qanastek/EMEA-V3 huggingface dataset:
In clinical trials investigating more than 1000 newborns it has been demonstrated that the incidence of congenital malformations in children born after COH treatment using Orgalutran is comparable with that reported after COH treatment using a GnRH agonist.
Fi studji kliniċi li nvestigaw aktar minn 1000 tarbija li għadha kif twieldet, intwera li l- inċidenza ta ’ malformazzjonijiet konġenitali fi tfal li twieldu wara t- trattament COH meta jintuża Orgalutran hi paragunabbli ma dak irrappurtat wara t - trattament COH meta jintuża l- antagonist GnRH.
The safety and efficacy of Orgalutran have not been established in women weighing less than 50 kg or more than 90 kg (see also section 5.1 and 5.2).
L- effikaċja u s- sigurtà ta ’ Orgalutran ma ġewx stabbiliti f ’ nisa li jiżnu anqas minn 50 kg jew aktar minn 90 kg (ara sezzjoni 5. 1 u 5. 2).
No interaction studies have been performed.
Ma sarux studji dwar l- effetti ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott.
The possibility of interactions with commonly used medicinal products, including histamine liberating products, cannot be excluded.
Il- possibbiltà ta ’ interazzjoni ma ’ prodotti mediċinali użati b ’ mod komuni inkluż prodotti li jilliberaw l- istamina, ma tistax tiġi eskluża.
There are no adequate data from the use of ganirelix in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ ganirelix waqt it- tqala.
In animals, exposure to ganirelix at the time of implantation resulted in litter resorption (see section 5.3).
Fl- annimali, esponiment għal ganirelix fiż- żmien ta 'l- impjant rriżulta f' assorbiment mill- ġdid fil- boton (ara sezzjoni 5. 3).
The relevance of these data for humans is unknown.
Ir- relevanza ta 'din l- informazzjoni għal bniedem għadu mhux magħruf.
3 It is not known whether ganirelix is excreted in breast milk.
(ara Sezzjoni 4. 3).
No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji fuq l- effetti fuq il- ħila biex issuq u tħaddem magni.
General disorders and administration site conditions Orgalutran may cause a local skin reaction at the site of injection (predominantly redness, with or without swelling).
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Orgalutran jista ’ jikkaġuna reazzjoni lokali fuq il- ġilda fil- lok tat- tilqima (l- aktar, ħmura b' nefħa jew mingħajr nefħa).
In clinical studies, one hour after injection, the incidence of at least once a moderate or severe local skin reaction per treatment cycle, as reported by patients, was 12% in Orgalutran treated patients and 25% in patients treated subcutaneously with a GnRH agonist.
Fi studji kliniċi, siegħa wara l- injezzjoni, l- inċidenza ta 'l- anqas ta' reazzjoni waħda lokali fil- ġilda, moderata jew serja għal kull ċiklu ta 'trattament, hekk kif kienet irrapportata mill - pazjenti kienet ta' 12% f 'pazjenti trattati b' Orgalutran u 25% f' pazjenti trattati b 'injezzjoni ta' agonista ta 'GnRh taħt il- ġilda.
The local reactions generally disappear within 4 hours after administration.
Ir- reazzjonijiet lokali ġeneralment ma jibqgħux jidhru fi żmien 4 sigħat mit - teħid.
Malaise was reported in 0.3% of patients.
Kien hemm rapporti ta ’ telqa f’ 0. 3% tal- pazjenti.
Immune system disorders Very rarely cases of hypersensitivity reactions including various symptoms such as rash, facial swelling and dyspnoea have been reported among patients administered Orgalutran with FSH.
Disturbi fis- sistema immuni Kien hemm rapporti rari ħafna ta ’ reazzjonijiet ta ’ sensittività eċċessiva nklużi sintomi varji bħal ngħidu aħna raxx, nefħa fil- wiċċ u qtugħ ta 'nifs f’ pazjenti li ngħataw Orgalutran bil- FSH.
Worsening of a pre-existing eczema has been reported in one subject after the first Orgalutran dose.
Kien hemm każ wieħed fejn persuna li kella diġà l- ekżema kellha tħarrix tal- kundizzjoni tagħha wara li ngħatat l- ewwel doża ta 'Orgalutran.
Nervous system disorders Headache (0.4%).
Disturbi fis- sistema nervuża Uġigħ ta ’ ras (0. 4%).
Gastrointestinal disorders Nausea (0.5%).
Disturbi gastro- intestinali Tqallih (0. 5%).
Other reported undesirable effects are related to the controlled ovarian hyperstimulation treatment for ART, notably pelvic pain, abdominal distension, OHSS (see also section 4.4), ectopic pregnancy and spontaneous abortion.
Effetti oħrajn mhux mixtieqa rrapportati li għandhom x ’ jaqsmu mat- trattament ikkontrollat ta 'stimulazzjoni eċċessiva ovarjana ART jinkludu b’ mod notevoli uġigħ fil- pelvis, nefħa ta' żaqq, OHSS (ara sezzjoni 4. 4), tqala barra mill- utru, u abort spontanju.
Overdose in humans may result in a prolonged duration of action.
Doża eċċessiva fil- bniedem tista 'ttawwal l- effett ta' l- azzjoni.
In case of overdose, Orgalutran treatment should be (temporarily) discontinued.
F ’ każ ta ’ doża eċċessiva, it- trattament ta ’ Orgalutran għandu jitwaqqaf (b' mod temporanju).
No data on acute toxicity of Orgalutran in humans are available.
M ’ hemmx informazzjoni dwar tossiċità akuta ta ’ Orgalutran fil- bniedem.
Clinical studies with subcutaneous administration of Orgalutran at single doses up to 12 mg did not show systemic undesirable effects.
Meta doża waħda ta ’ Orgalutran ingħatat taħt il- ġilda waqt studji kliniċi, nstab li ma kien hemm l- ebda effett sistemiku mhux mixtieq, sakemm d- doża laħqet it- 12 mg.
In acute toxicity studies in rats and monkeys non-specific toxic symptoms such as hypotension and bradycardia were only observed after intravenous administration of ganirelix over 1 and 3 mg/ kg, respectively.
4 osservati biss meta ngħatat injezzjoni ġol- vini ta 'ganirelix, b’ doża ta ’ aktar minn 1 u 3 mg/ kg rispettivament.
Pharmacotherapeutic group: anti-gonadotrophin-releasing hormones, ATC code:
Kategorija farmakoterapewtika: ormoni tar- rilaxx ta 'l- anti- gonadotrophin Kodiċi ATC:
Orgalutran is a GnRH antagonist, which modulates the hypothalamic-pituitary-gonadal axis by competitive binding to the GnRH receptors in the pituitary gland.
