qanastek/EMEA-V3 huggingface dataset:
Lutropin alfa shows linear pharmacokinetics, as assessed by AUC which is directly proportional to the dose administered.
Lutropin alfa għandhu farmakokinetika lineari, kif jidher mill- AUC li huwa direttament proporzjonali għad- doża li tingħata.
Total clearance is around 2 l/ h, and less than 5% of the dose is excreted in the urine.
It- tneħħija totali mill- ġisem hija madwar 2 l/ siegħa, u inqas minn 5% tad- doża toħroġ ma ’ l- urina.
The mean residence time is approximately 5 hours.
Il- medja tat- tul ta ’ residenza hija ta ’ madwar 5 siegħat.
Following subcutaneous administration, the absolute bioavailability is approximately 60%; the terminal half-life is slightly prolonged.
Wara li jingħata b’ injezzjoni taħt il- ġilda, il- biodisponibbilita assoluta hija ta ’ madwar 60%; il- half - life terminali jdum ftit iżjed.
The lutropin alfa pharmacokinetics following single and repeated administration of lutropin alfa are comparable and the accumulation ratio of lutropin alfa is minimal.
Il - farmakokinetika ta ’ lutropin alfa wara doża waħda jew aktar minn waħda ta ’ lutropin alfa, hija komparabbli u l- accumulation ratio ta ’ lutropin alfa huwa minimu.
There is no pharmacokinetic interaction with follitropin alfa when administered simultaneously.
Ma hemmx interazzjoni farmakokinetika meta follitropin alfa jingħata fl- istess ħin.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, u effett tossiku fuq is- sistema riproduttiva, ma ’ turi l- ebda periklu speċjali għall- bnedmin.
Sucrose Polysorbate 20 Methionine Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Phosphoric acid, concentrated for pH adjustment Sodium hydroxide for pH adjustment
Sukro\ ju Polysorbat 20 Metjonin Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Phosphoric acid, ikkun`entrat sabiex jirran[ a l - pH Sodium hydroxide sabiex jirran[ a l - pH
Water for Injections
Ilma għall- injezzjoni
For immediate and single use following first opening and reconstitution.
Għal użu immedjat u ta ’ darba wara li jintfetaħ u jitħallat.
Store in the original package in order to protect from light.
Aħżen fil- pakkett oriġinali sabiex tipproteġi mid- dawl.
3 ml vials (Type I glass) with a stopper (bromobutyl rubber) and aluminium flip-off cap.
Trab: ampulli ta ’ 3ml (ħġieġ Tip I) b’ tapp (gomma bromobutyl) protett b’ siġill ta ’ l- aluminju u tapp li jfaqqa f’ postu.
1 vial contains 11 micrograms r-hFSH and 3 micrograms r-hLH.
Fjala waħda fiha 11 mikrogrammi r- hFSH u 3 mikrogrammi r- hLH.
3 ml vials (Type I glass) with a Teflon coated rubber stopper and aluminium flip-off cap.
Solvent: ampulli ta ’ 3ml (ħġieġ Tip I) b’ tapp tal- gomma li huwa miksi b’ Teflon u siġill ta ’ l- aluminju u tapp li jfaqqa f’ postu.
1 vial of solvent contains 1 ml of water for injections.
Fjala waħda fiha 1ml ta ’ ilma għall- injezzjoni.
The medicinal product is supplied in pack sizes of 1, 3 and 10 vials with the corresponding number of 1, 3 and 10 vials of solvent.
Il- prodott mediċinali huwa disponibbli f’ pakketti ta ’ 1, 3 u 10 fjali bin- numru indikattiv ta ’ 1, 3 u 10 fjali ta ’ solvent.
6.6 Special precautions for disposal and other handling
Prekawzjonijiet specjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor 6. 6
Pergoveris must be reconstituted with the solvent before use.
Pergoveris għandu jiġi rrikostitwit mas- solvent qabel ma jintuża.
The reconstituted solution should not be administered if it contains particles or is not clear.
Is- soluzzjoni rrikostitwita m’ għandhiex tingħata jekk ikun fiha xi frak jew mhiex ċara.
Pergoveris may be mixed with follitropin alfa and co-administered as a single injection.
Pergoveris jista ’ jiġi rrikostitwit ukoll ma ’ follitropin alfa u jingħataw flimkien bħala injezzjoni waħda.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Dak li jibqa ’ mill- prodott li ma jiġix użat jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Serono Europe Limited 56 Marsh Wall London E14 9TP United Kingdom
56 Marsh Wall London E14 9TP Renju Unit
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
Name and address of the manufacturer of the biological active substances
Isem u indirizz tal- manifattur tas- sustanza bijoloġika attiva
C/ Batanes 1 28760 Tres Cantos (Madrid) Spain
C / Batanes 1 28770 Tres Cantos (Madrid) Spanja
The Marketing Authorisation Holder must ensure that the system of pharmacovigilance is in place and functioning prior to placing the product on the market.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq irid jassigura li hemm sistema ta ’ farmakoviġilanza u li din is- sistema qeda titħaddem qabel il- prodott joħroġ fis- suq.
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1, 3, 10 VIALS OF POWDER AND SOLVENT
13 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TA ’ 1, 3, 10 FJALI U 1, 3, 10 FJALI
Pergoveris 150 IU/ 75 IU powder and solvent for solution for injection.
Pergoveris 150 IU/ 75 IU, trab u solvent għal soluzzjoni għall- injezzjoni.
Follitropin alfa/ lutropin alfa
Follitropin alfa/ lutropin alfa.
STATEMENT OF THE ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA/ I ATTIVA
One vial contains 150 IU (equivalent to 11 micrograms) of follitropin alfa (r-hFSH) and 75 IU (equivalent to 3.0 micrograms) of lutropin alfa (r-hLH).
Ampulla waħda fiha 150 IU (ekwivalenti għal 11 mikrogrammi) ta ’ follitropin alfa (r- hFSH) u 75 IU (ekwivalenti għal 3. 0 mikrogrammi) ta ’ lutropin alfa (r- hLH).
Other ingredients: disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, methionine, polysorbate 20.
Sustanzi mhux attivi: disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, methionine, polysorbat 20.
Sucrose:
Sukrożju:
Solvent: water for injections.
Ara fuljett ta ’ tagħrif qabel l- użu Solvent: ilma għal injezzjonijiet
Powder and solvent for solution for injection.
Trab u solvent g] al soluzzjoni g] all- injezzjoni
1 vial of powder (11 µg r-hFSH and 3 µg r-hLH).
