natgillin/translations-raw huggingface dataset:
Swirl the contents of the vial gently until all material is dissolved.
Prašku zdravila Thyrogen v viali dodajte 1, 2 ml vode za injekcije.
Do not shake the solution.
Raztopine ne stresajte!
The pH of the Thyrogen solution is approximately 7.0.
Ko je prašek raztopljen, je skupna prostornina v viali 1, 2 ml. pH vrednost raztopine zdravila Thyrogen je približno 7, 0.
Visually inspect the Thyrogen solution in the vial for foreign particles and discoloration.
Raztopino zdravila Thyrogen si pozorno oglejte in se prepričajte, da v njej ni tujkov ali sprememb barve.
The Thyrogen solution should be a clear, colourless solution.
Raztopina zdravila Thyrogen mora biti prozorna in brezbarvna.
Do not use vials exhibiting foreign particles, cloudiness or discoloration.
Vial s tujki, motne ali obarvane raztopine ne uporabljajte.
Withdraw 1.0 ml of the Thyrogen solution from the product vial.
Iz viale vzemite 1, 0 ml raztopine zdravila Thyrogen.
This equals 0.9 mg thyrotropin alfa to be injected.
To ustreza 0, 9 mg tirotropina alfa za injiciranje.
Thyrogen does not contain preservatives.
9 Thyrogen ne vsebuje konzervansov.
Throw away any unused solution immediately.
Neuporabljeno raztopino nemudoma zavrzite.
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).
Raztopina zdravila Thyrogen ostane kemijsko stabilna do 24 ur, če jo shranjujete v hladilniku (med 2°C in 8°C).
Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, The Netherlands
Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, Nizozemska
9 March 2000 Date of last renewal:
9. marec 2000 Datum zadnjega podaljšanja dovoljenja za promet:
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Name and address of the manufacturer of the biological active substance(s)
Ime in naslov izdelovalca biološke zdravilne učinkovine (učinkovin)
51 New York Avenue Framingham, MA 01701-9322 USA
51 New York Avenue Framingham, MA 01701- 9322 ZDA
Genzyme Ltd 37 Hollands Road Haverhill Suffolk CB9 8PU United Kingdom
37 Hollands Road Haverhill Suffolk CB9 8PU Velika Britanija
LABELLING AND PACKAGE LEAFLET
Navedba smiselno ni potrebna
OUTER CARTON (PACK OF 1 VIAL)
ZUNANJA OVOJNINA (1 VIALA)
Thyrogen 0.9 mg powder for solution for injection. thyrotropin alfa
Thyrogen 0, 9 mg prašek za raztopino za injiciranje tirotropin alfa
Each vial contains 0.9 mg/ ml of thyrotropin alfa when reconstituted with 1.2 ml water for injection.
Ena viala vsebuje 0, 9 mg/ ml tirotropina alfa, po rekonstituciji z 1, 2 ml vode za injekcije.
Only 1 ml should be withdrawn equal to 0.9 mg of thyrotropin alfa.
Odvzeti se mora samo 1ml, kar je enakovredno 0, 9 mg tirotropina alfa.
Mannitol Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Sodium chloride See leaflet for further information.
Pomožne snovi: manitol natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat heptahidrat natrijev klorid Za nadaljnje informacije glejte navodilo za uporabo.
1 vial of powder for solution for injection.
1 viala praška za raztopino za injiciranje
Keep the vial in the outer carton.
Vialo shranjujte v zunanji ovojnini!
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PODATKI V BRAILLOVI PISAVI
OUTER CARTON (PACK OF 2 VIALS)
ZUNANJA OVOJNINA (2 VIALI)
Each vial contains 0.9 mg/ ml of thyrotropin alfa when reconstituted with 1.2 ml water for injection.
Ena viala vsebuje 0, 9 mg/ ml tirotropina alfa po rekonstituciji z 1, 2 ml vode za injekcije.
2 vials of powder for solution for injection equal to 2 doses to be administered at a 24-hour interval.
2 viali praška za raztopino za injiciranje, enaki 2 odmerkoma, se dajeta v 24- urnem razmiku.
Store in a refrigerator (2°C-8°C) Keep the vial in the outer carton.
Vialo shranjujte v zunanji ovojnini!
{LABEL}
NALEPKA (VIALA)
Thyrogen 0.9 mg powder for solution for injection. thyrotropin alfa Intramuscular use.
Thyrogen 0, 9 mg prašek za raztopino za injiciranje tirotropin alfa Intramuskularna uporaba
21 PACKAGE LEAFLET:
NAVODILO ZA UPORABO
INFORMATION FOR THE USER Thyrogen 0.9 mg powder for solution for injection thyrotropin alfa
22 NAVODILO ZA UPORABO Thyrogen 0, 9 mg prašek za raztopino za injiciranje tirotropin alfa
What Thyrogen is and what it is used for 2.