Orgalutran huwa antagonist ta ’ GnRH u jimmodola l- assi ipotalamika- pitwitarja- gonadali, billi jikkompeti biex jintrabat għar- riċetturi tal- GnRH fil- glandola pitwitarja.
As a result a rapid, profound, reversible suppression of endogenous gonadotrophins occurs, without initial stimulation as induced by GnRH agonists.
Minħabba f’ hekk jkun hemm trażżin veloċi, profond u riversibbli fil- gonadotrophins endoġeni mingħajr ma ’ jkun hemm stimulazzjoni mill- ewwel ikkaġunata minn agonisti tal- GnRH.
Following administration of multiple doses of 0.25 mg Orgalutran to female volunteers serum LH, FSH and E2 concentrations were maximally decreased by 74%, 32% and 25% at 4, 16 and 16 hours after injection, respectively.
Il- valur massimu ta ’ dan it- tnaqqis kien ta ’ 74%, 32% u 25% fir- 4, 16 u 16- il siegħa rispettivament, wara t- tilqima.
Serum hormone levels returned to pre-treatment values within two days after the last injection.
Il- livelli ta 'l- ormoni fis- serum reġgħu ġew kif kienu qabel it- trattament fi żmien jumejn wara li ngħatat l- aħħar injezzjoni.
4 In patients undergoing controlled ovarian stimulation the median duration of Orgalutran treatment was 5 days.
F 'pazjenti li qed jingħataw stimulazzjoni kkontrollata ovarjana il- perijodu medjan tat- trattament b' Orgalutran kien ta '5 t' ijiem.
During Orgalutran treatment the average incidence of LH rises (> 10 IU/ l) with concomitant progesteron rise (> 1 ng/ ml) was 1.2% compared to 0.8% during GnRH agonist treatment.
Waqt it- trattament b 'Orgalutran, l- inċidenza medja taż- żjieda fil- livell tal- LH (> 10 IU/ l) flimkien ma żjieda konkomitanti fil- progesteron (> 1 ng/ ml) kienet ta’ 1. 2% meta mqabbla ma ’ 0. 8% waqt trattament b’ agonist tal- GnRH.
There was a tendency towards an increased incidence of LH and progesterone rises in women with a higher body weight (> 80 kg), but no effect on clinical outcome was observed.
Nisa li għandhom piż ogħla tal- ġisem (> 80 kg), għandhom tendenza ta ’ inċidenza aktar għolja ta ’ żjidiet fil- livelli tal- LH u tal- proġesterone għalkemm ma ġie osservat l- ebda effett fuq ir- riżultat kliniku..
However, based on the small number of patients treated so far, an effect can not be excluded.
Madankollu, msejjes fuq numru żgħir ta 'pazjenti trattati s' issa l- ebda effett ma jista' jiġi eskluż.
Early LH rises, prior to the start of Orgalutran at day 6 of stimulation, did occur especially in high responders, but did not affect the clinical outcome.
Kien hemm xi uħud aktar u aktar dawk li kienu responders għoljin li kellhom żjieda bikrija fl- LH, qabel il- bidu tat- trattament bl- Orgalutran fis - sitt jum ta 'l- istimulazzjoni, iżda madankollu ma ’ ġew effettwati bl- ebda mod ir- riżultati kliniċi.
In these patients LH production was rapidly suppressed after the first Orgalutran administration.
F ’ dawn il- pazjenti, il- produzzjoni tal- LH trażżnet malajr wara l- ewwel għotja ta 'Orgalutran.
In controlled studies of Orgalutran, using a long protocol of GnRH agonist as a reference, treatment with the Orgalutran regimen resulted in a faster follicular growth during the first days of stimulation but the final cohort of growing follicles was slightly smaller and produced on average less oestradiol.
Waqt studji kkontrollati b 'Orgalutran, bl- użu ta' protokolli twal ta ’ agonisti ta ’ GnRH bħala referenza, trattament b' kors ta 'Orgalutran ikkaġuna żvilupp follikulari aktar malajr fl- ewwel jiem ta' l - istimulazzjoni, iżda ir- riżultat finali ta 'ko- orti ta' follikuli li qed jikbru kienu kemm xejn inqas u nixxew bejn wieħed u ieħor anqas oestradiol.
This different pattern of follicular growth, requires that FSH dose adjustments are based on the number and size of growing follicles, rather than on the amount of circulating oestradiol.
Dan il- mod differenti ta ’ żvillupp follikulari, jinħtieġ li aġġustamenti fid- doża tal- FSH tkun msejsa fuq in- numru u d- daqs tal- follikuli li qed jiżviluppaw, u mhux fuq l- ammont ta ’ oestradiol li jkun qed jiċċirkola.
After a single subcutaneous administration of 0.25 mg, serum levels of ganirelix rise rapidly and reach peak levels (Cmax) of approximately 15 ng/ ml within 1 to 2 hours (tmax).
Wara l- għoti ta 'doża waħda ta ’ 0. 25 mg taħt il- ġilda, il- livelli tas- serum ta' ganirelix jgħolew malajr u jilħqu livell massimu (Cmax) ta ’ madwar 15 ng/ ml fi żmien 1 jew 2 (tmax).
The elimination half-life (t½) is approximately 13 hours and clearance is approximately 2.4 l/ h.
Iż- żmien ta 'eliminazzjoni tal - half life (t½) madwar 13- il siegħa u r- rata ta' eliminazzjoni hija madwar 2. 4 l/ h.
Excretion occurs via faeces (approximately 75%) and urine (approximately 22%).
L- eliminazzjoni issir fil- ħmieġ (madwar 75%) u fl- awrina (madwar 22%).
The bioavailability of Orgalutran following subcutaneous administration is approximately 91%.
Il- biodisponibilità ta ’ Orgalutran wara li jingħata taħt il- ġilda hija madwar 91%.
Pharmacokinetic parameters after multiple subcutaneous dosing of Orgalutran (once daily injection) were similar to those after a single subcutaneous dose.
Il- parametri farmakokinetiċi wara aktar minn doża waħda ta ’ Orgalutran taħt il- ġilda (injezzjoni ta 'waħda kuljum) kienu bħal meta ngħatat doża waħda taħt il- ġilda.
After repeated dosing 0.25 mg/ day steady-state levels of approximately 0.6 ng/ ml were reached within 2 to 3 days.
Wara dożi ripettitivi ta ’ 0. 25 mg/ kuljum kien hemm livelli stabbli ta ’ madwar 0. 6 ng/ ml, li ntlaħqu fi żmien 2 sa 3 ijiem.
