natgillin/translations-raw huggingface dataset:
EU/ 1/ 06/ 366/ 005 14 tablets EU/ 1/ 06/ 366/ 006 28 tablets EU/ 1/ 06/ 366/ 007 30 tablets EU/ 1/ 06/ 366/ 008 50 tablets EU/ 1/ 06/ 366/ 009 90 tablets EU/ 1/ 06/ 366/ 010 98 tablets
EU/ 1/ 06/ 366/ 005 14 tablet EU/ 1/ 06/ 366/ 006 28 tablet EU/ 1/ 06/ 366/ 007 30 tablet EU/ 1/ 06/ 366/ 008 50 tablet EU/ 1/ 06/ 366/ 009 90 tablet EU/ 1/ 06/ 366/ 010 98 tablet
Tandemact 45 mg/ 4 mg tablets
Tandemact 45 mg/ 4 mg tablete
14 tablets 28 tablets 30 tablets 50 tablets 90 tablets 98 tablets 5.
14 tablet 28 tablet 30 tablet 50 tablet 90 tablet 98 tablet
EU/ 1/ 06/ 366/ 011 14 tablets EU/ 1/ 06/ 366/ 012 28 tablets EU/ 1/ 06/ 366/ 013 30 tablets EU/ 1/ 06/ 366/ 014 50 tablets EU/ 1/ 06/ 366/ 015 90 tablets EU/ 1/ 06/ 366/ 016 98 tablets
EU/ 1/ 06/ 366/ 011 14 tablet EU/ 1/ 06/ 366/ 012 28 tablet EU/ 1/ 06/ 366/ 013 30 tablet EU/ 1/ 06/ 366/ 014 50 tablet EU/ 1/ 06/ 366/ 015 90 tablet EU/ 1/ 06/ 366/ 016 98 tablet
53 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
53 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
NAME OF THE MARKETING AUTHORISATION HOLDER
IME IMETNIKA DOVOLJENJA ZA TRŽENJE
Batch number:
Ševilka serije:
ABBREVIATIONS FOR DAYS OF THE WEEK (PACK SIZES OF 14, 28, AND 98 TABLETS ONLY)
KRATICE ZA DNEVE V TEDNU (SAMO PAKIRANJA PO 14, 28 IN 98 TABLET)
INFORMATION FOR THE USER Tandemact 30 mg/ 2 mg tablets
57 NAVODILO ZA UPORABO Tandemact 30 mg/ 2 mg tablete
Pioglitazone / glimepiride
pioglitazon/ glimepirid
What Tandemact is and what it is used for 2.
Kaj je zdravilo Tandemact in za kaj ga uporabljamo 2.
Before you take Tandemact 3.
Kaj morate vedeti, preden boste vzeli zdravilo Tandemact 3.
How to take Tandemact 4.
Kako jemati zdravilo Tandemact 4.
Storing Tandemact 6.
Shranjevanje zdravila Tandemact 6.
WHAT TANDEMACT IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO TANDEMACT IN ZA KAJ GA UPORABLJAMO
Tandemact is used for the treatment of type 2 (non-insulin dependent) diabetes mellitus.
Tandemact je zdravilo za zdravljenje sladkorne bolezni tipa 2 (od insulina neodvisne sladkorne bolezni).
BEFORE YOU TAKE TANDEMACT
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO TANDEMACT
Do not take Tandemact:
Ne jemljite zdravila Tandemact:
- If you are allergic (hypersensitive) to pioglitazone, glimepiride, other sulphonylureas or
- če ste alergični (preobčutljivi za) na pioglitazon, glimepirid, druge sulfonilsečnine ali
sulphonamides, or any of the other ingredients of Tandemact.
sulfonamide ali katerokoli sestavino tablet Tandemact.
- If you have heart failure.
- če imate srčno popuščanje.
- If you have liver disease.
- če imate obolenje jeter.
- If you have severe problems with your kidneys.
- če imate resne težave z ledvicami.
- If you have insulin dependent diabetes (Type 1).
- če imate od insulina odvisno sladkorno bolezen (tip 1).
- If you are pregnant.
- če ste noseči.
Take special care with Tandemact:
Bodite posebno pozorni pri jemanju zdravila Tandemact:
- If you are planning to become pregnant.
- če načrtujete nosečnost.
