natgillin/translations-raw huggingface dataset:
However, since such a risk cannot completely be excluded, the Committee recommended that warnings on the possible risk of fibrosis in patients taking these medicines at high doses for long periods should be included in their prescribing information.
Ker takšnega tveganja ni mogo e popolnoma izklju iti, je Odbor priporo il, da je treba za ta zdravila v podatke o predpisovanju vklju iti opozorila o možnem tveganju fibroze pri bolnikih, ki dolgo asa jemljejo velike odmerke omenjenih zdravil.
• To reduce the risk of cardiac fibrosis, patients should be prescribed a daily maximum of 3 mg pergolide or cabergoline, or 30 mg bromocriptine.
• Za zmanjšanje tveganja sr ne fibroze je najve ji dnevni odmerek, ki se lahko predpiše bolnikom, 3 mg za pergolid ali kabergolin ali 30 mg za bromokriptin.
QUESTIONS AND ANSWERS ON THE REVIEW OF ERGOT-DERIVED DOPAMINE AGONISTS
VPRAŠANJA IN ODGOVORI V ZVEZI S PREGLEDOM AGONISTOV DOPAMINA, KI SO DERIVATI ERGOT ALKALOIDOV
For cabergoline and pergolide, the Committee noted that the risk of fibrosis of the heart valves is well established, that the prescribing information for both products already includes contraindications stating that patients with evidence of heart valve problems should not take them, and that the medicines should only be used for Parkinson's disease in patients who have already taken or cannot take other treatments.
Odbor je izpostavil, da je tveganje fibroze sr nih zaklopk pri kabergolinu in pergolidu dobro poznano, da podatki o predpisovanju za obe zdravili že vsebujejo kontraindikacije, in sicer da ju bolniki z dokazanimi težavami s sr nimi zaklopkami ne smejo jemati, ter da se lahko zdravili uporabljata za Parkinsonovo bolezen le pri bolnikih, ki so ju že jemali, ali bolnikih, ki ne morejo jemati drugih zdravil.
Ergot-derived dopamine agonists are a group of medicines consisting of bromocriptine, cabergoline, dihydroergocryptine, lisuride and pergolide.
Agonisti dopamina, ki so derivati ergot alkaloidov, so skupina zdravil, kamor spadajo bromokriptin, kabergolin, dihidroergokriptin, lisurid in pergolid.
In contrast, there is not enough evidence to determine whether there is an increased risk of fibrosis of the heart valves in patients taking bromocriptine, dihydroergocryptine or lisuride.
Ni pa dovolj dokazov, da bi ugotovili, ali obstaja pove ano tveganje fibroze sr nih zaklopk pri bolnikih, ki jemljejo bromokriptin, dihidroergokriptin ali lisurid.
• Ergot-derived dopamine agonists should not be taken by patients who have had fibrosis in the heart, lungs or abdomen.
• Agoniste dopamina, ki so derivati ergot alkaloidov, ne smejo jemati bolniki, ki so v preteklosti imeli fibrozo v srcu, plju ih ali trebuhu.
The absence of fibrosis in the heart should be verified before treatment is started.
Pred za etkom zdravljenja je treba potrditi odsotnost fibroze v srcu.
Based on the information available, the CHMP has concluded that the marketing authorisations for the ergot-derived dopamine agonists should be maintained, but changes to the prescribing information for the medicines should be introduced to reduce the risk of fibrosis.
CHMP je na podlagi razpoložljivih podatkov zaklju il, da naj se dovoljenja za promet z agonisti dopamina, ki so derivati ergot alkaloidov, ohranijo, vendar je za ta zdravila potrebno uvesti spremembe podatkov o predpisovanju, da bi se zmanjšalo tveganje fibroze.
The review focused on the risk of fibrosis (the formation of fibrous tissue in some body structures) in patients taking these medicines for long periods, particularly cardiac fibrosis (abnormal thickening of the heart valves).
