natgillin/translations-raw huggingface dataset:
An updated Risk Management Plan, as per the CHMP Guideline on Risk Management Systems for medicinal products for human use, should be submitted at the same time as the PSURs, within 60 days of an important (Pharmacovigilance or Risk minimisation) milestone being reached or when the results of a study become available or at the request of the Competent authority.
Posodobljen načrt obvladovanja tveganja v skladu s smernicami CHMP za sisteme obvladovanja tveganja za zdravila v humani uporabi je treba predložiti sočasno s PSUR, v 60 dneh od pomembne ugotovitve (farmakovigilanca ali zmanjšanje tveganja) ali kadar so rezultati študije na voljo ali na zahtevo pristojnih organov.
Intrinsa 300 micrograms/ 24 hours transdermal patch Testosterone
Intrinsa 300 mikrogramov/ 24 ur transdermalni obliž Testosteron
1 patch of 28 cm2 contains 8.4 mg of testosterone and provides 300 micrograms per 24 hours.
1 obliž s površino 28 cm2 vsebuje 8, 4 mg testosterona in sprosti 300 mikrogramov testosterona v 24 urah.
Sorbitan oleate, 2-Ethylhexylacrylate – 1-Vinyl-2-pyrrolidone copolymer, E110, E180, copper phthalocyanine blue pigment, polyethylene, siliconised polyester.
Vsebuje tudi: sorbitanoleat, 2- etilheksilakrilat – 1- vinil- 2- pirolidonski kopolimer, E 110, E 180, modri pigment bakrovega ftalocianina, polietilen, silikonizirani poliester.
Apply immediately upon removal from the sachet.
Namestite takoj, ko vzamete iz zaščitne vrečke.
Rusham Park Technical Centre, Whitehall Lane, Egham, Surrey TW20 9NW United Kingdom
Rusham Park Technical Centre, Whitehall Lane, Egham, Surrey TW20 9NW Velika Britanija
Change the patch only on these two days. o Sunday + Wednesday o Monday + Thursday o Tuesday + Friday o Wednesday + Saturday o Thursday + Sunday o Friday + Monday o Saturday + Tuesday
Obliž zamenjajte samo ob naslednjih dveh dneh: o nedelja in sreda o ponedeljek in četrtek o torek in petek o sreda in sobota o četrtek in nedelja o petek in ponedeljek o sobota in torek
16 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
16 PODATKI NA PRIMARNI OVOJNINI
SACHET
ZAŠČITNA VREČKA
Intrinsa 300 micrograms/ 24 hours transdermal patch Testosterone Transdermal use
Intrinsa 300 mikrogramov/ 24 ur transdermalni obliž Testosteron Transdermalna uporaba
Read all of this leaflet carefully before you start using this medicine.  Keep this leaflet.
Pred uporabo natančno preberite navodilo!  Navodilo shranite.
Do not pass it on to others.
Morda ga boste želeli ponovno prebrati.  Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.  Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
It may harm them, even if their symptoms appear to be the same as yours.  If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.  Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
What Intrinsa is and what it is used for 2.
Kaj je zdravilo Intrinsa in za kaj ga uporabljamo 2.
What you should consider before you use Intrinsa 3.
Kaj morate upoštevati, preden boste uporabili zdravilo Intrinsa 3.
How to use Intrinsa 4.
Kako uporabljati zdravilo Intrinsa 4.
How to store Intrinsa 6.
Shranjevanje zdravila Intrinsa 6.
Intrinsa is intended for use by women up to the age of 60 years who:  have a low sexual desire which is causing distress or concern, and  have had both of their ovaries removed, and  have had their womb removed (hysterectomy), and  are receiving estrogen therapy.
Zdravilo Intrinsa je namenjeno ženskam, starim do 60 let, ki:  imajo nizko spolno željo, ki povzroča stisko ali skrbi in  so jim odstranili oba jajčnika in  so jim odstranili maternico (histerektomija) in  prejemajo zdravljenje z estrogenom.
If you have not experienced a positive effect of Intrinsa within 3-6 months, you should inform your doctor, who will suggest that treatment be discontinued.