Pharmacokinetic analysis indicates an inverse relationship between bodyweight and serum concentrations of Orgalutran.
Analiżi farmakokinetika tindika li hemm relazzjoni inversa bejn il- piż tal- ġisem u l - konċentrazzjonijiet ta ’ Orgalutran fis- serum.
Metabolite profile:
Il- profil tal- metaboliti:
The major circulating component in plasma is ganirelix.
Il- komponent ewlieni li jiċċirkola fil- plażma huwa l- ganirelix.
Ganirelix is also the main compound found in urine.
Ganirelix huwa ukoll il- kompownd prinċipali li jinsab fl- awrina.
Faeces only contain metabolites.
Il- ħmieġ jkun fih biss metaboliti.
The metabolites are small peptide fragments formed by enzymatic hydrolysis of ganirelix at restricted sites.
Il- metaboliti huma biċċiet żgħar ta ’ peptidi ffurmati wara l- idrolosi enżimatika fuq il- ganirelix f ’ siti ristretti.
The metabolite profile of Orgalutran in humans was similar to that found in animals.
Il- profil tal- metaboliti ta ’ l - Orgalutran fil- bniedem huwa bħal dak ta ’ l- annimali.
5.3 Preclinical safety data
5 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
Preclinical data reveal no special hazard for humans based on safety pharmacology, repeated dose toxicity and genotoxicity.
Studju qabel l- użu kliniku magħmula fuq studji ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti u effett tossiku fuq il- ġeni ma juri l- ebda periklu speċjali għal- bnedmin.
Reproduction studies carried out with ganirelix at doses of 0.1 to 10 μ g/ kg/ day subcutaneously in the rat and 0.1 to 50 μ g/ kg/ day subcutaneously in the rabbit showed increased litter resorption in the highest dose groups.
Studji fuq is- sistema riproduttiva bil- ganirelix b ’ dożi ta ’ 0. 1 sa 10 μg/ kg/ kuljum taħt il- ġilda fil- far u 0. 1 sa 50 μg/ kg/ kuljum taħt il- ġilda fil- fenek, urew assorbiment mill- ġdid ogħla tal- boton f’ dawk il - gruppi li ngħataw l- ogħla doża.
No teratogenic effects were observed.
Ma ġewx osservati effetti teratoġeniċi.
Acetic acid; Mannitol; Water for injections.
Acetic acid; Mannitol; Ilma għal injezzjoni.
The pH may have been adjusted with sodium hydroxide and acetic acid.
Il- pH seta ’ kien aġġustat b’ sodium hydroxide u acetic acid.
Disposable pre-filled syringes (siliconised Type I glass), containing 0.5 ml of sterile, ready for use, aqueous solution closed with a rubber piston.
Siringi li jintużaw u jistgħu jintremew mimlijin lesti, (ħġieġ silikonizzat Tip I), li fihom 0. 5 ml soluzzjon ta ’ l- ilma li hi sterili u lesta biex tintuża magħluqa b ’ pistun tal- gomma.
Each pre-filled syringe is affixed with a needle closed by a needle shield of natural rubber.
Kull siringa mimlija lesta, għanda labra li hija magħluqa b 'tarka tal- labra tal- gomma naturali.
Supplied in cartons containing 1 or 5 pre-filled syringes.
Fornuti f 'kartun li fihom 1 jew 5 siringi mimlijin lesti.
Inspect the syringe before use.
Spezzjona bir- reqqa s- siringa qabel ma tużaha.
Use only syringes with clear, particle-free solutions and from undamaged containers.
Għandhom jintużaw biss siringi li fihom soluzzjonijiet ċari u mingħajr frak u minn kontenituri bla ħsara.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodottli li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, The Netherlands
Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, l- Olanda
EU/ 1/ 00/ 130/ 001, 1 pre-filled syringe EU/ 1/ 00/ 130/ 002, 5 pre-filled syringes
UE/ 1/ 00/ 130/ 001, 1 siringa mimlija lesta UE/ 1/ 00/ 130/ 002, 5 siringi mimlijin lesti
17 May 2000 Date of last renewal:
17 ta 'Mejju 2000 Data ta ’ l- aħħar aġġornament:
17 May 2005
17 ta ’ Mejju 2005
7 A.
7 ANNESS II
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
KONDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
Organon (Ireland) Ltd, P. O.
Organon (Ireland) Ltd P. O.
Box 2857, Drynam Road, Swords, Co.
Swords, Co.
Organon, Kloosterstraat 6 Postbus 20 5340 BH Oss, The Netherlands.
Organon, Kloosterstraat 6 Postbus 20 5340 BH Oss, L- Olanda
Medicinal product subject to restricted medical prescription (See annex I:
Prodott mediċinali jingħata b’ riċetta ristretta tat- tabib (Ara Anness I:
9 A.
9 ANNESS III
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
TIKKETTA
OUTER CARTON TEXT Orgalutran 1/ 5 pre-filled syringes
KLIEM FUQ IL- KARTUNA TA ’ BARRA Orgalutran 1/ 5 siringi mimlijin lesti
Orgalutran 0.25 mg/ 0.5 ml solution for injection Ganirelix
Orgalutran 0. 25 mg/ 0. 5 ml soluzzjoni għall- injezzjoni Ganirelix
1 pre-filled syringe contains 0.25 mg ganirelix in 0.5 ml aqueous solution
Siringa 1 mimlija lesta li fiha 0. 25 mg ganirelix f' 0. 5 ml soluzzjoni ta ’ l- ilma
Other ingredients: acetic acid and mannitol in water for injections, sodium hydroxide and/ or acetic acid as pH adjustment
Sustanzi oħra: acetic acid u mannitol fl- ilma għall- injezzjonijiet, sodium hydroxide u/ jew acetic acid bħala aġġustament tal- pH
Solution for injection, 1 pre-filled syringe containing 0.5 ml Solution for injection, 5 pre-filled syringes each containing 0.5 ml
Soluzzjoni għall- injezzjoni, 1 siringa mimlija lesta fiha 0. 5 ml Soluzzjoni għall- injezzjoni, 5 siringi mimlijin lesti kull waħda fiha 0. 5 ml
Subcutaneous use Read the package leaflet before use
Użu għal taħt il- ġilda Aqra il- fuljett ta 'tagħrif qabel l- użu.
For single use only.
Għal użu ta 'darba biss.