Ampulla 1 ta ’ trab (11 µg r- hFSH u 3 µg r- hLH).
1 vial of solvent (1 ml).
Ampulla 1 ta ’ solvent (1ml).
3 vials of solvent.
3 vjali ta ’ trab 3 vjali ta ’ solvent
10 vials of solvent.
10 vjali ta ’ trab 10 vjali ta ’ solvent
EXP (powder) EXP (solvent)
JIS (trab) JIS (solvent)
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma ntużax għandu jintrema skond il- liġijiet lokali.
1 vial of solvent.
Ampulla waħda ta ’ trab għas- soluzzjoni għall- injezzjoni Ampulla waħda ta ’ solvent
3 vials of solvent.
3 ampulli ta ’ trab għas- soluzzjoni għall- injezzjoni 3 ampulli 1 ta ’ solvent
10 vials of solvent.
10 ampulli ta ’ trab għas- soluzzjoni għall- injezzjoni 10 ampulli 1 ta ’ solvent
16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PERGOVERIS 150 IU/ 75 IU VIAL LABEL
15 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA ’ AMPULLA PERGOVERIS 150/ 75 IU
Pergoveris 150 IU/ 75 IU powder for solution for injection Follitropin alfa/ Lutropin alfa Subcutaneous use
Follitropin alfa/ lutropin alfa.
17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL
16 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA ’ SOLVENT
Solvent for Pergoveris Water for injections
Solvent g] al Pergoveris Ilma għal injezzjoni
PACKAGE LEAFLET
18 FULJETT TA ’ TAGĦRIF:
PERGOVERIS 150 IU/ 75 IU powder and solvent for solution for injection Follitropin alfa/ Lutropin alfa
Pergoveris 150/ 75 IU trab u solvent għal soluzzjoni għall- injezzjoni Follitropin alfa/ lutropin alfa
- If you have any further questions, ask your doctor or pharmacist.
- Jekk għandek aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew l- ispiżjar tiegħek.
Do not pass it on to others.
- Din il- mediċina ġiet mogħtija għall- użu personali tiegħek u m’ għandekx tagħtiha lil persuni
It may harm them, even if their symptoms are the same as yours.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollom l- istess sintomi bħal tiegħek.
Before you use Pergoveris 3.
Qabel ma tuża GONAL- f 3.
How to use Pergoveris 4.
Kif għandek tuża GONAL- f 4.
How to store Pergoveris 6.
Kif taħżen GONAL- f 6.
WHAT PERGOVERIS IS AND WHAT IT IS USED FOR
X’ INHU GONAL- f U GĦALXIEX JINTUŻA
Pergoveris is a medicine containing follitropin alfa and lutropin alfa, which is made in laboratories by special recombinant DNA techniques.
Pergoveris jagħmel parti mill- familja ta ’ ormoni magħrufa bħala gonadotrofini, li huma involuti fil - kontroll normali tar- riproduzzjoni Pergoveris huwa prodott mediċinali li fih follitropin alfa u lutropin alfa, li ġie magħmul f’ laboratorji permezz ta ’ teknika ta ’ DNA rikombinanti..
The medicine should only be used under the strict supervision of a physician.
Dan il- prodott mediċinali għandu jintuża biss taħt sorveljanza mill- qrib ta ’ tabib.
In women who are not ovulating due to very low production of the fertility hormones (FSH and LH) by their pituitary gland, Pergoveris is used to cause ovulation.
F’ nisa li mhumiex jovulaw minħabba li jipproduċu kwantità baxxa ħafna ta ’ ormoni tal- fertilità (FSH u LH) mill- glandola pitwitarja tagħhom, Pergoveris jintuża biex jistimula l- ovulazzjoni.
BEFORE YOU USE PERGOVERIS
QABEL MA TUŻA GONAL- f
Do not use Pergoveris
Tużax Pergoveris
• if you are allergic (hypersensitive) to follicle stimulating hormone, luteinising hormone or any of the other ingredients of Pergoveris, • if you have tumours of the hypothalamus and pituitary gland, • if you have ovarian enlargement or cyst not due to polycystic ovarian disease, • if you have gynaecological bleeding of unknown cause, • if you have ovarian, uterine or breast cancer.
• jekk ġieli kellek xi reazzjonjiet allerġiċi għall- mediċini li fihom l- ormon li jistimula l- follikolu jew għal xi waħda mis- sustanzi mhux attivi • jekk għandek xi tumuri fl- ipotalamu u fil- glandola pitwitarja • jekk l- ovarji huma kbar jew hemm xi ċista li mhix ikkaġunata minn mard poliċistiku ta ’ l- ovarji • għandek xi emorraġija ġinekoloġika li l- kawża tagħha mhix magħrufa • jekk tbati minn kanċer fl- ovarji, utru jew fis- sider
The medicine must not be used when a condition exists which would make a normal pregnancy impossible, such as:
Din il- mediċina m’ għandiex tintuża fejn hemm xi ħaġa li ma tippermettix li sseħħ tqala normali, bħal
• premature menopause, 20 • malformation of sexual organs, • specific tumours of the womb.
• menopawża bikrija • meta jkun hemm difett fiżiku fl- organi sesswali • tumuri speċifiċi fil- ġuf.
Take special care with Pergoveris
19 Oqgħod attenta ħafna b’ GONAL- f:
The use of certain medications may trigger an attack of the illness.
Jekk tbagħti minn porphyria jew għandek storja fil- familja ta ’ porphyria (marda li tista ’ tintiret mill - ġenituri għat- tfal), għandek tgħarraf lit- tabib tiegħek peress illi l- użu ta ’ ċerti mediċini jistgħu jistimulaw xi attakk ta ’ din il- marda.
Tell your doctor if you notice the following:
Tkellem mat- tabib tiegħek jekk tinduna b’ xi ħaġa bħal dawn:
• your skin becoming fragile and easily blistered (especially areas that are frequently exposed to sunlight) • and/ or you have stomach or limb pain.
• l- ġilda tiegħek issir fraġli u faċli jkkollok xi nuffata (speċjalment f’ postijiet li huma spiss esposti għax- xemx) • ikollok uġigħ ta ’ żaqq jew f’ riġlejk.
Your doctor who may recommend that you stop treatment.
It- tabib jista ’ jirrakomandalek li twaqqaf il- kura.
This treatment stimulates your ovaries sometimes leading to excessive growth of the follicles, which may be associated with the risk of excessive increase of ovarian size.
Din il- kura tistimula l- ovarji li xi kultant tista ’ ġġib tkabbir eċċessiv tal- follikuli, li jista ’ jkun assoċjat ma riskju ta ’ żieda eċċessiva tad- daqs ta ’ l- ovarji.