Če ugodnega učinka zdravila Intrinsa ne opazite v 3– 6 mesecih, morate obvestiti svojega zdravnika, ki vam bo predlagal, da zdravljenje prekinete.
WHAT YOU SHOULD CONSIDER BEFORE YOU USE INTRINSA
KAJ MORATE UPOŠTEVATI, PREDEN BOSTE UPORABILI ZDRAVILO INTRINSA
Do not use Intrinsa  if you are allergic (hypersensitive) to testosterone or any of the other ingredients of Intrinsa.  if you know that you have had in the past, currently have, or think that you might have, breast cancer or any other cancer which your doctor has described as being caused or stimulated by the female hormone estrogen, also called ‘ estrogen-dependent’ cancers.  if you have other conditions that your doctor may consider not appropriate for the use of estrogen and/ or testosterone.
Ne uporabljajte zdravila Intrinsa  če ste alergični na (preobčutljivi za) testosteron ali katerokoli sestavino zdravila Intrinsa;  če veste, da ste v preteklosti imeli, trenutno imate ali mislite, da bi lahko imeli rak dojke ali katerikoli drugi rak, za katerega zdravnik meni, da ga je povzročil ali spodbudil ženski hormon estrogen; tak rak se imenuje tudi "od estrogena odvisni rak";  če imate druge bolezni, zaradi katerih vaš zdravnik meni, da ne smete uporabljati estrogena in/ ali testosterona.
19 Take special care with Intrinsa  if you have a history of heart, liver or kidney disease.  if you are diabetic, as testosterone may lower blood glucose levels.  if you have a history of excessive adult acne, body or facial hair, hair loss, enlargement of the clitoris or voice deepening or hoarseness.
19 Bodite posebno pozorni pri uporabi zdravila Intrinsa  če ste v preteklosti imeli bolezen srca, ledvic ali jeter;  če ste sladkorna bolnica, ker testosteron lahko zniža raven glukoze v krvi;  če ste v preteklosti imeli hude akne v odrasli dobi, poraščenost telesa ali obraza, izpadanje las, povečanje klitorisa, znižanje glasu ali hripavost.
The efficacy of Intrinsa is reduced if your estrogen therapy is of a certain type (‘ conjugated equine estrogens’).
Učinkovitost zdravila Intrinsa se zmanjša, če se zdravite z določeno vrsto estrogenov (‘ konjugirani konjski estrogeni ’).
It is not known whether Intrinsa increases the risk of breast cancer.
Ni znano, ali zdravilo Intrinsa poveča tveganje za rak dojke.
Your doctor will carefully monitor you with regard to breast cancer.
Zdravnik vas bo skrbno spremljal z ozirom na raka dojke.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Jemanje drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Take particular care if you are taking medicines containing any of the following active substances:  blood-thinning (anticoagulant) treatment
Bodite posebno previdni, če jemljete zdravila, ki vsebujejo katerokoli od naslednjih zdravilnih učinkovin:  zdravila za redčenje krvi (antikoagulanti)
Children and adolescents Intrinsa is not for use in children and adolescents.
Otroci in mladostniki Zdravilo Intrinsa ni namenjeno uporabi pri otrocih in mladostnikih.
Intrinsa should be replaced twice weekly (each 3 to 4 days).
KAKO UPORABLJATI ZDRAVILO INTRINSA
The active substance is released from the patch constantly over 3 to 4 days and is absorbed through your skin.
Zdravilna učinkovina se 3 do 4 dni neprekinjeno sprošča iz obliža in se vpije skozi kožo.
You should check with your doctor or pharmacist if you are not sure of the instructions or if you want any more information.
Če ste negotovi da razumete navodila, ali če želite dodatne informacije, se posvetujte z zdravnikom ali s farmacevtom.
Where to stick the patch  Stick the patch onto your lower abdomen, below your waist.