There may be an increased possibility of your becoming
Glede na način delovanja vašega zdravila obstaja večja
pregnant because of how your medicine works.
možnost zanositve.
- If you have a problem with your liver or heart.
- če imate težave z jetri ali s srcem.
of the eye).
zadnjega dela očesa).
- If you are already taking other medicines for the treatment of diabetes.
- če že jemljete katerakoli zdravila za zdravljenje sladkorne bolezni.
- If you are under 18 years of age because use in such patients is not recommended.
- če ste mlajši od 18 let, saj pri takšnih bolnikih uporaba zdravila ni priporočljiva.
58 Taking other medicines:
58 Jemanje drugih zdravil:
This is because some medicines can weaken or strengthen the effect of Tandemact on the level of sugar in your blood.
Nekatera zdravila lahko oslabijo ali povečajo učinek Tandemacta na raven sladkorja v krvi.
Do not take Tandemact if you are pregnant or breast-feeding.
Zdravila Tandemact ne smete jemati, če ste noseči ali dojite.
Tell your doctor if you are, you think you might be or are planning to become pregnant, or if you are planning to breast-feed your baby.
Svojemu zdravniku povejte, če ste, ali če mislite, da bi lahko bili noseči, ali če nameravate zanositi ali dojiti svojega otroka.
Alertness and reaction time may be impaired due to low or high blood sugar due to glimepiride, especially when beginning or after altering treatment or when Tandemact is not taken regularly.
Na začetku ali pri spremembi zdravljenja ali ob nerednem jemanju zdravila Tandemact se lahko poslabša budnost in odzivni čas zaradi nizke ali visoke ravni sladkorja v krvi, ki jo povzroča glimepirid.
This may affect your ability to drive or operate machinery.
To lahko vpliva na vašo sposobnost upravljanja vozil in strojev.
Important information about some of the ingredients of Tandemact:
Pomembne informacije o nekaterih sestavinah zdravila Tandemact:
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Tandemact.
Če vam je vaš zdravnik povedal, da imate intoleranco za nekatere sladkorje, pokličite svojega zdravnika preden vzamete zdravilo Tandemact.
HOW TO TAKE TANDEMACT
KAKO JEMATI ZDRAVILO TANDEMACT
Always take Tandemact exactly as your doctor has told you.
Pri jemanju zdravila Tandemact natančno upoštevajte zdravnikova navodila.
The usual dose is one tablet taken once daily shortly before or with the first main meal.
Običajni odmerek je ena tableta dnevno neposredno pred ali s prvim glavnim obrokom.
Tablets should be swallowed whole with some liquid.
Tablete se pogoltnejo cele z nekaj tekočine.
If you have the impression that the effect of Tandemact is too weak, talk to your doctor.
Če menite, da je učinek zdravila prešibak, se posvetujte z zdravnikom.
If you are following a special diet for diabetes, you should continue with this while you are taking Tandemact.
Če ste na diabetični dieti, jo med jemanjem zdravila Tandemact nadaljujte.
Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
Vašo telesno maso je treba preverjati v rednih intervalih; če se vam telesna masa znatno poveča, o tem obvestite svojega zdravnika.
In clinical trials in which pioglitazone was compared to other oral anti diabetic drugs or placebo (dummy pill), a higher number of bone fractures was seen in women (but not in men) taking pioglitazone.
V kliničnih preskušanjih, v katerih so primerjali pioglitazon z drugimi peroralnimi antidiabetičnimi zdravili ali placebom (tableta brez zdravilne učinkovine), so opazili večje število zlomov kosti pri ženskah (vendar ne pri moških), ki so jemale pioglitazon.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure.
Pri nekaterih bolnikih z dolgo trajajočo sladkorno boleznijo tipa 2 in s srčno boleznijo ali predhodno kapjo, ki so bili zdravljeni s pioglitazonom in insulinom, pride do razvoja srčnega popuščanja.
If you take more Tandemact than you should:
Če ste vzeli večji odmerek zdravila Tandemact, kot bi smeli:
If you forget to take Tandemact:
Če ste pozabili vzeti zdravilo Tandemact:
Try to take Tandemact daily as prescribed.
Poskušajte jemati zdravilo Tandemact vsak dan, kakor vam je predpisano.
If you stop taking Tandemact:
59 Če ste prenehali jemati zdravilo Tandemact:
Do not stop taking Tandemact without first discussing it with your doctor or pharmacist.
