qanastek/EMEA-V3 huggingface dataset:
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 (d).
Fl- aħħar, żomm is- siringa bil- labra tipponta 'l fuq u bil- mod taptap il- ġenb tas- siringa sabiex tisforza xi bżieżaq tal- arja jitilgħu' l fuq: imbagħad 264 imbotta l- planġer sakemm l- arja kollha tkun ħarġet, u fis- siringa jkun hemm is- soluzzjoni biss (d).
253 Step 2 - The injection site The best site for subcutaneous injection is in the abdomen around the navel (e) where there is a lot of loose skin and layers of fatty tissue.
Stadju 2 – Is- sit ta ’ l- injezzoni L- aħjar sit ta ’ l- injezzjoni għal taħt il- ġilda huwa fl- addome madwar iż- żokkra (e) fejn hemm ħafna ġilda merħija u saffi ta ’ tessut tax- xaħam.
Inform your doctor.
265 Għarraf lit- tabib tiegħek.
254 If you forget to use Puregon
Jekk tinsa tuża Puregon:
6.
266 6.
255 • The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 200 IU in 0.5 ml aqueous solution per vial. • The other ingredients are sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections.
• Is- sustanza attiva hija follitropin beta, ormon magħruf bħala ormon li jistimula l- follikulu (FSH) f’ qawwa ta ’ 200 IU f’ 0. 5 ml ta ’ soluzzjoni akwea f’ kull fjala. • Is- sustanzi l- oħra huma sucrose, sodium citrate, L- methionine u polysorbate 20 f’ ilma għall - injezzjonijiet.
256 PACKAGE LEAFLET:
267 FULJETT TA ’ TAGĦRIF:
257 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.
HOW TO USE PUREGON
KIF GĦANDEK TIEĦU PUREGON
258 Always use Puregon exactly as your doctor has told you.
Dejjem għandek tuża Puregon skont il- parir eżatt tat- tabib.
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 (d).
Fl- aħħar, żomm is- siringa bil- labra tipponta 'l fuq u bil- mod taptap il- ġenb tas- siringa sabiex tisforza xi bżieżaq tal- arja jitilgħu' l fuq: imbagħad 270 imbotta l- planġer sakemm l- arja kollha tkun ħarġet, u fis- siringa jkun hemm is- soluzzjoni biss (d).
259 Step 2 - The injection site The best site for subcutaneous injection is in the abdomen around the navel (e) where there is a lot of loose skin and layers of fatty tissue.
Stadju 2 – Is- sit ta ’ l- injezzoni L- aħjar sit ta ’ l- injezzjoni għal taħt il- ġilda huwa fl- addome madwar iż- żokkra (e) fejn hemm ħafna ġilda merħija u saffi ta ’ tessut tax- xaħam.
You should vary the injection site a little with each injection.
Għandek tvarja daqsxejn is- sit ta ’ l- injezzjoni ma ’ kull injezzjoni.
If you use more Puregon than you should
271 Jekk tuża Puregon aktar milli suppost:
260 If you forget to use Puregon
Jekk tinsa tuża Puregon:
These measures will help to protect the environment.
272 protezzjoni ta ’ l- ambjent.
261 • The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 225 IU in 0.5 ml aqueous solution per vial. • The other ingredients are sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections.
• Is- sustanza attiva hija follitropin beta, ormon magħruf bħala ormon li jistimula l- follikoli (FSH) f’ qawwa ta ’ 225 IU f’ 0. 5 ml ta ’ soluzzjoni akwea f’ kull fjala. • Is- sustanzi l- oħra huma sucrose, sodium citrate, L- methionine u polysorbate 20 f’ ilma għall - injezzjonijiet.
Marketing Authorisation Holder N. V.
Id- detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq N. V.
262 PACKAGE LEAFLET:
273 FULJETT TA ’ TAGĦRIF:
Puregon solution for injection contains follitropin beta, a hormone known as follicle-stimulating hormone (FSH).
Puregon, soluzzjoni għall- injezzjoni fih follitropin beta, ormon magħruf bħala ormon li jistimula l - follikoli (FSH).
263 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.
264 Always use Puregon exactly as your doctor has told you.
Dejjem għandek tuża Puregon skont il- parir eżatt tat- tabib.
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 (d).
Fl- aħħar, żomm is- siringa bil- labra tipponta 'l fuq u bil- mod taptap il- ġenb tas- siringa sabiex tisforza xi bżieżaq tal- arja jitilgħu' l fuq: imbagħad 276 imbotta l- planġer sakemm l- arja kollha tkun ħarġet, u fis- siringa jkun hemm is- soluzzjoni biss (d).
265 Step 2 - The injection site The best site for subcutaneous injection is in the abdomen around the navel (e) where there is a lot of loose skin and layers of fatty tissue.
Stadju 2 – Is- sit ta ’ l- injezzoni L- aħjar sit ta ’ l- injezzjoni għal taħt il- ġilda huwa fl- addome madwar iż- żokkra (e) fejn hemm ħafna ġilda merħija u saffi ta ’ tessut tax- xaħam.
If you use more Puregon than you should
277 Jekk tuża Puregon aktar milli suppost:
266 If you forget to use Puregon
Jekk tinsa tuża Puregon:
The contents of a vial should be used immediately after piercing the rubber stopper.
Il- kontenut tal- kunjett għandu jintuża minnufih la darba ittaqqab it- tapp tal- lastku.
These measures will help to protect the environment.
278 protezzjoni ta ’ l- ambjent.
