natgillin/translations-raw huggingface dataset:
In adults, NutropinAq increased lean body mass and reduced total body fat.
Pri odraslih je zdravilo NutropinAq povečalo brezmaščobno telesno maso in zmanjšalo skupno telesno maščevje.
• children (before puberty) who fail to grow because of long-lasting kidney disease, up to the time when they receive a kidney transplant.
• otrok (pred puberteto), ki zaradi kronične odpovedi ledvic zaostajajo v rasti, do presaditve ledvice.
NutropinAq must not be used when the patient has an active tumour or a lifethreatening illness.
Ne smejo ga uporabljati bolniki, ki imajo aktiven tumor ali smrtno nevarno bolezen.
The main measures in the adult study were lean body mass and the decrease in total body fat.
Glavni merili v študiji pri odraslih sta bili brezmaščobna telesna masa in zmanjšanje skupnega telesnega maščevja.
Somatropin may interfere with the body's use of insulin.
Somatropin lahko vpliva na presnovo insulina v telesu.
Growth hormone is a substance secreted by a gland located at the base of the brain called the pituitary gland.
Rastni hormon je snov, ki jo izloča žleza na možganskem dnu, imenovana hipofiza.
They should use a different injection site each day.
Za injiciranje zdravila je treba vsak dan izbrati drug predel telesa.
NutropinAq is a solution for injection in a cartridge.
Zdravilo NutropinAq je raztopina za injiciranje v vložkih.
Why has NutropinAq been approved?
Zakaj je bilo zdravilo NutropinAq odobreno?
NutropinAq is also used to treat adults with a deficiency (low levels) of growth hormone.
Zdravilo NutropinAq se uporablja tudi za zdravljenje odraslih, ki jim primanjkuje rastnega hormona.
What is NutropinAq?
Kaj je zdravilo NutropinAq?
How has NutropinAq been studied?
Kako je bilo zdravilo NutropinAq raziskano?
What is NutropinAq used for?
Za kaj se zdravilo NutropinAq uporablja?
How is NutropinAq used?
Kako se zdravilo NutropinAq uporablja?
How does NutropinAq work?
Kako zdravilo NutropinAq deluje?
Both active substances have been available in the European Union (EU) for a number of years.
Obe zdravilni učinkovini sta v Evropski uniji (EU) na voljo že vrsto let.
Treatment should be for the shortest duration possible as long as benefits outweigh risks.
Zdravljenje mora trajati čim krajši čas in le, dokler so koristi večje od tveganj.
The European Commission granted a marketing authorisation valid throughout the European Union for Duavive on 16 December 2014.
Evropska komisija je dovoljenje za promet z zdravilom Duavive, veljavno po vsej Evropski uniji, izdala 16. decembra 2014.
The recommended dose of Duavive is one tablet once a day.
Priporočeni odmerek zdravila Duavive je ena tableta enkrat dnevno.
Regarding safety, the long-term risk of endometrial hyperplasia has not been fully investigated and the CHMP recommended further studies to be carried out.
Kar zadeva varnost, dolgoročno tveganje za hiperplazijo endometrija ni bilo v celoti proučeno in CHMP je priporočil, da se izvedejo nadaljnje študije.
What measures are being taken to ensure the safe and effective use of Duavive?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Duavive?
The full EPAR and risk management plan summary for Duavive can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Duavive sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Duavive.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Duavive.
What are the risks associated with Duavive?
Kakšna tveganja so povezana z zdravilom Duavive?
It is not intended to provide practical advice on how to use Duavive.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
A risk management plan has been developed to ensure that Duavive is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Duavive je bil pripravljen načrt obvladovanja tveganj.
Why is Duavive approved?
Zakaj je bilo zdravilo Duavive odobreno?
What is Duavive and what is it used for?
Kaj je zdravilo Duavive in za kaj se uporablja?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Duavive's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Duavive večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The most common side effect with Duavive (which may affect more than 1 in 10 people) is abdominal pain (stomach ache).
Najpogostejši neželeni učinek zdravila Duavive (ki lahko prizadene več kot 1 osebo od 10) je bolečina v trebuhu.
What benefits of Duavive have been shown in studies?
Kakšne koristi je zdravilo Duavive izkazalo v študijah?
Duavive conjugated oestrogens / bazedoxifene
Duavive konjugirani estrogeni/bazedoksifen
Other information about Duavive
Druge informacije o zdravilu Duavive
It is used in women who still have their uterus (womb) and who cannot be treated with progestogen-containing medicines (medicines derived from the hormone called progesterone).
