natgillin/translations-raw huggingface dataset:
Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
Pri ženskah pri 50 letih, ki ne uporabljajo HNZ, bi se po pričakovanjih krvni strdek v veni v petih letih pojavil pri 4 do 7 na 1.000 žensk.
[The text below should be all deleted from this section]
[Besedilo v nadaljevanju je treba v celoti izbrisati iz tega poglavja.]
- Otosclerosis
- porfirije.
[invented name] is not indicated during pregnancy.
Zdravilo [izmišljeno ime] ni indicirano med nosečnostjo.
Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period.
Pri ženskah pri 50 letih, ki ne uporabljajo HNZ, bi se po pričakovanjih možganska kap v petih letih pojavila pri 8 od 1.000 žensk.
In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods.
Med dolgotrajno uporabo samih estrogenov se pri ženskah z ohranjeno maternico poveča tveganje za hiperplazijo in karcinom endometrija.
Driving and using machines
Navodilo za uporabo
Do not use up any remaining content after completing treatment course.
Po končanem zdravljenju ne smete porabiti kreme, ki vam je morda ostala.
A relationship between ovarian cancer risk and local vaginal oestrogen therapy is uncertain.
Povezava med tveganjem za raka jajčnikov in lokalnim vaginalnim estrogenskim zdravljenjem je negotova.
- Risk factors for thromboembolic disorders (see below)
- leiomiomi (fibroidi v materničnem tkivu) ali endometrioza; - dejavniki tveganja za trombembolične motnje (glejte spodaj);
A relationship between breast cancer risk and local vaginal oestrogen therapy is uncertain.
Povezava med tveganjem za raka dojke in lokalnim vaginalnim estrogenskim zdravljenjem je negotova.
Gastrointestinal disorders
zvišani trigliceridi
The following adverse events have also been associated with oral and/or transdermal oestrogen therapy:
S peroralnim in/ali transdermalnim zdravljenjem z estrogenom so bili povezani tudi naslednji neželeni dogodki:
Risk estimates have been drawn from systemic exposure and it is not known how these apply to local treatments:
Ocene tveganja so bile podane na podlagi sistemske izpostavljenosti, zato ni znano,
WHI studies combined - Additional risk of ischaemic stroke* over 5 years' use
Študije WHI skupaj - dodatno tveganje za ishemično možgansko kap* med petletno uporabo Razpon starosti (leta)
Do not use [invented name] if - You are allergic (hypersensitive) to estradiol or any of the other ingredients of [invented name] (listed in Section 6 Further information) - You have or have ever had breast cancer, or you are suspected of having it - You have or have ever had cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or you are suspected of having it - You have any unexplained vaginal bleeding - You have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated - You have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism) - You have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency) - You have or have recently had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina - You have or have ever had a liver disease and your liver function tests have not returned to normal - You have a rare blood problem called “porphyria”, which is passed down in families (inherited).
- imate ali ste pred kratkim imeli bolezen, ki jo povzročajo krvni strdki v arterijah, na primer srčno kap, možgansko kap ali angino pektoris; - če imate ali ste kdaj imeli bolezen jeter in izvidi preiskav delovanja jeter še niso normalni; - če imate redko krvno motnjo, imenovano „porfirija“, ki se prenaša znotraj družine (dedna motnja).
Additional cases per 1000 users over 5 years
Dodatno število primerov na 1.000 žensk, ki so uporabljale HNZ, v petih letih
A relationship between ischaemic stroke and low dose local vaginal oestrogen therapy is uncertain.
Povezava med tveganjem za ishemično možgansko kap in nizkoodmernim lokalnim vaginalnim estrogenskim zdravljenjem je negotova.
Given that systemic exposure occurs during treatment with [Invented name], prolonged treatment beyond 4 week is not recommended.
Ker med zdravljenjem z zdravilom [izmišljeno ime] pride do sistemske izpostavljenosti,
[The text below should be deleted from this section]
[Besedilo v nadaljevanju je treba izbrisati iz tega poglavja.]
Other adverse reactions have been reported in association with oestrogen/progestogen treatment.
V povezavi z estrogensko-progestogenskim zdravljenjem so poročali tudi o drugih neželenih učinkih.
A relationship between venous thromboembolism and local vaginal oestrogen therapy is uncertain.
Povezava med tveganjem za vensko trombembolijo in lokalnim vaginalnim estrogenskim zdravljenjem je negotova.
