qanastek/EMEA-V3 huggingface dataset:
Breast-feeding Talk to your doctor if you are breast-feeding or intending to breast-feed as breastfeeding should be discontinued if you take Thymanax.
Treddigħ Tkellem mat- tabib tiegħek jekk int qed tredda` jew intenzjonata li tredda` minħabba li treddigħ għandu jitwaqqaf jekk int qed tieħu Thymanax.
Driving and using machines You might experience dizziness or sleepiness which could affect your ability to drive or operate machinery.
Sewqan u tħaddim ta ’ magni Int tista tesperjenza sturdament jew ngħas li jistgħu jaffetwaw l- abilita` li ssuq jew tħaddem magni.
Make sure that your reactions are normal before driving or operating machines.
Kun żgur/ a li r- reazzjonijiet tiegħek ikunu normali qabel issuq jew tħaddem magni.
Important information about some of the ingredients of Thymanax
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Thymanax Din il- mediċina fiha lactose.
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking Thymanax.
Jekk inti ġejt mgħarraf mit- tabib tiegħek li inti għandek intolleranza għal xi zokkor, kellem lit- tabib tiegħek qabel tieħu Thymanax.
HOW TO TAKE THYMANAX
KIF GĦANDEK TIEĦU THYMANAX
Always take Thymanax exactly as your doctor has told you.
Dejjem għandek tieħu Thymanax skond il- parir eżatt tat- tabib.
The recommended dose of Thymanax is one tablet (25 mg) at bedtime.
Id- doża li ssoltu tingħata hija pillola kuljum (25 mg) qabel l- irqad.
In some cases, your doctor may prescribe a higher dose (50 mg), i. e. two tablets to be taken together at bedtime.
F’ xi ċertu każijiet, it- tabib tiegħek jista ’ jippreskrivi doża ikbar (50 mg), żewġ pilloli meħudin flimkien qabel l- irqad.
Thymanax starts to act on symptoms of depression in most depressed people within two weeks of starting treatment.
20 Thymanax jibda jaħdem fuq is- sintomi tad- dipressjoni f’ ħafna min- nies bid- dipressjoni fi żmien ġimgħatejn minn meta tibda l- kura.
Your doctor may continue to give you Thymanax when you are feeling better to prevent your depression from returning.
It- tabib tiegħek jista jibqa` itik Thymanax meta inti tħossok aħjar biex jipprevjeni d- dipressjoni milli terġa` lura.
Do not stop taking your medicine without the advice of your doctor even if you feel better.
M’ għandekx twaqqaf il- mediċina mingħajr il- parir tat- tabib anke jekk inti tħossok aħjar.
Thymanax is for oral use.
Thymanax huwa għall- użu orali.
You should swallow your tablet with a drink of water.
Inti għandek tibla` il- pillola ma ’ xarba ilma.
Thymanax can be taken with or without food.
Thymanax jista jittiehed ma ’ l- ikel jew mingħajru.
Your doctor will run laboratory tests to check that your liver is working properly at the initiation of treatment and then periodically during treatment, usually after 6 weeks, 12 weeks and 24 weeks.
It- tabib tieghek jagħmel numru ta ’ testijiet tal- laboratorju biex jiċċekkja li l- fwied qed jaħdem sew fil - bidu tal- kura u imbaghad perjodikament waqt il- kura, generalment wara 6 gimgħat, 12 il- ġimgħa u 24 ġimgħa.
Thereafter tests will be taken if the doctor finds it necessary.
Wara dan it- testijiet jittiehdu jekk it- tabib isib li huwa neċessarju.
You must not use Thymanax if your liver does not work properly.
M’ għandekx tuża Thymanax jekk il- fwied mhux qed jaħdem sew.
If you have trouble with your kidneys, your doctor will make an individual evaluation of whether it is safe for you to take Thymanax.
Jekk inti għandek il- problemi fil- kliewi, it- tabib tiegħek jagħmel evalwazzjoni individwali għas - sigurta` tiegħek meta tieħu Thymanax.
If you take more Thymanax than you should If you have taken more Thymanax than you should, or if for example a child has taken medicine by accident, contact your doctor immediately.
Jekk tieħu Thymanax aktar milli suppost Jekk inti ħadt aktar Thymanax aktar milli suppost, jew jekk per eżempju tifel/ tifla ħadu l- mediċina aċċidentalment, għarraf lit- tabib tiegħek mill- ewwel.
The experience of overdoses with Thymanax is limited but reported symptoms include pain in the upper part of the stomach and drowsiness.
L- esperjenza ta ’ dozi eċċessivi b’ Thymanax hija limitata imma sintomi rapportati jinkludu ugigħ fil - parti ta ’ fuq ta ’ l- istonku u sturdament.
Just carry on with the next dose at the usual time.
Jekk tinsa tieħu Thymanax M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
The calendar printed on the blister containing the tablets should help you remembering when you last took a tablet of Thymanax.
Il- kalendarju li jkun stampat fuq il- folji li jkun fihom il- pilloli għandu jgħinek meta ħadt l- aħħar pillola ta ’ Thymanax.
If you have any further questions on the use of this product, please ask your doctor or pharmacist.
Jekk għandek iktar mistoqsijiet dwar l- użu ta ’ din il- prodott, jekk jogħġbok staqsi lit- tabib jew l - ispiżjar tiegħek.
Like all medicines, Thymanax can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Thymanax jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Most side effects are mild or moderate.
Ħafna mill- effetti sekondarji huma ħfief jew moderati.
They usually occur within the first two weeks of the treatment and are usually temporary.
Dawn normalment iseħħu fl- ewwel ġimgħatejn tal- kura u huma normalment temporanji.
21 The frequency of possible side effects listed below is defined using the following system: • very common (affects more than 1 user in 10) • common (affects 1 to 10 users in 100) • uncommon (affects 1 to 10 users in 1,000) • rare (affects 1 to 10 users in 10,000) • very rare (affects less than 1 user in 10,000) • not known (frequency cannot be estimated from the available data)
Il- frekwenza ta ’ dawn l- effetti sekondarji mniżżla hawn taħt hija definita ’ bl- użu ta ’ din is- sistema li ġejja: • komuni ħafna (taffetwa iktar minn pazjent 1 f’ 10) • komuni (taffetwa pazjent 1 sa 10 f’ 100) • mhux komuni (taffetwa pazjent 1 sa 10 f’ 1, 000) • rari (taffetwa pazjent 1 sa 10 f’ 10, 000) • rari ħafna (taffetwa inqas minn pazjent 1 f’ 10, 000) • mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
These side effects include:
Dawn l- effetti sekondarji jinkludu
- Common side effects: dizziness, sleepiness (somnolence), difficulty in sleeping (insomnia),
- Effetti sekondarji komuni sturdament, ngħas (aptit torqod), diffikulta` biex torqod (insomnia),
migraine, headache, feeling sick (nausea), diarrhoea, constipation, upper abdominal pain, excessive sweating (hyperhidrosis), back pain, tiredness, anxiety, increased levels of liver enzymes in your blood.
emigranja, uġigħ ta ’ ras, tħossok marid (dardir), dijareja, stitikezza, uġigħ addominali fin- naħa ta ’ fuq, tegħreq ħafna (iperidrożi), ugigħ fid- dahar, għejja, anzjeta`, żieda fil- livelli ta ’ l- enżimi tal - fwied fid- demm tiegħek.