EU/ 1/ 00/ 130/ 001 1 pre-filled syringe EU/ 1/ 00/ 130/ 002 5 pre-filled syringes
UE/ 1/ 00/ 130/ 001 1 siringa mimlija lesta UE 1/ 00/ 130/ 002 5 siringi mimlijin lesti
12 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
13 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PRE-FILLED SYRINGES TEXT Orgalutran 0.25 mg/ 0.5 ml
TEST FUQ IS- SIRINGI MIMLIJIN LESTI ORGALUTRAN 0. 25 MG/ 0. 5 ml
Orgalutran 0.25 mg/ 0.5 ml solution for injection Ganirelix Subcutaneous use
Orgalutran 0. 25mg/ 0. 5 ml soluzzjoni għall- injezzjoni Ganirelix Użu għal taħt il- ġilda
BN:
Lott:
Read all of this leaflet carefully before you start using this medicine.
Aqra sew dan- il fuljett kollu qabel tibda tuża din il- mediċina
- If you have further questions, ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew spiżjar.
their symptoms are the same as yours.
il- ħsara, anki jekk ikollom l- istess sintomi bħall- tiegħek.
What Orgalutran is and what it is used for 2.
X’ inhu Orgalutran u għalxiex jintuża 2.
Before you use Orgalutran 3.
Qabel ma ’ tuża Orgalutran 3.
How to use Orgalutran 4.
Kif għandek tuża Orgalutran 4.
How to store Orgalutran 6.
Kif taħżen Orgalutran 6.
WHAT ORGALUTRAN IS AND WHAT IT IS USED FOR
X’ INHU ORGALUTRAN U GĦALXIEX JINTUŻA
Orgalutran contains ganirelix, which antagonises the actions of the natural gonadotrophin releasing hormone (GnRH).
Orgalutran fiha ganirelix, li jantagonizza l- azzjonijiet tal- ormon naturali li jeħles il- gonadotrophin (GnRH).
GnRH regulates the release of gonadotrophins (luteinising hormone (LH) and FSH).
GnRH jirregola ir- rilaxx ta 'gonadotrophins (ormon luteinizzanti (LH) u FSH).
Gonadotrophins play an important role in human fertility and reproduction.
Il - gonadotrophins għandhom rwol importanti fil- fertilità u r- riproduzzjoni umana.
In women, FSH is needed for the growth and development of follicles in the ovaries.
Fin- nisa, l- FSH hu meħtieġ għat- tkabbir u l- iżvilupp tal- follikoli fl- ovarji.
Follicles are small round sacs that contain the egg cells.
Il- follikoli huma boroż zgħar u tondi li fihom iċ- ċelluli tal- bajd.
LH is needed to release the mature egg cells from the follicles and ovaries (i. e. ovulation).
LH hu meħtieġ biex joħroġ iċ- ċelluli maturi tal- bajda mill- follikoli u l- ovarji (i. e. ovalazzjoni).
Orgalutran inhibits the action of GnRH, resulting in suppression of the release of especially LH.
Orgalutran jimpedixxi l- azzjoni ta 'GnRH, li jirriżulta fit- trażżin tar- rilaxx, l- aktar ta' LH.
Therapeutic indication:
Indikazzjoni terapewtika:
In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, occasionally ovulation may occur too early causing a significant reduction in the chance of getting pregnant.
Fil- każ ta ’ nisa li jingħataw tekniċi tar- riproduzzjoni assistita, inkluż fertilizzazzjoni in vitro (IVF) u metodi oħra, kultant jiġri li l- ovulazzjoni għandha mnejn isseħħ kmieni wisq u dan jirriżulta fi tnaqqis sinifikanti fiċ- ċans li ssir tqila.
Orgalutran is used to prevent the premature LH surge that might cause such a premature release of egg cells.
Orgalutran huwa intiz biex jimpedixxi ż- żjieda primatura ta 'LH li għandha mnejn twassal għar- rilaxx primatur taċ- ċelluli tal- bajd.
In clinical trials Orgalutran was used with recombinant follicle stimulating hormone (FSH).
Fi provi kliniċi, Orgalutran ntuża ma 'l- ormon rikombinanti li jistimula l- follikulu (FSH).
BEFORE YOU USE ORGALUTRAN
QABEL MA ’ TUŻA ORGALUTRAN
Do not use Orgalutran, − if you are allergic (hypersensitive) to ganirelix or any of the other ingredients of Orgalutran; − if you are hypersensitive to gonadotrophin releasing hormone (GnRH) or a GnRH analogue; − if you have a moderate or severe kidney or liver disease; − if you are pregnant or breast-feeding.
Tieħux Orgalutran: − Jekk int allerġika (tbagħti minn sensittività eċċessiva) għal ganirelix jew għal xi sustanzi oħra ta ’ Orgalutran; − Jekk int tbagħti minn sensittività eċċessiva għall- ormon li jeħles il- gonadotrophin (GnRH) jew sustanza li tixbah il- GnRH; − Jekk int tbagħti minn indeboliment moderat jew serju fil- ħidma tal- kliewi jew tal- fwied; − Jekk int tqila jew qed tredda '.
Take special care with Orgalutran, If you have an allergy.
Oqgħod attent ħafna b' Orgalutran Jekk int għandek xi allerġija.
If you have an active allergic condition, please tell your doctor.
Jekk għandek xi kondizzjoni allerġika attiva, jekk jogħġbok għid lit- tabib tiegħek.
He will decide, depending on the severity, if additional monitoring is required during treatment.
Huwa jiddeċiedi skond is- serjetà tal- każ, jekk hemmx bżonn ta 'sorveljanza addizzjonali għal waqt it- trattament.
15 During or following hormonal stimulation of the ovaries ovarian hyperstimulation syndrome may develop; this syndrome is related to the stimulation procedure with gonadotrophins; please refer to the Package Leaflet of the gonadotrophin-containing medicine prescribed for you.
16 Waqt jew wara l- istimulazzjoni ormonali ta 'l- ovarji, is- sindrome ta' stimulazzjoni eċċessiva ovarjana tista 'tiżviluppa; din is- sindrome hija relattata mal- proċedura ta' stimulazzjoni bil- gonadotrophins; jekk jogħġbok irreferi għal Fuljett ta 'Tagħrif tal- mediċina li fiha l- gonadotrophins mogħtija lilek.
The incidence of congenital malformations after assisted reproduction techniques may be slightly higher than after spontaneous conceptions.
L- inċidenza ta ’ malformazzjonijiet konġenitali wara t- tekniċi tar- riproduzzjoni assistita għandha mnejn tkun kemm kemm ogħla wara konċepiment spontanju.
This slightly higher incidence is thought to be related to characteristics of the patients undergoing fertility treatment (e. g. age of the female, sperm characteristics) and to the higher incidence of multiple gestations after assisted reproduction techniques. The incidence of congenital malformations after assisted reproduction techniques using Orgalutran is not different from that after using other GnRH analogues in the course of assisted reproduction techniques.