267 • The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 250 IU in 0.5 ml aqueous solution per vial. • The other ingredients are sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections.
• Is- sustanza attiva hija follitropin beta, ormon magħruf bħala ormon li jistimula l- follikulu (FSH) f’ qawwa ta ’ 250 IU f’ 0. 5 ml ta ’ soluzzjoni akwea f’ kull fjala. • Is- sustanzi l- oħra huma sucrose, sodium citrate, L- methionine u polysorbate 20 f’ ilma għall - injezzjonijiet.
268 PACKAGE LEAFLET:
279 FULJETT TA ’ TAGĦRIF:
Puregon 150 IU/ 0.18 ml solution for injection contains a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ ml.
Puregon 150 IU/ 0. 18 ml soluzzjoni għall- injezzjoni fih l- ormon magħruf bħala l- ormon li jistimula l - follikoli (FSH) f' qawwa ta '833 IU/ ml.
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 m’ hux 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 d- defiċenża ta ’ ormoni, Puregon jista ’ jintuża għall - produzzjoni ta ’ l- isperma.
• 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- ovarju • 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
269 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.
Regular monitoring of the response to FSH-treatment helps your doctor to prevent ovarian overstimulation.
Monitoraġġ regolari tar- rispons għal- kura bl- FSH jgħin lit- tabib tiegħek sabiex jevita li jkun hemm stimulazzjoni żejda ta ’ l- ovarji.
Puregon is usually not effective in such cases.
Ġeneralment Purgon m’ huwiex effettiv f’ dawn il- każi.
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.
270 Always use Puregon exactly as your doctor has told you.
Dejjem għandek tuża Puregon skont il- parir eżatt tat- tabib.
Further details on the treatment schedule are given below.
Aktar dettalji ta’ l- iskeda tal- kura huma mogħtija hawn isfel.
The administration of Puregon is then stopped and ovulation can be induced by administering human chorionic gonadotrophin (hCG). • Medically assisted reproduction programs, e. g.
Ġeneralment, 7 sa 14- il jum ta ’ kura jkunu biżżejjed. puregon, imbagħad jitwaqqaf u l- ovulazzjoni tista ’ tiġi stimulata bl- għoti tal- gonadotrofina korjonika umana (hCG). • Programmi ta ’ riproduzzjoni medikament assistiti, eż.
Puregon solution for injection in cartridges has been developed for use in the Puregon Pen.
Puregon, soluzzjoni għall- injezzjoni fl- istoċċijiet ġie ddisinjat biex jintuża mal- Puregon Pen.
Using the pen, injections just under the skin (in the abdominal wall, for example) can be given by you or your partner.
Permezz tal- pinna, injezzjonijiet taħt il- ġilda (fil- wiċċ ta ’ l- addome per eżempju) jistgħu jingħataw minnek stess jew sieħeb/ sieħba tiegħek.
When the instructions are followed carefully, Puregon will be administered properly and with minimal discomfort.
Meta l- istruzzjonijiet jiġu segwiti bir- reqqa, Puregon jista 'jingħata sew u bl- inqas inkonvenjent.
The very first injection of Puregon should be given under medical supervision.
L- ewwel injezzjoni ta ’ Puregon għandha tingħata taħt superviżjoni medika.
If you use more Puregon than you should
Jekk tieħu Puregon aktar milli suppost għandek:
See section on Possible Side Effects below.
Ara s- sezzjoni fuq Effetti Sekondarji li Jista ’ Jkollu li tidher hawn isfel.
271 Minor side effects include bruising, pain, redness, swelling and itching at the site of the injection.
Effetti żgħar oħra jinkludu tbenġil, uġigħ, ħmura, nefħa u ħakk fil- lok ta ’ l- injezzjoni.
In more severe cases symptoms may include enlargement of the ovaries, accumulation of fluid in the abdomen and/ or chest, weight gain and the occurrence of blood clots in the circulation.
L- ewwel sintomi ta ’ stimulazzjoni żejda ta ’ l- ovarju jistgħu jkunu uġigħ fl - addome, tħossok marid jew dijarea, F’ każijiet aktar serji sintomi jistgħu jinkludu tkabbir ta ’ l- ovarji, akkumulazzjoni ta ’ fluwidu fl- addome u/ jew fis- sider, żieda fil- piż u l- preżenza ta ’ emboli tad- demm fiċ- ċirkulazzjoni.
Please put the day of first use of the cartridge on the dosing record table as shown in the Instruction Manual of the Puregon Pen.
Jekk jogħġbok niżżel id- data ta 'l- istoċċ fit- tabella skedata ta' dożaġġ kif muri fil Manwal ta 'l - Istruzzjonijiet tal- Puregon Pen.
Do not use Puregon if you notice that the solution contains particles or is not clear.
Tużax Puregon jekk tinnota li fis- soluzzjoni hemm xi frak jew li mhix ċara.
Puregon cartridges are not designed to allow any other drug to be mixed in the cartridges.
L- istoċċijiet ta 'Puregon m' humiex magħmula sabiex jippermettu xi mediċina oħra biex tiġi mħalta ma' l- istoċċi.
What Puregon contains
283 X’ fih Puregon
272 • The other ingredients are sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water for injections.
• Is- sustanza attiva hija follitropin beta, ormon magħruf bħala l- ormon li jistimula l- follikoli (FSH) f 'qawwa ta' 833 IU/ ml soluzzjoni akwea f’ kull stoċċ. • Is- sustanzi l- oħra huma sucrose, sodium citrate, L- methionine, polysorbate 20 u benzyl alcohol f' ilma għall- injezzjonijiet.