Daje se ženskam, ki imajo še vedno maternico in ki jih ni mogoče zdraviti z zdravili, ki vsebujejo progestogen (zdravila, pridobljena iz hormona, imenovanega progesteron).
Because the observed treatment effects were smaller than what is seen with alternative treatments (progestogen-containing treatments) the CHMP therefore concluded that Duavive should be reserved for women who cannot take these alternative medicines.
Ker so bili opaženi učinki zdravljenja manjši kot učinki alternativnih zdravljenj (z zdravili, ki vsebujejo progestogen), je CHMP zaključil, da lahko zdravilo Duavive jemljejo le ženske, ki ne smejo jemati teh drugih zdravil.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duavive, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Duavive in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For more information about treatment with Duavive, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Duavive preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Some women must not use Duavive including those who have had problems with venous thromboembolism (blood clots in the veins) such as deep-vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal-vein thrombosis (a blood clot at the back of the eye), or are at an increased risk of such problems.
Nekatere ženske ne smejo uporabljati zdravila Duavive, med drugim tiste, ki so imele težave zaradi venske trombembolije (krvnih strdkov v venah), kot so globoka venska tromboza, pljučna embolija (krvni strdek v pljučih) in tromboza mrežnične vene (krvni strdek v zadnjem delu očesa) ali imajo zvečano tveganje za takšne težave.
However, oestrogens used alone can cause hyperplasia (growth) of the endometrium (lining of the womb) which could lead to endometrial cancer.
Vendar pa lahko estrogeni, če se uporabljajo sami, povzročijo hiperplazijo (rast) endometrija (maternične sluznice), kar lahko privede do raka endometrija.
For practical information about using Duavive, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Duavive naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
An additional study also looked at the effects of Duavive on osteoporosis.
V dodatni študiji so proučili tudi učinke zdravila Duavive na osteoporozo.
The CHMP also noted that long-term use of Duavive is associated with a risk of stroke and venous thromboembolism which is similar to the risk with conjugated oestrogens and bazedoxifene when used alone.
CHMP je prav tako ugotovil, da je dolgotrajna uporaba zdravila Duavive povezana s tveganjem za kap in vensko trombembolijo, ki je podobno tveganju pri konjugiranih estrogenih in bazedoksifenu, kadar se uporabljajo ločeno.
Duavive is only for use in women who have been through the menopause, so it must not be used in women who could become pregnant.
Zdravilo Duavive lahko uporabljajo le ženske po menopavzi, zato ga ne smejo uporabljati ženske, ki lahko zanosijo.
Duavive was compared with placebo (a dummy treatment) in two main studies in 996 women who have been through the menopause, investigating the effects on either hot flushes or vulvovaginal atrophy (dryness, irritation and soreness around the genital area).
Zdravilo Duavive so primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, v katerih je sodelovalo 996 žensk po menopavzi, da bi proučili učinke na bodisi vročinske oblive bodisi vulvovaginalno atrofijo (suhost, draženje in bolečine v predelu genitalij).
One of the active substances in Duavive, conjugated oestrogens, works as hormone replacement therapy.
Ena od zdravilnih učinkovin zdravila Duavive, konjugirani estrogeni, deluje kot hormonsko nadomestno zdravljenje.
Conjugated oestrogens have been available for many years as hormone replacement therapy and bazedoxifene has been authorised in 2009 for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Konjugirani estrogeni so že več let na voljo kot hormonsko nadomestno zdravljenje, bazedoksifen pa je bil odobren leta 2009 kot zdravilo za osteoporozo (bolezen, ki povzroča krhkost kosti) pri ženskah po menopavzi.
For the full list of all side effects and restrictions with Duavive, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri zdravilu Duavive glejte navodilo za uporabo.
It must also not be used in women who have, are likely to have or have had breast cancer or other cancers that are known to be oestrogen-dependent.
Ne smejo ga uporabljati niti ženske, ki imajo ali so imele raka dojke oziroma pri katerih obstaja sum, da ga imajo; enako velja tudi za druge rake, ki so odvisni od estrogenov.
It replaces the oestrogen hormones that are no longer produced naturally in women who have been through the menopause, thereby alleviating symptoms such as hot flushes.