Possible side effects).
Dan jista ’ jirrizulta fis- sindromu ta ’ iperstimulazzjoni ta ’ ovarji (OHSS) (ara sezzjoni 4 - Effetti Oħra).
However, if you are not ovulating and the recommended dose and schedule of administration are adhered to, the occurrence of severe OHSS is uncommon (likely to occur in fewer than 1 in 100 patients).
Madankollu, jekk int m’ intix tovula u qed tieħu d- doża rrakkomandata u l- iskeda ta ’ kif tingħata, mhux komuni li jkun hemm OHSS( inqas minn pazjenta waħda minn kull100).
Pergoveris treatment seldom gives rise to significant OHSS unless the medicine used to induce final follicular maturation (containing human chorionic gonadotrophin - hCG) is administered.
Il- kura bi Pergoveris, rari tagħti lok għal OHSS sinifikanti sakemm ma tingħatax il- mediċina( li fiha l- gonadotrofina korjonika umana – hCG) li tinduċi il - maturita ’ finali tal- follikuli.
Possible side effects) and not to have sexual intercourse or use barrier methods for at least four days.
Għalhekk ikun prudenti li ma jingħatax l - hCG jekk OHSS tkun qed tiżviluppa( ara sezzjoni 4 – Effetti O] ra) u l- pazjenti ma jkollhomx x' jaqsmu mas- sieħeb tagħhom, jew jużaw metodi kontraċettivi ta ’ barriera għal mill- anqas erbat ijiem.
In patients undergoing induction of ovulation, the incidence of multiple pregnancies and births is increased compared with natural conception.
F’ pazjenti li qed ikollhom stimulazzjoni ta ’ l- ovulazzjoni, hemm żieda fir- rata ta ’ tqala u twelid multiplu meta mqabbel ma konċepiment naturali.
However, this can be minimised by using the recommended dose and schedule of administration.
Madankollu, dan jista ’ jitnaqqas jekk tittieħed id - doża rrakomandata u tiġi osservata l- iskeda ta ’ kif għandu jingħata.
To minimise the risk of OHSS or of multiple pregnancy, ultrasound scans as well as oestradiol measurements are recommended.
Sabiex tnaqqas ir- riskju ta ’ OHSS jew ta ’ tqala multipla, skans ta ’ l- ultrasawnd, kif ukoll kejl ta ’ oestradiol huma rrakomandati.
Miscarriages are higher than in the normal population, but comparable with the rates found in women with fertility problems.
Każi ta ’ korriment tat- tqala huma aktar spissi milli fil- popolazzjoni normali, iżda jaqblu mar- rata miksuba f’ nisa bi problemi tal- fertilità.
Women with a history of tubal disease are at risk of pregnancy where the embryo is implanted outside the womb (ectopic pregnancy), whether the pregnancy is obtained by spontaneous conception or with fertility treatments.
Nisa li kellhom mard tat- tubi għandhom riskju li jkollhom tqala fejn l- embriju jiġi impjantat barra mill- ġuf (tqala ektopika), kemm jekk it- tqala tkun minn konċepiment naturali kif ukoll wara kura tal - fertilita ’.
There have been reports of tumors to the ovary and other reproductive organs, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment.
Ma kienx hemm rapporti ta ’ tumuri fl- ovarji u l- organi riproddutivi oħra, la beninni u anqas malinni, f’ nisa li kienu ħadu mediċini għall- infertilita ’.
There have been isolated reports of non-serious allergic reactions to Pergoveris.
Kien hemm rapporti iżolati ta ’ reazzjonijiet allerġiċi mhux serji b’ Pergoveris.
Pergoveris should not be administered as a mixture with other medicinal products in the same injection, except for follitropin alfa, if prescribed by your doctor.
Pergoveris m’ għandux jittieħed bħala taħlita ma ’ prodotti mediċinali oħra fl- istess injezzjoni, ħlief mal- follitropin alfa, jekk inhu preskritt mit- tabib tiegħek.
21 Pregnancy and breast-feeding
Tqala u treddigħ:
Pergoveris is not indicated if you are pregnant or are breast-feeding.
Pergoveris m’ għandux jittieħed jekk int tqila jew jekk qed tredda ’.
Driving and using machines
20 Sewqan u tħaddim ta ’ magni:
No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji fuq l- effett ta ’ Pergoveris fuq il- ħila tas- sewqan u tħaddim ta ’ magni.
Important information about some of the ingredients of Pergoveris
Informazzjoni importanti dwar xi wħud mill- ingredjienti ta ’ Pergoveris
Pergoveris contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially “ sodium-free”.
Pergoveris fih inqas minn 1 mmol sodju (23 mg) għal kull doża, i. e. jista ’ jitqies ‘ mingħajr sodju ’.
Pergoveris contains 30 mg of sucrose per dose.
Pergoveris fih 30 mg ta ’ sukrożju kull doża.
HOW TO USE PERGOVERIS
KIF JINTUŻA PERGOVERIS
Always use Pergoveris exactly as your doctor has told you.
Dejjem għandek tieħu Pergoveris skond il- parir tat- tabib.
Pergoveris is intended for subcutaneous use, that means it is given by injection just under the skin.
Pergoveris huwa għal l- użu taħt il- ġilda, u għalhekk irid jingħata bħala injezzjoni eżatt taħt il- ġilda.
It is for single use only.
Għandu jintuża darba biss.
The usual dose is one vial of Pergoveris used every day for up to three weeks.
Ġeneralment id- doża hija ta ’ fjala waħda ta ’ Pergoveris kuljum sa ’ 3 ġimgħat.
According to your response, your doctor may increase your dose of follitropin alfa by preferably 37.5-75 IU at 7 to 14- day intervals.
Skond l- effett li jkollok, it- tabib tiegħek jista ’ jżid id- doża ta ’ follitropin alfa preferibbilment bi żieda ta ’ 37. 5- 75 IU f’ intervalli ta ’ 7- 14 il- jum.
Your physician may decide to extend your treatment up to 5 weeks.
L- ispeċjalista tieg] ek jista ’ jiddeċiedi li jestendi l- kura tiegħek sa 5 ġimgħat
When the desired response has been obtained, a single injection of hCG is given 24-48 hours after the last injections of Pergoveris.
Meta jinkiseb l- aħjar riżultat, injezzjoni waħda ta ’ mediċina oħra (hCG) tingħata 24- 48 siegħa wara l - aħħar injezzjoni ta ’ Pergoveris.