- Uncommon side effects: pins and needles in the fingers and toes (paraesthesia), blurred vision and
- Effetti sekondarji mhux komuni tniggiż fis- swaba ta ’ l- idejn u s- saqajn (paraesthesia), vista
eczema.
mċajpra u ekżema.
- Rare side effects: serious skin eruption (erythematous rash), hepatitis.
- Effetti sekondarji rari mard serju tal- ġilda (raxx eritematiku), epatite
- Other possible side effects: suicidal thoughts or behaviour (frequency not known).
- Effetti sekondarji oħrajn ħsibijiet u imġieba suwiċidali, (frekwenza mhix magħrufa).
HOW TO STORE THYMANAX
KIF TAĦŻEN THYMANAX
Do not use Thymanax after the expiry date which is stated on the carton and blister.
Tużax Thymanax wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja.
The expiry date refers to the last day of that month.
Id data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar.
This medicine does not require any special storage conditions.
Din il- mediċina m’ għandiex bżonn ħażna speċjali.
What Thymanax contains
X’ fih Thymanax
- The active substance is agomelatine.
- Is- sustanza attiva hi agomelatine.
Each tablet contains 25 mg of agomelatine.
Kull pillola fiha 25 mg t ’ agomelatine.
• tablet core: lactose monohydrate, maize starch, povidone, sodium starch glycolate type A, stearic acid, magnesium stearate, colloidal anhydrous silica. • tablet film-coating: hypromellose, glycerol, macrogol, magnesium stearate, yellow iron oxide (E172) and titanium dioxide (E171). • printing ink: shellac, propylene glycol and indigotine (E132) aluminium lake
• il- qalba tal- pillola: lactose monohydrate, maize starch, povidone, sodium starch glycolate type A, stearic acid, magnesium stearate, colloidal anhydrous silica. • il- kisja b’ rita tal- pillola: hypromellose, glycerol, macrogol, magnesium stearate, iron oxide isfar (E172), titanium dioxide (E171). • linka stampata: shellac, propylene glycol, indigotine (E132) aluminium lake
What Thymanax looks like and contents of the pack Thymanax 25 mg film-coated tablets are oblong, orange-yellow with a blue imprint of ‘ company logo ’ on one side.
Id- Dehra ta ’ Thymanax u l- kontenuti tal- pakkett Thymanax 25 mg pilloli miksija b’ rita huma rettangolari, oranġjo fl- isfar bil- logo tal- kumpanija imnaqqax bil- blu fuq naħa minnhom.
Thymanax 25 mg film-coated tablets are available in calendar blisters.
Thymanax 25 mg pilloli miksija b’ rita huma disponibbli f’ folji b’ kalendarju.
Packs contain 7, 14, 28, 42, 56, 84 or 98 tablets.
Il- pakketti fihom 7, 14, 28, 42, 56, 84 jew 98 pilloli.
Packs of 100 film-coated tablets are also available for hospital use.
Pakketti ta ’ 100 pillola miksija b’ rita huma disponibbli għall- użu ta ’ l - isptar biss.
22 Not all pack sizes may be marketed.
Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Marketing Authorisation Holder and Manufacturer:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u Il- Manifattur
Marketing Authorisation Holder Servier (Ireland) Industries Ltd Gorey road, Arklow, Co.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Servier (Ireland) Industries Ltd Gorey Road, Arklow, Co.
Manufacturer Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy France
Il- Manifattur Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy Franza
Wicklow – Ireland
Wicklow – L - Irlanda
and
22 u
Annopol 6B Poland
Annopol 6B Il - Polonja
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
What is Thyrogen?
X’ inhu Thyrogen?
Thyrogen is a powder to be made up into a solution for injection.
Thyrogen hu trab li jitħallat f’ soluzzjoni għall- injezzjoni.
Each vial contains 0.9 mg of the active substance thyrotropin alfa.
Kull fjala fiha 0. 9 mg tas- sustanza attiva thyrotropin alfa.
What is Thyrogen used for?
Għal xiex jintuża Thyrogen?
Thyrogen is used in patients who have had an operation to remove their thyroid gland (thyroidectomy) because they had cancer.
Thyrogen jintuża f’ pazjenti li tkun saritilhom operazzjoni biex titneħħielhom it- tirojde (thyroidectomy) minħabba kanċer.
Thyrogen is used with a ‘ thyroglobulin test’ and with or without a scan using radioactive iodine (131I) to detect any thyroid cells that might have been left over after surgery.
Thyrogen jintuża ma ’ ‘ test tat- thyroglobulin ’ u ma ’ jew mingħajr skenn bl- użu ta ’ jodju radjuattiv (131I) biex ikun magħruf jekk fadalx ċelloli tat- tirojde li setgħu baqgħu hemm wara l- kirurġija.
Thyrogen can also be used in combination with higher doses of radioactive iodine to ablate (kill) any remaining thyroid cells.
Thyrogen jista ’ jintuża flimkien ma ’ dożi għolja ta ’ jodju radjuattiv biex teqred (toqtol) iċ- ċelloli tat - tirojde li jkun fadal.
How is Thyrogen used?
Kif jintuża Thyrogen?
The use of Thyrogen should be supervised by a doctor with expertise in thyroid cancer.
L- użu ta ’ Thyrogen għandu jiġi sorveljat minn tabib b’ esperjenza fil- kanċer tat- tirojde.
It is given as two 0.9-mg injections into the buttock muscle, 24 hours apart.
Jingħata f’ żewġ injezzjonijiet ta ’ 0. 9- mg fil- muskolu tal- warrani, b’ 24 siegħa bejn doża u oħra.
When Thyrogen is used with a radioactive iodine scan, the iodine should be given 24 hours after the final Thyrogen injection, and the scan carried out 48 to 72 hours after this.
Meta Thyrogen jintuża ma ’ skenn tal- jodju radjuattiv, il- jodju jingħata 24 siegħa wara l- injezzjoni finali ta ’ Thyrogen, u l- iskenn isir bejn 48 u 72 siegħa wara dan.
When Thyrogen is given with higher doses of radioactive iodine in ablation therapy, the iodine is also given 24 hours after the final Thyrogen injection, but the scan to see if all remaining cells have been ablated will need to be carried out after a longer delay (a few days).