L- inċidenza ta ’ malformazzjonijiet konġenitali wara t - tekniċi tar- riproduzzjoni assistita meta jintuża Orgalutran mhix differenti minn dik wara l- użu ta 'analogi oħra GnRH fil- kors tat- tekniċi tar- riproduzzjoni assistita.
There is a slightly increased risk of extra-uterine pregnancy in women with damaged fallopian tubes.
Hemm riskju ħarira ogħla ta ’ tqala barra mill- utru f’ nisa bi ħsara fit- tubi fallopjani.
The efficacy and safety of Orgalutran has not been established in women weighing less than 50 kg or more than 90 kg.
L- effikaċja u sigurtà ta 'Orgalutran ma ġewx stabbiliti għal nisa li jiżnu anqas minn 50 kg jew aktar minn 90 kg.
Ask your doctor for further information.
Staqsi lit- tabib tiegħek għal aktar tagħrif.
Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta
Pregnancy and breast-feeding Orgalutran should be used during controlled ovarian stimulation for assisted reproduction techniques (ART).
Tqala u Treddigħ Orgalutran għandu jintuża matul l- istimulazzjoni kkontrollata ovarjana fil- każ tat- tekniċi tar - riproduzzjoni assistita (ART).
It should not be used during pregnancy and breast-feeding.
M’ għandux jintuża matul it- tqala u t- treddigħ.
Driving and using machines The effects of Orgalutran on ability to drive and use machines have not been studied.
L- effetti ta 'Orgalutran fuq il- ħila ta' sewqan u tħaddim ta 'magni ma ġewx studjati..
HOW TO USE ORGALUTRAN
KIF GĦANDEK TIEĦU ORGALUTRAN
Always use Orgalutran exactly as your doctor has told you.
Dejjem għandek tuża Orgalutran skond il- parir tat- tabib tiegħek.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat - tabib jew l- ispiżjar tiegħek jekk ikollok xi dubju.
Orgalutran is used as part of the treatment for assisted reproduction techniques (ART) including in- vitro fertilisation (IVF).
Orgalutran jintuża bħala parti mit- trattament fit- teknika ta 'riproduzzjoni assistita (ART) inkluż fertilizzazzjoni in vitro (IVF).
Ovarian stimulation with follicle stimulating hormone (FSH) may start at day 2 or 3 of your period.
Stimulazzjoni ovarjana bl- ormon li jistimula l- follikulu (FSH) jista 'jibda fit- 2 jew 3 jum tal- period tiegħek.
Orgalutran (0.25 mg) should be injected just under the skin once daily, starting on day 6 of FSH administration.
Orgalutran (0. 25 mg) għandu jiġi injettat sewwasew taħt il- ġilda, darba kuljum, jibda fis- 6 jum ta 'teħid bl- FSH.
Based on your response to FSH, your doctor may decide to start on another day.
Skond ir- rispons tiegħek għall- FSH, it- tabib tiegħek għandu mnejn jiddeċiedi li jibda f' xi jum ieħor.
However, the preparations should not be mixed and different injection sites are to be used.
Madankollu, il - preparazzjonijiet m’ għandhomx jitħalltu u l- injezzjonijiet għandhom isiru f’ siti differenti.
Final maturation of the egg cells in the follicles can be induced by administering human chorionic gonadotrophin (hCG).
Il- maturazzjoni finali taċ- ċelluli tal- bajd fil- follikuli tista ’ tiġi kkaġunata billi tingħata l - chorionic gonadotrophin tal- bniedem (hCG).
The time between two Orgalutran injections as well as the time between the last Orgalutran injection and hCG injection should not exceed 30 hrs, as otherwise a premature ovulation (i. e. release of egg cells) may occur.
Iż- żmien bejn żewġ injezzjonijiet ta 'Orgalutran, kif ukoll iż- żmien bejn l- aħħar injezzjoni ta' Orgalutran u l- injezzjoni ta 'hCG għandu jkun ta ’ mhux aktar minn 30 siegħa, billi inkella jista' jkun hemm ovulazzjoni prematura (i. e. rilaxx taċ- ċelluli tal- bajd).
Therefore, when injecting Orgalutran in the morning treatment with Orgalutran should be continued throughout the gonadotrophin treatment period including the day of triggering ovulation.
Għaldaqstant meta tingħata injezzjoni ta 'Orgalutran fil- għodu, it- trattament b' Orgalutran irid jissokta waqt il- perijodu tat- trattament bil- gonadotrophin, anke fil- jum ta ’ l- istimulazzjoni ta ’ l- ovulazzjoni.
When injecting Orgalutran in the afternoon the last Orgalutran injection should be given in the afternoon prior to the day of triggering ovulation.
Meta tingħata l- injezzjoni ta 'Orgalutran wara nofsinhar, l- aħħar injezzjoni ta' Orgalutran għandha tingħata wara nofsinhar qabel l- jum ta ’ l- istimulazzjoni ta ’ l- ovulazzjoni.
Orgalutran is supplied in pre-filled syringes and should be injected slowly, just under the skin, preferably in the upper leg.
Orgalutran huwa fornut f' siringi mimlijin lesti u għandu jiġi injettat bil- mod sewwasew taħt il- ġilda, preferibbilment fin- naħa ta 'fuq tar- riġel.
Inspect the solution before use.
Spezzjona sew is- soluzzjoni qabel ma teħodha.
If you administer the injections yourself or have it done by your partner, follow the instructions below carefully.
Tużahiex jekk is- soluzzjoni fiha l- frak jew mhix ċara Jekk tlaqqam lilek nnifsek jew jekk jagħmilhielek is - sieħeb tiegħek, segwi l- istruzzjonijiet ta 'hawn taħt b' attenzjoni.
Do not mix Orgalutran with any other medicines.
Thallatx Orgalutran ma 'mediċini oħra.
16 Instructions for use
17 Struzzjonijiet għal użu
Preparing the injection site Wash your hands thoroughly with soap and water.
Preparazzjoni tas- sit tat- tilqima Aħsel idejk sew bis- sapun u bl- ilma.
Swab the injection site with a disinfectant (for example alcohol) to remove any surface bacteria.
Imsaħ is- sit tat- tilqima b' diżinfettant (per eżempju alkoħol) sabiex jitneħħew xi batterja tal- wiċċ.
Clean about 5 cm (two inches) around the point where the needle will go in and let the disinfectant dry for at least one minute before proceeding.
Naddaf madwar 5 cm (żewġ pulzieri) madwar il- punt fejn il - labra trid tidħol u ħalli d- diżinfettant jinxef għal ta ’ l- anqas minuta qabel ma tipproċedi.