For women in their 50s who have been taking oestrogen-progestagen HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. 5 extra cases) For women in their 50s who have had their womb removed and have been taking oestrogenonly HRT for over 5 years, there will be 5 to 8 cases in 1000 users (i.e. 1 extra case).
Pri ženskah pri 50 letih, ki uporabljajo estrogensko-progestogensko HNZ več kot pet let, bo takih primerov od 9 do 12 na 1.000 žensk (torej pet dodatnih primerov).
If you notice any of the following when using HRT: - Migraine-like headaches which happen for the first time - Yellowing of your skin or the whites of your eyes (jaundice).
če zanosite; če opazite znake krvnega strdka, kot so: - boleče otekanje in rdečina nog; - nenadna bolečina v prsnem košu;
Nausea, bloating, abdominal pain
Bolezni prebavil navzeja, napihnjenost, bolečina v trebuhu
Abnormal uterine bleeding (breakthrough bleeding/spotting), breast pain, breast tenderness, breast enlargement, breast discharge, leukorrhoea
bolečine v dojkah, občutljivost dojk, povečanje dojk, izcedek iz dojk, levkoreja
- Leiomyoma (uterine fibroids) or endometriosis
- rak dojke; - hiperplazija in karcinom endometrija;
Skin and subcutaneous tissue disorders
Bolezni jeter, žolčnika in žolčevodov bolezen žolčnika
- Gall bladder disease - Various skin disorders: o discoloration of the skin especially of the face or neck known as “pregnancy patches (chloasma) o painful reddish skin nodules (erythema nodosum) o rash with target-shaped reddening or sores (erythema multiforme)
o boleči rdečkasti kožni vozliči (nodozni eritem), o izpuščaj z rdečino ali razjedami v obliki tarče (multiformni eritem).
Nervous system disorders
Ishemična možganska kap
- Asthma - Epilepsy - Diabetes - Gallstones - High blood pressure - Migraines or severe headaches - A liver disorder, such as a benign liver tumour
Zdravljenje je treba prekiniti, če se odkrije kontraindikacija ali če se pojavi karkoli od naslednjega: - zlatenica ali poslabšanje delovanja jeter; - znatno zvišanje krvnega tlaka; - novonastali glavobol migrenskega tipa;
- Growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia) - A disease affecting the eardrum and hearing (otosclerosis) - A disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE) - Increased risk of getting an oestrogen-sensitive cancer (such as having a mother,
- dejavniki tveganja za od estrogena odvisne tumorje, kot so na primer dedne predispozicije za raka dojke v 1. kolenu; - hipertenzija; - bolezni jeter (npr. adenom jeter); - sladkorna bolezen s prizadetostjo ožilja ali brez nje; - holelitiaza; - migrena ali (hud) glavobol; - sistemski eritematozni lupus; - hiperplazija endometrija v anamnezi (glejte spodaj); - epilepsija; - astma; - otoskleroza.
Do not use [invented name] immediately before sexual intercourse or as a lubricant, to prevent possible side effects in your partner.
Ne uporabljajte zdravila [izmišljeno ime] tik pred spolnim odnosom ali namesto lubrikanta,
Risk of ischaemic stroke
Tveganje za ishemično možgansko kap
05 March 2014
5. marec 2014
The European Commission issued a decision on 05 March 2014.
Evropska komisija je sklep izdala dne 5. marca 2014.
However, the Member States were not able to reach an agreement and the Spanish medicines regulatory agency referred the matter to the CHMP for arbitration on 31 October 2013.
Vendar države članice niso mogle doseči soglasja, zato je španska regulativna agencija za zdravila 31. oktobra 2013 zadevo napotila na odbor CHMP v arbitražo.
This is a procedure where one Member State (the ‘reference Member State', in this instance Spain) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Belgium, Germany and the Netherlands).
To je postopek, v katerem ena država članica („referenčna država članica“, v tem primeru Španija) oceni zdravilo zato, da se izda dovoljenje za promet, ki bo veljalo v tej državi in drugih državah članicah („zadevnih državah članicah“, v tem primeru v Belgiji, Nemčiji in na Nizozemskem).
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that bioequivalence to the reference medicinal product has been shown.
Na podlagi ocene trenutno razpoložljivih podatkov in interne znanstvene razprave je odbor CHMP zaključil, da je bila biološka enakovrednost z referenčnim zdravilom dokazana.