You are recommended to have sexual intercourse on the day of, and the day following administration of the hCG.
Hu rrakomandat li jkollok x’ taqsam mas- sieħeb tiegħek fil- ġurnata li tkun ħadt t- tieni mediċina, kif ukoll fil- ġurnata ta ’ wara.
Alternatively, intrauterine insemination (IUI) may be performed.
Inkella intrauterine insemination (IUI) tista ’ sseħħ.
Possible side effects).
Jekk ikun hemm rispons eċċessiv, il- kura għandha titwaqqaf u ma jigħatax l- hCG (ara sezzjoni 4 - Effetti oħra li jista ’ jkun hemm).
For the following cycle, your doctor will prescribe follitropin alfa at a lower dose than that of the previous cycle.
Għaċ- ċiklu li jmiss, it- tabib se jagħtik doża anqas ta ’ follitropin alfa minn dik mogħtija fiċ- ċiklu ta’ qabel.
If you administer Pergoveris to yourself, please carefully read the following instructions:
Jekk se tagħti Pergoveris lilek innifsek, jekk jogħġbok aqra sew dawn l- istruzzjonijiet li ġejjin.
• Assemble and lay out on a clean surface everything you need:
• Iġbor u ifrex kull m’ għandek bżonn fuq mejda nadifa:
one vial containing Pergoveris powder one solvent vial two alcohol swabs one syringe one needle for reconstitution and a fine bore needle for subcutaneous injection sharp container
ampulla waħda bit- trab ta ’ Pergoveris ampulla waħda bis- solvent żewġ biċċiet tajjar bl- alkoħol siringa labra li ser tintuża biex tħallat u labra fina għall- injezzjoni taħt il- ġilda kontenitur
• Remove the protective cap from the solvent vial.
l- kap protettiv minn fuq l- ampulla tas- solvent.
22 syringe and draw up some air into the syringe by pulling the plunger to approximately the 1 ml mark.
Waħħal il- labra li se tuża biex tħallat mas- siringa w iġbed ftit arja fis- siringa billi tiġbed il- plunġer sa ’ madwar il- marka ta ’ 1ml.
Then, insert the needle into the vial, push the plunger to expel the air, turn the vial upside down and gently draw up all the solvent.
Daħħal il- labra fil- fjala, imbotta l- plunġer sabiex tneħħi l- arja, dawwar il- fjala taħt fuq u bil- mod iġbed ‘ l fuq is- solvent kollu.
Set the syringe down carefully on the work-surface taking care not to touch the needle.
Poġġi s- siringa fuq il- mejdau oqgħod attent li ma tmissx il - labra.
• Prepare the injection solution:
21 • Ipprepara s- soluzzjoni għall- injezzjoni.
Remove the protective cap from the Pergoveris powder vial, pick up your syringe and slowly inject the solvent into the vial of powder.
Neħħi l- għatu protettiv mill- fjala ta ’ Pergoveris trab, ħu s- siringa f’ idejk u bil- mod, injetta s- solvent fil- fjala bit- trab.
Swirl gently without removing the syringe.
Dawwar il- fjala bil- mod, mingħajr ma tneħħi s- siringa.
Do not shake.
Tqanqalx il- fjala.
After the powder has dissolved (which usually occurs immediately), check that the resulting solution is clear and does not contain any particles.
Wara li t- trab jinħall, (li ssoltu jseħħ immedjatament) ara li s- soluzzjoni hija ċara u li ma fihiex biċċiet.
Turn the vial upside down, gently draw the solution back into the syringe.
Dawwar il- fjala ta ’ taħt fuq, u iġbed bil- mod is - soluzzjoni fis- siringa.
• Change the needle for the fine bore needle and remove any air bubbles:
• Biddel il- labra għal labra fina u neħħi l- bżieżaq ta ’ l- arja.
If you see air bubbles in the syringe, hold the syringe with the needle pointing upwards and gently flick the syringe until all the air collects at the top.
Jekk tara xi bżieżaq ta ’ l- arja fis - siringa, żomm is- siringa bil- labra tipponta ‘ l fuq u bil- mod taptap fuq s- siringa sakemm l- arja kollha tinġabar fuq.
Push the plunger until the air bubbles are gone.
Bil - mod imbotta il- planġer sakemm il- bżieżaq ta ’ l- arja jitilqu.
Wipe the chosen area with an alcohol swab.
Imsaħ il- parti magħżula għall- injezzjoni b’ tajjara mxarrba bl- alkoħol.
Inject the solution by pushing gently on the plunger.
Injetta s- soluzzjoni billi timbotta bil- mod il- planġer.
Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.
Immedjatament iġbed ‘ lura l- labra u naddaf il- ġilda billi timsaħha b' moviment ċirkolari b’ tajjara miblula bl- alkoħol.
Once you have finished your injection, immediately discard all needles and empty glass containers in the sharp container provided.
Hekk kif tkun lestejt l- injezzjoni, immedjatament armi l- labar u l - ampulli vojta kollha fil- kontenitur provdut.
If you use more Pergoveris than you should
Jekk tieħu Pergoveris aktar milli suppost:
The effects of an overdose of Pergoveris are unknown, nevertheless one could expect ovarian hyperstimulation syndrome to occur, which is further described in the Possible side effects Section.
L- effetti ta ’ doża eċċessiva ta ’ Pergoveris mhumiex magħrufa, iżda wieħed jista ’ jistenna li jseħħ is - sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji, li hu deskritt f’ aktar dettall f’ Effetti oħra li jistgħu jiġru.
Before you use Pergoveris).
Madankollu dan jiġri biss jekk jingħata l- hCG (ara s- sezzjoni 2 – Qabel ma tuża Pergoveris).
If you forget to take Pergoveris
Jekk tinsa tieħu Pergoveris
Like all medicines, Pergoveris can cause side effects, although not every body gets them.
Bħal kull mediċina oħra, GONAL- f jista ’ jkollu effetti oħra, għalkemm ma jidhrux fuq kulħadd.
The very commun (likely to occur in more than 1 in 10 patients) reported side effects are:
L- aktar effetti mhux mixtieqa komuni (ngħidu aħna f’ aktar minn 1 fi 10 pazjienti) li kienu rrapurtati huma:
• ovarian cysts • headache
• ċisti fl- ovarji • uġigħ ta ’ ras
Other commun (likely to occur in fewer than 1 in 100 patients) side effects are:
Effetti mhux mixtieqa o] rajn li huma komuni (jistg] u jse]] u f’ inqas minn 1 fi 100 pazjienti) huma:
• abdominal pain • pelvic pain • breast pain • nausea • vomiting • diarrhoea • abdominal cramp • bloating • somnolence (sleepiness) and local reactions at the injection site (pain, redness, itching, bruising, swelling and/ or irritation).
