qanastek/EMEA-V3 huggingface dataset:
In clinical trials, for the detection of thyroid remnants or cancer in ablated patients using a thyroglobulin assay with a lower limit of detection of 0.5 ng/ ml, Thyrogen-stimulated thyroglobulin levels of 3 ng/ ml, 2 ng/ ml and 1 ng/ ml corresponded with thyroglobulin levels after withdrawal of thyroid hormone of 10 ng/ ml, 5 ng/ ml and 2 ng/ ml, respectively.
6 F’ testijiet kliniċi, għall- intraċċar ta ’ fdal tat- tirojde jew kanċer f’ pazjenti asportati permezz ta ’ analiżi ta ’ thyroglobulin b’ livell ta ’ intraċċar ta ’ taħt 0. 5 ng/ ml, livelli ta ’ 3 ng/ ml, 2 ng/ ml u 1ng/ ml ta ’ thyroglobulin stimulat minn Thyrogen kienu jikkorispondu ma ’ livelli ta ’ thyroglobulin wara l- waqfien ta ’ l- ormon ta ’ 10ng/ ml, 5ng/ ml u 2ng/ ml rispettivament.
In these studies the use of thyroglobulin testing on Thyrogen was found to be more sensitive than thyroglobulin testing on TSHT.
F’ dawn l- istudji l- użu tat- testijiet ta ’ thyroglobulin fuq Thyrogen instab li kien aktar sensittiv mit- test ta ’ thyroglobulin fuq TSHT.
Specifically in a Phase III study involving 164 patients the detection rate of tissue of thyroid origin after a Thyrogen thyroglobulin test ranged from 73-87%, whereas, by using thyroglobulin on TSHT it was 42-62% for the same cut-off values and comparable reference standards.
Speċifikament, fi studju ta ’ Fażi III li kien jinvolvi 164 pazjent, ir- rata ta ’ intraċċar b ’ tessuti ta ’ l- oriġini tat- tirojde wara t- test ta ’ thyroglobulin kienet fuq firxa ta ’ 73- 87%, filwaqt, li permezz ta ’ l- użu ta ’ thyroglobulin fuq it- TSHT kienet ta ’ bejn 42- 62% għall- istess valuri minimi u standards ta ’ riferenza komparabbli.
Metastatic disease was confirmed by a post-treatment scan or by lymph node biopsy in 35 patients.
Il- marda metastastika kienet ikkonfermata permezz ta ’ skàn li sar wara t- trattament jew permezz ta ’ bijopsija tal- lymph node f’ 35 pazjent.
Thyrogen-stimulated thyroglobulin levels were above 2 ng/ ml in all 35 patients, whereas, thyroglobulin on THST was above 2 ng/ ml in 79% of these patients.
Il- livelli tat- thyroglobulin stimulati minn Thyrogen kienu ogħla minn 2 ng/ ml fil- 35 pazjent kollha, filwaqt, li t- thyroglobulin fuq it- THST kien ogħla minn 2 ng/ ml f’ 79% ta ’ dawn il- pazjenti.
Pre-therapeutic stimulation In a comparator study involving 60 evaluable low risk patients, the rates of successful ablation of thyroid remnants with 100 mCi radioiodine in post-thyroidectomy patients with thyroid cancer, were comparable for patients treated after withdrawal of THST versus patients treated after Thyrogen administration.
Stimulazzjoni qabel it- terapija Fi studju komparattiv li kien jinvolvi 60 pazjent li huma f’ riskju baxx u li jistgħu jiġu evalwati, ir- rati ta ’ asportazzjoni b’ suċċess ta ’ fdalijiet tat- tirojde b’ 100mCi jodju radjuattiv f’ pazjenti li kellhom tirojdektomija b’ kanċer tat- tirojde, kienu paragunabbli għal pazjenti trattati wara tneħħija ta ’ THST kontra pazjenti trattati wara l- għoti ta ’ Thyrogen.
Patients studied were adults (> 18 years), with newly diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant, characterised, principally (54 of 60), as T1-T2, NO-N1, MO (TNM classification).
Il- pazjenti studjati kienu adulti (> 18- il sena) b’ karċinoma papillari jew follikulari tat- tirojde differenzjata dijanjonizzata riċentement, li tinkludi varjant papillari- follikulari, ikkaraterizzat, prinċipalment (54 minn 60), bħala Ti- T2, NO- N1, MO (klassifikazzjoni TNM).
Success of remnant ablation was assessed with radioiodine imaging and with serum thyroglobulin testing at 8 months after treatment.
Is- suċċess ta ’ asportazzjoni tal- fdal kien assessjat b’ immaġini ta ’ jodju radjuattiv u b’ testijiet ta ’ thyroglobulin fis- serum, 8 xhur wara l- kura.
All 28 patients (100%) treated after withdrawal of THST and all 32 patients (100%) treated after Thyrogen administration had either no visible uptake of radioiodine in the thyroid bed or, if visible, thyroid bed uptake < 0.1% of the administered activity of radioiodine.
It- 28 pazjent (100%) lkoll trattati wara l- waqfien ta ’ THST u t- 32 pazjent (100%) lkoll trattati wara l- għoti ta ’ Thyrogen kellhom jew l- ebda teħid viżibbli ta ’ jodju radjoattiv fil- medda tat- tirojde jew, jekk viżibbli, it- teħid fil- medda tat- tirojde kienet < 0. 1% ta ’ l- attività mogħtija ta ’ jodju radjoattiv.
The success of thyroid remnant ablation also was assessed by the criterion of Thyrogen-stimulated serum Tg level < 2 ng/ ml eight months after ablation, but only in patients who were negative for interfering anti-Tg antibodies.
Is- suċċess ta ’ l- asportazzjoni tal- fdal tat- tirojde kienet assessjata wkoll bil- kriterju tal- livell ta ’ < 2 ng/ ml ta ’ Tg fis- serum stimulat minn Thyrogen tmien xhur wara l- asportazzjoni, imma għal pazjenti li kienu negattivi għall- antikorpi anti- Tg li jinterferixxu biss.
Using this Tg criterion, 18/ 21 patients (86%) and 23/ 24 patients (96%) had thyroid remnants successfully ablated in the THST withdrawal group and the Thyrogen treatment group, respectively.
B’ dan il- kriterju ta ’ Tg, 18/ 21 pazjent (86%) u 23/ 24 pazjent (96%) kellhom asportazzjoni tal- fdal tat- tirojde li rnexxiet fil- grupp ta ’ tneħħija ta ’ THST u fil- grupp ta ’ trattament ta ’ Thyrogen rispettivament.
There is evidence from the literature of lower efficacy of Thyrogen administration compared with withdrawal of THST when using 30 mCi.
Hemm evidenza mill- letteratura medika ta ’ effikaċja mnaqqsa fl- għoti ta ’ Thyrogen meta mqabbla mal - waqfien ta ’ THST meta jintuża 30mCi.
Therefore, efficacy of Thyrogen with doses of 131I < 100 mCi has not been established.
