natgillin/translations-raw huggingface dataset:
Overall, 94% of people who tested negative for growth hormone deficiency with ITT also tested negative with Macimorelin Aeterna Zentaris; 74% of people who tested positive with ITT also tested positive with Macimorelin Aeterna Zentaris.
Na splošno je imelo 94 % ljudi, ki so imeli negativen test ITT glede pomanjkanja rastnega hormona, negativen test tudi z zdravilom Macimorelin Aeterna Zentaris; 74 % ljudi, ki so imeli pozitiven test ITT, je imelo pozitiven rezultat tudi z zdravilom Macimorelin Aeterna Zentaris.
EMA considered that it is a priority to avoid over-diagnosis of adult growth hormone deficiency and that Macimorelin Aeterna Zentaris helps confirm positive diagnosis and so avoid unnecessary treatment of patients with a false positive test result.
Agencija EMA je menila, da se je treba izogniti pretiranemu diagnosticiranju pomanjkanja rastnega hormona pri odraslih in da zdravilo Macimorelin Aeterna Zentaris pomaga potrditi pozitivno diagnozo in tako preprečiti nepotrebno zdravljenje bolnikov z lažno pozitivnim rezultatom testa.
On the whole, Macimorelin Aeterna Zentaris has fewer side effects than the comparator test, which temporarily lowers the level of sugar in the blood.
Na splošno ima zdravilo Macimorelin Aeterna Zentaris manj neželenih učinkov kot primerjalni test, ki začasno zniža raven sladkorja v krvi.
The most common side effects with Macimorelin Aeterna Zentaris (which may affect up to 1 in 10 people) are a bitter or metallic taste, tiredness, headache, nausea (feeling sick), dizziness, diarrhoea and feeling hot. Macimorelin Aeterna Zentaris may also cause a change in heart rhythm.
Najpogostejši neželeni učinki zdravila Macimorelin Aeterna Zentaris (ki lahko prizadenejo največ 1 osebo od 10) so grenek ali kovinski okus, utrujenost, glavobol, navzeja (siljenje na bruhanje), omotica, driska in občutek vročine.
The level of growth hormone in the blood is then measured and indicates whether or not the body is able to produce growth hormone.
Nato se izmeri raven rastnega hormona v krvi, s čimer se ugotovi, ali lahko telo samo proizvaja rastni hormon ali ne.
EMA therefore decided that Macimorelin Aeterna Zentaris's benefits are greater than its risks and it can be authorised for use in the EU.
Agencija je zaključila, da so koristi zdravila Macimorelin Aeterna Zentaris večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Macimorelin Aeterna Zentaris 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 Macimorelin Aeterna Zentaris upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Side effects reported with Macimorelin Aeterna Zentaris are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Macimorelin Aeterna Zentaris, se skrbno ovrednotijo in po potrebi sprejmejo ukrepi za zaščito bolnikov.
As for all medicines, data on the use of Macimorelin Aeterna Zentaris are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Macimorelin Aeterna Zentaris stalno spremljajo.
What measures are being taken to ensure the safe and effective use of Macimorelin Aeterna Zentaris?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Macimorelin Aeterna Zentaris?
For more information about using Macimorelin Aeterna Zentaris, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Macimorelin Aeterna Zentaris glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
An overview of Macimorelin Aeterna Zentaris and why it is authorised in the EU
Pregled zdravila Macimorelin Aeterna Zentaris in zakaj je odobreno v EU
Among them, 140 were tested with both Macimorelin Aeterna Zentaris and ITT.
Pri 140 od teh bolnikov so opravili testiranje z zdravilom Macimorelin Aeterna Zentaris in testom ITT.
The active substance in Macimorelin Aeterna Zentaris, macimorelin, stimulates the release of growth hormone into the blood by activating receptors (targets) found on cells in the pituitary gland, a gland located at the base of the brain.
Učinkovina v zdravilu Macimorelin Aeterna Zentaris, macimorelin, spodbuja sproščanje rastnega hormona v kri z aktiviranjem receptorjev (prijemališč), ki so na celicah hipofize, tj. žleze na dnu možganov.
Why is Macimorelin Aeterna Zentaris authorised in the EU?
Zakaj je bilo zdravilo Macimorelin Aeterna Zentaris odobreno v EU?
Macimorelin Aeterna Zentaris can only be obtained with a prescription and its use must be supervised by a healthcare professional experienced in diagnosing growth hormone deficiency.