Ne prenehajte z jemanjem zdravila Tandemact dokler se ne posvetujete s svojim zdravnikom ali farmacevtom.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila Tandemact, se posvetujte z zdravnikom ali s farmacevtom.
Like all medicines, Tandemact can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Tandemact neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Between 1 in 10 and 1 in 100 patients experience
Med 1 od 10 in 1 od 100 bolnikov izkusi
- dizziness
- omotico
- upper respiratory tract infection
- infekcija zgornjega dihalnega trakta
Between 1 in 100 and 1 in 1000 patients experience
Med 1 od 100 in 1 od 1. 000 bolnikov izkusi
- vertigo
- vrtoglavico
- decreased blood sugar
- znižan krvni sladkor
- sugar in urine
- sladkor v urinu
- proteins in urine
- beljakovine v urinu
- increased appetite
- povečan apetit
Less than 1 in 10,000 patients experience
Manj kot 1 od 10. 000 bolnikov izkusi
- allergic reactions including allergic shock
- alergijske reakcije, vključno z alergijskim šokom
- nausea, vomiting and diarrhoea
- slabost, bruhanje in drisko
Blurred vision due to swelling (or fluid) in the back of the eye has been reported.
Poročali so zamegljenem vidu, ki je posledica otekline (ali tekočine) v zadnjem delu očesa.
If you experience these symptoms for the first time or if they get worse talk to your doctor as soon as possible.
Če imate te simptome prvič ali če so se ti simptomi poslabšali, čim prej obvestite svojega zdravnika.
It is important to know what symptoms to expect when hypoglycaemia (low blood sugar) occurs.
Pomembno je, da veste, katere simptome lahko pričakujete, če se pojavi hipoglikemija (nizek krvni sladkor).
Ask your doctor or pharmacist for more information if you are not sure how to recognise this.
Posvetujte se s svojim zdravnikom ali farmacevtom, če niste prepričani, da bi jih prepoznali.
The symptoms may include cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness or nausea.
Simptomi lahko vključujejo mrazenje, utrujenost, glavobol, hitrejše dihanje, občutek lakote, razdražljivost, živčnost ali slabost.
Tell your doctor if you notice such symptoms.
Če opazite takšne simptome, obvestite svojega zdravnika.
Lowering of the Hb level and breakdown of red blood cells (haemolytic anemia) can occur in patients missing the enzyme Glucose-6-phosphodehydrogenase.
Pri bolnikih, ki nimajo encima glukoza- 6- fosfat- dehidrogenaze se lahko pojavi nižanje ravni Hb in propadanje rdečih krvničk (hemolitična anemija).
STORING TANDEMACT
SHRANJEVANJE ZDRAVILA TANDEMACT
Do not use Tandemact after the expiry date which is stated on the carton and blister.
Zdravila Tandemact ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na kartonu in na pretisnem omotu.
Medicines should not be disposed of via waste water or household waste.
Zdravila ne smete odvreči v odpadno vode ali med gospodinjske odpadke.
What Tandemact contains:
Kaj vsebuje zdravilo Tandemact:
The active substances are pioglitazone and glimepiride.
Zdravilni učinkovini sta pioglitazon in glimepirid.
Each tablet contains 30 mg pioglitazone (as hydrochloride) and 2 mg glimepiride.
Vsaka tableta vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida) in 2 mg glimepirida.
The other ingredients are cellulose microcrystalline, croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate and polysorbate 80.
Pomožne snovi so mikrokristalna celuloza, premreženi natrijev karmelozat, hidroksipropilceluloza, laktoza monohidrat, magnezijev stearat in polisorbat 80.
What Tandemact looks like and contents of the pack:
Izgled tablet Tandemact in vsebina pakiranja:
The tablets are white to off-white, round, convex and embossed ‘ 4833 G’ on one face and 30/ 2 on the other.
Tablete so bele do umazano bele barve, okrogle, izbočene, z oznako ‘ 4833 G ’ na eni strani in 30/ 2 na drugi.
The tablets are supplied in blister packs containing either 14, 28, 30, 50, 90 or 98 tablets.
Tablete so na voljo v pretisnih omotih, ki vsebujejo bodisi 14, 28, 30, 50, 90 ali 98 tablet.
Takeda Italia Farmaceutici S. p. A., Via Crosa, 86, 28065 Cerano (NO), Italy.