273 PACKAGE LEAFLET:
284 FULJETT TA ’ TAGĦRIF:
Read all of this leaflet carefully before you start using this medicine. − Keep this leaflet.
Jista ’ jkollok bżonn terġa taqrah.
Puregon 300 IU/ 0.36 ml solution for injection contains a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ ml.
Puregon 300 IU/ 0. 36 ml soluzzjoni għall- injezzjoni fih l- ormon magħruf bħala l- ormon li jistimula l - follikuli (FSH) f' qawwa ta '833 IU/ ml.
• 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- ovarju • 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 il- fibrojdi fl- utru li jagħmel tqala normali impossibli • jekk tbati minn indeboliment primarju tat- testikoli.
Take special care with Puregon
285 Oqgħod attent ħafna b’ Puregon:
274 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.
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.
Barra minnhekk, 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.
275 Always use Puregon exactly as your doctor has told you.
Dejjem għandek tuża Puregon skont il- parir eżatt tat- tabib.
Puregon solution for injection in cartridges has been developed for use in the Puregon Pen.
Puregon, soluzzjoni għall- injezzjoni fl- istoċċi ġie iddisinjat biex jintuża mal- Puregon Pen.
Like all medicines, Puregon can cause side effects, although not everybody gets them.
287 Bħal mediċini kollha Puregon jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
276 Minor side effects include bruising, pain, redness, swelling and itching at the site of the injection.
Effetti żgħar oħra jinkludu tbenġil, uġigħ, ħmura, nefħa u ħakk fil- lok ta ’ l- injezzjoni.
Do not use Puregon if you notice that the solution contains particles or is not clear.
Tużax Puregon jekk tinnota li fis- soluzzjoni hemm xi frak jew li mhiex ċara.
277 • The other ingredients are sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water for injections.
288 • Is- sustanza attiva hija follitropin beta, ormon magħruf bħala l- ormon li jistimula l- follikulu (FSH) f 'qawwa ta' 833 IU/ ml soluzzjoni akwea f’ kull stoċċ. • Is- sustanzi l- oħra huma sucrose, sodium citrate, L- methionine, polysorbate 20 u benzyl alcohol f' ilma għall- injezzjonijiet.
278 PACKAGE LEAFLET:
289 FULJETT TA ’ TAGĦRIF:
Puregon 600 IU/ 0.72 ml solution for injection follitropin beta
Puregon 600 IU/ 0. 36 ml soluzzjoni għall- injezzjoni follitropin beta
Puregon 600 IU/ 0.72 ml solution for injection contains a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ ml.
Puregon 600 IU/ 0. 72 ml soluzzjoni għall- injezzjoni fih l- ormon magħruf bħala l- ormon li jistimula l - follikuli (FSH) f' qawwa ta '833 IU/ ml.
• if you have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus • if you areallergic (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 allerġiku/ a (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- ovarju • 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 il- fibrojdi fl- utru li jagħmel tqala normali impossibli
279 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.
280 Always use Puregon exactly as your doctor has told you.
Dejjem għandek tuża Puregon skont il- parir eżatt tat- tabib.
If you forget to use Puregon
Jekk tinsa tieħu Puregon:
281 Minor side effects include bruising, pain, redness, swelling and itching at the site of the injection.
Effetti żgħar oħra jinkludu tbenġil, uġigħ, ħmura, nefħa u ħakk fil- lok ta ’ l- injezzjoni.
Do not use Puregon after the expiry date which is stated on the label after'EXP: '.
Tużax Puregon wara d- data ta ’ skadenza li tidher fuq it- tikketta wara ‘ JIS: ’ Aħżen fi friġġ (2 °C – 8°C).
Do not use Puregon if you notice that the solution contains particles or is not clear.
Tużax Puregon jekk tara li fis- soluzzjoni hemm xi frak jew li mhix ċara.
Puregon cartridges are not designed to allow any other drug to be mixed in the cartridges.
L- istoċċijiet ta 'Puregon m' humiex magħmula sabiex jippermettu xi mediċina oħra biex tiġi mħallta ma' l- istoċċijiet.
What Puregon contains
293 X’ fih Puregon
282 • The other ingredients are sucrose, sodium citrate, L-methionine, polysorbate 20, benzyl alcohol in water for injections.
• Is- sustanza attiva hija follitropin beta, ormon magħruf bħala l- ormon li jistimula l- follikoli (FSH) f 'qawwa ta' 833 IU/ ml soluzzjoni akwea f’ kull stoċċ. • Is- sustanzi l- oħra huma sucrose, sodium citrate, L- methionine, polysorbate 20 u benzyl alcohol f' ilma għall- injezzjonijiet.
283 PACKAGE LEAFLET:
294 FULJETT TA ’ TAGĦRIF:
Puregon 900 IU/ 1.08 ml solution for injection contains a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ ml.
Puregon 900 IU/ 1. 08 ml soluzzjoni għall- injezzjoni fih l- ormon magħruf bħala l- ormon li jistimula l - follikuli (FSH) f' qawwa ta '833 IU/ ml.
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 m’ hux 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 d- defiċenża ta ’ ormoni, Puregon jista ’ jintuża għall - produzzjoni ta ’ l- isperma.
• 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 allerġiku/ a (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- ovarju • 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 il- fibrojdi fl- utru li jagħmel tqala normali impossibli
Take special care with Puregon:
Oqgħod attent ħafna b’ Puregon:
284 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.