Tibolone is a type of hormone replacement therapy (HRT) and is used to alleviate the symptoms of the menopause (such as hot flushes) in women who have not had a natural period for at least 12 months.
Tibolon je vrsta učinkovine za hormonsko nadomestno zdravljenje (HNZ), ki se uporablja za lajšanje simptomov menopavze (kot so na primer navali vročine) pri ženskah, pri katerih je od zadnje naravne menstruacije minilo najmanj 12 mesecev.
On 19 December 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicines Tibolona Aristo and Tibocina.
Evropska agencija za zdravila je dne 19. decembra 2013 zaključila arbitražni postopek, potem ko so države članice Evropske unije (EU) izrazile nestrinjanje glede odobritve zdravil Tibolona Aristo in Tibocina.
This means that storage conditions could potentially have been inadequate leading to the degradation of the active substance, making the samples inadequate for testing.
To pomeni, da so bili morda pogoji shranjevanja neustrezni, kar bi lahko povzročilo degradacijo zdravilne učinkovine, to pa bi pomenilo, da vzorci niso bili primerni za preskušanje.
Germany considered that these data were not reliable because of failings in the way the study samples were identified and registered and the cold storage and transport of the samples were recorded.
Nemčija je predvsem menila, da omenjeni podatki niso zanesljivi zaradi pomanjkljivosti v načinu identifikacije in registracije preiskovanih vzorcev ter dokumentiranja njihovega shranjevanja v hladilnici in prenosa.
The company had supplied additional evidence to indicate that the study samples had been stored and maintained under adequate temperature conditions, further supported by the concentrations recorded in the bioequivalence study.
Družba je predložila dodatne dokaze o tem, da so bili preiskovani vzorci ves čas shranjeni pri ustreznih temperaturnih pogojih, kar so potrdile tudi koncentracije, ki so jih zabeležili v študiji biološke enakovrednosti.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Tibolona Aristo and Tibocina outweigh their risks, and the marketing authorisations can be granted in Spain and in the following Member States of the EU: Belgium, Germany and the Netherlands.
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje v okviru agencije, je zaključil, da so koristi zdravil Tibolona Aristo in Tibocina večje od z njima povezanih tveganj in da se dovoljenji za promet lahko odobrita v Španiji in naslednjih državah članicah EU: v Belgiji, Nemčiji in na Nizozemskem.
The grounds for the referral were objections raised by Germany about the data submitted to show that Tibolona Aristo and Tibocina were ‘bioequivalent' to the reference medicine, Liviella.
Podlaga za napotitev so bili pomisleki Nemčije glede predloženih podatkov, ki naj bi dokazovali, da sta zdravili Tibolona Aristo in Tibocina „biološko enakovredni“ referenčnemu zdravilu Liviella.
Tibolona Aristo and Tibocina are generic medicines based on a ‘reference medicine', Liviella, which is authorised in Germany.
Zdravili Tibolona Aristo in Tibocina sta generični zdravili, ki temeljita na „referenčnem zdravilu“, imenovanem Liviella, ki je že odobreno v Nemčiji.
The CHMP therefore concluded that the benefits of Tibolona Aristo and Tibocina outweigh their risks and recommended that the marketing authorisations be granted in the concerned Member States.
Odbor CHMP je zato zaključil, da so koristi zdravil Tibolona Aristo in Tibocina večje od z njima povezanih tveganj, in priporočil, da se odobri dovoljenje za promet s tema zdraviloma v zadevnih državah članicah.
Why were Tibolona Aristo and Tibocina reviewed?
Zakaj sta bili zdravili Tibolona Aristo in Tibocina pregledani?
What are Tibolona Aristo and Tibocina?
Kaj sta zdravili Tibolona Aristo in Tibocina?
Aristo Pharma GmbH submitted Tibolona Aristo and Tibocina to the Spanish medicines regulatory agency for a decentralised procedure.
Družba Aristo Pharma GmbH je španski regulativni agenciji za zdravila predložila vlogo za začetek decentraliziranega postopka za zdravili Tibolona Aristo in Tibocina.
Tibolona Aristo and Tibocina are medicines that contain the active substance tibolone; they are available as tablets (2.5 mg).
Tibolona Aristo in Tibocina sta zdravili, ki vsebujeta zdravilno učinkovino tibolon.