22 • uġigħ fis- sider • dardir • rimettar • dijarrea • brim fiż- żaqq • nefħa addominali • nħas żejjed u reazzjonijiet fejn għamilt l- injezzjoni (uġigħ, ħmura, ħakk, tbenġil, nefħa u/ jew irritazzjoni).
Following treatment with Pergoveris when human chorionic gonadotrophin is administered, a condition called ovarian hyperstimulation syndrome (see 2.
Wara li tingħata l- kura permezz ta ’ Pergoveris, meta tittieħed l- gonadotrofina korjonika umana, tista ’ sseħħ il- kundizzjoni magħrufa bħala s- sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji (ara s- sezzjoni 2.
Before you use Pergoveris) can occur.
Qabel ma tuża Pergoveris).
This syndrome is characterised by large ovarian cysts.
Dan is- sindromu hu kkaratterizzat b’ ċisti kbar fl- ovarji.
The following are first symptoms of ovarian hyperstimulation:
L- ewwel sintomi ta ’ iperstimulazzjoni ta ’ l- ovarji huma:
• pain in the lower abdominal region, possibly in combination with nausea • vomiting and weight gain.
• uġigħ fil- parti t’ isfel ta ’ l- addome, possibbilment flimken ma ’ dardir • remettar u żieda fil- piż.
Should the above mentioned symptoms occur, a careful medical examination is indicated as soon as possible.
Jekk iseħħu dawn is- sintomi, għandu jsir eżamini mediku kemm jista ’ jkun malajr.
In serious, but rare cases (likely to occur in fewer than 1 in 1000 patients), an ovarian hyperstimulation syndrome with clearly enlarged ovaries, can go hand in hand with possible accumulation of fluid in the abdomen or thorax as well as ovarian torsion or more serious thromboembolic complications.
F’ każi serji, iżda rari (jista ’ jiġri f’ inqas minn 1 fi 1000 pazjenti), is- sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji bi tkabbir evidenti ta ’ l- ovarji, jista ’ jwassal, possibbilment, għal akkumulazzjoni ta ’ fluwidu fl- addome jew fit - toraċi, kif ukoll b’ mod aktar serju, komplikazjoniet tromboemboliċi.
In view of the above, to prevent such events, when the ovarian response is excessive, treatment with Pergoveris could be discontinued by your physician and the treatment with hCG abandoned.
B’ kunsiderazzjoni ta ’ dan kollu, biex jiġu evitati tali konsegwenzi, meta l- effett fuq l- ovarji jkun eċċessiv, il- kura bi Pergoveris għandha titwaqqaf mit- tabib tiegħek u l- kura bl- hCG tiġi abbandunata.
Rarely (likely to occur in fewer than 1 in 1000 patients) blood clots in blood vessels (abnormal blood clottings) have been seen to occur with similar medicines. Therefore, this could possibly occur with Pergoveris / hCG therapy.
Meta ntużaw mediċini simili, f’ każi rari (jista ’ jse]] f’ inqas minn 1 fi 1000 pazjenti), kien hemm koagulazzjonijiet tad- demm mhux normali (koagulazzjoniet tad- demm fil- vini jew fl- arterji), u għalhekk dan jista ’ jseħħ ukoll bit- terapija b’ Pergoveris / hCG.
Very rare (likely to occur in fewer than 1 in 10000 patients)cases of allergic reactions to follitropin alfa have occurred causing redness of the skin, rash, swelling, hives and difficulty in breathing.
Kienu rrapurtati każi rari] afna (jista ’ jse]] f’ inqas minn 1 fi 10000 pazjenti) ta ’ reazzjonijiet allerġiċi għal Pergoveris bħal hmura tal- ġilda, raxx, nefħa, irritazzjoni u diffikulta fin- nifs.
These reactions can sometimes be serious.
Dawn ir - reazzjonijiet jistaw xi drabi jkunu serji.
Very rarely (likely to occur in fewer than 1 in 10000 patients) patients with asthma may experience worsening of their condition.
F’ każi rar] afna (jista ’ jse]] f’ inqas minn 1 f’ 10000 pazjent), dawk li jbagħtu minn ażma, tista ’ tmur għall- agħar..
Pregnancy where the embryo is implanted outside the womb (ectopic pregnacy) may occur especially in women with a history of prior tubal disease.
Tqala ektopika (embriju impjantat barra l- ġuf) tista ’ tirriżulta speċjalment f’ nisa li għandhom storja ta ’ mard fit- tubi.
24 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk tinduna b' xi effetti oħra mhux imsemmija f’ dan il- fuljett, jekk jogħġbok avża lit- tabib jew lill - ispiżjar tiegħek.
HOW TO STORE PERGOVERIS
KIF TAĦŻEN GONAL- f
Do not use Pergoveris after the expiry date which is stated on the vials and the carton after EXP.
M’ għandekx tuża wara d- data li jiskadi li tidher fuq l- ampulli.
The medicine must be administered immediately after reconstitution.
Il- mediċina għandha tittieħed immedjatament wara li titħallat.
Do not use Pergoveris if you notice any visible signs of deterioration.
M’ għandekx tuża Pergoveris jekk tara xi sinjali viżibbli ta ’ deterjorazzjoni.
The reconstituted solution should not be administered if it contains particles or is not clear.
Is- soluzzjoni mħallta m’ għandiex tittieħed jekk ikun fiha xi frak jew mhiex ċara.
What Pergoveris contains
X’ fih Pergoveris
The active substances are follitropin alfa and lutropin alfa.
Is- sustanzi attivi huma follitropin alfa u lutropin alfa.
One vial of powder contains 150 IU follitropin alfa and 75 IU lutropin alfa.
Fjala waħda ta ’ trab fiha 150 IU follitropin alfa u 75 IU lutropin alfa.
The other ingredients are sucrose, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide.
Is- sustanzi l- oħra huma sukrożju, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide.
The solvent is water for injections.
Is- solvent huwa ilma għall- injezzjoni.
What Pergoveris looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
Pergoveris is presented as a powder and solvent for solution for injection.
Pergoveris huwa trab u solvent għal soluzzjoni għall- injezzjoni.
One vial of powder contains 150 IU of follitropin alfa and 75 IU of lutropin alfa.
Ampulla waħda ta ’ trab fiha 150 IU ta ’ follitropin alfa u 75 IU lutropin alfa.