285 Always use Puregon exactly as your doctor has told you.
Dejjem għandek tuża Puregon skont il- parir eżatt tat- tabib.
See section on Possible Side Effects below.
Ara s- sezzjoni fuq Effetti Sekondarji li Jista Jkollu li tidher hawn isfel.
POSSIBLE SIDE EFFECTS
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU 297 Bħal mediċini kollha Puregon jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
286 Minor side effects include bruising, pain, redness, swelling and itching at the site of the injection.
Effetti żgħar oħra jinkludu tbenġil, uġigħ, ħmura, nefħa u ħakk fil- lok ta ’ l- injezzjoni.
Please put the day of first use of the cartridge on the dosing record table as shown in the Instruction Manual of the Puregon Pen.
Jekk jogħġbok niżżel id- data ta 'l- istoċċ fit- tabella skedata ta' dożaġġ kif muri fil Manwal ta 'l - Istruzzjoni tal- Puregon Pen.
Do not use Puregon if you notice that the solution contains particles or is not clear.
Tużax Puregon jekk tinduna li fis- soluzzjoni hemm xi frak jew li mhix ċara.
What Puregon contains
298 X’ fih Puregon
287 • The other ingredients are sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water for injections.
• Is- sustanza attiva hija follitropin beta, ormon magħruf bħala l- ormon li jistimula l- follikuli (FSH) f 'qawwa ta' 833 IU/ ml soluzzjoni akweja f’ kull stoċċ. • Is- sustanzi l- oħra huma sucrose, sodium citrate, L- methionine, polysorbate 20 u benzyl alcohol f' ilma għall- injezzjonijiet.
What is Pylobactell?
X' inhu Pylobactell?
Pylobactell is a diagnostic test.
Pylobactell huwa test dijanjostiku.
It is available as a kit that includes a white soluble tablet containing 100 mg of the active substance 13C-urea.
Huwa disponibbli f' forma ta 'kitt li jinkludi pillola bajda li tinħall u li fiha 100 mg tas- sustanza attiva 13C- urea.
What is Pylobactell used for?
Għal xiex jintuża Pylobactell?
Pylobactell is used to diagnose Helicobacter pylori (H. pylori) infection in the stomach and duodenum (the part of the gut just below the stomach).
Pylobactell jintuża għad- dijanjożi ta 'l- infezzjoni Helicobacter pylori (H. pylori) fl- istonku u fid - duwodenu (l- ewwel parti tal- musrana żgħira li tiġi dritt taħt l- istonku).
H. pylori is a bacterium that is a factor in diseases such as dyspepsia (heartburn, bloating and nausea), gastritis (inflammation of the stomach) and peptic ulcer disease (ulcers in the stomach or the duodenum).
H. pylori huwa batterju li jikkostitwixxi fattur f' mard bħalma huma d- dispepsija (qrusa ta 'l- istonku, nefħa u nawżea), il- gastrite (infjammazzjoni fl- istonku) u l- ulċera peptika (ulċeri fl- istonku u fid- duwodenu).
How is Pylobactell used?
Kif jintuża Pylobactell?
Pylobactell is a breath test: breath samples are collected in the tubes provided in the kit.
Pylobactell huwa test tan- nifs: il- kampjuni tan- nifs jinġabru f' tubi li jinsabu fil- kitt.
These samples are then sent for analysis at a specialised laboratory.
Dawn il- kampjuni mbagħad jintbagħtu għal analiżi f' laboratorju speċjalizzat.
To carry out the test, the patient must collect six breath samples, three before taking the Pylobactell tablet and three after taking it.
Biex dan it- test isir, il- pazjent għandu jiġbor sitt kampjuni tan- nifs, tlieta qabel ma jieħu l- pillola ta 'Pylobactell u tlieta wara.
The patient should fast for four hours before the test so that it is done on an empty stomach.
Il- pazjent għandu jibqa 'sajjem għal erba' sigħat qabel it- test biex dan isir fuq stonku vojt.
If the patient has eaten a heavy meal then they should fast for six hours before the test.
Jekk il- pazjent ikun kiel ikla tqila, għandu jibqa 'sajjem għal sitt sigħat qabel ma jagħmel it- test.
First, the patient takes a ‘ test meal’ (such as 200 ml of pure undiluted orange juice).
Il- pazjent għandu l- ewwel jiekol 'ikla ta' prova '(pereżempju 200 ml meraq tal- larinġ pur mhux imħallat bl- ilma).
Five minutes later, the patient collects three breath samples.
Wara ħames minuti, il- pazjent jiġbor it- tliet kampjuni tan- nifs.
After a further five minutes, the patient takes the Pylobactell tablet dissolved in water.
Wara ħames minuti oħra, il- pazjenti jieħu l- pillola ta 'Pylobactell maħlula fl- ilma.
Finally, 30 minutes later (40 minutes after the test meal), the patient collects a further three breath samples.
Fl- aħħar, wara 30 minuta (jiġifieri 40 minuta wara l- ikla ta 'prova), il- pazjent jiġbor it- tliet kampjuni tan- nifs oħra.
For full information on how the test is carried out, see the Package Leaflet.
Għal aktar tagħrif dwar kif isir it- test, ara l- Fuljett ta 'Tagħrif.
Pylobactell is not recommended for use in patients below 18 years of age because there is insufficient information on its effectiveness in this group.