Takeda Italia Farmaceutici S. p. A., Via Crosa, 86, 28065 Cerano (NO), Italija.
Eesti Takeda Global R & D Centre (Europe) Tel: +44 (0)20 3116 8000
61 Eesti Österreich Takeda Global R & D Centre (Europe) Tel: +44 (0) 20 3116 8000
INFORMATION FOR THE USER Tandemact 30 mg/ 4 mg tablets
62 NAVODILO ZA UPORABO Tandemact 30 mg/ 4 mg tablete
63 Taking other medicines:
63 Jemanje drugih zdravil:
If you stop taking Tandemact:
64 Če ste prenehali jemati zdravilo Tandemact:
Each tablet contains 30 mg pioglitazone (as hydrochloride) and 4 mg glimepiride.
Vsaka tableta vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida) in 4 mg glimepirida.
The tablets are white to off-white, round, convex and embossed ‘ 4833 G’ on one face and 30/ 4 on the other.
Tablete so bele do umazano bele barve, okrogle, izbočene, z oznako ‘ 4833 G ’ na eni strani in 30/ 4 na drugi.
Eesti Takeda Global R & D Centre (Europe) Tel: +44 (0)20 3116 8000
66 Eesti Österreich Takeda Global R & D Centre (Europe) Tel: +44 (0) 20 3116 8000
INFORMATION FOR THE USER Tandemact 45 mg/ 4 mg tablets
67 NAVODILO ZA UPORABO Tandemact 45 mg/ 4 mg tablete
68 Taking other medicines:
68 Jemanje drugih zdravil:
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure.
Nekateri bolniki z dolgo trajajočo sladkorno boleznijo tipa 2 in s srčno boleznijo ali predhodno kapjo, ki so bili zdravljeni s pioglitazonom in insulinom, so doživeli razvoj srčnega popuščanja.
If you stop taking Tandemact:
69 Če ste prenehali jemati zdravilo Tandemact:
The active substances are pioglitazone and glimepiride.
Zdravilni učinkovini v tabletah Tandemact sta pioglitazon in glimepirid.
Each tablet contains 45 mg pioglitazone (as hydrochloride) and 4 mg glimepiride.
Vsaka tableta vsebuje 45 mg pioglitazona (v obliki pioglitazonijevega klorida) in 4 mg glimepirida.
The other ingredients are cellulose microcrystalline, croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate and polysorbate 80.
Pomožne snovi so mikrokristalna celuloza, premreženi natrijev karmelozat, hidroksipropilceluloza, lactoza monohidrat, magnezijev stearat in polisorbat 80.
The tablets are white to off-white, round, flat and embossed ‘ 4833 G’ on one face and ‘ 45/ 4’ on the other.
Tablete so bele do umazano bele barve, okrogle, ploske in z oznako ‘ 4833 G ’ na eni strani in ‘ 45/ 4 ’ na drugi.
The tablets are supplied in blister packs containing either 14, 28, 30, 50, 90, or 98 tablets.
Tablete so na voljo v pretisnih omotih, ki vsebujejo bodisi 14, 28, 30, 50, 90 ali 98 tablet.
Eesti Takeda Global R & D Centre (Europe) Tel: +44 (0)20 3116 8000
71 Eesti Österreich Takeda Global R & D Centre (Europe) Tel: +44 (0) 20 3116 8000
Suomi/ Finland Takeda Global R & D Centre (Europe) Puh/ Tel: +44 (0)20 3116 8000
Suomi/ Finland Takeda Global R & D Centre (Europe) Puh/ Tel: +44 (0) 20 3116 8000000
Tarceva are white to pale yellow round tablets, which contain 25, 100 or 150 mg of the active substance erlotinib.
Zdravilo Tarceva so okrogle tablete bele do bledo rumene barve, ki vsebujejo 25, 100 ali 150 mg zdravilne učinkovine erlotinib.
Tarceva is an anticancer medicine.
Zdravilo Tarceva je zdravilo proti raku.
It is used to treat adult patients with the following diseases: • non-small cell lung cancer.
Uporablja se za zdravljenje odraslih bolnikov z naslednjimi boleznimi: • nedrobnoceličnim rakom pljuč.
Tarceva is used in advanced cancer or metastatic cancer (when cancer cells have spread from the original site to other parts of the body), when at least one previous chemotherapy treatment has failed.
