natgillin/translations-raw huggingface dataset:
The European Commission granted a marketing authorisation valid throughout the European Union for Signifor on 24 April 2012.
Evropska komisija je dovoljenje za promet z zdravilom Signifor, veljavno po vsej Evropski uniji, izdala 24. aprila 2012.
What measures are being taken to ensure the safe and effective use of Signifor?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Signifor?
The summaries of the opinions of the Committee for Orphan Medicinal Products for Signifor can be found on the Agency's website:
Povzetka mnenj Odbora za zdravila sirote o zdravilu Signifor sta na voljo na spletni strani agencije:
Other information about Signifor
Druge informacije o zdravilu Signifor
The full EPAR for Signifor 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) za zdravilo Signifor je 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 Signifor.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Signifor.
It is not intended to provide practical advice on how to use Signifor.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
If side effects develop the dose may need to be temporarily reduced.
Če se pojavijo neželeni učinki, bo odmerek morda treba začasno zmanjšati.
What benefits of Signifor have been shown in studies?
Kakšne koristi je zdravilo Signifor izkazalo v študijah?
Continuation of both studies confirmed the long-term benefit of Signifor in patients with acromegaly.
Z nadaljevanjem obeh študij so potrdili dolgoročno korist zdravila Signifor pri bolnikih z akromegalijo.
Why is Signifor approved?
Zakaj je bilo zdravilo Signifor odobreno?
Pre-defined levels were less than 2.5 micrograms/liter for growth hormone or within normal limits for IGF-1.
Predhodno opredeljene ravni so bile manj kot 2,5 mikrograma/liter za rastni hormon oziroma normalne vrednosti za IGF-1.
Signifor must not be used in patients with severe liver problems.
Zdravila Signifor ne smejo uporabljati bolniki z resnimi težavami z jetri.
Those patients who do not experience clinical benefit can stop treatment.
Bolniki, pri katerih ni klinične koristi, lahko z zdravljenjem prenehajo.
What are the risks associated with Signifor?
Kakšna tveganja so povezana z zdravilom Signifor?
The European Medicines Agency concluded that the benefits of Signifor are greater than its risk and recommended that it approved in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Signifor večje od z njim povezanih tveganj, in priporočila, se odobri za uporabo v EU.
What is Signifor and what is it used for?
Kaj je zdravilo Signifor in za kaj se uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Signifor have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Signifor upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For this reason, Signifor should be used for acromegaly only when the condition is not controlled by other medicines of its class.
Zato se sme zdravilo Signifor pri bolnikih z akromegalijo uporabljati le, kadar bolezen ni nadzorovana z drugimi zdravili tega razreda.
For more information about treatment with Signifor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Signifor preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This means that it works in the same way as the natural hormone, somatostatin, to block the release of growth hormone from the pituitary glands located at the base of the brain and indirectly block the release of cortisol from the adrenal gland found above the kidneys.
To pomeni, da deluje enako kot naravni hormon somatostatin in zavira sproščanje rastnega hormona iz hipofize, žleze, ki se nahaja na možganskem dnu, in posredno zavira sproščanje kortizola iz nadledvične žleze, ki se nahaja nad ledvicami.
Because the numbers of patients with these diseases are low, the diseases are considered ‘rare', and Signifor was designated an ‘orphan medicine' (a medicine used in rare diseases).
Ker je bolnikov s tema boleznima malo, veljata ti bolezni za redki, zato je bilo zdravilo Signifor določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih boleznih).
(To reduce cortisol, pasireotide first reduces the production of another hormone ACTH, which controls cortisol production.)
(Pasireotid količino kortizola zmanjša tako, da najprej zmanjša tvorbo drugega hormona, ACTH, ki nadzoruje nastajanje kortizola.)
Signifor is used for these conditions when surgery has failed or is not possible and, in the case of acromegaly, when the condition is also not adequately controlled with other medicines similar to Signifor known as ‘somatostatin analogues'.
Zdravilo Signifor se pri teh boleznih uporablja, kadar kirurški poseg ni bil uspešen ali ni mogoč, pri akromegaliji pa se uporablja, kadar bolezni ni mogoče ustrezno nadzorovati z drugimi zdravili, podobnimi zdravilu Signifor, imenovanimi „analogi somatostatina“.