Kaj je zdravilo Thyrogen in za kaj ga uporabljamo 2.
Before you use Thyrogen 3.
Kaj morate vedeti, preden boste uporabili zdravilo Thyrogen 3.
How to use Thyrogen 4.
Kako uporabljati zdravilo Thyrogen 4.
How to store Thyrogen 6.
Shranjevanje zdravila Thyrogen 6.
WHAT THYROGEN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO THYROGEN IN ZA KAJ GA UPORABLJAMO
Thyrotropin alfa is human thyroid stimulating hormone produced by recombinant DNA technology.
Tirotropin alfa je humani ščitnico stimulirajoči hormon, izdelan s tehnologijo rekombinantne DNA.
Thyrotropin alfa stimulates thyroid tissue to take up iodine and produce thyroglobulin (Tg) and thyroid hormones (triiodothyronine (T3) and thyroxine (T4)).
Tirotropin alfa stimulira tiroidno tkivo tako, da privzema jod ter proizvaja tiroglobulin (Tg) in tiroidne hormone (trijodotironin (T3) in tiroksin (T4)).
Thyrogen (thyrotropin alfa) is to be used with serum thyroglobulin (Tg) testing with or without radioiodine imaging.
Thyrogen (tirotropin alfa) je namenjen uporabi pri določanju koncentracije tiroglobulina (Tg) v serumu z ali brez scintigrafije z radioaktivnim jodom.
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.
Ti preskusi se uporabljajo za detekcijo nekaterih vrst raka ščitnice pri bolnikih, ki so jim odstranili žlezo ščitnico in ki jemljejo tiroidne hormone.
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.
Pri nizko ogroženih bolnikih z dobro diferenciranim karcinomom ščitnice in nezaznavnimi količinami Tg pri zdravljenju s supresijo tiroidnih hormonov (THST) ter brez zvišanja koncentracije Tg, kljub stimuliranju s tirotropinom alfa, lahko nadaljujemo z uporabo tirotropina alfa za določanje koncentracije 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.
Thyrogen (tirotropin alfa) se uporablja pri zdravljenju z radioaktivnih jodom in neprekinjenim jemanjem tiroidnega hormona.
BEFORE YOU USE THYROGEN
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO 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.
Ne jemljite zdravila Thyrogen Preden vzamete to zdravilo, morate zdravniku povedati, če ste kadarkoli imeli alergijsko reakcijo (npr. izpuščaj ali srbenje) na ščitnico stimulirajoči hormon (TSH) človeškega ali govejega izvora ali katerokoli drugo sestavino.
You should not use Thyrogen during pregnancy.
Zdravila Thyrogen ne smete uporabljati med nosečnostjo.
22 Take special care with Thyrogen The injection with Thyrogen should never be injected into a vein.
23 Bodite posebno pozorni pri uporabi zdravila Thyrogen Injekcije zdravila Thyrogen ne smete nikoli injicirati v veno.
Effect on tumour growth In patients with thyroid cancer, tumour growth has been reported during withdrawal of thyroid hormones for diagnostic procedures.
Vpliv na rast tumorjev Pri bolnikih z rakom ščitnice poročajo o rasti tumorjev med odstranitvijo tiroidnih hormonov v diagnostične namene.
This was thought to be related to the elevated thyroid stimulating hormone (TSH) levels over a longer period.
Menijo, da je to povezano s povišanjem koncentracije ščitnico stimulirajočega hormona (TSH) skozi daljši čas.
Due to elevation of TSH levels after Thyrogen, patients with metastases can experience local swelling or bleeding at the site of these metastases.
Zaradi povišanja koncentracije TSH po dajanju zdravila Thyrogen bolniki z metastazami, lahko dobijo lokalne edeme ali krvavitve na mestu teh metastaz.
As a result the metastases may become bigger.
Posledica tega so lahko večje metastaze.
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.
Če so metastaze prisotne v ozkih prostorih npr. intracerebralno (v možganih) ali v hrbtenjači lahko pri bolnikih pride do akutnih simptomov kot je hemipareza (delna paraliza ene strani telesa) ali izguba vida.
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).
Vaš zdravnik se bo odločil, ali spadate v posebno skupino bolnikov, za katere je morda potrebno predhodno zdravljenje s kortikosteroidi (npr. pri bolnikih z intracerebralnimi metastazami ali metastazami hrbtenjače).
Please speak to your doctor about this if you have concerns.