Pylobactell mhuwiex rakkomandat għall- użu f' pazjenti taħt l- età tat- 18- il sena minħabba li m' hemmx biżżejjed tagħrif dwar l- effikaċja tal- mediċina f' dan il- grupp.
How does Pylobactell work?
Kif jaħdem Pylobactell?
The active substance in Pylobactell, 13C-urea, is the natural chemical urea that has been labelled with carbon-13 (13C).
Is- sustanza attiva f' Pylobactell, 13C- urea, hija l- urea kimika naturali mmarkata bil- karbonju- 13 (13C).
This means that it contains 13C, a rare form of the carbon atom, instead of carbon-12 (12C), the form that is the most common in nature.
Dan ifisser li fiha 13C, forma rara ta 'l- atomu tal- karbonju minflok karbonju- 12 (12C), l- aktar forma komuni fin- natura.
H. pylori produces enzymes called ureases that break down urea into ammonia and carbon dioxide.
H. pylori jipproduċi enzimi, li jissejħu ureażi (ureases) li jiddekomponu l- urea f' ammonja u f' dijossidu tal- karbonju.
The carbon dioxide is then removed from the body in the breath.
Id- dijossidu tal- karbonju mbagħad jitneħħa mill- ġisem bin- nifs.
Reproduction is authorised provided the source is acknowledged. contained in the Pylobactell tablet is broken down and the carbon dioxide in the breath also contains 13 C.
Reproduction is authorised provided the source is acknowledged. pylori fl- istonku jew fid- duwodenu, 13C- urea li tinsab fil- pillola ta 'Pylobactell tiġi dekomposta u d - dijossidu tal- karbonju fin- nifs ukoll fih 13C.
This 13C-labelled carbon dioxide can be measured by specialised laboratories using a technique called mass spectrometry.
Dan id- dijossidu tal- karbonju mmarkat 13C jista 'jitkejjel minn laboratorji speċjalizzati b' teknika li tissejjaħ "spettrometrija ta' massa".
If there is an increased level of labelled carbon dioxide in the breath sample after 30 minutes (a positive test), the patient may have H. pylori in the stomach or duodenum.
Jekk wara 30 minuta l - kampjun tan- nifs fih livell għoli ta 'dijossidu tal- karbonju mmarkat (test pożittiv), dan ifisser li l - pazjent aktarx għandu infezzjoni minn H. pylori fl- istonku jew fid- duwodenu.
If there is no increased level of labelled carbon dioxide in the breath, the patient might not have H. pylori in the stomach or duodenum.
Jekk in- nifs ma fihx livell għoli ta 'dijossidu tal- karbonju mmarkat, il- pazjent aktarx ma għandux infezzjoni minn H. pylori fl- istonku jew fid- duwodenu.
How has Pylobactell been studied?
Kif ġie studjat Pylobactell?
The data to support the use of Pylobactell comes from two main studies of the use of antibiotics to treat H. pylori infection, where it was used as a test.
Id- dejta li ssostni l- użu ta 'Pylobactell ġejja minn żewġ studji ewlenin dwar l- użu ta' antibijotiċi għat - trattament ta 'l- infezzjoni minn H. pylori, li matulhom intuża bħala test.
A total of 366 patients underwent both a Pylobactell test and a standard biopsy test (where a sample from the stomach is analysed to see if it is infected).
Total ta '366 pazjent ġie sottopost għal test b' Pylobactell u għal bijopsija standard (test li fih jittieħed kampjun mill- istonku biex jiġi analizzat jekk hemmx infezzjoni).
The results obtained were compared to see if they agreed.
Ir- riżultati miksuba tqabblu ma 'xulxin biex tkun eżaminata l- korrispondenza.
What benefit has Pylobactell shown during the studies?
Liema benefiċċju wera Pylobactell waqt l- istudji mwettqa?
Pylobactell was more than 95% sensitive in detecting infection with H. pylori.
Pylobactell irriżulta kellu sensittività ogħla minn 95% biex josserva jekk hemmx infezzjoni minn H. pylori.
What is the risk associated with Pylobactell?
X' inhu r- riskju assoċjat ma 'Pylobactell?
There are no known side effects of the test.
Mhu magħruf l- ebda effett sekondarju fit- test.
Pylobactell should not be used in people who may be hypersensitive (allergic) to 13C-urea or any of the other ingredients in the tablet.
Pylobactell ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal 13C- urea jew għal xi ingredjenti oħra fil- pillola.
Pylobactell should not be used in patients who have, or may have gastric (stomach) infection, which might interfere with the breath test.
Pylobactell ma għandux jintuża f' pazjenti b' infezzjoni gastrika (fl - istonku) aċċertata jew suspettata, li jista 'jinterferixxi mat- test tan- nifs.
Why has Pylobactell been approved?
Għaliex ġie approvat Pylobactell?
The Committee for Medicinal Products for Human Use (CHMP) decided that Pylobactell’ s benefits are greater than its risks for the in vivo diagnosis of gastroduodenal H. pylori infection.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Pylobactell huma ogħla mir- riskji tiegħu fid- dijanjożi in vivo ta' l- infezzjoni gastroduwodenali minn H. pylori.
The Committee recommended that Pylobactell be given marketing authorisation.
Il- Kumitat irrakkomanda li Pylobactell jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Pylobactell:
Aktar tagħrif dwar Pylobactell:
The European Commission granted a marketing authorisation valid throughout the European Union for Pylobactell on 7 May 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq fl- Unjoni Ewropea kollha għal Pylobactell fis- 7 ta 'Mejju 1998.