20 Kam nalepiti obliž  Obliž nalepite na spodnji del trebuha, pod pas.
20 Make sure that your skin at the application site is:  clean and dry (free of lotions, moisturisers, and powders)  as smooth as possible (no major creases or skin folds)  not cut or irritated (free of rashes or other skin problems)  unlikely to be rubbed by clothing excessively  preferably free from hair.  When changing your patch, stick the new patch on to a different area of the skin of your abdomen, otherwise you are more likely to cause skin irritation.
čista in suha (brez losjonov, sredstev za vlaženje kože in pudrov); čim bolj gladka (brez večjih pregibov ali kožnih gub); ni poškodovana ali razdražena (brez izpuščajev ali drugih težav s kožo); da je oblačila ne bodo pretirano drgnila; po možnosti brez dlak.
 Only one patch is to be worn at a time.
 Naenkrat smete uporabljati le en obliž.
 If you are also using estrogen patches, make sure that the patch and the estrogen patch do not overlap.
 Če uporabljate tudi estrogenske obliže, pazite, da se ta obliž in estrogenski obliž ne prekrivata.
 For at least one week after removing a patch, do not place a new patch in the same area.
 Potem ko odstranite obliž, novega vsaj en teden ne namestite na isto mesto.
How to stick on the patch Step 1 Tear open the sachet.
Kako nalepiti obliž 1. korak Odprite zaščitno vrečko.
Apply the patch immediately after removing it from the sachet.
Namestite ga takoj, ko ga vzamete iz zaščitne vrečke.
21 Step 4 Fold back the patch and carefully remove the other half of the liner.
21 4. korak Obliž prepognite in previdno odstranite drugo polovico zaščitne plasti.
How to change your patch  You will need to change your patch every 3 to 4 days, which means using two patches each week.
Kako zamenjati obliž  Obliž boste morali zamenjati vsake 3 do 4 dni, kar pomeni, da boste vsak teden uporabili dva obliža.
Decide which two days each week you are going to change your patch, and change the patch on the same two days each week.
Obliž vsak teden zamenjajte ob istih dveh dnevih.
If you decide to start treatment on a Monday, then you have to change your patch always on a Thursday and a Monday.
Če ste se odločili, da boste zdravljenje začeli v ponedeljek, morate obliž vedno zamenjati ob četrtkih in ponedeljkih.
Sunday + Wednesday Monday + Thursday Tuesday + Friday Wednesday + Saturday Thursday + Sunday Friday + Monday Saturday + Tuesday
nedelja in sreda ponedeljek in četrtek torek in petek sreda in sobota četrtek in nedelja petek in ponedeljek sobota in torek
 On the patch-change day, remove the used patch and immediately stick the new patch on to a different area of skin of your abdomen.
 Na dan, ko menjavate obliž, odstranite uporabljeni obliž in takoj nalepite novega na drugo mesto na koži trebuha.
 Fold the used patch in half, sticking the patch to itself, and discard it in a safe way in order to keep it away from children (e. g. in a rubbish bin).
 Uporabljeni obliž prepognite, tako da se zalepi sam nase in ga zavrzite na varen način, tako da bo zunaj dosega otrok (npr. v koš za smeti).
Then continue with your regular schedule of patch-change days, even if this means discarding a patch after you have worn it for less than 3-4 days.
Nato nadaljujte reden razpored menjave obliža, tudi če boste obliž zavrgli potem, ko ste ga imeli manj kot 3– 4 dni.
22 If you use more patches than you should If you have applied more than one patch at a time Remove all the patches sticking on to your skin and consult your doctor or pharmacist for further information on how to continue treatment with Intrinsa.
Če ste uporabili več obližev, kot bi smeli Če ste nalepili več kot en obliž hkrati Odstranite vse obliže in se posvetujte z zdravnikom ali s farmacevtom o tem, kako nadaljevati zdravljenje z zdravilom Intrinsa.
If you forget to use a patch If you forget to change your patch Change your patch as soon as you remember, and then continue with your regular schedule of patch- change days, even if this means discarding a patch after you have worn it for less than 3-4 days.
22 Če ste pozabili uporabiti obliž Če ste pozabili zamenjati obliž Obliž zamenjajte takoj, ko se spomnite, nato nadaljujte reden razpored menjave obliža, tudi če boste obliž zavrgli potem, ko ste ga imeli manj kot 3– 4 dni.