Zdravilo Tarceva se uporablja pri napredovalnem raku ali metastatskem raku (ko se celice raka širijo iz njihovega izvornega mesta na druge dele telesa), po neuspehu vsaj ene predhodne kemoterapije.
Tarceva has not been shown to be effective in patients whose tumours are ‘ EGFR-negative’. ‘ EGFR-negative’ means that some receptors, the epidermal growth factor receptors (EGFR), cannot be detected on the surface of the cancer cells, or can only be detected in small quantities. • metastatic pancreatic cancer, in combination with gemcitabine (another anticancer medicine).
„ EGFR negativen “ pomeni, da na površini rakavih celic ni mogoče zaznati receptorjev, znanih kot receptorji za epidermalni rastni dejavnik (EGFR), ali pa so ti prisotni le v majhnih količinah. • metastatskim rakom trebušne slinavke v kombinaciji z gemcitabinom (drugim zdravilom proti raku).
Treatment with Tarceva should be supervised by a doctor who has experience of the use of anticancer medicines.
Zdravljenje z zdravilom Tarceva mora nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
For pancreatic cancer, it is 100 mg.
Pri raku pljuč je priporočeni dnevni odmerek zdravila Tarceva 150 mg, pri raku trebušne pa 100 mg.
Tarceva is taken at least one hour before or two hours after food.
Zdravilo Tarceva se jemlje vsaj eno uro pred ali dve uri po obroku.
If needed (for example because of side effects), the dose may be reduced in 50 mg steps.
Če je potrebno (na primer zaradi neželenih učinkov), se lahko odmerek postopoma zniža v korakih po 50 mg.
Treatment of pancreatic cancer should be re-assessed after 4 to 8 weeks if no rash has developed.
V primeru, da se pri zdravljenju raka trebušne slinavke v prvih 4 do 8 tednih ne pojavijo kožni izpuščaji, je treba nadaljnje zdravljenje z zdravilom Tarceva ponovno pretehtati.
Tarceva is not recommended for use in patients with severe liver or kidney disease.
Zdravilo Tarceva ni priporočljivo za bolnike s hudim obolenjem jeter ali ledvic.
The active substance in Tarceva, erlotinib, is an anti-cancer medicine that belongs to the group ‘ epidermal growth factor receptor (EGFR) inhibitors’.
Zdravilna učinkovina zdravila Tarceva, erlotinib, je zdravilo proti raku, ki spada v skupino zaviralcev receptorja za epidermalni rastni dejavnik (EGFR).
Erlotinib blocks the epidermal growth factor receptors, which can be found on the surface of certain tumour cells.
Zdravilna učinkovina, erlotinib, zavira receptorje za epidermalno rast, ki jih lahko najdemo na površini nekaterih tumorskih celic.
As a result of this block, the tumour cell can no longer receive the messages needed for growth, progression and spreading (metastasis).
Posledica tega zaviranja je, da tumorske celice ne prejemajo več sporočil, potrebnih za svojo rast, napredovanje in širjenje (metastaziranje).
This helps Tarceva stop the cancer cells from growing and multiplying.
Zaradi tega zdravilo Tarceva ustavlja rast in razmnoževanje rakavih celic.
(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 How has Tarceva 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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Tarceva raziskano?
The effects of Tarceva were first tested in experimental models before being studied in humans.
Učinki zdravila Tarceva so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
The main study in non-small cell lung cancer involved 731 patients who had not responded to at least one previous chemotherapy treatment.
Glavna študija nedrobnoceličnega raka pljuč je vključevala 731 bolnikov, ki se niso odzvali na vsaj eno predhodno zdravljenje s kemoterapijo.
The main study in pancreatic cancer involved 569 patients with advanced, unresectable (unable to be removed by surgery) or metastatic pancreatic cancer, in combination with gemcitabine.
Glavna študija raka trebušne slinavke je vključevala 569 bolnikov z napredovalnim, neoperabilnim (kjer raka s kirurškim posegom ni mogoče odstraniti) ali metastatskim rakom trebušne slinavke v kombinaciji z gemcitabinom.
In both studies, Tarceva was compared with placebo (a dummy treatment) and the main measure of effectiveness was ‘ median survival’ (time until 50% of the patients were still alive).
V obeh študijah so zdravilo Tarceva primerjali s placebom (zdravilom brez zdravilne učinkovine), glavno merilo učinkovitosti pa je bil „ srednji čas preživetja “ (čas, v katerem je 50% bolnikov še živelo).