Għalhekk, l- effikaċja ta ’ Thyrogen b’ dożi ta’ 131I < 100mCi ma ġietx stabbilita.
Quality of life was significantly reduced following thyroid hormone withdrawal, but maintained following either dosage regimen of Thyrogen in both indications.
Il- kwalità tal- ħajja kienet tbaxxiet b’ mod sinifikanti wara li twaqqfu l- ormoni tat- tirojde, imma baqgħet miżmuma wara li ngħata reġimen tad- doża ta ’ Thyrogen fiż- żewġ indikazzjonijiet.
The pharmacokinetics of Thyrogen were studied in patients with well-differentiated thyroid cancer following a single 0.9 mg intramuscular injection.
Il- farmakokinetiċi ta ’ Thyrogen kienu studjati f’ pazjenti li kellhom kanċer tat- tirojde li kien differenzjat sewwa wara injezzjoni intermuskolari waħda ta ’ 0. 9 mg.
After injection, the mean peak (C max) level obtained was 116 ± 38 mU/ l and occurred approximately 13 ± 8 hours after administration.
Wara l- injezzjoni, l- ogħla livell medju (Cmax) li ntlaħaq kien ta ’ 116 ± 38 mU/ l u seħħ bejn wieħed u ieħor 13 ± 8 sigħat wara li ngħata.
The elimination half-life was 22 ± 9 hours.
Il- half life ta ’ eliminazzjoni kienet ta ’ 22 ± 9 sigħat.
The major elimination route of thyrotropin alfa is believed to be renal and to a lesser extent hepatic.
Il- passaġġ prinċipali ta ’ l- eliminazzjonit ta ’ thyrotropin alfa hu mifhum li hu renali u fuq livell aktar baxx epatiku.
Non-clinical data are limited, but reveal no special hazard to man from use of Thyrogen.
Tagħrif li mhux kliniku huwa limitat, iżda jidher li m’ hemm l- ebda periklu speċjali għall- bniedem bl- użu ta ’ Thyrogen.
Mannitol Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Sodium chloride
Mannitol Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Sodium chloride
In the absence of compatibility studies, Thyrogen should not be administered as a mixture with other medicinal products in the same injection.
Minħabba li ma sarux studji li juru jekk hemmx kompatibilitajiet ma ’ prodotti oħra, Thyrogen m’ għandux jingħata bħala taħlita ma ’ prodotti mediċinali oħra fl- istess injezzjoni.
Unopened vials 3 years.
Kunjetti mhux miftuħa 3 snin.
Shelf-life after reconstitution It is recommended that the Thyrogen solution be injected within three hours.
Żmien kemm idum tajjeb wara r- rikostituzzjoni Hu rrakkomandat li s- soluzzjoni ta ’ Thyrogen tkun injettata fi żmien tlett sigħat.
The reconstituted solution can be stored for up to 24 hours at a temperature at 2°C - 8°C under protection from light, while avoiding microbial contamination.
Is- soluzzjoni rikostitwita tista ’ tinħażen sa 24 siegħa f’ temperatura ta ’ 2°C - 8°C proteġut mid- dawl, waqt li tkun evitata kontaminazzjoni mikrobijali.
Store in a refrigerator (2°C - 8°C).
Aħżen f’ temperatura ta ’ bejn (2°C - 8°C).
For storage conditions of the reconstituted medicinal product, see section 6.3.
Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa mid- dawl Għall- kundizzjonijiet ta ’ ħażna tal- prodott mediċinali rikonstitwit, ara sezzjoni 6. 3.
Clear Type I glass 5 ml vials.
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
The closure consists of a siliconised butyl stopper with a tamper proof flip-off cap.
L- għatu jikkonsisti minn tapp ta ’ butyl silikonizzat u għandu għatu li ma tistax tbagħbsu u li jinfetaħ b’ daqqa ta ’ saba ’.
Each vial contains 1.1 mg thyrotropin alfa.
Kull kunjett fih 1. 1 mg thyrotropin alfa.
After reconstitution with 1.2 ml water for injection, 1.0 ml of solution (equal to 0.9 mg Thyrogen) is withdrawn and administered to the patient.
Wara r- rikostituzzjoni b’ 1. 2ml ilma għall- injezzjonijiet, 1. 0ml ta ’ soluzzjoni (ugwali għal 0. 9mg Thyrogen) tinġabar u tingħata lill- pazjent.
To provide sufficient volume to allow accurate dispensing, each vial of Thyrogen is formulated to contain an overfill of 0.2 ml.
Biex nipprovdu volum biżżejjed ħalli jkun jista ’ jingħata l- ammont eżatt, kull kunjett ta ’ Thyrogen ikun fih ammont żejjed ta ’ 0. 2ml.
Package size: one and two vials of Thyrogen per carton
Daqs tal- pakkett: kunjett wieħed u żewġ kunjetti ta ’ Thyrogen f’ kull pakkett.
The powder for solution for injection has to be reconstituted with water for injection.
It- trab għal soluzzjoni għall- injezzjoni irid ikun rikostitwit bl- ilma għall- injezzjonijiet.
Only one vial of Thyrogen is required per injection.
Tinħtieġ kunjett ta ’ Thyrogen wieħed biss għal kull injezzjoni.
Each vial of Thyrogen is for single use only.
Kull kunjett ta ’ thyrogen għandu jintuża darba biss.
Add 1.2 ml water for injection to the Thyrogen powder in the vial.
Użu ta ’ Teknika Asettika Żied 1. 2ml ta ’ ilma għal injezzjoni fil- kunjett għat- trab ta ’ Thyrogen.
Swirl the contents of the vial gently until all material is dissolved.
Dawwar bil- mod il- kontenut tal- kunjett sakemm il- materjal jinħall kollu.
Do not shake the solution.
Tħawwadx is- soluzzjoni bis- saħħa.
When the powder is dissolved the total volume in the vial is 1.2 ml.
Meta t- trab jinħall il- volum totali fil- kunjett ikun ta ’ 1. 2ml.
The pH of the Thyrogen solution is approximately 7.0.
Il- pH tas- soluzzjoni ta ’ Thyrogen għandha tkun madwar 7. 0.
Visually inspect the Thyrogen solution in the vial for foreign particles and discoloration.
8 Spezzjona viżwalment is- soluzzjoni ta ’ Thyrogen fil- kunjett biex tara jekk hemmx xi frak u telf ta ’ kulur.
The Thyrogen solution should be a clear, colourless solution.
Is- soluzzjoni ta ’ Thyrogen għandha tkun ċara u trasparenti.
Do not use vials exhibiting foreign particles, cloudiness or discoloration.
Tużax kunjetti li fihom frak, huma makkjati jew li tilfu l- kulur.
Withdraw 1.0 ml of the Thyrogen solution from the product vial.
Iġbed 1. 0ml ta ’ soluzzjoni ta ’ Thyrogen mill- kunjett tal- prodott.
This equals 0.9 mg thyrotropin alfa to be injected.