Tell your doctor immediately:  if you experience hair loss, enlargement of the clitoris, an increase in the amount of hair on the chin or upper lip, voice deepening or hoarseness, although these side effects may be mild.
Zdravniku takoj povejte:  če vam začnejo izpadati lasje, se vam poveča klitoris, poveča število dlak na bradi ali zgornji ustnici, če se vam zniža glas ali če ste hripavi, četudi so ti neželeni učinki blagi.
You should self assess for increased acne, increased hair growth on your face, loss of hair, deepening of your voice or enlargement of your clitoris, which all could be signs of adverse effects of testosterone, which is the active substance in Intrinsa.
Opazujte te znake povečanja pojava aken, povečane rasti dlak na obrazu, izpadanja las, znižanja glasu ali povečanja klitorisa, ker so lahko znaki neželenih učinkov testosterona, ki je zdravilna učinkovina v zdravilu Intrinsa.
 if you notice any skin reactions at the site of application such as redness, oedema, or blistering.
 če opazite kakršnekoli kožne reakcije na mestu namestitve, kot so rdečica, edem ali mehurji.
Very common side effects The following side effects may occur very commonly (in more than 1 out of 10 patients). o rash/ irritation/ itching/ redness at the site of the skin where the patch is applied o increase in the amount of hair on the chin or upper lip (likely to be mild and reversible)
Zelo pogosti neželeni učinki Naslednji neželeni učinki se lahko pojavijo zelo pogosto (pri več kot 1 bolnici od 10). o izpuščaj/ draženje/ srbenje/ rdečica na mestu na koži, kjer je nameščen obliž o povečanje števila dlak na bradi in zgornji ustnici (zelo verjetno blago in reverzibilno)
Common side effects The following side effects may occur commonly (in more than 1 out of 100, but less than 1 out of 10 patients), but most of them are mild in nature and reversible. o hair loss o acne o migraine o insomnia/ inability to sleep properly o voice deepening or hoarseness o breast pain o weight gain o abdominal pain
Večina teh učinkov je blagih in prehodnih: o izpadanje las o akne o migrena o nespečnost/ nezmožnost dobrega spanja o znižanje glasu ali hripavost o bolečine v dojkah o povečanje telesne mase o bolečina v trebuhu
If any of the side effects become serious, or if you notice any side effects mentioned above or side effects not listed in this leaflet, please tell your doctor.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli zgoraj omenjeni neželeni učinek, ali katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
 Keep out of the reach and sight of children.  Do not store above 30°C.  Do not refrigerate or freeze.
 Zdravilo shranjujte nedosegljivo otrokom!  Shranjujte pri temperaturi do 30 °C.  Ne shranjujte v hladilniku ali zamrzujte.
23 Do not use Intrinsa after the expiry date which is stated on the carton and sachet.
Zdravila Intrinsa ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in zaščitni vrečki.
What Intrinsa contains The active substance is testosterone.
Kaj vsebuje zdravilo Intrinsa Zdravilna učinkovina je testosteron.
Each patch contains 8.4 mg of testosterone, releasing 300 micrograms of testosterone over 24 hours.
Vsak obliž vsebuje 8, 4 mg testosterona, sprosti pa 300 mikrogramov testosterona v 24 urah.
Sorbitan oleate, 2-Ethylhexylacrylate – 1-Vinyl-2-pyrrolidone co-polymer.
Pomožne snovi so: sorbitanoleat, 2- etilheksilakrilat – 1- vinil- 2- pirolidonski kopolimer.
What Intrinsa looks like and contents of the pack Intrinsa is a thin, clear, oval patch with PG T001 stamped on the back.
Izgled zdravila Intrinsa in vsebina pakiranja Intrinsa je tanek, prozoren, ovalen obliž z napisom PG T001, natisnjenim na zadnji strani.
2, 8 and 24 patches.
2, 8 in 24 obližev.