Inserting the needle Remove needle cover.
Dħul tal- labra Neħħi l- għatu tal- labra.
Pinch up a large area of skin between finger and thumb.
Oqros parti sewwa mill- ġilda bejn is- saba 'u s- saba' l- kbir.
Insert the needle at the base of the pinched-up skin at an angle of 45° to the skin surface.
Daħal il- labra fil - bażi tal- ġilda maqrusa f' angolu ta '45° mal- wiċċ tal- ġilda.
Vary the injection site with each injection.
Biddel is- sit tat- tilqima ma 'kull injezzjoni.
Checking the correct needle position Gently draw back the plunger to check if the needle is positioned correctly.
Iċċekjar li l- pożizzjoni tal- labra hi korretta Iġbed lura l- plunġer bil- mod sabiex tiċċekja li l- labra hija pożizzjonata sew.
Any blood drawn into the syringe means the needle tip has penetrated a blood vessel.
Xi demm li jinġibed lura fis- siringa ifisser li r- ras tal- labra ppenetrat xi vina tad- demm.
If this happens, do not inject Orgalutran, but remove the syringe, cover the injection site with a swab containing disinfectant and apply pressure; bleeding should stop in a minute or two.
Jekk jiġri dan, tinjettax Orgalutran, imma neħħi s- siringa, kopri s- sit tat- tilqima b’ msiħ li fih hemm id- diżinfettant u applika l- pressjoni; Id- demm għandu jieqaf joħroġ wara minuta jew tnejn.
Do not use this syringe and dispose of it properly.
Tużax din is- siringa u armiha kif suppost.
Start again with a new syringe.
Ibda mill- ġdid b' siringa ġdida.
Injecting the solution Once the needle has been correctly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin tissues are not damaged.
Injezzjoni tas- soluzzjoni La darba l- labra tinsab fil- post korrett tagħha, agħfas il- plunġer bil- mod u bis- sod, sabiex is- soluzzjoni tiġi njettata sewwa u sabiex ma ssirx ħsara lit- tessuti tal- ġilda.
Removing the syringe Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant.
Tneħħija tas- siringa Iġbed is- siringa ‘ l barra malajr u applika l- pressjoni fuq is- sit tat- tilqima b’ msiħ li fiha id- diżinfettant.
Use the pre-filled syringe only once.
Uża s- siringa mimlija lesta darba biss.
If you use more Orgalutran than you should Contact your doctor.
Ikkuntattja lit- tabib tiegħek.
If you forget to use Orgalutran Do not inject a double dose to make up for a dose.
M' għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you realise that you forgot a dose, administer it as soon as possible.
Jekk tinduna li nsejt tieħu xi doża, ħudha kemm jista 'jkun malajr.
If you are more than 6 hours late (so the time between two injections is longer than 30 hours) administer the dose as soon as possible, and contact your doctor for further advice.
Jekk int aktar minn 6 sigħat tard (sabiex il- ħin bejn iż- żewġ injezzjonijiet huwa aktar minn 30 siegħa) agħti d- doża kemm jista 'jkun malajr u kkuntattja lit- tabib għal aktar parir.
Like all medicines, Orgalutran can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Orgalutran jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In about 1 in 10 patients Orgalutran may cause a local skin reaction at the site of injection (predominantly redness, with or without swelling).
F’ 1 minn kull 10 pazjenti Orgalutran jista ’ jikkaġuna reazzjoni lokali fuq il- ġilda fil- lok tat- tilqima (l - aktar, ħmura b 'nefħa jew mingħajr nefħa).
The local reaction normally disappears within 4 hours of administration.
L- irritazzjoni lokali ġeneralment tisparixxi fi żmien 4 sigħat mit- teħid.
Very rarely, in less than 1 in 10.000 patients, more widespread possibly allergic reactions have been observed.
F ’ każi rari ħafna, f’ inqas minn 1 minn kull 10, 000 pazjent, kienu osservati reazzjonijiet allerġiċi li possibilment kienu aktar mifruxa.
Undesirable effects which may occur are headache, nausea and malaise.
Effetti mhux mixtieqa li għandhom mnejn iseħħu huma uġigħ ta ’ ras u nawsja u telqa tal- ġisem mingħajr l- ebda sinjal ta ’ mard.
These effects occur in less than 1 in 100 patients.
Dawn l- effetti jseħħu f' inqas minn 1 minn kull 100 pazjent.
In addition, undesirable effects are reported which are known to occur with controlled ovarian hyperstimulation treatment (e. g. abdominal pain, ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy and miscarriage (see the patient information leaflet of the FSH-containing preparation you are treated with).
Barra minn hekk, effetti oħrajn mhux mixtieqa huma rrapportati magħrufa li jseħħu mat- trattament ikkontrollat ta 'stimulazzjoni eċċessiva ovarjana eż. uġigħ ta' żaqq, sindrome ta 'l- istimulazzjoni eċċessiva (OHSS), tqala barra mill- utru, u korriment (ara l- fuljett ta' tagħrif tal- preparazzjoni li fiha l - FSH li int trattat għaliha).
17 Worsening of a pre-existing rash (eczema) has been reported in one subject after the first Orgalutran dose.
Kien hemm każ wieħed fejn persuna kellha tħarrix tar- raxx (l- ekżema) li diġà kellha wara li ngħatat l - ewwel doża ta 'Orgalutran.
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.
18 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f' dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE ORGALUTRAN
KIF TAĦŻEN ORGALUTRAN
Keep out of the reach and sight of children Do not use Orgalutran after the expiry date which is stated on the carton and on the label after ‘ EXP :’.
Tużax Orgalutran wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq it- tikketta wara JIS.
The expiry date refers to the last day of that month.
Id- Data ta ’ skadenza tirreferi għall– aħħar ġurnata ta ’ dak ix- xhar.
Inspect the syringe before use.
Spezzjoni s- siringa qabel tużaha.
Use only syringes with clear, particle-free solutions and from undamaged containers.
Uża biss siringi li fihom soluzzjoni ċara mingħajr frak u minn kontenituri bla ħsara.
What Orgalutran contains
X’ fih Orgalutran
- The active substance is ganirelix (0.25 mg in 0.5 ml solution).
− Is- sustanza attiva hi ganirelix (0. 25 mg f' soluzzjoni ta '0. 5 ml) − Is- sustanzi l- oħra huma acetic acid u mannitol fl- ilma għall- injezzjonijiet.
been adjusted with sodium hydroxide and acetic acid.
Il- pH għandu mnejn ikun aġġustat għas- sodium hydroxide u acetic acid.