Dan hu ekwivalenti għal 0. 9mg thyrotropin alfa li jrid jiġi injettat. Thyrogen ma fihx preservattivi.
Thyrogen does not contain preservatives.
Armi s- soluzzjoni li ma gietx użata immedjatament.
There are no special requirements for disposal.
M’ hemmx ħtiġijiet speċjali għar- rimi.
The Thyrogen solution should be injected within three hours, however the Thyrogen solution will stay chemically stable for up to 24 hours, if kept in a refrigerator (between 2°C and 8°C).
Is- soluzzjoni ta ’ Thyrogen għandha tkun injettata fi żmien tlett sigħat, imma s- soluzzjoni ta ’ Thyrogen tibqa ’ kimikalment stabbli sa 24 siegħa, jekk tinżamm fil- friġg (bejn 2°C - 8°C).
It is important to note that the microbiological safety depends on the aseptic conditions during the preparation of the solution.
Hu importanti tinnota li s- sigurtà mikrobijoloġika tiddependi mill- kondizzjonijiet asettiċi matul il- preparazzjoni tas- soluzzjoni.
Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, The Netherlands
Genzyme Europe, B. V., Gooimeer 10, 1411 DD Naarden, l- Olanda
16 March 2005
16 ta ’ Marzu 2005
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Name and address of the manufacturer of the biological active substance(s)
Isem u indirizz tal- manifattur tas- sustanza( i) bijoloġika( ċi) attiva( i)
51 New York Avenue Framingham, MA 01701-9322 USA
Genzyme Corp 51 New York Avenue Framingham, MA 01701- 9322 USA
Genzyme Ltd 37 Hollands Road Haverhill Suffolk CB9 8PU United Kingdom
Genzyme Ltd 37 Hollands Road Haverhill Suffolk CB9 8PU Ir- Renju Unit
OUTER CARTON (PACK OF 1 VIAL)
{KARTUNA TA ’ BARRA (PAKKETT TA ’ KUNJETT 1)
Thyrogen 0.9 mg powder for solution for injection. thyrotropin alfa
Thyrogen 0. 9 mg trab għal soluzzjoni għall- injezzjoni. thyrotropin alfa
Each vial contains 0.9 mg/ ml of thyrotropin alfa when reconstituted with 1.2 ml water for injection.
Kull kunjett fih 0. 9 mg/ ml ta ’ thyrotropin alfa meta jiġi rikostitwit b’ 1. 2 ml ta ’ ilma għall- injezzjonijiet.
Only 1 ml should be withdrawn equal to 0.9 mg of thyrotropin alfa.
1 ml biss għandu jinġibed li hu ejwivalenti għal 0. 9 ta ’ thyrotropin alfa.
Mannitol Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Sodium chloride See leaflet for further information.
Mannitol Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Sodium chloride Ara l- fuljett għal aktar tagħrif.
1 vial of powder for solution for injection.
Kunjett 1 ta ’ trab għal soluzzjoni għall- injezzjoni.
For intramuscular injection only.
Għal fini ta ’ injezzjoni intramuskolari biss.
Administration within 3 hours after reconstitution.
L- għoti għandu jsir fi żmien 3 sigħat mir- rikostituzzjoni.
Store in a refrigerator (2°C - 8°C).
Aħzen fi friġġ (2°C - 8°C).
For single use only.
Użah darba biss.
Gooimeer 10 1411 DD Naarden The Netherlands
Gooimeer 10 1411 DE Naarden l- Olanda
INSTRUCTIONS ON USE
Prodott mediċinali jingħata bir- riċetta tat- tabib.
OUTER CARTON (PACK OF 2 VIALS)
{KARTUNA TA ’ BARRA (PAKKETT TA ’ 2 KUNJETTI)}
Only 1 ml should be withdrawn equal to 0.9 mg of thyrotropin alfa.
1 ml biss għandu jinġibed li hu ekwivalenti għal 0. 9 ta ’ thyrotropin alfa.
2 vials of powder for solution for injection equal to 2 doses to be administered at a 24-hour interval.
2 kunjetti tat- trab għas- soluzzjoni għall- injezzjoni jiġu daqs 2 dożi mogħtija f' intervalli ta '24 siegħa.
Store in a refrigerator (2°C-8°C) Keep the vial in the outer carton.
Żomm il- kunjett fil- kartuna ta ’ barra.
18 16.
18 16.
Thyrogen 0.9 mg powder for solution for injection. thyrotropin alfa Intramuscular use.
Thyrogen 0. 9 mg trab għal soluzzjoni għall- injezzjoni. thyrotropin alfa Użu għal ġol- muskoli.
INFORMATION FOR THE USER Thyrogen 0.9 mg powder for solution for injection thyrotropin alfa
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Thyrogen 0. 9 mg mg trab għal soluzzjoni għall- injezzjoni. thyrotropin alfa
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • 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.
Jista ’ jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Thyrogen is and what it is used for 2.
X’ inhu Thyrogen u għalxiex jintuża 2.
Before you use Thyrogen 3.
Qabel ma tuża Thyrogen 3.
How to use Thyrogen 4.
Kif għandek tuża Thyrogen 4.
How to store Thyrogen 6.
Kif taħżen Thyrogen 6.
WHAT THYROGEN IS AND WHAT IT IS USED FOR
X’ INHU THYROGEN U GĦALXIEX JINTUŻA
Thyrotropin alfa is human thyroid stimulating hormone produced by recombinant DNA technology.
Thyrotropin alfa hu ormon li jistimula t- tirojde umana u jiġi magħmul mit- teknoloġija tad- DNA rikombinant.
Thyrotropin alfa stimulates thyroid tissue to take up iodine and produce thyroglobulin (Tg) and thyroid hormones (triiodothyronine (T3) and thyroxine (T4)).
Thyrotropin alfa jistimula t- tessut tat- tirojde biex jieħu l- jodju u jipproduċi thyroglobulin (Tg) u ormoni tat- tirojde (triiodothyronine (T3) u thyroxine (T4)).
Thyrogen (thyrotropin alfa) is to be used with serum thyroglobulin (Tg) testing with or without radioiodine imaging.
Thyrogen (thyrotropin alfa) għandu jintuża mat- testijiet tat- thyroglobulin (Tg) fis- serum ma ’ jew mingħajr l- immaġini ta ’ jodju radjuattiv.
These tests are used to detect certain types of thyroid cancer in patients who have had their thyroid gland removed and who are taking thyroid hormones.
Dawn it- testijiet jintużaw biex jiddeterminaw jekk hemmx ċerti tipi ta ’ kanċer tat- tirojde fil- pazjenti li tneħħitilhom il- glandola tat- tirojde u li qegħdin jieħdu ormoni tat- tirojde.
Low risk patients with well-differentiated thyroid carcinoma who have undetectable Tg levels while taking thyroid hormone and no increase of Tg levels despite stimulation with thyrotropin alfa may be followed-up by using thyrotropin alfa for Tg level determination.