The active substance in Signifor, pasireotide is a somatostatin analogue.
Zdravilna učinkovina v zdravilu Signifor, pasireotid, je analog somatostatina.
Although the number of patients whose cortisol levels returns to normal is small, Signifor is expected tp help patients whose surgical treatments have failed or who cannot have surgery.
Čeprav je bolnikov, pri katerih se ravni kortizola vrnejo na normalno vrednost, malo, naj bi zdravilo Signifor pomagalo bolnikom, pri katerih kirurško zdravljenje ni bilo uspešno ali zanje ni primerno.
Signifor is a medicine for treating adults with Cushing's disease (a condition caused by too much of a hormone called cortisol) and acromegaly (excessive growth, particularly of bones in the hands, feet and face caused by too much growth hormone).
Zdravilo Signifor se uporablja za zdravljenje odraslih s Cushingovo boleznijo (boleznijo, ki jo povzroča prevelika količina hormona kortizola) in akromegalijo (čezmerno rastjo, zlasti kosti v dlaneh, stopalih in obrazu, ki jo povzroča prevelika količina rastnega hormona).
For acromegaly, Signifor is given as an injection into the buttock muscle every 4 weeks.
Pri akromegaliji se zdravilo Signifor daje z injekcijo v zadnjično mišico vsake štiri tedne.
By reducing levels of cortisol and growth hormone, the medicine can help alleviate symptoms of Cushing's disease and acromegaly.
Z zniževanjem ravni kortizola in rastnega hormona zdravilo lahko olajša simptome Cushingove bolezni in akromegalije.
For practical information about using Signifor, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Signifor naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Signifor is available as a solution for injection under the skin and as a powder and liquid used for injection into the muscle.
Zdravilo Signifor je na voljo v obliki raztopine za injiciranje pod kožo ter praška in vehikla za injiciranje v mišico.
Signifor is effective in reducing levels of growth hormone and IGF-1 (another hormone that is elevated in acromegaly patients).
Zdravilo Signifor je učinkovito pri zniževanju ravni rastnega hormona in IGF-1 (drugega hormona, ki je povišan pri bolnikih z akromegalijo).
In patients with Cushing's disease, Signifor is given as an injection either under the skin (preferably at the top of the thigh and the belly) twice a day or into the buttock muscle every 4 weeks.
Pri bolnikih s Cushingovo boleznijo se zdravilo Signifor daje z injekcijo v podkožje (po možnosti v zgornji del stegna ali trebuh) dvakrat na dan ali v zadnjično mišico vsake štiri tedne.
In a second study in 150 adult patients which used the muscle injection, around 41% of patients responded to treatment within 7 months.
V drugi študiji pri 150 odraslih bolnikih, ki so si zdravilo injicirali v mišico, se je po sedmih mesecih na zdravljenje odzvalo približno 41 % bolnikov.
The dose may need to be adjusted according to response, or if side effects develop.
Odmerek bo morda treba prilagoditi glede na bolnikov odziv ali v primeru pojava neželenih učinkov.
Although its side effects are similar to those of other somatostatin analogues, high blood sugar occurred more frequently and was more severe with Signifor.
Čeprav so neželeni učinki podobni kot pri drugih analogih somatostatina, je bilo zvišanje ravni sladkorja pri zdravljenju z zdravilom Signifor pogostejše in hujše.
34% of patients receiving 0.6 mg Signifor and 41% of patients receiving 0.9 mg Signifor partially responded to treatment, with their urine cortisol levels halved within 6 months.
34 % bolnikov, ki so prejemali 0,6 mg zdravila Signifor, in 41 % bolnikov, ki so prejemali 0,9 mg zdravila Signifor, se je delno odzvalo na zdravljenje, njihova koncentracija kortizola v urinu pa se je po šestih mesecih prepolovila.
The most common side effects with Signifor (seen in more than 1 patient in 10) are hyperglycaemia (high blood sugar levels), diabetes, diarrhoea, abdominal pain (stomach ache), nausea (feeling sick),
Najpogostejši učinki zdravila Signifor (ki se lahko pojavijo pri več kot 1 bolniku od 10) so hiperglikemija (povišana raven sladkorja v krvi), sladkorna bolezen, driska, bolečine v trebuhu, navzeja (siljenje na bruhanje), holelitiaza (žolčni kamni), reakcije na mestu injiciranja in utrujenost.
months, the patient's response to treatment should be evaluated, and the dose adjusted as appropriate or treatment stopped if no benefit is seen.