Pri pregledu so se osredoto ili na tveganje fibroze (nastanka fibroznega tkiva v dolo enih telesnih strukturah) pri bolnikih, ki jemljejo ta zdravila dolgo asa, zlasti pa sr ne fibroze (nenormalne odebelitve sr nih zaklopk).
This group of dopamine agonists are called ‘ergotderived', because they were first produced from a type of fungus called ergot.
To skupino agonistov dopamina imenujemo „derivati ergot alkaloidov“, ker so jih prvi pridobili iz plesni, imenovane ergot.
Consequently, the United Kingdom's medicines regulatory authority asked the CHMP to review the risk of fibrosis, including cardiac fibrosis, associated with the use of ergot-derived dopamine agonists.
Zato je regulativni organ za zdravila v Združenem kraljestvu prosil CHMP za pregled tveganja fibroze, vklju no s sr no fibrozo, ki je povezano z jemanjem agonistov dopamina, ki so derivati ergot alkaloidov.
Therefore, the CHMP recommended that the prescribing information for these two medicines should be updated to include:
Zato je CHMP priporo il, da se podatki o predpisovanju za zdravili posodobijo, tako da vklju ujejo naslednje:
Why have ergot-derived dopamine agonists been reviewed?
Zakaj so bili agonisti dopamina, ki so derivati ergot alkaloidov, pregledani?
Dopamine agonists work by stimulating brain and nerve cells in a similar way to dopamine, a messenger substance in the nervous system.
Agonisti dopamina delujejo tako, da stimulirajo možgane in živ ne celice podobno kot dopamin, ki je sporo ilna snov v živ evju.
• ‘cardiac fibrosis' as a ‘very common' side effect (seen in more than 1 patient in 10 taking either medicine).
• „sr na fibroza“ se ozna i kot „zelo pogost“ neželen u inek (opažen pri ve kot 1 bolniku izmed
The development of the symptoms of fibrosis has been known as a side effect of ergot-derived dopamine agonists for many years, particularly when the medicines are used for long periods.
Pojav simptomov fibroze je že ve let znan neželeni u inek agonistov dopamina, ki so derivati ergot alkaloidov, zlasti e jih bolniki jemljejo dolgo asa.
Among the ergot-derived dopamine agonists, cabergoline and pergolide activate these receptors most strongly, possibly explaining the greater risk of fibrosis seen with these medicines.
Med agonisti dopamina, ki so derivati ergot alkaloidov, te receptorje najmo neje aktivirata kabergolin in pergolid, kar je možna razlaga ve jega tveganja fibroze pri uporabi teh dveh zdravil.
The CHMP also recommended that companies that make these two medicines should conduct studies to look at how closely doctors follow the updated prescribing information and the impact that these changes have on the incidence of fibrosis of the heart valves.
Poleg tega je CHMP priporo il, da družbe, ki izdelujejo zdravili, izvedejo študije, s katerimi bi ugotovili, kako natan no zdravniki upoštevajo posodobljene podatke o predpisovanju ter u inek teh sprememb na pojavnost fibroze sr nih zaklopk.
What are ergot-derived dopamine agonists?
Kaj so agonisti dopamina, ki so derivati ergot alkaloidov?
The European Medicines Agency (EMEA) has completed a review of the safety of the ergot-derived dopamine agonists, a group of medicines that are mainly used to treat Parkinson's disease.
Evropska agencija za zdravila (EMEA) je zaklju ila pregled varnosti agonistov dopamina, ki so derivati ergot alkaloidov.
The CHMP reviewed all of the available information on the risk of fibrosis and valve problems from clinical trials, observational studies (studies looking at the effects of medicines as they are used by patients) and ‘spontaneous reports' of side effects made by patients or doctors to the companies that make the medicines or to health authorities.
CHMP je pregledal vse razpoložljive podatke o tveganju fibroze ter težav z zaklopkami iz klini nih preskušanj, opazovalnih študij (študij, v katerih preu ujejo u inke zdravil med njihovo uporabo pri len 31 Direktive 2001/83/ES, kakor je bila spremenjena, napotitveni postopek v interesu Skupnosti.