Pazjenti li għandhom riskju baxx u li għandhom karċinoma tat- tirojde li hi differenzjata sewwa u li għandhom livelli tat- Tg, li mhumiex traċċabbli waqt li qed jieħdu l- ormon tat- tirojde, u l- ebda żjieda tal- livelli tat- Tg minkejja stimulazzjoni b’ thyrotropin alfa għandhom mnejn jerġgħu jiġu osservati permezz ta ’ thyrotropin alfa sabiex jiġi stabbilit il- livell ta ’ Tg.
To eliminate (ablate) the thyroid tissue left over after surgical removal of the thyroid gland (remnant) in low risk patients, Thyrogen (thyrotropin alfa) is to be used with radioiodine treatment while you continue taking your thyroid hormone.
Sabiex jitneħħa (asportazzjoni) il- fdal tat- tessut tat- tirojde li jitħalla wara t- tneħħija kirurġika tal- glandola tat- tirojde (fdal) f’ pazjenti li jinsabu f’ riskju baxx, Thyrogen (thyrotropin alfa) għandu jintuża ma ’ trattament ta ’ jodju radjoattiv waqt li int tkompli tieħu l- ormon tat- tirojde.
Your treatment should be supervised by a doctor who has expertise in thyroid cancer.
Il- kura tiegħek għandha tkun taħt l- osservazzjoni ta ’ tabib li hu speċjalizzat fil- kanċer tat- tirojde.
BEFORE YOU USE THYROGEN
QABEL MA TUŻA THYROGEN
Do not use Thyrogen You should tell your doctor, if you have ever had an allergic reaction (for example, rash or itchiness) to bovine or human thyroid stimulating hormone (TSH), or any of the other ingredients before you take this medicine.
Tużax Thyrogen Int għandek tgħarraf lit- tabib tiegħek, jekk int qatt kellek reazzjoni allerġika (per eżempju raxx jew ħakk) għall- ormoni li jistimulaw it- tirojde (TSH) ta ’ l- ifrat jew tal- bniedem, jew xi wieħed mis- sustanzi l- oħra qabel ma tieħu din il- mediċina.
You should not use Thyrogen during pregnancy.
M’ għandekx tuża Thyrogen waqt it- tqala.
22 Take special care with Thyrogen The injection with Thyrogen should never be injected into a vein.
22 Oqgħod attent ħafna b ’ Thyrogen L- injezzjoni b’ Thyrogen qatt m’ għandha tiġi injettata ġol- vina Effett fuq l- iżvilupp tat- tumur F’ pazjenti li għandhom il- kanċer tat- tirojde, l- iżvilupp tat- tumur ġie rapportat waqt il- waqfien ta ’ ormoni tat- tirojde għal proċeduri dijanjostiċi.
This was thought to be related to the elevated thyroid stimulating hormone (TSH) levels over a longer period.
Kien maħsub li dan hu relatat mal- livell ogħla ta ’ ormon li jistimula t- trojde (TSH) fuq perijodu itwal.
It is possible that Thyrogen may also cause tumour growth.
Huwa possibbli li Thyrogen jista ’ jikkaġuna wkoll l- iżvilupp ta ’ tumur.
In clinical trials this was not seen.
Fi provi kliniċi dan ma seħħx.
Due to elevation of TSH levels after Thyrogen, patients with metastases can experience local swelling or bleeding at the site of these metastases.
Minħabba l- livelli ogħla ta ’ TSH wara it- teħid ta ’ Thyrogen, pazjenti b’ metastasi jista ’ jkollhom nefħa lokali jew emorraġija fis- sit ta ’ dawn il- metastasi.
As a result the metastases may become bigger.
Bħala riżultat il- metastasi tista ’ tikber.
If the metastases are present in narrow spaces e. g. intracerebral (in the brain) or in the spinal cord, patients could experience acute symptoms such as hemiparesis (partial paralysis effecting one side of the body) or loss of vision.
Jekk il- metastasi tkun preżenti fi spazji dojoq eż. intraċerebrali (fil- moħħ) jew fis- sinsla tad- dahar, il- pazjenti jista ’ jkollhom sintomi akuti bħal emiparesi (paralisi parzjali li taffettwa naħa waħda tal- ġisem) jew telf tal- vista.
Your doctor will decide if you belong to a specific group of patients for which pre-treatment with corticosteroids is to be considered (for example, patients with intracerebral or spinal cord metastases).
It- tabib tiegħek ser jiddeċiedi jekk intix wieħed minn dawk il- pazjenti li għandhom mnejn ikollhom bżonn jieħdu kortikosterojdi qabel il- kura (per eżempju pazjenti li għandhom metastasi intraċerebrali jew fis- sinsla tad- dahar).
Please speak to your doctor about this if you have concerns.
Jekk jogħġbok tkellem mat- tabib tiegħek dwar dan jekk tħossok inkwetat.
Using other medicines There are no known drug interactions with the thyroid hormones you may be taking.
Meta tuża mediċini oħra M’ hemmx interazzjonijiet magħrufa ma ’ l- ormoni tat- tirojde li tista ’ tkun qed tieħu.
Your nuclear medicine physician will determine the exact activity of radioiodine to use for the radioiodine imaging or ablation, taking into consideration the fact that you continue to take thyroid hormones.
It- tabib tiegħek tal- mediċina nuklejari ser jiddetermina l- attività eżatta tal- jodju radjuattiv għall- immaġini bil- jodju radjuattiv jew asportazzjoni, u ser iqies il- fatt li int ser tibqa ’ tieħu ormoni tat- tirojde.
Pregnancy You should not use Thyrogen during pregnancy.
Tqala M’ għandekx tuża Thyrogen matul it- tqala.
Please consult your doctor if you are pregnant.
Jekk jogħġbok itlob il- parir tat- tabib tiegħek jekk int tqila.
Breast-feeding You should not use Thyrogen while breastfeeding.
Treddigħ M’ għandekx tuża Thyrogen waqt li tkun qed tredda.
Breast-feeding should only be resumed following advice from your doctor.
Int għandek terġa ’ tibda tredda biss wara li tingħata parir mit- tabib tiegħek.
Important information about some of the ingredients of Thyrogen This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i. e. essentially ‘ sodium- free’.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Thyrogen Dan il- prodott mediċinali fih inqas minn 1 mmol sodju (23 mg) f’ kull injezzjoni, i. e essenzjalment mingħajr sodju.
HOW TO USE THYROGEN
KIF GĦANDEK TUŻA THYROGEN
The Thyrogen powder must be dissolved in water for injection.
It- trab ta ’ Thyrogen irid jinħall fl- ilma għall- injezzjonijiet.
Only one vial of Thyrogen is required per injection.
Hemm bżonn kunjett wieħed biss ta ’ Thyrogen għal kull injezzjoni.
The injection must be given intra-muscularly.
L- injezzjoni trid tingħata ġol- muskolu.
Your doctor, nurse or pharmacist will prepare the injection for you.
It- tabib, l- infermiera jew l- ispiżjar tiegħek ser jippreparaw l- injezzjoni tiegħek.