Meta Thyrogen jingħata f’ dożi għoljin ta ’ jodju radjuattiv fit- terapija tal- qerda taċ- ċelloli, il- jodju jingħata wkoll 24 siegħa wara l- aħħar injezzjoni ta ’ Thyrogen, iżda l- iskenn biex ikun magħruf jekk iċ- ċelloli li jkun fadal inqerdux ikollu jsir wara żmien itwal (ftit jiem).
How does Thyrogen work?
Kif jaħdem Thyrogen?
The active substance in Thyrogen, thyrotropin alfa, is used to test thyroid function.
Is- sustanza attiva f’ Thyrogen, thyrotropin alfa, jintuża biex jittestja l- funzjoni tat- tirojde.
It is a copy of the natural hormone thyroid stimulating hormone (TSH).
Hu kopja ta ’ l- ormon naturali magħruf bħala thyroid stimulating hormone (TSH).
It has been produced by a method known as ‘ recombinant DNA technology’: the thyrotropin alfa is made by a cell that has received a gene (DNA), which makes it able to produce the hormone.
Ġie prodott b’ metodu magħruf bħala ‘ teknoloġija rekombinanti tad- DNA ’: it- thyrotropin alfa isir fiċ- ċelloli li jkunu rċevew ġene (DNA), li jagħmilhom kapaċi jipproduċu l- ormon.
Patients whose thyroid has been removed receive replacement therapy with thyroxine (a hormone produced by the thyroid gland), which causes any thyroid cells remaining in their body to become inactive, and to stop producing TSH.
Il- pazjenti li tkun tneħħitilhom it- tirojde jingħataw terapija ta ’ sostituzzjoni bit- thyroxine (ormon prodott mit- tirojde), li tidisattiva ċ- ċelloli li jista ’ jkun fadal fil- ġisem, u ma tħallihomx jipproduċu t - TSH.
However, TSH is needed when doctors are looking for leftover thyroid cells after surgery, as active cells are easier to detect.
Madankollu, it- TSH hu meħtieġ meta t- tobba jkunu qed ifittxu ċ- ċelloli tat- tirojde li jkun fadal wara l- kirurġija, għax iċ- ċelloli attivi huma iktar faċli li jinstabu.
When Thyrogen is given, it acts like TSH and stimulates all leftover cells in the thyroid, including cancer cells.
Meta jingħata Thyrogen, dan jaġixxi bħat- TSH u jistimula ċ- ċelloli li jkun fadal fit- tirojde, inkluż iċ- ċelloli tal- kanċer.
Their activity can then be detected by measuring levels of a protein called thyroglobulin or by using an imaging technique with radioactive iodine, since active thyroid cells take up iodine and become visible on a scan.
L- attività tagħhom imbagħad tkun tista ’ tinqabad bil- kejl tal- livelli ta ’ proteina magħrufa bħala thyroglobulin jew bl- użu
(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 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Thyrogen been studied?
(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 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged ta ’ teknika ta ’ l- immaġni bil- jodju radjuattiv, billi ċ- ċelloli attivi tat- tirojde jieħdu l- jodju u jibdew jidhru fi skenn.
Thyrogen has been studied in two studies involving a total of 406 patients who had had a thyroidectomy and needed a test to detect any remaining thyroid cells.
Thyrogen ġie studjat f’ żewġ studji li fihom b’ kollox ħadu sehem 406 pazjenti li kienet tneħħitilhom it - tirojde u li kellhom bżonn test biex ikun magħruf kemm fadal ċelloli tat- tirojde.
Each patient ’ s production of thyrogobulin and uptake of radioactive iodine were measured twice, once after treatment with Thyrogen and once when the patient was using thyroid hormone suppression therapy (THST).
Il- produzzjoni tat - thyrogobulin u l- assorbiment tal- jodju radjuattiv ta ’ kull pazjent tkejjel darbtejn, darba wara t - trattament b’ Thyrogen u darba meta l- pazjenti kienu qed jużaw it- terapija tat- trażżin tat- tirojde (THST).
THST is a way of restoring the natural body production of TSH by stopping replacement therapy with thyroxine for four to six weeks.
It- THST hu mod li bih il- produzzjoni naturali tat- TSH titreġġa ’ għan- normal bit- twaqqif tat - terapija ta ’ sostituzzjoni b’ thyroxine għal bejn erba ’ u sitt ġimgħat.
The results of the two tests were compared to see if they were in agreement.
Ir- riżultati taż- żewġ testijiet tqabblu biex ikun magħruf jekk humiex l- istess.
Thyrogen has also been studied in the ablation of thyroid tissue in one study involving 63 patients with thyroid cancer, who received 131I either after Thyrogen or after THST.
Thyrogen ġie studjat ukoll fil- qerda ta ’ tessut tat- tirojde fi studju wieħed bis- sehem ta ’ 63 pazjent bil - kanċer tat- tirojde, li jkunu ngħataw 131I jew wara Thyrogen jew qabel it- THST.
The main measure of effectiveness was based on a check eight months after treatment to see if the patient had any thyroid cells remaining.
Il- mezz ewlieni tal - kejl ta ’ l- effettività kien ibbażat fuq kontroll tmien xhur wara t- trattament biex ikun magħruf jekk il - pazjent ikunx fadallu ċelloli tat- tirojde.
What benefit has Thyrogen shown during the studies?
X’ inhuma l- benefiċċji ta ’ Thyrogen li ntwerew f’ dawn l- istudji?
In the detection of leftover thyroid cells, using Thyrogen to stimulate thyroglobulin production and uptake of radioactive iodine was comparable to using THST.
Fis- sejbien taċ- ċelloli tat- tirojde li jkun fadal, l- użu ta ’ Tyrogen biex jistimula l- produzzjoni ta ’ thyroglobulin u l- assorbiment tal- jodju radjuattiv kien komparabbli ma ’ l- użu tat- THST.
Using Thyrogen allows patients to remain on their replacement therapy before the test is carried out, resulting in a better quality of life.
L- użu ta ’ Thyrogen jippermetti li l- pazjenti jibqgħu jieħdu t- terapija ta ’ sostituzzjoni qabel ma jsir it- test, u dan iwassal għal kwalità tal- ħajja aħjar.
For the ablation of thyroid tissue, radioiodine imaging eight months after treatment showed that both treatments were 100% successful.
Għall- qerda tat- tessut tat- tirojde, immaġni bil- jodju radjuattiv wara tmien xhur urew li ż- żewġ tipi ta ’ trattament kienu ta ’ suċċess100%.
What is the risk associated with Thyrogen?
X’ inhu r- riskju assoċjat ma ’ Thyrogen?
The most common side effect with Thyrogen (seen in more than 1 patient in 10) is nausea (feeling sick).