In addition, the CHMP recommended that a contraindication for patients with pre-existing valve problems should be included in the prescribing information for bromocriptine and dihydroergocryptine-containing medicines.
CHMP je priporo il tudi, da se za zdravila, ki vsebujejo bromokriptin in dihidroergokriptin, v podatke o predpisovanju vklju i kontraindikacija za bolnike z obstoje imi težavami s sr nimi zaklopkami.
--1 ≥ 394AU/ml (Antigenic units determined by ELISA) (1400 AU corresponding to ≥ 492 AU in the potency test)
--1 ≥ 492 AU/ml (Antigenske enote določene z ELISA testom) (1400 AU ustreza ≥ 492 AU v testu potentnost)
Vial (type I glass) closed with a rubber stopper secured with aluminium cap
Intramuskularno Viala (steklo tipa I) zaprta z gumijastim zamaškom zatesnjenim z aluminijasto zaporko
10 vials Zero days
10 vial
Strength Pharmaceutical form
Način uporabe zdravila
EU Number
Ovojnina
Invented name
EU številka Izmišljeno ime Jakost Farmacevtska oblika
It was to be available as 10 mg tablets.
Na voljo naj bi bilo v obliki 10-miligramskih tablet.
The main measure of effectiveness was the time patients lived until their disease got worse.
Glavno merilo učinkovitosti je bil čas preživetja bolnikov do poslabšanja bolezni.
This is expected to slow down the growth and proliferation of cancer cells.
S tem naj bi se upočasnila rast in proliferacija rakavih celic.
Withdrawal of the marketing authorisation application for Jenzyl (ridaforolimus)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Jenzyl (ridaforolimus)
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Vlogo so umaknili po tem, ko je CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
The company had not yet responded to the last round of questions at the time of the withdrawal.
Ob umiku vloge družba še ni odgovorila na zadnji krog vprašanj.
The summary of the opinion of the Committee for Orphan Medicinal Products for Jenzyl can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (soft tissue sarcoma and primary malignant bone tumours).
Povzetek mnenja Odbora za zdravila sirote o zdravilu Jenzyl je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (sarkom mehkih tkiv in primarni maligni kostni tumorji).
Jenzyl is a medicine that contains the active substance ridaforolimus.
Jenzyl je zdravilo, ki vsebuje zdravilno učinkovino ridaforolimus.
Since mTOR is involved in the control of cell division and the growth of blood vessels, ridaforolimus prevents the division of tumour cells and reduces their blood supply.
Ker mTOR sodeluje pri uravnavanju delitve celic in rasti krvnih žil, ridaforolimus preprečuje delitev tumorskih celic in zmanjšuje njihovo oskrbo s krvjo.
What is Jenzyl?
Kaj je zdravilo Jenzyl?
The CHMP also considered that the somewhat larger effect seen in patients who had received two or three previous regimens of chemotherapy compared with those who received one or more regimens might not reflect the medicine's true effect size, as the reason the medicine would work better at later stages of the disease was unclear.
CHMP je tudi menil, da nekoliko večji učinek zdravila pri bolnikih, ki so prejeli dva ali tri režime predhodne kemoterapije, v primerjavi z bolniki, ki so prejeli enega ali več režimov, ne odraža nujno dejanskega obsega učinka zdravila, saj ni bilo pojasnjeno, zakaj naj bi bilo zdravilo učinkovitejše v poznejšem obdobju bolezni.
The company presented the results of one main study involving 711 patients with metastatic soft tissue sarcoma or bone sarcoma who have received up to four cycles of one, two or three alternative chemotherapy regimens.
Družba je predložila rezultate ene glavne študije, ki je zajela 711 bolnikov z metastatskim sarkomom mehkih tkiv ali kostnim sarkomom, ki so prejeli do štiri cikluse enega, dveh ali treh alternativnih režimov kemoterapije.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Jenzyl.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Jenzyl.