The medicine is supplied in packs of 1, 3 and 10 vials with the corresponding number of 1, 3 and 10 vials of solvent.
Fjala waħda ta ’ solvent fiha 1ml ta ’ ilma għall- injezzjoni Il- prodott jiġi f’ pakketti ta ’ 1, 3, 10 ampulli ta ’ trab bl- istess ammont ta ’ 1, 3 u 10 ampulli bis- solvent.
25 Manufacturer
Il- Manifattur
Merck Serono S. p. A, Via delle Magnolie 15, I-70026 Modugno (Bari), Italy
Merck Serono S. p. A, Via delle Magnolie 15, I- 70026 Modugno (Bari), Italy
Danmark E.
24 Nederland Danmark Serono Benelux BV E.
Italia Merck Serono S. p. A.
25 Suomi/ Finland Italia Merck Oy Merck Serono S. p. A.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqa, biex jasal għar- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina.
What is PhotoBarr?
X’ inhu PhotoBarr?
PhotoBarr is a powder that is made up into a solution for injection.
PhotoBarr hu trab li jitħallat biex jifforma soluzzjoni għall- injezzjoni.
It contains the active substance porfimer sodium.
Fih is- sustanza attiva porfimer sodiku (polfimer sodium).
What is PhotoBarr used for?
Għal xiex jintuża PhotoBarr?
PhotoBarr is used in photodynamic therapy (treatment using light) for the ablation (destruction) of high-grade dysplasia (abnormal cells at high risk of turning into cancer) in patients with Barrett’ s oesophagus.
PhotoBarr jintuża fit- terapija fotodinamika (trattament bid- dawl) għall- ablazzjoni ta ’ displażija ta ’ grad għoli (ċelloli anomali b’ riskju kbir li jinbidlu f’ kanċer) f’ pazjenti li jbatu mill- esofagu ta ’ Barrett.
This is a disease where the lining at the lower end of the oesophagus (gullet) has changed because of damage due to acid from the stomach.
Din hi marda fejn il- kisja tal- parti ta ’ isfel tal- esofagu (il- pajp tal- ikel) tkun inbidlet minħabba ħsara kkawżata minn aċidu mill- istonku.
Because the number of patients with Barrett’ s oesophagus is low, the disease is considered ‘ rare’, and PhotoBarr was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 6 March 2002.
Minħabba li n- numru ta ’ pazjenti li jbatu bl- esofagu ta ’ Barrett huwa baxx, din il- marda hija kkonsidrata ‘ rari ’, u PhotoBarr ġie kklassifikat bħala ‘ mediċina orfni ’ (mediċina użata f’ mard rari) fis - 6 ta ’ Marzu 2002.
How is PhotoBarr used?
Kif jintuża PhotoBarr?
Photodynamic therapy with PhotoBarr should be carried out or supervised by a doctor who has experience in laser treatment using an endoscope (a thin tube used to look into the body) and who has been trained in photodynamic therapy.
It- terapija fotodinamika b’ PhotoBarr għandha ssir jew tiġi sorveljata minn tabib li jkollu esperjenza fit- trattament bil- lejżer bl- użu ta ’ endoskopju (tubu rqiq użat biex wieħed jittawwal ġol- ġisem) u li jkun imħarreġ fit- terapija fotodinamika.
Treatment with PhotoBarr is a two-step process: the medicine is given first before it is activated using a laser.
It- trattament b’ PhotoBarr hu proċess b’ żewġ fażijiet: il- mediċina tingħata qabel ma tiġi attivata bil - lejżer.
PhotoBarr is given by slow, careful injection into a vein at a dose of 2 mg per kilogram body weight over three to five minutes.
PhotoBarr jingħata b’ injezzjoni f’ vina bil- mod u b’ attenzjoni b’ doża ta ’ 2 mg kull kilogramma li jiżen il- pazjent u ddum tingħata bejn tlieta u ħames minuti.
Around two days later, the dysplasia, plus small areas of normal tissue above and below it, is illuminated with light from a laser at a specific wavelength using a fibre-optic cable through an endoscope.
Madwar jumejn wara, id- displażija, flimkien ma ’ żoni żgħar ta ’ tessut normali fuqha u taħtha, tiddawwal b’ dawl minn lejżer b’ wavelength speċifiku bl- użu ta ’ kejbil tal- fibra ottika minn ġo endoskopju.
The type of apparatus used, as well as the duration of the illumination, depends on how large the disease area is.
It- tip ta ’ apparat użat, kif ukoll it- tul tat- tidwil, jiddependi minn kemm tkun kbira ż- żona marida.
If necessary, patients may receive a second, shorter laser treatment two to three days later.
Jekk ikun hemm bżonn, il- pazjent jirċievi trattament bil- lejżer ieħor, iqsar minn l- ewwel wieħed, bejn jumejn u tlieta wara.
Up to two additional treatment courses (one injection and one or two laser treatments) can be given, separated by at least three months, as long as the risk of narrowing of the gullet is taken into account.
Jistgħu jingħataw sa żewġ korsijiet ta ’ trattament addizzjonali (injezzjoni u trattament bil- lejżer wieħed jew tnejn), isseparati b’ minn tal- inqas tliet xhur, sakemm jittieħed kont tar- riskju tat- tidjiq tal- pajp tal- ikel.
PhotoBarr should not be used in patients aged below 18 years, because of a lack of information on its safety and effectiveness in this group.
PhotoBarr m’ għandux jingħata lil pazjenti taħt it- tmintax- il sena, minħabba nuqqas ta ’ tagħrif fuq is - sigurtà u l- effikaċja f’ dan il- grupp.
Patients who receive PhotoBarr must be given a special card that summarises the safety information on the medicine.
Il- pazjenti li jingħataw PhotoBarr iridu jingħataw skeda speċjali li tiġbor fiha l- informazzjni dwar is- sigurtà tal- mediċina.
How does PhotoBarr work?
Kif jaħdem PhotoBarr?
The active substance in PhotoBarr, porfimer sodium, is a photosensitising agent (a substance that changes when exposed to light).
Is- sustanza attiva f’ PhotoBarr, porfimer sodiku, hu aġent fotosensitizzanti (sustanza li tinbidel meta tiġi esposta għad- dawl).
When PhotoBarr is injected, porfimer is absorbed into cells throughout the body.
Meta PhotoBarr jiġi injettat, il- porfimer jiġi assorbit fiċ- ċelloli madwar il - ġisem.
When it is illuminated with laser light of a specific wavelength, it is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen called ‘ singlet oxygen’ (a free radical).