Marketing Authorisation Holder Procter & Gamble Pharmaceuticals UK Ltd.
Imetnik dovoljenja za promet z zdravilom Procter & Gamble Pharmaceuticals UK Ltd.
Rusham Park Technical Centre Whitehall Lane Egham, Surrey TW20 9NW United Kingdom
Rusham Park Technical Centre Whitehall Lane Egham, Surrey TW20 9NW Velika Britanija
Manufacturer Procter & Gamble Pharmaceuticals – Germany GmbH Dr. -Otto-Röhm-Strasse 2-4 D-64331 Weiterstadt Germany
Izdelovalec Procter & Gamble Pharmaceuticals – Germany GmbH Dr. - Otto- Röhm- Strasse 2– 4 D- 64331 Weiterstadt Nemčija
This leaflet was last approved in {MM/ YYYY}
Navodilo je bilo odobreno {MM/ LLLL}.
IntronA is a medicine containing the active substance interferon alfa-2b.
IntronA je zdravilo, ki vsebuje zdravilno učinkovino interferon alfa- 2b.
It is available as a powder and solvent to be made into a solution for injection or infusion, as a ready-to-use solution for injection and as a multidose pen for injection.
Na voljo je kot prašek in vehikel za pripravo raztopine za injiciranje ali infudiranje, kot predhodno pripravljena raztopina za injiciranje ter kot večodmerni peresnik za injiciranje.
IntronA is used for the treatment of: • chronic (long-term) hepatitis B (a disease of the liver due to an infection by the hepatitis B virus) in adults, • chronic hepatitis C (a disease of the liver due to an infection by the hepatitis C virus).
Zdravilo IntronA se uporablja za zdravljenje: • kroničnega (dolgotrajnega) hepatitisa B (bolezni jeter, ki je posledica okužbe z virusom hepatitisa B) pri odraslih, • kroničnega hepatitisa C (bolezni jeter, ki je posledica okužbe z virusom hepatitisa C).
In adults IntronA can be used on its own but is best used in combination with ribavirin (an antiviral medicine), and in children, it is used with ribavirin, • hairy cell leukaemia (a cancer of the white blood cells), • chronic myelogenous leukaemia (CML, another cancer of the white blood cells) in adults.
Pri odraslih je zdravilo IntronA mogoče uporabljati samostojno, vendar je bolje, če se uporablja v kombinaciji z ribavirinom (protivirusnim zdravilom), pri otrocih pa se uporablja v kombinaciji z ribavirinom, • dlakastocelične levkemije (raka belih krvničk), • kronične mieloične levkemije (CML, druge vrste raka belih krvničk) pri odraslih.
IntronA can be used in combination with cytarabine (an anticancer medicine) in the first 12 months, • multiple myeloma (a cancer of the bone marrow).
Zdravilo IntronA je mogoče uporabljati v kombinaciji s citarabinom (zdravilom proti raku) v prvih 12 mesecih, • multiplega mieloma (raka kostnega mozga).
IntronA is used to maintain anticancer effects in patients who have responded to a previous treatment with anticancer medicines, • follicular lymphoma (a cancer of the lymph tissue).
Zdravilo IntronA se uporablja za vzdrževanje protirakavih učinkov pri bolnikih, ki so se odzvali na predhodno zdravljenje z zdravili proti raku, • folikularnega limfoma (raka limfatičnega tkiva).
IntronA is used as an add-on to anticancer treatments, • carcinoid tumour (a tumour of the endocrine system that produces hormones), • malignant melanoma (a type of skin cancer affecting cells called melanocytes).
Zdravilo IntronA se uporablja kot dodatek zdravilom proti raku, • karcinoidnega tumorja (tumorja endokrinega sistema, ki proizvaja hormone), • malignih melanomov (vrste kožnega raka, ki prizadene celice, imenovane melanociti).
Treatment with IntronA should be initiated by a doctor who has experience in the management of the disease it is being used for.
Zdravljenje z zdravilom IntronA mora uvesti zdravnik, ki ima izkušnje z zdravljenjem bolezni, za katero se uporablja.