What Orgalutran looks like and contents of the pack
Id- Dehra ta ’ Orgalutran u l- kontenuti tal- pakkett
Orgalutran is a clear and colourless aqueous solution for injection.
Orgalutran hu soluzzjoni ċara u bla kulur fl- ilma għall- injezzjoni.
The solution is sterile, ready for use and intended for subcutaneous administration.
Is- soluzzjoni hi sterili, lesta għall - użu u intiża biex tingħata taħt il- ġilda.
Orgalutran is available in packs of 1 or 5 pre-filled syringes.
Orgalutran jista ’ jinkiseb f’ pakketti ta ’ 1 jew 5 siringi mimlijin lesti.
N. V.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq; N. V.
Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, the Netherlands.
Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, Olanda
Organon (Ireland) Ltd, P. O.
Organon (Irlanda) Ltd, P. O.
In correspondence please quote the batch number.
Fil- korrispondenza ikkwota n- numru tal- lott.
Questions and answers on the withdrawal of the marketing application for Orplatna
Mistoqsija u Tweġiba dwar l- irtirar ta 'l- applikazzjoni għat- tqegħid fis- suq Orplatna
International non-proprietary name (INN): satraplatin
Denominazzjoni Komuni Internazzjonali (DKI): satraplatin
On 1 August 2008, Pharmion Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Orplatna, for the treatment of patients with metastatic hormone-refractory prostate cancer who have failed prior chemotherapy.
Fl- 1 ta ’ Awwissu 2008, Pharmion Ltd. uffiċjalment għarraf lill- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) li tixtieq tirtira l- applikazzjoni tagħha għall- awtorizzazzjoni tat - tqegħid fis- suq għal Orplatna, użata għat- trattament ta 'pazjenti li b’ kanċer tal- prostata metastatiku refrattorju għall- ormoni li l- kemjoterapija ma ħadmitx fuqhom.
What is Orplatna?
X' inhu Orplatna?
Orplatna is a medicine that contains satraplatin as the active substance.
Orplatna huwa mediċina li fiha satraplatin bħala sustanza attiva.
It was to be available as capsules to be taken by mouth containing 10 or 50 mg satraplatin.
Hija disponibbli f’ kapsuli għat- teħid orali li fihom 10 jew 50 mg satraplatin.
What was Orplatna expected to be used for?
Għal xiex kien mistenni li jintuża Orplatna?
Orplatna was expected to be used to treat prostate cancer.
Orplatna kien mistenni li jintuża għat- trattament tal- kanċer tal- prostata.
This is cancer that affects the prostate gland, the gland below the bladder in men that produces the liquid in the semen.
Dan huwa kanċer li jolqot il - glandola tal- prostata, il- glandola ta ’ taħt il- bużżieqa ta ’ l- awrina fl- irġiel li tipproduċi l- likwidu misjub fis- semen.
The medicine was to be used with prednisone or prednisolone (anti-inflammatory medicines) in patients who had failed to respond to other anti-cancer medicines, when their cancer had spread from the original site to other parts of the body (metastatic) and had been shown to be ‘ hormone-refractory’.
Il- mediċina kellha tintuża ma ’ prednisone jew prednisolone (mediċini antinfjammatorji) f’ pazjenti li ma rrispondewx għal mediċini oħrajn li huma kontra l- kanċer, meta l- kanċer tagħhom infirex mis- sit oriġinali għal partijiet oħra tal- ġisem (metastatiku) u li wera li huwa ‘ refrattorju għall - ormoni ’.
This means that the cancer does not respond to hormonal treatment.
Dan ifisser li l- kanċer tal- prostata ma jirrispondix għall- kura ormonali.
How is Orplatna expected to work?
Kif kien mistenni li jaħdem Orplatna?
The active substance in Orplatna, satraplatin, is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘ platinum compounds’.
Is- sustanza attiva f’ Orplatna, satraplatin, hija mediċina ċitotossika (mediċina li toqtol iċ- ċelloli li jkunu qed jimmoltiplikaw bħaċ- ċelloli tal- kanċer) li jkunu parti mill- grupp ta ’ ‘ komposti tal- platinu ’.
These compounds are made from the metal platinum.
Dawn il- komposti huma magħmula mill- metall tal- platinu.
In the body, satraplatin is expected to attach itself to the DNA within cells, stopping them reproducing.
Huwa mistenni li satraplatin jeħel mad- DNA fiċ - ċelloli u jżommhom milli jirriproduċu fil- ġisem.
As a result, it is expected to stop the growth of tumour cells, which eventually die.
B’ konsegwenza, huwa mistenni li jieqaf it- tkabbir taċ- ċelloli tat- tumur li eventwalment imutu.
The effects of Orplatna were first tested in experimental models before being studied in humans.
L- effetti ta 'Orplatna għall- ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fil - bniedem.
One main study compared the effectiveness of adding Orplatna or placebo (a dummy treatment) to prednisone in 950 patients with metastatic hormone-refractory prostate cancer in whom at least one previous treatment had failed.
Studju prinċipali qabbel l- effikaċja taż- żieda ta ’ Orplatna jew plaċebo (trattament finta) ma ’ prednisone f’ 950 pazjent b’ kanċer tal- prostata metastatiku refrattorju għall- ormoni li fih ta ’ l- anqas trattament preċedenti wieħed ma ħadimx.
The main measure of effectiveness was ‘ progression-free survival’ (the time taken for the disease to get worse) as well as overall survival time.
Il- kejl prinċipali ta ’ l- effikaċja kien il- perjodu ta ’ ‘ sopravivenza mingħajr progressjoni ’ (iż- żmien li l- marda tieħu biex tiggrava) kif ukoll iż- żmien globali ta ’ sopravivenza.
Progression-free survival was measured using a ‘ composite’ method, which means that there was more than one symptom that could be used as a measure.
Il- perjodu ta ’ sopravivenza mingħajr progressjoni tkejjel b’ metodu ‘ kompost ’, li jfisser li kien hemm aktar minn sintomu wieħed li seta ’ jintuża bħala kejl.
In this instance, progression could be measured as the appearance of new tumours as detected during a scan, the appearance of new bone problems, the progression of symptoms (such as pain, weight loss or problems with urination), or death.
F’ dan il- każ, il- progressjoni tista ’ titkejjel kif ifeġġu tumuri ġodda matul l- isken, il- feġġa ta ’ problemi ġodda ta ’ l - għadam, il- progressjoni ta ’ sintomi (bħalma huma wġigħ, telf ta ’ piż jew problemi relatati ta ’ l- awrina) jew mewt.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Fuq il- bażi tar- reviżjoni tad- dokumentazzjoni inizjali, is- CHMP iħejji lista ta 'mistoqsijiet fil- 120 jum, li mbagħad tintbagħat 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. giving an opinion, ask any remaining questions at day 180.