Predpisovanje in izdaja zdravila Macimorelin Aeterna Zentaris je le na recept, njegovo uporabo pa mora nadzorovati zdravstveni delavec z izkušnjami z diagnosticiranjem pomanjkanja rastnega hormona.
Macimorelin Aeterna Zentaris is a medicine used to test the ability of the body to produce growth hormone.
Zdravilo Macimorelin Aeterna Zentaris se uporablja za preverjanje sposobnosti telesa za tvorjenje rastnega hormona.
Other information about Macimorelin Aeterna Zentaris
Druge informacije o zdravilu Macimorelin Aeterna Zentaris
What is Macimorelin Aeterna Zentaris and what is it used for?
Kaj je zdravilo Macimorelin Aeterna Zentaris in za kaj se uporablja?
Macimorelin Aeterna Zentaris was compared with another test commonly used to diagnose growth hormone deficiency, called insulin tolerance test (ITT), in one main study.
V eni glavni študiji so zdravilo Macimorelin Aeterna Zentaris primerjali z drugim testom, ki se običajno uporablja za diagnosticiranje pomanjkanja rastnega hormona, imenovanega test tolerance insulina (ITT).
For the full list of side effects and restrictions with Macimorelin Aeterna Zentaris, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev zdravila Macimorelin Aeterna Zentaris glejte navodilo za uporabo.
What are the risks associated with Macimorelin Aeterna Zentaris?
Kakšna tveganja so povezana z zdravilom Macimorelin Aeterna Zentaris?
What benefits of Macimorelin Aeterna Zentaris have been shown in studies?
Kakšne koristi je zdravilo Macimorelin Aeterna Zentaris izkazalo v študijah?
Macimorelin Aeterna Zentaris is available as granules that are dissolved in water and taken by mouth.
Zdravilo Macimorelin Aeterna Zentaris je na voljo v obliki zrnc, ki jih je treba raztopiti v vodi in zaužiti peroralno.
Macimorelin Aeterna Zentaris contains the active substance macimorelin.
Zdravilo Macimorelin Aeterna Zentaris vsebuje zdravilno učinkovino macimorelin.
Macimorelin Aeterna Zentaris gave a similar number of negative test results for growth hormone deficiency as a comparator test; however, it gives fewer positive test results than the comparator.
Zdravilo Macimorelin Aeterna Zentaris je imelo podobno število negativnih rezultatov na test pomanjkljivosti rastnega hormona kot primerjalni test.
How is Macimorelin Aeterna Zentaris used?
Kako se zdravilo Macimorelin Aeterna Zentaris uporablja?
How does Macimorelin Aeterna Zentaris work?
Kako zdravilo Macimorelin Aeterna Zentaris deluje?
At the final analysis, 1,653 deaths were reported.
V končni analizi so poročali o 1.653 smrtnih primerih.
Your injection could take about 15 seconds.
Injiciranje lahko traja približno 15 sekund.
The healthcare professional's educational material should contain the following key elements:
Izobraževalno gradivo za zdravstvenega delavca mora vsebovati naslednje ključne elemente:
There may be local guidelines for disposal.
Morda obstajajo lokalne smernice za odlaganje.
study (study 20010184).
TREAT (študija 20010184).
This may vary depending on whether you are an adult or a child.
Odmerek se lahko razlikuje glede na to, ali ste odrasla oseba ali otrok.
• Serious allergic reactions which may include:
• Resne alergijske reakcije, ki lahko vključujejo:
To give yourself an injection you will need:
Da si boste dali injekcijo, potrebujete:
Please discuss this with your doctor.
Prosimo, da se o tem posvetujete z zdravnikom.
A risk to the suckling child cannot be excluded.
Tveganja za dojenčka ne moremo izključiti.
In some cases, your doctor may recommend that you take iron supplements.
V nekaterih primerih vam zdravnik lahko svetuje jemanje dodatkov železa.
• think you may be pregnant; or
• mislite, da ste noseči; ali
Do not administer more than one dose.
Ne aplicirajte več kot enega odmerka.
No alteration of fertility was detected.
Sprememb plodnosti niso odkrili.
The instructions for use, handling and disposal are given in section 6.6.
Navodila za uporabo, ravnanje z zdravilom in odlaganje so navedena v poglavju 6.6.
A reticulocyte count should be considered as part of the evaluation.