Po dveh do štirih mesecih je treba oceniti, kako se bolnik odziva na zdravljenje, in ustrezno prilagoditi odmerek ali pa prekiniti zdravljenje, če ni prišlo do izboljšanja.
It contains the active substance pasireotide.
Vsebuje zdravilno učinkovino pasireotid.
How is Signifor used?
Kako se zdravilo Signifor uporablja?
In a main study in 358 previously untreated adults, 31% of patients receiving Signifor had their growth hormone and IGF-1 levels reduced to pre-defined low levels after 1 year, compared with 19% of patients receiving octreotide, another somatostatin analogue.
V glavni študiji pri 358 predhodno nezdravljenih odraslih so se ravni rastnega hormona in IGF-1 po enem letu znižale na predhodno opredeljene nizke ravni pri 31 % bolnikov, ki so prejemali zdravilo Signifor, in pri 19 % bolnikov, ki so prejemali oktreotid, drug analog somatostatina.
Patients can inject themselves Signifor under the skin after they have been trained.
Bolniki si lahko po ustreznem usposabljanju zdravilo Signifor sami injicirajo v podkožje.
In the second study in 198 patients whose disease had not been adequately controlled with surgery or other medical treatment, 15% of patients receiving Signifor 40 mg and 20% of patients receiving Signifor 60 mg achieved pre-defined reductions in hormone levels after 24 weeks, compared with none of the 68 patients given the somatostatin analogues octreotide or lanreotide.
V drugi študiji pri 198 bolnikih, pri katerih bolezni ni bilo mogoče ustrezno obvladati s kirurškim posegom ali drugimi načini zdravljenja, je po 24 tednih doseglo predhodno opredeljeno znižanje ravni hormonov 15 % bolnikov, ki so prejemali zdravilo Signifor 40 mg, in 20 % bolnikov, ki so prejemali zdravilo Signifor 60 mg, ter nobeden od 68 bolnikov, ki so prejemali analoga somatostatina oktreotid ali lanreotid.
Signifor is also effective in reducing levels of growth hormone in patients with acromegaly.
Zdravilo Signifor je učinkovito tudi pri zniževanju ravni rastnega hormona pri bolnikih z akromegalijo.
Signifor is effective at normalising cortisol levels in some patients with Cushing's disease.
Zdravilo Signifor je učinkovito pri normalizaciji koncentracije kortizola pri nekaterih bolnikih s Cushingovo boleznijo.
For the full list of restrictions with Signifor, see the package leaflet.
Za celoten seznam omejitev pri uporabi zdravila Signifor glejte navodilo za uporabo.
For the full list of all side effects reported with Signifor, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Signifor, glejte navodilo za uporabo.
In a main study in 165 adult patients who were given the injection under the skin, 15% of patients receiving 0.6 mg Signifor and 26% of patients receiving 0.9 mg Signifor had normal urine cortisol levels within 6 months.
V glavni študiji pri 165 odraslih bolnikih, ki so prejemali injekcijo v podkožje, se je koncentracija kortizola v urinu po šestih mesecih normalizirala pri 15 % bolnikov, ki so prejemali 0,6 mg zdravila Signifor, in pri 26 % bolnikov, ki so prejemali 0,9 mg zdravila Signifor.
Signifor is effective at reducing elevated cortisol levels patients with Cushing's disease.
Zdravilo Signifor je učinkovito pri zniževanju povišanih ravni kortizola pri bolnikih s Cushingovo boleznijo.
How does Signifor work?
Kako zdravilo Signifor deluje?
Around 25 days after the first injection the dog's response is evaluated before a second injection is given.
Približno 25 dni po prvi injekciji se oceni odziv psa, preden se da druga injekcija.
Pregnant and breast-feeding women should avoid giving this medicine because it can affect the normal development of unborn and newborn children.
Tega zdravila naj ne dajejo nosečnice in ženske, ki dojijo, saj lahko vpliva na normalen razvoj še nerojenih otrok in novorojenčkov.