Patients should be monitored for at least one hour after the first infusion for any reactions.
Bolnike je treba spremljati najmanj eno uro po prvi infuziji zaradi morebitnih reakcij.
If a reaction occurs, the infusion should be stopped and patients should receive appropriate treatment.
Če pride do reakcije, je treba infuzijo prekiniti in bolnikom zagotoviti ustrezno zdravljenje.
Further information on Trogarzo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/trogarzo.
Nadaljnje informacije o zdravilu Trogarzo so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/trogarzoema.europa.eu/medicines/human/EPAR/tro garzo.
What measures are being taken to ensure the safe and effective use of Trogarzo?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Trogarzo?
Treatment is started with a single infusion of 2,000 mg followed by 800 mg every 2 weeks; if treatment is interrupted, it should be restarted in the same way.
Zdravljenje se začne z enkratnim infundiranjem v jakosti 2 000 mg, čemur sledi 800-miligramski odmerek vsaka dva tedna; če se zdravljenje prekine, je treba ponovno začeti na enak način.
The European Medicines Agency therefore decided that Trogarzo's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Trogarzo večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Overall, the safety profile of Trogarzo was considered to be acceptable.
Na splošno se je varnostni profil zdravila Trogarzo štel za sprejemljivega.
Although the studies submitted were small and did not include a direct comparison with other medicines, the results indicate that adding Trogarzo to other medicines could control the virus in these patients.
Čeprav so bile predložene študije majhne in ne vključujejo neposredne primerjave z drugimi zdravili, rezultati kažejo, da bi lahko dodajanje zdravila Trogarzo drugim zdravilom omogočilo nadzor nad virusom pri teh bolnikih.
Other information about Trogarzo
Druge informacije o zdravilu Trogarzo
In patients with multi-drug resistant HIV, treatment options are limited and there is therefore an unmet medical need in this group.
Pri bolnikih z multirezistentnim virusom HIV so možnosti zdravljenja omejene, zato v tej skupini obstaja neizpolnjena zdravstvena potreba.
As for all medicines, data on the use of Trogarzo are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Trogarzo stalno spremljajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trogarzo have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Trogarzo upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Side effects reported with Trogarzo are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Trogarzo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What benefits of Trogarzo have been shown in studies?
Kakšne koristi zdravila Trogarzo so se pokazale v študijah?
The most common side effects with Trogarzo (which may affect up to 1 in 10 patients) are rash, diarrhoea, dizziness, headache, nausea (feeling sick), vomiting and tiredness.
Najpogostejši neželeni učinki zdravila Trogarzo (ki se lahko pojavijo pri največ 1 bolniku od 10) so izpuščaj, driska, omotica, glavobol, navzeja (siljenje na bruhanje), bruhanje in utrujenost.
Why is Trogarzo authorised in the EU?
Zakaj je bilo zdravilo Trogarzo odobreno v EU?
For more information about using Trogarzo, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Trogarzo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
An overview of Trogarzo and why it is authorised in the EU
Pregled zdravila Trogarzo in zakaj je odobreno v EU
What are the risks associated with Trogarzo?
Kakšna tveganja so povezana z zdravilom Trogarzo?
Treatment should be started and monitored by a doctor who is experienced in the treatment of HIV infection.
Zdravljenje lahko uvede in spremlja le zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
The company that markets Trogarzo will carry out a study to confirm the benefits of treatment with Trogarzo in patients with multi-drug resistant HIV infection.
Podjetje, ki trži zdravilo Trogarzo, bo izvedlo študijo za potrditev koristi zdravljenja s tem zdravilom pri bolnikih z multirezistentno okužbo z virusom HIV.
What is Trogarzo and what is it used for?
Kaj je zdravilo Trogarzo in za kaj se uporablja?
Trogarzo is given with other HIV medicines when none of the standard combinations work to control the infection because the virus is resistant to them (multi-drug resistant HIV).
Daje se skupaj z drugimi zdravili za zdravljenje okužbe z virusom HIV, kadar nobena od standardnih kombinacij ne deluje za nadzor nad okužbo, ker je virus odporen proti njim (multirezistentni virus HIV).
Similar effects were seen in a second main study with 113 adults, where 44% of patients who had maintenance doses of Trogarzo added to standard treatment had undetectable HIV levels after 25 weeks.
