ l- anqas 3 sa 4 xhur.
If you have not responded after this period, your treatment may carry on for at least 18 months.
Jekk ma jkunx hemm rispons wara dan il- perijodu, il- kura tiegħek tista ’ titkompla sa ta ’ l- anqas 18- il xahar.
Method and route of administration
Mod ta ’ kif u mnejn jingħata:
Puregon only works if it is injected in a muscle or under the skin.
Puregon jaħdem biss jekk jiġi injettat ġol- muskolu jew taħt il- ġilda.
The very first injection of Puregon should be given under medical supervision.
L- ewwel injezzjoni ta ’ Puregon għandha tingħata taħt sorveljanza medika.
The dry powder should be dissolved with the solvent contained in the ampoule with fluid and this solution should be administered immediately.
It- trab niexef huwa maħlul bis- solvent li jinsab fl- ampulla bil- likwidu u din it- soluzzjoni għandha tingħata minnufih.
To avoid injection of large volumes 3 to 4 lyospheres of Puregon may be dissolved in 1 ml of solvent.
Sabiex tevita li jiġu injettati volumi kbar, 3 sa 4 lijosferi ta 'Puregon għandhom jiġu maħlula f' 1 ml ta' solvent.
When only 1 or 2 lyospheres are required the volume may be reduced to 0.5 ml.
Meta hemm bżonn biss ta '1 jew 2 lijosferi, il- volum jista' jiġi mnaqqas għal 0. 5 ml.
The injections are given slowly into a muscle (for instance in the buttock, upper leg or upper arm) or just under the skin (in the abdominal wall, for example).
L- injezzjonijiet jingħataw bil- mod f’ muskolu (per eżempju fil- warrani, il- parti ta ’ fuq tas- sieq jew fil - parti ta ’ fuq tad- driegħ) jew taħt il- ġilda (fil- wiċċ ta ’ l- addome per eżempju).
Injections into a muscle (intramuscular) should only be given by a doctor or a nurse.
Injezzjonijiet ġol - muskolu għandhom jingħataw biss minn tabib jew infermier.
Injections under the skin (subcutaneous) may, in some cases, be given by you or your partner.
Injezzjonijiet taħt il- ġilda jistgħu f’ xi każijiet jingħataw minnek stess jew mis- sieħeb/ sieħba tiegħek.
When the instructions are followed carefully, Puregon will be administered properly and with minimal discomfort.
Meta l- istruzzjonijiet ikunu segwiti bir- reqqa, Puregon jingħata sew u bl- inqas skumdità.
Instructions for use
Struzzjonijiet għall- użu:
Step 1 - Preparing the syringe Puregon comes in two glass ampoules whose contents must be mixed together.
Stadju 1 – Preparazzjoni tas- siringa Puregon jiġi f' żewġ ampulli tal- ħġieġ li l- kontenut tagħhom għandu jiġi mħallat flimkien.
Draw up the liquid through the needle into the syringe (c.).
L- ewwel, kisser ir- ras ta 'l- ampulla li fiha s- soluzzjoni ta ’ sodium chloride (a., b.) Iġbed il- likwidu mill- labra għal gos- siringa (c.).
Break open the second ampoule containing the freeze-dried sphere (with the black dot in the position as indicated in the figures a. and b.) and add the sodium chloride solution from the syringe (d.).
Ikser it- tieni ampulla li fiha l- isfera mnixxfa- ffriżata (bid- dott sewda fil - 216 pożizzjoni kif indikat fil- figuri a. u b.) u żid is- sodium chloride mis- siringa (d.).
DO NOT SHAKE, but gently swirl until the solution is clear.
IXXENGILX imma bil- mod dawwar sakem is- soluzzjoni tkun iċċarat.
Generally Puregon dissolves immediately.
Ġeneralment Puregon jinħall malajr.
Should the solution contain particles or not become clear, do not use.
Kemm- il darba s- soluzzjoni jkun fiha l- frak jew ma tkunx ċara, tużhiex.
If you need to dissolve more than one freeze-dried sphere, then repeat the actions described under points c. and d. until the required number of freeze-dried spheres is dissolved.
Jekk għandek bżonn li tħoll aktar minn sfera mnixxfa- ffriżata waħda, irrepeti l- azzjonijiet deskritti f' punti ċ. u d. sakemm in- numru meħtieġ ta 'sferi huma maħlula.
Please make sure that 205 all handling is performed in such a way that sterile conditions are maintained during the dissolution procedure (e. g. do not put the syringe down without covering the needle with the protective cap).
Jekk jogħġbok iżgura li l - manipulazzjoni ssir b' mod li l- kondizzjonijiet sterili jinżammu waqt il- proċess (eż. isseraħx is- siringa mingħajr ma tgħatti l- labra bl- għatu protettiv).
Draw the Puregon solution up into the empty syringe (e.), and now replace the needle with a sterile injection needle (f.).
Iġbed is- soluzzjoni fis- siringa vojta (e.), u issa ibdel il- labra b’ labra ma ’ labra ta ’ l- injezzjoni sterili (f.).
Finally hold the syringe with the needle pointing upwards and gently tap the side to force any air bubbles up to the top; then squeeze the plunger until all the air has been expelled, and only Puregon solution is left in the syringe (g.).