L- aktar effett sekondarju komuni b’ Thyrogen (li deher f’ iktar minn pazjent wieħed minn kull 10) hu d - dardir.
For the full list of all side effects reported with Thyrogen, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji rappurtati ma ’ Thyrogen, ara l- Fuljett ta ’ Tagħrif.
Thyrogen should not be used in people who may be hypersensitive (allergic) to bovine (cow) or human TSH or to any of the other ingredients.
Thyrogen m’ għandux jintuża minn persuni allerġiċi għat- TSH tal- baqar jew uman jew għal xi sustanza oħra tiegħu.
Thyrogen should not be used during pregnancy.
Thyrogen m’ għandux jingħata waqt it- tqala.
Why has Thyrogen been approved?
Għaliex ġie approvat Thyrogen?
The Committee for Medicinal products for Human Use (CHMP) decided that Thyrogen’ s benefits are greater than its risks for use in post-thyroidectomy patients maintained on hormone suppression therapy (THST) for the detection of thyroid remnants and well-differentiated thyroid cancer (with serum thyroglobulin testing with or without radioiodine imaging) and for the ablation of thyroid remnant tissue in combination with radioactive iodine (131I).
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Thyrogen huma ikbar mir- riskji tiegħu għall- użu minn pazjenti li tkun tneħħitilhom it- tirojde u jkunu mantnuti bit- terapija tat- trażżin ta ’ l- ormoni (THST) għas- sejbien ta ’ fdalijiet tat- tirojde u kanċer tat - tirojde differenzjat tajjeb (bit- testijiet għat- thyroglobulin fid- demm jew mingħajr l- immaġni bil- jodju radjuattiv) u għall- qerda tat- tessut tat- tirojde li jkun fadal flimkien mal- jodju radjuattiv (131I).
The Committee recommended that Thyrogen be given marketing authorisation.
Il - Kumitat irrakkomanda li Thyrogen jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Thyrogen:
Tagħrif ieħor dwar Thyrogen:
The European Commission granted a marketing authorisation valid throughout the European Union for Thyrogen to Genzyme Europe B. V. on 9 March 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea għal Thyrogen lil Genzyme Europe B. V. fid- 9 ta ’ Marzu 2000.
The marketing authorisation was renewed on 9 March 2005.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet imġedda fid- 9 ta ’ Marzu 2005.
The full EPAR for Thyrogen is available here.
L- EPAR sħiħ għal Thyrogen huwa disponibbli minn hawnhekk.
Route of administration Packaging
Trab għal soluzzjoni għall- injezzjoni
Content (concentration)
Kunjett (ħġieġ)
Powder for solution for injection Powder for solution for injection
Trab għal soluzzjoni għall- injezzjoni
Intramuscular use Vial, glass Intramuscular use Vial, glass
Użu għal ġol - muskoli
1 vial 2 vials
2 kunjetti
Thyrogen 0.9 mg powder for solution for injection
Thyrogen 0. 9 mg ta ’ trab għal soluzzjoni għall- injezzjoni
Each vial of Thyrogen contains a nominal value of 0.9 mg thyrotropin alfa.
Kull kunjett ta ’ Thyrogen fih valur nominali ta ’ 0. 9 mg thyrotropin alfa.
Following reconstitution, each vial of Thyrogen contains 0.9 mg of thyrotropin alfa in 1.0 ml.
Wara r- rikostituzzjoni, kull kunjett ta ’ Thyrogen ikun fih 0. 9 mg ta ’ thyrotropin alfa f’ 1. 0 ml.
White to off-white lyophilised powder.
Trab lajofilizzat abjad għal offwajt
Thyrogen (thyrotropin alfa) is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone suppression therapy (THST).
Thyrogen (thyrotropin alfa) hu indikat għal użu ma ’ testijiet tat- thyroglobulin (Tg) fis- serum bl- immaġini ta ’ jodju radjuattiv jew mingħajru biex ikun determinat jekk hemmx xi fdal tat- tirojde u kanċer tat- tirojde li hu differenzjat sewwa fil- pazjenti li kellhom tirojdektomija u li qegħdin fuq terapija ta ’ soppressjoni ta ’ l- ormoni (THST).
Low risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh TSH-stimulated increase of Tg levels may be followed-up by assaying rh TSH-stimulated Tg levels.
Pazjenti li għandhom riskju baxx u li għandhom karċinoma tat- tirojde li hi differenzjata sewwa u livelli tat- Tg fis- serum li ma jistgħux jiġu intraċċati, li qegħdin fuq it- THST u ma għandhomx żjieda fil- livelli tat- Tg stimulati minn rh TSH jistgħu jerġgħu ikunu eżaminati aktar tard permezz ta ’ analiżi tal- livelli tat- Tg stimulati minn rh TSH.
Thyrogen (thyrotropin alfa) is indicated for pre-therapeutic stimulation in low risk (see section 5.1) post-thyroidectomy patients maintained on hormone suppression therapy (THST) for the ablation of thyroid remnant tissue (in combination) with 100 mCi (3.7 GBq) radioactive iodine (131I).
Thyrogen (thyrotropin alfa) hu indikat għall- istimulazzjoni qabel it- terapija f’ pazjenti li kellhom tirojdektomija li jinsabu f’ riskju baxx (ara sezzjoni 5. 1) miżmuma fuq terapija ta ’ soppressjoni ta ’ l- ormoni (THST) għall- asportazzjoni ta ’ tessut tat- tirojde li jkun għad fadal (flimkien) ma ’ 100 mCi (3. 7 GBq) jodju radjuattiv (131I).
The recommended dose regimen is two doses of 0.9 mg thyrotropin alfa administered at a 24-hour interval by intramuscular injection only.
Ir- reġim tad- doża rrakkomandata hu żewġ dożi ta '0. 9 mg thyrotropin alfa li jingħataw f' intervall ta' 24 siegħa permezz ta 'injezzjoni intramuskolari biss.
Therapy should be supervised by physicians with expertise in thyroid cancer.
It- terapija għandha tkun taħt l- osservazzjoni ta 'tobba li huma esperti fil- qasam tal- kanċer tat- tirojde.
After reconstitution with water for injection, 1.0 ml solution (0.9 mg thyrotropin alfa) is administered by intramuscular injection to the buttock.
Wara r- rikonstituzzjoni bl- ilma għall- injezzjoni, 1. 0 ml soluzzjoni (0. 9 mg thyrotropin alfa) tingħata permezz ta 'injezzjoni intramuskolari fil- warrani.
See section 6.6 for instructions for handling.
Ara sezzjoni 6. 6 għal struzzjonijiet dwar l- immaniġġar.
For radioiodine imaging or ablation, radioiodine administration should be given 24 hours following the final Thyrogen injection.