Konjugirani estrogeni nadomeščajo hormone estrogene, ki se pri ženskah po menopavzi naravno več ne tvorijo, in tako lajšajo simptome, kot so vročinski oblivi.
Duavive is a medicine used for the treatment of symptoms (such as hot flushes) caused by low blood levels of the female hormone oestrogen in women who have been through the menopause.
Zdravilo Duavive se uporablja za zdravljenje simptomov (kot so vročinski oblivi), ki jih povzročajo nizke ravni ženskega hormona estrogena v krvi žensk po menopavzi.
Treatment with Duavive also led to a greater average fall in the daily severity score of hot flushes than placebo treatment: 0.9 versus 0.3.
Pri zdravljenju z zdravilom Duavive so zabeležili tudi večje povprečno zmanjšanje dnevne ocene resnosti vročinskih oblivov kot pri zdravljenju s placebom: 0,9 proti 0,3.
Duavive therefore also contains the active substance bazedoxifene, which blocks the effects of oestrogens on the womb and so reduces the risk of endometrial cancer.
Zdravilo Duavive zaradi tega vsebuje tudi zdravilno učinkovino bazedoksifen, ki zavira učinke estrogenov na maternico in tako zmanjšuje tveganje za raka endometrija.
In the study investigating the effects on hot flushes, treatment with Duavive (conjugated oestrogen 0.45 mg and bazedoxifene 20 mg) over 12 weeks reduced the average daily number of moderate and severe hot flushes by 7.6 compared with 4.9 for placebo.
V študiji, v kateri so preučevali učinke na vročinske oblive, je zdravljenje z zdravilom Duavive (konjugirani estrogeni 0,45 mg in bazedoksifen 20 mg) v 12 tednih zmanjšalo povprečno dnevno število zmernih in hudih vročinskih oblivov za 7,6 v primerjavi s 4,9 pri placebu.
It must not be used in women who have had a stroke or heart attack.
Zdravila Duavive prav tako ne smejo uporabljati ženske, ki so preživele možgansko kap ali srčni infarkt.
It is available as modified release tablets (containing 0.45 mg conjugated oestrogens and 20 mg bazedoxifene) which release bazedoxifene immediately and conjugated oestrogens over a longer period of time.
Na voljo je v obliki tablet s prirejenim sproščanjem (vsebujejo 0,45 mg konjugiranih estrogenov in 20 mg bazedoksifena), iz katerih se bazedoksifen sprosti takoj, konjugirani estrogeni pa se sproščajo dlje časa.
Duavive contains two active substances: conjugated oestrogens and bazedoxifene.
Zdravilo Duavive vsebuje dve zdravilni učinkovini: konjugirane estrogene in bazedoksifen.
How is Duavive used?
Kako se zdravilo Duavive uporablja?
The study looking at the effects of Duavive on vulvovaginal atrophy found an improvement in some of the signs of vaginal atrophy but not in the most bothersome symptoms when compared with placebo.
Študija, v kateri so proučevali učinke zdravila Duavive na vulvovaginalno atrofijo v primerjavi s placebom, je pokazala izboljšanje določenih znakov vaginalne atrofije, vendar ne najbolj motečih simptomov.
Duavive was shown to improve the symptoms caused by lack of oestrogen in postmenopausal women when compared with placebo.
Dokazano je bilo, da zdravilo Duavive izboljša simptome, ki jih povzroča pomanjkanje estrogena pri ženskah po menopavzi, ko so ga primerjali s placebom.
Duavive can only be obtained with a prescription.
Izdaja zdravila Duavive je le na recept.
Because studies with the higher strength combination did not sufficiently show that this strength was more effective than the approved strength of Duavive, the company withdrew its application for the former.
Ker študije s kombinacijo večje jakosti niso prepričljivo pokazale, da je ta jakost učinkovitejša kot odobrena jakost zdravila Duavive, je družba umaknila vlogo za pridobitev dovoljenja za promet za zdravilo večje jakosti.
Similar results were seen with a higher strength of conjugated oestrogen (0.625 mg) plus bazedoxifene 20 mg when compared with placebo.
Podobne rezultate je dalo zdravljenje s konjugiranim estrogenom večje jakosti (0,625 mg) skupaj z bazedoksifenom (20 mg), ko so ga primerjali z zdravljenjem s placebom.
How does Duavive work?
Kako zdravilo Duavive deluje?
One of the studies also looked at the effects of Duavive on osteoporosis; however, as there was no benefit of Duavive over the individual components the company withdrew its application for Duavive in the treatment of osteoporosis.