Reproduction is authorised provided the source is acknowledged. lill- kumpanija.
Following the CHMP’ s opinion, it usually takes around two months for the European Commission to grant a licence.
Wara l- opinjoni tas- CHMP, il- Kummissjoni Ewropea normalment iddum madwar xahrejn sakemm toħroġ l - awtorizzazzjoni.
Based on the review of the data and the company’ s response to the CHMP’ s list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Orplatna could not have been approved for the treatment of metastatic hormone-refractory prostate cancer.
Skond l- analiżi tad- dejta u t- tweġiba tal- kumpanija għal- lista ta ’ mistoqsijiet tas- CHMP, fi żmien l - irtirar, is- CHMP kellu xi tħassib u kellu opinjoni proviżorja li Orplatna ma setax jiġi approvat għat - trattament ta ’ kanċer tal- prostata metastatiku refrattorju għall- ormoni.
The CHMP was concerned that the effectiveness of Orplatna had not been sufficiently shown.
Is- CHMP huwa mħasseb li l- effikaċja ta ’ Orplatna ma ġietx murija biżżejjed.
Compared with placebo, Orplatna did not increase overall survival time, and the small improvement seen in progression-free survival was not considered relevant in the absence of a benefit in terms of overall survival time.
Meta mqabbel ma ’ plaċebo, Orplatna ma żiedx iż- żmien ta ’ sopravivenza u l- anqas progress muri fil- perjodu ta ’ sopravivenza mingħajr progressjoni ma kienx ikkonsidrat rilevanti fl- assenza ta ’ benefiċċju f’ termini ta ’ żmien ta ’ sopravivenza globali.
In addition, the CHMP had concerns over the composite measure of progression-free survival which the Committed noted had not been sufficiently justified.
Barra minn dan, is- CHMP kellha konċerni dwar il- kejl kompost ta ’ perjodu ta ’ sopravivenza mingħajr progressjoni li l- Kumitat innota li ma ġietx ġustifikata b’ mod suffiċjenti.
The Committee also noted that docetaxel is the standard first-line treatment for hormone-refractory prostate cancer, and that it is likely that most patients who would benefit from Orplatna treatment would have failed docetaxel treatment.
Il- Kumitat innota wkoll li docetaxel huwa t- trattament standard ta ’ l- ewwel linja għal kanċer tal - prostata metastatiku refrattorju għall- ormoni u li huwa probabbli li l- maġġoranza tal- pazjenti li jistgħu jibbenefikaw mit- trattament Orplatna kienu ġew trattati bi trattament docetaxel u dan ma kienx b’ suċċess.
However, the Committee was concerned that the patients in the main study who had previously treated been with docetaxel had more side effects when taking Orplatna than the patients who had received other medicines for their cancer before the study.
Minkejja dan, il- Kumitat kien konċernat li l- pazjenti fl- istudju prinċipali li kienu ġew ittrattati qabel b’ docetaxel kellhom aktar effetti sekondarji meta ħadu Orplatna meta mqabbla mal - pazjenti li rċevew mediċini oħrajn għal kanċer tagħhom qabel l- istudju.
Therefore, at the time of the withdrawal, the CHMP’ s view was that a benefit of Orplatna had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Għalhekk, fi żmien l- irtirar, l- opinjoni tas- CHMP kienet li l- benefiċċju ta 'Orplatna ma kienx intwera biżżejjed u li kwalunkwe benefiċċju li seta' kellu ma kienu jegħleb ir- riskji identifikati.
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Orplatna?
X' inhuma l- konsegwenzi ta 'l- irtirar għall- pazjenti li kienu qed jieħdu sehem fi provi kliniċi / programmi ta' użu b' kumpassjoni b’ Orplatna?
The company informed the CHMP that Orplatna will continue to be made available for patients included in ongoing clinical trials.
Il- kumpanija infurmat lis- CHMP li Orplatna ser ikun disponibbli għal pazjenti li ħadu sehem fil- provi kliniċi li għadhom għaddejjin.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Jekk inti qed tieħu sehem fi prova kliniku jew fi programm ta 'użu b’ kumpassjoni u tixtieq iżjed tagħrif dwar it- trattament tiegħek, ikkuntattja lit- tabib li jkun qed jagħtik dan it- trattament.
This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport tal- valutazzjoni Pubblika Ewropew (EPAR).
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 għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqa, biex jissodisfa r- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
What is Osigraft?
X’ inhu Osigraft?
Osigraft is a powder to be made up into a suspension for implantation.
Osigraft huwa trab li jista ’ jitħallat biex isir sospensjoni għal impjantazzjoni.
It contains the active substance eptotermin alfa.
Huwa fih is- sustanza attiva eptotermin alfa.
What is Osigraft used for?
Għal xiex jintuża Osigraft?
Osigraft is used to repair fractures of the tibia (shin bone) that have not healed after at least nine months.
Osigraft jintuża biex isewwi ksur tat- tibja (l- għadma tal- qasba tar- riġel) li ma jkunux fiequ wara minn ta ’ l- anqas disa ’ xhur.
It is used in patients who have previously had an autograft (a bone graft taken from their own bone, usually the hip) that has failed or when such a graft is not possible.
Huwa jintuża f’ pazjenti li qabel kellhom awtograft (graft ta ’ l- għadam meħuda mill- għadam tagħhom stess, ġeneralment il- ġenb) li ma tkunx irnexxiet jew meta graft bħal dan mhux possibbli.
It is used in skeletally mature patients (who have stopped growing).
Huwa jintuża f’ pazjenti skelettrikament maturi (li waqfu jikbru).
How is Osigraft used?
Kif jintuża Osigraft?
Osigraft should be used by a qualified surgeon.
Osigraft għandu jintuża minn kirurgu ikkwalifikat.
Immediately before use, Osigraft is mixed with 2 to 3 ml of sodium chloride solution to make up a suspension that has the consistency of wet sand.
Immedjatament qabel l- użu, Osigraft jitħallat ma ’ 2 sa 3 ml ta ’ soluzzjoni ta ’ sodium chloride biex titħallat sospensjoni li għandha l- konsistenza ta ’ ramel imxarrab.
This mixture is then placed by the surgeon directly at the fracture site in contact with the prepared broken bone ends.
Din it- taħlita mbagħad titqiegħed mill- kirurgu direttament fis- sit tal- ksur f’ kuntatt mat - trufijiet ta ’ l- għadam miksur ippreparat.