Għal fini ta 'immaġini jew ablazzjoni, il- jodju radjuattiv għandu jingħata 24 siegħa wara l- aħħar injezzjoni ta' Thyrogen.
Diagnostic scintigraphy should be performed 48 to 72 hours following radioiodine administration, whereas post-ablation scintigraphy may be delayed additional days to allow background activity to decline.
Xintegrafija dijanjostika għandha ssir fi żmien 48 sa 72 siegħa wara l- għoti tal- jodju radjoattiv, filwaqt li x- xintegrafija ta 'wara l- ablazzjoni għandha mnejn tiġi mtawla bi ġranet addizzjonali biex tippermetti t- tnaqqis ta' l- attività fl- isfond.
For diagnostic follow-up serum thyroglobulin (Tg) testing, the serum sample should be obtained 72 hours after the final injection of Thyrogen.
Għal follow- up dijanjostiku dwar it- testijiet tat- thyroglobulin (TG) fis- serum, il- kampjun tas- serum għandu jittieħed 72 siegħa wara l- injezzjoni finali ta 'Thyrogen.
Due to a lack of data on the use of Thyrogen in children, Thyrogen should be given to children only in exceptional circumstances.
Peress li m' hemmx biżżejjed tagħrif dwar l- użu ta 'Thyrogen fit- tfal, Thyrogen għandu jingħata lit- tfal f' ċirkustanzi eċċezzjonali biss.
The use of Thyrogen in patients with reduced liver function does not warrant special considerations.
M' hemmx bżonn ta 'konsiderazzjonijiet speċjali għall- użu ta' Thyrogen fil- pazjenti li l- fwied tagħhom mhux qed jaħdem tajjeb.
Information from post marketing surveillance, as well as published information, suggests that elimination of Thyrogen is significantly slower in dialysis-dependent end stage renal disease (ESRD) patients, resulting in prolonged elevation of TSH levels for several days after treatment.
Tagħrif minn osservazzjoni wara t- tqegħid fis- suq, flimkien ma 'tagħrif ippubblikat, jissuġġerixxi li t- tneħħija ta' Thyrogen hi ħafna iżjed bil- mod f' pazjenti li jbatu minn marda renali ta 'l- aħħar stadju li huma dipendenti mid- dijalisi (ESRD), u dan jirriżulta f' żieda prolongata tal- livelli tat- TSH għal ħafna ġranet wara t- trattament.
This may lead to increased risk of headache and nausea.
Dan għandu mnejn iwassal għal riskju ogħla ta 'uġigħ ta' ras u dardir.
There are no studies of alternative dose schedules of Thyrogen in patients with ESRD to guide dose reduction in this population.
M' hemm l- ebda studji dwar skedi ta 'dożi alternattivi ta' Thyrogen f' pazjenti b' ESRD biex jiggwidaw it- tnaqqis fid- doża f' din il- popolazzjoni.
In patients with significant renal impairment the activity of radioiodine should be carefully selected by the nuclear medicine physician.
Fil- każ ta 'pazjenti li għandhom indeboliment renali sinifikanti l- attività tal- jodju radjuattiv għandha tintgħażel bir- reqqa mit- tabib tal- mediċina nukleari.
Use of Thyrogen with Tg testing in follow up of post-thyroidectomy well differentiated thyroid cancer patients should be in accordance with official guidelines.
L- użu ta 'Thyrogen bl- ittestjar ta' TG fil- follow- up tal- pazjenti tal- kanċer tat- tirojdi differenzjati sewwa wara li jkunu neħħew it- tirojde, għandu ikunu skond il- linji gwida uffiċjali.
· Hypersensitivity to bovine or human thyroid stimulating hormone or to any of the excipients.
• Sensittività eċċessiva għal ormoni ta ’ l- ifrat jew tal- bniedem li jistimulaw it- tirojde. • Tqala.
Thyrogen should not be administered intravenously.
Thyrogen m’ għandux jingħata minn ġol- vina.
When used as an alternative to thyroid hormone withdrawal, the combination of the whole body scintigraphy (WBS) and Tg testing after Thyrogen administration assures the highest sensitivity for detection of thyroid remnants or cancer.
Meta jingħata bħala alternattiva wara waqfien ta ’ l- ormoni tat- tirojde, il- kombinazzjoni ta ’ sintingrafija tal- ġisem kollu (WBS) u testijiet tat - (Tg) flimkien, wara li jkun ingħata Thyrogen, jiżguraw l- ogħla sensittività biex jiġi determinat jekk hemmx xi frak tat- tirojde jew kanċer.
False negative results may occur with Thyrogen.
B’ Thyrogen jistgħu joħorġu riżultati negattivi foloz.
If a high index of suspicion for metastatic disease persists, a confirmatory withdrawal WBS and Tg testing should be considered.
Jekk jibqa ’ jkun hemm indiċi għoli ta ’ suspett tal- marda metastatika, wieħed għandu jikkonsidra jekk hemmx bżonn it- twaqqif b’ testijiet konfermatorji ta ’ WBS u Tg.
The presence of Tg autoantibodies can be expected in 18-40% of patients with differentiated thyroid cancer and may cause false negative serum Tg measurements.
Hu mistenni li 18% sa 40% tal- pazjenti li għandhom kanċer tat- tirojde li hu differenzjat jista ’ jkollhom awtoanti- korpi Tg u dan għandu mnejn jikkawża riżultati negattivi foloz ta ’ Tg fis- serum.
Therefore, both TgAb and Tg assays are needed.
Għalhekk, hemm bżonn li jsiru analiżi kemm ta ’ TgAb u kif ukoll ta ’ Tg.
3 Effect on tumour growth and/ or size:
3 L- effett fuq l- iżvilupp tat- tumur u/ jew daqs:
In patients with thyroid cancer, several cases of stimulated tumour growth have been reported during withdrawal of thyroid hormones for diagnostic procedures which have been attributed to the associated prolonged elevation of thyroid stimulating hormone (TSH) levels.
F’ pazjenti li għandhom kanċer tat- tirojde, ġew irrapportati diversi każi fejn ġie stimulat l- iżvilupp tat- tumur waqt il- waqfien ta ’ ormoni tat- tirojde għal fini ta ’ proċeduri dijanostiċi li ġew attribwiti għal żjieda prolongata assoċjata mal- livell ta ’ l- ormon li jistimula t- tirojde (TSH).
There is a theoretical possibility that Thyrogen, like thyroid hormone withdrawal, may lead to stimulated tumour growth.
Hemm il- possibbilità teoretika li Thyrogen, bħal ma jiġri bil- waqfien ta ’ l- ormoni, għandu mnejn jikkawża l- iżvilupp stimulat tat- tumur.
In clinical trials with thyrotropin alfa, which produces a short-term increase in serum TSH levels, no case of tumour growth has been reported.