Podobni učinki so bili opaženi v drugi glavni študiji s 113 odraslimi, saj je imelo po 25 tednih 44 % bolnikov, pri katerih so k standardnemu zdravljenju dodajali vzdrževalne odmerke zdravila Trogarzo, nezaznavne ravni virusa HIV.
By attaching to CD4, ibalizumab prevents the virus from entering the T-cells and reproducing, thereby slowing down the spread of infection.
Ibalizumab z vezavo na receptorje CD4 preprečuje, da bi virus vstopil v celice T in se razmnoževal, zaradi česar upočasni širjenje okužbe.
Trogarzo is a medicine used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Trogarzo je zdravilo za zdravljenje odraslih bolnikov, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
Trogarzo does not cure HIV-1 infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Trogarzo ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
Trogarzo is available as a solution for infusion (drip) into a vein.
Zdravilo Trogarzo je na voljo kot raztopina za infundiranje (kapalno infuzijo) v veno.
In a main study that included 40 adults with multi-drug resistant HIV whose HIV treatment was failing, levels of HIV virus in the blood were undetectable (fewer than 50 copies/ml) in 43% of patients after 25 weeks of combining standard treatment with Trogarzo.
V glavni študiji, v katero je bilo vključenih 40 odraslih z multirezistentnim virusom HIV, katerih zdravljenje okužbe s tem virusom HIV je bilo neuspešno, so bile po 25 tednih kombiniranega standardnega zdravljenja z zdravilom Trogarzo ravni virusa HIV v krvi nezaznavne (manj kot 50 kopij/ml) pri 43 % bolnikov.
For the full list of side effects and restrictions with Trogarzo, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Trogarzo glejte navodilo za uporabo.
How does Trogarzo work?
Kako zdravilo Trogarzo deluje?
The active substance in Trogarzo, ibalizumab, is a monoclonal antibody (a type of protein) designed to attach to CD4, a receptor (target) found on the surface of immune cells called T cells.
Učinkovina v zdravilu Trograzo, ibalizumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da se pritrdi na CD4, tj. receptor (prijemališče) na površini imunskih celic, imenovanih celice T. Celice T so glavno prijemališče za virus HIV, ki ga uporabi kot gostitelja za razmnoževanje.
How is Trogarzo used?
Kako se zdravilo Trogarzo uporablja?
Trogarzo taken with other HIV medicines was shown to be effective at reducing viral load (blood levels of HIV virus) in patients with multi-drug resistant HIV, that is, where standard HIV combination treatments have failed to suppress levels of HIV in the blood sufficiently.
Dokazano je bilo, da je zdravilo Trogarzo, ki se jemlje skupaj z drugimi zdravili za zdravljenje okužbe z virusom HIV, učinkovito pri zniževanju virusnega bremena (ravni virusa HIV v krvi) pri bolnikih z multirezistentnim virusom HIV.
Some of these reactions may be serious or life-threatening.
Nekatere od teh reakcij so lahko resne ali življenjsko nevarne.
• Your doctor will want to closely monitor your heart.
• Zdravnik bo skrbno spremljal vaše srce.
Some of these patients have been under 50 years of age.
Nekateri od teh bolnikov so bili tudi mlajši od 50 let.
If you are 65 or older, you have a greater risk.
Če ste stari 65 let ali več, je to tveganje večje.
EXP EXP, if not refrigerated ___________________
EXP EXP izven hladilnika___________________
These children must be 6 years of age or older.
Otroci morajo biti stari 6 let ali starejši.
Adults (≥ 18 years)
Odrasli bolniki (≥ 18 let)
PASI 75 response**
Odziv PASI 75**
Efficacy has been demonstrated with or without concomitant use of methotrexate.
Učinkovitost so dokazali z ali brez sočasne uporabe metotreksata.
Other special considerations are discussed below.
Druge posebnosti so obravnavane v nadaljevanju.
The median CDAI score was 180.
Mediana vrednost rezultata po CDAI je bila 180.
• Improve your physical function.
• izboljšanje telesne sposobnosti.
• Depression, problems sleeping
• depresija, težave s spanjem
The information above also applies to children and adolescents.
Otroci in mladostniki Zgoraj navedene informacije veljajo tudi za otroke in mladostnike.
Allow the reconstituted solution to stand for 5 minutes.
Rekonstituirana raztopina naj stoji 5 minut.
This type of cancer has usually resulted in death.
Ta vrsta raka je bila običajno smrtna.