It was expected to be used as maintenance therapy in patients who have already received two or three regimens of chemotherapy.
Zdravilo naj bi se uporabljalo za vzdrževalno zdravljenje bolnikov, ki so že bili zdravljeni z dvema ali tremi režimi kemoterapije.
In the body, ridaforolimus first attaches to a protein called FKBP-12 that is found inside cells to make a ‘complex'.
Ridaforolimus se v telesu najprej veže na beljakovino v celicah, imenovano FKBP-12, in z njo tvori „skupek”.
The study compared Jenzyl with placebo (a dummy treatment).
V študiji so zdravilo Jenzyl primerjali s placebom (zdravilom brez zdravilne učinkovine).
This complex then blocks mTOR.
Ta skupek nato zavira encim mTOR.
In terms of safety, the CHMP was concerned by the high frequency of side effects interfering with the patient's wellbeing as well as some uncommon but potentially lifethreatening side effects.
Pri ocenjevanju varnosti zdravila je bil CHMP zaskrbljen zaradi pogostih stranskih učinkov, ki vplivajo na dobro počutje bolnika, in zaradi občasnih stranskih učinkov, ki so lahko smrtno nevarni.
What was Jenzyl expected to be used for?
Za kaj naj bi se zdravilo Jenzyl uporabljalo?
The CHMP was concerned that taking Jenzyl only led to a small increase in the time patients lived until their disease got worse compared with placebo (18 versus 15 weeks in patients who had one or more regimens of previous chemotherapy, and 16 versus 10 weeks in patients who had received two or three previous regimens of chemotherapy).
CHMP je izrazil pomislek, da se je čas preživetja bolnikov do poslabšanja bolezni ob jemanju zdravila Jenzyl zgolj nekoliko podaljšal v primerjavi s placebom (s 15 na 18 tednov pri bolnikih, ki so prejeli enega ali več režimov predhodne kemoterapije, in z 10 na 16 tednov pri bolnikih, ki so prejeli dva ali tri režime predhodne kemoterapije).
Jenzyl was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 26 August 2005 and 28 October 2005 for the treatment of soft tissue sarcoma and primary malignant bone tumours.
Zdravilo Jenzyl je bilo dne 26. avgusta 2005 in 28. oktobra 2005 določeno kot „zdravilo sirota” (zdravilo za zdravljenje redkih bolezni) za zdravljenje sarkoma mehkih tkiv in primarnih malignih kostnih tumorjev.
On 27 November 2012, Merck Sharp & Dohme Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Jenzyl, for the maintenance treatment of patients with metastatic soft tissue sarcoma or bone sarcoma previously treated with chemotherapy.
Družba Merck Sharp & Dohme Limited je dne 27. novembra 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Jenzyl, namenjenim vzdrževalnemu zdravljenju bolnikov z metastatskim sarkomom mehkih tkiv ali kostnim sarkomom, ki so že bili zdravljeni s kemoterapijo.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Jenzyl could not have been approved for the treatment of patients with metastatic soft tissue sarcoma or bone sarcoma as maintenance therapy.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Jenzyl ni mogoče odobriti za vzdrževalno zdravljenje bolnikov z metastatskim sarkomom mehkih tkiv ali kostnim sarkomom.
Jenzyl was expected to be used for the treatment of adults with soft tissue sarcoma (a type of cancer that affects the soft, supporting tissues of the body) or bone sarcoma (bone cancer) that are metastatic (have spread to other parts of the body).
Zdravilo Jenzyl naj bi se uporabljalo za zdravljenje odraslih s sarkomom mehkih tkiv (vrsto raka, ki prizadene mehka vezivna tkiva v telesu) ali kostnim sarkomom (kostnim rakom), ki je metastaziral (se je razširil v druge dele telesa).
In its letter notifying the Agency of the withdrawal of application, the company stated that it decided to withdraw the application since the CHMP considered that the data provided did not allow the Committee to conclude on a positive benefit-risk balance.
Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da se je za umik vloge odločila, ker je CHMP presodil, da predloženi podatki ne dokazujejo pozitivnega razmerja med koristmi in tveganji.
The active substance in Jenzyl, ridaforolimus, blocks the action of an enzyme called ‘mammalian target of rapamycin' (mTOR), which regulates the growth and division of cells in the body and which has increased activity in patients with sarcoma.
Zdravilna učinkovina v zdravilu Jenzyl, ridaforolimus, zavira delovanje encima, imenovanega „tarča rapamicina pri sesalcih” (mTOR), ki uravnava rast in delitev celic v telesu in ki pri bolnikih s sarkomom deluje s povečano aktivnostjo.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Jenzyl did not outweigh its risks.
Zato je CHMP v času umika menil, da koristi zdravila Jenzyl ne odtehtajo z njim povezanih tveganj.
How is Jenzyl expected to work?
Kako naj bi zdravilo Jenzyl delovalo?
The CHMP considered this benefit to be modest, when taking into account that patients usually survived for a long time after their disease had progressed.
Ker so bolniki običajno živeli dolgo časa po tem, ko je bolezen napredovala, je CHMP presodil, da so koristi zdravila majhne.
5 x 2 tablets
5 x 2 tableti
Package sizes perforated unit dose blister (PVC/Alu)
Peroralno Perforiran pretisni omot za enkratni odmerek (PVC/Alu)
Invented name Strength Pharmaceutical form Route of administration Packaging
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
MA (EU) number (Invented) name
Številka (EU)
Route of Administration
dovoljenja za promet
Pack size
Error!
Content (concentration)
(Izmišljeno)
This difference was not statistically significant.
Ta razlika ni bila statistično pomembna.
Therefore, these findings are considered to be incidental.
Iz tega razloga se ta opažanja štejejo za naključna.
The significance for man is unknown.
Pomen tega opažanja za človeka ni znan.
Mice were maintained for an additional 12 weeks.
Miši so opazovali še dodatnih 12 tednov.
This includes studies with immunosuppressive medicinal products.
To vključuje študije z imunosupresivnimi zdravili.
While these changes have tended to improve with time, in some patients they may be permanent.
Čeprav so se te spremembe s časom izboljšale, pa so lahko nekaterih bolnikih trajne.
• if you have previously used this medicine or other similar preparations in a different concentration.
- če ste že kdaj uporabljali to zdravilo ali kakšen drug podoben pripravek drugačne koncentracije.
There is also a possibility that existing inflammation may temporarily worsen.
Obstaja tudi verjetnost začasnega poslabšanja obstoječega vnetja.
This medicine contains 5 mg benzyl alcohol in each sachet.
To zdravilo vsebuje 5 mg benzil alkohola v vsaki vrečki.
Do not use this medicine until your doctor has shown you the right way to use it.
Ne uporabljajte tega zdravila, dokler vam zdravnik ne bo pokazal, kako ga pravilno uporabljamo.
These patients should be monitored under the close supervision of an experienced physician.
Te bolnike je treba spremljati pod skrbnim nadzorom izkušenega zdravnika.
If you go outside during the day use sunscreen and wear protective clothing and a wide-brimmed hat.
Če greste podnevi na prosto, uporabite sončno kremo ter nosite zaščitna oblačila in klobuk s širokimi krajci.
Leave Zyclara on the skin for about 8 hours.
Pustite zdravilo Zyclara na koži približno 8 ur.
Frequencies are defined as:
Pogostnost neželenih učinkov je definirana kot:
It is the lead compound of the imidazoline family.
Je vodilna spojina družine imidazolinov.
- if you are allergic to imiquimod or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na imikvimod ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
These local skin reactions may be related to the stimulation of local immune response.
Te lokalne kožne reakcije so lahko povezane s stimulacijo lokalnega imunskega odziva.