Določanje števila retikulocitov mora biti del ocenjevanja.
Your blood pressure will also be checked regularly, particularly at the beginning of your treatment.
Redno vam bo preverjal tudi krvni tlak, še posebej na začetku zdravljenja.
If it is cloudy or there are particles in it, you must not use it.
Če je motna ali so v njej delci, je ne smete uporabiti.
Because it will take your body some time to make more red blood cells, it will be about four weeks before you notice any effect.
Ker telo za nastanek več rdečih krvnih celic potrebuje nekaj časa, bodo minili približno štirje tedni, preden boste opazili kakšen učinek.
Guidance is given separately for adult and paediatric patients.
Smernice so navedene ločeno za odrasle in pediatrične bolnike.
Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of ESAs and should therefore be corrected.
Pomanjkanje železa, folne kisline ali vitamina B12 zmanjša učinkovitost ESA in jih je zato treba korigirati.
Placental transfer was minimal.
Prehajanje skozi placento je bilo minimalno.
It is important to tell your doctor if you:
Zdravniku morate povedati, če:
- if you have been diagnosed with high blood pressure which is not being controlled with other medicines prescribed by your doctor.
- če imate ugotovljen visok krvni tlak in ta ni obvladan z drugimi zdravili, ki vam jih je predpisal zdravnik.
Correction phase:
Obdobje korekcije:
Important: Do not touch the red start button yet.
Pomembno: Ne dotikajte se še rdečega sprožilnega gumba.
Important: When you remove the pre-filled pen, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose.
Pomembno: Ko boste napolnjeni injekcijski peresnik odmaknili od kože in če okence ni postalo rumeno, ali če izgleda, kot da se zdravilo še vedno injicira, to pomeni, da niste prejeli celotnega odmerka.
2 Frequency cannot be estimated from the available data.
2 Pogostnosti iz razpoložljivih podatkov ni mogoče oceniti.
Do not use Aranesp if you think it has been frozen.
Ne uporabite zdravila Aranesp, če mislite, da je bilo zamrznjeno.
Epoetins are not approved in the management of anaemia associated with hepatitis C.
Epoetini niso odobreni za obvladovanje anemije, povezane s hepatitisom C.
Do not use Aranesp: - if you are allergic to darbepoetin alfa or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Aranesp: - če ste alergični na darbepoetin alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Poorly controlled hypertension.
Slabo urejena hipertenzija.
It is important to tell your doctor if you are taking either of these medicines.
Pomembno je, da zdravniku poveste, če jemljete katero od njiju.
J Keep pushing down on your skin.
J Še naprej pritiskajte ob kožo.
The carcinogenic potential of darbepoetin alfa has not been evaluated in long-term animal studies.
Kancerogenega potenciala darbepoetina alfa niso ocenili v dolgoročnih študijah na živalih.
Important: Follow your healthcare provider's instructions about selecting sites for injection appropriate to you and about changing the site for each injection.
Pomembno: Upoštevajte navodila zdravstvenega delavca o izbiri mest za injiciranje, ki vam ustrezajo, in o spremembi mesta za vsako injiciranje.
As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours.
Tako kot pri vseh rastnih dejavnikih tudi pri epoetinih obstaja skrb, da bi lahko spodbudili rast tumorjev.
Dose increases must not be made more frequently than once every four weeks.
Odmerka ne smete povečati pogosteje kot enkrat na štiri tedne.
In preclinical studies it has been shown that renal clearance is minimal (up to 2% of total clearance), and does not affect the serum half-life.
Predklinične študije so pokazale, da je ledvični očistek minimalen (do 2 % celotnega očistka) in ne vpliva na razpolovni čas v serumu.
C Gather all the materials needed for your injection.
C Pripravite ves material, potreben za injiciranje.
Despite these molecular changes, darbepoetin alfa retains a very narrow specificity for the erythropoietin receptor.
Kljub tem molekulskim spremembam darbepoetin alfa ohranja zelo ozko specifičnost za eritropoetinski receptor.
Depending on your individual situation a blood transfusion may be preferable.
Odvisno od vašega osebnega stanja je lahko primernejši ukrep transfuzija krvi.
Only use each syringe for one injection.
Vsako brizgo uporabite le za eno injiciranje.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Receptorji za eritropoetin so lahko izraženi na površini različnih tumorskih celic.