Fi provi kliniċi b’ thyrotropin alfa, li jikkawża żjieda fil- livelli tat- TSH fis- serum għall- żmien qasir, ma ġie rraportat l- ebda każ ta ’ żvilupp ta ’ tumur.
Due to elevation of TSH levels after Thyrogen administration patients with metastatic thyroid cancer particularly in confined spaces such as the brain, spinal cord and orbit or disease infiltrating the neck, may experience local oedema or focal haemorrhage at the site of these metastases resulting in increased tumour size.
Minħabba ż- żieda fil- livelli ta ’ TSH wara l- għoti ta ’ Thyrogen pazjent b ’ kanċer metastatiku tat- tirojde li b’ mod partikolari jinsab fi spażji ristretti bħal moħħ, is- sinsla tad- dahar u l- orbita jew mard li jinfiltra l- għonq, jista ’ jkollhom edema lokali jew emoraġġija fokata fis- sit ta ’ dawn il- metastasijiet li jirriżultaw f’ tumur akbar.
This may lead to acute symptoms, which depend on the anatomical location of the tissue e. g. hemiplegia, hemiparesis, loss of vision have occurred in patients with CNS metastases.
Dan jista ’ jwassal għal sintomi akuti li jiddependu mil- lok anatomiku tat- tessut e. ż. emipleġja, emiparesi, telf tal- vista seħħew f’ pazjenti b’ metastasi tas- CNS.
It is recommended that pretreatment with corticosteroids be considered for patients in whom local tumour expansion may compromise vital anatomic structures.
Huwa rakkomandat li jiġi kkonsidrat li jkun hemm trattament minn qabel b ’ kortikosterojdi għal pazjenti li l- espansjoni tat- tumur lokali jista ’ jikkomprometti strutturi anatomiċi vitali.
Formal interaction studies between Thyrogen and other medicinal products have not been performed.
Ma sarux studji formali dwar l- effett ta ’ mediċini oħra fuq l- effett farmaċewtiku ta ’ Thyrogen.
In clinical trials, no interactions were observed between Thyrogen and the thyroid hormones triiodothyronine (T3) and thyroxine (T4) when administered concurrently.
Fi provi kliniċi ma dehrux interazzjonijiet bejn Thyrogen u ormoni tat- tirojde magħruf bħala triiodothyronine (T3) u thyroxine( T4) meta ngħataw fl- istess ħin.
The use of Thyrogen allows for radioiodine imaging while patients are euthyroid on thyroid hormone suppression treatment.
L- użu ta ’ Thyrogen jippermetti l- użu ta ’ immaġini b’ jodju radjuattiv waqt li l- pazjenti jkollhom it- tirojde taħdem normali u jkunu qed jirċievu kura għat- trażżin ta ’ l- ormoni tat- tirojde.
Data on radioiodine kinetics indicate that the clearance of radioiodine is approximately 50% greater while euthyroid than during the hypothyroid state when renal function is decreased, thus resulting in less radioiodine retention in the body at the time of imaging.
L- informazzjoni li għandna dwar il- kinetiċi ta ’ jodju radjuattiv turi li t- tneħħija ta ’ jodju radjuattiv hi madwar 50% akbar meta t- tirojde tkun qed taħdem normali milli meta t- tirojde tkun qed taħdem bil- mod, meta l- funzjoni tal- kliewi tkun imnaqqsa, u b’ hekk ikun hemm anqas akkumulazzjoni ta ’ jodju radjuattiv fil- ġisem waqt l- użu ta ’ l- immaġini..
This factor should be considered when selecting the activity of radioiodine for use in radioiodine imaging although only a 3.7 GBq 131I activity have been tested in the trial of the pre-therapeutic stimulation.
Dan il- fattur għandu jiġi kkonsidrat meta tintgħazel l- attività tal- jodju radjuattiv għall- użu fl- immaġini ta ’ jodju radjoattiv, għalkemm ġiet ittestjata biss attività ta ’ 3. 7GBq131I fil- prova ta ’ stimulazzjoni qabel it- terapija.
Animal reproduction studies have not been conducted with Thyrogen.
Ma saru l- ebda studji fuq l- effett ta ’ Thyrogen fuq is- sistema riproduttiva ta ’ l- animali.
It is not known whether Thyrogen can cause foetal harm when administered to a pregnant woman or whether Thyrogen can affect reproductive capacity.
Mhux magħruf jekk Thyrogen jistax jikkawża ħsara lill- fetu meta jingħata lil mara tqila jew jekk Thyrogen jistax jaffettwa il- ħila riproduttiva.
Thyrogen in combination with diagnostic radioiodine whole body scintigraphy is contra-indicated in pregnancy, because of the consequent exposure of the foetus to a high dose of radioactive material.
Thyrogen flimkien ma ’ sintingrafija tal- ġisem kollu permezz ta ’ jodju radjuattiv għad- dijanjosi huwa kontra- indikat fit- tqala, minħabba l- espożizzjoni konsegwenzjali ta ’ doża qawwija ta ’ materjal radjuattiv għall- fetu.
Patients should not breast-feed.
Il- pazjenti m’ għandhomx ireddgħu.
The most commonly reported undesirable effects are nausea and headache, occurring in approximately 11%, and 6% of patients, respectively.
L- effetti mhux mixtieqa l- aktar komuni rrapportati huma d- dardir u l- uġigħ ta ’ ras, li jseħħu f’ madwar 11% u 6% tal- pazjenti, rispettivament.
4 The undesirable effects mentioned in the first table, were those considered related to treatment with Thyrogen and occurring in ≥ 1/ 1,000 patients in three prospective clinical trials (N=442).
L- effetti mhux mixtieqa msemmija fl- ewwel tabella, kienu dawk ikkonsidrati li huma relatati mat- trattament b’ Thyrogen u li seħħew f’ ≥1/ 1, 000 pazjent, fi tliet provi kliniċi prospettivi (N=442).
The second table includes undesirable effects that have been reported to Genzyme after licensure of Thyrogen.
It- tieni tabella tinkludi effetti mhux mixtieqa li ġew irraportati lil Genzyme wara l- għoti tal- liċenzja ta ’ Thyrogen.