For instructions see bottom of leaflet.
Għall- istruzzjonijiet ara l- parti t’ isfel tal- fuljett.
23 How much Thyrogen?
23 Kemm Thyrogen?
The recommended dose of Thyrogen is two doses of 0.9 mg thyrotropin alfa administered at a 24-hour interval.
Id- doża rrakkomandata ta 'Thyrogen hi żewġ dożi ta' 0. 9 mg thyrotropin alfa mogħtija f' intervall ta '24 siegħa.
Your doctor or nurse will inject 1.0 ml of the Thyrogen solution (0.9 mg thyrotropin alfa).
It- tabib jew l- infermiera tiegħek ser tinjetta 1. 0 ml ta 'soluzzjoni ta' Thyrogen (0. 9 mg thyrotropin alfa).
Thyrogen should only be administered into the buttock muscle.
Thyrogen għandu jingħata biss fil- muskolu tal- warrani.
Thyrogen solution should never be injected into a vein.
Is- soluzzjoni ta 'Thyrogen qatt m' għandha tkun injettata f' vina.
Your child’ s doctor will decide if Thyrogen should be given to your child.
It- tabib tat- tifel/ tifla tiegħek ser jiddeċiedi jekk Thyrogen għandux jingħata lit- tifel/ tifla tiegħek.
Do not mix Thyrogen with other medicines in the same injection.
Tħallatx Thyrogen ma 'mediċini oħra fl- istess injezzjoni.
If you have reduced liver function you should still be able to receive Thyrogen.
Jekk għandek funzjoni mnaqqsa tal- fwied int xorta waħda tista 'tirċievi Thyrogen.
If you have kidney disease and require dialysis, your doctor will decide how much Thyrogen to give to you.
Jekk tbati minn mard tal- kliewi u għandek bżonn id- dijalisi, it- tabib tiegħek ser jiddeċiedi kemm Thyrogen għandek tingħata.
You may have more chance of experiencing headache and nausea after receiving Thyrogen.
Għandu mnejn għandek aktar ċans tħoss uġigħ ta 'ras u dardir wara li tingħata Thyrogen.
If you have reduced kidney function your doctor will decide how much radioiodine to give you.
Jekk għandek funzjoni mnaqqsa tal- kliewi it- tabib tiegħek ser jiddeċiedi kemm għandek tingħata jodju radjoattiv.
When you undergo radioiodine imaging or ablation, your doctor will give you radioiodine 24 hours after your final Thyrogen injection.
Meta tesperjenza immaġni bil- jodju radjuattiv jew ablazzjoni, it- tabib tiegħek ser jagħtik jodju radjuattiv 24 siegħa wara l- injezzjoni finali ta 'Thyrogen.
Diagnostic scintigraphy should be performed 48 to 72 hours after the radioiodine administration (72 to 96 hours after the final injection of Thyrogen), whereas post-therapy scintigraphy may be delayed additional days to allow background activity to decline.
Ix- xjentigrafija dijanjostika għandha ssir fi żmien 48 sa 72 siegħa wara l- għoti ta 'jodju radjuattiv (72 sa 96 siegħa wara l- aħħar injezzjoni ta' Thyrogen), waqt li x- xintigrafija ta 'wara t- terapija għandha mnejn tkun postposta għal aktar ġranet biex tippermetti t- tnaqqis ta' l- attività ta 'l- isfond.
For serum thyroglobulin (Tg) testing, your doctor or nurse will take a serum sample 72 hours after the last injection of Thyrogen.
Fil- każ ta 'l- ittestjar ta' thyroglobulin (Tg), it- tabib jew l- infermiera tiegħek ser jieħdu kampjun tas- serum 72 siegħa wara l- aħħar injezzjoni ta 'Thyrogen.
If you use more Thyrogen than you should Patients who accidentally received too much Thyrogen have reported feeling nausea, weakness, dizziness, headache, vomiting and hot flushes.
Jekk tuża Thyrogen aktar milli suppost Pazjenti li aċċidentalment ħadu aktar Thyrogen milli suppost irraportaw li kellhom dardir, debbolizza, sturdamenti, uġigħ ta ’ ras, rimettar u fwawar.
If you think you have received too much Thyrogen, please contact your doctor’ s office for follow up.
Jekk taħseb li irċevejt aktar Thyrogen milli suppost, jekk jogħġbok ikkuntattja lit- tabib tiegħek għal follow- up.
Like all medicines, Thyrogen can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Thyrogen jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following effects have been reported in clinical studies with Thyrogen:
L- effetti li ġejjin ġew rapportati fi studji kliniċi b’ Thyrogen:
Very common (1 out of 10 patients): nausea Common (1 to 10 in 100 patients) vomiting, fatigue, dizziness and headache.
Komuni ħafna (1 minn kull 10 pazjenti):
Rare (1 to 10 in 1,000 patients): flu symptoms, paraesthesia (prickling or tingling sensation), weakness, fever, urticaria (hives), rash, chills, back pain, feeling hot.
Rari (minn 1 sa 10 minn kull 1, 000 sintomi ta ’ l- influwenza, paraestesija (sensazzjoni ta ’ qris u tingis), pazjent):
In a limited number of patients side effects related to the site of injection were reported, including redness, discomfort, itching, local pain or stinging, and an itchy rash.
debbulizza, deni, urtikarja (ħorriqija), raxx, sirdat, uġigħ fid- dahar, tħoss is- sħana.
Some additional side effects were very rarely reported (1 to 10 in 10,000 patients) after Thyrogen was available for subscription by physicians.
Kienu rraportati b’ mod rari ħafna effetti sekondarji oħra (minn 1 sa 10 minn kull 10, 000 pazjent) wara li Thyrogen kien disponibbli b’ abbonament lit- tobba.
These include: swelling of the tumour, palpitations, shortness of breath, diarrhoea, pain (including pain at the site of metastases (secondaries)), muscle or joint pain, low TSH, excessive sweating, pruritis (itching) and flushing.
Dawn jinkludu: nefħa tat- tumur, palpitazzjonijiet, qtugħ ta ’ nifs, dijarrea, uġigħ (inkluż uġigħ fis- sit tal- metastasi (sekondarji)), uġigħ fil- muskoli u fil- ġog, TSH baxx, għaraq eċċessiv, prurite (ħakk) u fwawar.
24 Very rare cases of hyperthyroidism (increased activity of the thyroid gland) have been reported when Thyrogen was administered to patients who had not undergone total or partial removal of the thyroid gland.
Kien hemm każijiet rari ħafna ta ’ ipertirojdiżmu (attività ogħla tal- glandola tat- tirojde) rrapportati meta Thyrogen ngħata lill- pazjenti li neħħew b’ mod totali jew parzjali l- glandola tat- tirojde.
Mild reactions suggestive of hypersensitivity (allergic reactions) have been reported in very few patients.
24 Kien hemm rapporti ta ’ reazzjonijiet ħfif li jissuġġerixxu sensittività eċċessiva (reazzjonijiet allerġiċi) fi ftit wisq pazjenti.