In this study, Zycortal was shown to be at least as effective as the other similar medicine.
V tej študiji je bilo dokazano, da je zdravilo Zycortal vsaj tako učinkovito kot drugo podobno zdravilo.
The full EPAR for Zycortal can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila za zdravilo Zycortal je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
A corticosteroid medicine is likely to be needed, in addition, to replace the cortisol.
Poleg tega je verjetno, da bo poleg tega potrebno tudi kortikosteroidno zdravilo za nadomestitev kortizola.
This is a summary of the European public assessment report (EPAR) for Zycortal.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zycortal.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Zycortal's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Zycortal večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
When satisfactory results are obtained then the treatment should continue to be given long-term using the same dose and interval between treatments.
Ko se dosežejo želeni rezultati, se zdravljenje nadaljuje dolgotrajno ob uporabi enakega odmerka in intervala odmerjanja.
Zycortal is given as an injection under the skin at an initial dose of 2.2 mg/kg.
Zdravilo Zycortal se daje kot podkožna injekcija v začetnem odmerku 2,2 mg/kg.
90 days after start of treatment, 84% (92 out of 109) of Zycortal-treated dogs had improved clinical signs and normal sodium and potassium blood levels.
90 dni po začetku zdravljenja so se pri 84 % (92 od 109) psov, zdravljenih z zdravilom Zycortal, izboljšali klinični znaki in vzpostavile normalne ravni natrija in kalija v krvi.
It works in the same way as aldosterone to retain sufficient water in the body (by retaining sodium and eliminating potassium).
Deluje na enak način kot aldosteron, da bi zadržal zadostno količino vode v telesu (tako da zadržuje natrij in izloča kalij).
Other information about Zycortal
Druge informacije o zdravilu Zycortal
The effectiveness of Zycortal was investigated in a field study involving 152 dogs with Addison's disease.
Učinkovitost zdravila Zycortal so raziskovali v terenski študiji, v katero je bilo vključenih 152 psov z Addisonovo boleznijo.
The lack of aldosterone can cause fluid loss, dehydration and weight loss.
Pomanjkanje aldosterona lahko povzroči izgubo tekočine, dehidracijo in izgubo telesne teže.
The most common side effects with Zycortal (which may affect more than 1 in 10 dogs) are polydipsia (increase in water intake) and polyuria (increase in urine production).
Najpogostejša stranska učinka pri zdravljenju z zdravilom Zycortal (ki se lahko pojavita pri več kot 1 od 10 psov) sta polidipsija (čezmerno pitje vode) in poliurija (povečana tvorba urina).
Zycortal may cause adverse effects on male reproductive organs and as a result can affect fertility.
Zdravilo Zycortal lahko povzroči neželene učinke na moške razmnoževalne organe in posledično na plodnost.
All dogs also received corticosteroids given by mouth.
Vsi psi so prav tako prejeli peroralne kortikosteroide.
Zycortal was given by injection under the skin to 113 dogs and 39 dogs were given a similar medicine, which also contains desoxycortone pivalate, for injection into the muscle.
113 psov je prejelo zdravilo Zycortal s podkožno injekcijo, 39 psov pa podobno zdravilo, ki prav tako vsebuje dezoksikorton pivalat in je namenjeno za injiciranje v mišico.
Prolonged-release means that the active substance is released slowly over a few weeks after being injected.
Podaljšano sproščanje pomeni, da se zdravilna učinkovina po injiciranju počasi sprošča več tednov.
For the full list of all side effects reported with Zycortal, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Zycortal, glejte navodilo za uporabo.
Zycortal is available as a prolonged-release suspension for injection.
Zdravilo Zycortal je na voljo v obliki suspenzije s podaljšanim sproščanjem za injiciranje.
It is not intended to provide practical advice on how to use Zycortal.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Desoxycortone pivalate
Zycortal dezoksikorton pivalat
Dogs with Addison's disease have insufficient levels of aldosterone in their blood and Zycortal is used to replace the missing hormone.
Psi z Addisonovo boleznijo nimajo zadostnih ravni aldosterona v krvi in zdravilo Zycortal se uporablja za nadomeščanje manjkajočega hormona.
Zycortal is used long-term to replace the missing aldosterone.
Zdravilo Zycortal se uporablja dolgotrajno za nadomestitev manjkajočega aldosterona.