The marketing authorisation was renewed on 7 May 2003 and on 7 May 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet mġedda fis- 7 ta 'Mejju 2008.
The marketing authorisation holder is Torbet Laboratories Limited.
Id- detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq huwa Torbet Laboratories Limited.
The full EPAR for Pylobactell is available here.
L- EPAR sħiħ għal Pylobactell jista 'jiġi kkonsultat hawn.
Packaging
Il- pakkett Kontenut
EU/ 1/ 98/ 064/ 001 Pylobactell
EU/ 1/ 98/ 064/ 001 Pylobactell 100 mg pillola li tinħall
100 mg
Qartas
Soluble tablet
Pillola waħda f’ kitt tat- test li fih
oral use
Is- sett fih:
Sachet
ħafna komponenti
one tablet in a One test kit contains: multicomponent - 1 sealed sachet containing 1 test kit Pylobactell tablet - 6 glass tubes with caps and bar code labels - 3 additional bar code labels - 30 ml mixing and administration vial. glass, with cap - 2 drinking straws - 1 package leaflet - 1 analysis request form - 1 security label for re-sealing
- Qartas b’ pillola waħda tal- Pylobactell. - Sitt tubi tal- ħġieġ, bit- tappijiet u t - tikketti tal- bar kowd. - tliet tikketti oħra bil- bar kowd. - Kunjett tal- ħġieġ ta ’ 30 ml bit- tapp, biex tħallat u minn fejn tagħti l- prodott. - Żewġ stros. - Fuljett ta ’ tagħrif. - Formola tat- Talba għal Analiżi. - Tikketta tas- Sigurtà
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
Pylobactell 100 mg soluble tablet
Pylobactell 100 mg pillola li tinħall
Each soluble tablet contains 100 mg of 13C-urea
Kull pillola li tinħall fiha 100 mg ta ’ 13C- urea
Soluble tablet.
Pillola li tinħall.
White, biconvex tablet.
Pillola bajda, ibbuzzata fuq iż- żewġ naħat.
For in vivo diagnosis of gastroduodenal Helicobacter pylori (H. pylori) infection.
Għal dijanjosi in vivo ta ’ infezzjoni gastro- duwodenali ta ’ Helicobacter pylori (H. pylori).
The Pylobactell tablet is for oral administration.
Il- pillola Pylobactell tittieħed mill- ħalq.
Adults:
L- Adulti:
The tablet is to be dissolved in water and taken 10 minutes after the start of the breath test procedure.
Il- pillola għandha tinħall fl- ilma u tittieħed 10 minuti wara li tkun bdiet l- proċedura tat- test tan- nifs.
The patient should fast for at least 4 hours before the test so that the test is taken on an empty stomach.
Il- pazjent għandu jsum għal ta ’ l- inqas 4 sigħat qabel it- test biex b’ hekk it- test jittieħed fuq stonku vojt.
If the patient has eaten a heavy meal, then it will be necessary to fast for 6 hours prior to the test.
Jekk il- pazjent ikun kiel ikla tqila, huwa neċessarju li jibqa ’ sajjem għal 6 sigħat qabel it- test.
Pylobactell is not recommended for use in children and adolescents below the age of 18 years due to insufficient data on efficacy.
Pylobactell mhux irrakkomandat għall- użu fit- tfal u adoloxxenti taħt 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar l- effikaċja.
It is important to follow the instructions for use described in section 6.6 adequately, otherwise the validity of the test result will be questionable.
Huwa importanti li ssegwi kif suppost l- istruzzjonijiet għall- użu deskritti f’ sezzjoni 6. 6, inkella l - validità tat- test tkun dubjuża.
The test must not be used in patients with documented or suspected gastric infection that might interfere with the urea breath test.
Dan it- test m’ għandux jintuża f’ pazjenti b’ infezzjonijiet ta ’ l- istonku magħrufa jew issuspettati li jistgħu jfixklu t- test tan- nifs ta ’ l- urea.
4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u l- prekawzjonijiet għall- użu
A positive urea breath test alone does not clinically confirm that eradication therapy is indicated.
It- test tan- nifs ta ’ l- urea pożittiv, waħdu, ma jikkonfermax b’ mod kliniku li t- terapija ta ’ tneħħija kompleta hija indikata.
Alternative diagnosis with invasive endoscopic methods might be indicated in order to examine the presence of any other complicating conditions, e. g. gastric ulcer, autoimmune gastritis and malignancies.
Tista ’ tkun indikata dijanjosi alternattiva b’ metodi endoskopiċi sabiex wieħed jidentifika jekk hemmx xi kondizzjonijiet oħrajn li jikkumplikaw is- sitwazzjoni, eż. ulċera ta ’ l - istonku, gastrite awtoimmuni u mard malinn.
2 In individual cases of atrophic gastritis, the breath test result may have a false positive outcome and other tests may be required to confirm the presence of H. pylori.
F’ każi individwali ta ’ gastrite atrofika, ir- riżultat tat- test tan- nifs jista ’ ikollu riżultat pożittiv falz u jista ’ jkun hemm il- bżonn ta ’ testijiet oħrajn biex jikkonfermaw il- preżenza ta ’ l- H. pylori.
If a repeat test is required, it should not be carried out until the following day.
Jekk ikun hemm bżonn li t- test jiġi ripetut, dan m’ għandux isir qabel il- jum ta ’ wara.
For patients who do not tolerate the recommended test meal, an alternative test meal should be given.