IntronA is generally given three times per week (every other day) but the injection can be given more frequently in some diseases (CML and melanoma).
Zdravilo IntronA se navadno daje trikrat tedensko (vsak drugi dan), injekcijo pa je pri nekaterih boleznih mogoče dajati pogosteje (CML in melanomi).
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Navadno se daje kot subkutana 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 the response of the patient, with doses ranging from 2 to 20 million IU per square metre of body surface area.
(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 injekcija (pod kožo), pri melanomih pa jo je mogoče dajati tudi kot intravensko infuzijo (dajanje v veno).
IntronA has to be stored in a refrigerator (2°C-8°C).
Zdravilo IntronA je treba hraniti v hladilniku (2°C- 8°C).
The active substance in IntronA, interferon alfa-2b, belongs to the group ‘ interferons’.
Zdravilna učinkovina zdravila IntronA, interferon alfa- 2b, spada v skupino interferonov.
Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
Interferoni so naravne snovi, ki jih telo proizvaja za obrambo pred napadi, kot so okužbe, ki jih povzročajo virusi.
The exact way alpha interferons work in cancer and viral diseases in not fully understood, but it is thought that they act as immunomodulators (substances that modify how the immune system, the body ’ s defence system, works).
Natančen način delovanja interferonov alfa pri raku in virusnih boleznih ni v celoti znan, vendar se domneva, da delujejo kot imunomodulatorji (snovi, ki spreminjajo način delovanja imunskega sistema, obrambnega sistema telesa).
The interferon alfa-2b in IntronA is produced by a method known as ‘ recombinant DNA technology’: the interferon alfa-2b is made by a bacterium that has received a gene (DNA), which makes it able to produce it.
Interferon alfa- 2b, ki ga vsebuje zdravilo IntronA, se proizvaja po metodi, imenovani „ rekombinantna DNA tehnologija “: interferon alfa- 2b proizvaja bakterija, ki je prejela gen (DNA), ki ji omogoča njegovo tvorjenje.
The replacement interferon alfa-2b acts in same way as naturally produced interferon alpha.
Nadomestni interferon alfa- 2b deluje na enak način kot naravno proizvedeni interferon alfa.
Because interferon alfa-2b has been used to treat a number of diseases in the European Union (EU) before, the company that makes IntronA supplied data from the scientific literature and from studies of its use with cytarabine in CML (745 patients) and of its use in children with chronic hepatitis B.
Ker se je interferon alfa- 2b že prej uporabljal za zdravljenje številnih bolezni v Evropski uniji (EU), je podjetje, ki izdeluje zdravilo IntronA, predložilo podatke iz znanstvene literature in iz študij o njegovi uporabi v kombinaciji s citarabinom pri CML (745 bolnikov) in njegovi uporabi pri otrocih s kroničnim hepatitisom B.
These included a total of 2,552 treatment-naïve patients (who had not been treated before) and a total of 345 patients whose disease had relapsed (returned) after previous treatment with interferon.
Podjetje je predložilo tudi podatke iz številnih študij zdravila IntronA, uporabljenega samostojno ali v kombinaciji z ribavirinom pri zdravljenju kroničnega hepatitisa C. V teh študijah je sodelovalo skupno 2552 predhodno nezdravljenih bolnikov (ki dotlej še niso prejemali zdravil) in skupno 345 bolnikov, pri katerih se je bolezen ponovila po predhodnem zdravljenju z interferonom.
The use of IntronA in combination with ribavirin has also been studied in 118 hepatitis C treatment-naïve children aged between 3 and 16 years.
Uporabo zdravila IntronA v kombinaciji z ribavirinom so preučevali tudi pri pr 118 predhodno nezdravljenih otrocih s hepatitisom C, starimi med 3 in 16 leti.
The main measures of effectiveness were response rates in the hepatitis studies and survival time in the cancer studies.
Glavni merili učinkovitosti sta bili stopnja odziva v študijah hepatitisa in čas preživetja v študijah raka.
What benefit has IntronA shown during the studies?
Kakšne koristi je zdravilo IntronA izkazalo med raziskavami?