Meta jiddawwal b’ dawl tal- lejżer ta ’ wavelength speċifiku, jiġi attivat u jirreaġixxi mal- ossiġnu fiċ- ċelloli biex joħloq tip ta ’ ossiġnu tossiku u reattiv ħafna u magħruf bħala ‘ singlet oxygen ’ (li huwa radikali liberu).
This kills the cells by reacting with and destroying their components, such as their proteins and DNA.
Dan joqtol iċ- ċelloli billi jirreaġixxi magħhom u jeqridilhom il- komponenti tagħhom, bħall- proteini u d- DNA.
By restricting the illumination to the area of dysplasia, only cells in this area are damaged, leaving other areas of the body unaffected.
Bir- restrizzjoni tat- tidwil taż- żona tad- displażija, jinqerdu biss iċ- ċelloli f’ din iż- żona, u ma jaffettwawx partijiet oħra tal- ġisem.
How has PhotoBarr been studied?
Kif ġie studjat PhotoBarr?
PhotoBarr has been studied in one main study involving 208 patients who had Barrett ’ s oesophagus with high-grade dysplasia.
PhotoBarr ġie studjat fi studju wieħed ewlieni li fih ħadu sehem 208 pazjenti li jbatu bl- esofagu ta ’ Barrett b’ displażija ta ’ grad għoli.
The effects of photodynamic therapy with PhotoBarr, used in combination with omeprazole (an antacid medicine), were compared with those of omeprazole alone.
L- effetti tat- terapija fotodinamika ma ’ PhotoBarr, użata flimkien ma ’ omeprazole (mediċina ta ’ kontra l- aċidu), tqabblu ma ’ dawk ta ’ omeprazole waħdu.
The main measure of effectiveness was the number of patients who had no high-grade dysplasia left at least six months after the first course of treatment.
Il- kejl ewlieni tal- kejl tal- effikaċja kien in- numru ta ’ pazjenti li ma kellhomx displażija ta ’ grad għoli tal- inqas sitt xhur wara l- ewwel kors ta ’ trattament.
Patients were followed up for at least two years.
Il- pazjenti ġew sorveljati għal tal- anqas sentejn.
What benefit has PhotoBarr shown during the studies?
X’ inhu l- benefiċċju ta ’ PhotoBarr li ntwera waqt dawn l- istudji?
Adding photodynamic therapy using PhotoBarr to omeprazole treatment increased the number of patients whose dysplasia was destroyed.
Iż- żieda ta ’ PhotoBarr mat- trattament b’ omeprazole żied in- numru ta ’ pazjenti li nqerdet id- displażija tagħhom.
After six months, 72% of the patients using PhotoBarr in combination with omeprazole had no high-grade dysplasia left, compared with 31% of those taking omeprazole alone.
Wara sitt xhur, 72% tal- pazjenti li kienu qed jingħataw PhotoBarr flimkien ma ’ omeprazole ma kellhom l- ebda displażija ta ’ grad għoli, imqabbla ma ’ 31% ta ’ dawk li kienu qed jieħdu omeprazole waħdu.
A similar difference was seen between the two groups after two years.
Dehret differenza simili bejn iż- żewġ gruppi wara sentejn.
What is the risk associated with PhotoBarr?
X’ inhu r- riskju assoċjat ma ’ PhotoBarr?
The most common side effects with PhotoBarr (seen in more than 1 patient in 10) are dehydration, oesophageal stenosis (narrowing of the oesophagus), vomiting, dysphagia (difficulty swallowing), constipation, nausea (feeling sick), photosensitivity reactions (sunburn-like reactions) and pyrexia (fever).
L- iktar effetti sekondarji komuni ma ’ PhotoBarr (li dehru f’ iktar minn pazjent wieħed minn kull għaxra) kienu d- diżidratazzjoni, stenożi tal- esofagu (tidjiq tal- esofagu), remettar, disfaġija (diffikultà biex wieħed jibla ’), stitikezza, nawżea (dardir), reazzjonijiet ta ’ fotosensittività (reazzjonijiet bħal meta wieħed ikun inħaraq bix- xemx) u piressija (deni).
Because it causes difficulty swallowing, including pain, nausea and vomiting, patients should only take liquid food for a few days after laser treatment, and for up to four weeks in some cases.
Billi jwassal għal diffikultà biex wieħed jibla ’, inkluż uġigħ, nawżea u remettar, il- pazjenti għandhom jieħdu biss ikel likwidu għal xi jiem wara t - trattament bil- lejżer, u f’ xi każijiet sa erba ’ ġimgħat wara.
For a more complete list of the side effects reported with PhotoBarr, see the Package Leaflet.
Għal lista iktar kompleta tal- effetti sekondarji rappurtati ma ’ PhotoBarr, ara l- Fuljett ta ’ Tagħrif.
PhotoBarr should not be used in people who may be hypersensitive (allergic) to porfimer sodium and other porphyrins, or to any of the other ingredients.
PhotoBarr m’ għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi (allerġiċi) għall- porfimer sodiku u porfirini oħra jew għal kwalunkwe mill- ingredjenti l- oħra.
PhotoBarr must not be used in patients with porphyria (an inability to break down porphyrins), severe problems with the liver or kidneys, varices (swollen veins) in the oesophagus or stomach, large ulcers in the oesophagus, fistulae (abnormal passageways) between the oesophagus and either the trachea (windpipe) or the bronchi (airways in the lungs), or suspected damage to major blood vessels.
PhotoBarr m’ għandux jintuża f’ pazjenti b’ porfirija (jiġifieri li ma jkunux kapaċi jkissru l- porfirini), bi problemi gravi fil- fwied jew fil- kliewi, vini minfuħa fl- esofagu jew fl- istonku, ulċeri kbar fl- esofagu u fistuli (passaġġi anomali) bejn l - esofagu u t- trakea (il- pajp tan- nifs) jew il- bronki (passaġġi tal- arja fil- pulmuni), jew ħsara suspetta f’ arterji jew vini maġġuri.
As all patients receiving PhotoBarr become more sensitive to light, they should take care to avoid exposure of their skin and eyes to bright light for at least three months after injection.
Billi l- pazjenti kollha li jingħataw PhotoBarr isiru iktar sensittivi għad- dawl, għandhom joqogħdu attenti ħafna biex jevitaw li jesponu għajnejhom u l- ġilda għal dawl qawwi għal tal- anqas tliet xhur wara l- injezzjoni.
Why has PhotoBarr been approved?
Għaliex ġie approvat PhotoBarr?