Ker pa zdravilo Duavive ni izkazalo večjih koristi kot posamezne sestavine, je družba umaknila svojo vlogo za zdravilo Duavive za indikacijo zdravljenja osteoporoze.
Further information on NovoEight can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/novoeight.
Nadaljnje informacije za zdravilo NovoEight so na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/novoeight.
What measures are being taken to ensure the safe and effective use of NovoEight?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila NovoEight?
The European Medicines Agency decided that NovoEight's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila NovoEight večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
As for all medicines, data on the use of NovoEight are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila NovoEight stalno spremljajo.
Hypersensitivity (allergic) reactions can occur rarely with NovoEight and may in some cases progress to severe allergic reactions.
Pri zdravilu NovoEight se lahko redko pojavijo preobčutljivostne (alergijske) reakcije, ki se lahko v nekaterih primerih razvijejo v hude alergijske reakcije.
An overview of NovoEight and why it is authorised in the EU
Pregled zdravila NovoEight in zakaj je odobreno v EU
What benefits of NovoEight have been shown in studies?
Kakšne koristi zdravila NovoEight so se pokazale v študijah?
Other information about NovoEight
Druge informacije o zdravilu NovoEight
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of NovoEight have 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 NovoEight upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
These inhibitors are antibodies that the immune system (the body's natural defences) produces against factor VIII.
Ti zaviralci so protitelesa, ki jih imunski sistem (naravni obrambni mehanizem telesa) proizvede kot odziv proti faktorju VIII.
In the second study involving 63 children less than 12 years of age, children treated with NovoEight had an average of 5.33 bleeding episodes per year.
V drugi študiji, ki je vključevala 63 otrok, mlajših od 12 let, so otroci, zdravljeni z zdravilom NovoEight, povprečno doživeli 5,33 krvavitve na leto.
NovoEight received a marketing authorisation valid throughout the European Union on 13 November
Za zdravilo NovoEight je bilo 13. novembra 2013 izdano dovoljenje za promet, veljavno po vsej EU.
The dose and frequency of treatment depend on whether it is used to treat or prevent bleeding, as well as the seriousness of the haemophilia, the extent and location of the bleeding and the patient's age and condition.
Odmerek in pogostnost injiciranja zdravila sta odvisna od tega, ali se uporablja za zdravljenje ali preprečevanje krvavitev, ter od resnosti hemofilije, obsega in mesta krvavitve ter bolnikove starosti in kliničnega stanja.
Side effects reported with NovoEight are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu NovoEight, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
For continuing treatment, the doctor may adjust the dose and frequency of injection according to the blood levels of factor VIII.
Pri nadaljnjem zdravljenju lahko zdravnik prilagodi odmerek in pogostnost injiciranja glede na ravni faktorja VIII v krvi.
What is NovoEight and what is it used for?
Kaj je zdravilo NovoEight in za kaj se uporablja?
Patients or their carers may be able to inject NovoEight themselves once they have been trained.
Bolniki ali njihovi negovalci lahko po ustreznem usposabljanju zdravilo NovoEight injicirajo sami.
In the first study involving 150 patients aged 12 years and above, adolescents who used NovoEight to prevent bleeding had an average of 5.55 bleeding episodes per year and adults had an average of 6.68 bleeding episodes per year.
V prvi študiji, ki je vključevala 150 bolnikov, starih 12 let in več, so mladostniki, ki so uporabljali zdravilo NovoEight za preprečevanje krvavitev, povprečno doživeli 5,55 krvavitve na leto, odrasli pa 6,68 krvavitve na leto.
NovoEight was effective at preventing and treating bleeding episodes in two main studies involving a total of 213 patients with haemophilia A. Neither study compared NovoEight with any other medicines.
Zdravilo NovoEight je bilo učinkovito pri preprečevanju in zdravljenju krvavitev v dveh glavnih študijah, ki sta skupaj vključevali 213 bolnikov s hemofilijo A. V nobeni od teh študij zdravila NovoEight niso primerjali z nobenim drugim zdravilom.
The active substance in NovoEight, turoctocog alfa, works in the same way as natural factor VIII and helps the blood to clot.
Učinkovina v zdravilu NovoEight, turoktokog alfa, deluje na enak način kot naravni faktor VIII in pomaga pri strjevanju krvi.
NovoEight is available for injection into a vein.