The tables are followed by a description of certain other additional effects.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
4 Kategorija tas- Sistema ta ’ l- Organi
System Organ Class Gastrointestinal disorders
Reazzjoni Avversa tal- Mediċina
Subject Incidence Very common (> 1/ 10):
Komuni ħafna (> 1/ 10):
Common (> 1/ 100 to ≤ 1/ 10):
Komuni (> 1/ 100 sa ≤1/ 10):
Adverse Drug Reaction Nausea Vomiting
Dardir Rimettar
Uncommon (> 1/ 1,000 to ≤ 1/ 100):
Mhux komuni (> 1/ 1, 000 sa ≤1/ 100):
Fatigue Influenza-like illness, Asthenia, Pyrexia, Rigors, Back pain
Għeja Mard bħal ta ’ l- influwenza, Astenja, Deni, Tertir, Uġigħ fid- dahar
Dizziness Headache Paraesthesia
Sturdament, Uġigħ ta ’ ras Paraestesija
Urticaria, Rash
Urtikarja, Raxx
Feeling hot
Tħoss is- sħana
The following list of undesirable effects, considered related to treatment with Thyrogen have been reported in post-marketing experience:
Kategorija tas- Sistema ta ’ l- Organi
System Organ Class Cardiac disorders Gastrointestinal disorders General disorders and administration site conditions
Disturbi fil- qalb Disturbi gastro- intestinali Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Subject Incidence Very rare (≤ 1/ 10,000):
Rari ħafna (≤1/ 10, 000):
Rare (> 1/ 10,000 to ≤ 1/ 1,000):
Rari (> 1/ 10, 000 sa ≤1/ 1, 000):
Very rare (≤ 1/ 10,000):
Rari ħafna (≤1/ 10, 000):
Adverse Drug Reaction Palpitations Vomiting, Nausea, Diarrhoea Influenza-like illness, Asthenia, Pyrexia, Rigors, Pain, Fatigue,
Palpitazzjonijiet Rimettar, Dardir, Dijarrea Mard bħal ta ’ l- influwenza, Astenja, Deni, Tertir, Uġigħ, Għeja,
Investigations Musculoskeletal and connective tissue disorders
Investigazzjonijiet Disturbi muskolu- skeltrali u tal- connective tissue
TSH decreased Arthralgia, Myalgia
TSH imnaqqas Artralġjia, Uġigħ fil- muskoli
Neoplasm swelling, Metastatic pain
Nefħa neoplażmika, Uġigħ metastatiku
Rare (> 1/ 10,000 to ≤ 1/ 1,000):
Rari (> 1/ 10, 000 to ≤1/ 1, 000):
Dizziness Headache Tremor
Sturdament Uġigħ ta ’ ras Tertir
Very rare (≤ 1/ 10,000):
Disturbi fil- ġilda u fit- tessuti ta ’ Rari ħafna (≤1/ 10, 000): taħt il- ġilda Disturbi vaskulari Rari ħafna (≤1/ 10, 000):
Urticaria, Rash, Pruritis, Hyperhydrosis,
Urtikarja, Raxx, Ħakk, Iperidroliżi, Ħmura
Very rare manifestations of undesirable effects related to the route of administration were reported, including discomfort, pain, pruritis, rash and urticaria at the site of intramuscular injection.
Manifestazzjonijiet rari ħafna ta ’ effetti mhux mixtieqa relatati mar- rotta ta ’ amministrazzjoni ġew rapportati, inkluż skumdità, uġigħ, ħakk, raxx u urtikarja fis- sit ta ’ mnejn ingħatat l- injezzjoni intramuskolari.
Very rare cases of hyperthyroidism or atrial fibrillation have been observed when Thyrogen 0.9 mg has been administered in patients with presence of either partial or entire thyroid gland.
Każijiet rari ħafna ta ’ ipertirojdiżmu jew fibrillazzjoni atrijali ġew osservati meta Thyrogen 0. 9mg ngħata f’ pazjenti li għandhom preżenza ta ’ glandola tat- tirojde parzjali jew sħiħa.
5 Manifestations of hypersensitivity have been reported uncommonly in both clinical and post-marketing settings.
Manifestazzjonijiet ta ’ sensittività eċċessiva ġew rapportati mhux daqshekk ta ’ spiss f’ ambjenti kemm kliniċi u ta ’ wara t- tqegħid fis- suq.
These reactions consisted of urticaria, rash, pruritis, flushing and respiratory signs and symptoms.
Dawn ir- reazzjonijiet jikkonsistu f’ urtikarja, raxx, ħakk, ħmurija u sinjali u sintomi respiratorji.
In clinical trials involving 442 patients, no patients have developed antibodies to thyrotropin alfa either after single or repeated limited (27 patients) use of the product.
Fi provi kliniċi li kienu jinvolvu 442pazjent, l- ebda pazjent ma żviluppa antikorpi għal thyrotropin alfa wara użu waħdani jew l- użu ripetut limitat (27 pazjent) tal- prodott.
The occurrence of antibodies which could interfere with endogenous TSH assays cannot be excluded.
Il- preżenza ta ’ antikorpi li jistgħu jinterferixxu ma ’ l- analiżi ta ’ TSH endoġenu ma tistax tiġi eskluża.
Data on exposure above the recommended dose is limited to clinical studies and a special treatment program.
Informazzjoni dwar espożizzjoni ogħla mid- doża rakkomandata hi limitata għal studji kliniċi u programm ta ’ trattament speċjali.
Three patients in clinical trials, and one patient in the special treatment program experienced symptoms after receiving Thyrogen doses higher than those recommended.
Tliet pazjenti fi provi kliniċi, u pazjent wieħed fi programm ta ’ trattament speċjali kellhom sintomi wara li rċevew Thyrogen f’ dożi akbar minn dawk rakkomandati.
Two patients had nausea after 2.7 mg IM dose, and in one of these patients, the event was also accompanied by weakness, dizziness and headache.
Żewġ pazjenti kellhom id- dardir wara doża IM ta ’ 2. 7 mg, u f’ wieħed minn dawn il- pazjenti, kien hemm ukoll debbulizza, sturdamenti u uġigħ ta ’ ras.
The third patient experienced nausea, vomiting and hot flushes after 3.6 mg IM dose.
It- tielet pazjent kellu dardir, rimettar u fwawar wara doża IM ta ’ 3. 6 mg.
In the special treatment program, a 77 year-old patient with metastatic thyroid cancer who had not been thyroidectomized received 4 doses of Thyrogen 0.9 mg over 6 days, developed atrial fibrillation, cardiac decompensation and terminal myocardial infarction 2 days later.
Fil- programm ta ’ trattament speċjali, pazjent ta ’ 77 sena b’ kanċer metastatiku tat- tirojde li ma kellux tirojdektomija rċieva 4 dożi ta ’ Thyrogen 0. 9 mg fuq sitt ijiem, żviluppa fibrillazzjoni atrijali, dekompensazzjoni kardijaka u infart mijokardjali terminali jumejn wara.
One additional patient enrolled in a clinical trial experienced symptoms after receiving Thyrogen intravenously.
Pazjent addizzjoni reġistrat fi prova klinika kellu sintomi wara li rċieva Thyrogen minn ġol- vina.
This patient received 0.3 mg of Thyrogen as a single intravenous (IV) bolus and, 15 minutes later experienced severe nausea, vomiting, diaphoresis, hypotension and tachycardia.