If the clinical response of the patient (fatigue, haemoglobin response) is inadequate after nine weeks, further therapy may not be effective.
Če bolnikov klinični odziv (utrujenost, odziv hemoglobina) po devetih tednih ni zadosten, nadaljnje zdravljenje morda ne bo učinkovito.
Important: Needle is inside
Pomembno: Znotraj je igla.
• Alcohol wipes
• alkoholne zložence
The injections will be given by a healthcare professional.
Injekcije vam bo dal zdravstveni delavec.
• High blood pressure (hypertension)
• visok krvni tlak (hipertenzija)
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsaki spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki bi lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Before you inject Aranesp you must do the following:
Pred injiciranjem zdravila Aranesp, morate narediti naslednje:
Date of latest renewal: 19 May 2006
Datum prve odobritve: 8. junij 2001 Datum zadnjega podaljšanja: 19. maj 2006
Maintenance phase:
Obdobje vzdrževanja:
A systematic review has also been performed involving more than 9,000 cancer patients participating in 57 clinical trials.
Sistematično so pregledali tudi podatke o več kot 9.000 bolnikih z rakom, ki so sodelovali v 57 kliničnih preskušanjih.
It is normal to see a drop of liquid at the end of the needle or yellow safety guard.
Normalno je, da se na koncu igle ali rumenega varnostnega ščitnika pokaže kapljica tekočine.
Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Za razvrstitev pogostnosti je uporabljen naslednji dogovor: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
For intravenous or subcutaneous use.
Za intravensko ali subkutano uporabo.
Important: You must push all the way down but do not touch the red start button until you are ready to inject.
Pomembno: Potisniti morate do konca dol, vendar se ne dotikajte rdečega sprožilnega gumba, dokler niste pripravljeni na injiciranje.
Treatment with Aranesp is divided into two stages, correction and maintenance phase.
Zdravljenje z zdravilom Aranesp delimo na dve obdobji - obdobje korekcije in obdobje vzdrževanja.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi bili lahko noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
The primary efficacy endpoint [change in haemoglobin between baseline and the evaluation period (week 21-28)] was comparable between the two groups.
Primarni opazovani dogodek učinkovitosti [sprememba hemoglobina od izhodišča do obdobja ovrednotenja (21. do 28. teden)] je bil med skupinama primerljiv.
• Tell your doctor if you have an allergy to latex.
• Zdravniku morate povedati, če ste alergični na lateks.
I When you are ready to inject, pressthe red start button.
I Ko ste pripravljeni na injiciranje, pritisnite rdeči sprožilni gumb.
Bioavailability is 37% with subcutaneous administration.
Biološka uporabnost po subkutani uporabi je 37 %.
In the chronic toxicity studies no tumourigenic or unexpected mitogenic responses were observed in any tissue type.
V študijah kronične toksičnosti niso v nobeni vrsti tkiva opazili tumorigenosti ali nepričakovanega mitogenega odziva.
In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name of the administered ESA should be clearly recorded (or stated) in the patient file.
Z namenom izboljšanja sledljivosti zdravil za stimulacijo eritropoeze (ESA) je treba v bolnikovi dokumentaciji jasno zabeležiti (ali navesti) trgovsko ime uporabljenega ESA.
• Shortness of breath (allergic bronchospasm)
• težko dihanje (alergijski bronhospazem)
There are no adequate and well-controlled studies with Aranesp in pregnant women.
Pri nosečnicah ni ustreznih in dobro kontroliranih študij z zdravilom Aranesp.
- If you are a cancer patient you should be aware that Aranesp may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
- Če ste bolnik z rakom, morate vedeti, da lahko zdravilo Aranesp deluje kot rastni dejavnik za krvne celice in lahko v nekaterih okoliščinah neugodno vpliva na vašo bolezen.
• Outer area of upper arm (only if someone else is giving you the injection) Clean the injection site with an alcohol wipe.
• zunanji del nadlakta (le če vam injekcijo da kdo drug) Očistite mesto injiciranja z alkoholnim zložencem.
Your doctor will tell you exactly when to stop taking Aranesp.
Zdravnik vam bo povedal, kdaj natančno morate nehati uporabljati zdravilo Aranesp.