Če imate pomisleke, se posvetujte z zdravnikom.
Using other medicines There are no known drug interactions with the thyroid hormones you may be taking.
Uporaba drugih zdravil Ni znanih interakcij s tiroidnimi hormoni, ki jih morda jemljete.
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.
Vaš zdravnik s področja nuklearne medicine bo določil natančen odmerek radioaktivnega joda za uporabo pri scintigrafiji z radioaktivnim jodom ali ablaciji, pri tem pa bo upošteval dejstvo, da še naprej jemljete tiroidne hormone.
Pregnancy You should not use Thyrogen during pregnancy.
Nosečnost Zdravila Thyrogen ne smete uporabljati med nosečnostjo.
Please consult your doctor if you are pregnant.
Če ste noseči, se posvetujte z zdravnikom.
Breast-feeding You should not use Thyrogen while breastfeeding.
Dojenje Zdravila Thyrogen med dojenjem ne smete uporabljati.
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’.
Pomembne informacije o nekaterih sestavinah zdravila Thyrogen To zdravilo vsebuje manj kot 1mmol (23 mg) natrija na injekcijo, kar v bistvu pomeni ‘ brez natrija ’.
HOW TO USE THYROGEN
KAKO UPORABLJATI ZDRAVILO THYROGEN
The Thyrogen powder must be dissolved in water for injection.
Prašek Thyrogen raztopite v vodi za injekcije.
The injection must be given intra-muscularly.
Injekcijo je treba dati intramuskularno.
Your doctor, nurse or pharmacist will prepare the injection for you.
Injekcijo bo za vas pripravil vaš zdravnik, medicinska sestra ali farmacevt.
For instructions see bottom of leaflet.
Za navodila glejte na koncu navodila za uporabo..
23 How much Thyrogen?
24 Koliko zdravila Thyrogen?
The recommended dose of Thyrogen is two doses of 0.9 mg thyrotropin alfa administered at a 24-hour interval.
Priporočeno odmerjanje zdravila Thyrogen sta dva odmerka po 0, 9 mg tirotropina alfa, dana v razmiku 24 ur.
Your doctor or nurse will inject 1.0 ml of the Thyrogen solution (0.9 mg thyrotropin alfa).
Vaš zdravnik ali medicinska sestra vam bosta injicirala 1, 0 ml raztopine zdravila Thyrogen (0, 9 mg tirotropina alfa).
Thyrogen should only be administered into the buttock muscle.
Thyrogen se sme injicirati samo v zadnjično mišico.
Thyrogen solution should never be injected into a vein.
Raztopina zdravila Thyrogen nikoli ne sme biti injicirana v veno.
Your child’ s doctor will decide if Thyrogen should be given to your child.
Vaš otroški zdravnik bo odločil, ali se lahko Thyrogen da otroku.
Do not mix Thyrogen with other medicines in the same injection.
Zdravila Thyrogen ne mešajte z drugimi zdravili v isti injekciji.
If you have reduced liver function you should still be able to receive Thyrogen.
Če imate zmanjšano jetrno delovanje, lahko kljub temu prejemate Thyrogen.
If you have kidney disease and require dialysis, your doctor will decide how much Thyrogen to give to you.
Če imate ledvično bolezen in ste na dializi, se bo vaš zdravnik odločil, koliko zdravila Thyrogen vam bo dal.
You may have more chance of experiencing headache and nausea after receiving Thyrogen.
Morda boste po prejemanju zdravila Thyrogen pogosteje izkusili glavobol in slabost.
If you have reduced kidney function your doctor will decide how much radioiodine to give you.
Če imate zmanjšano ledvično delovanje, bo vaš zdravnik določil, koliko radioaktivnega joda lahko dobite.
When you undergo radioiodine imaging or ablation, your doctor will give you radioiodine 24 hours after your final Thyrogen injection.
Med scintigrafijo ali ablacijo z radioaktivnim jodom vam bo zdravnik dal radioaktivni jod 24 ur po zadnji injekciji zdravila 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.
Diagnostična scintigrafija se nato opravi 48 do 72 ur po prejetju radioaktivnega joda (72 do 96 ur po zadnji injekciji Thyrogena), medtem ko lahko scintigrafijo po zdravljenju zakasnimo za nekaj dni, da se zmanjša aktivnost v ozadju.
For serum thyroglobulin (Tg) testing, your doctor or nurse will take a serum sample 72 hours after the last injection of Thyrogen.
Za določanje koncentracije tiroglobulina (Tg) v serumu vam bosta zdravnik ali medicinska sestra vzela vzorec seruma 72 ur po zadnji injekciji zdravila 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.