Zdravilo NovoEight je na voljo za injiciranje v veno.
For more information about using NovoEight, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila NovoEight glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with NovoEight?
Kakšna tveganja so povezana z zdravilom NovoEight?
Why is NovoEight authorised?
Zakaj je bilo zdravilo NovoEight odobreno?
In addition, 89.4% of the bleeding episodes resolved after 1 to 2 doses of NovoEight.
Poleg tega se je 89,4 % krvavitev ustavilo po enem do dveh odmerkih zdravila NovoEight.
The safety profile of NovoEight was also considered similar to other factor VIII products.
Varnostni profil zdravila NovoEight je prav tako podoben kot pri drugih zdravilih s faktorjem VIII.
When used for the treatment of spontaneous bleeding, NovoEight was rated as ‘excellent' or ‘good' at treating 403 of 499 of the bleeding episodes.
Pri uporabi zdravila NovoEight za zdravljenje spontanih krvavitev je bilo to pri zdravljenju 403 od 499 krvavitev ocenjeno kot „izvrstno“ ali „dobro“.
In addition, 95.2% of the bleeding episodes resolved after 1 to 2 doses of NovoEight.
Poleg tega se je 95,2 % krvavitev ustavilo po enem do dveh odmerkih zdravila NovoEight.
The medicine contains the active substance turoctocog alfa.
Vsebuje učinkovino turoktokog alfa.
Some patients may develop factor VIII inhibitors, which can cause the medicine to stop working, resulting in a loss of bleeding control.
Pri nekaterih bolnikih se lahko razvijejo zaviralci faktorja VIII, ki lahko onemogočijo delovanje zdravila, kar povzroči izgubo nadzora nad krvavitvami.
NovoEight can only be obtained with a prescription, and treatment should be started under the supervision of a doctor who has experience in the treatment of haemophilia.
Predpisovanje in izdaja zdravila NovoEight je le na recept, zdravljenje z njim pa se sme uvesti samo pod nadzorom zdravnika z izkušnjami z zdravljenjem hemofilije.
NovoEight must not be used in patients who are allergic to hamster protein.
Zdravilo NovoEight se ne sme uporabljati pri bolnikih z alergijo na beljakovine hrčka.
Patients with haemophilia A lack factor VIII, which prevents blood from clotting and can cause problems such as bleeding in the joints, muscles or internal organs.
Bolnikom s hemofilijo A primanjkuje faktorja VIII, kar preprečuje strjevanje krvi in povzroči težave, kot so krvavenje v sklepe, mišice ali notranje organe.
NovoEight is used to correct the factor VIII deficiency by replacing the missing factor VIII, thereby giving temporary control of the bleeding disorder.
Zdravilo NovoEight se uporablja za uravnavanje pomanjkanja faktorja VIII, in sicer z nadomeščanjem manjkajočega faktorja VIII, kar vzpostavi začasni nadzor nad krvavitvami.
The Agency concluded that NovoEight is effective for treating and preventing bleeding episodes, with effects similar to other factor VIII products.
Menila je, da je zdravilo NovoEight učinkovito pri zdravljenju in preprečevanju krvavitev in da ima podobne učinke kot druga zdravila s faktorjem VIII.
How is NovoEight used?
Kako se zdravilo NovoEight uporablja?
NovoEight is a medicine used to treat and prevent bleeding in patients with haemophilia A an inherited bleeding disorder caused by lack of factor VIII.
NovoEight je zdravilo, ki se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A (dedno motnjo strjevanja krvi zaradi pomanjkanja faktorja VIII).
How does NovoEight work?
Kako zdravilo NovoEight deluje?
NovoEight was rated as ‘excellent' or ‘good' at treating 116 of the 126 bleeding episodes.
Pri zdravljenju 116 od 126 krvavitev je bilo zdravilo NovoEight ocenjeno kot „izvrstno“ ali „dobro“.
3.1 mg / 24 h Transdermal patch Transdermal use sachet (coated paper/alu/LLDPE)
3,1 mg / 24 h transdermalni obliž transdermalna uporaba vrečica (prevlečen papir/aluminij/LLDPE)
(Invented) name
(Izmišljeno ime)
1 patch
1 obliž
Begin your treatment.
Začnite zdravljenje.
Date of first authorisation: 21 September 2009 Date of latest renewal: 26 May 2016
Datum prve odobritve: 21. september 2009 Datum zadnjega podaljšanja: 26. maja 2016