2 Għal dawk il- pazjenti li ma jittollerawx l- ikla tat- test irrakkomandata, għandha tingħata ikla tat- test alternattiva.
Care should be taken in patients where fasting may have medical implications.
Wieħed għandu joqgħod attent f’ pazjenti fejn is- sawm jista ’ ikollu implikazzjonijiet mediċi.
There are insufficient data on the diagnostic reliability of the Pylobactell test to recommend its use in patients with partial gastrectomy and in patients younger than 18 years (see section 4.2).
M’ hemmx informazzjoni biżżejjed dwar il- validità dijanjostika tat- test ta ’ Pylobactell biex l- użu tiegħu jkun irrakkomandat f’ pazjenti b’ gastrektomija parzjali u f’ pazjenti li għandhom inqas minn 18 - il sena (ara sezzjoni 4. 2).
The validity of the test result may be affected if the patient is currently being treated with antibiotics or a proton-pump inhibitor or has completed a course of treatment with these medicinal products.
Il- validità tar- riżultat tat- test tista ’ tkun affettwata jekk bħalissa l- pazjent ikun qed jiġi kkurat bl - antibijotiċi jew b’ inibitur tal- pompa tal- proton jew ikun temm kors ta ’ kura b’ dawn il- prodotti mediċinali.
The results may be affected in general by all treatments interfering with H. pylori status or urease activity.
Ir- riżultati jistgħu jkunu affettwati b’ mod ġenerali b’ kull kura li tinterferixxi ma ’ l- istat ta ’ l- H. pylori jew ma ’ l- attività ta ’ urease.
Suppression of H. pylori might give false negative results.
It- trażżin ta ’ l- H. pylori jista ’ jagħti riżultati negattivi foloz.
Therefore, the test must not be used until four weeks without systemic antibacterial therapy and two weeks after last dose of acid antisecretory agents.
Għalhekk, it- test m’ għandux jintuża qabel erba ’ ġimgħat mingħajr terapija anti- batterika sistematika u ġimgħatejn wara l- aħħar doża ta ’ sustanzi ta ’ kontra l- ħruġ ta ’ l- aċidu.
This is especially important after eradication therapy.
Dan huwa importanti ħafna speċjalment wara t- terapija li tneħħi kollox.
The endogenous production of urea amounts to 25 - 35 g/ day.
Il- produzzjoni endoġenika ta ’ l- urea tammonta għal 25 - 35 g/ jum.
It is therefore unlikely that the dose of 100 mg urea should cause any adverse effect on pregnancy and breast-feeding.
Għalhekk, m’ hux probabbli li d - doża ta ’ 100 mg ta ’ urea għandha toħloq xi effett avvers fuq it- tqala u t- treddigħ.
The Pylobactell test is not expected to be harmful during pregnancy or to the health of the foetus / newborn child.
It- test ta ’ Pylobactell mhux mistenni li jkun ta ’ ħsara waqt it- tqala jew għas- saħħa tal- fetu/ tarbija tat - twelied.
Pylobactell can be used during pregnancy and breast-feeding.
Pylobactell jista ’ jintuża waqt it- tqala u t- treddigħ.
None known.
L- ebda effett mhux mixtieq m’ huwa magħruf.
Overdose is unlikely to occur in the intended clinical circumstances.
F’ ċirkustanzi kliniċi maħsuba m’ hijiex mistennija doża eċċessiva.
No case of overdose has been reported.
Ma ġie rrappurtat l- ebda laż ta ’ doża eċċessiva.
Other diagnostic agents, ATC code:
Kodiċi ATC:
In the case of infection with H. pylori, orally ingested 13C-urea is metabolised by the enzyme urease which is present in H. pylori.
F’ każ ta ’ infezzjoni ta ’ l- H. pylori, il- 13C- urea li tinbela ’ mill- ħalq tiġi metabolizzata mill- enzima, urease li tinsab fl- H. pylori.
The carbon dioxide which is liberated diffuses into the blood vessels and is transported as bicarbonate to the lungs where it is then liberated as 13CO2 in exhaled air.
3 Il- carbon dioxide li joħroġ, jinxtered fil- vini u fl- arterji u jinġarr bħala bikarbonat għall- pulmuni fejn imbagħad jinħeles bħala 13CO2 ma ’ l- arja.
Infection with H. pylori will significantly change the 13C/ 12C - carbon isotope ratio.
L- infezzjoni bl- H. pylori tibdel b’ mod sinifikanti l - proporzjon ta ’ l- isotop tal- carbon 13C/ 12C.
The proportion of 13CO2 in the breath samples may be determined by isotope-ratio-mass spectrometry (IRMS) or by another suitably-validated method carried out by any qualified laboratory, and stated as an absolute difference (excess) in the value between the pre-urea and post-urea breath samples (see section 6.6).
Il- proporzjon tal - 13CO2 fil- kampjuni tan- nifs jista ’ jkun iddeterminat mill- ispettrometrija tal- isotope - ratio- mass (IRMS) jew b’ xi metodu ieħor li kien ippruvat b’ mod xieraq minn kwalunkwe laboratorju kkwalifikat, u ddikjarat bħala d- differenza assoluta (iż- żejjed) fil- valur bejn il- kampjuni tan- nifs ta ’ qabel u ta ’ wara l- urea (ara sezzjoni 6. 6).
The cut off point for discriminating between H. pylori negative and positive patients is set to an excess value of 3.5, i. e. < 3.5 is negative and ≥ 3.5 is positive.