What benefit has Tarceva shown during the studies?
Kakšne koristi je zdravilo Tarceva izkazalo med raziskavami?
For lung cancer, the median survival for the Tarceva patients was 6.7 months, compared with 4.7 months for the patients treated with placebo.
Pri raku pljuč je bil srednji čas preživetja bolnikov, zdravljenih z zdravilom Tarceva, 6, 7 mesecev v primerjavi s 4, 7 meseci pri bolnikih, zdravljenih s placebom.
After 12 months, 31.2% of the patients taking erlotinib were still alive, compared with 21.5% of patients treated with placebo.
Po 12 mesecih je bilo živih še 31, 2% bolnikov, ki so jemali erlotinib, v primerjavi z 21, 5% bolnikov, ki so jih zdravili s placebom.
When looking at the results in patients who received Tarceva, and according to their tumour type, the survival figures were 8.6 months in patients who were ‘ EGFR-positive’ (those who had tumour cells that were shown to carry EGFR), compared with 5.0 months in patients who were EGFR-negative.
Če si ogledamo rezultate za bolnike, ki so prejemali zdravilo Tarceva, upoštevajoč vrsto njihovega tumorja, je znašalo preživetje pri bolnikih, ki so bili „ EGRF pozitivni “ (bolniki s tumorskimi celicami, za katere je bilo dokazano, da nosijo EGFR), 8, 6 mesecev v primerjavi s 5, 0 meseci pri bolnikih, ki so bili EGFR negativni.
For metastatic pancreatic cancer, the mediansurvival in the patients treated with Tarceva was 5.9 months, compared to 5.1 months in those taking placebo.
Pri metastatskem raku trebušne slinavke je bil srednji čas preživetja bolnikov, zdravljenih z zdravilom Tarceva, 5, 9 mesecev v primerjavi s 5, 1 meseci pri bolnikih, zdravljenih s placebom.
However, there was no survival advantage for patients with advanced pancreatic cancer that had not spread beyond the pancreas.
Vendar pa pri bolnikih z napredovalnim rakom trebušne slinavke, ki se ni razširil na druge dele telesa, koristnega vpliva na podaljšanje preživetja ni bilo.
In clinical studies, the most common side effects when taking Tarceva (seen in more than 1 patient in 10) were rash and diarrhoea.
V kliničnih študijah sta najpogostejša neželena učinka (opažena pri več kot 1 bolniku od 10) bila izpuščaji in driska.
Most of these were not serious and could be managed without treatment.
Večina teh neželenih učinkov ni bila resnih in so jih lahko obvladovali brez zdravljenja.
More serious rash and diarrhoea occurred in approximately 5-10% of Tarceva-treated patients and each side effect caused up to 1% of patients to stop treatment.
Pri približno 5- 10% bolnikov, ki so prejemali zdravilo Tarceva, se je pojavila težja oblika izpuščajev in driske, zaradi katerih je do 1% bolnikov prekinilo zdravljenje.
Patients with persistent and severe diarrhoea should contact their doctor, as they may be at risk of low blood potassium levels and kidney failure.
Bolniki z dolgotrajno in hudo drisko morajo o tem obvestiti svojega zdravnika, saj so lahko izpostavljeni tveganju nizkega kalija v krvi in poslabšanja ledvičnega delovanja.
They may need to be treated in hospital.
Bolniki bodo morda potrebovali zdravljenje v bolnišnici.
For the full list of side effects reported with Tarceva, please see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tarceva, glejte Navodilo za uporabo.
Tarceva should not be used in people who may be hypersensitive (allergic) to erlotinib or any of the other ingredients.
Zdravila Tarceva se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) erlotinib ali katero koli drugo sestavino zdravila.
It should be used with caution if the patient is taking other medicines, including warfarin (a medicine used to thin the blood), ketoconazole (to treat fungal infections), antibiotics (erythromycin, clarithromycin) or St.
Zdravilo je treba uporabljati previdno, če bolnik sočasno jemlje tudi druga zdravila, vključno z varfarinom (zdravilom proti strjevanju krvi), ketokonazolom (zdravilom za zdravljenje glivičnih okužb), antibiotiki (eritromicin, klaritromicin) ali šentjanževko (rastlinsko zdravilo).