Če ste uporabili večji odmerek zdravila Thyrogen, kot bi smeli Boliki, ki so nenamerno prejeli preveč zdravila Thyrogen poročajo o občutku slabosti, šibkosti, omotičnosti, glavobolu, bruhanju in navalih vročine.
If you think you have received too much Thyrogen, please contact your doctor’ s office for follow up.
Če mislite, da ste prejeli preveč zdravila Thyrogen, se prosimo posvetujte s svojim zdravnikom.
Like all medicines, Thyrogen can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Thyrogen neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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.
Poročali so o naslednjih neželenih učinkih zdravila Thyrogen v kliničnih študijah: zelo pogosti (1 na 10 bolnikov): navzea pogosti (1 do 10 na 100 bolnikov): bruhanje, utrujenost, omotičnost in glavobol redki (1 do 10 na 1, 000 bolnikov): simptomi gripe, parestezija (ščemenje ali skelenje), šibkost, zvišana telesna temperatura, urtikarija (koprivnica), izpuščaj, mrzlica, bolečine v hrbtu, vročica.
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.
Pri manjšem številu primerov poročajo, da so bolniki zaznali neželene učinke, povezane z mestom injiciranja, vključno z rdečico, neugodjem, srbenjem, lokalno bolečino in srbečim izpuščajem.
Some additional side effects were very rarely reported (1 to 10 in 10,000 patients) after Thyrogen was available for subscription by physicians.
25 Zelo redko so poročali o nekaterih dodatnih neželenih učinkih (1 do 10 na 10, 000 bolnikov) potem, ko je postalo zdravilo Thyrogen na voljo zdravnikom za predpisovanje.
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.
Ti neželeni učinki vključujejo: otekanje tumorja, palpitacije, kratka sapa, diareja, bolečina (vključno z bolečino na mestu metastaz (dodatno)), bolečine v mišicah ali sklepih, nizek nivo TSH, prekomerno potenje, pruritis (srbenje) in rdečica.
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.
Poročali so o zelo redkih primerih hipertiroidizma (povečano delovanje žleze ščitnice), ko je bilo zdravilo Thyrogen dano bolnikom, katerim niso v celoti ali delno odstranili ščitnice.
Mild reactions suggestive of hypersensitivity (allergic reactions) have been reported in very few patients.
Pri majhnem številu bolnikov so bile opazne blage reakcije, ki kažejo na preobčutljivost (alergične reakcije).
These reactions could consist of urticaria (hives), pruritis (itching), flushing, difficulty in breathing and rash.
Mednje bi lahko spadala urtikarija (koprivnica), pruritis (srbenje), rdečica, težave z dihanjem in izpuščaji.
In clinical studies no patients developed antibodies to thyrotropin alfa.
V kliničnih študijah noben bolnik ni razvil protiteles na tirotropin alfa.
If antibodies would be developed, these may make test results to measure TSH difficult to interpret.
Če bi protitelesa nastala, bi bilo morda težko interpretirati testne rezultate za merjenje TSH.
HOW TO STORE THYROGEN
SHRANJEVANJE ZDRAVILA THYROGEN
Do not use Thyrogen after the expiry date which is stated on the label.
Zdravila Thyrogen ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na.
Each vial contains 0.9 mg/ ml of thyrotropin alfa when reconstituted with 1.2 ml water for injection.
Zdravilna učinkovina je tirotropin alfa Ena viala vsebuje 0, 9 mg/ ml tirotropina alfa, po rekonstituciji z 1, 2 ml vode za injekcije.
Only 1 ml should be withdrawn equal to 0.9 mg of thyrotropin alfa.
Odvzeti se mora samo 1ml, kar je enako 0, 9 mg tirotropina alfa
The other ingredients are: mannitol sodium phosphate monobasic, monohydrate sodium phosphate dibasic, heptahydrate sodium chloride
Pomožne snovi so: manitol natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat heptahidrat natrijev klorid
Powder for solution for injection.
26 Izgled zdravila Thyrogen in vsebina pakiranja Prašek za raztopino za injiciranje.
Package size: one and two vials of Thyrogen per carton.
Velikost pakiranja: ena ali dve viali zdravila Thyrogen na škatlico.
Marketing Authorisation Holder Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, The Netherlands
Imetnik dovoljenja za promet z zdravilom Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, Nizozemska
25 Manufacturer Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom
Izdelovalec Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Velika Britanija
France Genzyme S. A. S Tél: +33 (0) 825 825 863
27 France Genzyme S. A. S Tél: +33 (0) 825 825 863
26 This leaflet was last approved in
Navodilo je bilo odobreno
The recommended dose regimen of Thyrogen is two intramuscular injections of 0.9 mg thyrotropin alfa administered at a 24-hour interval.