Fl- aħħar, żomm is- siringa bil- labra tippunta 'l fuq u bil- mod taptap il- ġenb tas- siringa sabiex tisforza xi bżieżaq ta ’ l- arja jitilgħu' l fuq: imbagħad imbotta l- planġer sakemm l- arja kollha tkun ħarġet, u fis- siringa hemm is- soluzzjoni ta ’ Puregon biss (g.).
Step 2 - The injection site The best site for subcutaneous injection is in the abdomen around the navel (h.) where there is a lot of loose skin and layers of fatty tissue.
Stadju 2 – Is- sit ta ’ l- injezzjoni L- aħjar sit ta ’ l- injezzjoni għal taħt il- ġilda huwa fl- addome madwar iż- żokkra (h.) fejn hemm ħafna ġilda merħija u saffi ta ’ tessut tax- xaħam.
You should vary the injection site a little with each injection.
Għandek tvarja s- sit ta ’ l- injezzjoni ma ’ kull tilqima.
Step 3 - Preparing the area A few taps at the injection site will stimulate tiny nerve endings and help reduce discomfort when the needle goes in.
Stadju 3 – Preparazzjoni tas- sit ta ’ l- injezzjoni Ftit taptip fis- sit ta ’ l- injezzjoni għandu jistimula t- truf tan- nervituri u jnaqqas l- iskomdu meta tidħol il- labra.
Hands should be washed and the injection site swabbed with disinfectant (for example chlorohexidine 0.5%) to remove any surface bacteria.
L- idejn iridu jkunu maħsula u s- sit ta ’ l- injezzjoni mimsuħa b’ diżinfettant (eż. chlorohexidine 0. 5%) sabiex jitneħħew xi batterja tal- wiċċ.
Clean about two inches around the point where the needle will go in and let the disinfectant dry for at least one minute before proceeding.
Naddaf madwar żewġ pulzieri madwar il- punt fejn trid tidħol il- labra u ħalli d- diżinfettant jinxef għal ta ’ l- anqas minuta qabel ma tipproċedi.
With the other hand, insert the needle at an angle of 90 degrees into the skin’ s surface (i.).
B’ idejk l- oħra, daħħal il- labra f’ anglu ta ’ 90 grad fil- wiċċ tal- ġilda (i.).
Step 5 - Checking the correct needle position If the needle position is correct the plunger should be quite difficult to draw back.
Stadju 5 - L- iċċekjar tal- pożizzjoni korretta tal- labra Jekk il- pożizzjoni tal- labra hija korretta ikun diffiċli li tiġbed il- planġer lura.
You should then start again with Step 1 using a new syringe, new needles, and new ampoules of Puregon and sodium chloride solution.
Għandek terġa tibda mill- ġdid minn Stadju 1 billi tuża siringa u labra ġdida u ampulli ġodda ta 'Puregon u t- taħlita ta ’ sodium chloride.
Step 7 - Removing the syringe Pull the syringe out quickly and apply pressure to the injection site with a swab containing disinfectant.
217 Stadju 7 – Tneħħija tas- siringa Iġbed is- siringa l- barra malajr u agħfas fuq is- sit tat- tilqima b’ msiħ li fiha d- diżinfettant.
A gentle massage of the site - while still maintaining pressure - helps disperse the Puregon solution and relieve any discomfort.
Massaġġ ġentili fuq- sit – waqt li tkun qed tagħfas fuqha – jgħin biex tifrex is- soluzzjoni tal- Puregon u ttaffi kull skomdu.
206 Any remaining solution should be discarded.
Kull fdal tas- soluzzjoni li ma jkunx intuża għandu jintrema.
Do not mix Puregon with any other medicines.
Puregon m’ għandux jitħallat ma mediċini oħra.
If you use more Puregon than you should
Jekk tuża Puregon aktar milli suppost:
Too high a dose may cause overstimulation of the ovaries.
Doża għolja żżejjed tista ’ tikkawża stimulazzjoni żejda ta ’ l- ovarji.
See section on Possible side effects below.
Ara sezzjoni fuq Effetti Sekondarji li Jista ’ Jkollu li tidher hawn isfel.
If you forget to use Puregon
Jekk tinsa tuża Puregon:
Like all medicines, Puregon can cause side effects, although not everybody gets them.
Bħal mediċini kollha Puregon jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Minor side effects include bruising, pain, redness, swelling and itching at the site of injection.
Effetti żgħar oħra jinkludu tbenġil, uġigħ, ħmura, nefħa u ħakk fil- lok ta ’ l- injezzjoni.
A complication with FSH treatment is unwanted overstimulation of the ovaries.
Kumplikazzjoni bit- trattament ta ’ l- FSH hija l- istimulazzjoni żejda mhux mixtieqa fl- ovarji.
This condition can become very serious, but the risk can be reduced by careful monitoring of follicle development during treatment.
Din il - kondizzjoni tista ’ ssir serja ħafna imma r- riskju jista ’ jitnaqqas b’ sorveljanza bir- reqqa ta ’ l- iżvilupp tal- follikuli waqt il- kura.
The first symptoms of ovarian overstimulation may be noticed as pain in the abdomen, feeling sick or diarrhoea.
L- ewwel sintomi ta ’ stimulazzjoni żejda ta ’ l- ovarji jistgħu jkunu uġigħ fl - addome, tħossok marid jew dijarea.