Not known: frequency cannot be estimated from available data • Pure red cell aplasia (PRCA) - (anaemia, unusual tiredness, lack of energy)
Neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti • čista aplazija rdečih celic (PRCA) - (anemija, nenavadna utrujenost, pomanjkanje energije)
• Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
• oteklost obraza, ustnic, ust, jezika ali žrela, ki lahko povzroči težave pri požiranju ali dihanju (angioedem)
Patients < 6 years of age may need higher doses for maintenance of haemoglobin than patients above that age.
Bolniki, stari < 6 let, lahko za vzdrževanje hemoglobina potrebujejo večje odmerke kot bolniki nad to starostjo.
- Take special care with other products that stimulate red blood cell production: Aranesp is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does.
- Bodite posebno pozorni pri jemanju drugih zdravil, ki spodbujajo nastajanje rdečih krvnih celic: zdravilo Aranesp spada v skupino zdravil, ki spodbujajo nastajanje rdečih krvnih celic tako, kot ga spodbuja človeška beljakovina eritropoetin.
• Do not put the cap back on used needles, as you may accidentally prick yourself.
• Ne nameščajte pokrovčka nazaj na uporabljene igle, ker se lahko po nesreči zbodete.
To avoid bending the needle, gently pull the cap from the needle without twisting as shown in pictures 1 and 2.
Da ne boste zvili igle, previdno snemite pokrovček z igle, ne da bi ga upogibali, tako kot prikazujeta sliki 1 in 2.
Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly.
Primeri so bili opisani pri bolnikih s hepatitisom C, zdravljenih z interferonom in ribavirinom, če so sočasno uporabljeni epoetini.
Your treatment will continue until approximately four weeks after the end of your chemotherapy.
Zdravljenje boste končali približno štiri tedne po koncu kemoterapije.
Using Aranesp with food and drink
Uporaba zdravila Aranesp skupaj s hrano in pijačo
If you are unable to inject, please contact your healthcare provider immediately.
Če ne morete injicirati, nemudoma kontaktirajte zdravstvenega delavca.
Contact your healthcare provider immediately.
Takoj pokličite zdravstvenega delavca.
Because of individual variability, titration to optimal therapeutic doses is expected for individual patients.
Zaradi individualne variabilnosti je treba pričakovati, da bo pri posameznem bolniku potrebno titriranje do optimalnega terapevtskega odmerka.
In controlled clinical studies, use of Aranesp and other ESAs have shown:
V kontroliranih kliničnih študijah je uporaba zdravila Aranesp in drugih ESA:
Food and drink do not affect Aranesp.
Hrana in pijača ne vplivata na zdravilo Aranesp.
Do not try to inject yourself if you have not been trained.
Ne poskušajte si ga injicirati, če vas tega niso naučili.
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician's evaluation of the individual patient's clinical course and condition is necessary.
Simptomi in posledice anemije se lahko razlikujejo glede na starost, spol in celotno breme bolezni; zdravnik mora oceniti klinični potek in stanje pri posameznem bolniku.
Check that it is the correct dose that your doctor has prescribed.
Preverite, da imate pravi odmerek, ki ga je predpisal zdravnik.
Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life-expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1).
Med dejavniki, ki jih je treba upoštevati pri takšni oceni, so vrsta in stadij tumorja, stopnja anemije, pričakovana življenjska doba, okolje, v katerem poteka bolnikovo zdravljenje in bolnikove želje (glejte poglavje 5.1).
Not known: frequency cannot be estimated from available data
Neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
If you experience these symptoms you should contact your doctor who will determine the best course of action to treat your anaemia.
Če se vam pojavijo takšni simptomi, se morate posvetovati z zdravnikom, ki bo določil najustreznejše ukrepanje za zdravljenje vaše anemije.
In the absence of incompatibility studies, this medicinal product must not be mixed or administered as an infusion with other medicinal products.
V primeru pomanjkanja študij kompatibilnosti tega zdravila ne smete mešati ali aplicirati v infuziji z drugimi zdravili.
The clinical results obtained so far do not indicate any interaction of darbepoetin alfa with other substances.
Dosedanji klinični rezultati ne kažejo, da bi darbepoetin alfa medsebojno deloval z drugimi snovmi.
Any medicinal product remaining should be disposed of.
Ostanek zdravila morate zavreči.
If needed, you may cover the injection site with a plaster.
Če je treba, lahko mesto injiciranja pokrijete z obližem.
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Ob času predpisovanja zdravila je treba bolnike seznaniti z znaki in simptomi kožnih reakcij in jih glede takšnih reakcij skrbno spremljati.