The dose to be given and the interval between treatments depend on the dog's response as well as the blood levels of certain electrolytes (sodium and potassium).
Odmerek, ki se da, in interval odmerjanja sta odvisna od odziva psa ter ravni določenih elektrolitov (natrija in kalija) v krvi.
What benefits of Zycortal have been shown in studies?
Kakšne koristi je zdravilo Zycortal izkazalo v študijah?
What is Zycortal and what is it used for?
Kaj je zdravilo Zycortal in za kaj se uporablja?
What are the risks associated with Zycortal?
Kakšna tveganja so povezana z zdravilom Zycortal?
Desoxycortone pivalate is a synthetically produced steroid hormone very similar to the natural hormone aldosterone.
Dezoksikorton pivalat je sintetično izdelan steroidni hormon, ki je zelo podoben naravnemu hormonu aldosteronu.
Addison's disease is a condition, known as hypoadrenocorticism, where the adrenal glands (located above the kidneys) do not produce enough of two steroid hormones, called cortisol and aldosterone.
Addisonova bolezen je bolezen, znana kot hipoadenokorticizem, pri kateri nadledvične žleze, ki se nahajajo nad ledvicami, ne tvorijo zadostnih količin dveh steroidnih hormonov, kortizola in aldosterona.
The European Commission granted a marketing authorisation valid throughout the EU for Zycortal on
Evropska komisija je dovoljenje za promet z zdravilom Zycortal, veljavno po vsej Evropski uniji, izdala
Why is Zycortal approved?
Zakaj je bilo zdravilo Zycortal odobreno?
Zycortal is a veterinary medicine used to treat dogs with Addison's disease.
Zdravilo Zycortal je zdravilo za uporabo v veterinarski medicini za zdravljenje psov z Addisonovo boleznijo.
Zycortal can only be obtained with a prescription.
Izdaja zdravila Zycortal je le na recept.
If irritation occurs, seek medical advice immediately and show the package leaflet or the label to the doctor.
Če se pojavi draženje, nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
Safety information has been included in the summary of product characteristics and the package leaflet for Zycortal, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
V povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
This medicine may cause pain and swelling at the injection site if accidentally self-administered.
To zdravilo lahko v primeru nenamernega samoinjiciranja povzroči bolečino in oteklino na mestu injiciranja.
For practical information about using Zycortal, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Zycortal naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For more information about treatment with Zycortal, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Zycortal naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
How does Zycortal work?
Kako zdravilo Zycortal deluje?
How is Zycortal used?
Kako se zdravilo Zycortal uporablja?
Zycortal contains the active substance desoxycortone pivalate.
Zdravilo Zycortal vsebuje zdravilno učinkovino dezoksikorton pivalat.
In the future, if the animals are exposed to this infection, the immune system will be able to respond more quickly.
Ob ponovni izpostavitvi živali tej okužbi v prihodnosti se bo lahko imunski sistem nanjo hitreje odzval.
The effectiveness of Versican Plus Pi was investigated in a field study involving 129 dogs.
Učinkovitost zdravila Versican Plus Pi so raziskali v terenski študiji, v katero so vključili 129 psov.
The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus Pi on 4 July 2014.
Evropska komisija je dovoljenje za promet z zdravilom Versican Plus Pi, veljavno po vsej Evropski uniji, izdala 4. julija 2014.
The virus in Versican Plus Pi is alive but has been attenuated (weakened) so that does not cause disease.
Virus v zdravilu Versican Plus Pi je živ, vendar je bil atenuiran (oslabljen), tako da ne povzroča bolezni.
The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus Pi is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
Najpogostejši neželeni učinek cepiva Versican Plus Pi (opažen pri več kot 1 psu od 100) je kratkotrajna oteklina v velikosti do 5 cm, ki se lahko po cepljenju pojavi na mestu injiciranja.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus Pi exceed the risks for the approved indications and recommended that Versican Plus Pi be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Versican Plus Pi večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
For revaccination, a single dose of Versican Plus Pi is required annually.
Za ponovno cepljenje je potreben enkraten odmerek cepiva Versican Plus Pi enkrat na leto.
Versican Plus Pi is a vaccine.
Zdravilo Versican Plus Pi je cepivo.