These reactions could consist of urticaria (hives), pruritis (itching), flushing, difficulty in breathing and rash.
Dawn ir- reazzjonijiet kienu jinkludu urtikarja (ħorriqija), prurite (ħakk), fwawar, diffikultà fit- teħid tan- nifs u raxx.
In clinical studies no patients developed antibodies to thyrotropin alfa.
Fi studji kliniċi l- ebda pazjent ma ’ żviluppa antikorpi għal thyrotropin alfa.
If antibodies would be developed, these may make test results to measure TSH difficult to interpret.
Jekk jiżviluupaw l- antikorpi, ir- riżultati tat- testijiet biex jittkejjel TSH jistgħu ikunu diffiċli biex jiġu interpretati.
HOW TO STORE THYROGEN
KIF TAĦŻEN THYROGEN
Do not use Thyrogen after the expiry date which is stated on the label.
Tużax Thyrogen wara d- data ta ’ skadenza li tidher fuq it- tikketta..
The active substance in Thyrogen is thyrotropin alfa.
X’ fih Thyrogen Is- sustanza attiva f’ Thyrogen hi thyrotropin alfa.
Only 1 ml should be withdrawn equal to 0.9 mg of thyrotropin alfa.
Kull kunjett fih 0. 9 mg/ ml ta ’ thyrotropin alfa meta jiġi rikostitwit b’ 1. 2 ml ta ’ ilma għall- injezzjonijiet.
The other ingredients are: mannitol sodium phosphate monobasic, monohydrate sodium phosphate dibasic, heptahydrate sodium chloride
1 ml biss għandu jinġibed li hu ekwivalenti għal 0. 9 ta ’ thyrotropin alfa Is- sustanzi l- oħra huma: mannitol sodium phosphate monobasic, monohydrate sodium phosphate dibasic, heptahydrate sodium chloride
White to off-white lyophilised powder.
Id- Dehra ta 'Thyrogen u l- kontenuti tal- pakkett Trab għal soluzzjoni għall- injezzjoni.
Package size: one and two vials of Thyrogen per carton.
Trab lijofilizzat abjad għal offwajt Daqs tal- pakkett: kunjett wieħed u żewġ kunjetti ta ’ Thyrogen f’ kull kartuna.
Marketing Authorisation Holder Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, The Netherlands
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, l- Olanda.
25 Manufacturer Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom
Manifattur Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Ir- Renju Unit.
België/ Belgique/ Belgien/ Luxembourg/ Luxemburg Genzyme Belgium nv/ sa (Belgique/ Belgien) Tél/ Tel: + 32 2 714 17 11
25 Luxembourg/ Luxemburg Genzyme Belgium nv/ sa (Belgique/ Belgien) Tél/ Tel: + 32 2 714 17 11
Ísland Vistor hf Sími: +354 535 7000
Vistor hf Sími: +354 535 7000
26 This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ’
The recommended dose regimen of Thyrogen is two intramuscular injections of 0.9 mg thyrotropin alfa administered at a 24-hour interval.
26 Ir- reġimen tad- doża rrakkomandata ta 'Thyrogen hi żewġ injezzjonijiet intramuskulari ta' 0. 9 mg thyrotropin alfa mogħtija f' intervall ta '24 siegħa.
Use Aseptic Technique Add 1.2 ml water for injection to the Thyrogen powder in the vial.
Uża Teknika Asettika Żid 1. 2 ml ta 'ilma għall- injezzjoni fil- kunjett mat- trab ta' Thyrogen.
Swirl the contents of the vial gently until all material is dissolved.
Dawwar il- kontenut tal- kunjett bil- mod sakemm il- materjal jinħall kollu.
When the powder is dissolved the total volume in the vial is 1.2 ml.
Meta t- trab jinħall il- volum totali fil- kunjett hu 1. 2 ml.
The pH of the Thyrogen solution is approximately 7.0.
Il- pH tas- soluzzjoni ta 'Thyrogen hu madwaw 7. 0.
Visually inspect the Thyrogen solution in the vial for foreign particles and discoloration.
Spezzjona viżwalment is- soluzzjoni ta 'Thyrogen fil- kunjett biex tara jekk hemmx xi frak jew telf ta' kulur.
The Thyrogen solution should be a clear, colourless solution.
Is- soluzzjoni ta 'Thyrogen għandha tkun soluzzjoni ċara u bla kulur.
Do not use vials exhibiting foreign particles, cloudiness or discoloration.
Tużax kunjetti li fihom frak, soluzzjoni mċajpra jew li tilfu l- kulur.
Withdraw 1.0 ml of the Thyrogen solution from the product vial.
Iġbed 1. 0 ml ta 'soluzzjoni ta' Thyrogen mill- kunjett tal- prodott.
This equals 0.9 mg thyrotropin alfa to be injected.
Dan hu ekwivalenti għal 0. 9 mg thyrotropin alfa li għandu jkun injettat.
Thyrogen does not contain preservatives.
Thyrogen ma fihx preservattivi.
Dispose of any unused solution immediately.
Armi s- soluzzjoni li ma ntużatx minnufih.
After reconstitution, the solution should be injected within three hours, however the Thyrogen solution will stay chemically stable for up to 24 hours, when stored between 2°C and 8°C protected from light.
Wara r- rikonstituzzjoni, is- soluzzjoni għandha tkun injettata fi żmien tlett sigħat, imma is- soluzzjoni ta 'Thyrogen ser tibqa' kimikalment stabbli sa 24 siegħa, meta tkun maħżuna f' temperatura ta 'bejn 2°C u 8°C u tkun protetta mid- dawl.
It is important to note that the microbiological safety depends on the aseptic conditions during the preparation of the solution.
Hu importanti li tkun taf li s- sigurtà mikrobijoloġika tiddependi fuq il- kondizzjonijiet asettiċi matul il- preparazzjoni tas- soluzzjoni.
What is TORISEL?
X’ inhu TORISEL?
TORISEL is a concentrate and diluent that are made up into a solution for infusion (drip into a vein).
TORISEL hu konċentrat u dilwent li jitħalltu biex jiffurmaw soluzzjoni għal infużjoni (dripp f’ vina).
It contains the active substance temsirolimus.
Fih is- susanza attiva temsirolimus.
What is TORISEL used for?
Għal xiex jintuża TORISEL?
TORISEL is used to treat patients with advanced renal cell carcinoma (kidney cancer).
TORISEL jintuża fit- trattament ta ’ pazjenti b’ kanċer taċ- ċelloli tal- kiewi avvanzat.
Because the number of patients with renal cell carcinoma is low, the disease is considered ‘ rare’, and TORISEL was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 6 April 2006.
Billi n- numru ta ’ pazjenti b’ kanċer fil- kliewi huwa żgħir, il- marda hi meqjusa ‘ rari ’ u TORISEL kien indikat bħala ‘ mediċina orfni ’ (mediċina użata għal mardiet rari) fis- 6 ta ’ April ta ’ l- 2006.
How is TORISEL used?