The Committee for Medicinal Products for Human Use (CHMP) decided that PhotoBarr’ s benefits are greater than its risks when used in photodynamic therapy for the ablation of high-grade dysplasia in patients with Barrett’ s oesophagus.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ PhotoBarr huma ikbar mir- riskji tiegħu meta jintuża fit- terapija fotodinamika għall- ablazzjoni tad - displażija ta ’ grad għoli f’ pazjenti li jbatu bl- esofagu ta ’ Barrett.
The Committee recommended that PhotoBarr be given marketing authorisation.
Il- Kumitat irrakkomanda li PhotoBarr jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of PhotoBarr?
Liema miżuri qegħdin jittieħdu sabiex tiġi assigurata s- sigurtà meta wieħed jieħu PhotoBarr?
The company that makes PhotoBarr is preparing educational materials in agreement with medicines regulatory authorities in Member States.
Il- kumpanija li tipproduċi PhotoBarr qiegħda tħejji materjal edukattiv bi qbil mal- awtoritajiet regolatorji tal- mediċini fl- Istati Membri.
This will ensure that all doctors and pharmacists who will prescribe or dispense the medicine are provided with information packs for healthcare workers and patients.
Dan se jassigura li t- tobba u l- ispiżjara kollha li jippreskrivu jew ibigħu l- mediċina jingħataw ta ’ informazzjoni sabiex iqassmuhom lill- ħaddiema fil- qasam tas - saħħa u l- pazjenti.
The packs will include information on PhotoBarr and how it should be used safely.
Dawn il- pakketti ser jinkludu informazzjoni fuq PhotoBarr u kif dan għandu jintuża b’ mod sigur.
Other information about PhotoBarr:
Tagħrif ieħor dwar PhotoBarr:
The European Commission granted a marketing authorisation valid throughout the European Union for PhotoBarr to Axcan Pharma International B. V. on 25 March 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal PhotoBarr lil Axcan Pharma International B. V. fil- 25 ta ’ Marzu 2004.
The marketing authorisation was renewed on 25 March 2009.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fil- 25 ta ’ Marzu 2009.
2/ 3 The summary of opinion of the Committee for Orphan Medicinal Products for PhotoBarr is available here.
2/ 3 Is- sommarju tal- opinjoni tal- Kumitat għall- Prodotti Mediċinali Orfni għal PhotoBarr huwa disponibbli hawn.
The full EPAR for PhotoBarr can be found here.
L- EPAR sħiħ għal PhotoBarr jista ’ jiġi kkonsultat hawn.
This summary was last updated in 03-2009.
Dan is- sommarju ġie aġġornat l- aħħar fi:
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET LI JRIDU JIĠU IMPLIMENTATI MILL- ISTATI MEMBRI FIR- RIGWARD TAL- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
The Member States shall ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
L- Istati Membri għandhom jiżguraw li l- kundizzjonijiet jew r- restrizzjonijiet kollha fir- rigward tal- użu mingħajr periklu u effettiv tal- prodott mediċinali deskritt hawn isfel huma implimentati:
The Member States shall agree the details educational materials with the MAH according to national regulations and healthcare systems and ensure that it is implemented nationally so that all health care professionals who intend to prescribe and/ or dispense PhotoBarr are provided with the following:
L- Istati Membri għandhom jiftehmu d- dettalji dwar il- materjal edukattiv mad- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq skont ir- regolamenti nazzjonali u s- sistemi ta ’ kura tas- saħħa li għandu jiżgura li dan jiġi implimentat b’ mod nazzjonali sabiex il- professjonisti tal - kura tas- saħħa kollha li jixtiequ jippreskrivu u/ jew jagħtu PhotoBarr ikunu fornuti b’ dan li ġej:
• Prescriber guide • Prescriber slide kit • Healthcare professionals administration and monitoring guide • Patient alert card • Patient guide
Gwida għal min jikteb ir- riċetti Kitt ta ’ slides għal min jikteb ir- riċetti Gwida dwar l- għoti u l- monitoraġġ mill- professjonisti tal- kura tas- saħħa Kard ta ’ alert lil pazjent Gwida tal- pazjent
The following key elements should be included in the educational materials:
Il- gwida ta ’ min jikteb ir- riċetti u l- kitt a ’ slides ta ’ min jikteb ir- riċetti
Prescriber guide and Prescriber slide kit − The educational tools are designed to aid physicians in optimising the benefit-risk ratio of porfimer treatment. − Patients should NOT be treated with porfimer if: o they have severe hepatic disease. o they have trachea or broncho-oesophageal fistulas. o they have suspected erosions of major blood vessels.
L- għodod edukattivi huma maħsuba biex jgħinu lit- tobba sabiex jagħmlu l- aħjar użu fuq il- proporzjon ta ’ siwi- riskju għal trattament ta ’ porfimer.
− Caution should be exercised if patients have moderate hepatic disease
Pazjenti M’ GĦANDHOMX jiu trattati b’ porfimer jekk: o ikollhom mard tal- fwied sever o għandhom fistli fit- trakea jew bronki- esofaġeali o ikollhom tmermir suspettat tal- vażi tad- demm ewlenin.
− Before initiating therapy, o The patient should be screened for skin type o Patients should be aware of the long half-life of porfimer and that the compound gets activated by light. o Patients should avoid being exposed to light for 60-90 days post-exposure. o all patients should know that UV blocking is not effective in blocking visible light which activates porfimer. o Patients should be aware of potential risk factors (skin phototype and hepatic impairment). o Patients should be instructed to seek medical advice if signs/ symptoms suggestive of photosensitivity occur during or after therapy with porfimer.
Kawtela għandha tiġi eżerċitata jekk il- pazjenti ikollhom mard tal- fwied moderat Qabel tinbeda t- terapija, o Il- pazjent għandu jiġi skrinjat għat- tip ta ’ ġilda o Il- pazjenti għandhom ikunu konxji dwar il- half- life twil ta ’ porfimer u li l- kompost jiġi attivat bid- dawl. o Pazjenti għandhom jevitaw li jiġu esposti għad- dawl għal 60- 90 jum wara l- espożizzjoni o Il- pazjenti kollha għandhom ikunu jafu li imblokk bl- UV mhux effettiv biex jimblokka d- dawl viżibbli li jattiva porfimer o Pazjenti għandhom ikunu konxji dwar fatturi ta ’ riskju potenzjali (fototip tal- ġilda u indeboliment epatiku). o Pazjenti għandhom jingħataw struzzjonijiet sabiex ifittxu attenzjoni medika jekk ikun hemm sinjali/ sintomi ta ’ fotosensittività waqt u wara t- terapija b’ porfimer.