Il- pazjent rċieva 0. 3 mg ta ’ Thyrogen bħala doża bolus waħdanija ġol- vina (IV) u, 15- il minuta wara kellu dardir qawwi, rimettar, dijaforesi, pressjoni baxxa u takikardja.
A suggested treatment in case of overdose would be the reestablishment of fluid balance and administration of an antiemetic may also be considered.
It- tip ta ’ kura li tista ’ tkun meqjusa f’ każ ta ’ doża eċċessiva tinkludi li terġa ’ ġġib il- bilanċ tal- fluwidi mill- ġdid u l- għoti antiemetiku jista ’ jiġi ikkunsidrat ukoll.
Anterior Pituitary Lobe Hormones and Analogues, ATC code:
Ormoni u Analogi tal- Lobu Pitwitarju Anterjuri, Kodiċi ATC:
Thyrotropin alfa (recombinant human thyroid stimulating hormone) is a heterodimeric glycoprotein produced by recombinant DNA technology.
Thyrotropin alfa (ormon rikombinanti li jistimula t- tirojde umana) hi glikoproteina ħeterodimerika magħmula permezz tat- teknoloġija tad- DNA rikombinanti.
It is comprised of two non-covalently linked subunits.
Hi tikkonsisti minn żewġ subunitajiet li huma marbuta b’ rabta li mhix kovalenti.
The cDNAs encode for an alpha subunit of 92 amino acid residues containing two N-linked glycosylation sites, and a beta subunit of 118 residues containing one N-linked glycosylation site.
Il- kodiċi cDNAs qegħdin għal subunit alfa ta ’ 92 residwu ta ’ aċidi amminiċi li fihom żewġ N- linked glycosylation sites, u subunit beta ta ’ 118- il residwu li fihom N- linked glycosylation site wieħed.
It has comparable biochemical properties to natural human Thyroid Stimulating Hormone (TSH).
Għandha karatteristiċi bijokimiċi li jikkomparaw mal- Ormon uman li Jistimula t- Tirojde (TSH).
Binding of thyrotropin alfa to TSH receptors on thyroid epithelial cells stimulates iodine uptake and organification, and synthesis and release of thyroglobulin, triiodothyronine (T3) and thyroxine (T4).
Ir- rabta ta ’ thyrotropin alfa ma ’ riċettaturi ta ’ TSH fuq iċ- ċelluli epiteljali tat- tirojde tistimula l- assorbiment tal- jodju u l- organifikazzjoni, u sintesi u l- ħruġ ta ’ thyroglobulin,, triiodothyronine (T3) u thyroxin (T4).
In patients with well-differentiated thyroid cancer, a near total or total thyroidectomy is performed.
Fil- każ ta ’ pazjenti li għandhom kanċer tat- tirojde differenzjat tajjeb, issir tirojdektomija kważi totali jew totali.
For optimal diagnosis of thyroid remnants or cancer via either radioiodine imaging or thyroglobulin testing and for radioiodine therapy of thyroid remnants, a high serum level of TSH is needed to stimulate either radioiodine uptake and/ or thyroglobulin release.
Għall- aħjar dijanjosi ta ’ fdal tat- tirojde jew kanċer permezz ta ’ immaġini bil- jodju radjuattiv jew ittestjar ta ’ thyroglobulin u għal terapija ta ’ jodju radjuattiv ta ’ fdalijiet tat- tirojde, livell għoli ta ’ TSH fis- serum hu meħtieġ biex jistimula it- teħid tal- jodju radjuattiv u/ jew r- rilaxx ta ’ thyroidglobulin.
The standard approach to achieve elevated TSH levels has been to withdraw patients from thyroid hormone suppression therapy (THST), which usually causes patients to experience the signs and symptoms of hypothyroidism.
Il- proċedura standard sabiex jintlaħqu livelli elevati ta ’ TSH kienet li pazjenti jitneħħew minn fuq terapija ta ’ suppressjoni ta ’ l- ormon tat- tirojde (THST), li ġeneralment tikkaġuna ’ l pazjenti jesperjenzaw sinjali u sintomi ta ’ ipotirojdiżmu.
With the use of Thyrogen, the TSH stimulation necessary for radioiodine uptake and thyroglobulin release is achieved while patients are maintained euthyroid on THST, thus avoiding the morbidity associated with hypothyroidism.
Bl- użu ta ’ Thyrogen, l- istimulazzjoni ta ’ TSH meħtieġa għat- teħid ta ’ jodju radjuattiv u r- rilaxx ta ’ thyroglobulin tinkiseb waqt li pazjenti jinżammu eutirojde fuq it- THST, u b’ hekk tiġi evitata morbidità assoċjata b’ ipotajrojdiżmu.
6 Diagnostic use The efficacy and safety of Thyrogen for use with radioiodine imaging together with serum thyroglobulin testing for the diagnosis of thyroid remnants and cancer was demonstrated in two studies.
Użu dijanjostiku L- effikaċja u s- siġurtà ta ’ Thyrogen għall- użu b’ immaġini ta ’ jodju radjuattiv flimkien ma ’ testijiet tat- thyroglobulin fis- serum għad- dijanjożi tal- fdal tat- tirojde u l- kanċer intwerew f’ żewġ studji.
In one of the studies, two dose regimens were examined:
F’ wieħed minn dawn l- istudji, żewġ reġimeni ta ’ doża ġew eżaminati:
0.9 mg intramuscular every 24 hours for two doses (0.9 mg x 2) and 0.9 mg intramuscular every 72 hours for three doses (0.9 mg x 3).
0. 9 mg mogħtija ġol- muskolu kull 24 siegħa għal żewġ dożi (0. 9 mg x 2) u 0. 9 mg ġol- muskolu kull 72 siegħa għal tliet dożi (0. 9 mg x 3).
Both dose regimens were effective and not statistically different from thyroid hormone withdrawal in stimulating radioiodine uptake for diagnostic imaging.
Iż- żewġ reġimeni tad- doża kienu effettivi u ma kinux statistikament differenti mit- twaqqif ta ’ l- ormoni tat- tirojde fl- istimular tat- teħid tal- jodju radjuattiv għall- immaġini dijajostiku.
Both dose regimens improved the sensitivity, accuracy and negative predictive value of Thyrogen-stimulated thyroglobulin alone or in combination with radioiodine imaging as compared to testing performed while patients remained on thyroid hormones.
Iż- żewġ reġimi tad- dożi tejbu s- sensittività, il- preċiżjoni u l- valur negattiv imbassar ta ’ thyroglobulin waħdu li hu stimulat minn Thyrogen jew flimkien ma ’ immaġini ta ’ jodju radjuattiv meta mqabbel mat- testijiet li saru fuq il- pazjenti meta baqgħu jieħdu l- ormoni tat- tirojde.