Kif jintuża TORISEL?
TORISEL must be given under the supervision of a doctor who has experience in the use of anticancer medicines.
TORISEL għandu jingħata taħt is- sorveljanza ta ’ tabib li jkollu esperjenza fl- użu ta ’ mediċini ta ’ kontra l- kanċer.
The recommended dose is 25 mg given over 30 to 60 minutes once a week.
Id- doża rrakkomandata hi 25 mg mogħtija fuq perjodu u ta ’ bejn 30 u 60 sekonda darba f’ ġimgħa, u għandha ddum tingħata bejn 30 u 60 minuta darba f’ ġimgħa.
Patients should receive an antihistamine around 30 minutes before each dose of TORISEL.
Il- pazjenti għandhom jirċievu anti- istaminika madwar 30 minuta qabel kull doża ta ’ TORISEL.
Treatment with TORISEL should continue until the patient does not benefit any more or has unacceptable side effects.
It- trattament b’ TORISEL għandu jitkompla sakemm il- pazjent ma jibbenefikax minn effetti sekondarji inaċċettabbli.
Some side effects can be managed by interrupting treatment or reducing the dose.
Xi effetti sekondarji jistgħu jiġu ġestiti bit- twaqqif tat- trattament jew bit- tnaqqis tad- doża.
TORISEL should be used with caution in patients who have severe problems with their kidneys or who have liver problems.
TORISEL għandu jintuża b’ kawtela f’ pazjenti li jkollhom problemi severi fil- kliewi jew fil- fwied.
It is not recommended for patients with severe liver problems.
Mhux rakkomandat għal pazjenti bi problemi severi tal- fwied.
How does TORISEL work?
Għal xiex jintuża TORISEL?
The active substance in TORISEL, temsirolimus, is an anticancer medicine, which acts by blocking a protein called ‘ mammalian target of rapamycin’ (mTOR).
Is- sustanza attiva f’ TORISEL, temsirolimus, hi mediċina ta ’ kontra l- kanċer, mediċina li taġixxi billi timblokka proteina magħrufa bħala ‘ mammalian target of rapamycin ’ (mTOR).
In the body, temsirolimus attaches to a protein that is found inside cells to make a ‘ complex’.
Fil- ġisem, temsirolimus jeħel ma ’ proteina fiċ- ċelloli biex jiġi ffurmat ‘ kumpless ’.
This complex then blocks mTOR.
Dan il- kumpless jimblokka mTOR.
Since mTOR is involved in the control of cell division, TORISEL prevents the division of cancer cells, slowing down the growth and spread of kidney cancer.
Billi mTOR għandu dejjem x’ jaqsam mal- kontroll tad- diviżjoni taċ- ċelloli, TORISEL jipprevjeni d- diviżjoni taċ- ċelloli tal- kanċer, u b’ hekk itellef f’ daqqa l- firxa u t- tkabbir taċ- ċelloli tal - kanċer tal- kliewi.
How has TORISEL been studied?
Kif ġie studjat TORISEL?
The effectiveness of TORISEL has been studied in one main study involving 626 patients who had advanced renal cell carcinoma and a poor prognosis.
L- effett ta ’ TORISEL ġie studjat fi studju ewlieni wieħed li fih ħadu sehem 626 pazjent b’ karċinoma avvanzata tal- kliewi u bi pronjożi ħażina.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L- istudju qabbel l- effetti ta ’ 25 mg ta ’ TORISEL mogħtija darba f’ ġimgħa ma ’ dawk ta ’ kombinazzjoni ta ’ interferon alfa (mediċina oħra għal kontra l- kanċer) u 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has TORISEL shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged ma ’ dawk b’ kombinazzjoni ta ’ 15 mg ta ’ TORISEL darba f’ ġimgħa flimkien ma ’ interferon alfa.
Patients receiving TORISEL alone survived for longer than those taking interferon alfa alone.
Il- pazjenti li kienu qed jieħdu TORISEL waħdu għexu iktar fit- tul minn dawk li kienu qed jieħdu interferon alfa biss.
In the main study, the patients receiving TORISEL alone survived for an average of 10.9 months, compared with 7.3 months in those receiving interferon alfa alone.
Fl- istudju ewlieni, il- pazjenti li kienu qed jieħdu TORISEL waħdu għexu medja ta ’ 10. 9 xhur, meta mqabbla ma ’ 7. 3 xhur ta ’ dawk li kienu jingħataw interferon alfa biss.
The patients receiving the lower dose of TORISEL in combination with interferon alfa survived for a similar length of time (8.4 months) to those taking interferon alfa alone.
Il- pazjenti li ngħataw doża baxxa ta ’ TORISEL flimkien ma ’ interferon alfa għexu għal tul ta ’ żmien simili (8. 4 xhur) għal dawk li kienu qed jieħdu interferon alfa waħdu.
What is the risk associated with TORISEL?
X’ inhu r- riskju assoċjat ma ’ TORISEL?
The most common side effects with TORISEL (seen in more than 3 patients in 10) are anaemia (low red blood cell counts), nausea (feeling sick), rash, anorexia (loss of appetite), oedema (swelling) and asthenia (weakness).
L- iktar effetti sekondarji komuni ma ’ TORISEL (li dehru f’ iktar minn tliet pazjenti minn kull għaxra huma l- anemija (demm baxx), dardir, raxx, anoressija (nuqqas ta ’ aptit), nefħa u astenja (dgħufija).
For the full list of all side effects reported with TORISEL, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrappurtati ma ’ TORISEL, ara l- Fuljett ta ’ Tagħrif.
TORISEL should not be used in people who may be hypersensitive (allergic) to temsirolimus, to its metabolites (the substances that it is broken down into) including sirolimus (a medicine used to prevent rejection of transplanted kidneys), to polysorbate 80 or to any of the other ingredients of the medicine.
TORISEL m’ għandux jintuża minn persuni li jiistgħu jkunu allerġiċi għal temsirolimus, għall - metaboliti tiegħu (is- sustanzi li jitkisser fihom) inkluż sirolimus (mediċina użata għall- prevenzjoni tar - riġezzjoni ta ’ kliewi trapjantati), għal polysorbate 80 jew għal xi sustanza oħra tal- mediċina.
Why has TORISEL been approved?
Għaliex ġie approvat TORISEL?
The Committee for Medicinal Products for Human Use (CHMP) decided that TORISEL’ s benefits are greater than its risks for the first-line treatment of patients with advanced renal cell carcinoma who have at least three of the following prognostic risk factors: • less than one year from time of initial renal cell carcinoma diagnosis, • Karnofsky score status of less than 70, • haemoglobin less than the lower limit of normal, • corrected calcium of greater than 10 mg/ dl, • lactate dehydrogenase over 1.5 times the upper limit of normal, • more than one metastatic organ site.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ TORISEL huma ikbar mir- riskji tiegħu għat- trattament ta ’ l- ewwel linja ta ’ pazjenti b’ karċonoma avvanzata taċ- ċelloli tal- kliewi li jkollhom ta ’ l- inqas tlieta minn dawn il- fatturi tar- riskju pronjostiċi: • Inqas minn sena minn żmien id- dijanjożi inizjali tal- karċinoma, • Punteġġ ta ’ Karnofsky inqas minn 70, • Emoglobina inqas mil- limitu tan- normal, • Kalċju kkoreġut ta ’ iktar minn 10 mg/ dl, • lactate dehydrogenase iktar minn darba u nofs il- limitu normali, • iktar minn sit wieħed ta ’ metastasi.