Il- linja li tiddistingwi bejn pazjenti li huma pożittivi jew negattivi għall- H. pylori hija stabbilita bħala l- valur li huwa iżjed minn 3. 5, jiġifieri < 3. 5 huwa negattiv u ≥3. 5 huwa pożittiv.
In comparison with biopsy based techniques for diagnosing H. pylori infection, using data from two therapeutic trials, Pylobactell achieved during different conditions (pre-study and follow-up visits) sensitivity estimates above 95% with lower one-sided 95% confidence limit ranging from 93% to 98%.
Meta mqabbel ma ’ tekniċi bbażati fuq il- bijopsija bħala dijanjożi għall- infezzjoni ta ’ l- H. pylori u meta wieħed juża informazzjoni minn żewġ provi terapewtiċi, il- Pylobactell – f’ kondizzjoniet differenti (l- eżamijiet mediċi ta ’ qabel ma ’ beda l- istudju u dawk ta ’ wara) - laħaq stimi tas- sensittività ta ’ ’ l fuq minn 95% bil- lower one- sided 95% confidence limit bejn 93% sa 98%.
The specificity estimates were all above 90% with corresponding lower confidence limits ranging from 85% to 90%.
L- istimi ta ’ l - ispeċifiċità kienu kollha ’ l fuq minn 90%, bil- lower confidence limits korrispondenti minn 85% sa 90%.
Urea is rapidly absorbed from the gastro-intestinal tract and distributed into extracellular and intracellular fluids including lymph, bile, cerebrospinal fluid and blood.
L- urea hija assorbita malajr mill- passaġ gastrointestinali u tinxtered fil- fluwidi ekstraċellulari u intraċellulari li jinkludu l- lymph, il- bile, il- fluwidu ċerebrospinali u d- demm.
It is reported to cross the placenta and penetrate the eye.
Huwa rrappurtat li l - urea taqsam il- plaċenta u tippenetra l- għajnejn.
It is excreted unchanged in the urine.
Titneħħa mill- ġisem bħala sustanza mhux mibdula fl - awrina.
There are no concerns in relation to the clinical use of the product.
M’ hemm l- ebda tħassib dwar l- użu kliniku tal- prodott.
Povidone (E1201) Microcrystalline cellulose (E460i) Colloidal anhydrous silica Sodium benzoate (E211)
Povidone (E1201) Microcrystalline cellulose (E460i) Colloidal anhydrous silica Sodium benzoate (E211)
The dissolved tablet must be taken immediately.
Il- pillola maħlula għandha tittieħed minnufih.
4 The Pylobactell 13C-urea breath test kit contains a heat-sealed PET/ aluminium foil/ LDPE laminated sachet containing one Pylobactell tablet, six glass tubes with caps and bar code labels, three additional bar code labels, a 30 ml mixing and administration glass vial with cap, two straws, a package leaflet and an Analysis Request Form.
4 tappijiet u tikketti tal- bar kowd, bi tliet tikketti oħra bil- bar kowd, kunjett tal- ħġieġ ta ’ 30 ml bit- tapp fejn tħallat u minn fejn tagħti l- prodott, żewġ stros, fuljett ta ’ tagħrif u Formola tat- Talba għall - Analiżi.
A security label for re-sealing the kit is also provided.
It- tikketta tas- sigurtà biex terġa ’ tissiġilla s- sett hija pprovduta wkoll.
The patient should fast for at least 4 hours before the test so that the test is taken on an empty stomach.
Il - pazjent għandu jsum għal ta ’ l- inqas 4 sigħat qabel it- test biex b’ hekk it- test jittieħed fuq stonku vojt.
If the patient has eaten a heavy meal then it will be necessary to fast for 6 hours prior to the test.
Jekk il- pazjent ikun kiel ikla tqila, ikun hemm bżonn li jsum għal 6 sigħat qabel it- test.
It is recommended that the breath test is performed while the patient is in a seated position.
Huwa rrakkomandat li t- test tan- nifs isir waqt li l- pazjent ikun bilqiegħda.
The Pylobactell breath test procedure includes the administering of a suitable test meal.
Il- proċedura tat- test tan- nifs ta ’ Pylobactell tinkludi l- għoti ta ’ ikla adattata għat- test.
This is not supplied within the box.
Din mhix inkluża fil- kaxxa.
The optimal test meal recommended is 200 ml pure undiluted orange juice.
L- aħjar ikla rrakkomandata għat- test hija 200 ml ta ’ meraq tal- larinġ pur, mhux dilwit.
Sampling instructions
L- istruzzjoniet dwar kif tieħu l- kampjun
t = 0 minutes.
t = 0 minuti.
Note the time the patient drinks the test meal.
Innota l- ħin meta l- pazjent jixrob l- ikla tat- test.
t = 5 minutes.
t = 5 minuti.
Collect pre-urea breath samples.
Iġbor il- kampjuni tan- nifs ta ’ qabel l- urea.
Three tubes of breath are to be taken by breathing normally through a straw held at the base of a small tube (white top).
wieħed jieħu n- nifs b’ mod normali minn ġo stro miżmuma fil- qiegħ ta ’ tubu żgħir (bin- naħa ta ’ fuq bajda).
The patient must expire as the straw is slowly and completely withdrawn from the tube, which is then immediately capped.
Il- pazjent għandu jieħu n- nifs ’ il barra hekk kif l- istro tinġibed ’ il barra bil- mod u kompletament minn ġot- tubu, li mbagħad jingħalaq minnufih bit- tapp.