This medicine should not be given to children below the age of 18 years because the safety and efficacy in patients below the age of 18 years have not been established.
Tega zdravila ne smemo dati otrokom, starim do 18 let, ker varnost in učinkovitost pri bolnikih, starih do 18 let, še nista bili dokazani.
Follow-up information suggests that these skin colour changes may be permanent in some patients.
Spremljanje podatkov nakazuje, da so lahko te spremembe barve kože pri nekaterih bolnikih trajne.
Management of overdose should consist of treatment of clinical symptoms.
Zdravljenje prevelikega odmerjanja mora vsebovati zdravljenje kliničnih simptomov.
This medicine stimulates your body's own immune system to produce natural substances which help fight your actinic keratosis.
To zdravilo spodbuja vaš imunski sistem, da proizvaja naravne snovi, ki pomagajo v boju proti aktinični keratozi.
These areas can be the same colour as your skin or are greyish, pink, red or brown.
Ta področja so lahko enake barve kot koža ali pa sivkaste, rožnate ali rjave barve.
White to faintly yellow cream with a uniform appearance.
krema Bela do bledo rumena krema z enotnim videzom.
He may advise you to stop applying this medicine for a few days (i.e. to have a short rest from treatment).
Morda vam bo priporočil, da prekinete uporabo tega zdravila za nekaj dni (t.j.
Fertility No clinical data are available, potential risk for human is unknown.
Plodnost Kliničnih podatkov ni na voljo, morebitno tveganje za ljudi je neznano.
Studies in animals do not indicate direct or indirect harmful effects in pregnancy.
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov med nosečnostjo.
Your doctor will discuss the risks and benefits of using Zyclara during pregnancy.
Zdravnik se bo z vami pogovoril glede tveganj in koristi uporabe zdravila Zyclara med nosečnostjo.
Excipients with known effects:
Pomožne snovi z znanim učinkom:
These reductions are not considered to be clinically significant in patients with normal haematologic reserve.
Ta zmanjšanja se ne štejejo za klinično pomembna pri bolnikih z normalnimi hematološkimi vrednostmi.
In some individuals a lowering of blood counts was noted (frequency not known).
Pri nekaterih posameznikih so opazili zmanjšanje števila krvnih celic (neznana pogostnost).
Hypopigmentation and hyperpigmentation
Hipopigmentacija in hiperpigmentacija
Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use, antivirals, ATC Code: D06BB10
Farmakoterapevtska skupina: antibiotiki in kemoterapevtiki za uporabo v dermatologiji, protivirusna zdravila, oznaka ATC: D06BB10
Date of first authorisation: 23/08/2012 Date of latest renewal: 22/03/2017
Datum prve odobritve: 23.08.2012 Datum zadnjega podaljšanja: 22.03.2017
• if you have an abnormal blood count.
- če imate nenormalno krvno sliko.
• if you have problems with your immune system or if you take medicine to suppress your immune system (e.g. after an organ transplant).
- če imate težave z vašim imunskim sistemom ali če jemljete zdravila za zaviranje odziva imunskega sistema (npr. po presaditvi organa).
• Only use the cream externally (on the skin of face or scalp).
- Krema je namenjena samo za zunanjo uporabo (na koži obraza ali na lasišču).
What Zyclara is and what it is used for
Kaj je zdravilo Zyclara in za kaj ga uporabljamo
Zyclara should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Zdravilo Zyclara se lahko uporablja med nosečnostjo le če morebitna korist upravičuje morebitno tveganje za plod.
It is not known whether imiquimod passes into breast milk.
Ni znano, ali imikvimod prehaja v materino mleko.
The clinical outcome of therapy has to be determined after regeneration of the treated skin, approximately 8 weeks after the end of treatment and on appropriate intervals thereafter based on clinical judgment.
Klinični izid zdravljenja je treba oceniti po regeneraciji zdravljene kože, približno 8 tednov po končanem zdravljenju in ob primernih časovnih presledkih na osnovi klinične presoje.