Priporočeno odmerjanje zdravila Thyrogen sta dva odmerka po 0, 9 mg tirotropina alfa, dana v razmiku 24 ur.
When the powder is dissolved the total volume in the vial is 1.2 ml.
Ko je prašek raztopljen, je skupni volumen viale 1, 2 ml.
The pH of the Thyrogen solution is approximately 7.0.
Vrednost pH raztopine zdravila Thyrogen je približno 7, 0.
Visually inspect the Thyrogen solution in the vial for foreign particles and discoloration.
Raztopino zdravila Thyrogen si pozorno oglejte in se prepričajte, da v njej ni tujkov in da ni spremenila barve.
Thyrogen does not contain preservatives.
Thyrogen ne vsebuje konzervansov.
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.
Raztopina zdravila Thyrogen ostane kemijsko stabilna do 24 ur, če jo shranjujete med 2 °C in 8 °C in zaščiteno pred svetlobo.
What is TORISEL?
Kaj je zdravilo TORISEL?
TORISEL is a concentrate and diluent that are made up into a solution for infusion (drip into a vein).
Zdravilo TORISEL je koncentrat in vehikel, ki se uporabljata za pripravo raztopine za infundiranje (vnašanje tekočine v veno po kapljicah).
It contains the active substance temsirolimus.
Zdravilo vsebuje zdravilno učinkovino temsirolimus.
What is TORISEL used for?
Za kaj se zdravilo TORISEL uporablja?
TORISEL is used to treat patients with advanced renal cell carcinoma (kidney cancer).
Zdravilo TORISEL se uporablja za zdravljenje bolnikov z napredovalim renalnoceličnim karcinomom (rakom ledvic).
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.
Ker je število bolnikov z napredovalim renalnoceličnim karcinomom majhno, se ta bolezen šteje za „ redko “ in zdravilo TORISEL je bilo dne 6. aprila 2006 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja za redke bolezni).
How is TORISEL used?
Kako se zdravilo TORISEL uporablja?
TORISEL must be given under the supervision of a doctor who has experience in the use of anticancer medicines.
Zdravilo TORISEL se mora uporabljati pod nadzorom zdravnika, izkušenega v uporabi zdravil proti raku.
The recommended dose is 25 mg given over 30 to 60 minutes once a week.
Priporočeni odmerek je 25 mg, ki se daje v 30 do 60 minutah enkrat na teden.
Patients should receive an antihistamine around 30 minutes before each dose of TORISEL.
Bolniki morajo približno 30 minut pred začetkom vsakega odmerka zdravila TORISEL prejeti antihistaminsko zdravilo.
Treatment with TORISEL should continue until the patient does not benefit any more or has unacceptable side effects.
Zdravljenje z zdravilom TORISEL se nadaljuje, dokler bolniku klinično koristi ali dokler se ne pojavijo nesprejemljivi neželeni učinki.
Some side effects can be managed by interrupting treatment or reducing the dose.
Nekatere neželene učinke je mogoče uravnati s prekinitvijo zdravljenja ali zmanjšanjem odmerka.
TORISEL should be used with caution in patients who have severe problems with their kidneys or who have liver problems.
Pri bolnikih s težavami z jetri ali ledvicami je treba zdravilo TORISEL uporabljati previdno.
It is not recommended for patients with severe liver problems.
Zdravilo ni priporočeno za bolnike s hudimi težavami z jetri.
How does TORISEL work?
Kako zdravilo TORISEL deluje?
The active substance in TORISEL, temsirolimus, is an anticancer medicine, which acts by blocking a protein called ‘ mammalian target of rapamycin’ (mTOR).
Zdravilna učinkovina zdravila TORISEL, temsirolimus, je zdravilo proti raku, ki deluje z zaviranjem beljakovine, imenovane „ tarča rapamicina pri sesalcih “ (mTOR).
In the body, temsirolimus attaches to a protein that is found inside cells to make a ‘ complex’.
Temsirolimus se v telesu veže na beljakovino, ki se nahaja v celicah, in tako ustvari „ kompleks “.
This complex then blocks mTOR.
Ta kompleks potem zavira 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.
Ker je beljakovina mTOR vključena v nadzor nad deljenjem celic, zdravilo TORISEL preprečuje deljenje rakastih celic in tako upočasni rast in širjenje ledvičnega raka.
How has TORISEL been studied?
Kako je bilo zdravilo TORISEL raziskano?
The effects of TORISEL were first tested in experimental models before being studied in humans.
Učinki zdravila TORISEL so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.