The Committee recommended that TORISEL be given marketing authorisation.
Il- Kumitat irrakkomanda li TORISEL jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about TORISEL:
Tagħrif ieħor dwar TORISEL:
The European Commission granted a marketing authorisation valid throughout the European Union for TORISEL to Wyeth Europa Ltd on 19 November 2007.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal TORISEL lil Wyeth Europa Ltd fil- 19 ta ’ November 2007.
The record of TORISEL’ s designation as an orphan medicine is available here.
Ir- rekord tad- desinjazzjoni ta ’ TORISEL bħala mediċina orfni jinstab hawn.
The full EPAR for TORISEL can be found here.
L- EPAR sħiħ għal TORISEL jista ’ jinstab minn hawn.
This summary was last updated in 10-2007.
Dan is- Sommarju ġie aġġornat l- aħħar f’ Ottubru 2007.
Invented name
Numru ta ’ Proċedura ta ’ l -
Pharmaceutical
Isem ivvintat
Route of
Għamla
EU number
Kif jingħata
administration
Farmaċewtika
Concentrate and diluent for solution for infusion
Konċentrat u dilwent Użu għal ġol- vini għal soluzzjoni għall - infużjoni
vial (glass) + vial (glass)
kunjett (ħġieġ) + kunjett (ħġieġ)
1 vial TORISEL 25 mg/ ml concentrate contains:
1 kunjett ta ’ konċentrat TORISEL 25 mg/ ml fih:
30 mg temsirolimus dissolved in a total volume of 1.2 ml Therefore, 1 ml of TORISEL concentrate contains 25 mg temsirolimus.
Għalhekk, 1 ml ta ’ konċentrat ta ’ TORISEL fih 25 mg ta ’ temsirolimus.
After dilution of TORISEL 25 mg/ ml concentrate with 1.8 ml of withdrawn diluent, the concentration of temsirolimus is 10 mg/ ml.
Wara d- dilwizzjoni ta ’ konċentrat TORISEL 25 mg/ ml b’ 1. 8 ml ta ’ dilwent li jkun inġibed, il - konċentrazzjoni ta ’ temsirolimus tkun ta ’ 10 mg/ ml.
1 vial TORISEL 25 mg/ ml concentrate contains 474 mg anhydrous ethanol.
1 kunjett ta ’ konċentrat TORISEL 25 mg/ ml fih 474 mg ta ’ anhydrous ethanol.
1 vial of the diluent, provided contains 358 mg anhydrous ethanol.
1 kunjett tad- dilwent ipprovdut fih 358 mg ta ’ anhydrous ethanol.
Concentrate and diluent for solution for infusion.
Konċentrat u dilwent għal soluzzjoni għall- infużjoni.
The concentrate is a clear, colourless to light-yellow solution, essentially free from visible particulates.
Il- konċentrat hu soluzzjoni ċara, bla kulur sa safra ċara, u hi essenzjalment ħielsa minn partikuli viżibbli.
The diluent is a clear to slightly turbid, light-yellow to yellow solution, essentially free from visible particulates.
Id- dilwent hu soluzzjoni ċara sa ftit imdardra, minn safra ċara sa safra, u hi essenzjalment ħielsa minn partikuli viżibbli.
TORISEL is indicated for the first-line treatment of patients with advanced renal cell carcinoma who have at least three of six prognostic risk factors (see section 5.1).
TORISEL hu indikat għall- kura ewlenija ta ’ pazjenti li għandhom karċinoma avvanzata taċ- ċelluli renali li jkollhom mill- inqas tlieta minn sitt fatturi tar- riskju pronjostiku (ara sezzjoni 5. 1).
TORISEL must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
TORISEL għandu jingħata biss taħt is- superviżjoni ta ’ tabib b’ esperjenza fl- użu ta ’ prodotti mediċinali antineoplastiċi.
The total volume (1.2 ml) of 1 vial TORISEL 25 mg/ ml concentrate must be diluted with 1.8 ml of withdrawn diluent to achieve a concentration of temsirolimus of 10 mg/ ml.
Il- volum totali (1. 2 ml) ta ’ 1 kunjett ta ’ konċentrat TORISEL 25 mg/ ml irid ikun dilwit b’ 1. 8 ml ta ’ dilwent li jkun inġibed biex tinkiseb konċentrazzjoni ta ’ temsirolimus ta ’ 10 mg/ ml.
Withdraw the required amount of the temsirolimus 10 mg/ ml mixture and then inject rapidly into sodium chloride 9 mg/ ml (0.9%) solution for injection.
Iġbed l - ammont meħtieġ ta ’ taħlita ta ’ temsirolimus 10 mg/ ml u mbagħad injetta malajr ġo soluzzjoni għall- injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%).
2 The recommended dose of temsirolimus for advanced renal cell carcinoma administered intravenously is 25 mg infused over a 30- to 60-minute period once weekly (see section 6.6 for instructions on dilution, administration and disposal).
Id- doża rakkomandata ta ’ temsirolimus għal karċinoma avvanzata taċ- ċelluli renali mogħtija ġol- vini hi ta ’ 25 mg infuża fuq perijodu ta ’ 30 sa 60 minuta darba f’ ġimgħa (ara sezzjoni 6. 6 għal struzzjonijiet dwar id- dilwizzjoni, l- għoti u r- rimi).
Patients should be given intravenous diphenhydramine 25 to 50 mg (or similar antihistamine) approximately 30 minutes before the start of each dose of temsirolimus.
2 Il- pazjenti għandhom jingħataw diphenhydramine 25 sa 50 mg ġol- vini (jew antistamina simili) madwar 30 minuta qabel il- bidu ta ’ kull doża ta ’ temsirolimus.
Treatment with TORISEL should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Il- kura b’ TORISEL għandha tkompli sakemm il- pazjent ma jkunx qed jibbenefika aktar klinikament mit- terapija, jew sakemm isseħħ tossiċità inaċċettabbli.
No special dose modification is required for any of the populations that have been studied (gender, elderly).
L- ebda tibdil speċjali fid- doża mhu meħtieġ għal xi waħda mill- popolazzjonijiet li kienu studjati (sess, anzjani).
Management of suspected adverse reactions may require temporary interruption and/ or dose reduction of temsirolimus therapy.
L- immaniġġjar ta ’ reazzjonijiet avversi ssuspettati jista ’ jkollhom bżonn ta ’ interruzzjoni temporanja u/ jew tnaqqis tad- doża fit- terapija ta ’ temsirolimus.